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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/25/2025 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 4-8, 11-12 are 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over are rejected under 35 U.S.C. 103 as being unpatentable over Abuzaina (US Pat. Pub. No. 20130338437, “Abuzaina”) in view of Turquier et al. (US Pat. Pub. No. 20170273745, “Turquier”) and Duhamel et al. (US Pat. Pub. No. 20110141140, “Duhamel”).
Regarding claim 1 Abuzaina teaches A system for aiding selection of a hernia mesh for treating a hernia defect (Fig. 1, [0024] “….Image capturing unit 20 is configured to obtain or capture an image of the surgical site "S." Surgical site "S" includes a defect "D", for example a hernia defect”) comprising:
a camera positionable to capture image data corresponding to a treatment site that includes a hernia defect ([0024] “….Image capturing unit 20 is configured to obtain or capture an image of the surgical site "S." Surgical site "S" includes a defect "D", for example a hernia defect”);
an image display ([0030] “…..Additionally or alternatively, image processing unit 30 may be operated by a user via a graphical user interface and a surgeon/user may identify and/or mark the edges of the defect "D" manually via a graphical user interface”. Here “graphical user interface” is the image display where surgeon/user marks the edge);
at least one processor ([0025] “…..image capturing unit 20 may be coupled to image processing unit 30 by any means, such as, without limitation, wirelessly”).
However Abuzaina is silent at least one memory, the at least one memory storing instructions executable by said at least one processor.
Turquier teaches at least one memory, the at least one memory storing instructions executable by said at least one processor ([0102] “Memory 102 includes any non-transitory computer-readable storage media for storing data and/or software that is executable by processor 104 and which controls the operation of computing device 100”).
Abuzaina and Turquier are analogous art as they are related to surgical repair.
Therefore it would have been obvious for an ordinary skilled person in the art before the effective filing date of claimed invention to have modified Abuzaina by having at least one memory, the at least one memory storing instructions executable by said at least one processor as taught by Turquier.
The motivation for the above is to have a different way of implementation using software.
Abuzaina modified by Turquier teaches display in real time on the image display images of the hernia captured by the camera (Abuzaina “[0027] The image processing unit 30 is configured to adjust and/or scale the image captured by the image capturing unit 20. In addition, the image processing unit 30 may be configured to measure the size of the defect "D" and may further be configured to identify a perimeter, i.e., edges, of the defect "D." Additionally, or alternatively, a user may manually measure the size of the defect "D" and input the measurements via a graphic user interface. [0030] …..Additionally or alternatively, image processing unit 30 may be operated by a user via a graphical user interface and a surgeon/user may identify and/or mark the edges of the defect "D" manually via a graphical user interface”. Here “graphical user interface” is the image display where surgeon/user marks the edge);
identify at least a portion of the hernia defect within the images (Abuzaina [0024] “…..Image capturing unit 20 is configured to obtain or capture an image of the surgical site "S." Surgical site "S" includes a defect "D", for example a hernia defect, and anatomical features "A." All or a portion of the anatomical features "A" may be disposed on all or a portion of the defect "D" of the surgical site”);
Even though Abuzaina modified by Turquier teaches while the images of the hernia defect are displayed in real time on the image display, simultaneously display, on the image display, an overlay, representing a mesh (Abuzaina, Fig. 2A displays mesh and hernia defect “[0027] …..Additionally, or alternatively, a user may manually measure the size of the defect "D" and input the measurements via a graphic user interface”); and
a plurality of overlays, each representing a different mesh implant option, each mesh implant option having a predetermined size and shape, and each mesh implant option differing from the other mesh implant option within the plurality of mesh implant options in at least one of size and shape (Abuzaina “[0037] Although mesh 100a is shown as a rectangular shape in FIG. 2A, it is understood that mesh 100a will take the shape/size as set by image processing unit 30 (FIG. 1) or as set by the user, as described above. [0032] ….. the image processing unit 30 is configured to re-select a second substrate 100 shape and/or size”) and
Turquier teaches while the hernia defect is displayed in real time on the image display, simultaneously display, on the image display, a menu option for selecting a mesh, each representing a different mesh implant option, each mesh implant option having a predetermined size and shape, and each mesh implant option differing from the other mesh implant option within the plurality of mesh implant options in at least one of size and shape (Turquier “[0128] Referring specifically to FIG. 10A, the clinician may specify details about the indicated implantable repair material. For example, in the instance of a hernia mesh, the clinician may indicate a brand, a model, a size, a material resorption rate, a surfacic density, a transversal overlap, and a longitudinal overlap of the hernia mesh. As shown in FIG. 10A, each indicated detail about the hernia mesh may be illustrated on the display to help the clinician visualize the hernia mesh in actual size in relation to the defect”) but is silent about display a plurality of overlays on the image display;
Duhamel teaches while images of anatomical structure are displayed in real time on image display, simultaneously display, on the image display, a plurality of overlays (Fig. 6 shows anatomical structure in the left side and in the right side selectable overlays. “[0034] In step 206 the localization software 150 displays a plurality of selectable graphical overlays within the graphical user interface 160. In FIG. 6, the selectable graphical overlays are shown as 520-1, 520-2, and 520-3 (collectively referred to as 520).”);
Duhamel and Abuzaina modified by Turquier are analogous art as they are related to medical/anatomical field.
