DETAILED ACTION
Claims 1-25 and 28-30 are pending in this application, claims 26-27 are canceled and claims 1, 15 and 28 are amended. Claims 1-25 and 28-30 have been given the priority date of 07/29/2020 in accordance with the applicant’s claim for foreign priority.
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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been received. Claims 1-25 and 28-30 have been given the priority data of 7/29/2020 accordingly.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/26/2023, 03/12/2025 and 10/08/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/02/2026 has been entered.
Response to Arguments
35 U.S.C. 112(f)
Applicant’s request for withdrawal of the interpretations under 35 U.S.C. 112(f) (See Remarks filed 03/02/2026) have been fully considered by the examiner and are persuasive. In view of the amendments made to claim 25, the examiner agrees to withdraw the claim interpretations under 35
35 U.S.C. 102(a)
The applicant’s arguments (see Remarks filed 03/02/2026) regarding the rejections made under 35 U.S.C 102(a) have been fully considered by the examiner and are persuasive. However, in view of the newly added limitations to claim 1, a new grounds of rejection is presented over Unger in view of Singer as fully discussed below.
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.
Claims 1-8, 16-25, 28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Unger (WO 2009120228 A1) in view of Singer (US 5866331 A).
Regarding claim 1 Unger discloses; A method for imaging one or more body-parts of a patient in a medical application, wherein the method comprises, under the control of a computing circuit:
providing, to the computing circuit (Unger, Figure 2, image processing engine (50), [00024] the system components are linked with electrical connections (circuitry)), a plurality of luminescence images of the body-parts (Unger, [00026] Fluorescence and reflectance images of the subject are captured),
each of the luminescence images comprising a plurality of values representative of a luminescence light being emitted by a luminescence substance from corresponding locations of the body-parts (Unger, [00037] the system acquires a set of frames of reflectance and fluorescence data, each pixel will have an intensity value as well as a fluorescence lifetime value, the frames captured are images of a region of interest for a surgeon which would be a body part or lesion on a person’s body part),
[scanning for determining a lowest value and a highest value thereof defining a lower limit and a higher limit, respectively, of a global range of all the luminescence images,
determining, by the computing circuit, a mapping function being common for all the luminescence images, the mapping function mapping the global range to a dynamic range of a displayer being common for all the luminescence images,
generating corresponding to the luminescence images each of the mapped luminescence images being obtained by applying the mapping function to the values of the corresponding luminescence image
and displaying, by the computing circuit, processed images comprising the mapped luminescence images together on the displayer.]
Unger fails to disclose;
scanning for determining a lowest value and a highest value thereof defining a lower limit and a higher limit, respectively, of a global range of all the luminescence images,
determining, by the computing circuit, a mapping function being common for all the luminescence images, the mapping function mapping the global range to a dynamic range of a displayer being common for all the luminescence images,
generating corresponding to the luminescence images each of the mapped luminescence images being obtained by applying the mapping function to the values of the corresponding luminescence image
and displaying, by the computing circuit, processed images comprising the mapped luminescence images together on the displayer.
However, in the same field of endeavor, Singer teaches;
scanning (Singer, column 6 lines 25-60 the system uses a computer and multiple detectors), for determining a lowest value and a highest value thereof defining a lower limit and a higher limit, respectively, of a global range of all the luminescence images (Singer, Column 15 lines 1-40, all images in the fluorescent set were restored (mapped) using a common threshold determined using the absolute fluorescence intensity values (minimum and maximum), where this value is common for the whole set of images as described in column 15),
determining, by the computing circuit (Singer, column 6 lines 25-60 the system uses a computer and multiple detectors), a mapping function being common for all the luminescence images (Singer, Column 15 lines 1-40, all images in the fluorescent set were restored (mapped) using a common threshold, where column 15, 11-50 states that the function set all pixels in the set that were below the minimum threshold to zero and scales the levels of the other pixels based on the maximum value),
the mapping function mapping the global range to a dynamic range of a displayer being common for all the luminescence images (Singer, Column 15 lines 1-40, all images in the fluorescent set were restored (mapped) using a common threshold, the thresholding was applied to all images (common mapping function), where column 15, 11-50 states that the function set all pixels in the set that were below the minimum threshold to zero and scales the levels of the other pixels based on the maximum value),
generating (Singer, column 6 lines 25-60 the system uses a computer and multiple detectors), corresponding to the luminescence images each of the mapped luminescence images being obtained by applying the mapping function to the values of the corresponding luminescence image (Singer, Column 15 lines 30-58, the thresholding was used to generate a set of ”restored” or mapped images, which were mapped according to the determined threshold values, column 15 lines 1-25 state the threshold values are determined from the images),
and displaying, by the computing circuit, processed images comprising the mapped luminescence images together on the displayer (Singer, column 15 line 43 – column 16 line 18, the restored images were input into a display software and displayed along with heatmaps of the images).
