DETAILED ACTION
This Final Office Action is responsive to the claims filed on December 22, 2025. Claims 1-20 are under examination.
The drawings are objected you.
The specification is object
Claims 1-20 are rejected under 35 USC 112(b).
Claims 1-20 are rejected under 35 USC 101.
Claims 1-10, 12, and 17-20 are rejected under 35 USC 102 as anticipated by Perrin.
Claim 11 is rejected under 35 USC 103 over Perrin in view of Moatamedi.
Claims 13-15 are rejected under 35 USC 103 over Perrin in view of Arthur.
Claim 16 is rejected under 35 USC 103 over Perrin in view of Boston Scientific.
Response to Arguments
Objection To Abstract: The amendments and arguments have been considered and are persuasive. The objection is withdrawn.
Objections To Claims: The amendments and arguments have been considered and are persuasive. The objections are withdrawn.
35 USC 112(f) Interpretation: The amendments and arguments have been considered and are persuasive. The interpretation is withdrawn.
35 USC 112(b) Rejections: The amendments and arguments have been considered and are persuasive. The rejections are withdrawn.
35 USC 101 Rejections: Regarding the rejection of claim 19 as not being one of the four statutory categories, the amendments and arguments have been considered and are convincing. Those rejections are withdrawn. Regarding the remaining eligibility rejections, the amendments and arguments have been considered but are unpersuasive. The following are responses to the Applicant’s assertions in the order presented in the Applicant’s response.
The Claims Allegedly Do Not Recite A Mathematical Concept: The Applicant attempts to rely on the notion that if a claim does not explicitly recite a specific mathematical relationship that the claim does not recite a mathematical concept. The Applicant fails to appreciate that the choice of words of the claim is not dispositive of whether a mathematical concept is recited. First of all, the Applicant specific recites “calculate” and derivatives thereof as the actions taken in the claim. Were the Applicant to state otherwise, it would likely be new matter. However, even the recitation of calculation on its own is not dispositive. The question is whether the language used in the claim is a placeholder for mathematical concepts as expressed in the specification. The use of the term calculate and its derivatives provides a presumption that the step is a calculation unless the specification dispels this. However, when looking at the specification and the dependent claims to provide context, several determinations include “calculating […] as a function of […].” A function, as used in the claims and the specification, is a mathematical concept. Accordingly, the claims not only use presumed mathematical language, “calculate” and its derivatives, but also demonstrates that the calculations are functions. Accordingly, regardless of how the Applicant amends the claims, these operations, if claimed at all, will be construed as reciting mathematical concepts. The Applicant is invited to remove these operations by amendment, provided the operations are not considered essential to the invention.
The Claims Allegedly Do Not Recite A Mental Process: The Applicant generically restates all of the elements of the claim and asserts, without any reasoning to rebut the reasoning provided in the Non-Final Office Action, that the elements cannot be practically performed in the mind or with the aid of pen and paper. The Applicant then states that “[i]n particular a three-dimensional numerical model of a natural cavity of a patient, as recited in amended claim 1, includes a “discretized three-dimensional surface which approximates the real wall of the artery” and is therefor not an abstract dataset. That which the data represents is not dispositive of the inquiry. The determination of whether a claim recites a mental process does not rely on that which input and output data represent. Specifically, MPEP 2106.05(h) is specifically invoked to avoid merely limiting the abstract idea to a particular technological environment. None of these arguments respond to the specific allegations of the elements that are designated in the Office Action as being a mental process.
The Claims Allegedly Integrate The Judicial Exception By Improving The Computer: The Applicant cites the Applicant’s specification paragraphs [0002]-[0005] and [0014]-[0016] to demonstrate a problem with simulation. The problems expressed have to do with the manipulation of the calculations used to make a determination, but these represent improvements to the math and methods performed by the computer rather than HOW the computer processes them. Any improvement, if present in the claim, would represent improved math, which fails to confer eligibility under SAP v. InvestPic and Parker v. Flook.
In order to integrate the abstract idea into a practical application, the Applicant must demonstrate the existence of additional limitations in the claim that participate in some way in integrating the abstract idea into a practical application. The Applicant has failed to identify a single additional limitation and has also failed to demonstrate how the unidentified additional limitation participates in this integration. The Applicant cannot integrate the abstract idea into the practical application using the abstract idea itself. Accordingly, the Applicant has failed to rebut the assertion in the Office Action that the claims are directed to an abstract idea.
The Claims Allegedly Recite Significantly More Than The Abstract Idea: The Applicant merely restates the elements of the claims and states that these steps generically represent an inventive concept. However, the Applicant has failed to identify any additional limitations or how those additional limitations combine with the other elements of the claims to provide significantly more than the abstract idea. Again, the claimed improvement over the art, if any, resides entirely within the abstract idea. The Applicant cannot maintain that the claim provides significantly more than the abstract idea if the Applicant fails to identify a single additional limitation and describe how that additional limitations combines with the abstract idea to provide significantly more than the abstract idea that would confer an inventive concept. Even if, arguendo, the claims recited an inventive concept, if the inventive concept is entirely contained within the abstract idea, this is insufficient to provide significantly more THAN THE ABSTRACT IDEA.
The Applicant’s amendments and arguments are unpersuasive. The rejections are maintained.
Art Rejections: The Applicant argues that the claims as amended recite “calculating a predictive local apposition.” The Applicant then refers to the Perrin reference, stating that the reference merely discloses “contacts were modeled using the general penalty algorithm implemented in Abaqus, with standard Coulomb friction law.” Without even looking to the reference with this quote, the Applicant has demonstrated that the Perrin reference demonstrates calculating apposition in the form of a friction determination. Contrary to the assertions of the Applicant, this alleged quotation from the prior art reference teaches the modeling of the apposition force by calculating friction. This is further confirmed by the recitations in the Applicant’s claim 12 and the Applicant’s Specification, Page 20, Lines 15-32, which calculate friction for this purpose. Accordingly, the art rejections are maintained.
Drawing Objections
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following must be shown or the feature(s) canceled from the claim(s):
Claim 1:
“three-dimensional apexes”
The claimed mechanical equilibrium state as opposed to the relaxing state, and the intermediate deformation state
The relaxing state as opposed to the rest state and the equilibrium state
The equilibrium state, as opposed to the final state
FIG. 2 illustrates a determination 300a of an intermediate deformation state that includes the return to rest of the wall model 303 and a subsequent calculation 400 of a mechanical equilibrium of the cage. However, in claim 1, the relaxing step is provided as an element of the calculating a mechanical equilibrium state.
Claim 9:
“a first diameter or thickness” “a slenderness coefficient” “a first gyration radius” (and second equivalents in the next element)
Claim 11:
“field of displacements […] and rotations”
Claim 13
“a general shape of the IMD being flattened at a level of the at least one end pole.”
Claim 14
“a first concavity” and “a second concavity”
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification Objections
The specification at Pages 19-20, among other places in the specification, discusses using “the fundamental dynamic principle” and “the fundamental static principle.” It is not universally known in the art how these principles would apply to the determinations in the specification. This lack of clarity makes it difficult to examine the claim features that the specification states involves using “the fundamental dynamic principle” and “the fundamental static principle.” The Applicant must resolve this by clarification with subject matter from the specification without adding new matter.
Claim Rejections - 35 USC § 112
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 1-20 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.
Wall Models
Claim 1 recites “from a numerical model of a wall of the natural cavity” in the preamble and “a wall model” in the body of the claim. It is unclear what the relationship is between these claimed walls. For purposes of examination, the walls will be construed as a single wall of the natural cavity. Appropriate correction is still required.
Calculating […] Comprising […] Relaxing
The Applicant’s claim 1 recites, “ii. calculating a mechanical equilibrium state of the numerical IMD starting from the intermediate deformation state, comprising: […] relaxing of said mechanical stresses.” It is unclear from the claim how relaxing the mechanical stresses is an element of the calculation of a mechanical equilibrium state.
Apexes
Claim 1 recites “three-dimensional apexes of the numerical IMD on the wall model. “Apex” is a relative term of degree, represent a maximal value relative to some other metric. The Applicant has provided no standard as to what represents an apex, especially as it would relative to nodes. Accordingly, a person of ordinary skill in the art would not be able to discern the metes and bounds of the claims.