Therefore it would have been obvious for an ordinary skilled person in the art before the effective filing date of claimed invention to have modified Abuzaina modified by Turquier by having while the images of the hernia defect are displayed in real time, simultaneously display, on the image display, a plurality of overlays similar to while images of anatomical structure are displayed in real time, simultaneously display, on the image display, a plurality of overlays as taught by Duhamel and use this teaching with Abuzaina modified by Turquier as Abuzaina has the teaching of plurality of mesh overlays and can be selected as appropriate.
The motivation for the above is to have a choice of visual display of overlay for easy and better understanding for selection.
Abuzaina modified by Turquier and Duhamel teaches measure a dimension relating to the hernia defect based on the image data (Abuzaina [0027] “The image processing unit 30 is configured to adjust and/or scale the image captured by the image capturing unit 20. In addition, the image processing unit 30 may be configured to measure the size of the defect "D" and may further be configured to identify a perimeter, i.e., edges, of the defect "D.") and
provide output to a user based on the measured dimension (Turquier [0116] “With reference to FIG. 4D, the anatomo-pathology presented to the clinician via the user interface 118 may include, but is not limited to, tissue defect width, tissue defect height, and tissue defect type (e.g., unique hernia, "swiss cheese")”.
Therefore it would have been obvious for an ordinary skilled person in the art before the effective filing date of claimed invention to have further modified Abuzaina modified by Turquier and Duhamel by provide output to a user based on the measured dimension as further taught by Turquier for providing data for easy visualization);
Abuzaina modified by Turquier and Duhamel teaches receiving user input indicating a user's selection of a selected one of the mesh implant options displayed on the display (Turquier 10A shows user selection of mesh implant options “[0128] Referring specifically to FIG. 10A, the clinician may specify details about the indicated implantable repair material. For example, in the instance of a hernia mesh, the clinician may indicate a brand, a model, a size, a material resorption rate, a surfacic density, a transversal overlap, and a longitudinal overlap of the hernia mesh. As shown in FIG. 10A, each indicated detail about the hernia mesh may be illustrated on the display to help the clinician visualize the hernia mesh in actual size in relation to the defect”.
Duhamel [0035] “In step 207 the localization software 150 receives a selection of a graphical overlay (e.g. 520-1) from a plurality of available graphical overlays 520. The surgeon may select an overlay of his or her choice at any time”);
in response to said user input, displaying a selected-type overlay over the hernia defect in the images displayed in real time on the image display, said selected-type overlay depicting said selected one of the mesh implant options (Abuzaina [0029] “Upon setting a desired minimum margin "M," the image processing unit 30 may further be configured to select an appropriate substrate 100 shape and/or size from a collection of common shapes and sizes based on the measured size of the defect "D," the minimum margin "M" required between the edge of the defect "D" and the edge of the substrate 100, and the surgical site "S”……. Additionally, or alternatively, a user may select a substrate 100 shape and the image processing unit 30 would then select the appropriate size of the selected shape in accordance with the set minimum margins "M" so that the substrate 100 will be sure to properly fit over the defect "D.".
Turquier “[0128]….. As shown in FIG. 10A, each indicated detail about the hernia mesh may be illustrated on the display to help the clinician visualize the hernia mesh in actual size in relation to the defect”).
