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 .
Response to Amendment
This office action is in response to the remarks filed on 09/15/2025.
The amendment filed 09/15/2025 has been entered. Claims 1-13 remain pending in the application.
The 112(b) rejection has been withdrawn in light of claim amendments.
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.
Claims 7, 11, and 13 are rejected under 35 U.S.C. 102a(1) as being anticipated by Pewowaruk et al. (Pewowaruk, Ryan, et al. "A pilot study of bladder voiding with real-time MRI and computational fluid dynamics." PLoS One 15.11 (2020): e0238404, hereinafter "Pewowaruk").
Regarding claim 7, Pewowaruk teaches a method comprising:
receiving time-resolved images of a urinary tract of a subject as a bladder of the urinary tract begins, continues through, and completes a filling or voiding process including a of the bladder (An MRI urodynamics protocol was implemented which involved a fluid challenge and voiding during MRI. Three-dimensional ‘Fast-spin echo’ (FSE) T2-weighted acquisitions were performed immediately before and after voiding- page 2/10, “Materials and Methods”);
segmenting the time-resolved images of the urinary tract to identify boundaries of anatomical structures of the urinary tract (The bladder was segmented from pre- and post- voiding 3D images of the bladder, while bladder cross-sectional area change during voiding was calculated from the 2D RTI- page 2/10, “Materials and Methods”);
performing a surface mapping of the boundaries of the anatomical structures to produce a consistent set of mapped anatomical structures across the time-resolved images (Fig 2. Schematic of the bladder wall divided into anterior-posterior, dome-base, and left-right regions for regional displacement and asymmetry analysis- page 5/10; For each point on the bladder surface d0 the distance between the pre and post voiding anatomies was calculated using a fast, minimum storage ray-triangle intersection algorithm- page -10, paragraph 3, “MRI post-processing”);
using a flow model and the consistent set of mapped anatomical structures, calculating metrics describing function of the urinary tract during the filling or voiding process (Using 3D FSE T2-weighted images the bladder was segmented (Mimics, Materialise, Leuven, Belgium) for both pre and post voiding. The pre and post voiding bladder volumes were then exported as stereolithography (STL) files. From 2D RTI data during voiding, the area of a sagittal plane through the bladder was measured over time. To estimate the motion of the bladder wall during voiding a spherical coordinate system was defined for the bladder, similar to previous motion estimation algorithms used in cardiac chambers [16, 17]. The coordinate system origin was set to be the center of the post voiding bladder volume. In general, the bladder wall displacement (d) is a three dimensional vector that has spatial and time dependence, page -10, paragraph 3, “MRI post-processing”); and
generating a report using the metrics describing function of the urinary tract during the filling or voiding process (Fig 4. Top row: Pre- and post-voiding bladder anatomies for each subject, page 6/10; Urodynamics results from computational fluid dynamics (CFD) are shown in Fig 6 for a sagittal plane near the center of the bladder, page 6/10 “Results”).
Regarding claim 11, Pewowaruk teaches method of claim 7, as discussed above. Pewowaruk further teaches determining at least one of bladder capacity (Using 3D FSE T2-weighted images the bladder was segmented (Mimics, Materialise, Leuven, Belgium) for both pre and post voiding. The pre and post voiding bladder volumes were then exported as stereolithography (STL) files. From 2D RTI data during voiding, the area of a sagittal plane through the bladder was measured over time. To estimate the motion of the bladder wall during voiding a spherical coordinate system was defined for the bladder, similar to previous motion estimation algorithms used in cardiac chambers [16, 17]. The coordinate system origin was set to be the center of the post voiding bladder volume. In general, the bladder wall displacement (d) is a three dimensional vector that has spatial and time dependence, page -10, paragraph 3, “MRI post-processing”) voiding pressure, flow dynamics, pressure at maximum flow, post voiding residual volume, emptying efficiency, or maximum flow to determine the metrics describing function of the urinary tract during the filling or voiding process.
