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 Applicants
This communication is in response to the amendment filed on 07/20/2026.
Claim 1-5 and 7-21 are pending. Claim 6 has been cancelled.
Claims 1-5 and 7-21 remain rejected.
Response to Arguments
Applicant’s arguments and amendments with respect to claim(s) 1-5 and 7-21 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.
For claim 14, applicant’s amendments and arguments (cited on page 10 of the remarks filed on 07/20/2026) with respect to the limitations, “… model to determine an annuloplasty ring to implant along a surface of an annulus of the heart valve” have been considered, but PIAZZA discloses creating a 3-D cardiac model from scans, analyzing annular and papillary geometry (distances between papillary muscle heads, diameters around the annulus), and using those measurements to determine the size of an implant to be implanted ([0010] The method may include generating a three-dimensional (“3-D”) model of a patient's heart from scanned images of the patient's heart and defining a 3-D mitral valve annulus. The method may also include fitting a plane through the 3-D mitral valve annulus. Distance may be measured between a first papillary muscle head and a second papillary muscle head in the 3-D model, and an average diameter of at least one cross section around the mitral valve annulus may be defined. The method may further include determining a size of an implant to be implanted; [0039] based on the measurements taken … , and appropriately sized mitral valve device may then be selected). The implant determined from the measured 3-D mitral annulus model functionally and structurally maps to determining an annuloplasty ring to implant along the annulus surface.
Even though PIAZZA discloses the above applicant’s amendments in claim 14, the applicant’s arguments are moot because the new ground of rejection does not rely on reference(s) applied in the prior rejection of record for teaching or matter specifically challenged in the argument.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 1 and 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over PIAZZA et al. (U.S. Publication No. 2025/0045920) (hereafter, "PIAZZA") in view of Lang (U.S Publication No. 2025/0173879).
Regarding claim 1, PIAZZA teaches a system comprising ([0029] the computing environment 100; [0031] The computer system 200): control circuitry ([0031] a processor 202); and memory communicatively coupled to the control circuitry and storing executable instructions that, when executed by the control circuitry, cause the control circuitry to perform operations comprising ([0031] The computer system 200 may generally take the form of computer hardware configured to execute certain processes and instructions ... The computing device 200 includes a processor 202; [0032] The computing device 200 may further include memory 208 ... the memory 208 may include volatile memory 210. The volatile memory 210 may be some form of random access memory, and may be generally configured to load executable software modules into memory so that the software modules may be executed by the processor 202 in a manner well known in the art): receiving image data depicting a heart valve and ([0035] quantification of space and/or volume of a particular area of a patient's anatomy, in this example the mitral valve … Process begins at block 302, wherein image of the patient's heart acquired. The image may be acquired using the scanning device 112 shown in FIG. 1, such as a CT scanner or an MRI machine; [0029] the scanning device 112 may be configured to create cross-sectional images of a patient's heart. Those images may be stored in the image data storage 106, and utilized to create three-dimensional models of the heart) … identifying one or more image features in the image data that represent one or more anatomical features of the heart valve ([0035] The 3-D model may be calculated using the image processing module 108, or some other software and/or hardware designed to generate 3-D models from CT and/or MRI image data; [0036] Using the 3-D model of the blood volume, the anatomical structures of the heart may be reconstructed ... This reconstruction may also be performed using the image processing module 108. The reconstruction of the heart anatomy typically begins with segmentation of the left side of the heart; [0040] The sub process begins at block 401 where, using the image processing module, the mitral valve annulus is defined within the reconstructed heart model); based at least in part on the one or more image features, generating heart valve data indicating a measurement of the heart valve ([0040] The sub process begins at block 401 where, using the image processing module, the mitral valve annulus is defined within the reconstructed heart model … Once the mitral valve annulus has been defined, the process moves to block 403. There, the 3-D surface area of the mitral valve annulus is calculated … the 3-D surface area of the mitral valve annulus (the mitral surface) may be used as the fitting entity; [0038] With the mitral valve annulus defined, the measurements may further include calculation of the 3-D surface area of the mitral valve annulus based on the spline. Additional measurements and analysis may be performed relating to the mitral valve annulus) … obtaining annuloplasty ring data indicating one or more characteristics of an annuloplasty ring ([0037] the anatomy of the mitral valve apparatus is characterized by defining control points and taking measurements of relevant anatomical structures; [0046] A transcatheter mitral valve implant may include various metallic components. When implanted into the mitral valve annulus, it takes a specific height and shape. The height and shape of the implanted device may interact substantially with several anatomical structures within the patient; [0049] a primitive cylinder may be generated to simulate the implant; FIG. 18A); based at least in part on the heart valve data and the annuloplasty ring data, identifying the annuloplasty ring for implantation on the heart valve; and ([0049] The primitive cylinder may be generated based indirectly on the measurements determined in connection with FIG. 7, and also more directly based on the captured contour of the lumen of the mitral valve annulus obtained using the process described in connection with FIG. 8A above. Once the primitive cylinder has been created, the process then moves to block 813 where the primitive cylinder implant is verified by visualizing the contours of the objects overlaid on the original scanned images; [0041] At block 409, distance measurements are performed on the model in order to determine various dimensional attributes that may impact the size of the transcatheter mitral valve implant; [0039] at block 312, based on the measurements taken and the assessed vulnerabilities, and appropriately sized mitral valve device may then be selected; [0010] The method may include generating a three-dimensional (“3-D”) model of a patient's heart from scanned images of the patient's heart and defining a 3-D mitral valve annulus. The method may also include fitting a plane through the 3-D mitral valve annulus. Distance may be measured between a first papillary muscle head and a second papillary muscle head in the 3-D model, and an average diameter of at least one cross section around the mitral valve annulus may be defined. The method may further include determining a size of an implant to be implanted; [0060]) generating user interface data indicating the annuloplasty ring ([0058] FIG. 17 provides a visual illustration of one graphical user interface environment that may be used to simulate an implant using a primitive cylinder as described in connection with FIG. 8B above; [0059] FIGS. 18A and 18B provide examples of a graphical user interface which may be used to create a simulated implant using a primitive cylinder. As shown in FIG. 18A, the create cylinder operation in the 3-D measurement and analysis module 110 is applied using the measurements obtained above. FIG. 18B shows the generated cylinder 1801 positioned within the mitral valve annulus).