Regarding claim 11 Abuzaina teaches A method for aiding selection of a hernia mesh for treating a hernia defect (Fig. 1, [0024] “….Image capturing unit 20 is configured to obtain or capture an image of the surgical site "S." Surgical site "S" includes a defect "D", for example a hernia defect”),, comprising the steps of:
capturing image data corresponding to a treatment site that includes a hernia defect (Fig. 1, [0024] “….Image capturing unit 20 is configured to obtain or capture an image of the surgical site "S." Surgical site "S" includes a defect "D", for example a hernia defect”),;
using computer vision to identify at least a portion of the hernia defect within images captured using the camera (Abuzaina [0024] “…..Image capturing unit 20 is configured to obtain or capture an image of the surgical site "S." Surgical site "S" includes a defect "D", for example a hernia defect, and anatomical features "A." All or a portion of the anatomical features "A" may be disposed on all or a portion of the defect "D" of the surgical site. [0027] “The image processing unit 30 is configured to adjust and/or scale the image captured by the image capturing unit 20.”);
measuring a dimension relating to the hernia defect based on the image data(Abuzaina [0027] “The image processing unit 30 is configured to adjust and/or scale the image captured by the image capturing unit 20. In addition, the image processing unit 30 may be configured to measure the size of the defect "D" and may further be configured to identify a perimeter, i.e., edges, of the defect "D.") but is silent about providing output to a user based on the measured dimension;
Turquier teaches provide output to a user based on the measured dimension (Turquier [0116] “With reference to FIG. 4D, the anatomo-pathology presented to the clinician via the user interface 118 may include, but is not limited to, tissue defect width, tissue defect height, and tissue defect type (e.g., unique hernia, "swiss cheese. ")”.
Abuzaina and Turquier are analogous art as they are related to surgical repair.
Therefore it would have been obvious for an ordinary skilled person in the art before the effective filing date of claimed invention to have modified Abuzaina by providing output to a user based on the measured dimension as taught by Turquier.
The motivation for the above is to provide data for easy visualization.
Even though Abuzaina modified by Turquier teaches while displaying the images of the hernia defect in real time on the image display, simultaneously displaying, on the image display, an overlay, representing a mesh (Abuzaina Fig. 2A displays mesh and hernia defect);
a plurality of overlays, each representing a different mesh implant option, each mesh implant option having a predetermined size and shape, and each mesh implant option differing from the other mesh implant option within the plurality of mesh implant options in at least one of size and shape (Abuzaina “[0037] Although mesh 100a is shown as a rectangular shape in FIG. 2A, it is understood that mesh 100a will take the shape/size as set by image processing unit 30 (FIG. 1) or as set by the user, as described above. [0032] ….. the image processing unit 30 is configured to re-select a second substrate 100 shape and/or size”) and
Turquier teaches while the hernia defect are displayed in real time on the image display, simultaneously display, on the image display, a menu option for selecting a mesh, each representing a different mesh implant option, each mesh implant option having a predetermined size and shape, and each mesh implant option differing from the other mesh implant option within the plurality of mesh implant options in at least one of size and shape (Turquier “[0128] Referring specifically to FIG. 10A, the clinician may specify details about the indicated implantable repair material. For example, in the instance of a hernia mesh, the clinician may indicate a brand, a model, a size, a material resorption rate, a surfacic density, a transversal overlap, and a longitudinal overlap of the hernia mesh. As shown in FIG. 10A, each indicated detail about the hernia mesh may be illustrated on the display to help the clinician visualize the hernia mesh in actual size in relation to the defect”) but is silent about display a plurality of overlays on the image display;
Duhamel teaches while displaying images of anatomical structure in real time, simultaneously display, on the image display, a plurality of overlays (Fig. 6 shows anatomical structure in the left side and in the right side selectable overlays. “[0034] In step 206 the localization software 150 displays a plurality of selectable graphical overlays within the graphical user interface 160. In FIG. 6, the selectable graphical overlays are shown as 520-1, 520-2, and 520-3 (collectively referred to as 520).”);
Duhamel and Abuzaina modified by Turquier are analogous art as they are related to medical/anatomical field.
Therefore it would have been obvious for an ordinary skilled person in the art before the effective filing date of claimed invention to have modified Abuzaina modified by Turquier by having while displaying the images of the hernia defect in real time, simultaneously display, on the image display, a plurality of overlays similar to while displaying images of anatomical structure in real time, simultaneously display, on the image display, a plurality of overlays as taught by Duhamel and use this teaching with Abuzaina modified by Turquier as Abuzaina has the teaching of plurality of mesh overlays and can be selected as appropriate.
