DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation (BRI) using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The BRI of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification.
The BRIs for certain claim elements in light of the specification are provided below. Should Applicant that different BRIs should be used for these claim elements, Applicant should point to the portions of the specification that provide a basis for the different BRIs.
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
As indicated above, the claims in this application are given their broadest reasonable interpretation (BRI) using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The BRI of a claim element is limited by the description in the specification when 35 U.S.C. 112(f), is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f), is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f), except as otherwise indicated. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f), except as otherwise indicated in this Office action.
Such a claim limitation is recited in claim 13, namely, “computer program code means”. Because claim 13 does not claim sufficient structure to perform the claimed function, it is being interpreted under 35 U.S.C. 112(f) to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Although the preamble of claim 13 mentions structure in terms of a computing device having a processing system that can perform the function when it executes the computer program code, this structure is not claimed as an element of claim 13. The examiner finds that the present disclosure discloses adequate structure for performing the claimed function, namely, processor circuit 610 of Fig. 6.
If Applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f), Applicant may: (1) amend the claim limitation to avoid it being interpreted under 35 U.S.C. 112(f) (e.g., by claiming sufficient structure to perform the claimed function); or (2) present a sufficient showing that sufficient structure to perform the claimed function is claimed in claim 13 so as to avoid it being interpreted under 35 U.S.C. 112(f).
Response to Arguments
Applicant's arguments filed December 29, 2025 have been fully considered but they are not persuasive.
Applicant argues that Camus does not disclose the newly added limitations of claim 1 of:
“fitting a model of the interventional device placeable within the left atrial appendage of the patient into the anatomical model of the left atrial appendage at the determined position
measuring a dimension of the model of the interventional device to predict a model-derived size of the interventional device”. The examiner disagrees.
Applicant acknowledges that Camus teaches “the creation of a biomechanical model of the patient anatomy, to which a model of a closure device is selected and placement is guided”. Applicant states that Camus teaches “that the closure device is selected from a pre-determined list of closure devices, and best geometric fit position for a closure device is found rather than fully optimizing an interventional device by fitting (i.e., adapting) a model of the interventional device to the geometry of a determined position itself.” Applicant argues further that Camus does not teach “measuring a dimension of the model of an interventional device that has been fitted to the anatomical model of the LAA at the determined position, as required by the measuring limitation of amended Claim 1.”
The examiner disagrees with Applicants allegation that Camus does not teach “fitting a model of the interventional device placeable within the left atrial appendage of the patient into the anatomical model of the left atrial appendage at the determined position”. Camus explicitly discloses fitting the model of the closure device to the anatomical model of the LAA. For example, para. [0051] discusses fitting the model of the closure device to the anatomical model: “[t]he image processor calculates the fit, such as a geometric fit, of each selected closure device to the anatomical model.” See also para. [0049] discussing modeling the geometry of the closure device model relative to the geometry of the anatomical model: “[t]he geometry of the closure device is modeled with respect to the geometry of the anatomy model.”
With regard to the limitation of “measuring a dimension of the model of an interventional device that has been fitted to the anatomical model to predict a model-derived size of the interventional device”, this is also taught by Camus. In Camus, the dimensions of the ostium of the LAA are measured (para. [0045]), the anatomical model is then fitted to the measured ostium (para. [0039]), and then the geometric fit of the closure device model to the anatomical model is determined (para. [0051]). The combination of these steps constitutes measuring the dimensions of the closure device fitted to the anatomical model because the dimensions of the closure device model fitted to the anatomical model are based on the determined dimensions of the ostium, as discussed in para. [0051]: “[t]he fit of the closure device with the LAA may be measured for any given placement. Any fit measure may be used, such as a minimum sum of absolute differences or standard deviation.” This measurement is a prediction of a model-derived size of the closure device because the closure device that is selected for the procedure has a geometry that is derived from the fit of the closure device model with the anatomical model, paras. [0052]-[0053]: “the geometric fit is used for selection and to plan for device delivery by optimizing placement.” Therefore, the above-quoted newly added limitations of claim 1 are taught by Camus.
Claim Objections
Claim 16 is objected to because of the following informalities: the phrase “the interventional comprising” in line 3 should be changed to --the interventional device comprising--. Appropriate correction is required.
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(s) 1-6 and 8-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publ. Appl. No. 2019/0090951 A1 to Camus et al. (hereinafter referred to as “Camus”).
