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 .
Applicant’s response to the Non-final Office Action dated 05/06/2026, filed with the office on 07/24/2026, has been entered and made of record.
Information Disclosure Statement
The information disclosure statement (“IDS”) filed on 09/24/2026 has been reviewed and the listed references have been considered.
Response to Amendment
In light of Applicant’s amendment of the claims, the claim objection of record with respect to claim 11 has been withdrawn.
In light of Applicant’s amendment of the claims, the claims are no longer interpreted under 35 U.S.C. 112(f).
In light of Applicant’s amendment of the claims, the 35 U.S.C. 112(b) rejection of record with respect to claim 22 has been withdrawn.
In light of Applicant’s amendment of the claims, the 35 U.S.C. 112(d) rejections of record with respect to claims 16 and 20 have been withdrawn.
In light of Applicant’s amendments of the independent claims, the amended claims now recite significantly more than abstract idea. Specifically, the claim language “determining the abnormality includes extending the first segmented region and the second segmented region to 3D volumes containing voxels in different adjacent image slices in the ASPECTS regions” as amended, in independent claim 1, for example, recites more than an abstract idea, therefore, the rejections of record of claims under 35 U.S.C. 101 have been withdrawn.
Status of Claims
Claims 1-10,12-17,19 and 21-23 are pending. Claims 1, 12-17, 19 and 21-23 are amended. Claims 11, 18, 20 and 24 are cancelled.
Response to Arguments
Applicant’s amendment of independent Claims 1, 12 and 21, which has altered the scope of the claims of the instant application, has necessitated the new ground(s) of rejection presented in this office action with respect to claims of the instant application. Accordingly, in response to Applicant’s arguments that are merely directed to the amended portion of the claims, new analyses have been presented below, which make Applicant’s arguments moot.
Consequently, THIS ACTION IS MADE FINAL.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5-7, 9, 10, 12-17 and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Joshi et al. (US 2010/0145194 A1) in view of Ueda (US 2022/0101622A1) and in further view of Purushottam et al. (US 11,263,749 B1).
Regarding claim 1, Joshi teaches, A method for processing medical information, the method comprising: receiving an image slice of a brain (Joshi, ¶0003: “methods for monitoring physiological activity in the brain and more specifically to the use of histograms representing brain scan image data”) including segmented regions; (Joshi, ¶0070: “segmenting a PET scan of the brain into volumes of interest for each of several regions of interest”) forming a first histogram of intensity values for the image slice; (Joshi, ¶0014: “obtaining image data of at least a portion of the cranium of the patient, generating a histogram from the image data”) forming a second histogram of intensity values for the image slice; (Joshi, ¶0014: “obtaining image data of at least a portion of the cranium of the patient, generating a histogram from the image data”) and determining an abnormality in the image slice based on the first histogram and the second histogram, (Joshi, ¶0014: “analyzing a feature of the histogram to detect the presence of the pathologic target in the patient's brain”). However, Joshi does not explicitly teach, wherein the first histogram corresponds to a first segmented region in a first portion of the image slice and the second histogram corresponds to a second segmented region in a second portion of the image slice which is complementary to the first portion, wherein the first segmented region and the second segmented region are in complementary Alberta Stroke Program Early CT Score (ASPECTS) regions on different lateral portions of the brain, wherein determining the abnormality includes extending the first segmented region and the second segmented region to 3D volumes containing voxels in different adjacent image slices in the ASPECTS regions.
In an analogous field of endeavor, Ueda teaches, wherein the first histogram corresponds to a first segmented region in a first portion of the image slice and the second histogram corresponds to a second segmented region in a second portion of the image slice (Ueda, ¶0034: “generating a histogram of saturation of the first region and a histogram of saturation of the second region as a first saturation histogram and a second saturation histogram”) which is complementary to the first portion, (Ueda, ¶0066: “first region 201 including the center region of image 200 and second regions 202, 203 remaining after excluding first region 201 from image 200”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Joshi using the teachings of Ueda to introduce generating histograms representing different cerebral regions of an image. A person skilled in the art would be motivated to combine the known elements as described above and achieve the predictable result of locating abnormalities in a scanned brain. Therefore, it would have been obvious to combine the analogous arts Joshi and Ueda to obtain the above-described limitations in claim 1.
However, the combination of Joshi and Ueda does not explicitly teach wherein the first segmented region and the second segmented region are in complementary Alberta Stroke Program Early CT Score (ASPECTS) regions on different lateral portions of the brain, wherein determining the abnormality includes extending the first segmented region and the second segmented region to 3D volumes containing voxels in different adjacent image slices in the ASPECTS regions.
