DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: cylinder 39 (interpreted as the element “36” that is pointed to the cylinder in Fig. 9), Step 2708 (interpreted as “2706” following the first 2706 in Fig. 27), Step 2710 (interpreted as “2708” in Fig. 27). 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 126 (Fig. 2), 46 (Fig. 11). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The use of the term Wi-FiTM, WiMaxTM, BluetoothTM, ZIGBEETM, FIREWIRETM, Samsung Gear VRTM, Sony Playstation VRTM, Oculus RiftTM in at least [0036]-[0038] and MimicsTM and MaterialiseTM in [0042], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 37 is objected to because of the following informalities: minor grammatical error. The claim should be amended to “[…] evaluating at least one patient specific [[least one]] clinical outcome […]” in order to make sense grammatically. Appropriate correction is required.
Claim 45 is objected to because of the following informalities: minor grammatical error. The claim should be amended to “[…] evaluating at least one patient specific [[at least one]] clinical outcome […]” in order to make sense grammatically. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 42 and 53 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The limitations “α2D1,” “α2D2,” “α3D1,” and “α3D2” fail to comply with the written description requirement, as no such elements are distinguished in the disclosure. For purposes of applying prior art, the elements are interpreted as distinguishing as right and left measurements of α2D and α3D as in [0071] and [0076].
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 47 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The limitation “performing a surgical mitigative step according to the simulated parameters” is interpreted as the same limitation under broadest reasonable interpretation as “performing the surgical procedure according to the simulated parameters that optimize the at least one clinical outcome,” as in Claim 45. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “simulation system” in Claims 37 and 48 and “virtual reality device” in Claim 56.
The disclosure cites:
The simulation system can be configured to collect image data characterizing a heart of a patient 20 and can include an imaging device 100 ([0029]);
The virtual reality device is interpreted as a virtual reality headset ([0038]) or any device that displays the claimed limitations in virtual reality ([0084]).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 37-41, 43-52 are rejected under 35 U.S.C. 103 as being unpatentable over Mortier (US 20150112659) in view of Zaeuner et al. (US 20110153286).
Regarding Claim 37, Mortier teaches a method of planning a surgical procedure using a simulation system, (Abstract “a method for patient-specific virtual percutaneous implantation”), the method comprising:
a) evaluating patient-specific least one clinical outcome during or after a surgical procedure involving at least one surgical object according to simulated parameters selected from options comprising at least one of: type, size, deployment configuration, and positioning of the at least one surgical object ([0110] “virtually deploying said implant model into each of a plurality of the patient specific anatomical models maintained in said library to evaluate said implant model for a percutaneous implantation procedure.”); and
b) planning the surgical procedure according to the simulated parameters that optimize the at least one clinical outcome, wherein the at least one clinical outcome are predicted using the simulation system every time the simulated parameters are selected, ([0012] “the invention aims to provide a web-based pre-operative planning service for TAVI using computer simulations that predict stent frame deformation and incomplete frame apposition, allowing to assess the risk on regurgitation and other complications such as coronary obstruction and conduction abnormalities prior to the intervention,” [0081] “The term `patient-based model` as used herein is to be understood as a generic and/or parametric adaptable model. Based on measurement(s) and/or 2D or 3D medical images of a patient, certain parameters will be determined for the patient-based model,” [0103] “It is advantageous to determine or calibrate model parameters and specifications in order to provide improving and/or optimal results for a broad population of patients or a number of subpopulations of patients. These parameters can be material dependent parameters, tissue dependent parameters, layer thicknesses, etc.,” and [0159] “The model parameters were adjusted until a good correlation was obtained between the deformed stent frame as predicted by the simulations and the geometry of the stent frame as observed from the post-operative image data”), based on a computer-implemented method, ([0012] “the invention aims to provide a web-based pre-operative planning service for TAVI using computer simulations that predict stent frame deformation and incomplete frame apposition, allowing to assess the risk on regurgitation and other complications such as coronary obstruction and conduction abnormalities prior to the intervention.”), comprising: executing, by at least a processor, program code stored in a non-transitory computer-readable-medium to perform a simulation in responding to a selection of simulated parameters, the simulation comprising:
i) generating analytical model data comprising a three-dimensional mesh and parametric measurements based on image data characterizing anatomical regions of a heart or blood vessels of a patient (Claim 1 “A method for patient-specific virtual percutaneous implantation, comprising: estimating a patient-specific anatomical model of a patient-specific aorta based on cardiovascular 2D or 3D medical image data comprising: a) using segmentation techniques to create a finite element aorta mesh based on 2D or 3D medical image data, said aorta mesh representing a patient-specific aorta, preferably comprising the aortic root and the ascending aorta; b) using segmentation techniques to create a finite element aortic valve mesh based on 2D or 3D medical image data, said aortic valve mesh representing a patient-specific aortic valve, comprising 2 or 3 valve leaflets; c) said patient-specific anatomical model comprising a patient-specific aorta model and a patient-specific aortic valve model (43)”);
