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 .
Status of Claims
Claims 1-20 are currently under examination.
Information Disclosure Statement
The information disclosure statement (IDS) document(s) submitted on 01/14/2025, 03/12/2024, is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS document(s) has/have been fully considered by the examiner.
Priority
This application is a CON of US application 18/508,098, filed 11/13/2023, which is a CIP of US application 18/179,921, filed 03/07/2023.
Applicant' s claim for the benefit of priority under 35 U.S.C. 119(e) for this application to provisional application 63/477,985, filed 12/30/2022, 63/478,076, filed 12/30/2022, 63/477,961, filed 12/30/2022, 63/478,084, filed 12/30/2022, 63/477,656, filed 12/29/2022, 63/477,638, filed 12/29/2022, 63/477,640, filed 12/29/2022, 63/476,251, filed 12/20/2022, 63/476,245, filed 12/20/2022, 63/476,255, filed 12/20/2022, 63/386,376, filed 12/07/2022, 63/386,297, filed 12/06/2022, 63/385,472, filed 11/30/2022, 63/385,179, filed 11/28/2022, 63/383,904, filed 11/15/2022, 63/383,632, filed 11/14/2022.
After review of the provisional applications, the examiner notes that the earliest disclosure of “prestored” “user annotations” and “annotated versions” as claimed is disclosed in provisional application 63/478,084, filed 12/30/2022. The priority date is therefore given at 12/30/2022.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding independent claim 1,
Step 1: Statutory Category: YES - The claim recites a computer-implemented method of generating a graphical training tool configured to facilitate training a user to identify arterial plaque on a medical image, therefore, is a method.
Step 2A, Prong 1, Judicial Exception: YES - The claim recites the limitations “accessing, by a computer system, a medical image of a subject, the medical image comprising one or more regions of arterial plaque”, “receiving, by the computer system, one or more user annotations of the medical image from a user, the one or more user annotations comprising identification of the one or more regions of arterial plaque”, “accessing, by the computer system, a prestored annotated version of the medical image, the prestored version of the medical image comprising one or more prestored annotations comprising identification of the one or more regions of arterial plaque”, “graphically overlaying, by the computer system, the one or more user annotations of the medical image on the prestored annotated version of the medical image”, “identifying, by the computer system, a first subset of the one or more user annotations of the medical image, the first subset of the one or more user annotations absent in the prestored annotated version of the medical image”, and “graphically assigning, by the computer system, a first color to the first subset of the one or more user annotations of the medical image, wherein the graphically assigned first color is configured to facilitate training of the user to identify arterial plaque” which are of accessing old data, receiving new data, analyzing and comparing the data and identifying within the imaging data the differences between previous and new annotations for changes in the imaging data with time or with reference data regarding patient’s plaque. These limitations, as drafted, are steps of a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components as recited “wherein the computer system comprises a computer processor and an electronic storage medium” and with the limitations which are nothing more than the mental knowledge of the practitioner to identify and compare patient images with reference images for providing differences in the data using color coded annotations as based on his experience and knowledge for comparing medical reports and visualizing diagnosis using highlighting coloring options.
That is, other than reciting “computer system” via an algorithm nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “computer system” language, the claim encompasses a user simply taking patient specific image with previous annotations from the imaging system/medical report and receiving new medical report with new patient specific image with new annotations for visually analyzing the differences within the image as reported by the annotations and highlighting the differences with different colors as a medical practitioner would present the diagnosis results to others for clarification as performed based on the practitioner knowledge and training for accurate diagnosis and prognosis. The mere nominal recitation of a generic computer system appliance with a generic machine learning algorithm does not take the claim limitation out of the mental processes grouping. Thus, the claim recites a mental process.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not recite additional elements beside the “electronic storage medium” which is recited at a high level of generality (i.e., as a general means of storing data), and amounts to mere data gathering, which is a form of insignificant extra-solution activity. The computer system that performs the above recited steps is also recited at a high level of generality, and merely automates the different steps. Therefore, the additional limitations are no more than mere instructions to apply the exception using a generic computer component (the computer system with machine learning algorithm).