The combination of Unger and Singer would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. The motivation for the combination lies in that scaling and restoring the images to the scale of their original point source allows for improved sensitivity for lower or reduced light signals in the image data. This would be advantageous in allowing the imaging system to capture better quality fluorescent images which improves the diagnostic capability of the system. (Singer, columns 15 and 16, and abstract)
Regarding claim 2 the combination of Unger and Singer teaches; The method according to claim 1, wherein the method comprises:
providing, to the computing circuit (Singer, column 6 lines 25-60 the system uses a computer and multiple detectors), the luminescence images being acquired from the patient and/or from one or more samples extracted from the patient (Singer, column 4 lines 63- column 5 line 44, samples are taken from a patient, stained and imaged to determine if certain genes are present).
The combination of Unger and Singer would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. The motivation for the combination lies in that extracting samples from the patient allow for detection of sequences and structures of interest which may be indicators of disease. (Singer, columns 1-4 and abstract)
Regarding claim 3 the combination of Unger and Singer teaches; The method according to claim 1, wherein the method comprises: determining, by the computing circuit (Singer, column 6 lines 25-60 the system uses a computer and multiple detectors), the global range from the lowest value to the highest value of the values of all the luminescence images being filtered to remove outliers thereof (Singer, column 2 lines 44-55, the threshold (global range) is determined using the mean and standard deviations of the image values to obtain a distribution, therefore the outliers would be excluded based on the distribution).
The combination of Unger and Singer would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. The motivation for the combination lies in that scaling and restoring the images to the scale of their original point source allows for improved sensitivity for lower or reduced light signals in the image data. This would be advantageous in allowing the imaging system to capture better quality fluorescent images which improves the diagnostic capability of the system. (Singer, columns 2, 15 and 16, and abstract)
Regarding claim 4 the combination of Unger and Singer teaches; The method according to 1 wherein the method comprises: providing, to the computing circuit, the luminescence images representing a common one of the body-parts from different imaging directions (Unger, [00073] and [00077] the endoscope is inserted into a subject’s body cavity to provide images of the inside of the body, because an endoscope or in some examples a laparoscope is used to view the inside of the body or the blood vessel of interest, since a laparoscope or endoscope is used the surgeon would be able to move the scope and image different directions or regions, additionally [00082]-[00083] because of the motion of vessels or tissues the system would have the capacity to track the vessel [00085] the vessel can be tracked using images of different axes or directions of the vessel), different regions of a common one of the body-parts (Unger, [00082]-[00083] tissues and vessels of interest are identified, displacement of the tissue or vessel of interest is detected over time using images, which indicates motion images of different regions/areas of the tissue or vessel taken over the course of the procedure) and/or different body-parts (Unger, [00082]-[00083] tissues and vessels of interest are identified).
Regarding claim 5 the combination of Unger and Singer teaches; The method according to 1 wherein the method comprises:
prompting, by the computing circuit (Unger, Figure 2, image processing engine (50), [00024] the system components are linked with electrical connections (circuitry)), a user to set corresponding imaging arrangements of the patient for acquiring the luminescence images in succession (Unger, [00030]-[00032] the surgeon may manually set the imaging parameters through the interface to control the methods of imaging during surgery, where multiple images are being taking over the course of a surgery, given that the surgeon or other user is entering multiple parameters there must be a prompt allowing them to enter the data described using the control mechanism, further figure 3 shows a pipeline of steps ending with “continue imaging?”, where it must be determined whether imaging would continue, indicating a prompt or input of some kind from the user as described in [00035]-[00036]),
and acquiring, by the computing circuit (Unger, Figure 2, image processing engine (50), [00024] the system components are linked with electrical connections (circuitry)), each of the luminescence images in response to a confirmation by the user of the corresponding imaging arrangement (Unger, [00030] the surgeon or assistant may modify the imaging method during the surgery, images may be viewed and refined, Examiner is interpreting this to mean images are captured during the surgery and are therefore displayed in real-time).