Regarding claim 13, Pewowaruk teaches method of claim 7, as discussed above. Pewowaruk further teaches wherein the time-resolved images are volumetric magnetic resonance images (we used an MRI sequence that consists of a series of parallel sagittal 2D spoiled gradient echo (SGRE) dynamic real-time images capturing the bladder neck and urethra as well as other regions of the bladder. In this protocol, images are constantly acquired for four minutes allowing complete capture of voiding mechanics during bladder voiding without inducing any discomfort. Dynamic images were segmented to measure the relative displacement of the bladder wall during voiding- Page 3/10, “Dynamic imaging of the bladder”).
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.
Claims 1 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Mori et al. (US 20190146044 A1) in view of Pewowaruk et al. (Pewowaruk, Ryan, et al. "A pilot study of bladder voiding with real-time MRI and computational fluid dynamics." PLoS One 15.11 (2020): e0238404, hereinafter "Pewowaruk") and Ruff et al. (US 20100087726 A1, of record, hereinafter "Ruff").
Regarding claim 1, Mori teaches a magnetic resonance (MR) imaging system (The MRI apparatus 100 [0017]) comprising:
a magnet system configured to generate a static magnetic field (Bo) about at least a portion of a subject (The static field magnet 101 is, for example, a magnet formed in a hollow and essentially cylindrical shape. The static field magnet 101 generates a homogeneous static magnetic field in a bore 111 [0017]) including a urinary tract ([0037], [0039] discloses that any target region, including the abdomen/ entire chest region, the urinary tract is inherently within those regions);
a plurality of gradient coils configured to apply magnetic gradients to the static magnetic field (The gradient coil 103 is formed by combining three coils respectively corresponding to the X-, Y-, and Z-axes which are orthogonal to each other. … these three coils in the gradient coil 103 are separately supplied with a current from the gradient magnetic field power supply 105, and respectively generate gradient fields in which a magnetic field intensity changes along each of the X-, Y-, and Z-axes [0019])
a radio frequency (RF) system configured to apply an excitation field to the subject (The transmission coil 115 is an RF coil disposed inside of the gradient coil 103. The transmission coil 115 receives an RF signal from the transmission circuitry 113, and generates a transmission RF wave (RF pulse) which corresponds to a high frequency magnetic field [0025]) and acquire time-resolved, three-dimensional (3D) MR image data from the urinary tract of the subject ([0043]-[0044] disclose that slices and volumetric data is acquired; [0033] disclose that time information is acquired while imaging; [0037], [0039] discloses that any target region, including the abdomen/ entire chest region, the urinary tract is inherently within those regions) ;
a computer system programmed to:
control the plurality of gradient coils (The gradient coil 103 is formed by combining three coils respectively corresponding to the X-, Y-, and Z-axes which are orthogonal to each other. … these three coils in the gradient coil 103 are separately supplied with a current from the gradient magnetic field power supply 105, and respectively generate gradient fields in which a magnetic field intensity changes along each of the X-, Y-, and Z-axes [0019]) and the RF system (The transmission coil 115 is an RF coil disposed inside of the gradient coil 103. The transmission coil 115 receives an RF signal from the transmission circuitry 113, and generates a transmission RF wave (RF pulse) which corresponds to a high frequency magnetic field [0025])
Mori, however, does not teach:
acquire the time-resolved 3D MR image data from the urinary tract as a bladder of the urinary tract begins, continues through, and completes a filling or voiding process;
reconstruct the time-resolved 3D MR image data to produce volumetric, time-resolved images of the urinary tract;
segment the volumetric, time-resolved images of the urinary tract to identify anatomical structures of the urinary tract;
perform a surface mapping of the anatomical structures to produce a consistent set of mapped anatomical structures across the volumetric, time-resolved images;
process the consistent set of mapped anatomical structures using a flow model to calculate metrics describing a function of the urinary tract during the filling or voiding process;
generate a report using the metrics describing function of the urinary tract during the filling or voiding process; and
display the report for clinical analysis of the function of the urinary tract.
Pewowaruk is considered analogous to the instant application as “A pilot study of bladder voiding with real-time MRI and computational fluid dynamics” is disclosed (title).