Corresponds To
Claim 1 recites, “wherein the calculated mechanical equilibrium state corresponds to the simulated deformation of the IMD after implantation.” It is unclear what “corresponds to” means. Accordingly, a person of ordinary skill in the art would not be able to discern the metes and bounds of the claims.
Integrating
Claim 5 recites, “integrating, in the wall model, the numerical IMD confined in the tool surface in order to obtain the intermediate deformation state.” It is unclear how the numerical IMD can be simultaneously confined in the tool surface and also be integrated into the wall model. Accordingly, a person of ordinary skill in the art would not be able to discern the metes and bounds of the claims.
General… Flattened Shape
Claim 13 recites, “a general shape of the IMD being flattened at a level of the at least one end pole. “General” and “flattened” are both relative terms of degree for which the specification fails to provide an objective standard. Accordingly, a person of ordinary skill in the art would not be able to discern the metes and bounds of the claims.
Repeated or Overlapping Steps
Claim 20 recites, “determine an intermediate deformation state wherein the numerical IMD is deformed as a function of a shape of a wall model, while remaining included in said shape, calculate a mechanical equilibrium state of the numerical IMD as a function of a mechanical behaviour of the numerical IMD and a mechanical behaviour of the wall model,” with many instances of primary antecedence. However, claim 1 includes similar steps, also with primary antecedence, so it is unclear how the steps of claim 20 interact with the analogous steps of claim 1. For example, are these the same steps, or are they repeated.
Dependent claims dependent from rejected independent claims are rejected based on their dependency.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected as directed to an abstract idea without significantly more.
Subject Matter Eligibility
Independent Claim
Step 1
Claim 1 is a process.
Step 2A, Prong 1
Claim 1 recites mental processes and mathematical concepts.
Specifically, claim 1 recites (claim language in bold italics, references are to the Applicant’s published application US 2022/0367047 A1):
A method for simulating a deformation, after implantation, of an implantable medical device, called IMD, in a natural cavity, from a patient from a three-dimensional numerical model of a wall of the natural cavity, the method comprising the following steps implemented […]: (Evaluation – Mental process practically performable in the mind or with aid of pen, paper, or calculator; Mathematical Calculation – Mathematical Concept [0024] “The determination of the intermediate deformation state, before calculating a mechanical equilibrium state, makes it possible to simplify the calculation of the mechanical equilibrium because it provides an efficient initialisation of said calculation.”)
i. determining an intermediate deformation state of a numerical IMD representing the IMD, the numerical IMD at the intermediate deformation state being deformed according to geometry of a wall model while remaining fully included within that geometry, (Evaluation – Mental process practically performable in the mind or with aid of pen, paper, or calculator; Mathematical Calculation – Mathematical Concept [0103] “For the later calculation of the intermediate deformation state and for the calculation of the mechanical equilibrium, it is not necessary that the processing unit 20 has at its disposal a physical model of the mechanical behaviour of the elements of the wall model 1. A geometric representation of the surface of the wall model 1 may suffice.” - The determination of the intermediate deformation state is a calculation according to the specification. A calculation is an evaluation, which is a mental process. A calculation is also a mathematical concept.”)
ii. calculating a mechanical equilibrium state of the numerical IMD starting from the intermediate deformation state, comprising: calculating mechanical stresses applied to the numerical IMD in the intermediate deformation state, these mechanical stresses depending on a mechanical behaviour of the numerical IMD and a mechanical behaviour of the three-dimensional numerical model of the wall of the natural cavity, and relaxing of said mechanical stresses, (Evaluation – Mental process practically performable in the mind or with aid of pen, paper, or calculator; Mathematical Calculation – Mathematical Concept [0103] “For the later calculation of the intermediate deformation state and for the calculation of the mechanical equilibrium, it is not necessary that the processing unit 20 has at its disposal a physical model of the mechanical behaviour of the elements of the wall model 1. A geometric representation of the surface of the wall model 1 may suffice.” - The determination of the intermediate deformation state is a calculation according to the specification. A calculation is an evaluation, which is a mental process. A calculation is also a mathematical concept.)
iii. calculating a predictive local apposition of at least one part of three-dimensional apexes of the numerical IMD on the wall model, wherein a mechanical behaviour of the numerical IMD, during determining the intermediate deformation state is not identical to the mechanical behaviour of the numerical IMD, during calculating the mechanical equilibrium state, a rest state of the numerical IMD during determining the intermediate deformation state is not identical to a rest state of the numerical IMD during calculating the mechanical equilibrium state, and wherein the calculated mechanical equilibrium state corresponds to the simulated deformation of the IMD after implantation, and (Evaluation – Mental process practically performable in the mind or with aid of pen, paper, or calculator; Mathematical Calculation – Mathematical Concept - The calculation of the predictive local apposition is a calculation according to the specification. A calculation is an evaluation, which is a mental process. A calculation is also a mathematical concept.)
iv. predicting a final state of the IMD in the natural cavity from the calculated mechanical equilibrium state and the predictive local apposition, the final state being usable for optimizing an implantation procedure. (Evaluation – predicting a final state based on a model is a mental process practically performable in the mind or with aid of pen, paper, or calculator.)
Claim 1 recites a mental process and a mathematical concept, which are abstract ideas under MPEP 2106.04(a)(2)(III) and MPEP 2106.04(a)(2)(I).
Claim 1 recites an abstract idea.
Step 2A, Prong 2
Claim 1 fails to recite any additional limitations that integrate the abstract idea into a particular application.
Claim 1 recites the following additional limitations:
by a processing unit:
The claimed implementation by a processing unit is a generic computer implementation, a recitation of a general-purpose computer with no specific configurations to execute the claimed method. As such, the computer implementation implements the recited abstract idea on a generic computer, and, under MPEP 2106.05(f), does not integrate the abstract idea into a practical application at Step 2A, Prong Two.
numerical IMD
a three-dimensional numerical model of a wall of the cavity […] wall model
Should it be found that the models used are other than abstract ideas, the numerical model and three-dimensional numerical model of a wall of the cavity (i.e., the wall model) are generic computing elements that merely state at a general level that which is being modeled, an “apply it” construct of generic computer modeling. Because these are generic computer elements under MPEP 2106.05(f), they also fail to integrate the abstract idea into a practical application. Further, the types of models merely limit the abstract idea to a particular field of medical technology and fail to integrate the abstract idea into a practical application under MPEP 2106.05(h).
Accordingly, claim 1 fails to recite any additional limitations that integrate the abstract idea into a practical application at step 2A, Prong 2.
Claim 1 is directed to the abstract idea.
Step 2b
Claim 1 fails to provide any additional limitations that combine with the other elements of the claims to provide significantly more than the abstract idea that would confer an inventive concept.
Claim 1 recites the following additional limitations:
a processing unit:
The claimed implementation by a processing unit is a generic computer implementation, a recitation of a general-purpose computer with no specific configurations to execute the claimed method. As such, the computer implementation implements the recited abstract idea on a generic computer, and, under MPEP 2106.05(f), does not combine with the other elements of the claims to provide significantly more than the abstract idea that would confer an inventive concept at Step 2B.
numerical IMD
a three-dimensional numerical model of a wall of the cavity […] wall model
Should it be found that the models used are other than abstract ideas, the numerical model and three-dimensional numerical model of a wall of the cavity (i.e., the wall model) are generic computing elements that merely state at a general level that which is being modeled, an “apply it” construct of generic computer modeling. Because these are generic computer elements under MPEP 2106.05(f), they also fail to combine with the other elements of the claims to provide significantly more than the abstract idea that would confer an inventive concept. Further, the types of models merely limit the abstract idea to a particular field of medical technology and fail to combine with the other elements of the claims to provide significantly more than the abstract idea that would confer an inventive concept under MPEP 2106.05(h).
Accordingly, claim 1 fails to recite any additional limitations that combine with the other elements of the claims to provide significantly more than the abstract idea that would confer an inventive concept at step 2B.
Claim 1 is ineligible.