ii) generating, using a numerical analysis engine, a deformed analytical model based on the analytical model data and based on a three-dimensional mesh of a virtually deployed at least one surgical object (Fig. 8 and [0161]-[0163] “FIG. 8 depicts the deformed structures from the finite element analysis (left panel). […] an implant device leaflet 61, a device frame model 49, a computational grid of the fluid domain 62”); and
iii) predicting the at least one clinical outcome based on patient-specific criteria, ([0062] “The method provides a better medical prediction of the functional behavior of the implant procedure. It allows to better understand the performance of an implant device or how to efficiently deploy an implant device into a patient”), wherein the patient-specific predictive criteria of confirmed at least one clinical outcome has been established from a database of image data from patients with and without at least one clinical outcome during or after the surgical procedure, ([0107] “By providing a database of device models representing the actual device geometry and having similar mechanical behavior, interventional cardiologists or hospitals can select optimal device size and type for patients” and [0159] “The model parameters have been calibrated by using pre- and post-operative CT data of minimum 10 patients that underwent TAVI. A patient-specific model has been created for all these patients and the same TAVI procedure was performed using finite element computer simulations as it was done in the hospital (same balloon for pre-dilatation and postdilatation, same size of the CoreValve device, same device position, etc.). Further calibration will be done by adding more patients to the database. The model parameters were adjusted until a good correlation was obtained between the deformed stent frame as predicted by the simulations and the geometry of the stent frame as observed from the post-operative image data (see FIGS. 5 and 6).”), by determining a data fitting model ([0159] “The model parameters were adjusted until a good correlation was obtained between the deformed stent frame as predicted by the simulations and the geometry of the stent frame as observed from the post-operative image data” and Figs. 5-6).
However, Mortier does not teach displaying a virtualization of the surgical procedure that allows a clinician to have a visual feedback of simulated results of the surgical procedure.
In an analogous virtual percutaneous valve implantation field of endeavor, Zaeuner teaches a method of planning a surgical procedure using a simulation system, ([0019] “FIG. 1 illustrates a method of virtual valve implantation according to an embodiment of the present invention. The method of FIG. 1 transforms 3D medical image data representing a patient's anatomy to generate a patient-specific anatomical model and uses the anatomical model to virtually simulate the implantation of one or more implants (also referred to herein as "stents").”), the method comprising: displaying a virtualization of the surgical procedure that allows a clinician to have a visual feedback of simulated results of the surgical procedure ([0031] “The virtual valve deployment results may be output as a visualization of the implant model in the patient-specific valve model.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Mortier with the display of Zaeuner because by simulating the procedure visually, physicians can predict complications of the procedure, minimize risks of the procedure, and treatment options may be optimized by testing different hypotheses to select the best deployment options, as taught by Zaeuner in [0031].
Regarding Claim 38, the modified method of Mortier teaches all limitations of Claim 37, as discussed above. Furthermore, Mortier teaches wherein the at least one clinical outcome comprise at least one risk of at least one clinical complication ([0097] “In a further preferred step, the amount of paravalvular regurgitation is predicted based on a geometrical analysis of said blood mesh. Hemodynamic performance of the implant can be predicted by quantifying paravalvular leakages, valve insufficiency, and effective orifice and systolic gradients across the aortic prosthesis,” [0101] “he risk of coronary obstruction, annular rupture and conduction abnormalities is predicted by virtually deploying an implant model representing an implant into the patient-specific anatomical model.”).
Regarding Claim 39, the modified method of Mortier teaches all limitations of Claim 38, as discussed above. Furthermore, Mortier teaches wherein the at least one clinical complication comprise one or more of: coronary obstruction, [0101] “the risk of coronary obstruction […] is predicted by virtually deploying an implant model representing an implant into the patient-specific anatomical model.”), paravalvular leakage, ([0097] “In a further preferred step, the amount of paravalvular regurgitation is predicted based on a geometrical analysis of said blood mesh. Hemodynamic performance of the implant can be predicted by quantifying paravalvular leakages, valve insufficiency, and effective orifice and systolic gradients across the aortic prosthesis.”), thrombosis, conduction abnormalities, [0101] “the risk of […] conduction abnormalities is predicted by virtually deploying an implant model representing an implant into the patient-specific anatomical model.”), and cerebrovascular events.
