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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/30/2025 has been entered.
Response to Amendment
In the present applications, claims 1, 3-28, and 30-37 are currently pending. Claims 2 and 29 have been canceled. Claims 1, 3-4, 20-21, 30, and 37 are currently amended. The amendment filed 06/30/2025 has been entered.
Response to Arguments
Applicant’s arguments, see pages 9-16, filed 06/30/2025, with respect to the pending claims have been fully considered but are moot in view of the new ground of rejection necessitated by Applicant’s amendments to the claims. Therefore the rejections identified in the final office action dated 03/25/2025 have been withdrawn.
However, a new ground of rejection was necessitated because Applicant’s amended the independent claims. Such amendments changed the scope of the claims. As such, a new ground of rejection is presented below. Please see section 35 U.S.C. §103 below for further explanation.
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.
Claims 1, 3, 8, 10-14, 16-19, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Hagai Krupnik (US9412054) hereinafter Krupnik, in view of Tada et al. (US2021/0153808) hereinafter Tada.
Regarding Claim 1, Krupnik discloses a method of identifying a colon anatomical part associated with a location of a capsule device (Fig. 1a device 100) within a human GI tract ([col. 11 lines 46-56] “A tissue model may be designed and generated Such that it may be suitable for use with any patient and/or any tissue. In other embodiments, a model may be specifically generated or adapted to a specific tissue, patient, patient condition or other relevant aspects. For example, it may be empirically or otherwise determined that tissues in the colon exhibit specific attributes, behavior, response or other aspects or traits related to light and/or imaging. Accordingly, a model may be generated in accordance with Such attributes or aspects such that the model may be used in order to process images of colon tissues as described herein.”), the method comprising:
receiving a regular image captured by the capsule device when the capsule device is inside the human GI tract ([col. 12 line 60 col. 13 line 2] “A tissue model may map the intensity of light reflected from a tissue (e.g., the colon) and detected by the red channel (or red pixel sensors) of the imager, to a distance. For example, assuming light traveling through a medium is attenuated according to a reciprocal relation or function of distance, a distance of an object may be determined by the equation: D-A-B/VR, where D is the distance of the object from the imaging device at the time the image was acquired, A and B are constants selected as described herein and R is the intensity of red light.” Also, Fig. 5 step 510)
deriving capsule-to-perimeter distances in a target set of measuring rays of a measuring cone (Fig. 3), wherein the capsule-to-perimeter distances are derived based on structured light beams projected from the capsule device toward a surrounding lumen wall, and wherein the capsule-to-perimeter distances are measured from the capsule device to intersections of the surrounding lumen wall and the measuring cone (Fig. 5 step 530-535, Fig. 3 illustrates a measuring cone [col. 3 lines 1-3], [col. 18 line 29 – 67 and col. 21 line 12 – col. 22 line 12]), wherein the target set of measuring rays (Fig. 3 distances 310, 320, 330, 340, 350) are on a plane perpendicular to a longitudinal axis (see annotated Fig. 3) of the capsule device (Figs. 1a, 3 device 100) and each of the target set of measuring rays (Fig. 3 distances 310, 320, 330, 340, 350) ends at an intersection of the plane and an interior point of the surrounding lumen wall (Fig. 3 tissue 360/object 370); and
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identifying a corresponding colon anatomical part, based on the capsule-to-perimeter distances, and the corresponding colon anatomical part (Fig. 5 step 540-545, [col 11 line45-64] “Accordingly, a model may be generated in accordance with such attributes or aspects such that the model may be used in order to process images of colon tissues as described herein.” …. [col. 12 48-67] “A tissue model may map the intensity of light reflected from a tissue (i.e. colon) and detected by the red channel (or red pixel sensors) of imager, to a distance.” [col. 13 line 1- col. 14 line 10]). is located within a human colon ([col. 2 lines 19-39] “A suitable tissue model may be associated with, or related to an image of inner region of a human or mammal, and may be obtained by an in-vivo device described herein.”).
While Krupnik discloses images are taken from the colon and an ascending colon, a transverse colon, and a descending colon are all parts of the colon, Krupnik fails to specifically teach wherein the corresponding colon anatomical part belongs to a group consisting of an ascending colon, a transverse colon, and a descending colon,
However Tada, in the same field of endeavor, teaches a capsule device obtaining images within the GI tract (Tada – [0009]) and identifying a corresponding colon anatomical part (Tada – Fig. 5) based on the capsule -to-perimeter distances (Tada –[0231, 0268, 0270-0273]) wherein the corresponding colon anatomical part belongs to a group consisting of an ascending colon part (Tada – Fig. 5), a transverse colon part (Tada – Fig. 5), and a descending colon part (Tada – Fig. 5), and the corresponding anatomical part is located within a human colon (Tada – Fig. 5, [0165]).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Krupnik with the teachings of Tada to identify images of a corresponding anatomical part, which are taken from the colon; wherein the corresponding colon anatomical part belongs to a group consisting of an ascending colon, a transverse colon, and a descending colon for the benefit of increasing the accuracy of diagnosing based on endoscopic images and reduce the burden placed on endoscopy specialists. It is also beneficial to modify the teachings of Krupnik with the teachings of Tada and specifically identify whether the corresponding anatomical part belongs to a specific part within the colon “…because clinical characteristics of a disease differ depending on the anatomical sites of the colon and the rectum. For example, according to some recent researches, it has been pointed out that, with regard to colorectal cancers, there are some differences between the right colon and the left colon in epidemiology, prognosis, and a clinical result of chemotherapy” (Tada – [0029-0044]).