The motivation for the above is to have a choice of visual display of overlay for easy and better understanding for selection.
Abuzaina modified by Turquier and Duhamel teaches receiving user input indicating a user's selection of a selected one of the mesh implant options (Turquier 10A shows user selection of mesh implant options “[0128] Referring specifically to FIG. 10A, the clinician may specify details about the indicated implantable repair material. For example, in the instance of a hernia mesh, the clinician may indicate a brand, a model, a size, a material resorption rate, a surfacic density, a transversal overlap, and a longitudinal overlap of the hernia mesh. As shown in FIG. 10A, each indicated detail about the hernia mesh may be illustrated on the display to help the clinician visualize the hernia mesh in actual size in relation to the defect”.
Duhamel [0035] “In step 207 the localization software 150 receives a selection of a graphical overlay (e.g. 520-1) from a plurality of available graphical overlays 520. The surgeon may select an overlay of his or her choice at any time”);
in response to said user input, displaying a selected-type overlay over the hernia defect displayed on the image display, said selected-type overlay depicting said selected one of the mesh implant options Abuzaina [0029] “Upon setting a desired minimum margin "M," the image processing unit 30 may further be configured to select an appropriate substrate 100 shape and/or size from a collection of common shapes and sizes based on the measured size of the defect "D," the minimum margin "M" required between the edge of the defect "D" and the edge of the substrate 100, and the surgical site "S”……. Additionally, or alternatively, a user may select a substrate 100 shape and the image processing unit 30 would then select the appropriate size of the selected shape in accordance with the set minimum margins "M" so that the substrate 100 will be sure to properly fit over the defect "D.".
Turquier “[0128]….. As shown in FIG. 10A, each indicated detail about the hernia mesh may be illustrated on the display to help the clinician visualize the hernia mesh in actual size in relation to the defect”).
Regarding claim 4 Abuzaina modified by Turquier and Duhamel teaches determine dimensions of a recommended one of the mesh implant options for covering the hernia defect (Abuzaina [0027] “…..In addition, the image processing unit 30 may be configured to measure the size of the defect "D" and may further be configured to identify a perimeter, i.e., edges, of the defect "D. [0028] “…..By setting a minimum margin "M," an appropriate shape and/or size substrate 100 may be selected, as will be described in further detail below. [0035] Turning now to FIG. 2A, the substrate 100 is shown as a mesh 100a"), and
wherein the output includes signals to generate a display of the dimensions of the recommended one of the mesh implant options on the image display (Turquier “[0128] Referring specifically to FIG. 10A, the clinician may specify details about the indicated implantable repair material. For example, in the instance of a hernia mesh, the clinician may indicate a brand, a model, a size, a material resorption rate, a surfacic density, a transversal overlap, and a longitudinal overlap of the hernia mesh. As shown in FIG. 10A, each indicated detail about the hernia mesh may be illustrated on the display to help the clinician visualize the hernia mesh in actual size in relation to the defect”).
Regarding claim 5 Abuzaina modified by Turquier and Duhamel teaches determine dimensions of a recommended one of the mesh implant options for covering the hernia defect (Abuzaina [0027] “…..In addition, the image processing unit 30 may be configured to measure the size of the defect "D" and may further be configured to identify a perimeter, i.e., edges, of the defect "D. [0028] “…..By setting a minimum margin "M," an appropriate shape and/or size substrate 100 may be selected, as will be described in further detail below. [0035] Turning now to FIG. 2A, the substrate 100 is shown as a mesh 100a"), and
wherein the output includes displaying, on the image display, a recommendation of the recommended one of the mesh implant options (Turquier [0128] Referring specifically to FIG. 10A, the clinician may specify details about the indicated implantable repair material. For example, in the instance of a hernia mesh, the clinician may indicate a brand, a model, a size, a material resorption rate, a surfacic density, a transversal overlap, and a longitudinal overlap of the hernia mesh. As shown in FIG. 10A, each indicated detail about the hernia mesh may be illustrated on the display to help the clinician visualize the hernia mesh in actual size in relation to the defect and to assess the transversal and longitudinal overlap to ensure adequate coverage to reduce the risk of recurrence”).