Pewowaruk teaches:acquire the time-resolved 3D MR image data from the urinary tract as a bladder of the urinary tract begins, continues through, and completes a filling or voiding process (An MRI urodynamics protocol was implemented which involved a fluid challenge and voiding during MRI. Three-dimensional ‘Fast-spin echo’ (FSE) T2-weighted acquisitions were performed immediately before and after voiding- page 2/10, “Materials and Methods”)
reconstruct the time-resolved 3D MR image data to produce volumetric, time-resolved images of the urinary tract (we used an MRI sequence that consists of a series of parallel sagittal 2D spoiled gradient echo (SGRE) dynamic real-time images capturing the bladder neck and urethra as well as other regions of the bladder. In this protocol, images are constantly acquired for four minutes allowing complete capture of voiding mechanics during bladder voiding without inducing any discomfort. Dynamic images were segmented to measure the relative displacement of the bladder wall during voiding- Page 3/10, “Dynamic imaging of the bladder”);
segment the volumetric, time-resolved images of the urinary tract to identify anatomical structures of the urinary tract (The bladder was segmented from pre- and post- voiding 3D images of the bladder, while bladder cross-sectional area change during voiding was calculated from the 2D RTI-- page 2/10, “Materials and Methods”)
perform a surface mapping of the anatomical structures to produce a consistent set of mapped anatomical structures across the volumetric, time-resolved images (Fig 2. Schematic of the bladder wall divided into anterior-posterior, dome-base, and left-right regions for regional displacement and asymmetry analysis- page 5/10; For each point on the bladder surface d0 the distance between the pre and post voiding anatomies was calculated using a fast, minimum storage ray-triangle intersection algorithm- page -10, paragraph 3, “MRI post-processing”)
process the consistent set of mapped anatomical structures using a flow model to calculate metrics describing a function of the urinary tract during the filling or voiding process (Using 3D FSE T2-weighted images the bladder was segmented (Mimics, Materialise, Leuven, Belgium) for both pre and post voiding. The pre and post voiding bladder volumes were then exported as stereolithography (STL) files. From 2D RTI data during voiding, the area of a sagittal plane through the bladder was measured over time. To estimate the motion of the bladder wall during voiding a spherical coordinate system was defined for the bladder, similar to previous motion estimation algorithms used in cardiac chambers [16, 17]. The coordinate system origin was set to be the center of the post voiding bladder volume. In general, the bladder wall displacement (d) is a three dimensional vector that has spatial and time dependence, page -10, paragraph 3, “MRI post-processing”);
generate a report using the metrics describing function of the urinary tract during the filling or voiding process (Fig 4. Top row: Pre- and post-voiding bladder anatomies for each subject, page 6/10; Urodynamics results from computational fluid dynamics (CFD) are shown in Fig 6 for a sagittal plane near the center of the bladder, page 6/10 “Results”)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Mori to include acquire the time-resolved 3D MR image data from the urinary tract as a bladder of the urinary tract begins, continues through, and completes a filling or voiding process, reconstruct the time-resolved 3D MR image data to produce volumetric, time-resolved images of the urinary tract, segment the volumetric, time-resolved images of the urinary tract to identify anatomical structures of the urinary tract, perform a surface mapping of the anatomical structures to produce a consistent set of mapped anatomical structures across the volumetric, time-resolved images, and process the consistent set of mapped anatomical structures using a flow model to calculate metrics describing a function of the urinary tract during the filling or voiding process, and generate a report using the metrics describing function of the urinary tract during the filling or voiding process, as taught by Pewowaruk. Doing so would the physical and physiological realism of urodynamic simulations, as suggested by Pewowaruk (The CFD methodology presented here represents a significant step towards improving the physical and physiological realism of urodynamic simulation, page 8/10 “Discussion”).
The combined invention still does not teach: display the report for clinical analysis of the function of the urinary tract.
Ruff is considered analogous to the instant application as “Magnetic resonance method and apparatus for determining a kidney function parameter” is disclosed (title).