Regarding Claim 40, the modified method of Mortier teaches all limitations of Claim 37, as discussed above. Furthermore, Mortier teaches wherein the at least one clinical outcome comprise blood flow information indicative of one or more of: a paravalvular leakage, ([0097] “In a further preferred step, the amount of paravalvular regurgitation is predicted based on a geometrical analysis of said blood mesh. Hemodynamic performance of the implant can be predicted by quantifying paravalvular leakages […] across the aortic prosthesis” and [0140]-[0142] “It is the aim of the current invention to provide a report to the medical doctor, comprising: figures of the implanted device(s), colour plots of the incomplete apposition of the device(s). These plots give insight into possible paravalvular leaks”), thrombosis, pressure gradient, ([0097] “In a further preferred step, the amount of paravalvular regurgitation is predicted based on a geometrical analysis of said blood mesh. Hemodynamic performance of the implant can be predicted by quantifying […] effective orifice […] gradients across the aortic prosthesis.”), energy loss, and effective orifice area ([0097] “In a further preferred step, the amount of paravalvular regurgitation is predicted based on a geometrical analysis of said blood mesh. Hemodynamic performance of the implant can be predicted by quantifying […] effective orifice […] across the aortic prosthesis.”).
Regarding Claim 41, the modified method of Mortier teaches all limitations of Claim 37, as discussed above. Furthermore, Zaeuner teaches wherein the virtualization of the surgical procedure comprises real time comparisons of the simulated parameters of a transcatheter aortic valve (TAV), ([0028] “In order to simulate valve replacement under various conditions, different implant models can be selected from the library and virtually deployed under different parameters, into the extracted patient-specific model.”), including a type of the TAV, (Abstract “The implant models maintained in the library are virtually deployed into the patient specific anatomical model of the heart valve to select an implant type […] for percutaneous valve implantation.”), a size of the TAV, (Abstract “The implant models maintained in the library are virtually deployed into the patient specific anatomical model of the heart valve to select an implant […] size […] for percutaneous valve implantation.”), and positioning of the TAV, (Abstract “The implant models maintained in the library are virtually deployed into the patient specific anatomical model of the heart valve to select […] deployment location and orientation for percutaneous valve implantation.”), and each corresponding to one of the at least one clinical outcome ([0031] “Returning to FIG. 1, at step 108, the virtual implant model deployment results are output. The virtual implant deployment results can provide quantitative and qualitative information used in planning and performing the percutaneous valve implantation. For example, using the virtual-deployment framework various implants can be tested and compared to select the best implant and implant size. Further, the virtual implantation can provide an optimal position and orientation for the selected implant with respect to the patient-specific model. Quantitatively, the forces that hold the stent to the wall can be calculated after virtual deployment. Hemodynamic performance of the implant can be predicted by quantifying paravalvular leakages, valve insufficiency, and effective orifice and systolic gradients across the aortic prosthesis.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Mortier with the real time comparisons of the simulated parameters of a TAV of Zaeuner because the modification avoids improper placement of the implant (surgical object), which may result in a life threatening ischemic condition, poor hemodynamic performance, high gradients and suboptimal effective orifice, damaged vessel tissue, and/or arterial dissection, as taught by Zaeuner in [0004].
Regarding Claim 43, the modified method of Mortier teaches all limitations of Claim 37, as discussed above. Furthermore, Mortier teaches wherein the deployment configuration comprises different depths, yaw, and pitch angles relative to one of the anatomical regions of the heart or blood vessels where the at least one surgical object is deployed (Claim 12 “determining a position and an orientation for implanting the implant based on the complications” and [0159] “The model parameters were adjusted until a good correlation was obtained between the deformed stent frame as predicted by the simulations and the geometry of the stent frame as observed from the post-operative image data”).