PIAZZA does not teach a physical fiduciary marker providing a point of reference for measuring distance in the image data … based at least in part on the point of reference of the physical fiduciary marker.
However, Lang teaches a physical fiduciary marker providing a point of reference for measuring distance in the image data ([0257] The camera or video systems can be arranged at discrete, defined angles thereby utilizing angular information including parallax information for tracking distances, angles, orientation or alignment of optical markers attached to the probe; [0376] calibration or registration phantoms or devices, and image capture markers as used throughout the application can include optical markers, e.g. optical markers with different geometric shapes or patterns, with QR codes, with bar codes, with alphanumeric codes; [0700] The angle and/or the distance of the image and/or video capture system to the physical changes, e.g. surface/surface area, perimeter, perimeter shape, and/or shape of the cut surface or otherwise modified or altered surface, can be assessed, for example, using one or more RF markers, optical markers ... attached to the image and/or video capture system, and/or the OHMD, and/or the patient, and/or the cut, modified or altered surface; [0416] an image and/or video capture system integrated into, attached to or separate from the OHMD can detect the location, position, and/or orientation of the optical markers and software can be used, for example, to analyze the location, position, and/or orientation information of the optical markers to derive information on the periphery and/or edge and/or shape of the cut bone or surgical alteration) … generating heart valve data indicating a measurement of the heart valve based at least in part on the point of reference of the physical fiduciary marker ([0263] The OHMD 48 is configured to use a built-in camera or image capture or video capture system 50 to optionally detect and/or measure the position and/or orientation and/or alignment of one or more optical markers 51, which can be used for the coordinate measurements 52, which can be part of the intra-operative measurements 47; [0219] Live data 18 of the patient, for example from the surgical site, … an altered surface can be measured, for example using one or more IMU's, optical markers, navigation markers, image or video capture systems; [0352] The foregoing concepts of projecting arbitrary virtual planes and aligning them with one or more anatomic landmarks … these concepts can be applied to organ surgery, where one or more virtual planes can be projected or displayed and moved to be tangent with or intercept one or more landmarks, e.g. ... one or more cardiac valves etc.; [0218] The foregoing embodiments can be achieved since the IMUs, optical markers, RF markers, infrared markers and/or navigation markers placed on the operator and/or the patient as well as any spatial anchors can be registered in the same coordinate system as the primary OHMD and any additional OHMDs; [0416] an image and/or video capture system integrated into, attached to or separate from the OHMD can detect the location, position, and/or orientation of the optical markers and software can be used, for example, to analyze the location, position, and/or orientation information of the optical markers to derive information on the periphery and/or edge and/or shape of the cut bone or surgical alteration; [0382] Optical markers can include markers with select geometric patterns and/or geometric shapes that an image and/or video capture system, for example integrated into, attached to or separate from the OHMD, can recognize, for example using image processing and/or pattern recognition techniques; [1566] Operator and/or patient body parts about which such information … can be measured using one or more optical markers and/or navigation markers include … inner organs, e.g. brain, heart).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device and method of PIAZZA to incorporate the step/system of using optical/navigation markers as a reference to track positions and calculate distances and measuring heart valves to derive spatial and geometric information taught by Lang.
The suggestion/motivation for doing so would have been to improve the display accuracy of virtual data and surgical surface measurements ([0233] Systems, methods and techniques to improve the accuracy of the display of the virtual data superimposed onto the live data of the patient; [0396] Optical markers attached to fixed structures such as OR walls can also be used to enhance the determination of the location and pose and change in location or pose or the coordinates and change in coordinates of one or more optical head mounted displays, which can assist with increasing the accuracy of the display of virtual data and their superimposition on corresponding live data; [0467] By using multiple radiopaque optical markers in multiple different locations and in different planes around the surgical site, the accuracy of any three-dimensional spatial registration and cross-reference of the optical markers in different modalities, e.g. radiographs, image capture, can be increased; [0621] intraoperative imaging may only be used for enhancing the accuracy of the registration of preoperative virtual data of the patient and live data of the patient; [1574] The accuracy of some of the measurements can optionally be improved by using a finer grid or an array with more IMU's and/or navigation markers and/or image capture markers, e.g. optical markers with geometric patterns). Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predicted results. Therefore, it would have been obvious to combine PIAZZA and Lang to obtain the invention as specified in claim 1.
Regarding claim 3, the combination of PIAZZA and Lang teaches all the limitations of claim 1 above. PIAZZA teaches wherein the operations further comprise: causing the image data to be displayed ([0031] The computing device 200 may also include a display 204; [0052] FIG. 10 illustrates how the 3-D surface area of the mitral valve annulus is displayed); and receiving user input data indicating the one or more image features in the image data; wherein the identifying the one or more image features is based at least in part on the user input data ([0042] the mitral valve annulus may be defined by first placing control points on a user interface which graphically displays the 3-D model of the heart to the user; [0051] The spline 406 defines the mitral valve annulus and is created by the user inputting the control points shown enclosing the spline by selecting the initial control point).
Regarding claim 4, the combination of PIAZZA and Lang teaches all the limitations of claim 1 above. PIAZZA teaches wherein the operations further comprise: performing image processing on the image data ([0060] a distance mapping may be performed with respect to the anatomy. This distance mapping may quantify the space that is available between the implanted device and each relevant item of anatomy. As shown a primitive 1902 (which in this example is a cylinder, but may take various other forms) has been virtually placed within the mitral valve annulus); wherein the identifying the one or more image features is based at least in part on the image processing ([0060] Turning to FIG. 19B, a distance mapping is used to identify anatomical the position of anatomical structures in the heart (such as the walls of the atrium) or other anatomical features 1908 as shown in FIG. 19C. The distance mapping provides a clear visualization of the spacing between the proposed implant and the relevant item of anatomy).