Regarding Claim 3, Krupnik in view of Tada teach the method Claim 1, further comprising displaying visual representation of ending points (Krupnik - Fig. 3 points 311, 321, 331, 341, 351) of the target set of measuring rays (Krupnik - Fig. 3 distances 310, 320, 330, 340, 350) in a Cartesian coordinate on a display device (Krupnik - Fig. 5 step 545, [col. 18 lines 43-67] “By determining a location or position of an object in an image, e.g., with respect to a reference point such as imaging system 110 and further determining a distance of such object from the reference point, an object's location in a three dimensional space may be defined and/or determined. In some embodiments, three dimensional (e.g., X, Y, Z values in a cartesian coordinate system) coordinates of selected pixels in the image may be determined.” And [col. 24 lines 41-47] “. As shown by block 545, the flow may include providing the size estimation. For example, the size estimation may be displayed on a computer display screen, e.g., overlaid on an image, possibly located on the object of interest. Other embodiments may print the size estimation, send it over a network or store the size estimation as known in the art.” And Fig. 6 [col. 14 Line 11-35] “FIG. 6 which shows a plot of red light intensity as a function of distance. … actual measured values 680 may be used to compute curve 675 which may be used to map an intensity of red light to distance. Based on actual measurements and a computed curve as shown in FIG. 6, a tissue model may be generated. Any other applicable measurements and curves or mapping may be similarly made and generated, e.g., other colors, brightness, luminance, chromaticity or saturation of colors may be measured and a respective curve may be computed. Accordingly, any measured parameters may be used to compute a curve similar to the one shown by 675. A tissue model may be generated based on any number of measured parameters and/or computed curves or mapping as described herein. For example, a tissue model may be based on a number of curves, graphs or functions related to a respective number of parameters such as brightness, luminance and chromaticity. Various methods, functions or other means may be employed in order to combine any number of Such graphs or functions such that given a pixel in an image, the distance of the object or region associated with Such pixel may be determined.”).
Regarding Claim 4, Krupnik in view of Tada teach the method Claim 1, said identifying the corresponding colon anatomical part comprises determining a shape of the surrounding lumen wall based on the capsule-to-perimeter distances (Krupnik - [col. 18 line 42-68] “Based on distances calculated as described herein, a number of geometrical shapes may be derived. For example, the triangle defined by points or locations 395, 311 and 351, the triangle defined by points or locations 395, 321 and 341 and circles (or spheres in the 3D case) 380 and 390 may all be calculated, computed, derived or otherwise obtained such that their location, orientation, position, size, volume and/or any relevant parameters are known. Based on determining such geometrical shapes and their relevant attributes, a size of an object may be determined or estimated according to a geometrical relation. For example, a geometrical relation may be the confinement of object 370 by circle 380, the confinement circle 380 by the triangle with vertices at points 395, 311 and 351, the intersection area of circles 380 and 390 etc.”).and (Tada – Fig. 5, [0231, 0268, 0270-0273]).
Regarding Claim 5, Krupnik in view of Tada teach the method Claim 4, wherein said determining the shape of the surrounding lumen wall based on the capsule-to-perimeter distances comprises curve fitting to indicate whether the shape of the surrounding lumen wall resembles a triangle (Krupnik - [col. 18 line 42-68] “Based on distances calculated as described herein, a number of geometrical shapes may be derived. For example, the triangle defined by points or locations 395, 311 and 351, the triangle defined by points or locations 395, 321 and 341 and circles (or spheres in the 3D case) 380 and 390 may all be calculated, computed, derived or otherwise obtained such that their location, orientation, position, size, volume and/or any relevant parameters are known. Based on determining such geometrical shapes and their relevant attributes, a size of an object may be determined or estimated according to a geometrical relation. For example, a geometrical relation may be the confinement of object 370 by circle 380, the confinement circle 380 by the triangle with vertices at points 395, 311 and 351, the intersection area of circles 380 and 390 etc.”) and (Tada – Fig. 5, [0231, 0268, 0270-0273]).
Regarding Claim 6, Krupnik in view of Tada teach the method Claim 4, further comprising displaying the shape of the surrounding lumen wall in one axis and a frame number or a frame time in another axis on a display device for a user to visualize (Krupnik - [col. 20 line 46-60] “By analyzing an image, embodiments of the invention may determine an actual or estimated distance of an object or region from the imaging device, namely, the distance between the imaging device and the object at the time the image was acquired.” And [col. 18 lines 35-41] “Reference is now made to FIG. 3, which illustrates a method of determining or estimating a size of an in-vivo object according to embodiments of the invention. It will be understood that although FIG. 3 provides a schematic, two dimensional illustration, embodiments of the invention are not limited in this regard and, in fact, may be applicable to three dimensional (3D) shapes or objects. It will further be understood that FIG. 3 is a simplified illustration, produced for explanatory purposes. As shown in FIG. 3, an image of a tissue 360 and of an object 370 (that may be for example a polyp, a lesion, a tumor, a cyst, a choristoma, a hamartoma, a tissue malformation or nodule or any other pathology or malignancy) may be acquired by imaging device 100.” [col. 4 line 18 – col. 5 line 8]) and (Tada – Fig. 5, [0231, 0268, 0270-0273]).