In an analogous field of endeavor, Purushottam teaches, wherein the first segmented region and the second segmented region are in complementary (Purushottam, col 2, lines 44-46: “automatically segmenting, through a neural network, one or more second images of at least one structure that resides within the one or more first images”) Alberta Stroke Program Early CT Score (ASPECTS) regions (Purushottam, col. 2, lines 52-53: “feature comprises at least one of the one or more volumes of the region of interest (ROI)… alberta stroke programme early CT score (ASPECTS) calculation”) on different lateral portions of the brain, (Purushottam, Fig 24(a-j) – 27(a-g): different lateral portions of the brain) wherein determining the abnormality (Purushottam, col. 11, lines 39-42: “detecting at least one spike within the one or more physiological signals that indicates abnormality, and predicting a prognosis based on correlation and integrated analysis of the at least one spike detected and the one or more volumes”) includes extending the first segmented region and the second segmented region to 3D volumes containing voxels in different adjacent image slices in the ASPECTS regions. (Purushottam, col. 2, lines 49-53: “determining a feature associated with the at least one structure based on the one or more volumes and one or more inputs; and rendering the feature in at least one of a two-dimensional (2D) format, a three-dimensional (3D) format”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Joshi in view of Ueda using the teachings of Purushottam to introduce computing ASPECTS for adjacent brain region slices. A person skilled in the art would be motivated to combine the known elements as described above and achieve the predictable result of rendering the brain in 3D to visualize an abnormality. Therefore, it would have been obvious to combine the analogous arts Joshi, Ueda and Purushottam to obtain the invention in claim 1.
Regarding claim 2, Joshi in view of Ueda and in further view of Purushottam teaches, The method of claim 1, further comprising: generating at least one difference histogram based on the first histogram and the second histogram, wherein determining the abnormality in the image slice is based on the at least one difference histogram. (Joshi, ¶0082: “After a comparison of the areas under the curves within the 125-200 pixel/voxel intensity region on the x-axis of each of the histograms, it was observed that there was a substantial difference between the areas of the histograms of the AD patients and the histograms of the healthy control patients”).
Regarding claim 3, Joshi in view of Ueda and in further view of Purushottam teaches, The method of claim 2, wherein determining the abnormality includes: identifying that the at least one difference histogram has values in a range; (Joshi, ¶0052: “analysis of brain scan images is used to generate voxel versus numerical range bar graphs”) and determining the abnormality based on the values of the at least one difference histogram in the range. (Joshi, ¶0052: “distributions of voxel values and the associated histogram shapes differ in a regular and repeatable fashion between the images of healthy control subjects and those of patients exhibiting the clinical or preclinical symptoms of AD or other neurodegenerative disease”).
Regarding claim 5, Joshi in view of Ueda and in further view of Purushottam teaches, The method of claim 2, wherein generating the at least one difference histogram includes subtracting the intensity values of the first histogram from the intensity values of the second histogram. (Ueda, ¶0034: “calculating a differential saturation histogram by subtracting the second saturation histogram from the first saturation histogram in each bin of corresponding saturation”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Joshi in view of Ueda and in further view of Purushottam using the additional teachings of Ueda to introduce subtracting a histogram from another histogram. A person skilled in the art would be motivated to combine the known elements as described above and achieve the predictable result of computing a difference histogram for anomaly detection. Therefore, it would have been obvious to combine the analogous arts Joshi, Ueda and Purushottam to obtain the invention in claim 5.
Regarding claim 6, Joshi in view of Ueda and in further view of Purushottam teaches, The method of claim 2, wherein generating the at least one difference histogram includes: generating a first difference histogram based on a difference between the first histogram and a first reference histogram; and generating a second difference histogram based on a difference between the second histogram and a second reference histogram. (Joshi, ¶0082: “After a comparison of the areas under the curves within the 125-200 pixel/voxel intensity region on the x-axis of each of the histograms, it was observed that there was a substantial difference between the areas of the histograms of the AD patients and the histograms of the healthy control patients”).
Regarding claim 7, Joshi in view of Ueda and in further view of Purushottam teaches, The method of claim 6, wherein: the first reference histogram is indicative of brain tissue without a lesion in the first segmented region, (Joshi, ¶0081: “other histogram form was indicative of a healthy control (HC) subject”) and the second reference histogram is indicative of brain tissue without a lesion in the second segmented region. (Joshi, ¶0081: “One histogram form characterized a patient with Alzheimer's disease”).
Regarding claim 9, Joshi in view of Ueda and in further view of Purushottam teaches, The method of claim 2, further comprising: determining whether the first histogram has a concentration of intensity values in a predetermined range; (Joshi, ¶0067: “a histogram displaying more than two peaks or a dispersed distribution of voxel bin counts over a segment of the histogram”) and identifying that the image slice has an old abnormality when the first histogram has the concentration of intensity values in the predetermined range. (Joshi, ¶0067: “more than two peaks… is indicative of the presence of higher concentrations of the pathologic target in the patient's brain”).
