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 Application filed on 05/07/2024.
Claims 1-20 are pending.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1, 3-5, 7, 9, 13, 14, 16-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by PIAZZA et al. (U.S. Publication No. 2025/0045920) (hereafter, "PIAZZA").
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 ([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; [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).
Regarding claim 3, PIAZZA 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, PIAZZA 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, PIAZZA 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).
Regarding claim 7, PIAZZA 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 a leaflet of the heart valve, a height of the leaflet, a surface area defined by an annulus of the heart valve, a height of the annulus, or an inter-commissural distance of the heart valve ([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; [0040] the 3-D surface area of the mitral valve annulus is calculated; [0052] As shown the surface area 1002 of the mitral valve annulus is referenced and various properties 1004, including the calculated surface area 1006 are shown).
With respect to claim 9, arguments analogous to those presented for claim 1, are applicable.
With respect to claim 13, arguments analogous to those presented for claim 5, are applicable.
With respect to claim 14, arguments analogous to those presented for claim 1, 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.
With respect to claim 20, arguments analogous to those presented for claim 7, are applicable.
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 2, 8, 11, 12 and 15 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 2, PIAZZA teaches all the limitations of claim 1 above. PIAZZA 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 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 Petersen to obtain the invention as specified in claim 2.
Regarding claim 8, PIAZZA teaches all the limitations of claim 1 above. Petersen teaches wherein the one or more characteristics of the annuloplasty ring comprise at least one of a size of the annuloplasty ring, a shape of the annuloplasty ring, a type of suture feature of the annuloplasty ring, whether the annuloplasty ring is a closed or open ring, or a flexibility of the annuloplasty ring ([0012] determining an optimized configuration of the annuloplasty ring based on at least one of a shape of a frame of the annuloplasty ring; [0021] determining an optimized configuration based on at least one configuration characteristic of the plurality of components using at least one computational model, the at least one configuration characteristic may include one of a shape of the implantable medical device; [0049] in an annuloplasty ring example, it may be desirable to adjust the overall implant size and/or shape to adjust the size and/or shape of the valve in which the implantable device has been implanted. In some embodiments, the implantable device may be configured (such as with struts joined along distal and proximal apices) to be expandable or retractable (e.g., radially) to move or otherwise be adjusted between a reduced-diameter configuration for delivery and an expanded-diameter configuration for implantation; [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 (see, for example, FIGS. 3 and 6B); [0085] Frame member 302 may form a generally tubular shape, the term “tubular” being understood herein to include circular as well as other rounded or otherwise closed shapes. Frame member 302 may be configured to change shape, size, dimension, and/or configuration).
With respect to claim 11, arguments analogous to those presented for claim 2, are applicable.
Regarding claim 12, the combination of PIAZZA and 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).
With respect to claim 15, arguments analogous to those presented for claim 2, are applicable.
Claim 6, 10 and 19 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 Wei et al. (U.S Publication No. 2023/0009891) (hereafter, "Wei").
Regarding claim 6, PIAZZA teaches all the limitations of claim 1 above. PIAZZA does not expressly teach wherein: the image data depicts a fiduciary marker indicating a predetermined distance; and the generating heart valve data is based at least in part on the predetermined distance.
However, Wei teaches wherein: the image data depicts a fiduciary marker indicating a predetermined distance; and the generating heart valve data is based at least in part on the predetermined distance ([0051] At block 340, the one or more processors transmit the image frames and the reference mark to the one or more image display devices for display. The image frames and reference mark may be displayed on a common display, such as by overlay. An example overlay or composite image 500 is shown in FIG. 5. The image 500 includes each of echocardiograph details 510 and a reference mark arrow 520; [0066] In the example of FIG. 7C, a TEE view is shown with each of the left atrium (LA), right atrium (RA) and mitral valve (MV) having been labeled. Additionally, a reference marker 730 and label are included to illustrate a measurement of distance (“height”) from the transeptal crossing to the valve, which otherwise may not be easily discernable from the TEE view).
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 reference mark arrow illustrating a measurement of distance and utilizing the measurement to facilitate the evaluation of the heart 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 and Wei to obtain the invention as specified in claim 6.
With respect to claim 10, arguments analogous to those presented for claim 6, are applicable.
Regarding claim 19, PIAZZA teaches all the limitations of claim 14 above. Wei teaches wherein the measurement of the heart valve includes at least one of a surface area of a leaflet of the heart valve or a height of the leaflet ([0078] The portions of the leaflet edges detected in the offset plane may be manually detected and selected, or they may be automatically identified. In the case of automated detection, the leaflet edges may be detected using an algorithm or machine learning algorithm ... The computed leaflet edges may in turn be used to determine leaflet length interacting with the device; [0079] leaflet edges can be determined according to contrast between image pixels having at least a predetermined amount of contrast. Leaflet lengths may further be estimated based on a length from the leaflet edge to a valve edge and according to fitted angles to segments of the leaflets).
Conclusion
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.
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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.
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/DANIEL C CHANG/Examiner, Art Unit 2669 /CHAN S PARK/Supervisory Patent Examiner, Art Unit 2669