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 .
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 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.
Claim(s) 1-2, 5-6 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orth et al. (US Pub No. 2018/0289488) in view of Sharma et al. (US Pub No. 2013/0144573) and Jones et al. (“Computational fluid dynamic analysis of the effect of morphologic features on distraction forces in fenestrated stent grafts”, December 2014).
With regards to claim 1, Orth et al. disclose a method, comprising:
receiving, via at least one processor, anatomical measurements of a lumen of a patient (paragraph [0038], referring to the measurements that can be obtained from images to assess useful physical parameters of the anatomy, wherein such useful measurements can include cross-sectional measurements such as diameter or perimeter at a sub-valve A, supra-valve B, etc., and length measurements; paragraph [0049], referring to auto-segmentation of the uploaded images wherein “This process outputs 3D segmented volume that is divided into different anatomical structures of interest within the imaging volume (e.g., device landing zone, anatomical structures and landmarks”, and thus anatomical measurements of the anatomical structures of interest, including that of a lumen (i.e. cardiac lumens), would be provided via the auto-segmentation; further referring to the input of physical measurements; Figures 1-2, 8);
performing, via the at least one processor, a geometrical fit analysis based on the anatomical measurements to identify potential prostheses to be implanted in the lumen and an optimal implantation landing zone within the lumen for at least one of the potential prostheses, wherein the geometrical fit analysis includes comparing a geometry of the lumen, including anatomical shape factors for the lumen, to geometries of a plurality of candidate prostheses at a plurality of potential implant deployment positions within the lumen (paragraphs [0050]-[0051], referring to the software conducting automatic virtual device geometrical fit testing, wherein “the software conducts an automatic interactive device-based analysis performing device-versus-anatomy geometrical comparison at different device landing scenarios (e.g., variety of device landing zone locations and/or axis orientations). This provides evaluation of factors such as oversizing, gap and fit of one or more devices with respect to the modeled patient anatomy. The software is configured to evaluate a plurality of devices for device position and, also, vectors (i.e. device axis angle).”; paragraph [0053], referring to comparatively identifying the best landing candidate point (a combination of device location and orientation) and providing device-based fit score and fit analysis (e.g. perimeter profile of the device versus that of the anatomy, wherein such a fit analysis which involves the perimeter profile [i.e. defining a shape] of the device vs. that of the anatomy would involve comparing anatomical shape factors for the anatomical lumen to geometries of candidate prostheses/devices)); paragraph [0061], referring to statistical shape modeling being used in analysis as disclosed in Figures 8-13(b) and an optimal prosthesis or device deployment position and axis orientation within the lumen is determined; Figure 8);
performing, via the at least one processor, a biomechanical interaction analysis to select one of the identified potential prostheses based on a risk of migration within the lumen of each of the identified potential prostheses (paragraph [0009], referring to the software including a biomechanical interaction module that is programmed to predict and evaluate the biomechanical interaction between the device and the host anatomy; paragraphs [0054]-[0061], referring to the biomechanical interaction analysis/module wherein one of the top scoring/best candidates for implant, device position and corresponding device axis is identified, wherein paragraphs [0054], [0056] and [0060] in particular refer to the software providing assessments on post-implant risks, including device migration and further paragraph [0057] discloses that the biomechanical interaction is summarized using device and anatomy geometrical parameters/factors/identifiers, wherein the parameters/factors/identifiers may be measured for anatomy on device based landing planes of a landing zone candidate for critical phases, or all phases, of the cardiac cycle (e.g., systole and diastole)); and
outputting, via the at least one processor, an indication of the selected prosthesis and the landing zone for the selected prosthesis (paragraph [0060], referring to the software outputting recommendations on device (model/size) as well as a suggested optimal position or zone for implantation including an implant position and device axis orientation; Figure 8).
However, Orth et al. do not specifically disclose that the biomechanical interaction analysis comprises a probabilistic mechanical force analysis and the probabilistic mechanical force analysis comprises a comparison between a migration force, in a first axial direction through the lumen, based on physiological pressure to a resistance force, in a second opposite axial direction through the lumen, that resists migration, wherein the resistance force includes an anatomical barrier force component based on anatomical shape factors.