Regarding claim 1, Camus discloses a computer-implemented method (para. [0004]) of generating and displaying a rendering of a left atrial appendage of a patient (para. [0005], “[a] three-dimensional anatomical model of the left atrial appendage of a patient is generated from ultrasound data representing a heart volume of the patient. An image of an ostium of the left atrial appendage is displayed from the ultrasound data”), the computer-implemented method comprising:
obtaining, from an image processing system (Fig. 6, image processor 12) or memory (Fig. 6, memory 14), image data (I) comprising a three-dimensional image of the left atrial appendage of the patient (paras. [0023]-[0026]: “[t[he scanning is three-dimensional, such as with a wobbler array, a two-dimensional array, and/or parallel beam formation. Each ultrasound dataset represents the LAA in three dimensions”; Fig. 1, step 22);
obtaining, from an image processing system or memory, model data (M) comprising an anatomical model of the left atrial appendage of the patient (Fig. 1, step 26; para. [0032]: “[a] 3D anatomy model of the LAA of the patient is generated from the ultrasound data representing the heart volume”);
automatically determining, using the anatomical model, a position in the left atrial appendage of the patient for deriving one or more characteristics of an interventional device placeable in the left atrial appendage of the patient, wherein the characteristics include size, shape and type of the interventional device (paras. [0033]-[0036], disclose that using the anatomical model, landmarks corresponding to features of the LAA are detected and an oriented bounding box is placed around the LAA to define the LAA region; the oriented bounding box identifies a position in the LAA for deriving one or more characteristics of the an interventional device placeable in the LAA of the patient because once the bounding box has been placed, the model is refined to represent the geometry of the ostium of the LAA (paras. [0043]-[0045]) and then that refined geometry is used to derive the characteristics of the interventional device that is placeable in the position within the LAA, as indicated in para. [0049]: “[t]he shape and/or size of the LAA and/or ostium of the LAA is used to select the closure device”; in Camus, the interventional device is referred to generally as a “closure device”; Paras. [0019]-[0079] of Camus disclose, with reference to Fig. 1, a process performed by the processor 12 shown in Fig. 6 comprising generating a personalized anatomical model of the patient’s LLA over one or more heart cycles of the patient’s heart (steps 24 and 26 of Fig. 1), using the model to determine the geometry of the ostium of the LAA (steps 28 and 30 of Fig. 1), and using the model having the determined ostium geometry along with a closure device model to model placement of the closure device within the LAA (step 32 of Fig. 1, para. [0049]); during or after modeling placement of the closure device in the LLA, the image processor 12 selects the closure device based on “[t]he shape and/or size of the LAA and/or ostium of the LAA”, as described in para. [0049]; this means that a closure device having the proper shape and size is selected for the shape and size of the modeled LAA and/or the ostium geometry of the modeled LAA. This, in turn, means that the personalized anatomical model is used to determine a position of the LAA for deriving at least a shape and size of the closure device; regarding the further limitation of deriving the “type” of the interventional device, para. [0070] of Camus discloses that in selecting the closure device to be used in step 40 of Fig. 1, the image processor may select closure devices of “the same type or brand but different sizes” or “[c]losure devices of different types and/or brands but a same size”);
fitting a model of the interventional device placeable within the left atrial appendage of the patient into the anatomical model of the left atrial appendage at the determined position (Para. [0038] of Camus discusses first fitting the anatomical model to the anatomy of the LLA by using landmarks of the anatomy and then fitting the model of the closure device to the anatomical model: “[t]he anatomical model is a statistical shape model based on landmark distribution across a plurality of patients…Algorithms for virtual therapy planning may be used to fit a model of a device or implant.” (Emphasis Added). Para. [0051] also discusses fitting the model of the closure device to the anatomical model: “[t]he image processor calculates the fit, such as a geometric fit, of each selected closure device to the anatomical model.”);
measuring a dimension of the model of the interventional device to predict a model-derived size of the interventional device (In Camus, the dimensions of the ostium of the LAA are measured (para. [0045]), the anatomical model is then fitted to the measured ostium (para. [0039]), and then the geometric fit of the closure device model to the LAA is determined (para. [0051]). The combination of these steps constitutes measuring the dimensions of the closure device fitted to the anatomical model, as discussed in para. [0051]: “[t]he fit of the closure device with the LAA may be measured for any given placement. Any fit measure may be used, such as a minimum sum of absolute differences or standard deviation.” This measurement constitutes a prediction of a model-derived size of the closure device because the closure device that is selected for the procedure has a geometry that is derived from the fit of the closure model with the anatomical model, paras. [0052]-[0053]: “the geometric fit is used for selection and to plan for device delivery by optimizing placement.” );