Regarding claim 6 the combination of Unger and Singer teaches; The method according to 1 wherein the method comprises:
receiving, by the computing circuit (Singer, column 6 lines 25-60 the system uses a computer and multiple detectors), a manual adjustment of the dynamic range (Singer, column 9 line 45- column 10 line 10, the threshold may be adjusted to adjust the scaling of the images (adjustment of the dynamic range)),
and repeating, said determining the mapping function and said displaying the processed images in response to the manual adjustment of the dynamic range (Singer, Column 15 lines 30-58, the thresholding was used to generate a set of ”restored” or mapped images, which were mapped according to the determined threshold values, column 15 lines 1-25 state the threshold values are determined from the images, column 15 line 43 – column 16 line 18, the restored images were input into a display software and displayed along with heatmaps of the images, this was done for all images, therefore would be repeated in a case where the threshold changes).
The combination of Unger and Singer would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. The motivation for the combination lies in that scaling and restoring the images to the scale of their original point source allows for improved sensitivity for lower or reduced light signals in the image data. This would be advantageous in allowing the imaging system to capture better quality fluorescent images which improves the diagnostic capability of the system. (Singer, columns 15 and 16, and abstract)
Regarding claim 7 Unger discloses; The method according to 1 wherein the method comprises:
calculating, by the computing circuit (Singer, column 6 lines 25-60 the system uses a computer and multiple detectors), corresponding ranking indexes of the mapped luminescence images each indicative of a quality of said mapping the corresponding luminescence image according to a content of the corresponding mapped luminescence image (Singer, column 15 lines 43-50, the system verified the restored images (mapped images) signals by comparing them to a predetermined signal to verify if the signal was correct),
and displaying, by the computing circuit (Singer, column 6 lines 25-60 the system uses a computer and multiple detectors), the processed images together in association with the corresponding ranking indexes of the mapped luminescence images on the displayer (Singer, column 15 lines 43-50, the system verified the restored images (mapped images) signals by comparing them to a predetermined signal to verify if the signal was correct, column 15 lines 44-58, a heatmap was generated to show the verifications of the signals (ranked indexes of the mapped signals), these were then displayed).
The combination of Unger and Singer would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. The motivation for the combination lies in that scaling and restoring the images to the scale of their original point source allows for improved sensitivity for lower or reduced light signals in the image data. This would be advantageous in allowing the imaging system to capture better quality fluorescent images which improves the diagnostic capability of the system. (Singer, columns 15 and 16, and abstract)
Regarding claim 8 the combination of Unger and Singer teaches; The method according to claim 7, wherein the method comprises: calculating, by the computing circuit (Singer, column 6 lines 25-60 the system uses a computer and multiple detectors), the ranking index of each of the mapped luminescence images according to a central tendency statistical parameter of the values of the mapped luminescence image (Singer, column 15 lines 50-58, the images are compared to a known signal amount where the comparison would be the computation of the ranking index, the total fluorescent intensity is computed for the images, where column2 line 44 through column 3 line 26 notes that the data has been adjusted using a distribution, a mean and a standard deviation prior to the heat map generation and the verification of the signal).
The combination of Unger and Singer would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. The motivation for the combination lies in that scaling and restoring the images to the scale of their original point source allows for improved sensitivity for lower or reduced light signals in the image data. This would be advantageous in allowing the imaging system to capture better quality fluorescent images which improves the diagnostic capability of the system. Further, the use of the signal verification would be advantageous for assuring the signal that has been mapped and enhanced is from the cell of interest to improve accuracy. (Singer, columns 2, 3, 15 and 16, and abstract)
Regarding claim 16 the combination of Unger and Singer teaches; The method according to 1, wherein the method comprises:
retrieving, by the computing circuit (Unger, Figure 2, image processing engine (50), [00024] the system components are linked with electrical connections (circuitry)), one or more comparison images (Unger, [00040]-[00041] combination images are generated from 2 fluorescence images, to create a combined image, the 2 or more received images are the comparison images in the Examiner’s interpretation, Pages 9-10 of the applicant’s specification notes that comparison images are luminescence or fluorescence images that are being compared for the concentration of the contrast substance/agent being used),
each of the comparison images comprising a plurality of values representative of the luminescence light being emitted by the luminescence substance from corresponding locations of a comparison entity (Unger, [00045] the image/images contain, for each pixel, a maximum and minimum value associated with the fluorescent emission of the contrast agent, fluorescence is shown on the image, which would show the locations of the emitted light from the contrast),
determining, by the computing circuit (Unger, Figure 2, image processing engine (50), [00024] the system components are linked with electrical connections (circuitry)), the global range further according to the values of all the comparison images (Unger, [00045] the image/images contain, for each pixel, a maximum and minimum value associated with the fluorescent emission of the contrast agent),
mapping, by the computing circuit (Singer, column 6 lines 25-60 the system uses a computer and multiple detectors), the comparison images into corresponding mapped comparison images each by converting the values of the comparison image according to the mapping function (Singer, column 15 lines 43-50, the system verified the restored images (mapped images) signals by comparing them to a predetermined signal to verify if the signal was correct, column 15 lines 44-58, a heatmap (comparison image) was generated to show the verifications of the signals, where the heatmaps generated would be analogous to comparison images),
and displaying, by the computing circuit (Singer, column 6 lines 25-60 the system uses a computer and multiple detectors), the processed images further comprising the mapped comparison images together on the displayer (Singer, column 15 lines 44-58, a heatmap (comparison image) was generated to show the verifications of the signals, where the heatmaps generated would be analogous to comparison images which are then displayed).
