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 .
Detailed
This is in response to the amendment filed 09/13/2024.
Allowable Subject Matter
Claims 4, 6, 7, 8,10, 12, 13, 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: claim 4 recites wherein segmenting the one or more digital images comprises verifying a geometry of the leaflets identified in multiple digital images, claims 6, 7 recite wherein connecting the one or more first ones of the modeled structures to the one or more second ones and the one or more third ones comprises clustering the modeled chordae into circular zones on each modeled leaflet, each circular zone corresponding to a location of the multiple locations on the modeled papillary muscles, wherein calibrating the CAD model comprises: determining an initial chordae length for the modeled chordae based on a thermal analysis of the CAD model in a systole condition and in a diastole condition; simulating movement of the modeled structures in the CAD model by iteratively determining modeled leaflet positions, orifice areas for the modeled leaflet positions, and pressures applied to the modeled leaflets, the pressures being determined using the second hemodynamics model and the orifice areas; determining a distance error between the simulated movement and a position of the mitral valve in the one or more digital images; and in response to determining that the distance error exceeds a threshold distance error, adjusting geometries of the modeled leaflets, a number of the modeled chordae, chordae insertion locations of the modeled chordae, or modeled chordae lengths to correct the distance error. Claim 8 recites further comprising extending, by the data processing system, the modeled annulus in the CAD model to represent tissue in association with the mitral valve, claim 10 recites wherein generating the CAD model comprises generating modeled leaflet geometry at a diastole condition of the mitral valve, and generating modeled leaflet geometry at a systole condition of the mitral valve, wherein performing treatment simulations using the CAD model comprises placing a model of a medical device in contact with one or more of the modeled structures in the CAD model of the mitral valve. Claim 14 recites wherein specified area comprises: defining two or more parallel cut planes in the CAD model; forming one or more connected segments; determining a coaptation point and a coaptation length on each of the two or more parallel cut planes based on the one or more connected segments; and determining the specified area based on the coaptation length and a distance between two parallel cut planes of the two or more parallel cut planes. Claim 15 recites wherein the first and the second hemodynamics models comprise parameters determined by minimizing a difference between outputs of the first and the second hemodynamics models and corresponding measurements from the patient and literature data. Claim 16 recites generating clinical metrics for use in assessment of mitral valve regurgitation in pre-operative and post-operative states of treated patients, wherein the clinical metrics include left atrial pressure, transmitral pressure gradient, and mitral valve regurgitant volume. Claim 18 recites determining an initial chordae length for the modeled chordae based on a thermal analysis of the CAD model in a systole condition and in a diastole condition; simulating movement of the modeled structures in the CAD model by iteratively determining modeled leaflet positions, orifice areas for the modeled leaflet positions, and pressures applied to the modeled leaflets, the pressures being determined using the second hemodynamics model and the orifice areas; determining a distance error between the simulated movement and a position of the mitral valve in the one or more digital images; and in response to determining that the distance error exceeds a threshold distance error, adjusting geometries of the modeled leaflets, a number of the modeled chordae, chordae attachment locations of the modeled chordae, or modeled chordae lengths to correct the distance error.
The Office agrees the art of record fails to teach or suggest these features.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5, 17, 19, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Finite Element Analysis of Patient-Specific Mitral Valve with Mitral Regurgitation, Annals of Biomedical Engineering Kluwer Academic Publishers-Plenum Publishers, NE, vol. 41, no. 1, 18 July 2012 (2012-07-18), pages 142-153, XP035138772, ISSN:S10439-012-0620-6 (Wang et al.)
