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 ACTION
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 1-3, 7, 8, 10-13, 18-20 are 22-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 13 of U.S. Patent No. 10,546,378. Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variant.
Instant application
10546378
1.A computer-implemented method of determining a size of an valve implant to be implanted in an organ, the method comprising:
accessing scanned images of the organ;
defining a 3-D valve annulus with respect to the organ based on the scanned images;
performing one or more measurements relating to at least one of the 3-D valve annulus or the organ; and
determining the size of the valve implant to be implanted based on the one or more measurements,
wherein determining the size of the implant to be implanted comprises:
generating a primitive shape to simulate the implant; and
verifying the primitive shape by visualizing the primitive shape overlaid on a visualization of the organ.
2. The computer-implemented method of claim 1, wherein performing the one or more measurements comprises one or more of:
calculating a 3-D surface area of the 3-D valve annulus;
calculating a circumference of a projection of the 3-D valve annulus; or
calculating a diameter of a projection of the 3-D valve annulus.
3. The computer-implemented method of claim 1, wherein performing the one or more measurements comprises one or more of:
measuring a distance between a first location and a second location with respect to the organ based on the scanned images; or
defining, based on the scanned images, an average diameter of at least one cross section of a lumen of the organ in a plane above or below the 3-D valve annulus.
7. The computer-implemented method of claim 1,wherein the organ is a patient's heart, and wherein performing the one or more measurements comprises at least one of:
measuring a distance between a first papillary muscle head and a second papillary muscle head;
measuring a distance from at least one papillary muscle head to the a _plane above or below the 3-D valve annulus;
measuring a distance from the at least one papillary muscle head to a geometric center of the defined 3-D valve annulus;
measuring a distance from a ventricular apex of the patient's heart to the geometric center of the defined 3-D valve annulus; or
measuring a distance from an atrium roof to the geometric center of the defined 3-D valve annulus.
8. The computer-implemented method of claim 3, wherein defining the average diameter of the at least one cross section of the lumen of the organ in the plane above or below the 3-D valve annulus comprises:
defining one or more cross-sections of the lumen of the organ above and or below the 3-D valve annulus;
capturing a contour of the lumen through each cross-section; and
extracting an average measurement for each cross-section.
10.The computer-implemented method of claim 3, wherein defining the average diameter of the at least one cross section of the lumen of the organ in the plane above or below the 3-D valve annulus comprises defining a plurality of average diameters of a plurality of cross sections of the lumen of the organ in at least one plane above and at least one plane below the 3-D valve annulus.
11. The computer-implemented method of claim 1, further comprising generating a 3-D model of the organ based on the scanned images, wherein the 3-D valve annulus is defined in the 3-D model of the organ, and wherein the one or more measurements are performed in the 3-D model of the organ.
12. The computer-implemented method of claim 11, wherein the organ is a patient's heart, and wherein generating the 3-D model comprises: obtaining an image of the patient's heart; calculating a 3-D model of a blood volume of the patient's heart; and reconstructing the patient's heart using the calculated 3-D model of the blood volume.
13. The computer-implemented method of claim 1, wherein the organ is a patient's heart, and wherein the 3-D valve annulus is of a mitral valve .
18. The computer-implemented method of claim 1, wherein the scanned images of the organ are at least one of CT images or MRI images.
19. see claim 1.
20. The computer-implemented method of claim 1, wherein the visualization of the organ comprises at least one of the scanned images of the organ or a 3-D model of the organ generated based on the scanned images.
22. The computer-implemented method of claim 1, wherein the implant is a valve implant.
23. The computer-implemented method of claim 13, wherein performing the one or more measurements comprises measuring a distance between a first papillary muscle head and a second papillary muscle head.
24.The computer-implemented method of claim 1, wherein defining the 3-D valve annulus comprises: defining control points with respect to the organ based on the scanned images; verifying the control points using one or more reformatted image views of the organ; and storing the control points for use with respect to the organ based on the scanned images.