Regarding Claim 7, Krupnik in view of Tada teach the method Claim 6, wherein the corresponding colon anatomical part associated with the location of the capsule device is indicated according to the shape of the surrounding lumen wall, and wherein if the shape resembles a triangle, the corresponding colon anatomical part associated with the location of the capsule device is the transverse colon (Krupnik - [col. 18 line 42-68] “Based on distances calculated as described herein, a number of geometrical shapes may be derived. For example, the triangle defined by points or locations 395, 311 and 351, the triangle defined by points or locations 395, 321 and 341 and circles (or spheres in the 3D case) 380 and 390 may all be calculated, computed, derived or otherwise obtained such that their location, orientation, position, size, volume and/or any relevant parameters are known. Based on determining such geometrical shapes and their relevant attributes, a size of an object may be determined or estimated according to a geometrical relation. For example, a geometrical relation may be the confinement of object 370 by circle 380, the confinement circle 380 by the triangle with vertices at points 395, 311 and 351, the intersection area of circles 380 and 390 etc.”). and (Tada – Fig. 5, [0231, 0268, 0270-0273]).
Regarding Claim 8, Krupnik in view of Tada teach the method Claim 4, further comprising displaying a shape index of the surrounding lumen wall in one axis and a frame number or a frame time in another axis on a display device for a user to visualize (Krupnik - [col. 20 line 46-60] “By analyzing an image, embodiments of the invention may determine an actual or estimated distance of an object or region from the imaging device, namely, the distance between the imaging device and the object at the time the image was acquired.” And [col. 4 line 18 – col. 5 line 8] “The image recordation rate, the frame capture rate, the total number of images captured, the total number of images selected if the moving image is edited, and the view time of the moving image, may each be fixed or varied. … According to some embodiments, a distance from an imaging device and/or a size of an object may be determined or estimated by obtaining a tissue model designed to provide at least a mapping of at least one imaging parameter to at least one distance parameter, obtaining, by an imaging system, a digital image of the object, selecting at least one pixel in the digital image, wherein such at least one pixel is associated with the object, e.g., represents at least part of the object in the digital image and calculating, based on the tissue model and data associated with the pixel, a distance parameter related to a distance of the object from the imaging system.”), wherein the shape index is derived based on frequency-domain data of the capsule-to- perimeter distances represented in a polar coordinate. (Krupnik - [col. 17 line 8 – col. 18 line 3] “In another example, an optics module may be used for size calculations in order to obtain corrected (e.g., XY) coordinates that along with distance coordinates (e.g., Z) calculated with the tissue model may create 3D points in (XYZ) space.”)
Regarding Claim 10, Krupnik in view of Tada teach the method Claim 4, wherein the corresponding colon anatomical part associated with the location of the capsule device is indicated according to the shape index and if the shape index indicates the corresponding colon anatomical part associated with the location of the capsule device is the transverse colon (Tada – Fig. 5, [0231, 0268, 0270-0273]).
Regarding Claim 11, Krupnik in view of Tada teach the method Claim 4, said determining the shape of the surrounding lumen wall based on the capsule-to-perimeter distances comprises displaying the shape of the surrounding lumen wall in one axis and a travelled distance of the capsule device in another axis a display device for a user to visualize (Krupnik - Figs. 3 and 9, [col. 17 lines 9 -57] and [col. 18 lines 29-41]).
Regarding Claim 12, Krupnik in view of Tada teach the method Claim 1, wherein said identifying the corresponding colon anatomical part comprises determining a size of the surrounding lumen wall based on the capsule-to-perimeter distances between the capsule device and the surrounding lumen wall. (Tada – Fig. 5, [0231, 0268, 0270-0273]).
Regarding Claim 13, Krupnik in view of Tada teach the method Claim 12, further comprising displaying the size of the surrounding lumen wall in one axis and a frame number or a frame time in another axis on a display device for a user to visualize (Krupnik - [col. 20 line 46-60] “By analyzing an image, embodiments of the invention may determine an actual or estimated distance of an object or region from the imaging device, namely, the distance between the imaging device and the object at the time the image was acquired.” And [col. 4 line 18 – col. 5 line 8] “The in-vivo imaging device may record images at a rate of, for example, four to forty images per second (other rates, such as two frames per second, may be used). … The image recordation rate, the frame capture rate, the total number of images captured, the total number of images selected if the moving image is edited, and the view time of the moving image, may each be fixed or varied. And. [col. 7 lines 22-51] “Device 100 may communicate with an external computing or communication system that may receive, process, store, communicate and display images or other data or information received from device 100. … such remote system may display images to a physician….”)