Sharma et al. disclose a patient-specific hemodynamic assessment of virtual stent implantation in the aorta using medical image data for treatment planning and decision support, wherein the images are acquired over a period of time to cover one or more cardiac cycles (paragraphs [0001], [0003], [0012], [0014], note that a cardiac cycle would include diastole, and therefore the probabilistic force analysis would use diastole conditions). Fluid structure interaction (FSI) can be performed by coupling hemodynamics simulation to simulate the blood flow with the biomechanical simulation for the deformation of the aortic wall, wherein the aorta is modeled as a passive tissue whose motion is governed by a constitutive law and a Finite Element Model (FEM) may be used to solve the partial differential equations related to that law (paragraphs [0018]-[0019]; Figure 1). The wall motion of the aorta is driven by an internal force and an external force (paragraphs [0019]-[022], Figures 1-3). Virtual stent implantation is performed for each of the stable deformation configurations of the model , wherein a mesh (242) representing a stent is virtually implanted in the aorta (244) and the force generated by the deployment of the stent deforms the aortic wall locally at the anchored sections of the stent (paragraph [0025]-[0026]; Figures 1-2, 5; note that the hemodynamic assessment of virtual stent implantation as set forth in Figure 1 includes a probabilistic mechanical force analysis and it models the internal force, external force and force generated by the deployment of the stent, etc.). The fluid structure interactions are used to model the deformation, wherein modeling this deformation is crucial to assess the strength and the stent anchoring and its impact on the blood flow (paragraph [0025]). A stent can be selected and time for actual stent implantation and optimal placement and effectiveness of stent implantation may be determined (paragraph [0028]). Based on the forces shown in FIG. 5, the implantation of the stent in the aortic aneurysm is simulated virtually (paragraph [0026]). With such a framework, a different stent designs can be tested for each of the time stages in order to choose the optimal stent for the patient (paragraph [0026]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the biomechanical interaction analysis of Orth et al. comprise a probabilistic mechanical force analysis, as taught by Sharma et al., in order to provide a patient-specific hemodynamic assessment of virtual stent implantation using medical image data for treatment planning and decision support (paragraphs [0001], [0003], [0012]), assess the strength and the stent anchoring and its impact on the blood flow (paragraph [0025]), effectively select a stent, and determine a time for actual stent implantation and optimal placement and effectiveness of stent implantation (paragraph [0028]).
However, the above combined references do not specifically disclose that the probabilistic force analysis comprises a comparison between a migration force, in a first axial direction through the lumen, based on physiological pressure to a resistance force, in a second opposite axial direction through the lumen, that resists migration, wherein the resistance force includes an anatomical barrier force component based on anatomical shape factors.
Jones discloses providing blood flow simulations to describe the relationship between morphologic features of the aortoiliac vessels and distraction forces, wherein hemodynamic distraction forces are generated by blood pressure and blood flow and encourage migration of the stent graft and further are in the axial (flow) direction (pg. 1648, Abstract, right column, first full paragraph, note that the “distraction forces” correspond to the claimed migration force and is based on physiological pressure (i.e. blood pressure)). The hemodynamic distraction forces (i.e. migration force) act against fixation force to encourage migration that may eventually lead to late stent graft failure, wherein if the distraction force overcomes fixation force, migration carries the added risk of visceral vessel loss as well as endoleak, aneurysm expansion, and subsequent rupture (pg. 1648, Abstract; pg. 1649, left column, last paragraph, note that for the axial distraction/migration forces to “act against” the fixation/resistance force, requires that the fixation/resistance force acts in a second opposite axial direction through the lumen). CFD analysis was performed to understand the factors affecting distraction forces in fenestrated stent grafts, wherein fixation forces (i.e. resistance forces) are compared with compartment-specific total resultant distraction force (RDF) to predict stent graft failure (Abstract; pg. 1653, Section “Discussion”). The addition of one stented fenestration increased the initial fixation force (pg. 1653, right column, last paragraph-pg. 1654, left column, first paragraph, wherein the fixation/resistance force is thus dependent upon the addition of fenestrations and wherein a fenestration/hole corresponds to an anatomical shape factor and thus the resistance/fixation force includes an anatomical barrier force component based on anatomical shape factors; Figure 2, wherein a fenestration (F1) as depicted in Fig. 1 corresponds to an anatomical shape factor as it defines a shape).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the probabilistic force analysis of the above combined references comprise a comparison between a migration force, in a first axial direction through the lumen, based on physiological pressure to a resistance force, in a second opposite axial direction through the lumen, that resists migration, wherein the resistance force includes an anatomical barrier force component based on anatomical shape factors, as taught by Jones et al., in order to predict prosthesis/stent graft failure (Abstract; pg. 1653, Section “Discussion”).
With regards to claim 2, Orth et al. disclose that the anatomical shape factors include curvature and ellipticity (paragraph [0057], referring to anatomy geometrical parameters including curvature and cross-sectional ellipticity, etc.; paragraph [0036]; Figures 13A, B).