The combination of the additional elements is no more than mere instructions to apply the exception using a generic computer component (the computer system). Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to the abstract idea.
Step 2B, Inventive Concept: No - As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B. Under the 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B. Here, the initial value accessing step and analyzing/identifying/determining steps were considered to be extra-solution activity in Step 2A, and thus it is re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The background of the example does not provide any indication that the processing circuitry and storage is anything other than a generic, off-the-shelf computer component, and the Symantec, TLI, and OIP Techs. court decisions cited in MPEP 2106.05(d)(II) indicate that mere collection or receipt of data over a network is a well‐understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here). Accordingly, a conclusion that the collecting and analyzing/identifying/determining steps are well-understood, routine, conventional activity is supported under Berkheimer Option 2. For these reasons, there is no inventive concept in the claim, and thus claim 1 is ineligible.
Regarding dependent claims 2-3, 6, claims 2-3, 6 are directed to identify differences in annotations and graphically dedicate different color for the annotation differences which are part of the abstract idea in itself which therefore do not take out the claims out of the judicial exception grouping.
Regarding dependent claims 4-5, claims 4-5 are directed to the different colors which does not impose any meaningful limits on practicing the abstract idea and therefore do not take out the claims out of the judicial exception grouping.
Regarding dependent claim 7, claim is directed to the generation of a score which is the result of analyzing the annotations differences and is therefore considered as part of the abstract idea in itself which therefore do not take out the claims out of the judicial exception grouping.
Regarding dependent claim 8, claim 8 is directed to the receiving step and the type of practitioner which does not impose any meaningful limits on practicing the abstract idea and therefore do not take out the claims out of the judicial exception grouping.
Regarding dependent claim 9, claim 9 is directed to the origin of the data and does not impose any meaningful limits on practicing the abstract idea and therefore do not take out the claims out of the judicial exception grouping.
Regarding dependent claims 10-17, claims 10-17 are directed to the type of data included for the annotations as being accessed or received as directed to the type of plaque which do not impose any meaningful limits on practicing the abstract idea and therefore do not take out the claims out of the judicial exception grouping.
Regarding dependent claims 18-20, claims 18-20 are directed to the origin of the data and does not impose any meaningful limits on practicing the abstract idea and therefore do not take out the claims out of the judicial exception grouping.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 7 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 7, claim 7 recites “a read score” which appears to be “based at least in part on the first subset of the one or more user annotations of the medical image”. However, the disclosure does not provide any description or details on what is the “read score” and how the “read score” is obtained with sufficient details or description. Therefore claim 7 contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 7, claim 7 recites “a read score” which appears to be “based at least in part on the first subset of the one or more user annotations of the medical image”. However, the disclosure does not provide any description or details on what is the “read score” and how the “read score” is obtained with sufficient details or description. Therefore it is unclear what limitation is intended with the term “read score” and in what way the “read score” is based at least in part on the first subset of the one or more user annotations of the medical image. Clarifications are requested via amendments.
Examiner’s Comment – Prior Art Rejection of Indefinite Claims
In view of the indefiniteness and lack of clarity in the instant claims, as set forth in the 35 USC 112 2nd rejections above, the Examiner has had difficulty in properly interpreting instant claims. However, to avoid piecemeal prosecution and to give applicant a better appreciation for relevant prior art if the claims are redrafted to avoid the 35 USC 112 2nd rejections, the Examiner has broadly interpreted the claims for purposes of applying the following prior art rejections.
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.