Regarding Claim 44, the modified method of Mortier teaches all limitations of Claim 37, as discussed above. Furthermore, Mortier teaches wherein the at least one surgical object is selected from options comprising at least one of a surgical bioprosthetic heart valve, ([0004] “Trans-catheter aortic valve implantation (TAVI) or trans-catheter aortic valve repair (TAVR) is a minimally-invasive procedure for treating aortic stenosis: (1) the valve (e.g. a bioprosthetic valve made of porcine pericardium sutured on a metal stent) is crimped inside a catheter”), a trans-catheter heart valve, ([0004] “Trans-catheter aortic valve implantation (TAVI) or trans-catheter aortic valve repair (TAVR) is a minimally-invasive procedure for treating aortic stenosis: (1) the valve (e.g. a bioprosthetic valve made of porcine pericardium sutured on a metal stent) is crimped inside a catheter”), an artificial root, a surgical instrument, and a stent graft ([0159] “predicted stent frame 50”).
Regarding Claim 45, Mortier teaches a method of computer assisted procedure using a simulation system, (Abstract “a method for patient-specific virtual percutaneous implantation” and [0012] “Also the invention aims to provide a web-based pre-operative planning service for TAVI using computer simulations”), the method comprising:
a) evaluating patient-specific at least one clinical outcome during or after a surgical procedure involving at least one surgical object according to simulated parameters selected from options comprising at least one of: type, size, deployment configuration, and positioning of the at least one surgical object ([0110] “virtually deploying said implant model into each of a plurality of the patient specific anatomical models maintained in said library to evaluate said implant model for a percutaneous implantation procedure.”); and
b) predicting at least one clinical outcome based on the patient-specific criteria, ([0062] “The method provides a better medical prediction of the functional behavior of the implant procedure. It allows to better understand the performance of an implant device or how to efficiently deploy an implant device into a patient”), wherein the patient-specific predictive criteria of confirmed at least one clinical outcome has been established from a database of image data from patients with and without at least one clinical outcome during or after the surgical procedure, ([0107] “By providing a database of device models representing the actual device geometry and having similar mechanical behavior, interventional cardiologists or hospitals can select optimal device size and type for patients” and [0159] “The model parameters have been calibrated by using pre- and post-operative CT data of minimum 10 patients that underwent TAVI. A patient-specific model has been created for all these patients and the same TAVI procedure was performed using finite element computer simulations as it was done in the hospital (same balloon for pre-dilatation and postdilatation, same size of the CoreValve device, same device position, etc.). Further calibration will be done by adding more patients to the database. The model parameters were adjusted until a good correlation was obtained between the deformed stent frame as predicted by the simulations and the geometry of the stent frame as observed from the post-operative image data (see FIGS. 5 and 6).”), by determining a data fitting model ([0159] “The model parameters were adjusted until a good correlation was obtained between the deformed stent frame as predicted by the simulations and the geometry of the stent frame as observed from the post-operative image data” and Figs. 5-6).
However, Mortier does not explicitly teach performing the surgical procedure according to the simulated parameters that optimize the at least one clinical outcome.
In an analogous virtual percutaneous valve implantation field of endeavor, Zaeuner teaches a method of computer assisted procedure using a simulation system, ([0017] “Accordingly, is to be understood that embodiments of the present invention may be performed within a computer system using data stored within the computer system” and [0019] “FIG. 1 illustrates a method of virtual valve implantation according to an embodiment of the present invention. The method of FIG. 1 transforms 3D medical image data representing a patient's anatomy to generate a patient-specific anatomical model and uses the anatomical model to virtually simulate the implantation of one or more implants (also referred to herein as "stents").”), the method comprising: performing the surgical procedure according to the simulated parameters that optimize the at least one clinical outcome ([0018] “In the pre-operative framework, pre-operative medical images, such as cardiac CT images, are acquired, a patient-specific anatomical model of the valve is estimated, and 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.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Mortier with the teachings of Zaeuner because the modification avoids improper placement of the implant (surgical object), which may result in a life threatening ischemic condition, poor hemodynamic performance, high gradients and suboptimal effective orifice, damaged vessel tissue, and/or arterial dissection, as taught by Zaeuner in [0004].
