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 .
Notice to Applicant
Limitations appearing inside of {} are intended to indicate the limitations not taught by said prior art(s)/combinations.
Claims 1-23 are pending in the application.
Response to Amendment
This office action is in response to amendment filed on 04/01/2026. Claims 1-15 are amended. Claims 16-20 are original. Claims 21-23 are new. Correction to specification has been entered and the objection to the drawings has is withdrawn. The rejection under 35 USC §101 is maintained. The rejections of claims 1-20 under 35 USC §112(b) are withdrawn in light of the amended claims.
Response to Arguments/Remarks
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The rejection under 35 USC §101 is maintained because the amended claim recites “computer-readable medium” which is interpreted as a signal per se. A signal is not a statutory category.
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 1-12, and 21-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one -of the four categories of patent eligible subject matter (i.e., process machine, manufacture, or composition of matter) because the claim, reciting a model of a heart valve device, is directed to a program/signal per se, mere information in the form of data, without a tangible medium. Note, it is not necessary for a claim to fall into a single category, as long as it is clear that it falls into at least one category (see MPEP §2106.03).
Examiner recommends the wording “non-transitory computer-readable medium”.
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.
Claims 1-5, 8, 11-17, and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over “Gessat” (Gessat, M., et al., "Image-based mechanical analysis of stent deformation: concept and exemplary implementation for aortic valve stents", IEEE Trans Biomed Eng, 2014. 61(1): p. 4-15.), as cited in the IDS (02/22/2024), in view of “Gunning” (Gunning, P.S., Vaughan, T.J. & McNamara, L.M. Simulation of Self Expanding Transcatheter Aortic Valve in a Realistic Aortic Root: Implications of Deployment Geometry on Leaflet Deformation. Ann Biomed Eng 42, 1989–2001 (2014). https://doi.org/10.1007/s10439-014-1051-3).
Regarding claim 1, Gessat teaches a computer-readable medium comprising instructions when executed causing a processor to generate a of an in vivo heart valve device implanted in a patient, by:
obtaining a computer-aided design (CAD) model of a pre-implantation heart valve device (Gessat, [p7, §II.C., col 2, ¶2], A reference model of the stent in its undeformed (unloaded) state was created based on microCT images of CoreValves that were acquired under no mechanical load (other than gravity); and See Fig 2 appears to exhibit a CAD mode of a stent (i.e., pre-implantation heart valve device)
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performing an imaging scan on the patient having an implanted heart valve device to obtain at least one patient specific landmark associated with the implemented heart valve device (ECG-gated Chest CTs were collected from patients who had undergone CoreValve implantation and given their consent for accessing their data; Gessat, [p 6, §II.B., Col 2, ¶1]; The objective of the image preprocessing performed to this point was the identification of the voxels which very likely belong to the stent; [p 7, §II.C., col 1, ¶1];… those 15 landmarks with the highest level of confidence are selected; [p 7, §II.C., col 2, ¶4]); and
performing a stent {registration} process comprising deforming the CAD model to align it with the implanted heart valve device based on fitting of the at least one patient specific landmark (Gessat, [p4, §II.C., col 2, ¶3] teaches stent registration process: Principal component analysis is applied to find the center of gravity (mean) and the longest axis of the landmark candidates. The reference model is registered according to this axis and the mean; teaches deforming the model: [p 9, §II.D.3., col 1, ¶1-2] An incremental routine using alternating straining and relaxation steps is employed to move the landmark coordinates P = {pi, i ∈ [1, 165]} from the initial positions P0 to more accurate positions Pn (i.e. fitting the landmarks); After a couple of iterations (in practice 3 to 5), all nodes moved to a local minimum of the overall stent energy),
applying transformation functions obtained from the stent registration process to an original geometry file of the CAD model to obtain a constructed patient-specific valve model (Gessat, [p 6, §III.E., col 1, ¶1]; The reaction forces fi,n in the springs are transformed to these coordinate systems and only the radial component is used for the analysis of the radial force between the stent and the tissue); and
{simulating a valve leaflet and skirt for the constructed patient-specific valve model by computational simulation with boundary conditions derived from the stent registration process}. Gessat does not explicitly disclose simulating a valve leaflet and skirt for the constructed patient-specific valve model by computational simulation with boundary conditions derived from the stent registration process.
However, Gunning, a similar field of endeavor of TAVR simulation, teaches simulating a valve leaflet and skirt for the constructed patient-specific valve model by computational simulation with boundary conditions derived from the stent registration process ([Gunning, p1990, §Materials and Methods. Transcatheter Aortic Valve Model, col 1, ¶1]; A self expanding Nitinol TAVR was modeled in this study, consisting of a self expanding valve stent, a paravalvular skirt and pericardial tissue leaflets).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a simulation of the valve leaflet and skirt as taught by Gunning to the invention of Gessat. The motivation to do so would be to obtain a realistic patient-specific aortic root model and compare leaflet stresses and closing kinematics to TAVRs deployed in idealized orifices..