Regarding claim 5, the combination of PIAZZA and Lang teaches all the limitations of claim 1 above. PIAZZA teaches wherein the user interface data indicates at least one of a size of the annuloplasty ring, a shape of the annuloplasty ring, whether the annuloplasty ring is a closed or open ring, or a flexibility of the annuloplasty ring ([0058] FIG. 17 provides a visual illustration of one graphical user interface environment that may be used to simulate an implant using a primitive cylinder as described in connection with FIG. 8B above. As shown, the mitral annulus curve 1702 is projected into the plane 1704 fit through the mitral annulus. The mitral annulus curve has been exported resulting in a flattened annulus 1706 and the diameter of the flattened annulus may be measured and used to size the primitive implant; [0060] the cylinder or some other type of geometry (e.g., primitive shape, CAD or scan file of the device as above) may be “virtually” implanted as shown in FIG. 19A; [0037] the anatomy of the mitral valve apparatus is characterized by defining control points and taking measurements of relevant anatomical structures; [0046] A transcatheter mitral valve implant may include various metallic components. When implanted into the mitral valve annulus, it takes a specific height and shape. The height and shape of the implanted device may interact substantially with several anatomical structures within the patient).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over PIAZZA et al. (U.S. Publication No. 2025/0045920) (hereafter, "PIAZZA") in view of Lang (U.S Publication No. 2025/0173879) and further in view of Petersen et al. (U.S Publication No. 2023/0017801) (hereafter, "Petersen").
Regarding claim 2, the combination of PIAZZA and Lang teaches all the limitations of claim 1 above. The combination of PIAZZA and Lang does not expressly teach wherein the operations further comprise: receiving additional image data depicting another heart valve before a procedure; receiving post-operative data indicating an effectiveness of another annuloplasty ring implanted on the other heart valve; and based at least in part on the additional image data and the post-operative data, performing one or more machine-learning techniques to generate a machine-trained model; wherein the identifying the annuloplasty ring includes using the machine-trained model.
However, Petersen teaches wherein the operations further comprise: receiving additional image data depicting another heart valve before a procedure ([0069] a NN or other ML model may be trained to receive input in the form of a device information 142 and patient information; [0070] patient information (for instance, physiological information of the patient and/or patient anatomy, such as heart valve characteristics, dimensions, and/or the like); [0075] anatomical region 220 may be an actual image or video of patient anatomy based on a camera or medical diagnostic image; [0047] For a non-invasive procedure, a surgeon may rely on diagnostic imaging techniques to view the implantable medical device); receiving post-operative data indicating an effectiveness of another annuloplasty ring implanted on the other heart valve ([0069] the computational models may be trained based on information associated with a population of patients with the same or similar surgical procedures, implants, anatomy; [0128] the deployment application may receive performance information, such as regurgitation information, heart performance information, patient vitals, surgeon-provided information (for instance, indicating a positive/negative outcome of a configuration) ... the feedback information may be used to determine an optimized configuration, for instance, as part of a feedback loop for optimizing the placement and/or configuration of the annuloplasty ring and/or components thereof (for instance, placement of anchors, cinching of collars, and/or the like) in the current surgery and/or future surgeries (for instance, as part of model information to train computational models)); and based at least in part on the additional image data and the post-operative data ([0070] components of an implanted implantable medical device may be associated with coordinates, for example, relative to other components and/or patient anatomy ... Coordinates, shapes, or other implant configuration information may be determined and stored for a population of patients (for instance, as historical implant configuration information) along with patient information (for instance, physiological information of the patient and/or patient anatomy, such as heart valve characteristics, dimensions, and/or the like) and outcome information … may be stored as model information. One or more computational models may be trained to determine an optimized configuration (for instance, a shape-based, coordinate-based, and/or based on another configuration structure) for implantable medical device 160 based on the patient information; [0128] surgeon-provided information (for instance, indicating a positive/negative outcome of a configuration) ... the feedback information may be used to determine an optimized configuration, for instance, as part of a feedback loop for optimizing the placement and/or configuration of the annuloplasty ring … in the current surgery and/or future surgeries (for instance, as part of model information to train computational models)), performing one or more machine-learning techniques to generate a machine-trained model ([0069] model information 146 may include machine learning (ML), neural network (NN), and/or other artificial intelligence (AI) models that may be trained to determine optimized placement information for implantable medical device 160 and/or components 162a-n … a NN or other ML model may be trained to receive input in the form of a device information 142 and patient information (including information determined during a surgical procedure) and determine one or more optimized installation configurations, for instance, based on outcomes of a population of patients); wherein the identifying the annuloplasty ring includes using the machine-trained model ([0070] computational models may be trained to determine an optimized configuration (for instance, a shape-based, coordinate-based, and/or based on another configuration structure) for implantable medical device 160 based on the patient information; [0015] the implantable medical device may include an annuloplasty ring).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device and method of PIAZZA and Lang to incorporate the step/system of using a trained model for optimizing the configuration of the annuloplasty ring based on patient anatomy image data and feedback data about indicating an outcome of a configuration taught by Petersen.
The suggestion/motivation for doing so would have been to improve the efficiency and accuracy of implant placement by delivering enhanced imaging ([0051] a computer-assisted surgical process may operate to present a device image configured to provide an accurate and comprehensive view of the implantable medical device to a surgeon during a surgical procedure; [0052] An additional non-limiting example of a technological advantage may include emulating an annuloplasty ring and components thereof to present a surgeon with an accurate and comprehensive view of the annuloplasty ring during a surgical procedure; [0054] providing visual images and/or information for to facilitate easier, more efficient, more comprehensive, and more accurate evaluations of implantable medical device placement). Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predicted results. Therefore, it would have been obvious to combine PIAZZA and Lang with Petersen to obtain the invention as specified in claim 2.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over PIAZZA et al. (U.S. Publication No. 2025/0045920) (hereafter, "PIAZZA") in view of Lang (U.S Publication No. 2025/0173879) and further in view of Dasi et al. (U.S Publication No. 2025/0099183) (hereafter, "Dasi") and Wei et al. (U.S Publication No. 2023/0009891) (hereafter, "Wei").