Regarding Claim 46, the modified method of Mortier teaches all limitations of Claim 45, as discussed above. Furthermore, Mortier teaches wherein the at least one clinical outcome comprise at least one risk of at least one clinical complication comprising one or more of: coronary obstruction, [0101] “the risk of coronary obstruction […] is predicted by virtually deploying an implant model representing an implant into the patient-specific anatomical model.”), paravalvular leakage, ([0097] “In a further preferred step, the amount of paravalvular regurgitation is predicted based on a geometrical analysis of said blood mesh. Hemodynamic performance of the implant can be predicted by quantifying paravalvular leakages […] across the aortic prosthesis” and [0140]-[0142] “It is the aim of the current invention to provide a report to the medical doctor, comprising: figures of the implanted device(s), colour plots of the incomplete apposition of the device(s). These plots give insight into possible paravalvular leaks”), thrombosis, conduction abnormalities, [0101] “the risk of […] conduction abnormalities is predicted by virtually deploying an implant model representing an implant into the patient-specific anatomical model.”), cerebrovascular events, and blood flow information indicative of one or more of: a paravalvular leakage, ([0097] “In a further preferred step, the amount of paravalvular regurgitation is predicted based on a geometrical analysis of said blood mesh. Hemodynamic performance of the implant can be predicted by quantifying paravalvular leakages […] across the aortic prosthesis” and [0140]-[0142] “It is the aim of the current invention to provide a report to the medical doctor, comprising: figures of the implanted device(s), colour plots of the incomplete apposition of the device(s). These plots give insight into possible paravalvular leaks”), thrombosis, pressure gradient, ([0097] “In a further preferred step, the amount of paravalvular regurgitation is predicted based on a geometrical analysis of said blood mesh. Hemodynamic performance of the implant can be predicted by quantifying […] effective orifice […] gradients across the aortic prosthesis.”), energy loss, and effective orifice area ([0097] “In a further preferred step, the amount of paravalvular regurgitation is predicted based on a geometrical analysis of said blood mesh. Hemodynamic performance of the implant can be predicted by quantifying […] effective orifice […] across the aortic prosthesis.”).
Regarding Claim 47, the modified method of Mortier teaches all limitations of Claim 37, as discussed above. Furthermore, Zaeuner teaches performing a surgical mitigative step according to the simulated parameters ([0018] “In the pre-operative framework, pre-operative medical images, such as cardiac CT images, are acquired, a patient-specific anatomical model of the valve is estimated, and 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.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Mortier with the teachings of Zaeuner because the modification avoids improper placement of the implant (surgical object), which may result in a life threatening ischemic condition, poor hemodynamic performance, high gradients and suboptimal effective orifice, damaged vessel tissue, and/or arterial dissection, as taught by Zaeuner in [0004].
Regarding Claim 48, Mortier teaches a simulation system for planning a surgical procedure, comprising:
a) at least one processor ([0012] “Also the invention aims to provide a web-based pre-operative planning service for TAVI using computer simulations”);
b) a non-transitory computer readable medium having stored thereon, a computer program having at least one code section for predicting at least one surgical outcome during or after the surgical procedure involving at least one surgical object deployed into a heart or blood vessels of a patient, (Claim 1 “A method for patient-specific virtual percutaneous implantation, comprising: estimating a patient-specific anatomical model of a patient-specific aorta based on cardiovascular 2D or 3D medical image data comprising: a) using segmentation techniques to create a finite element aorta mesh based on 2D or 3D medical image data, said aorta mesh representing a patient-specific aorta, preferably comprising the aortic root and the ascending aorta; b) using segmentation techniques to create a finite element aortic valve mesh based on 2D or 3D medical image data, said aortic valve mesh representing a patient-specific aortic valve, comprising 2 or 3 valve leaflets; c) said patient-specific anatomical model comprising a patient-specific aorta model and a patient-specific aortic valve model (43)”), the at least one code section being executable by the at least one processor, causing the simulation system to perform simulations every time the simulated parameters are selected, the simulations comprising steps of:
i) generating analytical model data comprising a three-dimensional mesh and parametric measurements based on image data characterizing anatomical regions of a heart or blood vessels of a patient (Claim 1 “A method for patient-specific virtual percutaneous implantation, comprising: estimating a patient-specific anatomical model of a patient-specific aorta based on cardiovascular 2D or 3D medical image data comprising: a) using segmentation techniques to create a finite element aorta mesh based on 2D or 3D medical image data, said aorta mesh representing a patient-specific aorta, preferably comprising the aortic root and the ascending aorta; b) using segmentation techniques to create a finite element aortic valve mesh based on 2D or 3D medical image data, said aortic valve mesh representing a patient-specific aortic valve, comprising 2 or 3 valve leaflets; c) said patient-specific anatomical model comprising a patient-specific aorta model and a patient-specific aortic valve model (43)”);
ii) generating, using a numerical analysis engine, a deformed analytical model based on the analytical model data and based on a three-dimensional mesh of a virtually deployed at least one surgical object (Fig. 8 and [0161]-[0163] “FIG. 8 depicts the deformed structures from the finite element analysis (left panel). […] an implant device leaflet 61, a device frame model 49, a computational grid of the fluid domain 62”); and