25. The computer-implemented method of claim 24, wherein a spline is defined by selecting the control points.
26. The computer-implemented method of claim 1, wherein the 3-D valve annulus is of a pulmonary valve.
1. A computer-implemented method of determining a size of an implant to be implanted in an organ, the method comprising:
generating on a computing device a digital three-dimensional (“3-D”) model of the organ from scanned images of the organ;
defining an annulus in the 3-D model;
fitting a first plane through the annulus in the 3-D model;
measuring a separation between a first location and a second location in the 3-D model;
defining an average diameter of at least one cross section of the 3-D model around the annulus in a plane not coinciding with the first plane;
and determining the size of the implant to be implanted based on the measured separation and the average diameter.
9. . The method of claim 1, wherein determining the size of the implant to be implanted comprises:
generating a primitive shape to simulate the implant; and
verifying the primitive shape by visualizing the primitive shape overlaid on the scanned images of the organ.
Claim 1
defining an average diameter of at least one cross section of the 3-D model around the annulus in a plane not coinciding with the first plane;
Claim 1
defining an average diameter of at least one cross section of the 3-D model around the annulus in a plane not coinciding with the first plane;
2. The method of claim 1, wherein the annulus is of a mitral valve, and wherein the organ is a patient's heart, and wherein measuring the separation between the first location and the second location comprises measuring the separation between a first papillary muscle head and a second papillary muscle head in the 3-D model.
3. The method of claim 2, wherein measuring separation between the first papillary muscle head and the second papillary muscle head comprises: visualizing the inside of the heart's anatomy; and performing the measuring using a point to point measurement tool.
4. The method of claim 2, wherein measuring separation between the first papillary muscle head and the second papillary muscle head comprises: defining a second plane through the 3-D model intersecting a septum and an ascending aorta of the patient's heart; applying a cut function along the second plane to reveal a cutaway view of the patient's heart anatomy; and performing the measuring using a point to point measurement tool.
8. The method of claim 1, wherein the organ is a patient's heart and wherein measuring a separation between a first location and a second location in the 3-D model comprises at least one of: measuring a separation between a first papillary muscle head and a second papillary muscle head; measuring a separation from at least one papillary muscle head to the first plane; measuring a separation from at least one papillary muscle head to a geometric center of the defined annulus; measuring a separation from a ventricular apex of the patient's heart to the geometric center of the defined annulus; or measuring a distance from an atrium roof to the geometric center of the defined annulus.
11. The method of claim 1, wherein defining the average diameter of at least one cross section of the 3-D model around the annulus in the plane not coinciding with the first plane comprises: slicing the 3-D model above and below the first plane to obtain two or more cross-sections;
capturing a contour of lumen through each cross-section;
and extracting an average measurement for each cross-section.
11. The method of claim 1, wherein defining the average diameter of at least one cross section of the 3-D model around the annulus in the plane not coinciding with the first plane comprises: slicing the 3-D model above and below the first plane to obtain two or more cross-sections;
capturing a contour of lumen through each cross-section;
and extracting an average measurement for each cross-section.
Claim 1
5. The method of claim 2, wherein generating the 3-D model comprises: obtaining an image of the patient' s heart; calculating a 3-D model of a blood volume of the patient's heart;
and reconstructing the patient's heart using the calculated 3-D model of the blood volume.
2. The method of claim 1, wherein the annulus is of a mitral valve, and wherein the organ is a patient's heart, and wherein measuring the separation between the first location and the second location comprises measuring the separation between a first papillary muscle head and a second papillary muscle head in the 3-D model.
10. The method of claim 1, wherein the scanned images of the organ are at least one of CT images and MRI images.
claim 1.
Claim 2
Claim 2
Claim 6
Claim 7
Claim 13
Claims 1-3, 7, 8, 10-13 and 18-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 6-8, 10, 11, 13 and 30 of U.S. Patent No. 11,568,534. Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variant.
Instant application
11568534
1.A computer-implemented method of determining a size of an valve implant to be implanted in an organ, the method comprising:
accessing scanned images of the organ;
defining a 3-D valve annulus with respect to the organ based on the scanned images;
performing one or more measurements relating to at least one of the 3-D valve annulus or the organ; and
determining the size of the valve implant to be implanted based on the one or more measurements,
wherein determining the size of the implant to be implanted comprises:
generating a primitive shape to simulate the implant; and
verifying the primitive shape by visualizing the primitive shape overlaid on a visualization of the organ.