generating a rendering of the left atrial appendage of the patient using the image data (the BRI for the term “generating a rendering” of the LAA is that it means modeling the LAA based on the image data as a separate step from displaying the rendering; para. [0049] of Camus “[t]he geometry of the closure device is modeled with respect to the geometry of the anatomy model”); and
displaying, at a user interface, the rendering of the left atrial appendage of the patient (Fig. 1, step 28, para. [0039]: “[i]n act 28, the ultrasound scanner and/or image processor, using a display device, displays an image of an ostium of the LAA”; see also paras. [0040]-[0042]; Fig. 6 of Camus shows the display 16 on which the image processor 12 renders images of the modeling described with reference to Fig. 1, which include images of modeling the placement of the closure device within the LAA.),
wherein one or more visual parameters of the displayed rendering are based upon the determined position in the left atrial appendage of the patient and the predicted, model-derived size of the interventional device (since the rendered images include images of modeling the placement of the closure device within the LAA, the rendered images are based upon “the determined position” in the LAA and the predicted model-derived size of the closure device because they are based on the determined geometry of the ostium of the LAA anatomical model and the model of the closure device fitted to the anatomical model; Figs. 4 and 5, para. [0039] disclose that visual parameters, such as certain planar and/or axial views, of the displayed rendering are based on the determined location of the ostium of the LAA: “[t]he ostium location is used to generate an image. For example, the ostium is an oval or other enclosed shape in a plane or generally planar region (e.g., within a slab). A plane or slab (multiple adjacent planes) fit to or most closely aligned with the ostium is determined. A long axis view (see FIGS. 4 and 5) may alternatively or additionally be displayed”; para. [0049] discloses that the one or more visual parameters of the displayed rendering are based upon the predicted size of the interventional device derived from the anatomical model: “[t]he shape and/or size of the LAA and/or ostium of the LAA is used to select the closure device…[t]he geometry of the closure device is modeled with respect to the geometry of the anatomy model”).
Regarding claim 2, Camus discloses that the position is a position for the interventional device within the left atrial appendage of the patient (para. [0053] discusses the anatomical model automatically selecting a default position for the interventional device based on the determined position and geometry of the LAA that defines the position: “[f]rom the anatomical model, a default position is automatically computed, such as orienting a center of the closure device at a center line of the LAA through the center of the ostium”; see also para. [0076]).
Regarding claim 3, the phrase “one or more of” is interpreted to mean that the claim requires only one of the limitations that are separated by the semicolons in the claim. Camus discloses that the one or more visual parameters comprises: a rotation of the displayed rendering; a zoom level of the displayed rendering and a position of a cutting plane of the rendering, and an orientation of the cutting plane of the rendering (paras. [0039]-[0040] discuss the visual properties comprising different positions and orientations of a cutting plane; see also para. [0046] discussing rotation of a displayed rendering: “[f]or example, the ultrasound images of FIG. 4 are displayed, such as showing the line from the center of the LAA ostium to the deepest structure of the LAA. An additional display functionality allows the user to visualize MPR planes that rotate 360° around this line. FIG. 2 shows two ultrasound images for perpendicular planes along center line of the LAA (rotation around center line shown by arrow”).
Regarding claim 4, Camus discloses determining a position for the interventional device comprises receiving a user input signal indicating a user-desired position for the interventional device, wherein the user input signal is received by a user interface that displays the rendering of the left atrial appendage (para. [0042] discusses the user indicating a user-desired position for the interventional device: “[i]n a semi-automatic or manual approach, the user participates in annotating the displayed image of the ostium or other portion of the LAA…[f]or example, a circular cursor or a cursor defined for pressing or pulling on the ostium outline is provided. The user positions the cursor relative to the outline to move the outline (e.g., dilate or shrink the contour and indicate the size of the affected portion by its size”; see also para. [0053] discussing either automatically determining the position for placement of the interventional device or the user selecting it: “[f]rom the anatomical model, a default position is automatically computed, such as orienting a center of the closure device at a center line of the LAA through the center of the ostium. Alternatively or additionally, the user may interactively place or adjust the position of the device”).
Regarding claim 5, Camus discloses that the one or more visual parameters comprise a property of one or more pixels of the rendering that represent an area in the vicinity of the determined position, wherein the property of the one or more pixels is a color property of the one or more pixels (para. [0041] discusses Fig. 2 showing the determined position of the ostium being outlined and highlighted with a graphic or coloring; see also para. [0047] discussing lobes within the LAA that may also need to have an interventional device placed therein being visualized in different colors to help the user understand them).