Regarding claim 10, Joshi in view of Ueda and in further view of Purushottam teaches, The method of claim 9, further comprising: generating the difference histogram based on an exclusion of the intensity values in the predetermined range of the first histogram corresponding to the old abnormality. (Joshi, ¶0061: “the portion of the brain analyzed or portions of the image data excluded from analysis… excluding any portion of the image having voxel data over a predetermined intensity threshold”).
Regarding claim 12, it recites a system with elements corresponding to the steps of the method recited in claim 1. Therefore, the recited elements of system claim 12 are mapped to the proposed combination in the same manner as the corresponding steps in method claim 1. Additionally, the rationale and motivation to combine Joshi, Ueda and Purushottam presented in rejection of claim 1, apply to this claim. Joshi further teaches, A system for processing medical information (Joshi, ¶0065: “image data is derived from images that are scanned and inputted into a processor”).
Regarding claim 13, it recites a system with elements corresponding to the steps of the method recited in claim 2. Therefore, the recited elements of system claim 13 are mapped to the proposed combination in the same manner as the corresponding steps in method claim 2. Additionally, the rationale and motivation to combine Joshi, Ueda and Purushottam presented in rejection of claim 1, apply to this claim.
Regarding claim 14, it recites a system with elements corresponding to the steps of the method recited in claim 3. Therefore, the recited elements of system claim 14 are mapped to the proposed combination in the same manner as the corresponding steps in method claim 3. Additionally, the rationale and motivation to combine Joshi, Ueda and Purushottam presented in rejection of claim 1, apply to this claim.
Regarding claim 16, it recites a system with elements corresponding to the steps of the method recited in claim 5. Therefore, the recited elements of system claim 16 are mapped to the proposed combination in the same manner as the corresponding steps in method claim 5. Additionally, the rationale and motivation to combine Joshi, Ueda and Purushottam presented in rejection of claim 5, apply to this claim.
Regarding claim 17, it recites a system with elements corresponding to the steps of the method recited in claim 6. Therefore, the recited elements of system claim 17 are mapped to the proposed combination in the same manner as the corresponding steps in method claim 6. Additionally, the rationale and motivation to combine Joshi, Ueda and Purushottam presented in rejection of claim 1, apply to this claim.
Regarding claim 20, it recites a system with elements corresponding to the steps of the method recited in claim 5. Therefore, the recited elements of system claim 20 are mapped to the proposed combination in the same manner as the corresponding steps in method claim 5. Additionally, the rationale and motivation to combine Joshi, Ueda and Purushottam presented in rejection of claim 5, apply to this claim.
Regarding claim 21, it recites a system with elements corresponding to the steps of the method recited in claim 9. Therefore, the recited elements of system claim 21 are mapped to the proposed combination in the same manner as the corresponding steps in method claim 9. Additionally, the rationale and motivation to combine Joshi, Ueda and Purushottam presented in rejection of claim 1, apply to this claim.
Regarding claim 22, it recites a system with elements corresponding to the steps of the method recited in claim 10. Therefore, the recited elements of system claim 22 are mapped to the proposed combination in the same manner as the corresponding steps in method claim 10. Additionally, the rationale and motivation to combine Joshi, Ueda and Purushottam presented in rejection of claim 1, apply to this claim.
Regarding claim 23, it recites a computer program including instructions corresponding to the steps of the method recited in claim 1. Therefore, the recited instructions of the computer program of claim 23 are mapped to the proposed combination in the same manner as the corresponding elements of the method claim 1. Additionally, the rationale and motivation to combine Joshi, Ueda and Purushottam presented in rejection of claim 1, apply to this claim. In addition, Ueda teaches, A non-transitory computer-readable storage medium having stored a computer program comprising instructions, which, when executed by a processor, cause the processor to (Ueda, Claim 1: “A non-transitory computer-readable recording medium having stored thereon a program for causing a computer to perform an image processing method”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Joshi in view of Ueda and in further view of Purushottam using the additional teachings of Ueda to introduce a recording medium. A person skilled in the art would be motivated to combine the known elements, as described above, and achieve the predictable result of recording a program for processing the medical information. Therefore, it would have been obvious to combine the analogous arts Joshi, Ueda and Purushottam to obtain the invention in claim 23.
Claims 4 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Joshi et al. (US 2010/0145194 A1) in view of Ueda (US 2022/0101622 A1), in further view of Purushottam et al. (US 11,263,749 B1) and still in further view of Gatayama et al. (US 20160100815 A1).