Dependent Claims
Claim 2
wherein the intermediate deformation state is determined as a function of contact interactions calculated between three- dimensional apexes of the IMD and three-dimensional apexes of the wall model.
This merely qualifies the abstract idea of the determining an intermediate deformation step, so it is an element of the abstract idea. This does not provide any additional limitations to confer eligibility at Step 2A, Prong 2 or at Step 2B.
Should it be found that the calculation of interaction between three-dimensional apexes of the IMD and the wall model is somehow other than an abstract idea, for example by virtue of them being interactions of elements of three dimensional models, the models, their apexes, and the interactions therebetween are generic computing elements recited at a high level as to recite “apply it” with generic computational models, which fails to confer eligibility under MPEP 2106.05(f). Should it be found otherwise, the models, their apexes, and the interactions therebetween merely limit the abstract idea to a particular medical technological environment or to a three-dimensional interaction modeling technological environment, which fails to confer eligibility under MPEP 2106.05(h).
Claim 2 is ineligible.
Claim 3
wherein the mechanical behaviour of the wall model for the calculation of a mechanical equilibrium state is a non-deformable rigid behaviour.
This merely describes a parameter of the elements of the abstract idea and is therefore an element of the abstract idea. Therefore, it fails to provide any additional limitations to confer eligibility.
Should it be found that the property of the wall model is other than an abstract idea, the property of the wall model merely limits the abstract idea to a particular field of medical modeling of cavities that are rigid and do not move when flexible elements are implanted, which fails to confer eligibility under MPEP 2106.05(h).
Claim 3 is ineligible.
Claim 4
wherein, during the determination of the intermediate deformation state, the wall model is deformed geometrically from an initial state so as to contain wholly the numerical IMD in a rest state of the numerical IMD, the wall model next being brought back to the initial state to obtain the intermediate deformation state of the numerical IMD.
This merely qualifies the evaluation of the determining an intermediate deformation state of claim 1, which is an element of the abstract idea. Therefore, this claim is an element of the abstract idea. Accordingly, claim 4 fails to recite any additional limitations that could confer eligibility.
Claim 4 is ineligible.
Claim 5
wherein determining the intermediate deformation state comprises:
- obtaining a numerical IMD confined in a tool surface associated with a model of implantation tool,
- integrating, in the wall model, the numerical IMD confined in the tool surface in order to obtain the intermediate deformation state.
This merely describes the sequence being simulated, which is an element of the evaluation, the mental process, the abstract idea. Accordingly, these steps are elements of the abstract idea. Because claim 5 merely provides elements of the abstract idea, claim 5 fails to provide any additional limitations that could confer eligibility at Step 2A, Prong 2 or at Step 2B.
Claim 5 is ineligible.
Claim 6
further comprising determining a central line of the natural cavity, from the wall model, and wherein the numerical IMD is deformed in a course of its integration so as to follow the central line.
The added determining step is merely an evaluation, a mental process, an abstract idea, that combines with the other elements of the abstract idea. Similarly, the wherein clause merely qualifies the other steps from claim 1, which are also abstract ideas. Claim 6 merely adds elements of the abstract idea and fails to provide any additional limitations that could confer eligibility at Step 2A, Prong 2 or Step 2B.
Claim 6 is ineligible.
Claim 7
wherein the numerical IMD comprises a plurality of segments and further comprises a plurality of nodes, each node connecting ends of two consecutive segments.
This merely qualifies the simulated mathematical structure of the numerical IMD, which is an element of the abstract idea. Accordingly, the features of claim 7 are elements of the abstract idea and fail to provide any additional limitations to confer eligibility at Step 2A, Prong 2 and Step 2B.
Should it be found otherwise, the model and its structure are generic computer modeling elements recited at a high level and do not confer eligibility as additional elements under MPEP 2106.05(f) at Step 2A, Prong 2 and Step 2B.
Should it be found otherwise, the models and structures merely limit the abstract idea to a particular technological environment of modeling real world elements and/or doing so in a medical context, which fails to confer eligibility as an additional limitation under MPEP 2106.05(h) at Step 2A, Prong 2 and Step 2B.
Claim 7 is ineligible.
Claim 8
wherein the mechanical behaviour of at least one segment corresponds to a behaviour of a beam.
This merely qualifies the simulated mathematical structure of the numerical IMD, which is an element of the abstract idea. Accordingly, the features of claim 8 are elements of the abstract idea and fail to provide any additional limitations to confer eligibility at Step 2A, Prong 2 and Step 2B.
Should it be found otherwise, the model and its structure are generic computer modeling elements recited at a high level and do not confer eligibility as additional elements under MPEP 2106.05(f) at Step 2A, Prong 2 and Step 2B.
Should it be found otherwise, the models and structures merely limit the abstract idea to a particular technological environment of modeling real world elements and/or doing so in a medical context, which fails to confer eligibility as an additional limitation under MPEP 2106.05(h) at Step 2A, Prong 2 and Step 2B.
Claim 8 is ineligible.
Claim 9
wherein at least one segment of the numerical IMD having a beam mechanical behaviour is modelled during the determination of the intermediate deformation state with a first diameter, and/or with a first thickness, and/or with a first elasticity modulus, and/or with a first slenderness coefficient, and/or with a first gyration radius, and/or with a first set of critical instability loads, and
wherein the at least one segment is modelled during the calculation of the mechanical equilibrium state respectively with a different second diameter, and/or a different second thickness, and/or a different second elasticity modulus, and/or a different second slenderness coefficient, and/or a different second gyration radius, and/or a different second set of critical instability loads.
These wherein clauses merely qualify the simulated mathematical structure and evaluation method of the numerical IMD, which is an element of the abstract idea. Accordingly, the features of claim 9 are elements of the abstract idea and fail to provide any additional limitations to confer eligibility at Step 2A, Prong 2 and Step 2B.
Should it be found otherwise, the model and its structure are generic computer modeling elements recited at a high level and do not confer eligibility as additional elements under MPEP 2106.05(f) at Step 2A, Prong 2 and Step 2B.
Should it be found otherwise, the models and structures merely limit the abstract idea to a particular technological environment of modeling real world elements and/or doing so in a medical context, which fails to confer eligibility as an additional limitation under MPEP 2106.05(h) at Step 2A, Prong 2 and Step 2B.
Claim 9 is ineligible.
Claim 10
wherein the mechanical behaviour of at least one node corresponds to a behaviour of a swivel.
This merely qualifies the simulated mathematical structure of the numerical IMD, which is an element of the abstract idea. Accordingly, the features of claim 10 are elements of the abstract idea and fail to provide any additional limitations to confer eligibility at Step 2A, Prong 2 and Step 2B.
Should it be found otherwise, the model and its structure are generic computer modeling elements recited at a high level and do not confer eligibility as additional elements under MPEP 2106.05(f) at Step 2A, Prong 2 and Step 2B.
Should it be found otherwise, the models and structures merely limit the abstract idea to a particular technological environment of modeling real world elements and/or doing so in a medical context, which fails to confer eligibility as an additional limitation under MPEP 2106.05(h) at Step 2A, Prong 2 and Step 2B.
Claim 10 fails to provide any additional limitations that confer eligibility at Step 2A, Prong 2 or Step 2B.
Claim 10 is ineligible.
Claim 11
wherein the calculation (100) of the mechanical equilibrium state of the numerical IMD comprises the calculation of a field of displacements Dxi, Dyi, Dzi and a field of rotations Rxi, Ryi, Rzi of each node i of the numerical IMD in a three-dimensional frame of reference linked to the wall model.
It’s anyone’s guess what the fundamental dynamic principle is (maybe the fundamental principle of dynamics, which is Newton’s second law, which is essentially F=MA, a mathematical calculation), but this explicitly states that the calculating step of claim 1 is further qualified with further calculations, which are evaluations, mental processes practically performable in the mind or with the aid of pen, paper, or a calculator, and are mathematical calculations, which are mathematical concepts. Mental processes and mathematical concepts are abstract ideas. Therefore, the elements of claim 11 are abstract ideas that merge with the abstract ideas of the claims on which claim 11 depends.