Regarding claim 6 Abuzaina modified by Turquier and Duhamel teaches wherein the output includes text describing measured dimension (Turquier Fig. 4D shows text output).
Regarding claim 7 Abuzaina modified by Turquier and Duhamel teaches wherein the output includes a display of a boundary overlay, said boundary overlay indicating the boundaries of the determined dimensions overlaying the hernia defect on the display (Abuzaina [0029] “Upon setting a desired minimum margin "M," the image processing unit 30 may further be configured to select an appropriate substrate 100 shape and/or size from a collection of common shapes and sizes based on the measured size of the defect "D," the minimum margin "M" required between the edge of the defect "D" and the edge of the substrate 100, and the surgical site "S”……. Additionally, or alternatively, a user may select a substrate 100 shape and the image processing unit 30 would then select the appropriate size of the selected shape in accordance with the set minimum margins "M" so that the substrate 100 will be sure to properly fit over the defect "D.");
Regarding claims 8 and 19 Abuzaina modified by Turquier and Duhamel teaches determine, based on the measured dimension, a size and/or shape of a recommended mesh implant option for covering the defect, and wherein the plurality of overlays includes a representation of the recommended mesh implant option (Abuzaina [0042] “….the image processing unit 30 may further be configured to select an appropriate substrate 100 shape and/or size from a collection of common shapes and sizes sufficient to maintain the minimum margin "M" and cover the area of defect "D."
Turquier “[0128] Referring specifically to FIG. 10A, the clinician may specify details about the indicated implantable repair material. For example, in the instance of a hernia mesh, the clinician may indicate a brand, a model, a size, a material resorption rate, a surfacic density, a transversal overlap, and a longitudinal overlap of the hernia mesh”).
Regarding claim 12 Abuzaina modified by Turquier and Duhamel teaches wherein displaying the selected-type overlay includes displaying said selected-type overlay scaled to match the scale of the displayed image (Abuzaina [0029] “Upon setting a desired minimum margin "M," the image processing unit 30 may further be configured to select an appropriate substrate 100 shape and/or size from a collection of common shapes and sizes based on the measured size of the defect "D," the minimum margin "M" required between the edge of the defect "D" and the edge of the substrate 100, and the surgical site "S”……. Additionally, or alternatively, a user may select a substrate 100 shape and the image processing unit 30 would then select the appropriate size of the selected shape in accordance with the set minimum margins "M" so that the substrate 100 will be sure to properly fit over the defect "D.");
Regarding claim 15 Abuzaina modified by Turquier and Duhamel teaches further including determining dimensions of a recommended mesh implant for covering the defect (Abuzaina [0027] “…..In addition, the image processing unit 30 may be configured to measure the size of the defect "D" and may further be configured to identify a perimeter, i.e., edges, of the defect "D. [0028] “…..By setting a minimum margin "M," an appropriate shape and/or size substrate 100 may be selected, as will be described in further detail below. [0035] Turning now to FIG. 2A, the substrate 100 is shown as a mesh 100a"), and
wherein the output includes displaying, on the image display, a recommendation of the recommended one of the mesh implant options (Turquier [0128] Referring specifically to FIG. 10A, the clinician may specify details about the indicated implantable repair material. For example, in the instance of a hernia mesh, the clinician may indicate a brand, a model, a size, a material resorption rate, a surfacic density, a transversal overlap, and a longitudinal overlap of the hernia mesh. As shown in FIG. 10A, each indicated detail about the hernia mesh may be illustrated on the display to help the clinician visualize the hernia mesh in actual size in relation to the defect and to assess the transversal and longitudinal overlap to ensure adequate coverage to reduce the risk of recurrence”).
Regarding claim 16 Abuzaina modified by Turquier and Duhamel teaches wherein determining dimensions of a recommended mesh implant includes determining dimensions that will cover the defect with a predetermined margin width (Abuzaina [0028] “….The minimum margin "M" may be automatically set by the image processing unit 30 or it may be selected by the user, as will be described in further detail below”).
Regarding claim 17 Abuzaina modified by Turquier and Duhamel teaches wherein the method includes receiving user input selecting the predetermined margin width (Abuzaina [0028] “….The minimum margin "M" may be automatically set by the image processing unit 30 or it may be selected by the user, as will be described in further detail below”).