The combination of Unger and Singer would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. The motivation for the combination lies in that scaling and restoring the images to the scale of their original point source allows for improved sensitivity for lower or reduced light signals in the image data. This would be advantageous in allowing the imaging system to capture better quality fluorescent images which improves the diagnostic capability of the system. (Singer, columns 15 and 16, and abstract)
Regarding claim 17 the combination of Unger and Singer teaches; The method according to claim 16, wherein the method comprises: retrieving, by the computing circuit (Singer, column 6 lines 25-60 the system uses a computer and multiple detectors), the comparison images comprising at least one reference image of a reference device having one or more sites containing corresponding known concentrations of the luminescence substance (Singer, column 15 lines 43-50, the system verified the restored images (mapped images) signals by comparing them to a predetermined signal (reference image) to verify if the signal was correct, column 14 lines 35-50 detail that a control image or reference image with a known concentration is used to compare the fluorescence signals between the processed images and the known value in order to calculate the concentration, column 15 lines 44-58, a heatmap (comparison image) was generated to show the verifications of the signals, where the heatmaps generated would be analogous to comparison images).
The combination of Unger and Singer would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. The motivation for the combination lies in that scaling and restoring the images to the scale of their original point source allows for improved sensitivity for lower or reduced light signals in the image data. This would be advantageous in allowing the imaging system to capture better quality fluorescent images which improves the diagnostic capability of the system. (Singer, columns 15 and 16, and abstract)
Regarding claim 18 the combination of Unger and Singer teaches; The method according to claim 16 wherein the method comprises
retrieving, by the computing circuit (Unger, Figure 2, image processing engine (50), [00024] the system components are linked with electrical connections (circuitry)), the comparison images comprising one or more evaluation images of one or more further body-parts of further patients corresponding to the body-parts of the patient (Unger, [00033]-[00035] the images used to make the “combined”/comparison images are multiple fluorescence images and multiple reflectance images, which show a region of tissue and its fluorescence emissions).
Regarding claim 19 the combination of Unger and Singer teaches; The method according to claim from 1, wherein the luminescence substance is a luminescence agent being pre- administered to the patient before performing the method (Unger, [00070] the contrast is administered prior to the incision and insertion of the endoscope).
Regarding claim 20 the combination of Unger and Singer teaches; The method according to claim 1, wherein the luminescence substance is a fluorescence substance (Unger, [0009] the contrast data is fluorescent data from emissions from a fluorescent contrast agent injected in a patient before or during surgery), the luminescence images being fluorescence images (Unger, [00026] contrast images are captured during surgery which may be fluorescence, absorption or chemiluminescent images) and the values of each of the fluorescence images being representative of a fluorescence light emitted by the fluorescence substance from the corresponding locations of the body-parts illuminated by an excitation light of the fluorescence substance (Unger, [0003] after the agent is injected the subject may have an excitation light source applied to excite the agent into emission of light to obtain information, [00026] during the surgery the surgeon positions the subject such that the light illuminates the subject so contrast images can be acquired. [00037] the contrast images have pixel values corresponding to the brightness, intensity, fluorescence lifetime, quantum yield and absorption).
Regarding claim 21 the combination of Unger and Singer teaches; A computer program configured for causing a computing (Unger, [0010] the system has computer readable medium causing the computing device to execute the methods of the system, [00029] the system has processors that execute code to process the images and carry out the methods described, [00024] the system components are linked with electrical connections (circuitry)).