Claim 11 fails to provide any additional limitations that would confer eligibility at Step 2A, Prong 2 and Step 2B.
Claim 11 is ineligible.
Claim 12
wherein the calculation of the mechanical equilibrium state of the numerical IMD comprises, for at least one node of the numerical IMD, a calculation of a normal force, a friction force, or both applied by the wall model on the at least one node, modelling a penetration resistance of the wall based at least in part on the normal force and the friction between the IMD and the wall based at least in part on the friction force, or both.
This explicitly states that the calculating step of claim 1 is further qualified with further calculations, which are evaluations, mental processes practically performable in the mind or with the aid of pen, paper, or a calculator, and are mathematical calculations, which are mathematical concepts. Mental processes and mathematical concepts are abstract ideas. Therefore, the elements of claim 12 are abstract ideas that merge with the abstract ideas of the claims on which claim 12 depends.
Claim 12 fails to provide any additional limitations that would confer eligibility at Step 2A, Prong 2 and Step 2B.
Claim 12 is ineligible.
Claim 13
wherein the plurality of segments and the plurality of nodes of the numerical IMD have at least one end pole, a general shape of the IMD being flattened at a level of the at least one end pole.
This merely qualifies the simulated mathematical structure of the numerical IMD, which is an element of the abstract idea. Accordingly, the features of claim 13 are elements of the abstract idea and fail to provide any additional limitations to confer eligibility at Step 2A, Prong 2 and Step 2B.
Should it be found otherwise, the model and its structure are generic computer modeling elements recited at a high level and do not confer eligibility as additional elements under MPEP 2106.05(f) at Step 2A, Prong 2 and Step 2B.
Should it be found otherwise, the models and structures merely limit the abstract idea to a particular technological environment of modeling real world elements and/or doing so in a medical context, which fails to confer eligibility as an additional limitation under MPEP 2106.05(h) at Step 2A, Prong 2 and Step 2B.
Claim 13 fails to provide any additional limitations that confer eligibility at Step 2A, Prong 2 or Step 2B.
Claim 13 is ineligible.
Claim 14
wherein the at least one end pole is modelled with a first concavity during the determination of the intermediate deformation state and is modelled with a second concavity different from the first concavity during the calculation of the mechanical equilibrium state.
This merely qualifies the simulated mathematical structure of the numerical IMD, which is an element of the abstract idea. Accordingly, the features of claim 14 are elements of the abstract idea and fail to provide any additional limitations to confer eligibility at Step 2A, Prong 2 and Step 2B.
Should it be found otherwise, the model and its structure are generic computer modeling elements recited at a high level and do not confer eligibility as additional elements under MPEP 2106.05(f) at Step 2A, Prong 2 and Step 2B.
Should it be found otherwise, the models and structures merely limit the abstract idea to a particular technological environment of modeling real world elements and/or doing so in a medical context, which fails to confer eligibility as an additional limitation under MPEP 2106.05(h) at Step 2A, Prong 2 and Step 2B.
Claim 14 fails to provide any additional limitations that confer eligibility at Step 2A, Prong 2 or Step 2B.
Claim 14 is ineligible.
Claim 15
wherein the numerical IMD is a model of an intrasaccular cage.
Claim 15 merely qualifies elements of the abstract idea and is, therefore, an element of the abstract idea. Accordingly, claim 15 fails to provide any additional limitations that could confer eligibility at Step 2A Prong 2 and Step 2B.
Should it be found otherwise, this merely limits the abstract idea to a particular technological field, which is medical technology. Therefore, under MPEP 2106.05(h), it fails to provide an additional limitation that confers eligibility at Step 2A, Prong 2 and Step 2B.
Claim 15 fails to provide any additional limitations that confer eligibility at Step 2A, Prong 2 or Step 2B.
Claim 15 is ineligible.
Claim 16
wherein the numerical IMD is a model of a laser-cut stent.
Claim 16 merely qualifies elements of the abstract idea and is, therefore, an element of the abstract idea. Accordingly, claim 16 fails to provide any additional limitations that could confer eligibility at Step 2A Prong 2 and Step 2B.
Should it be found otherwise, this merely limits the abstract idea to a particular technological field, which is medical technology. Therefore, under MPEP 2106.05(h), it fails to provide an additional limitation that confers eligibility at Step 2A, Prong 2 and Step 2B.
Claim 16 fails to provide any additional limitations that confer eligibility at Step 2A, Prong 2 or Step 2B.
Claim 16 is ineligible.
Claim 17
wherein at step iii. calculating the predictive local apposition is for a plurality of nodes of the numerical IMD on the wall model.
This explicitly recites calculations, which are evaluations, mental processes practically performable in the mind or with the aid of pen, paper, or a calculator, and are mathematical calculations, which are mathematical concepts. Mental processes and mathematical concepts are abstract ideas. Therefore, the elements of claim 17 are abstract ideas that merge with the abstract ideas of the claims on which claim 17 depends.
Claim 17 fails to provide any additional limitations that would confer eligibility at Step 2A, Prong 2 and Step 2B.
Claim 17 is ineligible.
Claim 18
wherein the numerical IMD corresponds to an IMD reference derived from a set of IMD references recorded in a database,
This is mere data gathering, which is insignificant extra-solution activity under MPEP 2106.05(g), so it does not integrate the abstract idea into a practical application at Step 2A, Prong 2. This is also well-understood, routine, and conventional (WURC) activity under MPEP 2106.05(d) as in the following cited examples: “i. Receiving or transmitting data over a network,” “iii. Electronic recordkeeping,” “iv. Storing and retrieving information in memory,” and “vi. Arranging a hierarchy of groups, sorting information, eliminating less restrictive pricing information and determining the price.” Because the wherein clause represents WURC activity and insignificant extra-solution activity, under MPEP 2106.05(d) and 2106.05(g), respectively, the wherein clause fails to combine with other elements of the claim to provide significantly more than the abstract idea that would confer an inventive concept at Step 2B.)
steps i., ii. and iii. being repeated for each reference of the set of IMD references.
This is merely a repetition of the steps indicated to be elements that provide an abstract idea and fail to provide additional limitations that confer eligibility with respect to the abstract idea for the reasons described with respect to claims 1 and 17.
Accordingly, claim 18 fails to provide any additional limitations that confer eligibility at Step 2A, Prong 2, and Step 2B.
Claim 18 is ineligible.
Claim 19
A non-transitory computer program product comprising code instructions for an implementation of the simulation method according to claim 1, when said code instructions are executed by a processing unit.
The computer program product and the execution by a processing unit merely describe a generic computer implementation, which, under MPEP 2106.05(f) fail to provide additional limitations that would confer eligibility at Step 2A, Prong 2 and Step 2B.
The elements of claim 1 are ineligible for the reasons stated.
Accordingly, claim 19 fails to provide any additional limitations that confer eligibility at Step 2A, Prong 2, and Step 2B.
Claim 19 is ineligible.
Claim 20
a computing device comprising a processor and a memory; and machine readable instructions stored in the memory that, when executed by the processor, cause the computing device to at least:
These are generic computing elements recited at a high level which fail to confer eligibility under MPEP 2106.05(f).
obtain a three-dimensional wall model of a natural cavity, obtain a numerical IMD, wherein the numerical IMD is generated in accordance with an IMD reference derived from a database,
These steps are insignificant extra-solution activity (e.g., mere data gathering in MPEP 2106.05(g)) and well-understood, routine, and conventional (WURC) activity (e.g., similar to the MPEP 2106.05(d) examples: “i. Receiving or transmitting data over a network” “iii. Electronic recordkeeping” “iv. Storing and retrieving information in memory” “vi. Arranging a hierarchy of groups, sorting information, eliminating less restrictive pricing information and determining the price”), so they fail to confer eligibility under MPEP 2106.05(g) and 2106.05(d).
determine an intermediate deformation state wherein the numerical IMD is deformed as a function of a shape of a wall model, while remaining included in said shape, calculate a mechanical equilibrium state of the numerical IMD as a function of a mechanical behaviour of the numerical IMD and a mechanical behaviour of the wall model, and
These are mental processes and mathematical concepts for the at least the same reasons as the elements of claim 1.
implement the method of claim 1.