Regarding claim 18 Abuzaina modified by Turquier and Duhamel teaches wherein the output includes a display of an overlay indicating the boundaries of the determined dimensions overlaying the hernia defect on the display (Abuzaina [0029] “Upon setting a desired minimum margin "M," the image processing unit 30 may further be configured to select an appropriate substrate 100 shape and/or size from a collection of common shapes and sizes based on the measured size of the defect "D," the minimum margin "M" required between the edge of the defect "D" and the edge of the substrate 100, and the surgical site "S”……. Additionally, or alternatively, a user may select a substrate 100 shape and the image processing unit 30 would then select the appropriate size of the selected shape in accordance with the set minimum margins "M" so that the substrate 100 will be sure to properly fit over the defect "D.");
Claim(s) 2-3, 9, 13-14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Abuzaina modified by Turquier and Duhamel as applied to claim 1 above, and further in view of Toro et al. (US Pat. Pub. No. 20210369463, “Toro”).
Regarding claims 2 and 13 Abuzaina modified by Turquier and Duhamel is silent about determine variations in topography of tissue at the treatment site, and to display the selected-type overlay to depict deformation of the selected one of the mesh implant options to conform to variations in the topography.
Toro teaches determine variations in topography of tissue at treatment site, and to display the selected-type overlay to depict deformation of the selected one of the mesh implant options to conform to variations in the topography ([0083]” In step 420 of method 400 of FIG. 4, a surface topography of the resected portion on the image of the tissue section is determined. [0084] In step 430 of method 400 of FIG. 4, an image of a bioscaffold implant is determined with a surface portion that matches the surface topography of the resected portion. [0036] In accordance with various embodiments, the bioscaffold implant can take many other forms including, for example, membranes, microbeads, fleece, fibers, gels and fiber meshes.”);
Toro and Abuzaina modified by Turquier and Duhamel are analogous art as they are related to surgical repair.
Therefore it would have been obvious for an ordinary skilled person in the art before the effective filing date of claimed invention to have modified Abuzaina modified by Turquier and Duhamel by determining variations in topography of tissue at treatment site, and to display the selected-type overlay to depict deformation of the selected one of the mesh implant options to conform to variations in the topography as taught by Toro.
The motivation for the above is to design a proper surface of a mesh so that the designed mesh can be constructed for surgery.
Regarding claims 3 and 14 Abuzaina modified by Turquier and Duhamel and Toro teaches wherein the instructions are executable by the processor to determine the variations in topography using image data from the camera (Toro [0147] “….For example, image capture device 560 can be connected via a LAN or WAN connection that allows for the transmission of imaging data acquired by image capture device 560 to the computing device 510 for analysis. Similarly, and as illustrated, computing device 510 can be communicatively connected to image capture device 560 via a LAN or WAN connection through physical storage 570, cloud server 580, or both”).
Regarding claims 9 and 20 Abuzaina modified by Turquier and Duhamel and Toro teaches display the selected-type overlay to maintain tension across depth disparities exceeding a predetermined change in depth (Turquier “[0161]….. For example, the clinician may choose to generate a simulation of (1) how and to what extent the indicated patient activity affects the force at the fixations securing a mesh to the abdominal wall of the patient (FIG. 30A), (2) how and to what extent the indicated patient activity causes bulging of the mesh (FIG. 30B), or (3) how and to what extent the indicated patient activity causes a stress field on the mesh (FIG. 30C). [0170]….Experimental data may include stress threshold (e.g., threshold at which a mesh tears), maximum fixation pull out force, acceptable amount of bulging (e.g., visually undetectable). Turquier’s simulation calculates a force between fixations (fixation is the connection between tissue and simulated mesh/overlay) that is maintained to secure the overlay/mesh with abdominal wall or tissue such that even high amount of patient activity (indicating depth disparity over predetermined threshold) that causes a small amount of bulging (visually undetectable) of mesh/overlay so that mesh is fixed/secured properly with the abdominal tissue. ).
Claims 10 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Abuzaina modified by Turquier and Duhamel as applied to claim 1 above, and further in view of Glennie et al. (US Pat. Pub. No. 20140022433, “Glennie”).
Regarding claim 10 even though Abuzaina modified by Turquier and Duhamel teaches a user input (Turquier [0108] “Application 116 communicates with a user interface 118 that presents visual interactive features to a clinician, for example, on display 110 and for receiving clinician input, for example, via a user input device”) but is silent about move or rotate the position of the selected-type overlay depicting the selected one of the mesh implant options relative to the displayed image in response to input from the user input.