Regarding claim 2, the combination of Gessat and Gunning teaches the computer-readable medium of claim 1. Gessat further teaches wherein the constructed patient-specific valve model accurately represents the geometries of the implanted heart valve device in its current in vivo form with an error less than 0.5 mm (Gessat Fig 9 exhibits standard deviations (i.e., errors) falling below 0.1mm, and a final mean circumferential error below 1 mm, [Gessat, p 14, §V, col 1, ¶2]).
Regarding claim 3, the combination of Gessat and Gunning teaches the computer-readable medium of claim 1. Gessat further teaches wherein the CAD model of the pre-implantation heart valve device is reconstructed from a micro-CT scan of the pre-implantation valve (A reference model of the stent in its undeformed (unloaded) state was created based on microCT images of CoreValves that were acquired under no mechanical load (other than gravity). Gessat, [p 7, §II.C., col 2, ¶2]).
Regarding claim 4, the combination of Gessat and Gunning teaches the computer-readable medium of claim 1. Gessat further teaches wherein the heart valve device is a transcatheter aortic valve (TAV), a transcatheter mitral valve (TMV), a bioprosthetic surgical valve (SAV), a metal or radiopaque implant (we present an exemplary implementation of the concept applied to the stent of the Medtronic CoreValve revalving System, which is one of the two most frequently used TAVI (transcatheter aortic valve implantation)Prostheses; Gessat, [p 5, §I. A., col 1, ¶2]).
Regarding claim 5, the combination of Gessat and Gunning teaches the computer-readable medium of claim 1. Gessat further teaches wherein the constructed patient-specific valve model further comprises a model for patient-specific post-surgical evaluation and assessment (Our approach, however, uses FEM for retrospective analysis of the observed postinterventional situation of the aortic root; Gessat, [p 5, §I.B., col 2, ¶2]).
Regarding claim 8, the combination of Gessat and Gunning teaches the computer-readable medium of claim 1. Gessat further teaches wherein the imaging scan is a CT scan or an MRI scan (A reference model of the stent in its undeformed (unloaded) state was created based on microCT images of CoreValves that were acquired under no mechanical load (other than gravity); Gessat, [p 7, §II.C., Col 2, ¶2]).
Claim 11 is similarly analyzed as analogous claim 1.
Claim 12 is similarly analyzed as analogous claim 2.
Claim 13 is similarly analyzed as analogous claim 1.
Claim 14 is similarly analyzed as analogous claim 2.
Claim 15 is similarly analyzed as analogous claim 3.
Claim 16 is similarly analyzed as analogous claim 4.
Claim 17 is similarly analyzed as analogous claim 5.
Claim 20 is similarly analyzed as analogous claim 8.
Regarding claim 21, the combination of Gessat and Gunning teaches the computer-readable medium of claim 1. Gunning further teaches wherein the computational simulation comprises finite element analysis (FEA) (Gunning, [§Materials and Methods, p 1994, col 1, ¶1]; Simulations were performed using Abaqus Explicit 6.12. Abaqus is a type of FEA according to the software company (https://www.3ds.com/products/simulia/abaqus.)).
Claims 22 and 23 are similarly analyzed as analogous claim 21.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Gessat in view of Gunning and further in view of “Sakuragi” (Sakuragi, US 20200357127 A1).
Regarding claim 10, the combination of Gessat and Gunning teaches the computer-readable medium of claim 1. Gessat further teaches wherein the stent registration process is performed based on a {multi-pass} registration framework (Gessat teaches a -pass framework for registration, however it is not a multi-pass framework; (Gessat, teaches stent registration process: [p4, §II.C., col 2, ¶3] Principal component analysis is applied to find the center of gravity (mean) and the longest axis of the landmark candidates. The reference model is registered according to this axis and the mean. Gessat further teaches incremental routine using alternating straining and relaxation steps: [p 9, §II.D Relaxation 3) Incremental Stent Relaxation, col 1, ¶1] An incremental routine using alternating straining and relaxation steps is employed to move the landmark coordinates P = {pi, i ∈ [1, 165]} from the initial positions P0 to more accurate positions Pn), however this “straining and relaxation” is not equivalent to “stent registration”.) Gessat does not explicitly teach a multi-pass registration framework.