Regarding Claim 14, Krupnik in view of Tada teach the method Claim 13, wherein the corresponding colon anatomical part associated with the location of the capsule device (Krupnik - device 100) is indicated according to the size or a trend of the size of the surrounding lumen wall (Krupnik - [col. 24 lines 41-47] “As shown by block 545, the flow may include providing the size estimation. For example, the size estimation may be displayed on a computer display screen, e.g., overlaid on an image, possibly located on the object of interest. Other embodiments may print the size estimation, send it over a network or store the size estimation as known in the art.”).
Regarding Claim 16, Krupnik in view of Tada teach the method Claim 13, wherein the size of the surrounding lumen wall is determined based on the capsule-to-perimeter distances associated with multiple distance-measuring frames close to each other in a temporal order (Krupnik - [col. 20 line 46-60] “By analyzing an image, embodiments of the invention may determine an actual or estimated distance of an object or region from the imaging device, namely, the distance between the imaging device and the object at the time the image was acquired.” And [col. 4 line 18 – col. 5 line 8] “The image recordation rate, the frame capture rate, the total number of images captured, the total number of images selected if the moving image is edited, and the view time of the moving image, may each be fixed or varied. … According to some embodiments, a distance from an imaging device and/or a size of an object may be determined or estimated by obtaining a tissue model designed to provide at least a mapping of at least one imaging parameter to at least one distance parameter, obtaining, by an imaging system, a digital image of the object, selecting at least one pixel in the digital image, wherein such at least one pixel is associated with the object, e.g., represents at least part of the object in the digital image and calculating, based on the tissue model and data associated with the pixel, a distance parameter related to a distance of the object from the imaging system.”).
Regarding Claim 17, Krupnik in view of Tada teach the method Claim 16, wherein the corresponding colon anatomical part associated with the location of the capsule device is indicated based on the capsule-to- perimeter distances associated with the-multiple sets of measuring rays, and a decision of the corresponding colon anatomical part associated with the location of the capsule device is confirmed when a same decision out of multiple consecutive decisions is reached. (Krupnik - [col. 20 line 46-60] “By analyzing an image, embodiments of the invention may determine an actual or estimated distance of an object or region from the imaging device, namely, the distance between the imaging device and the object at the time the image was acquired.” And [col. 4 line 18 – col. 5 line 8] “The image recordation rate, the frame capture rate, the total number of images captured, the total number of images selected if the moving image is edited, and the view time of the moving image, may each be fixed or varied. … According to some embodiments, a distance from an imaging device and/or a size of an object may be determined or estimated by obtaining a tissue model designed to provide at least a mapping of at least one imaging parameter to at least one distance parameter, obtaining, by an imaging system, a digital image of the object, selecting at least one pixel in the digital image, wherein such at least one pixel is associated with the object, e.g., represents at least part of the object in the digital image and calculating, based on the tissue model and data associated with the pixel, a distance parameter related to a distance of the object from the imaging system.”).
Regarding Claim 18, Krupnik in view of Tada teach the method Claim 13, wherein the size of the surrounding lumen wall corresponds an average or filtered size of the surrounding lumen wall associated with multiple measuring frames (Krupnik - [col. 16 line 50-col. 17 line 7] “Some embodiments may use an average or most often optimal illumination model or may iteratively select and switch to the optimal illumination model for each image or image stream segment.” And [col. Lines 36-57] “A tissue model may be generated based on measurements obtained from any number of tissues. For example, images of a specific tissue or region (e.g., the colon) from a plurality of patients may be used to produce a plurality of plots and curves as shown by FIG. 6. Such plurality of curves may then be used to derive a curve that may be used in a tissue model suitable for most of the patients. For example, a universal tissue model may be generated based on an average, estimation or other representation of a plurality of plots, curves or models related to a plurality of patients. Reference is now made to FIG. 7 showing a plurality of curves 720 which may be similar to curve 675 described herein. Curves 720 may be generated based on measurements obtained from a plurality of patients. Curve 730 may be derived by computing an average, a weighted average, a mean, a midrange, a median or any other suitable value or function associated with curves 720. Accordingly, a curve that may be suitable for use with most patients may be derived. Likewise, based on such and other curves, mapping and other information as described herein, a tissue model (that may be referred to herein as a universal tissue model) that may be used with, or suitable for, any patient may be generated.”)
Regarding Claim 19, Krupnik in view of Tada teach the method Claim 12, wherein said determining a size of the surrounding lumen wall based on the capsule-to-perimeter distances between the capsule device and the surrounding lumen wall comprise displaying the size of the surrounding lumen wall in one axis and a travelled distance of the capsule device in another axis on a display device for a user to visualize (Krupnik - Fig. 8 [col. 15 lines 40-67] “For example, in correlation with plot 810, a function may reduce the size of regions at a distance of 60 pixels from the center of the image (where, as shown, a substantial magnification may be exhibited) and increase the size of regions at a distance of 120 pixels from the center of the image (where, as shown, a distortion related to a reduced size is seen).”).