Glennie teaches move or rotate position of overlay relative to the displayed image in response to input from user input (Fig. 4B shows the boundary line overlay moved from initial position 410 to a new position 420 by touch input, [0068] “…..default ROI 325 is defined by the image processor 202 and displayed on the display 112 using a boundary line which overlays the real-time image 305. The boundary line is shown in dotted lines in the illustrated embodiment. The default ROI is located in the centre of the real-time image 305 in the illustrated embodiment. In the shown embodiment, the display 112 is part of a touch-sensitive display 118 and a drag touch gesture sometimes referred to as a touch and drag gesture) may be used to Set a user-defined ROI by moving the default ROI to a user-designated location”).
Glennie and Abuzaina modified by Turquier and Duhamel are analogous art as they are related to image processing.
Therefore it would have been obvious for an ordinary skilled person in the art before the effective filing date of claimed invention to have modified Abuzaina modified by Turquier and Duhamel by moving or rotating the position of the selected-type overlay depicting the selected one of the mesh implant options relative to the displayed image in response to input from the user input similar to moving or rotating position of overlay relative to the displayed image in response to input from user input as taught by Glennie.
The motivation for the above to provide the controllability to the user to design proper size of mesh that matches with the boundary of hernia defect.
Regarding claim 21 Abuzaina modified by Turquier and Duhamel is silent about changing the position or orientation of the selected-type overlay relative to the displayed image in response to user input.
Glennie teaches changing the position or orientation of the selected-type overlay relative to the displayed image in response to user input (Fig. 4B shows the boundary line overlay moved from initial position 410 to a new position 420 by touch input, [0068] “…..default ROI 325 is defined by the image processor 202 and displayed on the display 112 using a boundary line which overlays the real-time image 305. The boundary line is shown in dotted lines in the illustrated embodiment. The default ROI is located in the centre of the real-time image 305 in the illustrated embodiment. In the shown embodiment, the display 112 is part of a touch-sensitive display 118 and a drag touch gesture sometimes referred to as a touch and drag gesture) may be used to Set a user-defined ROI by moving the default ROI to a user-designated location”).
Glennie and Abuzaina modified by Turquier and Duhamel are analogous art as they are related to image processing.
Therefore it would have been obvious for an ordinary skilled person in the art before the effective filing date of claimed invention to have modified Abuzaina modified by Turquier and Duhamel by changing the position or orientation of the selected-type overlay relative to the displayed image in response to user input as taught by Glennie.
The motivation for the above to provide the controllability to the user to design proper size of mesh that matches with the boundary of hernia defect.
Response to Arguments
Applicant's arguments see remarks filed 11/25/2025 with respect to rejection of claim 1 have been fully considered but they are not persuasive. Therefore the rejection has been maintained.
Applicant argues see remarks page 2, “The Office Action has taken the position that Fig. 2A of Abuzaina depicts an image display with a mesh displayed on the image shown on the image display. This interpretation is not supported by the language or images of Abuzaina. Instead, the specification and drawings of Abuzaina make clear that Fig. 2A depicts the physical mesh that has been printed with an image of the site printed on it. It does not depict an image display with an overlay of a mesh overlaying the image of the hernia defect. First, Paras. [0018] - [0020] describe Figs. 2A - 3 as follows: [0018] FIG. 2A is a perspective view of a mesh according to an embodiment of the present disclosure; [0019] FIG. 2B is a perspective view of a film before being attached to a mesh substrate according to an embodiment of the present disclosure; [0020] FIG. 3 is a view of the printed image on the mesh placed over a hernia according to an embodiment of the present disclosure…………..an image display with the film shown as an overlay”.
Examiner wants to note that Fig. 2A of Abuzaina doesn’t depict physical mesh rather it’s a digital/virtual mesh which is later gets printed. Paragraph [0018] and paragraph [0019] both describe that Fig. 2A and 2B are perspective view of mesh. Perspective view can be seen in a display. According to paragraph “[0027] …..Additionally, or alternatively, a user may manually measure the size of the defect "D" and input the measurements via a graphic user interface”, user can measure defect “D” in a GUI which is shown in a display.