Regarding claim 6, Camus discloses that the one or more pixels comprise only pixels representing tissue within the immediate vicinity of the determined position in the left atrial appendage (the BRI for this limitation is that this means that the one or more visual properties relate to visual properties of only the pixels corresponding to locations at which the interventional device would come into contact with tissue surrounding the LAA; paras. [0041]-[0042] discuss Figs. 2 and 3 of Camus showing how the user refines the pixels outlining the tissue surrounding the LAA and that the pixels corresponding to the outline are displayed color; the colored pixels of the outline correspond to locations where the interventional device would come into contact with the tissue surrounding the LAA).
Regarding claim 8, Camus discloses predicting a rendering-derived size and/or shape of an interventional device placeable in the left atrial appendage by processing the rendering of the left atrial appendage and the determined position in the left atrial appendage (paras. [0043, [0049]-[0050], [0053]-[0055] and [0070]-[0071], the size and shape of the interventional device is predicted by processing the rendering of the LAA anatomical model to obtain the geometry metrics of the LLA of the LAA anatomical model and then the rendered model having those metrics is used to predict the shape and size of the interventional device).
Regarding claim 9, Camus discloses that predicting the rendering-derived size and shape of the interventional device comprises using pixel information of the rendering of the left atrial appendage to predict the size and shape of the interventional device (paras. [0041]-[0042] discuss Figs. 2 and 3 of Camus showing how the user refines the pixels outlining the tissue surrounding the LAA; these pixels and their locations define the geometry of the LAA in the refined model and therefore constitute pixel information that is used to predict the shape and size of the interventional device since its shape and size are predicted based on the geometry of the refined anatomical model of the LAA).
Regarding claim 10, Camus discloses that the anatomical model data comprises mesh data that represents the anatomical model of the left atrial appendage of the patient, wherein the model data is generated using a model-based segmentation approach (para. [0032]: “[a] 3D anatomy model of the LAA of the patient is generated from the ultrasound data representing the heart volume. The geometry is a mesh, surface, or other representation of the size and shape of the LAA for the patient”; para. [0038]: “[f]or example, the anatomical model is a template (e.g., annotated mesh), so the landmark locations in the anatomical model are aligned or registered with the landmark locations as detected for the patient. The landmarks are linked or aligned over time. The rest of the anatomical model may, in one realization, be interpolated or distorted based on the landmark locations and/or fit to the ultrasound data. In another realization, each point of the 3D mesh is fit to the data with a statistical shape model constraining the fit to provide a smooth, natural shape”; regarding the model-based segmentation limitation, see paras. [0002], [0018] and [0030]-[0031] discussing the model data being generated using a model-based segmentation approach).
Regarding claim 11, Camus discloses that the interventional device comprises an occlusion device for the left atrial appendage (paras. [0070]-[0073] discuss the type, shape and size of the “closure device” for the LAA being selected that is believed will have the “least leakage”, which means that it is an occlusion device).
Regarding claim 12, Camus discloses that the obtaining model data comprises performing a segmentation process on the image data to generate model data comprising a model of the left atrial appendage of the patient (paras. [0002], [0018] and [0030]-[0031] discussing the model data being generated using a model-based segmentation approach).
Regarding claim 13, Camus discloses a computer program product embodied in anon-transitory computer readable storage medium (Fig. 6, memory 14, paras. [0095]-[0096]) and comprising computer program code means which, when executed on a computing device having a processing system, cause the processing system to perform all of the steps of the method according to claim 1.
Regarding claim 14, to the extent that claim 14 recites limitations that are recited in claim 1, the rejection of claim 1 applies mutatis mutandis to claim 14. The only limitations that are recited in claim 14 that are not also recited in claim 1 is a processor for performing the steps recited in claim 14 and a user interface for displaying the rendering. Camus discloses a processor (Fig. 6, image processor 12) for performing the steps and a user interface (Fig. 6, display 16) for displaying the rendering.
Regarding claim 15, Camus discloses that the processor circuit generates display data comprising the rendering for display by the user interface (Fig. 6 and paras. [0091]-[0099]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Camus in view of U.S. Publ. Appl. No. 2014/0088698 A1 to Roels et al. (hereinafter referred to as “Roels”).