Regarding claim 7, the combination of PIAZZA and Lang teaches all the limitations of claim 1 above. PIAZZA teaches wherein the measurement of the heart valve includes at least one of a surface area of … the heart valve ([0040] The sub process begins at block 401 where, using the image processing module, the mitral valve annulus is defined within the reconstructed heart model … Once the mitral valve annulus has been defined, the process moves to block 403. There, the 3-D surface area of the mitral valve annulus is calculated … the 3-D surface area of the mitral valve annulus (the mitral surface) may be used as the fitting entity; [0038] With the mitral valve annulus defined, the measurements may further include calculation of the 3-D surface area of the mitral valve annulus based on the spline. Additional measurements and analysis may be performed relating to the mitral valve annulus; [0030] the 3-D measurement and analysis module may be a specialized application created specifically for mitral valve quantification purposes).
The combination of PIAZZA and Lang does not expressly teach … a leaflet of …, a height of the leaflet, a height of the annulus, or an inter-commissural distance of the heart valve.
However, Dasi teaches wherein the measurement of the heart valve includes at least one of ([0056] the image data 22 can include a plurality of slices of CT data 52 representative of the left coronary leaflet 54 and the right coronary leaflet 56, such as shown in FIGS. 16, 17, 18, and 19. The CT data 52 can be directly measured for determining parameters for the anatomical regions 26; [0057] model parameters can be determined based on the plurality of slices of CT data 52 of the left coronary leaflet 54 and the right coronary leaflet 56) a surface area of a leaflet of the heart valve ([0043] the anatomical regions 26 can include an aortic root 28, native aortic leaflets 30 ... Once segmented, each of the anatomical regions 26 can be transformed into a CAD shape within the anatomical model data 24; [0045] The meshes can be mapped to the CAD shapes of the anatomical regions 26 and the surgical objects 36. For example, the nodes can be mapped to curves, surfaces, points, or the like of the anatomical model data 24 ... 10-node tetrahedral elements were mapped with a patch-independent algorithm to the anatomical regions 26 corresponding to soft tissue regions ... The total number of mesh elements varied for each patient, and was a function of the shape and size of the anatomical regions 26 (e.g., aortic wall 38, aortic leaflets 30); [0080] evaluate patient geometrical factors prior to TAV implantation based on CT image data ... various types and sizes of valves can be evaluated in order to identify a valve and diameter size that is best suited for the patient; "shape and size" of a 3D anatomical surface mathematically dictates its surface area. Because a mesh mapped to a CAD shape represents the physical boundaries of the leaflet, the generated data is inherently "indicative" of its surface area), a height of the leaflet ([0057] model parameters can be determined based on the plurality of slices of CT data 52 of the left coronary leaflet 54 and the right coronary leaflet 56. The model parameters 58 can include a height h of coronary artery 40 from the annulus, ... a leaflet length l of the left coronary leaflet 54, and a leaflet length l of the right coronary leaflet 56), a height of the annulus, or ([0056] The parameters can include, for example, a coronary ostium height relative to the annulus baseline, an annulus diameter, and/or a sinotubular junction (STJ) diameter, which can correspond to the final position of the coronary leaflets 30 after deployment).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device and method of PIAZZA and Lang to incorporate the step/system of measuring parameters from CT images of heart valve (aortic/coronary leaflets) and calculating a shape and size of the leaflets, a diameter/relative height to the annulus baseline and a leaflet length (vertical extension) taught by Dasi.
The suggestion/motivation for doing so would have been to improve the accuracy of the diagnosis for heart valve ([0052] the deformed analytical model 42 can improve an accuracy of the diagnosis by providing a full three-dimensional geometric representation of the calcific nodule 32, the aortic leaflets 32, and the coronary artery 40; [0082] The systems and method described herein can make use of three-dimensional anatomical model data to improve an accuracy and consistency of collecting parameter information; [0066] the systems and methods described herein can substantially improve an accuracy and quality of a TAVR procedure, and thereby substantially reduces the risks associated with the procedure). Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predicted results.
The combination of PIAZZA and Lang with Dasi does not teach an inter-commissural distance of the heart valve.
However, Wei teaches an inter-commissural distance of the heart valve ([0070] One approach for determining a view for obtaining anatomic features may involve acquiring a range of 2D and/or 3D X-plane echocardiography data and rotating the measurement plane either until leaflet lengths appear as having a maximum dimension, or until leaflet gaps appear as having a maximum, or to a point where commissure-to-commissure distances appear to have a maximum; [0067] anatomical features may include commissures ... parameters of such a dataset collection includes but is not restricted to: atrial and ventricular length and width; valve annular dimensions (e.g. medial/later and anterior/posterior); anterior leaflet and posterior leaflet lengths; location commissures; [0069] One or more TEE imaging strategies may involve sweeping through the entire valve from different orientations. For instance, a first sweep may be conducted from a 0° orientation from lateral to medial positions through the esophagus. A second sweep may be conducted from an inter-commissural view between medial and lateral commissures of the mitral valve, whereby the probe is rotated to move between anterior and posterior leaflets and find a maximum width between the leaflets).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device and method of PIAZZA and Lang with Dasi to incorporate the step/system of measuring or identifying a commissure-to-commissure distances of the mitral valve taught by Wei.
The suggestion/motivation for doing so would have been to improve the visual guidance streamlines the implantation process ([0006] it would be advantageous for a surgeon to be provided with useful imagery in a clear and straightforward fashion in order to simplify the delivery and implantation process and to flatten the learning curve and remove as much guesswork as possible from the procedure; [0043] the TEE and TTE data may be co-registered in order to improve image quality). Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predicted results. Therefore, it would have been obvious to combine PIAZZA, Lang and Dasi and Wei to obtain the invention as specified in claim 7.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over PIAZZA et al. (U.S. Publication No. 2025/0045920) (hereafter, "PIAZZA") in view of Lang (U.S Publication No. 2025/0173879) and further in view of Migliazza et al. (U.S Publication No. 2019/016742) (hereafter, "Migliazza").
Regarding claim 8, the combination of PIAZZA and Lang teaches all the limitations of claim 1 above. The combination of PIAZZA and Lang does not expressly teach wherein the one or more characteristics of the annuloplasty ring comprise whether the annuloplasty ring is a closed or open ring.
