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 .
Notice to Applications
This communication is in response to the Application filed on March 22, 2024.
Claims 2-21 are pending.
Information Disclosure Statement
The information disclosure statement(s) (IDS(s)) submitted on January 02, 2025 are in compliance with the provisions of 27 CFR 1.97. Accordingly, the information disclosure statements are being considered and attached by the examiner.
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 2-21 are rejected under 35 U.S.C. 103 as being unpatentable of Min et al., US 20210209757 A1, (hereinafter “Min”) in view of Ohashi et al., Visceral fat accumulation as a predictor of coronary artery calcium as assessed by multislice computed tomography in Japanese patients, (hereinafter “Ohashi”).
Regarding claim 2, Min teaches a computer-implemented method of acquisition of medical images for analysis to facilitate risk assessment of arterial plaque disease for a subject, the computer- implemented method comprising:
acquiring, by a second computer system ([0294] “CT images, or CT scans, as used herein, is a broad term that refers to pictures of structures within the body created by computer controlled scanner.” wherein a second computer system is CT), a second medical image ([0156] “In some embodiments, the system can be configured to identify and/or segment arteries on the medical image or non-contrast CT image using the identified epicardial fat as outer boundaries of the arteries. For example, the system can be configured to first identify regions of epicardial fat on the medical image and assign a volume in between epicardial fat as an artery, such as a coronary artery.” wherein a second medical image of one or more arterial beds of the subject is the medical image containing arteries) ([0379] “At block 1010, the process 1000 can generate and display in a user interface a first panel including an artery tree comprising a three-dimensional (3D) representation of coronary vessels based on the CT images and depicting coronary vessels identified in the CT images, and depicting segment labels, the artery tree not including heart tissue between branches of the artery tree.” wherein a reconstructed three-dimensional image of the one or more arterial beds is a three-dimensional representation of coronary vessels) ([0164] “Similar to the processes described above, in some embodiments, the system can be configured to access a DECT or spectral CT image, identify epicardial fat on the DECT image or spectral CT and/or segment one or more arteries on the DECT image or spectral CT, identify and/or classify a first set of pixels or regions within the arteries as a first set of low-attenuated or non-calcified plaque, and/or identify a second set of pixels or regions within the arteries as a second set of low-attenuated or non-calcified plaque.”),
wherein each of the first computer system and the second computer system comprises a computer processor and an electronic storage medium ([0456] “wherein the computer system comprises a computer processor and an electronic storage medium.”).
Min does not specifically disclose acquiring, by a first computer system, a first medical image, the first medical image comprising a two-dimensional axial slice image of an abdomen of the subject, the first medical image comprising one or more regions of visceral adiposity, wherein quantification of an amount of the one or more regions of visceral adiposity is indicative of volume of arterial plaque in one or more arterial beds of the subject;
analyzing the first medical image to quantify the amount of the one or more regions of visceral adiposity to determine whether the amount of the one or more regions of visceral adiposity is above a predetermined threshold.
However, Ohashi teaches acquiring, by a first computer system ([pg.193] “In addition to MSCT heart scans, abdominal scans were performed at the lumbar 4–5 levels in spine position, and single 5-mm slices were taken during suspended respiration after normal expiration.” wherein a first computer system is MSCT), a first medical image, the first medical image comprising a two-dimensional axial slice image of an abdomen of the subject, the first medical image comprising one or more regions of visceral adiposity, wherein quantification of an amount of the one or more regions of visceral adiposity is indicative of volume of arterial plaque in one or more arterial beds of the subject ([pg.193] “In addition to MSCT heart scans, abdominal scans were performed at the lumbar 4–5 levels in spine position, and single 5-mm slices were taken during suspended respiration after normal expiration.” wherein the scans were acquired using multislice computer tomography (MSCT)) ([pg.194] “In Model 2, which additionally standardized for VFA, BMI, SFA and WC, only VFA persisted to show a significant relationship with CAC in both logistic and ordinal regression analyses and was regarded as an independent determinant of CAC.” wherein quantification of an amount of visceral adiposity is VFA and volume of arterial plaque is measured by CAC);
analyzing the first medical image to quantify the amount of the one or more regions of visceral adiposity to determine whether the amount of the one or more regions of visceral adiposity is above a predetermined threshold ([pg.195] “From the ROC curve analysis, the optimal cut-off value of VFA to predict the presence of CAC was identified as 116 cm2 in men, and 82 cm2 in women. These values provided sensitivities of 79% and 84%, and specificities of 63% and 72% for men and women, respectively (Fig. 2A). Fig. 2B shows the sex-specific correlation between the measured values of VFA and WC using MSCT.” wherein a predetermined threshold is the cut-off value of VFA to predict the presence of CAC).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to quantify visceral adiposity of Ohashi to be used as a factor in determining the risk of arterial plaque disease in the method of Min because Ohashi teaches visceral adiposity has a confirmed correlation with calcium presence in atherosclerotic plaques that form in coronary arteries. Thus, quantifying visceral adiposity aids in more accurately determining the risk of arterial plaque disease.