Ruff teaches
display the report for clinical analysis of the function of the urinary tract (determine a kidney function parameter of kidneys of an examination person with the aid of magnetic resonance tomography, at least one magnetic resonance measurement is conducted in an examination region of the examination person that includes the urinary bladder of the examination person, to acquire magnetic resonance data from the examination region that represent at least image data [0011]; The determined kidney function parameter can be additionally processed in computer 113; however, it can also be presented at display 111 or can be stored in a database for a later use [0042]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Mori to include display the report for clinical analysis of the function of the urinary tract, as taught by Ruff. Doing so would allow for a precise and fast method to automatically determine a kidney function parameter, as suggested by Ruff ([0052]).
Regarding claim 5, modified Mori teaches the system of claim 1, as discussed above. Mori, however, does not teach wherein the computer system is further configured to determine at least one of bladder capacity, voiding pressure, flow dynamics, pressure at maximum flow, post voiding residual volume, emptying efficiency, or maximum flow to determine the metrics describing function of the urinary tract during the filling or voiding process.
Pewowaruk, however, teaches wherein the computer system is further configured to determine at least one of bladder capacity to determine the metrics describing function of the urinary tract during the filling or voiding process (Using 3D FSE T2-weighted images the bladder was segmented (Mimics, Materialise, Leuven, Belgium) for both pre and post voiding. The pre and post voiding bladder volumes were then exported as stereolithography (STL) files. From 2D RTI data during voiding, the area of a sagittal plane through the bladder was measured over time. To estimate the motion of the bladder wall during voiding a spherical coordinate system was defined for the bladder, similar to previous motion estimation algorithms used in cardiac chambers [16, 17]. The coordinate system origin was set to be the center of the post voiding bladder volume. In general, the bladder wall displacement (d) is a three dimensional vector that has spatial and time dependence, page -10, paragraph 3, “MRI post-processing).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Mori to include wherein the computer system is further configured to determine at least one of bladder capacity to determine the metrics describing function of the urinary tract during the filling or voiding process, as taught by Pewowaruk. Doing so would the physical and physiological realism of urodynamic simulations, as suggested by Pewowaruk (The CFD methodology presented here represents a significant step towards improving the physical and physiological realism of urodynamic simulation, page 8/10 “Discussion”).
Claims 2-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Mori et al. (US 20190146044 A1) in view of Pewowaruk et al. (Pewowaruk, Ryan, et al. "A pilot study of bladder voiding with real-time MRI and computational fluid dynamics." PLoS One 15.11 (2020): e0238404, hereinafter "Pewowaruk"), Ruff et al. (US 20100087726 A1, of record, hereinafter "Ruff") and Ben-Haim et al (US 20200286225 A1, hereinafter “Ben”).
Regarding claim 2, modified Mori teaches the system of claim 1, as discussed above. Mori, however, does not teach wherein the computer system is further configured to define a series of structural element shapes across a segmented bladder in a given image frame in the volumetric, time resolved images and utilize a common number of structural element shapes across each image frame in the volumetric, time resolved images.
Ben is considered analogous to the instant application as “Flattened view for intra-lumenal navigation” is disclosed (title).
Ben teaches wherein the computer system is further configured to define a series of structural element shapes across a segmented bladder ([0095] a three-dimensional model of an inner three-dimensional surface of any type of body. For example, the body may be any type of internal organ of an animal or human or of any type of body lumen … kidney/urinary tract portion) in a given image frame in the volumetric, time resolved images and utilize a common number of structural element shapes across each image frame in the volumetric, time resolved images ([0332]-[0335] discloses use of equal size triangular mesh across two images; [0335] The triangles in these two images remain more nearly equal in area and shape over the extent of the image; The 3-D image source 1222 comprises, for example, an MRI image, CT image, radiography image, or another image type [0302]; [0435] discloses that information obtained throughout a period of time).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Mori to include wherein the computer system is further configured to define a series of structural element shapes across a segmented bladder in a given image frame in the volumetric, time resolved images and utilize a common number of structural element shapes across each image frame in the volumetric, time resolved images, as taught by Ben. Doing so would improve visualization of the image.
Regarding claim 3, modified Mori teaches the system of claim 2, as discussed above. Mori, however, does not teach wherein the computer system is configured to utilize triangles as the structural element shape and enforce a consistent number of triangles across each image frame in the volumetric, time resolved images, while preserving a shape of the bladder wall within each image frame.