However, Migliazza teaches wherein the one or more characteristics of the annuloplasty ring comprise whether the annuloplasty ring is a closed or open ring ([0009] The present application provides an annuloplasty ring comprising an inner core member extending around the entire periphery of the ring in either a closed or open shape. The inner core member has a majority of its length with a first elastic modulus sufficiently flexible to enable the core member to be compressed from its relaxed ring shape into a narrow shape suitable for passage through a tubular access device. The inner core member further includes a plurality of discrete control points located at spaced apart locations, the control points creating localized regions of higher elastic modulus than the first elastic modulus).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device and method of PIAZZA and Lang to incorporate the step/system of using an annuloplasty ring that can be configured in either a closed or open shape taught by Migliazza.
The suggestion/motivation for doing so would have been to improve cardiac implants and reduce risks by utilizing flexible annuloplasty rings ([0002] The present invention relates generally to cardiac implants and particularly to flexible annuloplasty rings; [0008] What is needed, therefore, are devices and methods for carrying out heart valve repair that reduce the trauma, risks, recovery time and pain that accompany current techniques; [0101] one advantage of the flexible annuloplasty rings described herein is their ability to elongate and be delivered through a catheter, or access tube; [0106] One advantage of this delivery system 380 is that they are no frictional pushing or sliding forces resulting from relative motion of the ring and catheter during deployment). Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predicted results. Therefore, it would have been obvious to combine PIAZZA and Lang with Migliazza to obtain the invention as specified in claim 8.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over PIAZZA et al. (U.S. Publication No. 2025/0045920) (hereafter, "PIAZZA") in view of Dasi et al. (U.S Publication No. 2025/0099183) (hereafter, "Dasi").
Regarding claim 9, PIAZZA teaches a method comprising: capturing image data using an imaging device ([0028] the image data storage 106 takes the form of a large database designed to store image files captured by a scanning device 112), the image data depicting a heart valve ([0010] The method may include generating a three-dimensional (“3-D”) model of a patient's heart from scanned images of the patient's heart and defining a 3-D mitral valve annulus; [0035] quantification of space and/or volume of a particular area of a patient's anatomy, in this example the mitral valve … Process begins at block 302, wherein image of the patient's heart acquired. The image may be acquired using the scanning device 112 shown in FIG. 1, such as a CT scanner or an MRI machine; [0029] the scanning device 112 may be configured to create cross-sectional images of a patient's heart. Those images may be stored in the image data storage 106, and utilized to create three-dimensional models of the heart); performing, by control circuitry, image processing on the image data to identify multiple image features that represent anatomical features of the heart valve, respectively ([0035] quantification of space and/or volume of a particular area of a patient's anatomy, in this example the mitral valve … Process begins at block 302, wherein image of the patient's heart acquired. The image may be acquired using the scanning device 112 shown in FIG. 1, such as a CT scanner or an MRI machine; [0029] the scanning device 112 may be configured to create cross-sectional images of a patient's heart. Those images may be stored in the image data storage 106, and utilized to create three-dimensional models of the heart … the computing environment 100 may also include an image processing module 108); generating, by the control circuitry, heart valve data indicative of a surface area of … the heart valve ([0040] The sub process begins at block 401 where, using the image processing module, the mitral valve annulus is defined within the reconstructed heart model … Once the mitral valve annulus has been defined, the process moves to block 403. There, the 3-D surface area of the mitral valve annulus is calculated … the 3-D surface area of the mitral valve annulus (the mitral surface) may be used as the fitting entity; [0038] With the mitral valve annulus defined, the measurements may further include calculation of the 3-D surface area of the mitral valve annulus based on the spline. Additional measurements and analysis may be performed relating to the mitral valve annulus; [0030] the 3-D measurement and analysis module may be a specialized application created specifically for mitral valve quantification purposes) … retrieving, by the control circuitry, annuloplasty ring data indicative of one or more characteristics of an annuloplasty ring ([0037] the anatomy of the mitral valve apparatus is characterized by defining control points and taking measurements of relevant anatomical structures; [0046] A transcatheter mitral valve implant may include various metallic components. When implanted into the mitral valve annulus, it takes a specific height and shape. The height and shape of the implanted device may interact substantially with several anatomical structures within the patient; [0049] a primitive cylinder may be generated to simulate the implant; FIG. 18A); determining, by the control circuitry and based at least in part on the heart valve data and the annuloplasty ring data, to use the annuloplasty ring for the heart valve; and ([0049] The primitive cylinder may be generated based indirectly on the measurements determined in connection with FIG. 7, and also more directly based on the captured contour of the lumen of the mitral valve annulus obtained using the process described in connection with FIG. 8A above. Once the primitive cylinder has been created, the process then moves to block 813 where the primitive cylinder implant is verified by visualizing the contours of the objects overlaid on the original scanned images; [0041] At block 409, distance measurements are performed on the model in order to determine various dimensional attributes that may impact the size of the transcatheter mitral valve implant; [0039] at block 312, based on the measurements taken and the assessed vulnerabilities, and appropriately sized mitral valve device may then be selected; [0060]) generating, by the control circuitry, user interface data indicative of the annuloplasty ring ([0058] FIG. 17 provides a visual illustration of one graphical user interface environment that may be used to simulate an implant using a primitive cylinder as described in connection with FIG. 8B above; [0059] FIGS. 18A and 18B provide examples of a graphical user interface which may be used to create a simulated implant using a primitive cylinder. As shown in FIG. 18A, the create cylinder operation in the 3-D measurement and analysis module 110 is applied using the measurements obtained above. FIG. 18B shows the generated cylinder 1801 positioned within the mitral valve annulus).
PIAZZA not expressly teach … a leaflet of ... or a height of the leaflet.