Regarding claim 22 the combination of Unger and Singer teaches; A computer program product comprising a computer readable storage medium embodying a computer program (Unger, [0010] the system has computer readable medium causing the computing device to execute the methods of the system), the computer program being loadable into a working memory of a computing (Unger, [00029] the system has processors that execute code stored in a memory to process the images and carry out the methods described, [00024] the system components are linked with electrical connections (circuitry)).
Regarding claim 23 the combination of Unger and Singer teaches; A computing circuit comprising means configured for performing the steps of the method according to claim 1 to 20 (Unger, [0010] the system has computer readable medium causing the computing device to execute the methods of the system, [00029] the system has processors that execute code to process the images and carry out the methods described, [00024] the system components are linked with electrical connections (circuitry)).
Regarding claim 24 the combination of Unger and Singer teaches; A computing circuit comprising a circuitry for performing each step of the method according to claim 1 (Unger, [00032] the system has processors, hardware, including application specific integrated chips, field programmable gate arrays and other means for storing and executing the code to carry out the image processing methods described, [00024] the system components are linked with electrical connections (circuitry)).
Regarding claim 25 the combination of Unger and Singer teaches; An imaging system comprising the computing circuit according to claim 23 (Unger, [0010] the system has computer readable medium causing the computing device to execute the methods of the system, [00029] the system has processors that execute code to process the images and carry out the methods described, [00024] the system components are linked with electrical connections (circuitry)), and an image-acquisition assembly including collection optics and at least one cameras, the image-acquisition assembly for acquiring the luminescence images (Unger, [00027] the system has fluorescence cameras and video cameras for capturing the data).
Regarding claim 28 the combination of Unger and Singer teaches; A surgical method comprising: imaging the body-parts according to the method of claim 1 thereby displaying the processed images together on the displayer during a surgical procedure of the patient (Unger, [00026] images are captured of a patient during a procedure and displayed to assist the surgeon in visualizing the area being operated on), and operating on the patient according to said displaying the processed images (Unger, [00026] images are captured of a patient during a procedure and displayed to assist the surgeon in visualizing the area being operated on, [00045] the images can be used in identifying and visualizing vessels of the subject during surgery, [0005] the visualization of vessels may allow the surgeon to avoid the vessels of interest according to the images while the patient is being operated on).
Regarding claim 30 the combination of Unger and Singer teaches; A therapeutic method comprising:
imaging the body-parts according to the method of claim 1 (Unger, [00026] images are captured of a patient during a procedure and displayed to assist the surgeon in visualizing the area being operated on)
thereby displaying the processed images together on the displayer during a therapeutic procedure of the patient (Unger, [00026] images are captured of a patient during a procedure and displayed to assist the surgeon in visualizing the area being operated on, [00045] the images can be used in identifying and visualizing vessels of the subject during surgery), and treating the patient according to said displaying the processed images (Unger, [00026] images are captured of a patient during a procedure and displayed to assist the surgeon in visualizing the area being operated on, [00045] the images can be used in identifying and visualizing vessels of the subject during surgery, [0005] the visualization of vessels may allow the surgeon to avoid the vessels of interest according to the images).
Claims 9-15 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Unger (WO 2009120228 A1) in view of Singer (US 5866331 A) and in further view of Flewelling (US 20060013454 A1).
Regarding claim 9 the combination of Unger and Singer fails to teach; The method according to 1 wherein the method comprises:
providing, by the computing circuit, at least one segmentation threshold for a plurality of starting images, the starting images being equal to all the luminescence images or the mapped luminescence images, wherein the segmentation threshold is common for all the starting images and wherein the segmentation threshold is determined according to a statistical distribution of the values of all the starting images for separating the values of all
generating, by the computing
and displaying, by the computing circuit, the processed images being further based on the segmented images together on the displayer.