Camus discloses that fitting the model of the closure device comprises fitting the model of the closure device into the anatomical model of the left atrial appendage to identify a maximum size and/or shape of the closure device model that can be placed at the determined position (as indicated above in the rejection of claim 1, Camus discloses fitting the model of the closure device to the anatomical model; para. [0055] of Camus discusses the fitting process being performed until the optimum geometric fit and the optimum position of the closure device model is obtained, which means identifying the maximum size of the closure device model that achieves the optimal fit to the ostium of the LAA; para. [0051] discusses fitting of the closure device model to the anatomical model to achieve “a minimum sum of absolute differences” between the surfaces where the closure device model and the anatomical model meet, which means identifying a maximum size of the closure device model as the closure device model that best fits the anatomical model; however, Camus does not explicitly disclose that the closure device model is an ellipse), and
wherein measuring a dimension of the model of the interventional device comprises measuring a major and a minor axis of the fitted ellipse (as indicated above in the rejection of claim 1, Camus discloses measuring a dimension of the closure device model through the fitting of the closure device model to the anatomical model, which has been fitted to the image data representing the ostium having dimensions that have been determined; Camus does not explicitly disclose that measuring the closure device model comprises measuring the major and minor axes of the closure device model).
As indicated above, Camus does not explicitly disclose that the closure device is modelled as an ellipse. However, Camus discloses modeling the anatomical model as an oval, which is an asymmetric ellipse, and discloses that “[t]he long and short axis measurements are derived from the oval fit.” (para. [0045]). Since the model of the closure device in Camus is fitted to the oval anatomical model, the closure device model would have to have a similar geometry to that of the anatomical model of the ostium. However, Camus is silent as to the starting geometry of the closure device model.
It is well known in the art to use ellipses as models that are fitted to other models of similar geometry. Roels, in the same field of endeavor, discloses using an ellipse model that is fitted to image data representing the anatomy of a lumen in order to generate a prosthetic implant designed to fit into the lumen (paras. [0012], [0040], [0043], [0062]-[0064] and Figs. 5A-5C).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the present disclosure, to modify the systems and methods of Camus to use the ellipse model of Roels as the closure device model in Camus and to fit it to the oval anatomical model of Camus, which can be an elliptical model since an ellipse is a type of oval. One of ordinary skill in the art would have been motivated to make the modification to ensure an optimum fit of the closure device model to the anatomical ostium model and improved compute efficiency by starting with a closure device model that is similar to the shape of the anatomical model to which it is fitted. The modification could have been made by one of ordinary skill in the art before the effective filing date of the present disclosure with a reasonable expectation of success because making the modification merely involves combining prior art elements according to known methods to yield predictable results (modifying the software executed by the image processor 12 shown in Fig. 6 of Camus).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Camus in view of U.S. Publ. Appl. No. 2016/0199135 A1 to Koch et al. (hereinafter referred to as “Koch”).
Camus discloses that the anatomical model of the left atrial appendage of the patient comprises a mesh, and wherein predicting a model-derived size of the interventional device comprises identifying elements of the mesh at the determined position and measuring dimensions of the model of the interventional device that makes contact with these mesh elements (paras. [0031]-[0032]: “[t]he detection is repeated for different phases or datasets. Alternatively, the fit anatomy model (e.g., mesh representing a detected or segmented surface) from one phase is then tracked through other phases…A 3D anatomy model of the LAA of the patient is generated from the ultrasound data representing the heart volume. The geometry is a mesh, surface, or other representation of the size and shape of the LAA for the patient.”; as indicated above in the rejection of claim 1, the dimensions of the anatomical model are determined based on the dimensions of the ostium determined from landmarks in the image data and then the closure device model is fitted to the anatomical model, which requires identifying the mesh elements of the mesh of the anatomical model at the determined position and measuring the distance between the surface of the closure device model and the mesh elements during the closure model fitting process; however, Camus does not explicitly disclose that the elements comprising the mesh are triangles).
Koch, in the same field of endeavor, discloses using a triangular mesh to model the left atria, where the mesh is generated from 3-D data sets of the left atria (para. [0030]: “[t]he left atria are segmented from 3-D data sets (CT, C-arm CT, MRI) and modeled as triangle meshes.”). It would been obvious to one of ordinary skill in the art, before the effective filing date of the present disclosure, to modify the systems and methods of Camus to use the triangular mesh of Koch as the mesh in Camus for representing the anatomical model of Camus. One of ordinary skill in the art would have been motivated to make the modification to take advantage of the well-known computational efficiencies of using triangular meshes due to triangles being the simplest of polygons, thereby allowing for faster rendering and lower memory usage. The modification could have been made by one of ordinary skill in the art before the effective filing date of the present disclosure with a reasonable expectation of success because making the modification merely involves combining prior art elements according to known methods to yield predictable results (modifying the software executed by the image processor 12 shown in Fig. 6 of Camus to generate the models using triangular meshes).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL J SANTOS whose telephone number is (571)272-2867. The examiner can normally be reached M-F 9-5.
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/DANIEL J. SANTOS/ Examiner, Art Unit 2667
/MATTHEW C BELLA/ Supervisory Patent Examiner, Art Unit 2667
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