Claims 1-3, 6-20 are rejected under 35 U.S.C. 103 as being unpatentable over Min et al. (USPN 20200237329 A1; Pub.Date 07/30/2020; Fil.Date 01/23/2020) in view of Min et al. (USPN 20210334961 A1; Pub.Date 10/28/2021; Fil.Date 07/05/2021) hereafter Min’2021 in view of Rossant et al. (2021 Computer Methods and Programs in Biomedicine 208:106234 11 pages; Pub.Date 2021) in view of Hayley (2010 PhD University of Calgary CA Chapt 2; Pub.Date 2010) and in view of in view of Smit et al. (2020 Circ. Cardiovasc. Imaging 13:e009750 9 pages; Pub.Date 2020).
Regarding independent claim 1, Min teaches a computer-implemented method of generating a graphical training tool configured to facilitate training a user to identify arterial plaque on a medical image (Title, abstract, [0003], [0006]-[0008] and [0117], Fig. 7 for visualization of coded plaque regions and determination of plaque vulnerability presenting a risk for the patient for cardiovascular event with the assessment of a risk score ([0151])), the method comprising:
accessing, by a computer system, a medical image of a subject, the medical image comprising one or more regions of arterial plaque ([0053] CCTA image with coronary arteries and the presence of plaques with representations of the different types of plaques according to radiodensities with annotations as in [0117], Fig. 7);
receiving, by the computer system, one or more user annotations of the medical image from a user, the one or more user annotations comprising identification of the one or more regions of arterial plaque ([0117] and Fig. 7 with identification of regional plaques and their type using coded annotations with different coded regions);
accessing, by the computer system, a prestored annotated version of the medical image, the prestored version of the medical image comprising one or more prestored annotations comprising identification of the one or more regions of arterial plaque ([0064] tracking the changes of the atherosclerotic plaque features with time with co-registering images over a period of time, wherein the processor is also directed to retrieve images from storage ([0066]), therefore teaching considering the medical images being characterized according to the annotated representation in Fig. 7 over a period of time, retrieving prestored annotated representation/version of the medical image with identification of the regions of arterial plaque over a period of time);
While Min teaches the co-registering of images reading on graphically overlaying medical images or version of medical images, Min does not teach graphically overlaying, by the computer system, the one or more user annotations of the medical image on the prestored annotated version of the medical image; identifying, by the computer system, a first subset of the one or more user annotations of the medical image, the first subset of the one or more user annotations absent in the prestored annotated version of the medical image; and graphically assigning, by the computer system, a first color to the first subset of the one or more user annotations of the medical image, wherein the graphically assigned first color is configured to facilitate training of the user to identify arterial plaque, as in claim 1.
Min teaches wherein the computer system comprises a computer processor and an electronic storage medium [0088]-[0090]).
However, Min’2021 teaches within the same field of endeavor of imaging coronary arteries and identifying plaque at risk (Title and abstract and [0008]) using imaging for tracking the progression or regression of plaque for patient diagnosis and prognosis ([0217]) with the method accessing the medical images at at least two times and after co-registration performing a comparison of the medical images allowing for the determination of the differences in coronary artery atherosclerosis features ([0015], [0217]-[0218]) reading on performing a difference of medical images for accessing the difference in progression for the different regions of the different types of plaques, therefore, when considering the image version with the annotated plaque region types taught by Min for characterizing the plaque types, teaching the overlaying of one image or image version onto the other image or image version in order to perform/obtain the differences in plaque features or graphically overlaying, by the computer system, the one or more user annotations of the medical image on the prestored annotated version of the medical image and therefore identifying the differences in the different plaque regions between the second time and the first time images or image version reading on identifying, by the computer system, a first subset of the one or more user annotations of the medical image, the first subset of the one or more user annotations absent in the prestored annotated version of the medical image as claimed.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the method of Min such that the method further comprises: graphically overlaying medical images or version of medical images, Min does not teach graphically overlaying, by the computer system, the one or more user annotations of the medical image on the prestored annotated version of the medical image; identifying, by the computer system, a first subset of the one or more user annotations of the medical image, the first subset of the one or more user annotations absent in the prestored annotated version of the medical image, since one of ordinary skill in the art would recognize that tracking the progression of the plaques within the blood vessels using CCTA with determining the changes of the different vascular types of plaques with time and visualizing them with images/graphical representations for assessing the progression of these plaques after specific treatments or without treatment was known in the art by performing co-registration and difference between image or image representation as taught by Min’2021 and Min. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Min and Min’2021 teach analyzing image data for characterizing the coronary vascular system and the plaques present within using computer tomographic techniques. The motivation would have been to provide a direct visual support for assessing the plaque progression and the clinical prognosis for the used treatment, as suggested by Min’2021.