Regarding Claim 37, Krupnik discloses a system for identifying a colon anatomical part associated with a location of a capsule device within a human GI tract, (abstract, [col. 11 lines 45-64] “For example, it may be empirically or otherwise determined that tissues in the colon exhibit specific attributes, behavior, response or other aspects or traits related to light and/or imaging. Accordingly, a model may be generated in accordance with such attributes or aspects such that the model may be used in order to process images of colon tissues as described herein.”), the system comprising one or more electronic circuits or processors (claim 11 “a workstation comprising a memory and a processor, the memory to store an image captured by an in-vivo imaging system”) configured to:
receive a regular image captured by the capsule device when the capsule device is inside the human GI tract (Fig. 5 step 510);
derive capsule-to-perimeter distances in a target set of measuring rays of a measuring cone, wherein the capsule-to-perimeter distances are derived based on structured light beams projected from the capsule device toward a surrounding lumen wall, and wherein the capsule-to-perimeter distances are measured from the capsule device to intersections of the surrounding lumen wall and the measuring cone (Fig. 5 step 530-535, Fig. 3 illustrates a measuring cone [col. 3 lines 1-3], [col. 18 line 29 – 67 and col. 21 line 12 – col. 22 line 12] ), and wherein the target set of measuring rays (Fig. 3 distances 310, 320, 330, 340, 350) are on a plane perpendicular to a longitudinal axis (see annotated Fig. 3) of the capsule device (Figs. 1a, 3 device 100) and each of the target set of measuring rays (Fig. 3 distances 310, 320, 330, 340, 350) ends at an intersection of the plane and an interior point of the surrounding lumen wall (Fig. 3 tissue 360/object 370); and
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Identify a corresponding colon anatomical part, based on the capsule-to-perimeter distances, and the corresponding colon anatomical part (Fig. 5 step 540-545, [col 11 line45-64] “Accordingly, a model may be generated in accordance with such attributes or aspects such that the model may be used in order to process images of colon tissues as described herein.” …. [col. 12 48-67] “A tissue model may map the intensity of light reflected from a tissue (i.e. colon) and detected by the red channel (or red pixel sensors) of imager, to a distance.” [col. 13 line 1- col. 14 line 10]). is located within a human colon ([col. 2 lines 19-39] “A suitable tissue model may be associated with, or related to an image of inner region of a human or mammal, and may be obtained by an in-vivo device described herein.”).
While Krupnik discloses images are taken from the colon and an ascending colon, a transverse colon, and a descending colon are all parts of the colon, Krupnik fails to specifically teach wherein the corresponding colon anatomical part belongs to a group consisting of an ascending colon, a transverse colon, and a descending colon,
However Tada, in the same field of endeavor, teaches a capsule device obtaining images within the GI tract (Tada – [0009]) and identify a corresponding colon anatomical part (Tada – Fig. 5) based on the capsule -to-perimeter distances (Tada –[0231, 0268, 0270-0273]) wherein the corresponding colon anatomical part belongs to a group consisting of an ascending colon part (Tada – Fig. 5), a transverse colon part (Tada – Fig. 5), and a descending colon part (Tada – Fig. 5), and the corresponding anatomical part is located within a human colon (Tada – Fig. 5, [0165]).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Krupnik with the teachings of Tada to identify images of a corresponding anatomical part, which are taken from the colon; wherein the corresponding colon anatomical part belongs to a group consisting of an ascending colon, a transverse colon, and a descending colon for the benefit of increasing the accuracy of diagnosing based on endoscopic images and reduce the burden placed on endoscopy specialists. It is also beneficial to modify the teachings of Krupnik with the teachings of Tada and specifically identify whether the corresponding anatomical part belongs to a specific part within the colon “…because clinical characteristics of a disease differ depending on the anatomical sites of the colon and the rectum. For example, according to some recent researches, it has been pointed out that, with regard to colorectal cancers, there are some differences between the right colon and the left colon in epidemiology, prognosis, and a clinical result of chemotherapy” (Tada – [0029-0044]).
Claims 9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Krupnik, in view Tada, in view of Kang-Huai Wang (US Pub. No.: US2020/0113422) hereinafter Wang.
Regarding Claim 9, Krupnik in view of Tada teach the method Claim 4. Krupnik in view of Tada fail to explicitly teach further comprising displaying a shape index of the surrounding lumen wall in one axis and a travelled distance of the capsule device in another axis
However Wang, in the same field of endeavor teaches, further comprising displaying a shape index of the surrounding lumen wall in one axis and a travelled distance of the capsule device in another axis ([0010] “A diagnostician is expected to examine all images and correctly identify all anomalies. Furthermore, it is desirable to gather location information of the anomalies, which is useful for possible operations or treatment of the anomalies. While various location detection devices could be embedded or attached to the capsule device, it is desirable to develop methods for determining the travelled distance based on images captured.” [0042] “The captured image sequence can be viewed to identify any possible anomaly. If any anomaly is found, it is of interest to identify the characteristics of the anomaly as well as its location. “)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teaching of Krupnik in view of Tada with the teachings of Wang to include further comprising displaying a shape index of the surrounding lumen wall in one axis and a travelled distance of the capsule device in another axis for the benefit of “gather location information of the anomalies, which is useful for possible operations or treatment of the anomalies” (Wang – [0010]).