However, in the same field of endeavor, Flewelling teaches; providing, by the computing (Flewelling, Figures 1-3, computer (152)), at least one segmentation threshold (Flewelling, [0397] mean and standard deviation of the luminance values from the images are used to threshold the image prior to segmentation), the starting images being equal to all the luminescence images (Flewelling, [0397] mean and standard deviation of the luminance values from the images are used to threshold the image prior to segmentation, meaning the luminescence images are equal to the starting images in the segmentation algorithm) or the mapped luminescence images , wherein the segmentation threshold is common for all the starting images and wherein the segmentation threshold is determined according to a statistical distribution of the values of all the starting images for separating the values of all number of segments (Flewelling, [0402] the thresholding is used to separate the image into two segments, [0573] the image is divided into two segments, the segmentation is determined by the threshold, and the resulting binary image(s) are a result of thresholding based segmentation using the two segments (separation number of segments), further [0397] the mean and standard deviation of the luminance values from the images (statistical distribution measure which are used as the threshold) are used to threshold the image prior to segmentation),
generating, by the computing circuit (Flewelling, Figures 1-3, computer (152)), corresponding segmented images from the starting images each by segmenting the corresponding starting image into said separation number of segments according to a comparison of the values of the starting image with the segmentation threshold (Flewelling, [0400]-[0402] the images (starting images) are have the mean and standard deviation for the pixel values computed, they then undergo thresholding and are divided into two segments (separation number of segments) and then the resulting segmentation is binary images),
and displaying, by the computing circuit (Flewelling, Figures 1-3, computer (152)), the processed images being further based on the segmented images together on the displayer (Flewelling, Figure 74, images are displayed after the thresholding, segmentation and mask determination (step 138), [0534]-[0540] the final results of the masking/segmentation display the images).
The combination of Unger, Singer, and Flewelling would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. Unger teaches a method of thresholding fluorescence images and creating a combined image to display data to a physician during surgery. It does not teach the use of thresholding for separation into separation segments, however Flewelling teaches this deficiency. The addition of the segmentation method of Flewelling would have been obvious because segmenting a region of interest in a luminescence image based upon thresholding allows the physician to see lesions in an ROI that may not be detected by looking at unprocessed images, therefore the combination of Unger and Flewelling would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. (Flewelling, [0013]-[0015], [0397], [0400]-[0402], [0573] and [0534]-[0540])
Regarding claim 10 the combination of Unger, Singer and Flewelling teaches; The method according to claim 9, wherein the method comprises:
segmenting, by the computing circuit (Flewelling, Figures 1-3, computer (152)), each of the starting images into a detection one of the segments and a non-detection one of the segments representative of detection and of non-detection (Flewelling, [0400]-[0402] the image is divided into two segments, where the two segments have pixels sorted into them by labeling the pixels as either “on” or “off’ to determine if they belong to the Region of interest or not, further, [0619]-[0620] it is described the system can segment blood in images, and the segment values are assigned based on whether or not blood is detected), respectively, of the luminescence substance according to the comparison of the values of the starting image with the segmentation threshold (Flewelling, [0400]-[0402] the image is divided into two segments, where the two segments have pixels sorted into them by labeling the pixels as either “on” or “off’ to determine if they belong to the Region of interest or not, further, [0619]-[0620] it is described the system can segment blood in images, and the segment values are assigned based on whether or not blood is detected, all the segmentations are based on thresholding and comparison of the pixel brightness values in the images).
The combination of Unger, Singer and Flewelling would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. Unger teaches a method of thresholding fluorescence images and creating a combined image to display data to a physician during surgery. It does not teach the use of thresholding for separation into separation segments, or the use of thresholding for detection or non-detection labelling/segmenting, however Flewelling teaches this deficiency. The addition of the segmentation method of Flewelling would have been obvious because segmenting a region of interest in a luminescence image based upon thresholding, and further determining using segmentation that the pixels/values of the pixels in the segment either belongs to a detected class/lesion or not, would allow the physician to see lesions in an ROI that may not be detected by looking at unprocessed images. Therefore, the combination of Unger and Flewelling would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. (Flewelling, [0013]-[0015], [0397], [0400]-[0402], [[0619]-[0620])
Regarding claim 11 the combination of Unger, Singer and Flewelling teaches; The method - according to claim 9, wherein the method comprises:
determining, by the computing circuit (Flewelling, Figures 1-3, computer (152)), said at least one segmentation threshold according to the values of all the starting images for separating the values of all the starting images into said separation number of groups (Flewelling, [0573] the image is divided into two segments, the segmentation is determined by the threshold, and the resulting binary image(s) are a result of thresholding-based segmentation using the two segments (separation number of segments)).