The implementation of the features of claim 1 is ineligible for reasons described with respect to claim 1.
Accordingly, claim 20 fails to provide any additional limitations that confer eligibility at Step 2A, Prong 2, and Step 2B.
Claim 20 is ineligible.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claims 1-10, 12, and 17-20: Perrin
Claim(s) 1-10, 12, and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NPL: “Patient-specific numerical simulation of stent-graft deployment: Validation on three clinical cases” by Perrin et al. (Perrin).
Claim 1
Regarding claim 1, Perrin teaches:
A method for simulating a deformation, after implantation, of an implantable medical device, called IMD, in a natural cavity of a patient, from a three-dimensional numerical model of a wall of the natural cavity, the method comprising the following steps implemented by a processing unit: (Perrin Abstract “The purpose of this work is therefore to develop a new numerical methodology to predict stent-graft final deployed shapes after surgery. The simulation process was applied on three clinical cases, using pre-operative scans to generate patient-specific vessel models.” – A natural cavity is modeled. Page 1869, 2.2 “Surgery oriented Endosizes software (Therenva, France) was used to extract aortic and iliac vessel centerlines and vascular lumen contours from pre-operative scans (Kaladji et al., 2013). […] The continuous geometry of lumen surface was generated by surface interpolation driven by the B-splines in ANSYS Design Modeler software (ANSYS, Inc., Canonsburg, PA). The arterial lumen surface was then meshed […] 3D pre-operative scans (A) and corresponding triangular meshes (B) are shown in Fig. 1.” – The natural cavity is simulated in 3D. Pages 3-4, 2.4 “The main body, the iliac limbs and extensions were first compressed radially (slight crimping stage) and assembled (Fig. 2A). Then, the assembled SG was inserted inside a virtual tubular shell (Fig. 2B). From this configuration, proper displacements were prescribed onto the nodes of the virtual shell to morph its geometry onto the pre-operative geometry of the patient's aneurysm while prescribing contact to maintain the SG inside the shell.” – The deformation by the stent is modeled in this simulation. Page 1871, Left Column, Second Paragraph “The FE simulations were run on 12 CPUs computers, 2.66 GHz, 24 GB RAM.”)
i. determining an intermediate deformation state of a numerical IMD representing the IMD, the numerical IMD at the intermediate deformation state being deformed according to a geometry of a wall model while remaining fully included within that geometry, (Perrin Page 1870-1871, 2.4 “Then, the assembled SG was inserted inside a virtual tubular shell (Fig. 2B). From this configuration, proper displacements were prescribed onto the nodes of the virtual shell to morph its geometry onto the pre-operative geometry of the patient's aneurysm while prescribing contact to maintain the SG inside the shell. Note that, during this step, the shell did not present any mechanical behavior and only acted as a geometrical constraint. At the end of this step, the deployment of the SG inside the pre-operative geometry of the AAA was simulated (Fig. 2C).” – The simulation is done through an intermediate deformation state. )
ii. calculating a mechanical equilibrium state of the numerical IMD starting from the intermediate deformation state, comprising: calculating mechanical stresses applied to the numerical IMD in the intermediate deformation state these mechanical stresses depending on a mechanical behaviour of the numerical IMD and a mechanical behaviour of the three-dimensional numerical model of a wall of the natural cavity, and relaxing of said mechanical stresses, iii. calculating a predictive local apposition of at least one part of three-dimensional apexes of the numerical IMD on the wall model (Perrin Page 1871, Left Column, First-Second Paragraphs “Finally, the shell elements were ascribed the linearized AAA mechanical properties and all the boundary conditions previously assigned onto the AAA were released, for the SG to recoil and deform the vascular lumen until reaching static mechanical equilibrium (Fig. 2D). All simulations were carried out with the explicit FE solver of Abaqus v6.12 software. Time increments (adjusted via mass scaling) and time steps (Table 3) were chosen to obtain fast results while keeping the ratio of kinematic and internal energies under 10% to avoid spurious dynamic effects, as shown in Fig. 3.” See Table 2 on Page 1870 for the types of stresses modeled. – The mechanical properties/stresses are applied to determine when the geometries of the vessel and stent reach equilibrium.)
wherein
a mechanical behaviour of the numerical IMD, during determining the intermediate deformation state is not identical to the mechanical behaviour of the numerical IMD, during calculating the mechanical equilibrium state, a rest state of the numerical IMD during determining the intermediate deformation state is not identical to a rest state of the numerical IMD during calculating the mechanical equilibrium state, wherein the calculated mechanical equilibrium state corresponds to the simulated deformation of the IMD after implantation, and (Perrin Page 1870-1871, 2.4 “Then, the assembled SG was inserted inside a virtual tubular shell (Fig. 2B). From this configuration, proper displacements were prescribed onto the nodes of the virtual shell to morph its geometry onto the pre-operative geometry of the patient's aneurysm while prescribing contact to maintain the SG inside the shell. Note that, during this step, the shell did not present any mechanical behavior and only acted as a geometrical constraint. At the end of this step, the deployment of the SG inside the pre-operative geometry of the AAA was simulated (Fig. 2C). Finally, the shell elements were ascribed the linearized AAA mechanical properties and all the boundary conditions previously assigned onto the AAA were released, for the SG to recoil and deform the vascular lumen until reaching static mechanical equilibrium (Fig. 2D).” – The interactions are initially modeled purely geometrically, e.g., in the intermediate deformation state. Then, to determine the final geometry of the stent, the system is further modeled with the mechanical properties that were ignored to allow the system to reach equilibrium of the deformation of the vessel and/or stent e.g., including multiple rest states between iterations of perturbations/deformations.)
iv. predicting a final state of the IMD in the natural cavity from the calculated mechanical equilibrium state and the predictive local apposition, the final state being usable for optimizing an implantation procedure. (Perrin Abstract “The numerical results were compared to the actual deployed geometry of the stent-grafts after surgery that was extracted from postoperative scans. We observed relevant matching between simulated and actual deployed stent-graft geometries, especially for proximal and distal stents outside the aneurysm sac which are particularly important for practitioners. Stent locations along the vessel centerlines in the three simulations were always within a few millimeters to actual stents locations. This good agreement between numerical results and clinical cases makes finite element simulation very promising for preoperative planning of endovascular repair. – The final state after the numerical analysis is usable for optimizing an implantation procedure.)
Claim 2
Regarding claim 2, Perrin teaches the features of claim 1 and further teaches:
wherein the intermediate deformation state is determined as a function of contact interactions calculated between three-dimensional apexes of the IMD and three-dimensional apexes of the wall model. (Perrin “From this configuration, proper displacements were prescribed onto the nodes of the virtual shell to morph its geometry onto the pre-operative geometry of the patient's aneurysm while prescribing contact to maintain the SG inside the shell. Note that, during this step, the shell did not present any mechanical behavior and only acted as a geometrical constraint.” – Contact interactions are geometric interactions, which would be modeled as apexes (areas that protrude the most to make the interactions between the vessel and the stent). These geometric interactions are modeled in the intermediate deformation state.)
Claim 3
Regarding claim 3, Perrin teaches the features of claim 1 and further teaches:
wherein the mechanical behaviour of the wall model for a calculation of the mechanical equilibrium state is a non-deformable rigid behaviour. (Perrin Page 1874, Second Paragraph “During simulations, we imposed as only boundary conditions that aortic and iliac extremities were motionless.” – This shows a non-deformable rigid behaviour.)
Claim 4
Regarding claim 4, Perrin teaches the features of claim 1 and further teaches:
wherein, during the determination of the intermediate deformation state, the wall model is deformed geometrically from an initial state so as to contain wholly the numerical IMD in a rest state of the numerical IMD, the wall model next being brought back to the initial state to obtain the intermediate deformation state of the numerical IMD. (Perrin Pages 1870-1871, 2.4 “the assembled SG was inserted inside a virtual tubular shell (Fig. 2B). From this configuration, proper displacements were prescribed onto the nodes of the virtual shell to morph its geometry onto the pre-operative geometry of the patient's aneurysm while prescribing contact to maintain the SG inside the shell. Note that, during this step, the shell did not present any mechanical behavior and only acted as a geometrical constraint. At the end of this step, the deployment of the SG inside the pre-operative geometry of the AAA was simulated (Fig. 2C). Finally, the shell elements were ascribed the linearized AAA mechanical properties and all the boundary conditions previously assigned onto the AAA were released, for the SG to recoil and deform the vascular lumen” - During the determination of the intermediate deformation state (prior to reaching the calculated equilibrium), the vessel is allowed to deform but it returns to a rest state.)