Min and Min’2021 do not teach specifically graphically assigning, by the computer system, a first color to the first subset of the one or more user annotations of the medical image, wherein the graphically assigned first color is configured to facilitate training of the user to identify arterial plaque as in clam 1.
However, Rossant teaches within the same field of endeavor of medical imaging analysis (Title and abstract) the practice of performing difference between time lapse images and visualizing the progression of regions of interest (Fig. 2) wherein Halley, within the same field of endeavor of imaging analysis (title and abstract) teaches additionally using color coded with graphically assigning color to the subset of regions as annotated additional regions or growing regions while a different color is assigned for other regions not being growing after performing the image difference (Fig. 4 considering the difference between images as the user annotated representation of the medical image). Additionally Smit teaches within the same field of endeavor of imaging vascular system for the presence of atherosclerosis disease characteristics using computer tomographic imaging techniques (Title and abstract) the follow-up of treatment of patients for cardiovascular disease with the progression of plaque with time (Title, abstract, p.4 col.1 2nd ¶– col.2 1st ¶) wherein Smit teaches also generating, by the computer system, a graphical representation of arterial plaque progression of the subject, wherein generating the graphical representation comprises assigning a first color to the first subset of the one or more regions of plaque wherein the progression of the plaque is directed to the difference between the determined/predicted risks and the baseline risk, wherein the graphical representation of arterial plaque progression in the subject is configured to facilitate tracking of progression of arterial disease for the subject (Fig.3 with identification and mapping of regions as additional or modified regions with coded colors corresponding to necrotic core tissue, dense calcium tissue, fibro-fatty tissue and fibrous tissue wherein the colors provide a direct visual location of plaque modification or progression) in order to better visualize the presence, growing or progression/regression of regions of interest therefore teaching with Rossant and Halley for medical images such as those taught by Min and Min’2021 graphically assigning, by the computer system, a first color to the first subset of the one or more user annotations of the medical image, wherein the graphically assigned first color is configured to facilitate training of the user to identify arterial plaque as claimed.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the method of Min as modified by Min’2021 such that the method further comprises: graphically assigning, by the computer system, a first color to the first subset of the one or more user annotations of the medical image, wherein the graphically assigned first color is configured to facilitate training of the user to identify arterial plaque, since one of ordinary skill in the art would recognize that assigning colors to regions of interest appearing, progressing or regressing from a previous spatial range was known in the art as taught by Rossant and Halley and since tracking the progression of the plaques within the blood vessels using CCTA with determining the changes of the different vascular types of plaques with time and visualizing them with images/graphical representations using added coded colors for assessing the progression of these plaques after specific treatments or without treatment was known in the art by performing co-registration and difference between image or image representation as taught by Smit. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Min, Rossant and Smit teach analyzing image data for characterizing the medical images. The motivation would have been to provide a direct visual support for assessing the plaque progression and the clinical prognosis for the used treatment, as suggested by Smit (col.1 2nd ¶– col.2 1st ¶).
Regarding the dependent claims 2, 3, 6-20, all the elements of these claims are instantly disclosed or fully envisioned by the combination of Min, Shrivastava and Abdelrahman.
Regarding claim 2, as discussed above, Halley teaches the color annotation of the different regions present and absent in the second image at the second time from the first image at the first time with each being colored with different colors (Fig.4) therefore teaching identifying, by the computer system, a second subset of the one or more user annotations of the medical image, the second subset of the one or more user annotations present in the prestored annotated version of the medical image; and graphically assigning, by the computer system, a second color to the second subset of the one or more user annotations of the medical image.