Ben teaches wherein the computer system is configured to utilize triangles as the structural element shape and enforce a consistent number of triangles across each image frame in the volumetric, time resolved images, while preserving a shape of the bladder wall within each image frame ([0332]-[0335] discloses use of equal size triangular mesh across two images; [0335] The triangles in these two images remain more nearly equal in area and shape over the extent of the image; a three-dimensional model of an inner three-dimensional surface of any type of body. For example, the body may be any type of internal organ of an animal or human or of any type of body lumen … kidney/urinary tract portion [0095]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Mori to include wherein the computer system is configured to utilize triangles as the structural element shape and enforce a consistent number of triangles across each image frame in the volumetric, time resolved images, while preserving a shape of the bladder wall within each image frame, as taught by Ben. Doing so would improve visualization of the image.
Regarding claim 4, modified Mori teaches the system of claim 1, as discussed above. Mori, however, does not teach wherein the computer system is further configured to utilize a common coordinate system between image frames in the volumetric, time resolved images to bin segmented surfaces in the volumetric, time-resolved images to increase computational efficiency of the surface mapping.
Ben is considered analogous to the instant application as “Flattened view for intra-lumenal navigation” is disclosed (title).
Ben, however teaches:
wherein the computer system is further configured to utilize a common coordinate system between image frames in the volumetric ([0351]-[0352] discloses use of a common coordinate system in the images; ), time resolved images to bin segmented surfaces in the volumetric, time-resolved images to increase computational efficiency of the surface mapping ([0339] discloses image capturing sequences over time ; a three-dimensional model of an inner three-dimensional surface of any type of body. For example, the body may be any type of internal organ of an animal or human or of any type of body lumen … kidney/urinary tract portion [0095]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Mori to include wherein the computer system is further configured to utilize a common coordinate system between image frames in the volumetric, time resolved images to bin segmented surfaces in the volumetric, time-resolved images to increase computational efficiency of the surface mapping, as taught by Ben. Doing so would improve visualization of the image.
Regarding claim 6, modified Mori teaches the system of claim 1, as discussed above. Mori, however, does not teach, wherein, to generate the report, the computer system is configured to produce at least one of images with functional overlays, graphs showing metrics over time, or metric-correlated indices including at least one of bladder outlet obstruction index (BOOI) or bladder contractility index (BCI).
Ben is considered analogous to the instant application as “Flattened view for intra-lumenal navigation” is disclosed (title).
Ben teaches wherein, to generate the report, the computer system is configured to produce at least one of images with functional overlays ([0265]-[0266] discloses using image overlays to determine wall thickness).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Mori to include wherein, to generate the report, the computer system is configured to produce at least one of images with functional overlays, as taught by Ben. Doing so helps in emphasizing 3-D structure, as suggested by Ben ([0267]).
Claims 8-10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Pewowaruk et al. (Pewowaruk, Ryan, et al. "A pilot study of bladder voiding with real-time MRI and computational fluid dynamics." PLoS One 15.11 (2020): e0238404, hereinafter "Pewowaruk") in view of and Ben-Haim et al (US 20200286225 A1, hereinafter “Ben”).
Regarding claim 8, Pewowaruk teaches the method of claim 7, as discussed above. Pewowaruk, however, does not teach defining a series of structural elements across a segmented bladder in a given image frame in the time resolved images and utilize a common number of structural elements across each image frame in the time-resolved images.
Ben is considered analogous to the instant application as “Flattened view for intra-lumenal navigation” is disclosed (title).
Ben teaches defining a series of structural elements across a segmented bladder ([0095] a three-dimensional model of an inner three-dimensional surface of any type of body. For example, the body may be any type of internal organ of an animal or human or of any type of body lumen … kidney/urinary tract portion) in a given image frame in the time resolved images and utilize a common number of structural elements across each image frame in the time-resolved images ([0332]-[0335] discloses use of equal size triangular mesh across two images; [0335] The triangles in these two images remain more nearly equal in area and shape over the extent of the image; The 3-D image source 1222 comprises, for example, an MRI image, CT image, radiography image, or another image type [0302]; [0435] discloses that information obtained throughout a period of time).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Pewowaruk to include defining a series of structural elements across a segmented bladder in a given image frame in the time resolved images and utilize a common number of structural elements across each image frame in the time-resolved images.as taught by Ben. Doing so would improve visualization of the image.