However, Dasi teaches generating, by the control circuitry, heart valve data indicative of a surface area of a leaflet of the heart valve ([0056] the image data 22 can include a plurality of slices of CT data 52 representative of the left coronary leaflet 54 and the right coronary leaflet 56 ... The CT data 52 can be directly measured for determining parameters for the anatomical regions 26; [0057] model parameters can be determined based on the plurality of slices of CT data 52 of the left coronary leaflet 54 and the right coronary leaflet 56; [0043] the anatomical regions 26 can include an aortic root 28, native aortic leaflets 30 ... Once segmented, each of the anatomical regions 26 can be transformed into a CAD shape within the anatomical model data 24; [0045] The meshes can be mapped to the CAD shapes of the anatomical regions 26 and the surgical objects 36. For example, the nodes can be mapped to curves, surfaces, points, or the like of the anatomical model data 24 ... 10-node tetrahedral elements were mapped with a patch-independent algorithm to the anatomical regions 26 corresponding to soft tissue regions ... The total number of mesh elements varied for each patient, and was a function of the shape and size of the anatomical regions 26 (e.g., aortic wall 38, aortic leaflets 30, coronary arteries 40); [0080] evaluate patient geometrical factors prior to TAV implantation based on CT image data ... various types and sizes of valves can be evaluated in order to identify a valve and diameter size that is best suited for the patient; "shape and size" of a 3D anatomical surface mathematically dictates its surface area. Because a mesh mapped to a CAD shape represents the physical boundaries of the leaflet, the generated data is inherently "indicative" of its surface area) … or a height of the leaflet ([0057] model parameters can be determined based on the plurality of slices of CT data 52 of the left coronary leaflet 54 and the right coronary leaflet 56. The model parameters 58 can include a height h of coronary artery 40 from the annulus, ... a leaflet length l of the left coronary leaflet 54, and a leaflet length l of the right coronary leaflet 56).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device and method of PIAZZA to incorporate the step/system of measuring parameters from CT images of heart valve (aortic/coronary leaflets) and calculating a shape and size of the leaflets and a leaflet length (vertical extension) taught by Dasi.
The suggestion/motivation for doing so would have been to improve the accuracy of the diagnosis for heart valve ([0052] the deformed analytical model 42 can improve an accuracy of the diagnosis by providing a full three-dimensional geometric representation of the calcific nodule 32, the aortic leaflets 32, and the coronary artery 40; [0082] The systems and method described herein can make use of three-dimensional anatomical model data to improve an accuracy and consistency of collecting parameter information; [0066] the systems and methods described herein can substantially improve an accuracy and quality of a TAVR procedure, and thereby substantially reduces the risks associated with the procedure). Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predicted results. Therefore, it would have been obvious to combine PIAZZA and Dasi to obtain the invention as specified in claim 9.
Claim 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over PIAZZA et al. (U.S. Publication No. 2025/0045920) (hereafter, "PIAZZA") in view of Dasi et al. (U.S Publication No. 2025/0099183) (hereafter, "Dasi") and further in view of Lang (U.S Publication No. 2025/0173879).
The combination of PIAZZA and Dasi does not teach further comprising: placing a physical fiduciary marker within a field-of-view of the imaging device, the physical fiduciary marker providing a point of reference for measuring distance in the image data; wherein the image data depicts the physical fiduciary marker and the heart valve data is generated based at least in part on the point of reference indicated by the physical fiduciary marker.
However, Lang teaches further comprising: placing a physical fiduciary marker ([0257] optical markers attached to the probe) within a field-of-view of the imaging device ([0416] an image and/or video capture system integrated into, attached to or separate from the OHMD can detect the location, position, and/or orientation of the optical markers), the physical fiduciary marker providing a point of reference for measuring distance in the image data ([0257] The camera or video systems can be arranged at discrete, defined angles thereby utilizing angular information including parallax information for tracking distances, angles, orientation or alignment of optical markers attached to the probe; [0376] calibration or registration phantoms or devices, and image capture markers as used throughout the application can include optical markers, e.g. optical markers with different geometric shapes or patterns, with QR codes, with bar codes, with alphanumeric codes; [0700] The angle and/or the distance of the image and/or video capture system to the physical changes, e.g. surface/surface area, perimeter, perimeter shape, and/or shape of the cut surface or otherwise modified or altered surface, can be assessed, for example, using one or more RF markers, optical markers ... attached to the image and/or video capture system, and/or the OHMD, and/or the patient, and/or the cut, modified or altered surface; [0416] an image and/or video capture system integrated into, attached to or separate from the OHMD can detect the location, position, and/or orientation of the optical markers and software can be used, for example, to analyze the location, position, and/or orientation information of the optical markers to derive information on the periphery and/or edge and/or shape of the cut bone or surgical alteration); wherein the image data depicts the physical fiduciary marker and the heart valve data is generated based at least in part on the point of reference indicated by the physical fiduciary marker ([0263] The OHMD 48 is configured to use a built-in camera or image capture or video capture system 50 to optionally detect and/or measure the position and/or orientation and/or alignment of one or more optical markers 51, which can be used for the coordinate measurements 52, which can be part of the intra-operative measurements 47; [1566] patient body parts about which such information can be transmitted by the one or more IMUs or can be measured using one or more optical markers and/or navigation markers include, but are not limited to: … organs, e.g. brain, heart, lungs; [0219] Live data 18 of the patient, for example from the surgical site, e.g. a spine, optionally with minimally invasive access, … an altered surface can be measured, for example using one or more IMU's, optical markers, navigation markers, image or video capture systems and/or spatial anchors; [0352] these concepts can be applied to organ surgery, where one or more virtual planes can be projected or displayed and moved to be tangent with or intercept one or more landmarks, e.g. ... one or more cardiac valves etc.; [1566] Operator and/or patient body parts about which such information … can be measured using one or more optical markers and/or navigation markers include, but are not limited to: … inner organs, e.g. brain, heart; [0416] an image and/or video capture system integrated into, attached to or separate from the OHMD can detect the location, position, and/or orientation of the optical markers and software can be used, for example, to analyze the location, position, and/or orientation information of the optical markers to derive information on the periphery and/or edge and/or shape of the cut bone or surgical alteration; [0265] The operator can adjust the magnification of the live data so that the size, shape, length, thickness of certain features of the virtual data matches that of the live data for a given distance to the object/patient; [0382] Optical markers can include markers with select geometric patterns and/or geometric shapes that an image and/or video capture system, for example integrated into, attached to or separate from the OHMD, can recognize, for example using image processing and/or pattern recognition techniques).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device and method of PIAZZA and Dasi to incorporate the step/system of using optical/navigation markers as a reference to track positions and calculate distances and measuring heart valves to derive spatial and geometric information taught by Lang.