Regarding claim 3, as discussed above, Halley teaches the color annotation of the different regions present and absent in the second image at the second time from the first image at the first time with each being colored with different colors wherein one tissue region is replaced by another tissue (Fig.4) therefore teaching identifying, by the computer system, a first subset of the prestored annotations, the first subset of the prestored annotations absent in the one or more user annotations; and graphically assigning, by the computer system, a third color to the first subset of the prestored annotations.
Regarding claim 6, as discussed above, Halley teaches the identification of the tissue regions that remain the same within at the first time and at the second wherein the difference image is graphically representing the annotation as a color different from the ones representing the regions which are different between the first and the second representation of the medical images therefore teaching identifying, by the computer system, a second subset of the prestored annotations, the second subset of the prestored annotations present in the one or more user annotations; and graphically assigning, by the computer system, a fourth color to the second subset of the prestored annotations.
Regarding claim 7, as discussed above, Min’2021 teaches the determination of the progression/regression of the plaque leading to the determination of a risk score ([0280] generation of a CAD-RADS score) therefore teaching generating, by the computer system, a read score for the user based at least in part on the first subset of the one or more user annotations of the medical image.
Regarding claim 8, Min’2021 teaches one or more of the prestored annotations are received from an expert reader ([0382] processed data being analyzed for comparison by an expert reader).
Regarding claim 9, as discussed above Min teaches the representation and characterization of the plaque regions (Fig.7) which is performed using machine learning techniques ([0069]) therefore teaching one or more of the prestored annotations are generated by a machine learning algorithm.
Regarding claims 10 and 11, as discussed above Min teaches the representation and characterization of the plaque regions (Fig.7) which is performed using machine learning techniques ([0069]) including classification of the plaques for characterizing the types of plaques according to their radiodensity and natural density ([0013]) teaching the one or more user annotations and the prestored annotations further comprise classification of one or more regions of plaque as in claim 10 and wherein classification of the one or more regions of plaque in the prestored annotations is based at least in part on density.
Regarding claim 12 and claim 13, as discussed above, Min teaches the characterization of the type of plaques using CCTA with the analysis of the radiodensity ([0116]-[0117] Fig.7) and Min’2021 teaches that radiodensity corresponds to the density of the material depicted in the CCTA images ([0178]), therefore teaching the density comprises material density as in claim 12 and the density comprises radiodensity as in claim 13.
Regarding claim 14, as discussed above, Min teaches the classification of the one or more regions of plaque in the prestored annotations comprises classification of the one or more regions of plaque as one or more of low-density non-calcified plaque, noncalcified plaque, or calcified plaque ([0116]-[0117], Fig.7, with calcified plaque [0055]) and Min’2021 teaching low-density non-calcified plaque, noncalcified plaque, or calcified plaque according to their Hounsfield Unit range ([0407] and Table 3).
Regarding claim 15, as discussed above, Min and Min’2021 teach wherein low density non-calcified plaque corresponds to one or more regions of plaque comprising one or more pixels with a radiodensity value between about -189 and about 30 Hounsfield units, wherein noncalcified plaque corresponds to one or more regions of plaque comprising one or more pixels with a radiodensity value between about 190 and about 350 Hounsfield units, and wherein calcified plaque corresponds to one or more regions of plaque comprising one or more pixels with a radiodensity value between about 351 and 2500 Hounsfield units with Min’2021 teaching low density non-calcified plaque comprises a region of plaque with a radiodensity value between about -189 and about 30 Hounsfield units ([0407] Table 3), non-calcified plaque comprises a region of plaque with a radiodensity value between about 30 and about 350 Hounsfield units ([0407] Table 3), calcified plaque comprises a region of plaque with a radiodensity value between about 351 and 2500 Hounsfield units ([0407] Table 3).