However, Sakuragi, a similar field of endeavor a registration method in stent deployment, teaches wherein the stent registration process is performed based on a multi-pass registration framework (Sakuragi, [0062] The second registration unit 26 registers the first stent region As1 and the second stent region As2 on the basis of the first registration result to acquire a second registration result.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a multi-pass registration framework as taught by Sakuragi to the combined invention of Gessat and Gunning. The motivation to do so would be to adjust parameters for correcting the difference between stent and patient-specific anatomy when quantifying the amount of movement and the amount of deformation of the stent.
Claims 6-7, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Gessat in view of Gunning, and further in view of Morganti (Morganti S et al: "Simulation of transcatheter aortic valve implantation through patient-specific finite element analysis: Two clinical cases", JOURNAL OF BIOMECHANICS, PERGAMON PRESS, NEW YORK, NY, US, vol. 47, no. 11, 20 June 2014 (2014-06-20), pages 2547-2555, XP029015301, ISSN: 0021-9290, DOI: 10.1016/J.JBIOMECH.2014.06.007.), as cited in the IDS (05/06/2025).
Regarding claim 6, the combination of Gessat and Gunning teaches the computer-readable medium of claim 1. The combination does not explicitly disclose wherein the constructed patient-specific valve model further comprises a high-fidelity pre-surgical evaluation or modeling interventional pre-procedural planning necessary for heart valve device replacement or reconstruction.
However, Morganti, a similar field of endeavor of realistic TAVI simulation, teaches wherein the constructed patient-specific valve model further comprises a high-fidelity pre-surgical evaluation or modeling interventional pre-procedural planning necessary for heart valve device replacement or reconstruction (See Fig 5, shown below, exhibits computer simulation of TAVI procedural; Computational analyses, which take into account both the patient-specific structure of the native aortic valve and an accurate evaluation of calcifications, can be used to predict several parameters which, being of clinical interest, can support and guide device selection. In the present work, a complete frame work to reproduce transcatheter aortic valve implantation has been developed and applied to two real clinical cases; Morganti, [p 2551, §4, col 2, ¶1];
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include pre-surgical evaluation as taught by Morganti to the combined invention of Gessat and Gunning. The motivation to do so would be to predict the post-operative performance of the prosthesis with respect to the specific anatomical features.
Regarding claim 7, the combination of Gessat, Gunning, and Morganti teaches the computer-readable medium method of claim 6. Gessat further teaches wherein the high-fidelity pre-surgical evaluation comprises developing a boundary condition in the Valve-in-Valve (ViV) (See Fig 4, shown below, exhibits “5. Computation of inner and outer boundaries based on maximum of each sector”; and “Based on the maxima in all sectors, the stent boundaries are approximated according to the known thickness of the strings, Gessat, [p 7, §II.B., col 2, ¶1]).
Claim 18 is similarly analyzed as analogous claim 6.
Claim 19 is similarly analyzed as analogous claim 7.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gessat in view of Gunning, and further in view of “Faquir” (El Faquir, N., et al., "Patient-Specific Computer Simulation in TAVR With the Self-Expanding Evolut R Valve", JACC Cardiovasc Interv, 2020. 13(15): p. 1803-1812.), as cited in the IDS (02/22/2024).
Regarding claim 9, the combination of Gessat and Gunning teaches the computer-readable medium of claim 1. Gessat further teaches, wherein no more than {twelve} patient specific landmarks are obtained from the imaging scan (15 landmarks with the highest level of confidence are selected; Gessat, [p 7, §II. C., col 2, ¶4]). Gessat does not explicitly teach no more than twelve patient specific landmarks.
However, Faquir, a similar field of endeavor patient-specific computer simulation of transcatheter aortic valve implantation, teaches wherein no more than twelve patient specific landmarks (Faquir, [p 1805, Col 1, §Methods. Assessment of Valve Performance, ¶1]; PVL locations were assigned to 1 or more of the 12 locations on the basis of a clockface model in the cross-sectional parasternal short-axis view. See excerpt of Figure 3, shown below, exhibits 12 points of the valve detectable in the medical image:
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include no more than 12 landmarks as taught by Faquir to the combined invention of Gessat and Gunning. The motivation to do so would be to obtain the landmarks available on the specific make and manufacture of valve that may contain no more than 12.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Azadani, US 20200188094 A1, teaches optimizing a shape of a replacement valve leaflet, wherein the shape of the replacement valve leaflet is determined by defining variable parameters of the replacement valve leaflet.
Mortier et al., US 20190357981 A1, teaches simulation of TAV deformation in a patient-specific model and would have been relied upon for teaching 3D representations of the cardiac valve implant.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANDHANA PEDAPATI whose telephone number is (571)272-5325. The examiner can normally be reached M-F 8:30am-6pm (ET).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chan Park can be reached at 5712727409. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHANDHANA PEDAPATI/ Examiner, Art Unit 2669
/CHAN S PARK/ Supervisory Patent Examiner, Art Unit 2669
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