Regarding claims 1, 3, 5, 17, 19 Wang et al. discloses as shown in page 6, a method implemented by a data processing system for generating a patient specific computer-aided design (CAD) model of a mitral valve; see abstract; the method comprising: receiving, by a data processing system, one or more digital images of a mitral valve of a patient; see page 4, col. 2, paragraphs 2, 4; segmenting, by the data processing system, the one or more digital images to identify structures of the mitral valve; see page 4, col. 2, paragraphs 2, 3, 5; generating, by the data processing system, a CAD model of the mitral valve, the CAD model comprising data for modeled structures representing the identified structures of the mitral valve; see page 5, paragraph 1; connecting, by the data processing system in the CAD model, one or more first ones of the modeled structures to one or more second ones of the modeled structures and third ones of the modeled structures, the one or more first ones connecting to the one or more second ones and third ones at multiple locations; see page 5, paragraph 3; determining, by the data processing system, one or more first loading conditions for the modeled structures in the CAD model using a first hemodynamics model; simulating, by the data processing system, movement of the modeled structures in the CAD model based on the first loading conditions applied to the modeled structures; see page 6, Boundary and Loading Conditions; determining, by the data processing system, a specified area based on the CAD model; see page 6, section “Boundary and Loading Conditions”; determining, by the data processing system, one or more second loading conditions using a second hemodynamics model that receives data representing the specified area as an input; see page 7, paragraph 2; and calibrating, by the data processing system, the CAD model by modifying a configuration of one or more first ones of the modeled structures and one or more second ones of the modeled structures in the CAD model; see page 7, paragraph 2; with the modifying based on (i) the one or more second loading conditions determined using the second hemodynamics model, and (ii) positions of the modeled structures in the CAD model based on the movement of the modeled structures in the CAD model in comparison to positions of the identified structures, wherein the identified structures comprise an annulus, leaflets, papillary muscles, and chordae, wherein the modeled structures comprise a modeled annulus, modeled leaflets, modeled papillary muscles, and modeled chordae based on the identified structures, wherein the one or more first ones comprise modeled chordae, the one or more second ones comprise the model leaflets, the one or more third ones comprise the modeled papillary muscles, and the fourth one comprises the modeled annulus. see page 7, paragraph 2.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Finite Element Analysis of Patient-Specific Mitral Valve with Mitral Regurgitation, Annals of Biomedical Engineering Kluwer Academic Publishers-Plenum Publishers, NE, vol. 41, no. 1, 18 July 2012 (2012-07-18), pages 142-153, XP035138772, ISSN:S10439-012-0620-6 (Wang et al.) in view of U.S. Patent Publication Number 20120308094 (Harish)
Wang et al. fails to disclose wherein segmenting the one or more digital images comprises rotating the one or more digital images to align with an annulus plane of the mitral valve.
Harish, from a related field of endeavor teaches a similar method as shown in Figure 1, where the method includes the step of segmenting the one or more digital images comprises rotating the one or more digital images to align with a plane of body tissue, for the purpose of normalizing images. See paragraph [0034].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to include the steps of wherein segmenting the one or more digital images comprises rotating the one or more digital images to align with a plane such that wherein segmenting the one or more digital images comprises rotating the one or more digital images to align with an annulus plane of the mitral valve in order to normalize the images.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Finite Element Analysis of Patient-Specific Mitral Valve with Mitral Regurgitation, Annals of Biomedical Engineering Kluwer Academic Publishers-Plenum Publishers, NE, vol. 41, no. 1, 18 July 2012 (2012-07-18), pages 142-153, XP035138772, ISSN:S10439-012-0620-6 (Wang et al.) in view of U.S. Patent Publication Number 2021/0158541 (Figueroa-Alvarez et al.)
Regarding claim 9, Wang fails to disclose wherein the first and the second hemodynamics models comprise first and second lumped parameter hemodynamics models.
Figueroa-Alvarez et al., from the same field of endeavor teaches a similar method as shown in Figure 1, wherein hemodynamics models include lumped parameter hemodynamics model. See paragraph [0060].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Wang by substituting the first and the second hemodynamics models disclosed by Wang for the hemodynamics models taught by Figueroa-Alvarez et al. such that the first and the second hemodynamics models comprise first and second lumped parameter hemodynamics models because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Finite Element Analysis of Patient-Specific Mitral Valve with Mitral Regurgitation, Annals of Biomedical Engineering Kluwer Academic Publishers-Plenum Publishers, NE, vol. 41, no. 1, 18 July 2012 (2012-07-18), pages 142-153, XP035138772, ISSN:S10439-012-0620-6 (Wang et al.) in view of U.S. Patent Publication Number 2007/004 (Schwartz)
Regarding claim 11, Wang et al. fails to disclose comprising treating a patient based on performing pre-operative simulations and treatment simulations using the CAD model of the mitral valve.
Schwartz, from the same field of endeavor teaches a similar method as shown in Figure 1, treating a patient based on performing pre-operative simulations. See paragraph [0102].
It would have been obvious to one of ordinary skill in the art, before the effective to modify the method disclosed by Wang to include the step of treating a patient based on performing pre-operative simulations such that the method includes treating a patient based on performing pre-operative simulations and treatment simulations using the CAD model of the mitral valve in order to treat a patient based on the simulations generated, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
.Conclusion
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771
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