Claim 5
Regarding claim 5, Perrin teaches the features of claim 1 and further teaches:
wherein determining the intermediate deformation state comprises: - obtaining a numerical IMD confined in a tool surface associated with a model of implantation tool, - integrating, in the wall model, the numerical IMD confined in the tool surface in order to obtain the intermediate deformation state. (Perrin Page 1870, 2.4 “A major challenge of simulating SG deployment in patientspecific models of aneurysm is to find appropriate boundary conditions for SG introduction. Our methodology, although different from the actual surgical procedure, has the potential to be used for any SG model and any aneurysm model. Also, it avoids simulating the full crimping and progressive deployment of the SG which are time expensive and may lead to numerical instabilities. A detailed description of the four steps of our simulation, which are described hereafter, is provided in Appendix A.” – While Perrin did not implement the method, it being time-expensive and causing instabilities in the model, Perrin teaches modeling how the stent is introduced to the vessel.)
Claim 6
Regarding claim 6, Perrin teaches the features of claim 5 and further teaches:
further comprising determining a central line of the natural cavity, from the wall model, and wherein the numerical IMD is deformed in a course of its integration so as to follow the central line. (Perrin Page 1869, 2.2 “Surgery oriented Endosizes software (Therenva, France) was used to extract aortic and iliac vessel centerlines and vascular lumen contours from pre-operative scans (Kaladji et al., 2013). Centerlines of the arteries were constituted of a set of points, spaced by 5 mm to obtain a smooth centerline interpolation, onto which were centered B-splines describing the vascular lumen contour. Each B-spline had 10 control points on the lumen surface, in each plane orthogonal to the centerline. The continuous geometry of lumen surface was generated by surface interpolation driven by the B-splines in ANSYS DesignModeler software (ANSYS, Inc., Canonsburg, PA). The arterial lumen surface was then meshed with 3-node linear shell elements (1.5 mm mean edge length) with 1.5 mm and 1.0 mm thicknesses for aortic and iliac surfaces, respectively.” – The vessels are modeled based on a vessel centerline. Page 1871, Right Column, First Full Paragraph “Therefrom, stent centerlines were segmented by manually picking the center of stent cross-sections on each slice of the postoperative scans (Fig. 4A). Stents located in overlap regions or in areas where vessels were highly calcified could not be properly segmented and were not considered in the validation process.” – The stents follow the centerlines of the vessels.)
Claim 7
Regarding claim 7, Perrin teaches the features of claim 1 and further teaches:
wherein the numerical IMD comprises a plurality of segments and further comprises a plurality of nodes, each node connecting ends of two consecutive segments. (Perrin Page 1870, 2.3 “Digitized geometries of SG main bodies and limbs were provided by the manufacturer, except the Cook Medical limb whose model had been validated in Demanget et al. (2012b), the dimensions of which were scaled to the current clinical case. Stents were meshed with linear beam elements (0.075 mm mean length). The superelastic behavior of Nitinol stents was modeled with Auricchio's model (Auricchio and Taylor, 1997) and implemented in a subroutine included in FEA software Abaqus (Simulia, Dassault Systems, Providence, RI, USA). The constitutive parameters of Nitinol, in the range of literature values, were provided by the manufacturer. Grafts were meshed with linear 4-node shell elements (0.4 mm mean edge length). Polyester fabric was modeled as an orthotropic elastic material. In-plane and bending stiffnesses characterized in a previous study of our group (Demanget et al., 2012a) were used.” – FEA systems were used to model the IMD/SG models, and the mesh includes nodes and connecting beams.)
Claim 8
Regarding claim 8, Perrin teaches the features of claim 7 and further teaches:
wherein the mechanical behaviour of at least one segment corresponds to a behaviour of a beam. (Perrin Page 1870, 2.3 “Stents were meshed with linear beam elements (0.075 mm mean length).” – The edges of the mesh are modeled as lines, which are cylinders of arbitrary thickness)
Claim 9
Regarding claim 9, Perrin teaches the features of claim 8 and further teaches:
wherein at least one segment of the numerical IMD having a beam mechanical behaviour is modelled during the determination of the intermediate deformation state with a first diameter, and/or with a first thickness, and/or with a first elasticity modulus, and/or with a first slenderness coefficient, and/or with a first gyration radius, and/or with a first set of critical instability loads, and wherein the at least one segment is modelled during the calculation of the mechanical equilibrium state respectively with a different second diameter, and/or a different second thickness, and/or a different second elasticity modulus, and/or a different second slenderness coefficient, and/or a different second gyration radius, and/or a different second set of critical instability loads. (Perrin Page 1870, Table 2 (shown below). Page 1870, First Paragraph “Then, the tangent stiffness matrix around these in-vivo conditions was derived by subjecting the pipe to different loading increments: pressure (5 mmHg), twist (2°) or longitudinal displacements (0.2 mm). The longitudinal, circumferential and shear elastic moduli, along with the Poisson ratio were obtained from the results of these simulations. The same value as in-plane shear modulus was chosen for the transverse shear moduli. The parameters of the hyperelastic model and the linearized elastic moduli are reported in Table 2.” – The elastic modulus is an element of the modeling for each element of the FEA, and it changes as the vessel and the stent deform. Therefore, this would change in at least some positions in different stages of the deformation, until equilibrium is reached.)
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Claim 10
Regarding claim 10, Perrin teaches the features of claim 8 and further teaches:
wherein the mechanical behaviour of at least one node corresponds to a behaviour of a swivel. (Perrin Page 1873, Left Column, First Paragraph “The initial rotation of the prosthesis around its longitudinal axis was not implemented in our simulations. This may explain the large errors (14.1 mm maximum et) at the main body stumps and proximal limb extremities.” – A swivel is not a term of art in the FEA space. However, the Perrin reference teaches that rotation can be modeled. Modeling of rotation requires rotatability of the finite elements, including the nodes.)
Claim 12
Regarding claim 12, Perrin teaches the features of claim 8 and further teaches:
wherein the calculation of the mechanical equilibrium state of the numerical IMD comprises, for at least one node of the numerical IMD, a calculation of a normal force, a friction force, or both applied by the wall model on the at least one node, modelling a penetration resistance of the wall based at least in part on the normal force, a friction between the IMD and the wall based at least in part on the friction force, or both. (Perrin Page 1871, Left Column, Third Paragraph “Contacts were modeled using the general penalty algorithm implemented in Abaqus, with the standard Coulomb friction law. The friction coefficient was set to 0.4, i.e. in the range of literature values (Vad et al., 2010). – The contacts were modeled using friction forces applied by the vessel wall model on the (nodes of) the SG/IMD.)
Claim 17
Regarding claim 17, Perrin teaches the features of claim 1 and further teaches:
wherein at step iii. calculating the predictive local apposition is for a plurality of nodes of the numerical IMD on the wall model. (Perrin Page 1871, Left Column, Third Paragraph “Contacts were modeled using the general penalty algorithm implemented in Abaqus, with the standard Coulomb friction law. The friction coefficient was set to 0.4, i.e. in the range of literature values (Vad et al., 2010). – Contacts are representative of apposition.)