2. The computer-implemented method of claim 1, wherein performing the one or more measurements comprises one or more of:
calculating a 3-D surface area of the 3-D valve annulus;
calculating a circumference of a projection of the 3-D valve annulus; or
calculating a diameter of a projection of the 3-D valve annulus.
3. The computer-implemented method of claim 1, wherein performing the one or more measurements comprises one or more of:
measuring a distance between a first location and a second location with respect to the organ based on the scanned images; or
defining, based on the scanned images, an average diameter of at least one cross section of a lumen of the organ in a plane above or below the 3-D valve annulus.
7. The computer-implemented method of claim 1,wherein the organ is a patient's heart, and wherein performing the one or more measurements comprises at least one of:
measuring a distance between a first papillary muscle head and a second papillary muscle head;
measuring a distance from at least one papillary muscle head to the a _plane above or below the 3-D valve annulus;
measuring a distance from the at least one papillary muscle head to a geometric center of the defined 3-D valve annulus;
measuring a distance from a ventricular apex of the patient's heart to the geometric center of the defined 3-D valve annulus; or
measuring a distance from an atrium roof to the geometric center of the defined 3-D valve annulus.
8. The computer-implemented method of claim 3, wherein defining the average diameter of the at least one cross section of the lumen of the organ in the plane above or below the 3-D valve annulus comprises:
defining one or more cross-sections of the lumen of the organ above and or below the 3-D valve annulus;
capturing a contour of the lumen through each cross-section; and
extracting an average measurement for each cross-section.
10.The computer-implemented method of claim 3, wherein defining the average diameter of the at least one cross section of the lumen of the organ in the plane above or below the 3-D valve annulus comprises defining a plurality of average diameters of a plurality of cross sections of the lumen of the organ in at least one plane above and at least one plane below the 3-D valve annulus.
11. The computer-implemented method of claim 1, further comprising generating a 3-D model of the organ based on the scanned images, wherein the 3-D valve annulus is defined in the 3-D model of the organ, and wherein the one or more measurements are performed in the 3-D model of the organ.
12. The computer-implemented method of claim 11, wherein the organ is a patient's heart, and wherein generating the 3-D model comprises: obtaining an image of the patient's heart; calculating a 3-D model of a blood volume of the patient's heart; and reconstructing the patient's heart using the calculated 3-D model of the blood volume.
13. The computer-implemented method of claim 1, wherein the organ is a patient's heart, and wherein the 3-D valve annulus is of a mitral valve
18. The computer-implemented method of claim 1, wherein the scanned images of the organ are at least one of CT images or MRI images.
19. see claim 1.
20. The computer-implemented method of claim 1, wherein the visualization of the organ comprises at least one of the scanned images of the organ or a 3-D model of the organ generated based on the scanned images.
21. The computer-implemented method of claim 1, wherein the primitive shape comprises at least one cylinder.
22. The computer-implemented method of claim 1, wherein the implant is a valve implant.
23. The computer-implemented method of claim 13, wherein performing the one or more measurements comprises measuring a distance between a first papillary muscle head and a second papillary muscle head.
24.The computer-implemented method of claim 1, wherein defining the 3-D valve annulus comprises: defining control points with respect to the organ based on the scanned images; verifying the control points using one or more reformatted image views of the organ; and storing the control points for use with respect to the organ based on the scanned images.
25. The computer-implemented method of claim 24, wherein a spline is defined by selecting the control points.
26. The computer-implemented method of claim 1, wherein the 3-D valve annulus is of a pulmonary valve.
1. A computer-implemented method of determining a size of a valve implant to be implanted in an organ, the method comprising:
acquiring scanned images of the organ;
defining a 3-D valve annulus with respect to the organ based on the scanned images;
measuring a distance between a first location and a second location with respect to the organ based on the scanned images;
defining, based on the scanned images, an average diameter of at least one cross section of a lumen of the organ in a plane above or below the 3-D valve annulus;
and determining the size of the valve implant to be implanted based on the measured distance and the average diameter, wherein determining the size of the valve implant to be implanted comprises: generating a primitive shape to simulate the valve implant; and verifying the primitive shape by visualizing the primitive shape overlaid on a visualization of the organ.