According to paragraph” [0048] At step 335, a determination is made as to whether the image will be printed directly onto mesh 100a……. The determination may be made by any component of system 10 (FIG. 1) such as, without limitation, image processing unit 30 (FIG. 1). Alternatively, a user may make the determination via the graphical user interface described above”, based on Fig. 2A it is determined using GUI/display whether to print it or not. Therefore Fig. 2A is not a printed version.
Applicant argues see remarks pages 2-3 “Second, Paragraphs [0034] through [0040] reinforce that Figs. 2A through 3 display the physical output from the described printing unit 70 and not a real time image display showing a mesh overlay. For example:
Para. [0034] states: Continuing with reference to FIG. 1, printing unit 70 is configured to print the image captured by image capturing unit 20 subsequent to proper
adjustment by image processing unit 30. Printing unit 70 prints the image……. and Fig. 2B shows the film 100b offset from the mesh 100c so the mesh can be seen. This configuration in the figure would have no purpose if Fig. 2B showed an image display with the film shown as an overlay”.
Examiner wants to note that according to paragraph [0034] “…..Printing unit 70 prints the image on a substrate 100 which can take the form of a mesh 100a (FIG. 2A) or a film 100b (FIG. 2B)”, Fig. 2A is not the printed version. Printed version will be in the form of Fig. 2A.
Applicant argues see remarks pages 3-4 “Finally, there is no language in Abuzaina that describes Fig. 2A (or 2B or 3) as showing an image display with a graphical overlay of a mesh on the real time image display. Abuzaina states that a user may use a graphical user interface to perform various tasks, such as entering measurements of the defect, identifying the edges of the defect, and editing the image by marking anatomical features of the defect so they can be printed onto the mesh or film substrate……….size of the defect, and select a shape and size of the substrate sufficient to maintain the minimum margin set. See, for example, Paras. [0012], [0027] - [0029] and [0042]. As with the other functions of the image processing unit discussed above, there is no indication that these steps involve a graphical overlay of a mesh displayed as an overlay on the real time image”.
Examiner wants to note that Fig. 2A of Abuzaina shows a digital/virtual mesh which is later gets printed. Paragraph [0018] and paragraph [0019] both describe that Fig. 2A and 2B are perspective view of mesh. Perspective view can be seen in a display. According to paragraph defect “D” is shown in GUI which is shown in Fig. 2A, “[0027] …..Additionally, or alternatively, a user may manually measure the size of the defect "D" and input the measurements via a graphic user interface”, user can measure defect “D” in a GUI which is shown in a display.
According to paragraph” [0048] At step 335, a determination is made as to whether the image will be printed directly onto mesh 100a……. The determination may be made by any component of system 10 (FIG. 1) such as, without limitation, image processing unit 30 (FIG. 1). Alternatively, a user may make the determination via the graphical user interface described above”, based on Fig. 2A it is determined using GUI/display whether to print it or not. Therefore Fig. 2A is not a printed version.
Applicant argues see remarks pages 4-5 “The Turquier reference does not provide the features missing from Abuzaina. Turquier describes a tool that allows a user to plan a mesh implantation procedure. The system generates and displays graphical models of patient anatomy based on patient data, and allows the user to evaluate the chosen mesh, distribution, etc. based on patient characteristics such as muscle and tissue quality and morphotype. The user can enter further data pertaining to the brand, type and size of mesh desired to be used, as well as the user's target distribution for suture fixation………operative images to determine surgical approach and sizing, but lack the ability to perform simulations of how the tissue to which the mesh is attached will behave during patient activity. Para. [0006].”
Examiner wants to note that real time image of hernia is shown from primary reference Abuziana. Turquier displays hernia defect with menu option for mesh selection See Turquier “[0128] Referring specifically to FIG. 10A, the clinician may specify details about the indicated implantable repair material. For example, in the instance of a hernia mesh, the clinician may indicate a brand, a model, a size, a material resorption rate, a surfacic density, a transversal overlap, and a longitudinal overlap of the hernia mesh. As shown in FIG. 10A, each indicated detail about the hernia mesh may be illustrated on the display to help the clinician visualize the hernia mesh in actual size in relation to the defect”
Examiner proposed to further modify Abuziana by Tarquier’s teaching for better user control.
Conclusion
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/SAPTARSHI MAZUMDER/ Primary Examiner, Art Unit 2612