Claim 18
Regarding claim 18, Perrin teaches the features of claim 17 and further teaches:
wherein the numerical IMD corresponds to an IMD reference derived from a set of IMD references recorded in a database, steps i., ii. and iii. being repeated for each reference of the set of IMD references. (Perrin Abstract “Finite element simulations could help to predict and anticipate possible complications biomechanically induced, thus enhancing practitioners' stent-graft sizing and surgery planning, and giving indications on patient eligibility to endovascular repair. The purpose of this work is therefore to develop a new numerical methodology to predict stent-graft final deployed shapes after surgery. The simulation process was applied on three clinical cases, using preoperative scans to generate patient-specific vessel models. The marketed devices deployed during the surgery, consisting of a main body and one or more iliac limbs or extensions, were modeled and their deployment inside the corresponding patient aneurysm was simulated.” Page 1869 “Following these pioneering studies, a number of researchers (De Bock et al., 2013; Kleinstreuer et al., 2008) have used FEA to model stentgraft structures, with both stents and graft mechanical behaviors. Our group recently achieved similar simulations (Demanget et al., 2013, 2012a) on several marketed SG limbs, which were validated against in-vitro bending tests (Demanget et al., 2012b). A step further has consisted in simulating SG deployment in aneurysm models. We developed simulations of SG deployment in idealized iliac aneurysm models (Perrin et al., 2015). De Bock et al. (2012) performed a SG deployment inside a silicone model and compared simulated and invitro SG positions. Auricchio et al. (2013) simulated the deployment of a custom-made tube aortic SG inside the corresponding patient-specific aneurysm model.” Page 1869, 2.1 “The devices were marketed by Medtronic (Santa Rosa, CA, USA) except for one right limb in clinical case #2 made by Cook Medical (Bloomington, Indiana, USA). Pre-operative and one-month postoperative computed tomography angiography (CTA) scans were available for all patients.” Page 1870, 2.3 “Digitized geometries of SG main bodies and limbs were provided by the manufacturer, except the Cook Medical limb whose model had been validated in Demanget et al. (2012b), the dimensions of which were scaled to the current clinical case. Stents were meshed with linear beam elements (0.075 mm mean length). The superelastic behavior of Nitinol stents was modeled with Auricchio's model (Auricchio and Taylor, 1997) and implemented in a subroutine included in FEA software Abaqus (Simulia, Dassault Systems, Providence, RI, USA). The constitutive parameters of Nitinol, in the range of literature values, were provided by the manufacturer. Grafts were meshed with linear 4-node shell elements (0.4 mm mean edge length). Polyester fabric was modeled as an orthotropic elastic material. In-plane and bending stiffnesses characterized in a previous study of our group (Demanget et al., 2012a) were used. During the SG manufacturing process, expanded stents diameters are oversized compared to graft diameters. For Medtronic components, a preliminary FEA was performed to tie the oversized stents to the graft. For the Cook limb, Z-stents were not oversized and modeled according to Demanget et al. (2012b). The resulting pre-stressed SG models are depicted in Fig. 1C.” See claim mappings of the claims from which this depends for steps i-iii, which are repeated for each model.– The different models of the stents were provided as data from the manufacturer and, for each case, the different models were used in the deformation simulation, including all of the steps.)
Claim 19
Regarding claim 19, Perrin teaches the features of claim 1 and further teaches:
A non-transitory computer program product comprising code instructions for an implementation of a simulation method according to claim 1, when said code instructions are executed by a processing unit. (Perrin Page 1870, Right Column, First Paragraph “The superelastic behavior of Nitinol stents was modeled with Auricchio's model (Auricchio and Taylor, 1997) and implemented in a subroutine included in FEA software Abaqus (Simulia, Dassault Systems, Providence, RI, USA). The constitutive parameters of Nitinol, in the range of literature values, were provided by the manufacturer. Grafts were meshed with linear 4-node shell elements (0.4 mm mean edge length). Polyester fabric was modeled as an orthotropic elastic material. In-plane and bending stiffnesses characterized in a previous study of our group (Demanget et al., 2012a) were used.” Page 1871, Left Column, Second-Third Paragraphs “All simulations were carried out with the explicit FE solver of Abaqus v6.12 software. Time increments (adjusted via mass scaling) and time steps (Table 3) were chosen to obtain fast results while keeping the ratio of kinematic and internal energies under 10% to avoid spurious dynamic effects, as shown in Fig. 3. The FE simulations were run on 12 CPUs computers, 2.66 GHz, 24 GB RAM. Contacts were modeled using the general penalty algorithm implemented in Abaqus, with the standard Coulomb friction law. The friction coefficient was set to 0.4, i.e. in the range of literature values (Vad et al., 2010).” – FEA software was used to do the modeling. See the rejection of claim 1 for the mapping of the claim 1 elements.)
Claim 20
Regarding claim 20, Perrin teaches the features of claim 1 and further teaches:
A system, comprising: a computing device comprising a processor and a memory; and machine-readable instructions stored in the memory that, when executed by the processor, cause the computing device to at least: obtain a three-dimensional wall model of a natural cavity, obtain a numerical IMD, wherein the numerical IMD is generated in accordance with an IMD reference derived from a database, determine an intermediate deformation state wherein the numerical IMD is deformed as a function of a shape of a wall model, while remaining included in said shape, calculate a mechanical equilibrium state of the numerical IMD as a function of a mechanical behaviour of the numerical IMD and a mechanical behaviour of the wall model, and implement a simulation method according to claim 1. (Perrin Page 1870, Right Column, First Paragraph “The superelastic behavior of Nitinol stents was modeled with Auricchio's model (Auricchio and Taylor, 1997) and implemented in a subroutine included in FEA software Abaqus (Simulia, Dassault Systems, Providence, RI, USA). The constitutive parameters of Nitinol, in the range of literature values, were provided by the manufacturer. Grafts were meshed with linear 4-node shell elements (0.4 mm mean edge length). Polyester fabric was modeled as an orthotropic elastic material. In-plane and bending stiffnesses characterized in a previous study of our group (Demanget et al., 2012a) were used.” Page 1871, Left Column, Second-Third Paragraphs “All simulations were carried out with the explicit FE solver of Abaqus v6.12 software. Time increments (adjusted via mass scaling) and time steps (Table 3) were chosen to obtain fast results while keeping the ratio of kinematic and internal energies under 10% to avoid spurious dynamic effects, as shown in Fig. 3. The FE simulations were run on 12 CPUs computers, 2.66 GHz, 24 GB RAM. Contacts were modeled using the general penalty algorithm implemented in Abaqus, with the standard Coulomb friction law. The friction coefficient was set to 0.4, i.e. in the range of literature values (Vad et al., 2010).” – FEA software was used with processing computer hardware to do the modeling. See the rejection of claim 1 for the mapping of the claim 1 elements. The computer hardware with the FEA software teach all of the means recited in claim 20.)
Claim Rejections - 35 USC § 103
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 factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 11: Perrin and Moatamedi
Claim 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over NPL: “Patient-specific numerical simulation of stent-graft deployment: Validation on three clinical cases” by Perrin et al. (Perrin) in view of NPL: “Finite Element Analysis” to Moatamedi et al. (Moatamedi).