Motivation for this combination has been stated in claim 1.
With respect to claim 13, arguments analogous to those presented for claim 5, are applicable.
Claim 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over PIAZZA et al. (U.S. Publication No. 2025/0045920) (hereafter, "PIAZZA") in view of Dasi et al. (U.S Publication No. 2025/0099183) (hereafter, "Dasi") and further in view of Petersen et al. (U.S Publication No. 2023/0017801) (hereafter, "Petersen").
With respect to claim 11, arguments analogous to those presented for claim 2, are applicable.
Regarding claim 12, the combination of PIAZZA and Dasi with Petersen teaches all the limitations of claim 11 above. Petersen teaches wherein the post-operative data includes user input indicating the effectiveness of the other annuloplasty implanted on the other heart valve ([0104] performance information 686 may include feedback, such as a regurgitation rate, heart rate, blood pressure, and/or other physiological information of patient based on the placement and/or configuration of annuloplasty ring 660 and/or components thereof. In some embodiments, performance information 686 may include actual measurements from the patient, simulated values based on historical information, and/or combinations thereof. In this manner, a surgeon may evaluate potential outcomes of the surgical procedure while performing the implantation of annuloplasty ring 660).
Claim 14-18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over PIAZZA et al. (U.S. Publication No. 2025/0045920) (hereafter, "PIAZZA") in view of Petersen et al. (U.S Publication No. 2023/0017801) (hereafter, "Petersen").
Regarding claim 14, PIAZZA teaches One or more non-transitory computer-readable media storing computer-executable instructions that, when executed by control circuitry, instruct the control circuitry to perform operations comprising ([0031] The computer system 200 may generally take the form of computer hardware configured to execute certain processes and instructions ... The computing device 200 includes a processor 202; [0032] The computing device 200 may further include memory 208 ... the memory 208 may include volatile memory 210. The volatile memory 210 may be some form of random access memory, and may be generally configured to load executable software modules into memory so that the software modules may be executed by the processor 202 in a manner well known in the art): receiving pre-implantation image data depicting a heart valve ([0035] quantification of space and/or volume of a particular area of a patient's anatomy, in this example the mitral valve … Process begins at block 302, wherein image of the patient's heart acquired. The image may be acquired using the scanning device 112 shown in FIG. 1, such as a CT scanner or an MRI machine; [0029] the scanning device 112 may be configured to create cross-sectional images of a patient's heart. Those images may be stored in the image data storage 106, and utilized to create three-dimensional models of the heart; [0010] The method may include generating a three-dimensional (“3-D”) model of a patient's heart from scanned images of the patient's heart … determining a size of an implant to be implanted; Because the image data is being used to determine the size of an implant before it is put in, it is explicitly "pre-implantation" data); identifying one or more image features in the pre-implantation image data that represent one or more anatomical features of the heart valve ([0035] The 3-D model may be calculated using the image processing module 108, or some other software and/or hardware designed to generate 3-D models from CT and/or MRI image data; [0036] Using the 3-D model of the blood volume, the anatomical structures of the heart may be reconstructed ... This reconstruction may also be performed using the image processing module 108. The reconstruction of the heart anatomy typically begins with segmentation of the left side of the heart; [0040] The sub process begins at block 401 where, using the image processing module, the mitral valve annulus is defined within the reconstructed heart model); based at least in part on the one or more image features in the pre-implantation image data, generating heart valve data indicating a measurement of the heart valve ([0040] The sub process begins at block 401 where, using the image processing module, the mitral valve annulus is defined within the reconstructed heart model … Once the mitral valve annulus has been defined, the process moves to block 403. There, the 3-D surface area of the mitral valve annulus is calculated … the 3-D surface area of the mitral valve annulus (the mitral surface) may be used as the fitting entity; [0038] With the mitral valve annulus defined, the measurements may further include calculation of the 3-D surface area of the mitral valve annulus based on the spline. Additional measurements and analysis may be performed relating to the mitral valve annulus); based at least in part on the heart valve data, using a … model to determine an annuloplasty ring to implant along a surface of an annulus of the heart valve; and ([0049] The primitive cylinder may be generated based indirectly on the measurements …, and also more directly based on the captured contour of the lumen of the mitral valve annulus obtained using the process ... Once the primitive cylinder has been created, the process then moves to block 813 where the primitive cylinder implant is verified by visualizing the contours of the objects overlaid on the original scanned images; [0041] distance measurements are performed on the model in order to determine various dimensional attributes that may impact the size of the transcatheter mitral valve implant; [0039] based on the measurements taken and the assessed vulnerabilities, and appropriately sized mitral valve device may then be selected; [0010] generating a three-dimensional (“3-D”) model of a patient's heart from scanned images of the patient's heart and defining a 3-D mitral valve annulus ... fitting a plane through the 3-D mitral valve annulus. Distance may be measured between a first papillary muscle head and a second papillary muscle head in the 3-D model, and an average diameter of at least one cross section around the mitral valve annulus may be defined. The method may further include determining a size of an implant to be implanted; [0046] When implanted into the mitral valve annulus, it takes a specific height and shape. The height and shape of the implanted device may interact substantially with several anatomical structures within the patient); generating recommendation data indicating the annuloplasty ring ([0058] FIG. 17 provides a visual illustration of one graphical user interface environment that may be used to simulate an implant using a primitive cylinder as described in connection with FIG. 8B above; [0059] FIGS. 18A and 18B provide examples of a graphical user interface which may be used to create a simulated implant using a primitive cylinder. As shown in FIG. 18A, the create cylinder operation in the 3-D measurement and analysis module 110 is applied using the measurements obtained above. FIG. 18B shows the generated cylinder 1801 positioned within the mitral valve annulus).
PIAZZA not expressly teach … machine-trained.