iii) predicting the at least one clinical outcome based on the patient-specific criteria, ([0062] “The method provides a better medical prediction of the functional behavior of the implant procedure. It allows to better understand the performance of an implant device or how to efficiently deploy an implant device into a patient”), wherein the patient-specific predictive criteria of confirmed at least one clinical outcome has been established from a database of image data from patients with and without at least one clinical outcome during or after the surgical procedure, ([0107] “By providing a database of device models representing the actual device geometry and having similar mechanical behavior, interventional cardiologists or hospitals can select optimal device size and type for patients” and [0159] “The model parameters have been calibrated by using pre- and post-operative CT data of minimum 10 patients that underwent TAVI. A patient-specific model has been created for all these patients and the same TAVI procedure was performed using finite element computer simulations as it was done in the hospital (same balloon for pre-dilatation and postdilatation, same size of the CoreValve device, same device position, etc.). Further calibration will be done by adding more patients to the database. The model parameters were adjusted until a good correlation was obtained between the deformed stent frame as predicted by the simulations and the geometry of the stent frame as observed from the post-operative image data (see FIGS. 5 and 6).”), by determining a data fitting model ([0159] “The model parameters were adjusted until a good correlation was obtained between the deformed stent frame as predicted by the simulations and the geometry of the stent frame as observed from the post-operative image data” and Figs. 5-6); and
However, Mortier does not explicitly teach a display for displaying a virtualization of the surgical procedure that allows a clinician to have a visual feedback of simulated results of the surgical procedure.
In an analogous virtual percutaneous valve implantation field of endeavor, Zaeuner teaches a simulation system for planning a surgical procedure, (Abstract “A method and system for virtual percutaneous valve implantation”), comprising: a display for displaying a virtualization of the surgical procedure that allows a clinician to have a visual feedback of simulated results of the surgical procedure ([0031] “The virtual valve deployment results may be output as a visualization of the implant model in the patient-specific valve model.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Mortier with the display of Zaeuner because by simulating the procedure visually, physicians can predict complications of the procedure, minimize risks of the procedure, and treatment options may be optimized by testing different hypotheses to select the best deployment options, as taught by Zaeuner in [0031].
Regarding Claim 49, the modified system of Mortier teaches all limitations of Claim 48, as discussed above. Furthermore, Mortier teaches wherein the at least one clinical outcome comprise at least one risk of at least one clinical complication ([0097] “In a further preferred step, the amount of paravalvular regurgitation is predicted based on a geometrical analysis of said blood mesh. Hemodynamic performance of the implant can be predicted by quantifying paravalvular leakages, valve insufficiency, and effective orifice and systolic gradients across the aortic prosthesis,” [0101] “he risk of coronary obstruction, annular rupture and conduction abnormalities is predicted by virtually deploying an implant model representing an implant into the patient-specific anatomical model.”).
Regarding Claim 50, the modified system of Mortier teaches all limitations of Claim 49, as discussed above. Furthermore, Mortier teaches wherein the at least one clinical complication comprise one or more of: coronary obstruction, [0101] “the risk of coronary obstruction […] is predicted by virtually deploying an implant model representing an implant into the patient-specific anatomical model.”), paravalvular leakage, ([0097] “In a further preferred step, the amount of paravalvular regurgitation is predicted based on a geometrical analysis of said blood mesh. Hemodynamic performance of the implant can be predicted by quantifying paravalvular leakages, valve insufficiency, and effective orifice and systolic gradients across the aortic prosthesis.”), thrombosis, conduction abnormalities, [0101] “the risk of […] conduction abnormalities is predicted by virtually deploying an implant model representing an implant into the patient-specific anatomical model.”), and cerebrovascular events.
Regarding Claim 51, the modified system of Mortier teaches all limitations of Claim 48, as discussed above. Furthermore, Mortier teaches wherein the at least one clinical outcome comprise blood flow information indicative of one or more of: a paravalvular leakage, ([0097] “In a further preferred step, the amount of paravalvular regurgitation is predicted based on a geometrical analysis of said blood mesh. Hemodynamic performance of the implant can be predicted by quantifying paravalvular leakages […] across the aortic prosthesis” and [0140]-[0142] “It is the aim of the current invention to provide a report to the medical doctor, comprising: figures of the implanted device(s), colour plots of the incomplete apposition of the device(s). These plots give insight into possible paravalvular leaks”), thrombosis, pressure gradient, ([0097] “In a further preferred step, the amount of paravalvular regurgitation is predicted based on a geometrical analysis of said blood mesh. Hemodynamic performance of the implant can be predicted by quantifying […] effective orifice […] gradients across the aortic prosthesis.”), energy loss, and effective orifice area ([0097] “In a further preferred step, the amount of paravalvular regurgitation is predicted based on a geometrical analysis of said blood mesh. Hemodynamic performance of the implant can be predicted by quantifying […] effective orifice […] across the aortic prosthesis.”).