Claim 1,
defining, based on the scanned images, an average diameter of at least one cross section of a lumen of the organ in a plane above or below the 3-D valve annulus;
Claim 1,
defining, based on the scanned images, an average diameter of at least one cross section of a lumen of the organ in a plane above or below the 3-D valve annulus;
4. The method of claim 3, wherein measuring the distance between the first papillary muscle head and the second papillary muscle head comprises: visualizing an inside of an anatomy of the patient's heart; and performing the measuring using a point to point measurement tool.
Claim 1,
defining, based on the scanned images, an average diameter of at least one cross section of a lumen of the organ in a plane above or below the 3-D valve annulus
Claim 1,
defining, based on the scanned images, an average diameter of at least one cross section of a lumen of the organ in a plane above or below the 3-D valve annulus
The computer-implemented method of claim 1, further comprising generating a 3-D model of the organ based on the scanned images, wherein the 3-D valve annulus is defined in the 3-D model and wherein the distance is measured in the 3-D model.
6. The method of claim 3, further comprising generating a 3-D model of the organ based on the scanned images, wherein the 3-D valve annulus is defined in the 3-D model and wherein the distance is measured in the 3-D model, wherein generating the 3-D model comprises: obtaining an image of the patient's heart; calculating a 3-D model of a blood volume of the patient's heart; and reconstructing the patient's heart using the calculated 3-D model of the blood volume.
3. The method of claim 1, wherein the 3-D valve annulus is of a mitral valve, and wherein the organ is a patient's heart, and wherein measuring the distance between the first location and the second location comprises measuring the distance between a first papillary muscle head and a second papillary muscle head.
10. The method of claim 1, wherein the scanned images of the organ are at least one of CT images and MRI images.
6. The method of claim 3, further comprising generating a 3-D model of the organ based on the scanned images, wherein the 3-D valve annulus is defined in the 3-D model and wherein the distance is measured in the 3-D model, wherein generating the 3-D model comprises: obtaining an image of the patient's heart; calculating a 3-D model of a blood volume of the patient's heart; and reconstructing the patient's heart using the calculated 3-D model of the blood volume.
30. The method of claim 1, wherein the primitive shape comprises at least one cylinder.
1. A computer-implemented method of determining a size of a valve implant to be implanted in an organ,
3. The method of claim 1, wherein the 3-D valve annulus is of a mitral valve, and wherein the organ is a patient's heart, and wherein measuring the distance between the first location and the second location comprises measuring the distance between a first papillary muscle head and a second papillary muscle head.
7. The method of claim 1, wherein defining the 3-D valve annulus comprises: defining control points with respect to the organ based on the scanned images; verifying the control points using one or more reformatted image views of the organ; and storing the control points for use with respect to the organ based on the scanned images.
8. The method of claim 7, wherein a spline is defined by selecting the control points.
13. The method of claim 1, wherein the 3-D valve annulus is of a pulmonary valve.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 7, 11, 13, 18-23 and 26 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zaeuner et al. (US 2011/0153286).
With respect to claim 1, Zaeuner et al. teach a computer-implemented method of determining a size of an valve implant to be implanted in an organ, the method comprising: (Abstract: A method and system for virtual percutaneous valve implantation is disclosed. A patient-specific anatomical model of a heart valve is estimated based on 3D cardiac medical image data and an implant model representing a valve implant is virtually deployed into the patient-specific anatomical model of the heart valve, para [0005], The present invention provides a method and system of virtual valve implantation for planning, guidance, and assessment of percutaneous valve implantation techniques);
accessing scanned images of the organ (para [0020], Referring to FIG. 1, at step 102, 3D cardiac medical image data is received; the 3D medical image data may include image data may be obtained from CT, Dyna CT--C-arm 3D reconstruction, MRI, or 3D echocardiography);
defining a 3-D valve annulus with respect to the organ based on the scanned images(para [0006] In one embodiment of the present invention, a patient-specific anatomical model of a heart valve is estimated based on 3D cardiac medical image data. Para [0022] FIG. 2 illustrates an aortic valve and ascending aortic root model);
performing one or more measurements relating to at least one of the 3-D valve annulus or the organ (para [0026] Each implant model includes two parts: a geometric representation, or "stent mesh", which precisely mimics the exact geometry of the device, and a second superimposed 2-simplex mesh, or "computational mesh", which is used for accurate and efficient computation and to guide the expanding deformation of the implant model; Para [0027] In order to infer the geometrical properties of the stent model, various dimensions can be measured from stereolithographic scans of the modeled implants. These geometrical properties are the strut lengths, the characteristic angles in each cell, and the device's circumferences at each level, where each level is defined by the strut joints; para [0031] 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); and
determining the size of the valve implant to be implanted based on the one or more measurements, wherein determining the size of the implant to be implanted comprises: generating a primitive shape to simulate the implant; and verifying the primitive shape by visualizing the primitive shape overlaid on a visualization of the organ(Para [0026], FIG. 1, at step 106, one or more implant models (primitive shape) are virtually deployed into the patient-specific model of the valve; Para [0031], using the virtual-deployment framework various implants can be tested and compared to select the best implant and implant size. The virtual valve deployment results may be output as a visualization of the implant model in the patient-specific valve model. By simulating the procedure visually, physicians can predict complications of the procedure and minimize risks of the procedure).