Regarding claim 4, Joshi in view of Ueda and in further view of Purushottam teaches, The method of claim 2, wherein determining the abnormality includes. However, the combination of Joshi, Ueda and Purushottam does not explicitly teach, identifying that the at least one difference histogram has one or more values that exceed a predetermined reference value; and determining the abnormality based on the one or more values of the at least one difference histogram exceeding the predetermined reference value.
In an analogous field of endeavor, Gatayama teaches, identifying that the at least one difference histogram has one or more values that exceed a predetermined reference value; and determining the abnormality based on the one or more values of the at least one difference histogram exceeding the predetermined reference value. (Gatayama, ¶0067: “acquires the difference between the reference histogram and the comparison target histogram by comparing the reference histogram with the comparison target histogram, and determines whether the CT value represented by the difference exceeds the predetermined threshold. If it is determined that the CT value represented by the difference exceeds the threshold”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Joshi in view of Ueda and in further view of Purushottam using the teachings of Gatayama to introduce a threshold for histogram differences. A person skilled in the art would be motivated to combine the known elements, as described above, and achieve the predictable result of detecting an anomaly when the difference values exceed the threshold. Therefore, it would have been obvious to combine the analogous arts Joshi, Ueda, Purushottam and Gatayama to obtain the invention in claim 4.
Regarding claim 15, it recites a system with elements corresponding to the steps of the method recited in claim 4. Therefore, the recited elements of system claim 15 are mapped to the proposed combination in the same manner as the corresponding steps in method claim 4. Additionally, the rationale and motivation to combine Joshi, Ueda, Purushottam and Gatayama presented in rejection of claim 4, apply to this claim.
Claims 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Joshi et al. (US 2010/0145194 A1) in view of Ueda (US 2022/0101622 A1), in further view of Purushottam et al. (US 11,263,749 B1) and still in further view of Drori et al. (US 2021/0015991 A1).
Regarding claim 8, Joshi in view of Ueda and in further view of Purushottam teaches, The method of claim 2, wherein determining the abnormality includes. However, the combination of Joshi, Ueda and Purushottam does not explicitly teach generating a feature vector based on the at least one difference histogram; inputting the feature vector into a classifier model; and predicting the abnormality based on an output of the classifier model.
In an analogous field of endeavor, Drori teaches, generating a feature vector based on the at least one difference histogram; (Drori, ¶0396: “and comparing the histogram to a histogram of a “reference” image, the system can create a features vector that describes a change”) inputting the feature vector into a classifier model; (Drori, ¶0416: “features vector 1414 is input to a classifier”) and predicting the abnormality based on an output of the classifier model. (Drori, ¶0057: “classifier configured to classify the patient's status”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Joshi in view of Ueda and in further view of Purushottam using the teachings of Drori to introduce computing a feature vector based on histogram of difference values. A person skilled in the art would be motivated to combine the known elements as described above and achieve the predictable result of detecting abnormality within a region of interest. Therefore, it would have been obvious to combine the analogous arts Joshi, Ueda, Purushottam and Drori to obtain the invention in claim 8.
Regarding claim 19, it recites a system with elements corresponding to the steps of the method recited in claim 8. Therefore, the recited elements of system claim 19 are mapped to the proposed combination in the same manner as the corresponding steps in method claim 8. Additionally, the rationale and motivation to combine Joshi, Ueda, Purushottam and Drori presented in rejection of claim 8, apply to this claim.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Joshi et al. (US 2010/0145194 A1) in view of Ueda (US 2022/0101622 A1), in further view of Purushottam et al. (US 11,263,749 B1) and still in further view of Fuchigami et al. (US 2019/0267132 A1).
Regarding claim 11, Joshi in view of Ueda and in further view of Purushottam teaches, The method of claim. However, the combination of Joshi, Ueda and Purushottam does not explicitly teach, wherein the first segmented region and the second segmented region are complementary ASPECTS regions.
In an analogous field of endeavor, Fuchigami teaches, wherein the first segmented region and the second segmented region are complementary ASPECTS regions. (Fuchigami, ¶0071: “in FIG. 9, ten regions of ASPECTS are shown”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Joshi in view of Ueda and in further view of Purushottam using the teachings of Fuchigami to introduce ASPECTS regions. A person skilled in the art would be motivated to combine the known elements, as described above, and achieve the predictable result of early assessment of stroke severity. Therefore, it would have been obvious to combine the analogous arts Joshi, Ueda, Purushottam and Fuchigami to obtain the invention in claim 11.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEHRAZUL ISLAM whose telephone number is (571)270-0489. The examiner can normally be reached Monday-Friday: 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Saini Amandeep can be reached at (571) 272-3382. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEHRAZUL ISLAM/Examiner, Art Unit 2662
/AMANDEEP SAINI/Supervisory Patent Examiner, Art Unit 2662