Regarding Claim 52, the modified system of Mortier teaches all limitations of Claim 37, as discussed above. Furthermore, Zaeuner teaches wherein the virtualization of the surgical procedure comprises real time comparisons of the simulated parameters of a transcatheter aortic valve (TAV), ([0028] “In order to simulate valve replacement under various conditions, different implant models can be selected from the library and virtually deployed under different parameters, into the extracted patient-specific model.”), including a type of the TAV, (Abstract “The implant models maintained in the library are virtually deployed into the patient specific anatomical model of the heart valve to select an implant type […] for percutaneous valve implantation.”), a size of the TAV, (Abstract “The implant models maintained in the library are virtually deployed into the patient specific anatomical model of the heart valve to select an implant […] size […] for percutaneous valve implantation.”), and positioning of the TAV, (Abstract “The implant models maintained in the library are virtually deployed into the patient specific anatomical model of the heart valve to select […] deployment location and orientation for percutaneous valve implantation.”), and each corresponding to one of the at least one clinical outcome ([0031] “Returning to FIG. 1, at step 108, the virtual implant model deployment results are output. The virtual implant deployment results can provide quantitative and qualitative information used in planning and performing the percutaneous valve implantation. For example, using the virtual-deployment framework various implants can be tested and compared to select the best implant and implant size. Further, the virtual implantation can provide an optimal position and orientation for the selected implant with respect to the patient-specific model. Quantitatively, the forces that hold the stent to the wall can be calculated after virtual deployment. Hemodynamic performance of the implant can be predicted by quantifying paravalvular leakages, valve insufficiency, and effective orifice and systolic gradients across the aortic prosthesis.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Mortier with the real time comparisons of the simulated parameters of a TAV of Zaeuner because the modification avoids improper placement of the implant (surgical object), which may result in a life threatening ischemic condition, poor hemodynamic performance, high gradients and suboptimal effective orifice, damaged vessel tissue, and/or arterial dissection, as taught by Zaeuner in [0004].
Regarding Claim 54, the modified system of Mortier teaches all limitations of Claim 37, as discussed above. Furthermore, Mortier teaches wherein the deployment configuration comprises different depths, yaw, and pitch angles relative to one of the anatomical regions of the heart or blood vessels where the at least one surgical object is deployed (Claim 12 “determining a position and an orientation for implanting the implant based on the complications” and [0159] “The model parameters were adjusted until a good correlation was obtained between the deformed stent frame as predicted by the simulations and the geometry of the stent frame as observed from the post-operative image data”).
Regarding Claim 55, the modified system of Mortier teaches all limitations of Claim 37, as discussed above. Furthermore, Mortier teaches wherein the at least one surgical object is selected from options comprising at least one of a surgical bioprosthetic heart valve, ([0004] “Trans-catheter aortic valve implantation (TAVI) or trans-catheter aortic valve repair (TAVR) is a minimally-invasive procedure for treating aortic stenosis: (1) the valve (e.g. a bioprosthetic valve made of porcine pericardium sutured on a metal stent) is crimped inside a catheter”), a trans-catheter heart valve, ([0004] “Trans-catheter aortic valve implantation (TAVI) or trans-catheter aortic valve repair (TAVR) is a minimally-invasive procedure for treating aortic stenosis: (1) the valve (e.g. a bioprosthetic valve made of porcine pericardium sutured on a metal stent) is crimped inside a catheter”), an artificial root, a surgical instrument, and a stent graft ([0159] “predicted stent frame 50”).
Claims 42 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Mortier (US 20150112659) in view of Zaeuner et al. (US 20110153286), as applied to Claims 37 and 48, further in view of Chaturvedi et al. (“MRI evaluation prior to Transcatheter Aortic Valve Implantation […]”).