Regarding claim 16, Min and Min’2021 teach the arterial plaque comprises coronary arterial plaque (Min (abstract) and Min’2021 ([0008]-[0009])).
Regarding claim 17, Min teaches the arterial plaque comprises plaque in one or more coronary arteries, carotid arteries, aorta, upper extremity arteries, or lower extremity arteries (abstract).
Regarding claim 18, Min teaches the medical image is obtained using coronary computed tomography angiography (CCTA) ([0006]).
Regarding claim 19, Min teaches medical image is obtained using computed tomography (CT) (abstract and [0006]).
Regarding claim 20, Min teaches the medical image is obtained using an imaging modality comprising one or more of CT (abstract and [0006]), x-ray, ultrasound ([0075]), echocardiography, MR imaging ([0075]), optical coherence tomography (OCT), nuclear medicine imaging, positron-emission tomography (PET) ([0004]), single photon emission computed tomography (SPECT) ([0004]), or near-field infrared spectroscopy (NIRS), while Min’2021 teaches using an imaging modality comprising one or more of CT, x-ray, ultrasound, echocardiography, 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) ([0173]).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Min et al. (USPN 20200237329 A1; Pub.Date 07/30/2020; Fil.Date 01/23/2020) in view of Min et al. (USPN 20210334961 A1; Pub.Date 10/28/2021; Fil.Date 07/05/2021) hereafter Min’2021 in view of Rossant et al. (2021 Computer Methods and Programs in Biomedicine 208:106234 11 pages; Pub.Date 2021) in view of Hayley (2010 PhD University of Calgary CA Chapt 2; Pub.Date 2010) and in view of in view of Smit et al. (2020 Circ. Cardiovasc. Imaging 13:e009750 9 pages; Pub.Date 2020) as applied to claim 1 and 3 and further in view of Chamberlin et al. (2021 Case Reports in Oncology 14:17-23; Pub.Date 2021).
Min, Min’2021, Rossant, Hayley and Smit teach a method as set forth above.
Min, Min’2021, Rossant, Hayley and Smit do not teach specifically the first color and the third color are the same as in claim 4 or the first color and the third color are different as in claim 5.
However, Chamberlin teaches within the same field of endeavor of time lapsed medical image analysis (Title and abstract) the overlay of the later medical image with the region modifications overlay on the original medical image with the representation of the modified tissue region from the original image as a different color from the other tissue region for better visualization wherein the color is considered as a mere matter of choice for achieving a color contrast with the tissue present in the original medical image (Fig. 2). Since as discussed above the first color as taught by Hayley (Fig.4) is different from all colors from the original region of the original images, it would have been obvious to use any color different from the original colors used in the annotated representation of the first or original image including the one used as first color for the second annotated representation of the second image therefore teaching the first color and the third color are the same as in claim 4 and also the first color and the third color are different as in claim 5 since the number of color used in the first annotated prestored image is finite compared to the available number of different color in the visible spectrum.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the method of Min as modified by Min’2021, Rossant, Hayley and Smit such that the method further comprises: the first color and the third color are the same as in claim 4 and the first color and the third color are different as in claim 5, since one of ordinary skill in the art would recognize that assigning colors to regions of interest appearing, progressing or regressing from a previous spatial range to be overlaid in the original medical image with colors different from the other tissue regions was known in the art as taught by Chamberlin and since the choice of different colors would have been a mere matter of choice to achieve a good visual contrast to observe the changes from the original to the later images when viewing the original images. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Min, Rossant, Smit and Chamberlin teach analyzing image data for characterizing the medical images. The motivation would have been to provide a direct visual support for assessing the medical progression of a treatment or a disease, as suggested by Smit (col.1 2nd ¶– col.2 1st ¶) and Chamberlin (Fig.2 for a tumor regression).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK M MEHL whose telephone number is (571)272-0572. The examiner can normally be reached Monday-Friday 9AM-6PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEITH M RAYMOND can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK M MEHL/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798