The combination of Unger and Flewelling would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. Unger teaches a method of thresholding fluorescence images and creating a combined image to display data to a physician during surgery. It does not teach the use of thresholding for separation into separation segments, however Flewelling teaches this deficiency. The addition of the segmentation method of Flewelling would have been obvious because segmenting a region of interest in a luminescence image based upon thresholding allows the physician to see lesions in an ROI that may not be detected by looking at unprocessed images, therefore the combination of Unger and Flewelling would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. (Flewelling, [0013]-[0015], [0397], [0400]-[0402], [0573])
Regarding claim 12 the combination of Unger, Singer and Flewelling teaches; The method according to 9 wherein the method comprises:
receiving, by the computing circuit (Flewelling, Figures 1-3, computer (152)), a manual adjustment of the segmentation threshold (Flewelling, [0245] the system enables to user to enter commands such as selection of spectrums or wavelengths for analysis for each segment, which is used in the determination of the threshold, so adjusting these values would adjust the threshold, [0396]-[0398] the wavelength/color threshold is used in determining the segmentation threshold), and
repeating, by the computing circuit (Flewelling, Figures 1-3, computer (152)), said segmenting the starting images (Flewelling, [0245] the system enables to user to enter commands such as selection of spectrums or wavelengths for analysis for each segment, which is used in the determination of the threshold, so adjusting these values would adjust the threshold, [0396]-[0398] the wavelength/color threshold is used in determining the segmentation threshold) and said displaying the processed images in response to the manual adjustment of the segmentation threshold (Flewelling, [0397] mean and standard deviation of the luminance values from the images are used to threshold the image prior to segmentation, [0400]-[0402] the images (starting images) are have the mean and standard deviation for the pixel values computed, they then undergo thresholding and are divided into two segments (separation number of segments) and then the resulting segmentation is binary images, Figure 74, images are displayed after the thresholding, segmentation and mask determination (step 138), [0534]-[0540] the final results of the masking/segmentation displays the images).
The combination of Unger, Singer and Flewelling would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. Unger teaches a method of thresholding fluorescence images and creating a combined image to display data to a physician during surgery. It does not teach the use of thresholding for separation into separation segments or allowing the user to select wavelengths of interest to threshold the image, however Flewelling teaches this deficiency. The addition of the segmentation method of Flewelling would have been obvious because segmenting a region of interest in a luminescence image based upon thresholding allows the physician to see lesions in an ROI that may not be detected by looking at unprocessed images, therefore the combination of Unger and Flewelling would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. (Flewelling, [0013]-[0015], [0245], [0397], [0400]-[0402], [0534]-[0540])
Regarding claim 13 the combination of Unger, Singer, and Flewelling teaches; The method according to 9, wherein the method comprises:
calculating, by the computing circuit (Flewelling, Figures 1-3, computer (152)), corresponding ranking indexes of the segmented images each indicative of a quality of said segmenting the corresponding starting image according to a content of the corresponding segmented image (Flewelling, [0692]-[0695] the ROI masks (generated using segmentation) are evaluated using brightness, luminance values, and other metrics that equivalent to the ranking indexes as described in the specification),
and displaying, by the computing circuit (Flewelling, Figures 1-3, computer (152)), the processed images together in association with the corresponding ranking indexes of the segmented images on the displayer (Flewelling, [0701]-[703] the segmentation masks are displayed over the reference image to show localization of disease or other regions of interest on the image, [0007]-[00010] the spectral information/ranking information is used to determine diseased tissue).
The combination of Unger, Singer and Flewelling would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. Unger teaches a method of thresholding fluorescence images and creating a combined image to display data to a physician during surgery. It does not teach the use of thresholding for separation into separation segments or allowing the user to select wavelengths of interest to threshold the image, however Flewelling teaches this deficiency. The addition of the segmentation method of Flewelling would have been obvious because segmenting a region of interest in a luminescence image based upon thresholding allows the physician to see lesions in an ROI that may not be detected by looking at unprocessed images. Further the ROI segmentation and analysis method of Flewelling would allow a physician to obtain information about ROI’s containing potential indicators of disease, such as cancerous or necrotic tissues, as described in [0701]-[0703], and [0007]-[0011] of Flewelling. Therefore, the combination of Unger and Flewelling would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. (Flewelling, [0001]-[0010], [0013]-[0015], and [0692]-[0696])
Regarding claim 14 the combination of Unger, Singer and Flewelling teaches; The method according to claim 13, wherein the method comprises:
calculating, by the computing circuit (Flewelling, Figures 1-3, computer (152)), the ranking index of each of the segmented images according to a comparison between corresponding central tendency statistical parameters of the values of the segments of the segmented image (Flewelling, [0692]-[0695] the ROI masks (generated using segmentation) are evaluated using brightness, luminance values, and other metrics that equivalent to the ranking indexes as described in the specification, [0693]-[695] specifically discuses finding luminance values and statistics on luminance values for the for the ROIs, which are a product of the segmentation method).