With regards to claim 5, Sharma et al. disclose that the resistance force includes at least one of a friction force component based on anatomical size and prosthesis specifications, and a prosthesis-tissue embedding force component based on a biomechanical interaction between prosthesis and tissue (paragraphs [0025]-[0026], referring to the virtual of stent deployment in the aorta, wherein the force generated by the deployment of the stent deforms the aortic wall locally at the anchored sections of the stent, wherein such a force at the anchored sections of the stent corresponds to a prosthesis-tissue embedding force component; Figures 1-2, 4-5). Jones et al. further discloses this limitation (i.e. resistance force includes at least one of a friction force component based on anatomical size and prosthesis specifications, and a prosthesis-tissue embedding force component based on a biomechanical interaction between prosthesis and tissue (pg. 1648, right column, first full paragraph; pg. 1653, right column, 2nd paragraph).
With regards to claim 6, Sharma et al. disclose that the force analysis comprises a finite element analysis (paragraphs [0019], referring to the use of a Finite Element Model (FEM)).
With regards to claim 9, Orth et al. disclose that the prostheses are prosthetic heart valves (paragraph [0040], referring to the stented prosthetic heart valves, such as bioprosthetic heart valve or a synthetic heart valve).
With regards to claim 10, Orth et al. disclose that the landing zone is within a pulmonary artery (paragraphs [0043], [0049], referring to the anatomy in which the stented prosthesis is to be implanted corresponds to a pulmonary artery).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orth et al. in view of Sharma et al. and Jones et al., as applied to claim 1 above, and further in view of von Jako et al. (US Pub No. 2008/0161680).
With regards to claim 7, as discussed above, the above combined references meet the limitations of claim 1. However, the above combined references do not specifically disclose that their method further comprises displaying the landing zone on a simulated intraoperative fluoroscopic image.
Von Jako et al. disclose an image guided surgical system and method for targeting the precise patient specific anatomical placement of implants with surgical navigation, wherein simulation software is used which comprises of using CT, MR, PET, ultrasound, X-ray or any suitable imaging technology is used to define the points/locations (i.e. loading zone) of the body which is critical for proper placement of an implant (Abstract; paragraphs [0044]-[0047]). The planning software will assist the surgeon to identify and mark the points/locations during the surgery (paragraphs [0044]-[0047]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the method of Orth et al. further comprise displaying the landing zone on a simulated intraoperative fluoroscopic image, as taught by von Jako et al., in order to provide proper placement of the implant (Abstract; paragraphs [0044]-[0047]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orth et al. in view of Sharma et al. and Jones et al., as applied to claim 1 above, and further in view of Zaeuner et al. (US Pub No. 2011/0153286).
With regards to claim 8, as discussed above, the above combined references meet the limitations of claim 1. However, they do not specifically disclose that their method further comprises displaying the landing zone on a live intraoperative fluoroscopic image for intraoperative visual guidance.
Zaeuner et al. disclose a method and system for virtual percutaneous valve implantation, wherein the virtual valve replacement framework allows for accurate navigation during the actual intervention (Abstract; paragraph [0032]). The optimal deployment position and orientation determined during the virtual planning stage can be superimposed on top of live fluoroscopic images and tracked during the actual procedure (paragraph [0032]). Clinicians can guide their deployment device to exactly match the virtual deployment point and proceed with the deployment at the optimal location determined using the virtual valve replacement (paragraph [0032]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the method of the above combined references further comprise displaying the landing zone on a live intraoperative fluoroscopic image for intraoperative visual guidance, as taught by Zaeuner et al., in order to allow clinicians to guide their deployment device to exactly match the virtual deployment point and proceed with the deployment at the optimal location determined using the virtual valve replacement, thus allowing for accurate navigation during the actual intervention (paragraph [0032]).
Allowable Subject Matter
Claim 21 is allowed.
The following is a statement of reasons for the indication of allowable subject matter:
With regards to claim 21, the prior art does not teach or suggest that the migration force is calculated based on a diastolic back pressure applied to the identified potential prosthesis, in combination with the other claimed steps.
Response to Arguments
Applicant’s arguments, see pgs. 8-9, filed July 9, 2026, with respect to the rejection of claim 21 have been fully considered and are persuasive. The 35 USC 103 rejection of claim 21 has been withdrawn.
With regards to claim 1, Applicant's arguments filed July 9, 2026 have been fully considered but they are not persuasive.
With regards to claim 1, Applicant argues that none of the cited references discloses that “….the resistance force includes an anatomical barrier force component based on anatomical shape factors”.
Examiner respectfully disagrees and points to pg. 1653, right column, last paragraph-pg. 1654, left column, first paragraph of Jones, which discloses that the addition of one stented fenestration increased the initial fixation force, and thus the fixation/resistance force is dependent upon the addition of fenestrations. Fenestrations/holes, which define/describe a shape, corresponds to an anatomical shape factor and thus the resistance/fixation force includes an anatomical barrier force component based on anatomical shape factors. Further, see Figure 2 of Jones, wherein a fenestration (F1) as depicted in Fig. 1 corresponds to an anatomical shape factor as it defines a shape.
Claim 1 therefore remains rejected under the previously applied references.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798
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