However, Petersen teaches based at least in part on the heart valve data, using a machine-trained model to determine an annuloplasty ring to implant along a surface of an annulus of the heart valve ([0080] model information 246 may be used to determine an optimized configuration of implantable medical device 260 within patient anatomy 220 … an optimized shape (or shape range) and/or optimized coordinates (or coordinates range) may be determined for a particular patient anatomy; [0069] model information 146 may include information associated with computational models, historical information, and/or the like that may be used to deliver, position, implant, adjust, or otherwise manipulate implantable medical device 160 and/or components 162a-n … model information 146 may include machine learning (ML), neural network (NN), and/or other artificial intelligence (AI) models that may be trained to determine optimized placement information for implantable medical device 160; [0057] implantable medical device 160 may be or may include an annuloplasty ring (see, for example, implantable medical device 300 of FIGS. 3 and 4) for implantation within the heart of a patient; [0084] Implantable device 300 in this example is an implantable device for annuloplasty, such as for custom reshaping of a heart valve (e.g., the mitral valve, as illustrated, or the tricuspid valve), and is capable of moving between the collapsed and expanded configurations and positions therebetween to modify the shape of the valve annulus VA at which it is implanted).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device and method of PIAZZA to incorporate the step/system of using a machine-trained model on patient-specific heart valve/annulus data to determine implantation of an annuloplasty ring taught by Petersen.
Motivation for this combination has been stated in claim 2.
With respect to claim 15, arguments analogous to those presented for claim 2, are applicable.
With respect to claim 16, arguments analogous to those presented for claim 3, are applicable.
With respect to claim 17, arguments analogous to those presented for claim 4, are applicable.
With respect to claim 18, arguments analogous to those presented for claim 5, are applicable.
Regarding claim 21, the combination of PIAZZA and Petersen teaches all the limitations of claim 14 above. Petersen teaches wherein the annuloplasty ring has a non-circular cross-sectional shape ([0078] implantable medical device 260 may have a shape or pattern 270. In one example, for an annuloplasty ring, the a top-down view of the annuloplasty ring may have a generally star shape).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over PIAZZA et al. (U.S. Publication No. 2025/0045920) (hereafter, "PIAZZA") in view of Petersen et al. (U.S Publication No. 2023/0017801) (hereafter, "Petersen") and further in view of Dasi et al. (U.S Publication No. 2025/0099183) (hereafter, "Dasi").
Regarding claim 19, the combination of PIAZZA and Petersen teaches all the limitations of claim 14 above. PIAZZA teaches wherein the measurement of the heart valve includes at least one of a surface area of …. the heart valve ([0040] The sub process begins at block 401 where, using the image processing module, the mitral valve annulus is defined within the reconstructed heart model … Once the mitral valve annulus has been defined, the process moves to block 403. There, the 3-D surface area of the mitral valve annulus is calculated … the 3-D surface area of the mitral valve annulus (the mitral surface) may be used as the fitting entity; [0038] With the mitral valve annulus defined, the measurements may further include calculation of the 3-D surface area of the mitral valve annulus based on the spline. Additional measurements and analysis may be performed relating to the mitral valve annulus; [0030] the 3-D measurement and analysis module may be a specialized application created specifically for mitral valve quantification purposes).
PIAZZA not expressly teach … a leaflet of ... or a height of the leaflet.
However, Dasi teaches a surface area of a leaflet of the heart valve ([0056] the image data 22 can include a plurality of slices of CT data 52 representative of the left coronary leaflet 54 and the right coronary leaflet 56 ... The CT data 52 can be directly measured for determining parameters for the anatomical regions 26; [0057] model parameters can be determined based on the plurality of slices of CT data 52 of the left coronary leaflet 54 and the right coronary leaflet 56; [0043] the anatomical regions 26 can include an aortic root 28, native aortic leaflets 30 ... Once segmented, each of the anatomical regions 26 can be transformed into a CAD shape within the anatomical model data 24; [0045] The meshes can be mapped to the CAD shapes of the anatomical regions 26 and the surgical objects 36. For example, the nodes can be mapped to curves, surfaces, points, or the like of the anatomical model data 24 ... 10-node tetrahedral elements were mapped with a patch-independent algorithm to the anatomical regions 26 corresponding to soft tissue regions ... The total number of mesh elements varied for each patient, and was a function of the shape and size of the anatomical regions 26 (e.g., aortic wall 38, aortic leaflets 30, coronary arteries 40); [0080] evaluate patient geometrical factors prior to TAV implantation based on CT image data ... various types and sizes of valves can be evaluated in order to identify a valve and diameter size that is best suited for the patient; "shape and size" of a 3D anatomical surface mathematically dictates its surface area. Because a mesh mapped to a CAD shape represents the physical boundaries of the leaflet, the generated data is inherently "indicative" of its surface area) or a height of the leaflet ([0057] model parameters can be determined based on the plurality of slices of CT data 52 of the left coronary leaflet 54 and the right coronary leaflet 56. The model parameters 58 can include a height h of coronary artery 40 from the annulus, ... a leaflet length l of the left coronary leaflet 54, and a leaflet length l of the right coronary leaflet 56).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device and method of PIAZZA to incorporate the step/system of measuring parameters from CT images of heart valve (aortic/coronary leaflets) and calculating a shape and size of the leaflets and a leaflet length (vertical extension) taught by Dasi.
Motivation for this combination has been stated in claim 9.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over PIAZZA et al. (U.S. Publication No. 2025/0045920) (hereafter, "PIAZZA") in view of in view of Petersen et al. (U.S Publication No. 2023/0017801) (hereafter, "Petersen") and further in view of Dasi et al. (U.S Publication No. 2025/0099183) (hereafter, "Dasi") and Wei et al. (U.S Publication No. 2023/0009891) (hereafter, "Wei").
With respect to claim 20, arguments analogous to those presented for claim 7, are applicable.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL C. CHANG whose telephone number is (571)270-1277. The examiner can normally be reached Monday-Thursday and Alternate Fridays 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chan S. Park can be reached at (571) 272-7409. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANIEL C CHANG/Examiner, Art Unit 2669 /CHAN S PARK/Supervisory Patent Examiner, Art Unit 2669