The combination of Unger, Singer, and Flewelling would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. Unger teaches a method of thresholding fluorescence images and creating a combined image to display data to a physician during surgery. It does not teach the use of thresholding for separation into separation segments or allowing the user to select wavelengths of interest to threshold the image, however Flewelling teaches this deficiency. The addition of the segmentation method of Flewelling would have been obvious because segmenting a region of interest in a luminescence image based upon thresholding allows the physician to see lesions in an ROI that may not be detected by looking at unprocessed images. Further the ROI segmentation and analysis method of Flewelling would allow a physician to obtain information about ROI’s containing potential indicators of disease, such as cancerous or necrotic tissues, as described in [0701]-[0703], and [0007]-[0011] of Flewelling. Therefore, the combination of Unger and Flewelling would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. (Flewelling, [0001]-[0010], [0013]-[0015], and [0692]-[0696])
Regarding claim 15 the combination of Unger, Singer and Flewelling teaches; The method according to 9, wherein the method comprises:
providing, to the computing circuit (Unger, Figure 2, image processing engine (50)), a plurality of reflectance images corresponding to the luminescence images (Unger, [0033], multiple Fluorescence and reflectance images are captured),
each of the reflectance images comprising a plurality of values for the locations of the body-parts each representative of a visible light being reflected from the corresponding location (Unger, [0026] during the surgery the surgeon captures reflectance and fluorescence images of the subject during surgery, to be used in viewing tissues and vessels during the operation, the reflectance images contain the reflected light data from the region imaged, which in this case is a body part/location in the body),
generating, by the computing circuit (Unger, Figure 2, image processing engine (50)), a corresponding plurality of overlaid images by overlaying the segmented images onto the corresponding reflectance images (Unger, [00057] generated fluorescence data is overlaid onto reflectance images, [00084]-[00086] the vessel of interest data, which is fluorescent data, can be generated using segmentation, therefore in displaying the fluorescence data overlaid on the reflectance data, this data can include segmentations and registrations of the segmentations from the fluorescence images),
and displaying, by the computing circuit (Unger, Figure 2, image processing engine (50)), the processed images comprising the overlaid images together on the displayer (Unger, [00057] generated fluorescence data is overlaid onto reflectance images).
Regarding claim 29 the combination of Unger, Singer and Flewelling teaches; A diagnostic method comprising:
imaging the body-parts according to the method of claim 1 thereby displaying the processed images together on the displayer during a diagnostic procedure of the patient (Unger, [0026] during the surgery the surgeon captures reflectance and fluorescence images of the subject during surgery, to be used in viewing tissues and vessels during the operation, the reflectance images contain the reflected light data from the region imaged, which in this case is a body part/location in the body,[00057] generated fluorescence data is overlaid onto reflectance images and displayed),
and evaluating a health condition of the patient according to said displaying the processed images (Flewelling, [0701]-[703] the segmentation masks are displayed over the reference image to show localization of disease or other regions of interest on the image, [0007]-[00010] the spectral information/ranking information is used to determine diseased tissue).
The combination of Unger, Singer, and Flewelling would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. Unger teaches a method of thresholding fluorescence images and creating a combined image to display data to a physician during surgery. It does not teach the use of thresholding for separation into separation segments or allowing the user to select wavelengths of interest to threshold the image, however Flewelling teaches this deficiency. The addition of the segmentation method of Flewelling would have been obvious because segmenting a region of interest in a luminescence image based upon thresholding allows the physician to see lesions in an ROI that may not be detected by looking at unprocessed images. Further the ROI segmentation and analysis method of Flewelling would allow a physician to obtain information about ROI’s containing potential indicators of disease, such as cancerous or necrotic tissues, as described in [0701]-[0703], and [0007]-[0011] of Flewelling. Therefore, the combination of Unger and Flewelling would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. (Flewelling, [0001]-[0010], [0013]-[0015], and [0692]-[0696] and Unger, [00026] and [00057])
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Refer to PTO-892, Notice of References Cited for a listing analogous art.
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/J.M.E./Examiner, Art Unit 2666
/EMILY C TERRELL/Supervisory Patent Examiner, Art Unit 2666
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