Regarding claim 3, Min in view of Ohashi teaches the computer-implemented method of Claim 2, wherein the first medical image and the second medical image are acquired using a single image acquisition system (Ohashi - [pg.193] “In addition to MSCT heart scans, abdominal scans were performed at the lumbar 4–5 levels in spine position, and single 5-mm slices were taken during suspended respiration after normal expiration.” wherein a first medical image is acquired using MSCT) (Ohashi - [pg.193] “Total of 321 consecutive patients were imaged using either a 16-slice MSCT scanner (LightSpeed Ultrafast16, GE Healthcare, Waukesha, Wisconsin) between August 2005 and November 2005 (men, 27; women, 17; age 66 ± 10 years) or a 64-slice CT scanner (LightSpeed VCT, GE Healthcare) between December 2005 and June 2007 (men, 186; women, 91; age 65 ± 11 years).” wherein Ohashi teaches the acquisition of the second image containing plaque using MSCT).
The motivation for combining Min and Ohashi is the same motivation as used for claim 2.
Regarding claim 4, Min in view of Ohashi teaches the computer-implemented method of Claim 2, wherein the first medical image and the second medical image are acquired using different image acquisition systems (Ohashi - [pg.193] “In addition to MSCT heart scans, abdominal scans were performed at the lumbar 4–5 levels in spine position, and single 5-mm slices were taken during suspended respiration after normal expiration.” wherein the first medical image is acquired using MSCT) (Min - [0294] “CT images, or CT scans, as used herein, is a broad term that refers to pictures of structures within the body created by computer controlled scanner.” wherein the second medical image is acquired using CT).
The motivation for combining Min and Ohashi is the same motivation as used for claim 2.
Regarding claim 5, Min in view of Ohashi teaches the computer-implemented method of Claim 2, wherein the first computer system and the second computer system are part of a single computer system (Ohashi - [pg.193] “In addition to MSCT heart scans, abdominal scans were performed at the lumbar 4–5 levels in spine position, and single 5-mm slices were taken during suspended respiration after normal expiration.” wherein the first computer system is MSCT) (Ohashi - [pg.193] “Total of 321 consecutive patients were imaged using either a 16-slice MSCT scanner (LightSpeed Ultrafast16, GE Healthcare, Waukesha, Wisconsin) between August 2005 and November 2005 (men, 27; women, 17; age 66 ± 10 years) or a 64-slice CT scanner (LightSpeed VCT, GE Healthcare) between December 2005 and June 2007 (men, 186; women, 91; age 65 ± 11 years).” wherein Ohashi teaches the use of MSCT for CAC scoring).
The motivation for combining Min and Ohashi is the same motivation as used for claim 2.
Regarding claim 6, Min in view of Ohashi teaches the computer-implemented method of Claim 2, wherein the first computer system and the second computer system are separate (Ohashi - [pg.193] “In addition to MSCT heart scans, abdominal scans were performed at the lumbar 4–5 levels in spine position, and single 5-mm slices were taken during suspended respiration after normal expiration.” wherein a first computer system is MSCT) (Min - [0294] “CT images, or CT scans, as used herein, is a broad term that refers to pictures of structures within the body created by computer controlled scanner.” wherein a second computer system is CT).
The motivation for combining Min and Ohashi is the same motivation as used for claim 2.
Regarding claim 7, Min in view of Ohashi teaches the computer-implemented method of Claim 2, wherein the one or more arterial beds comprise one or more of a coronary artery, an aorta, a carotid artery, a lower extremity artery, or an upper extremity artery (Min - [0239] “In some embodiments, the medical image of the subject can comprise the coronary region, coronary arteries, carotid arteries, renal arteries, abdominal aorta, cerebral arteries, lower extremities, and/or upper extremities of the subject.”).
The motivation for combining Min and Ohashi is the same motivation as used for claim 2.
Regarding claim 8, Min in view of Ohashi teaches the computer-implemented method of Claim 2, wherein the first medical image and the second medical image comprise a computed tomography (CT) image (Min - [0294] “CT images, or CT scans, as used herein, is a broad term that refers to pictures of structures within the body created by computer controlled scanner.” wherein the second medical image is acquired by CT) (Ohashi - [pg.193] “In addition to MSCT heart scans, abdominal scans were performed at the lumbar 4–5 levels in spine position, and single 5-mm slices were taken during suspended respiration after normal expiration.” wherein the first image was acquired using multislice computer tomography (MSCT)).
The motivation for combining Min and Ohashi is the same motivation as used for claim 2.