Regarding Claim 15, Krupnik in view of Tada teach the method Claim 14. Krupnik teaches “…the size estimation may be displayed on a computer display screen, e.g., overlaid on an image, possibly located on the object of interest. [col. 24 lines 41-47]. Tada teaches displaying an image that corresponds to an ascending colon (Tada – Fig. 5). But Krupnik in view of Tada, alone or in combination, fail to explicitly teach wherein a section of the human colon corresponds to an ascending colon if the section corresponds to a first part of the human colon and the size is reduced or the size is gradually reducing.
However Wang, in the same field of endeavor, teaches wherein a section of the human colon corresponds to an ascending colon if the section corresponds to a first part of the human colon and the size is reduced or the size is gradually reducing (Fig. 16 ascending colon, [0068] “FIG. 16 illustrates yet another example of displaying the travelled distance information along with the image information, where the anatomic parts 1610 of the GI tract are labelled across the graphic representation of the travelled distance. Similar to the case in FIG. 15, a user may pick a point in the travelled distance line (e.g. using a cursor displayed above the distance line) and the image corresponding to the location will be displayed in area 1510 on display 1410 in FIG. 16.”).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Krupnik in view of Tada, which teaches the size displayed on the screen with the teachings of Wang to include a labeled location of the device also and have wherein a section of the human colon corresponds to an ascending colon if the section corresponds to a first part of the human colon and the size is reduced or the size is gradually reducing for the benefit of the particular anatomic part being captured for an image ([Wang – [0068]).
Claims 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over Krupnik, in view of Tada, in view of Kimchy et al. (US2010/0303200) hereinafter Kimchy.
Regarding Claim 30, Krupnik in view of Tada teach the method Claim 1 but fail to explicitly teach wherein said determining the corresponding colon anatomical part comprises determining fold depth information of the surrounding lumen wall based on the capsule-to-perimeter distances.
However Kimchy, in the same field of endeavor, teaches wherein said determining the corresponding colon anatomical part comprises determining fold depth information of the surrounding lumen wall based on the capsule-to-perimeter distances. ([0128] “FIGS. 14A-C and 15A-C schematically illustrate surfaces representing morphologies of the GI tract, generated in accordance with an embodiment of the present invention. A dynamic tracking algorithm is provided for detecting polyps in the GI tract, such as in the colon, and discriminating them from other morphologies normally found in the colon, such as curving colon walls, haustra rings, and folds of the colon. This algorithm makes use of movement of the capsule within the colon to detect and separate the morphology of polyps from the morphologies of the other normal structures in the colon.” )
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify Krupnik in view of Tada with the teaching of Kimchy to have wherein said determining the corresponding colon anatomical part comprises determining fold depth information of the surrounding lumen wall based on the capsule-to-perimeter distances for the benefit of “…separate[ing] the morphology of polyps from the morphologies of the other normal structures in the colon” (Kimchy - [0128]).
Regarding Claim 31, Krupnik in view of Tada in view of Kimchy teach the method Claim 30, wherein said determining the corresponding colon anatomical part comprises determining fold depth information of the surrounding lumen wall based on the capsule-to-perimeter distances (Kimchy – Figs. 14A-C and 15A-C, [0049], [0128] “FIGS. 14A-C and 15A-C schematically illustrate surfaces representing morphologies of the GI tract, generated in accordance with an embodiment of the present invention. A dynamic tracking algorithm is provided for detecting polyps in the GI tract, such as in the colon, and discriminating them from other morphologies normally found in the colon, such as curving colon walls, haustra rings, and folds of the colon. This algorithm makes use of movement of the capsule within the colon to detect and separate the morphology of polyps from the morphologies of the other normal structures in the colon.”[0131] “At a first step of the dynamic tracking algorithm, for every subdivision on the 2D representing surface, a relative distance that each collimator “sees” is calculated, e.g., using the matrix algorithm of Equation 1, described hereinabove. Surfaces 120A, 120B, and 120C of FIGS. 14A, 14B, and 14C, respectively, and surfaces 122A, 122B, and 122C of FIGS. 15A, 15B, and 15C, respectively, are exemplary representations of such a relative distance-indicating surface, at respective points in time.”)