Regarding Claims 42 and 53, the modified method and system of Mortier teaches all limitations of Claims 37 and 48, as discussed above. However, the modified method and system of Mortier does not explicitly teach wherein generating the deformed analytical model comprises: calculating a first set of size measurements of the virtually deployed surgical at least one object in deployment comprising respective gap sizes, α2D1 and α2D2, each corresponding to a two-dimensional distance between a tip of a coronary leaflet and a coronary ostium of a coronary artery; calculating a second set of size measurements of the virtually deployed surgical at least one object in deployment comprising respective gap sizes, α3D1 and α3D2, each corresponding to a shortest three-dimensional distance between the coronary ostium of the coronary artery and a potential obstruction; and performing systematic data-fitting on at least the first and second sets of size measurements, and determining the data fitting model further comprises determining a statistical correlation, R2, based on the systematic data-fitting.
In an analogous evaluation prior to TAVI field of endeavor, Chaturvedi teaches wherein generating the deformed analytical model comprises:
a) calculating a first set of size measurements of the virtually deployed surgical at least one object in deployment comprising respective gap sizes, α2D1 and α2D2, each corresponding to a two-dimensional distance between a tip of a coronary leaflet and a coronary ostium of a coronary artery (Fig. 3, where measurements are understood to be taken from both left and right coronary arteries, and Coronary ostia “minimum distance values of 10-14 mm between the coronary ostia and leaflet insertion are usually suggested.”);
b) calculating a second set of size measurements of the virtually deployed surgical at least one object in deployment comprising respective gap sizes, α3D1 and α3D2, each corresponding to a shortest three-dimensional distance between the coronary ostium of the coronary artery and a potential obstruction (Aortic annulus “The annular plane is identified by the end systolic image below the insertion of leaflets by scrolling through this cine stack (Fig. 2c). This slice is used for assessing the minor & major diameters, area, and perimeter of the annulus. Annular diameters can also be obtained from a navigator-assisted free breathing diastolic phase 3-D SSFP sequence”); and
c) performing systematic data-fitting on at least the first and second sets of size measurements, and determining the data fitting model further comprises determining a statistical correlation, R2, based on the systematic data-fitting (Aortic annulus “Measurement of the annulus is important for correct selection of prosthesis size, type, and to avoid damage of the annulus if the valve is oversized and avoid paravalvular regurgitation if the valve is undersized,” Coronary ostia “The distance from the annulus to the coronary ostia is of importance to prevent occlusion of the coronary arteries by the displacement of the native aortic valve leaflets by the prosthesis,” and Post TAVI paravalvular regurgitation “Aortic regurgitation (AR) is the most frequent post procedural complication after TAVI and is linked to ad verse outcomes and mortality.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with Chaturvedi because the modification ensures minimal complications following the procedure by ensuring the proper sizing and location.
Claim 56 is rejected under 35 U.S.C. 103 as being unpatentable over Mortier (US 20150112659) in view of Zaeuner et al. (US 20110153286), as applied to Claim 48, further in view of Nazy (WO 2016154571), cited from its respective US Patent Application Publication containing the same information, US 20180168730).
Regarding Claim 56, the modified system of Mortier teaches all limitations of Claim 48, as discussed above. However, the modified system of Mortier does not explicitly teach wherein the display comprises a virtual reality device.
In an analogous medical procedure planning field of endeavor, Nazy teaches a simulation system for planning a surgical procedure, ([0032] “mixed reality simulation system 10” and [0065] “an example process 200 for performing a medical procedure in accordance with an embodiment of the system 10”), wherein the display comprises a virtual reality device ([0067] “In step 214, visualization is generated based on the results of the scan. The visualization may be presented, for example, on a display such as the user interface 102. In certain embodiments the visualization may be presented so as to allow a user to experience fly-through of the visualization. Such embodiments may include virtual reality elements or allow a user to experience the visualization as a virtual reality experience.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the virtual reality display of Nazy because the modification the 3D visualization provides a personalized aspect of the surgical planning which can be optimized to achieve the best results intended for process and application, as taught by Nazy in [0003] and [0006].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Neumann is cited for teaching a method of planning a surgical procedure using a simulation system, ([0019] and [0022]), the method comprising: evaluating patient-specific least one clinical outcome during or after a surgical procedure involving at least one surgical object according to simulated parameters selected from options comprising at least one of: type, size, deployment configuration, and positioning of the at least one surgical object ([0021]); and displaying a virtualization of the surgical procedure that allows a clinician to have a visual feedback of simulated results of the surgical procedure (Claims 13 and 28).
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/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795