Regarding claim 9, modified Pewowaruk teaches the method of claim 8, as discussed above. Pewowaruk, however, does not teach wherein the structural elements are triangles and further comprising enforcing a consistent number of triangles across each image frame in the time resolved images, while preserving a shape of the bladder wall within each image frame.
Ben, however, teaches wherein the structural elements are triangles and further comprising enforcing a consistent number of triangles across each image frame in the time resolved images, while preserving a shape of the bladder wall within each image frame ([0332]-[0335] discloses use of equal size triangular mesh across two images; [0335] The triangles in these two images remain more nearly equal in area and shape over the extent of the image; a three-dimensional model of an inner three-dimensional surface of any type of body. For example, the body may be any type of internal organ of an animal or human or of any type of body lumen … kidney/urinary tract portion [0095]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Pewowaruk to include wherein the structural elements are triangles and further comprising enforcing a consistent number of triangles across each image frame in the time resolved images, while preserving a shape of the bladder wall within each image frame, as taught by Ben. Doing so would improve visualization of the image.
Regarding claim 10, Pewowaruk teaches the method of claim 7 as discussed above. Pewowaruk, however, does not teach utilizing a common coordinate system between image frames in the time resolved images to bin segmented surfaces in the time- resolved images to increase computational efficiency of the surface mapping.
Ben is considered analogous to the instant application as “Flattened view for intra-lumenal navigation” is disclosed (title).
Ben, however teaches:
utilizing a common coordinate system between image frames in the time resolved images to bin segmented surfaces in the time- resolved images ([0351]-[0352] discloses use of a common coordinate system in the images; ), to increase computational efficiency of the surface mapping ([0339] discloses image capturing sequences over time ; a three-dimensional model of an inner three-dimensional surface of any type of body. For example, the body may be any type of internal organ of an animal or human or of any type of body lumen … kidney/urinary tract portion [0095]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Pewowaruk to include utilizing a common coordinate system between image frames in the time resolved images to bin segmented surfaces in the time- resolved images to increase computational efficiency of the surface mapping, as taught by Ben. Doing so would improve visualization of the image.
Regarding claim 12, Pewowaruk the method of claim 7, as discussed above. Pewowaruk, however, does not teach, wherein, producing at least one of images with functional overlays, graphs showing metrics over time, or metric-correlated indices including at least one of bladder outlet obstruction index (BOOI) or bladder contractility index (BCI).
Ben is considered analogous to the instant application as “Flattened view for intra-lumenal navigation” is disclosed (title).
Ben teaches, producing at least one of images with functional overlays ([0265]-[0266] discloses using image overlays to determine wall thickness).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Pewowaruk to producing at least one of images with functional overlays, as taught by Ben. Doing so helps in emphasizing 3-D structure, as suggested by Ben ([0267]).
Response to Arguments
Applicant's arguments filed 09/15/2025 have been fully considered but they are moot.
Applicant arguments on pages 6-9, regarding the 35 USC § 103 rejection of claims 1 and 7, are premised upon the assertion that the prior art does not teach or suggest the limitations regarding the imaging process of the bladder during the voiding or filling process. These arguments are moot in view of new grounds of rejection which rely upon Pewowaruk et al. (Pewowaruk, Ryan, et al. "A pilot study of bladder voiding with real-time MRI and computational fluid dynamics." PLoS One 15.11 (2020): e0238404, hereinafter "Pewowaruk") to teach these limitations. Accordingly, the argument is moot.
Applicant argument’s on page 9 regarding the 35 USC § 103 claims 2-6 and 8-13 are premised upon the assertion that the claims are allowable for due to dependency on an allowable claim. The examiner respectfully disagrees for the reasons discussed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/N.B./ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798
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