Regarding Claim 32, Krupnik in view of Tada in view of Kimchy teach the method Claim 31, further comprising displaying the fold depth information of the surrounding lumen wall in one axis and a frame number or a frame time in another axis on a display device for a user to visualize (Kimchy – Figs. 14A-C and 15A-C, [0049], [0128] “FIGS. 14A-C and 15A-C schematically illustrate surfaces representing morphologies of the GI tract, generated in accordance with an embodiment of the present invention. A dynamic tracking algorithm is provided for detecting polyps in the GI tract, such as in the colon, and discriminating them from other morphologies normally found in the colon, such as curving colon walls, haustra rings, and folds of the colon. This algorithm makes use of movement of the capsule within the colon to detect and separate the morphology of polyps from the morphologies of the other normal structures in the colon.”[0131-139] “At a first step of the dynamic tracking algorithm, for every subdivision on the 2D representing surface, a relative distance that each collimator “sees” is calculated, e.g., using the matrix algorithm of Equation 1, described hereinabove. Surfaces 120A, 120B, and 120C of FIGS. 14A, 14B, and 14C, respectively, and surfaces 122A, 122B, and 122C of FIGS. 15A, 15B, and 15C, respectively, are exemplary representations of such a relative distance-indicating surface, at respective points in time. … The outcome of this representation is a series of 2D morphologies in time that represent time derivatives outlining the movement of the capsule within the colon and showing different morphologies as the capsule travels. ”)
Regarding Claim 33, Krupnik in view of Tada in view of Kimchy teach the method Claim 30, further comprising displaying the fold depth information of the surrounding lumen wall in one axis and a travelled distance of the capsule device in another axis on a display device for a user to visualize (Kimchy – Figs. 14A-C and 15A-C, [0049], [0128] “FIGS. 14A-C and 15A-C schematically illustrate surfaces representing morphologies of the GI tract, generated in accordance with an embodiment of the present invention. A dynamic tracking algorithm is provided for detecting polyps in the GI tract, such as in the colon, and discriminating them from other morphologies normally found in the colon, such as curving colon walls, haustra rings, and folds of the colon. This algorithm makes use of movement of the capsule within the colon to detect and separate the morphology of polyps from the morphologies of the other normal structures in the colon.”[0131] “At a first step of the dynamic tracking algorithm, for every subdivision on the 2D representing surface, a relative distance that each collimator “sees” is calculated, e.g., using the matrix algorithm of Equation 1, described hereinabove. Surfaces 120A, 120B, and 120C of FIGS. 14A, 14B, and 14C, respectively, and surfaces 122A, 122B, and 122C of FIGS. 15A, 15B, and 15C, respectively, are exemplary representations of such a relative distance-indicating surface, at respective points in time.”)
Claims 20-28 and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Krupnik, in view of Tada, in view of Vakoc et al., Comprehensive esophageal microscopy by using optical frequency-domain imaging (with video). Gastrointestinal Endoscopy. Vol. 65, No. 6: 2007., hereinafter Vakoc.
Regarding Claim 20, Krupnik in view of Tada teach the method Claim 1 but are fail to explicitly teach said identifying the corresponding colon anatomical part comprises transforming the capsule-to-perimeter distances represented in a polar coordinate into discrete frequency-domain information, wherein the corresponding colon anatomical part associated with the location of the capsule device is indicated by the discrete frequency-domain information.
However Vakoc, in the same field of endeavor, teaches said identifying the corresponding colon anatomical part comprises transforming the capsule-to-perimeter distances represented in a polar coordinate into discrete frequency-domain information, wherein the corresponding colon anatomical part associated with the location of the capsule device is indicated by the discrete frequency-domain information (Vakoc – Page 898 objective, graph page 901, 903-904, whole document).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Krupnik in view of Tada with the teachings of Vakoc to have the anatomical part comprises transforming the capsule-to-perimeter distances represented in a polar coordinate into discrete frequency-domain information, wherein the corresponding colon anatomical part associated with the location of the capsule device is indicated by the discrete frequency-domain information as taught by Vakoc for the added benefit of “..a new optical imaging technology, optical frequency-domain imaging (OFDI), derived from OCT, that enables comprehensive imaging of….[anatomical parts]…with microscopic resolution” (Vakoc – page 898 objective).
Regarding Claim 21, Krupnik in view of Tada in view of Vakoc teach the method Claim 20, wherein said transforming the capsule-to-perimeter distances represented in the polar coordinate into discrete frequency-domain information comprises Discrete Fourier Transform (DFT) or Fast Fourier Transform (FFT) (Vakoc – Page 898 objective, graph page 901, 903-904, whole document).
Regarding Claim 22, Krupnik in view of Tada in view of Vakoc teach the method of Claim 20, wherein if all frequency terms are insignificant except for zero-th frequency term, the corresponding colon anatomical part associated with the location of the capsule device corresponds to ascending or descending colon. (Vakoc – Page 898 bottom right, graph page 901, 903-904, whole document).
Regarding Claim 23, Krupnik in view of Tada in view of Vakoc teach the method of Claim 20, wherein if the discrete frequency-domain information has a maximum at zero-th frequency term of the discrete frequency-domain information and a second largest term at third frequency term of the discrete frequency-domain information, the corresponding colon anatomical part associated with the location of the capsule device corresponds to the transverse colon. (Vakoc – Page 898 bottom right, graph page 901, 903-904, whole document).
Regarding Claim 24, Krupnik in view of Tada in view of Vakoc teach the method of Claim 20, further comprising determining a magnitude ratio of zero-th frequency term and third frequency term of the discrete frequency-domain information, wherein if ratio is larger than a threshold, the corresponding colon anatomical part associated with the location of the capsule device corresponds to the transverse colon and, otherwise the corresponding colon anatomical part associated with the location of the capsule device corresponds to ascending/descending colon, and wherein the threshold includes a range between 0.13 and 0.27. (Vakoc – Page 898 bottom right, graph page 901, 903-904, whole document).