Claim 11
Regarding claim 11, Perrin teaches the features of claim 8, but doesn’t appear to explicitly teach, but Perrin in view of Moatamedi teaches:
wherein the calculation (100) of the mechanical equilibrium state of the numerical IMD comprises a calculation of a field of displacements Dxi, Dyi, Dzi and a field of rotations Rxi, Ryi, Rzi of each node i of the numerical IMD in a three-dimensional frame of reference linked to the wall model. (NOTE Calculating force displacement fields in three dimensions and rotational fields about each of the dimensions is a fundamental aspect of finite element analysis when calculating displacement and rotation. Moatamedi Page 4, Last Paragraph – Page 5 “When the structure is loaded, each node can move from its original location. If the node is considered as a small solid particle there are six possible displacements in three dimensions. It can translate in any direction, and in general this translation will have a component along each of the three global axes. It can also rotate, and similarly the rotation has a component about each of the three global axes. Each of the components of translation and rotation is referred to as a degree of freedom, and in three dimensions each node, therefore, has six degrees of freedom.” Page 13, 2.3 “Following the procedure outlined in the preceding section, a stiffness matrix for the complete structure can be assembled, and attention is now turned to the solution of Equation (2.7). The ith node in the assembly has two degrees of freedom (ui and vi), and each degree of freedom has an associated component of force (Xi or Yi). In general, one of each associated pair (either the degree of freedom or its associated force component) has a specified numerical value, and the other is unknown.” See Chapter 3 for fundamental equations. – The displacement in the axes and rotations about them are degrees of freedom, and forces for each degree of freedom are calculated.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claims to elaborate on the finite element analysis recited in Perrin by the fundamental aspect of finite element analysis of determining force fields for relevant degrees of freedom in Moatamedi because the person of ordinary skill in the art would be motivated based on the conducting of finite element analysis in Perrin to calculate the underlying force fields, as taught in Moatamadi, that would be part of calculating a rotating and extending deformation because Moatomadi covers principles of finite element analysis, including the mathematical fundamentals AS REQUIRED, to construct an appropriate finite element model of a physical system. (Perrin Abstract “We observed relevant matching between simulated and actual deployed stent-graft geometries, especially for proximal and distal stents outside the aneurysm sac which are particularly important for practitioners. Stent locations along the vessel centerlines in the three simulations were always within a few millimeters to actual stents locations. This good agreement between numerical results and clinical cases makes finite element simulation very promising for preoperative planning of endovascular repair.” Page 1870, Right Column, First Paragraph “The superelastic behavior of Nitinol stents was modeled with Auricchio's model (Auricchio and Taylor, 1997) and implemented in a subroutine included in FEA software Abaqus (Simulia, Dassault Systems, Providence, RI, USA). The constitutive parameters of Nitinol, in the range of literature values, were provided by the manufacturer.”; Moatamedi Page iv, Last Paragraph “The book covers the principles of finite element analysis, including the mathematical fundamentals as required, to construct an appropriate finite element model of a physical system, and interpret the results of the analysis.”)
Claims 13-15: Perrin and Arthur
Claims 13-15 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over NPL: “Patient-specific numerical simulation of stent-graft deployment: Validation on three clinical cases” by Perrin et al. (Perrin) in view of NPL: “The safety and effectiveness of the Woven Endobridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study” by Arthur et al. (Arthur).
Claim 13
Regarding claim 13, Perrin teaches the features of claim 7, but doesn’t appear to explicitly teach, but Perrin in view of Arthur teaches:
wherein the plurality of segments and the plurality of nodes of the numerical IMD have at least one end pole, a general shape of the IMD being flattened at a level of the at least one end pole. (NOTE: Arthur teaches using a WEB Intrasaccular cage instead of a stent for certain geometries of aneurysms and shows it in various configurations. Arthur Figures 1-6 illustrate different configurations of the WEB depending on the aneurysm and the stage of implantation, including illustrating end poles. See also Table 2 showing different geometries of aneurysm. Depending on how much the WEB is deformed, the poles will be positioned on a protruding, convex surface, a substantially flat surface, or a concave surface.)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claims to modify the stent and its various associated deformations in Perrin by the WEB (intrasaccular cage) and its associated analogous deformations within a vessel in Arthur, because the person of ordinary skill in the art would have been motivated to replace the stent in Perrin with its various deformations with the WEB of Arthur and its various deformations in wide-necked bifurcation aneurysms because it is markedly safer than available therapies (e.g., stents). (Perrin Abstract “Finite element simulations could help to predict and anticipate possible complications biomechanically induced, thus enhancing practitioners' stent-graft sizing and surgery planning, and giving indications on patient eligibility to endovascular repair. The purpose of this work is therefore to develop a new numerical methodology to predict stent-graft final deployed shapes after surgery.”; Arthur Page 924, Conclusions “The prespecified safety and effectiveness endpoints for the aneurysms studied in the WEB-IT trial were met. The results of this trial suggest that the WEB device provides an option for patients with wide-neck bifurcation aneurysms that is as effective as currently available therapies and markedly safer.” Page 925, Right Column, First Paragraph “the use of implanted adjunctive devices (ie, coils or stents) were considered effectiveness failures.” Page 927, Left Column, Retreatment “One subject was re-treated with coils alone, four were re-treated with stent-assisted coiling, and three were re-treated with flow diversion. The cases of all eight re-treated subjects were considered failures for the primary effectiveness endpoint.” Page 927, Right Column, Fifth-Sixth Paragraphs “The periprocedural safety of the WEB device has been previously described.12 The high safety profile documented for the WEB device for the treatment of ruptured WNBAs is important. The complication profile for stent-assisted coiling of ruptured WNBAs is not trivial and an endovascular treatment option that does not require dual antiplatelet medication fills an unmet clinical need. […] In the present study, no postprocedural device, procedure-related serious adverse events or deaths were observed between days 31 and 365. This level of postprocedural safety is unparalleled for the treatment of WNBAs. Parent artery stenting has been associated with significant rates of postprocedural events, related to delayed in-stent stenosis or thrombosis, and hemorrhagic events related to dual antiplatelet therapy.”)
Claim 14
Regarding claim 14, Perrin in view of Arthur teaches the features of claim 13 and further teaches:
wherein the at least one end pole is modelled with a first concavity during the determination of the intermediate deformation state and is modelled with a second concavity different from the first concavity during the calculation of the mechanical equilibrium state. (NOTE: Arthur teaches using a WEB Intrasaccular cage instead of a stent for certain geometries of aneurysms and shows it in various configurations. Arthur Figures 1-6 illustrate different configurations of the WEB depending on the aneurysm and the stage of implantation, including illustrating end poles. See also Table 2 showing different geometries of aneurysm. Depending on how much the WEB is deformed, the poles will be positioned on a protruding, convex surface, a substantially flat surface, or a concave surface.)
Claim 15
Regarding claim 15, Perrin in view of Arthur teaches the features of claim 1 and further teaches:
wherein the numerical IMD is a model of an intrasaccular cage. (Arthur Page 924, Right Column, First Paragraph “The Woven EndoBridge (WEB) device is the first intrasaccular device developed specifically for the treatment of WNBAs.” See Figure 1 illustrating the WEB intrasaccular cages.)
Claim 16: Perrin and Boston Scientific
Claim 16 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over NPL: “Patient-specific numerical simulation of stent-graft deployment: Validation on three clinical cases” by Perrin et al. (Perrin) in view of NPL: “Epic Biliary Endoscopic Stent System” by Boston Scientific et al. (Boston Scientific).
Claim 16
Regarding claim 16, Perrin teaches the features of claim 1, but appears to fail to explicitly teach, but Perrin in view of Boston Scientific teaches:
wherein the numerical IMD is a model of a laser-cut stent. (Boston Scientific Page 1 “Laser Cut Self-Expanding Metal Stent” – Using a laser to cut a stent is a well-known convention, and this is merely an example of it.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claims, to modify the generic stent of Perrin with the laser-cut stent of Boston Scientific because the person of ordinary skill in the art, when selecting from any generic stent, as in Perrin, would be motivated to select the laser cut self-expanding metal stent of Boston Scientific because it is a preference among physicians and complements the best in class braided metal stent portfolio. (Perrin Page 1868, Right Column “Within this context, finite-element analysis (FEA) could help predicting SG positioning inside patient-specific AAA, thus enabling surgeons to anticipate complications.”; Boston Scientific Page 1 “The Epic Biliary Endoscopic Stent System was developed to complement our best-in-class braided metal stent portfolio. The Epic Biliary Endoscopic Stent System is indicated for the palliation of malignant neoplasms in the biliary tree. It may be used to palliate strictures caused by unresectable Bile Duct Cholangiocarcinoma. The Epic Biliary Stent was developed for physicians who prefer a laser cut stent.”)
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
NPL: “Image-Based Mechanical Analysis of Stent Deformation: Concept and Exemplary Implementation for Aortic Valve Stents” by Gessat et al. (This is an alternative 102 and primary 103 reference to the Perrin reference and teaches most of the elements of the claims.)
US 20210030475 A1 to Breininger et al. (Teaches modeling of deformation due to stents)
The contemporaneous art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20200323592 A1 to Ferrara et al. (Teaches modeling deformation along a centreline “comprising points at different longitudinal positions along the vascular structure so as to minimise travel time of fluid along said points” – Contemporaneous Filing By Same Entity, Different Inventorship Including Inventors From Instant Application)
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/J.M.W./Examiner, Art Unit 2188
/RYAN F PITARO/Supervisory Patent Examiner, Art Unit 2188
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