With respect to claim 2, Zaeuner et al. teach that performing the one or more measurements relating to the 3=D valve annulus comprises one or more of: calculating a 3-D surface area of the 3-D valve annulus; calculating a circumference of a projection of the 3-D valve annulus; or calculating a diameter of a projection of the 3-D valve annulus. (para [0029] – [0030], Fig. 5, (c) represent fcirc which enforces the circumference, At step 604, computational mesh fcirc (pin) are calculated).
With respect to claim 3, Zaeuner et al. teach performing one or more measurements relating to the organ, wherein performing the one or more measurements relating to the organ comprises one or more of: measuring a distance between a first location and a second location with respect to the organ based on the scanned images; or defining, based on the scanned images, an average diameter of at least one cross section of a lumen of the organ in a plane above or below the 3-D valve annulus. (para [0036] calculating the distances of the segmented device to various anatomical landmarks of the patient-specific anatomical model).
With respect to claim 7, Zaeuner et al. teach that the organ is a patient's heart, and wherein performing the one or more measurements comprises at least one of: measuring a distance between a first papillary muscle head and a second papillary muscle head; measuring a distance from at least one papillary muscle head to the a _plane above or below the 3-D valve annulus; measuring a distance from the at least one papillary muscle head to a geometric center of the defined 3-D valve annulus; measuring a distance from a ventricular apex of the patient's heart to the geometric center of the defined 3-D valve annulus; or measuring a distance from an atrium roof to the geometric center of the defined 3-D valve annulus. (para [0036] calculating the distances of the segmented device to various anatomical landmarks of the patient-specific anatomical model).
With respect to claim 11, Zaeuner et al. teach that generating a 3-D model of the organ based on the scanned images, wherein the 3-D valve annulus is defined in the 3-D model of the organ, and wherein the one or more measurements are performed in the 3-D model of the organ. (Fig. 4, para [0027], geometrical properties of the stent model, various dimensions can be measured from stereolithographic scans of the modeled implants).
With respect to claim 13, Zaeuner et al. teach that the organ is a patient's heart, and wherein the 3-D valve annulus is of a mitral valve. (para [0024])
With respect to claim 18, Zaeuner et al. teach that the scanned images of the organ are at least one of CT images or MRI images. (para [0020]).
Claim 19 is rejected as same reason as claim 1 above.
With respect to claim 20, Zaeuner et al. teach that the visualization of the organ comprises at least one of the scanned images of the organ or a 3-D model of the organ generated based on the scanned images (para [0025], Fig. 3).
With respect to claim 21, Zaeuner et al. teach that the primitive shape comprises at least one cylinder (Fig. 4 and 5).
With respect to claim 22, Zaeuner et al. teach that the implant is a valve implant. (para [0027]).
With respect to claim 23, Zaeuner et al. teach that performing the one or more measurements comprises measuring a distance between a first papillary muscle head and a second papillary muscle head (para [0036] calculating the distances of the segmented device to various anatomical landmarks of the patient-specific anatomical model).
With respect to claim 26, Zaeuner et al. teach that the 3-D valve annulus is of a pulmonary valve.(para [0005]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Randolph Chu whose telephone number is 571-270-1145. The examiner can normally be reached on Monday to Thursday from 7:30 am - 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Matthew Bella can be reached on (571) 272-7778.
The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RANDOLPH I CHU/
Primary Examiner, Art Unit 2663
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