Regarding Claim 25, Krupnik in view of Tada in view of Vakoc teach the method of Claim 20, wherein said transforming the capsule-to-perimeter distances represented in the polar coordinate into discrete frequency-domain information comprises applying coordinate translation to the capsule-to-perimeter distances represented in the polar coordinate to correct eccentricity prior to said transforming the capsule-to-perimeter distances into the discrete frequency-domain information. (Vakoc – Page 898 bottom right, graph page 901, 903-904, whole document).
Regarding Claim 26, Krupnik in view of Tada in view of Vakoc teach the method of Claim 20, wherein said transforming the capsule-to-perimeter distances represented in the polar coordinate into discrete frequency- domain information comprises applying coordinate rotation to the capsule-to perimeter distances represented in the polar coordinate to correct tilting prior to said transforming the capsule-to-perimeter distances into the discrete frequency-domain information (Vakoc – Page 898 bottom right, graph page 901, 903-904, whole document).
Regarding Claim 27, Krupnik in view of Tada in view of Vakoc teach the method of Claim 20, wherein said transforming the capsule-to-perimeter distances represented in the polar coordinate into discrete frequency- domain information comprises applying coordinate translation to the capsule-to-perimeter represented in the polar coordinate to correct eccentricity following by applying coordinate rotation to the capsule-to-perimeter distances to correct tilting prior to said transforming the capsule-to-perimeter distances into the discrete frequency-domain information. (Vakoc – Page 898 bottom right, graph page 901, 903-904, whole document).
Regarding Claim 28, Krupnik in view of Tada in view of Vakoc teach the method of Claim 20, wherein said transforming the capsule-to-perimeter distances represented in the polar coordinate into discrete frequency- domain information comprises applying coordinate rotation to the capsule-to-perimeter distances represented in the polar coordinate to correct tilting following by applying coordinate translation to the capsule-to-perimeter distances to correct eccentricity prior to said transforming the capsule-to-perimeter distances into the discrete frequency-domain information. (Vakoc – Page 898 bottom right, graph page 901, 903-904, whole document).
Regarding Claim 34, Krupnik in view of Tada teach the method of Claim 1, but are silent as to explicitly teach further comprising displaying discrete frequency-domain data in one axis and a frame number or a frame time in another axis on a display device for a user to visualize, wherein the discrete frequency-domain data are derived by applying frequency transformation to the capsule-to- perimeter distances represented in a polar coordinate.
However Vakoc, in the same field of endeavor, teaches further comprising displaying discrete frequency-domain data in one axis and a frame number or a frame time in another axis on a display device for a user to visualize, wherein the discrete frequency-domain data are derived by applying frequency transformation to the capsule-to- perimeter distances represented in a polar coordinate. (Vakoc – Page 898 bottom right, graph page 901, 903-904, whole document).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Krupnik in view of Tada with the teachings of Vakoc to have the anatomical part comprises transforming the capsule-to-perimeter distances represented in a polar coordinate into discrete frequency-domain information, wherein displaying discrete frequency-domain data in one axis and a frame number or a frame time in another axis on a display device for a user to visualize, wherein the discrete frequency-domain data are derived by applying frequency transformation to the capsule-to- perimeter distances represented in a polar coordinate as taught by Vakoc for the added benefit of “..a new optical imaging technology, optical frequency-domain imaging (OFDI), derived from OCT, that enables comprehensive imaging of….[anatomical parts]…with microscopic resolution” (Vakoc – page 898 objective).
Regarding Claim 35, Krupnik in view of Tada in view of Vakoc teach the method of Claim 34, wherein the discrete frequency-domain data corresponds to comprises a ratio of a magnitude of third frequency term to a magnitude of zero-th frequency term. (Vakoc – Page 898 bottom right, graph page 901, 903-904, whole document).
Regarding Claim 36, Krupnik in view of Tada teach the method of Claim 1, but are silent as to explicitly teaching further comprising displaying discrete frequency-domain data in one axis and a travelled distance of the capsule device in another axis on a display device for a user to visualize, wherein the discrete frequency-domain data are derived by applying frequency transformation to the capsule-to-perimeter distances represented in a polar coordinate.
However Vakoc, in the same field of endeavor, teaches further comprising displaying discrete frequency-domain data in one axis and a travelled distance of the capsule device in another axis on a display device for a user to visualize, wherein the discrete frequency-domain data are derived by applying frequency transformation to the capsule-to-perimeter distances represented in a polar coordinate. (Vakoc – Page 898 bottom right, graph page 901, 903-904, whole document).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Krupnik in view of Tada with the teachings of Vakoc to have the anatomical part comprises transforming the capsule-to-perimeter distances represented in a polar coordinate into discrete frequency-domain information, wherein displaying discrete frequency-domain data in one axis and a travelled distance of the capsule device in another axis on a display device for a user to visualize, wherein the discrete frequency-domain data are derived by applying frequency transformation to the capsule-to-perimeter distances represented in a polar coordinate as taught by Vakoc for the added benefit of “..a new optical imaging technology, optical frequency-domain imaging (OFDI), derived from OCT, that enables comprehensive imaging of….[anatomical parts]…with microscopic resolution” (Vakoc – page 898 objective).
Conclusion
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/MEGAN ELIZABETH MONAHAN/ Examiner, Art Unit 3795
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