Regarding claim 9, Min in view of Ohashi teaches the computer-implemented method of Claim 2, wherein one or more of the first medical image or the second medical image is obtained using an imaging technique comprising one or more of CT, x-ray, ultrasound, echocardiography, magnetic resonance (MR) imaging, optical coherence tomography (OCT), nuclear medicine imaging, positron- emission tomography (PET), single photon emission computed tomography (SPECT), or near-field infrared spectroscopy (NIRS) (Min - [0015] “the medical image is obtained using an imaging technique comprising one or more of CT, x-ray, ultrasound, echocardiography, intravascular ultrasound (IVUS), MR imaging, optical coherence tomography (OCT), nuclear medicine imaging, positron-emission tomography (PET), single photon emission computed tomography (SPECT), or near-field infrared spectroscopy (NIRS).”).
The motivation for combining Min and Ohashi is the same motivation as used for claim 2.
Regarding claim 10, Min in view of Ohashi teaches the computer-implemented method of Claim 2, wherein low-density non-calcified plaque comprises a region of plaque on a CT image comprising a radiodensity value between about -189 and about 30 Hounsfield units, wherein non-calcified plaque comprises a region of plaque on a CT image comprising a radiodensity value between about 31 and about 350 Hounsfield units, and wherein calcified plaque comprises a region of plaque on a CT image comprising a radiodensity value between about 351 and about 2500 Hounsfield units (Min - [0358] See below table).
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The motivation for combining Min and Ohashi is the same motivation as used for claim 2.
Regarding claim 11, the claim recites similar limitations to claim 2 but in the form of a system comprising a non-transitory computer storage medium configured to at least store computer- executable instructions; and one or more computer hardware processors in communication with the non-transitory computer storage medium, the one or more computer hardware processors configured to execute the computer-executable instructions of claim 2 (Min – [0378] “For example, by one or more computer hardware processors in communication with the one or more non-transitory computer storage mediums, executing the computer-executable instructions stored on one or more non-transitory computer storage mediums.”). Therefore, claim 11 recites similar limitations to claim 2 and is rejected for similar rationale and reasoning (see the analysis for claim 2 above).
Regarding claim 12, the claim recites similar limitations to claim 3 but in the form of a system. Therefore, claim 12 recites similar limitations to claim 3 and is rejected for similar rationale and reasoning (see the analysis for claim 3 above).
Regarding claim 13, the claim recites similar limitations to claim 4 but in the form of a system. Therefore, claim 13 recites similar limitations to claim 4 and is rejected for similar rationale and reasoning (see the analysis for claim 4 above).
Regarding claim 14, the claim recites similar limitations to claim 5 but in the form of a system. Therefore, claim 14 recites similar limitations to claim 5 and is rejected for similar rationale and reasoning (see the analysis for claim 5 above).
Regarding claim 15, the claim recites similar limitations to claim 6 but in the form of a system. Therefore, claim 15 recites similar limitations to claim 6 and is rejected for similar rationale and reasoning (see the analysis for claim 6 above).
Regarding claim 16, the claim recites similar limitations to claim 7 but in the form of a system. Therefore, claim 16 recites similar limitations to claim 7 and is rejected for similar rationale and reasoning (see the analysis for claim 7 above).
Regarding claim 17, the claim recites similar limitations to claim 8 but in the form of a system. Therefore, claim 17 recites similar limitations to claim 8 and is rejected for similar rationale and reasoning (see the analysis for claim 8 above).
Regarding claim 18, the claim recites similar limitations to claim 9 but in the form of a system. Therefore, claim 18 recites similar limitations to claim 9 and is rejected for similar rationale and reasoning (see the analysis for claim 9 above).
Regarding claim 19, the claim recites similar limitations to claim 10 but in the form of a system. Therefore, claim 19 recites similar limitations to claim 10 and is rejected for similar rationale and reasoning (see the analysis for claim 10 above).
Regarding claim 20, the claim recites similar limitations to claim 2 but in the form of a non-transitory computer readable medium having program instructions for causing a hardware processor to perform a method of claim 2 (Min – [0378] “For example, by one or more computer hardware processors in communication with the one or more non-transitory computer storage mediums, executing the computer-executable instructions stored on one or more non-transitory computer storage mediums.”). Therefore, claim 20 recites similar limitations to claim 2 and is rejected for similar rationale and reasoning (see the analysis for claim 2 above).
Regarding claim 21, the claim recites similar limitations to claim 9 but in the form of a non-transitory computer readable medium. Therefore, claim 21 recites similar limitations to claim 9 and is rejected for similar rationale and reasoning (see the analysis for claim 9 above).
Conclusion
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/AMANDA H PEARSON/Examiner, Art Unit 2666
/MING Y HON/Primary Examiner, Art Unit 2666