DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/22/2025 has been entered.
Response to Amendment
This office action is in response to the remarks filed on 12/22/2025.
The amendment filed 12/22/2025 has been entered. Claims 1-18 remain pending in the application, and claims 19-20 have been newly added.
The 112(b) rejection of claims 1-7 have been withdrawn in light of claim amendments.
Claim Rejections - 35 USC § 112
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.
Claims 19-20 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.
Claim 19 recites the claim limitation “low speed measurements at key-point locations of the body” in line 4. This claim is indefinite as it is unclear what a “low speed measurement is”. The specification merely discloses “This limited set of input parameters may include, but are not limited to, CPPs, US BFS data from the specific locations (e.g., specific locations 201˜207) of the portion of the body, low speed measurements at key-point locations, plus heart rate and blood pressure”, ([0066]) but does not describe what a low speed measurement is. Clarification is needed. For examination purposes, this claim will be interpreted as “…input to the computational model one or more of: ultrasound (US) blood flow speed data from the specific locations of a portion of the body”.
Claim 20 recites the claim limitation “low speed measurements at key-point locations of the body” in lines 4-5. This claim is indefinite as it is unclear what a “low speed measurement is”. The specification merely discloses “This limited set of input parameters may include, but are not limited to, CPPs, US BFS data from the specific locations (e.g., specific locations 201˜207) of the portion of the body, low speed measurements at key-point locations, plus heart rate and blood pressure”, ([0066]) but does not describe what a low speed measurement is. Clarification is needed. For examination purposes, this claim will be interpreted as “…input to the computational model: ultrasound (US) blood flow speed data from the specific locations of a portion of the body”.
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.
Regarding claim 1,
Step 1: Statutory category: a method of performing a computer tomography angiography is disclosed, therefore, is method.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes
The claim recites the limitations “updating a measurement of blood flow speed at least some of a plurality of specific locations in a portion of a body, or at least one other location in the portion of the body, or both”, “inferring, … , a blood flow speed throughout the portion of the body executing the computational model”, “inputting cardiac physiological parameters (CPP) to the computational model”, “determining contrast medium injection duration, or a speed of a table, or both, prior to the CT scan based on the inferred blood flow speed”, “programming... contrast medium to be injected for the determined contrast medium injection duration, or to move the table at the determined speed, or both, prior to the CT scan”.
This limitation, as drafted, according to its broadest reasonable interpretation, recites a mental-process type abstract idea, which can practically be performed in the mind and/or with the with the aid of pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. The blood flow speed can be calculated using known position and time in at least two different instances, using a pen and paper or a generic computer, or can be inferred and calculated by looking at images of blood flow and grouping the blood flow images with an estimated blood flow speed through the use of a model which associates the two. The computational model are merely algorithmic and mathematical expressions which can be used for calculations either using a pen or paper or a generic computer. Different cardiac physiological parameters can be used in the calculation of blood flow speed or to determine the duration of the contrast medium duration. The duration of the contrast medium can be selected based off the blood flow speed.
That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No
The claim further recites “providing the updated measurements of the blood flow speed to a computational model”, “inferring, with a controller”, “programming, with the controller”. Providing updated measurements is a form of data gathering that is a form of a pre-solution insignificant activity.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into
a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to
significantly more than the judicial exception. For these reasons, there is no inventive
concept in the claim. Further a “controller” is well known in the art to be generic hardware used for computer processing.
Accordingly, claim 1 is directed to non-eligible patent subject matter and is therefore rejected.
Regarding claim 2,
Step 1: Statutory category: a method of performing a computer tomography angiography is disclosed, therefore, is method.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes.
This claim contains a judicial exception as noted above for claim 1.
Step 2A, Prong 2, Integrated into Practical Application: No.
The claim further recites the limitation “prior to measuring blood flow, assessing a heart rate and a blood pressure of a patient”.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities of data gathering and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to
significantly more than the judicial exception. For these reasons, there is no inventive
concept in the claim. Further, use computer tomography (CT) angiography are well-known in the art.
Accordingly, claim 2 is directed to non-eligible patent subject matter and is therefore rejected.
Regarding claim 3,
Step 1: Statutory category: a method of performing a computer tomography angiography is disclosed, therefore, is method.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes
The claim recites the limitation “wherein the determining the contrast medium injection duration further comprises determining a contrast injection protocol to provide a lowest bolus duration for the inferred blood flow speed and the speed of the table”.
This limitation, as drafted, according to its broadest reasonable interpretation, recites a mental-process type abstract idea, which can practically be performed in the mind and/or with the with the aid of pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. The a contrast injection protocol can be created such that there is a lowest bolus duration for the inferred blood flow speed and the speed of the table using a pen and paper or mentally. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No- The claim does not
contain additional elements. Therefore, the claim does not integrate the judicial
exception into a practical application.
Step 2B, Inventive Concept: No- The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Accordingly, claim 3 is directed to non-eligible patent subject matter and is
therefore rejected.
Regarding claim 4,
Step 1: Statutory category: a method of performing a computer tomography angiography is disclosed, therefore, is method.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes
The claim recites the limitations “wherein the specific locations comprise locations of common stenosis”.
This limitation, as drafted, according to its broadest reasonable interpretation, recites a mental-process type abstract idea, which can practically be performed in the mind and/or with the with the aid of pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. The specific locations that contain common stenosis can be outlined in an image. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No- The claim does not
contain additional elements. Therefore, the claim does not integrate the judicial
exception into a practical application.
Step 2B, Inventive Concept: No- The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Accordingly, claim 4 is directed to non-eligible patent subject matter and is
therefore rejected.
Regarding claim 5,
Step 1: Statutory category: a method of performing a computer tomography angiography is disclosed, therefore, is method.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes.
This claim contains a judicial exception as noted above for claim 1.
Step 2A, Prong 2, Integrated into Practical Application: No.
The claim further recites the limitation “applying ultrasound to a portion of a body to provide an image of arterial blood flow by applying three-dimensional (3D) flow volumetry ultrasound or applying color Doppler ultrasound; and measuring blood flow speed in an artery at a plurality of specific locations of the body”.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities of data gathering and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to
significantly more than the judicial exception. For these reasons, there is no inventive
concept in the claim.
Accordingly, claim 5 is directed to non-eligible patent subject matter and is therefore rejected.
Regarding claim 6,
Step 1: Statutory category: a method of performing a computer tomography angiography is disclosed, therefore, is method.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes
The claim recites the limitations “wherein the determining the speed of the table further comprises determining from the specific locations where a relative speed is increased based on the blood flow speed, and determining from the specific locations where a relative speed is decreased based on the blood flow speed”
This limitation, as drafted, according to its broadest reasonable interpretation, recites a mental-process type abstract idea, which can practically be performed in the mind and/or with the with the aid of pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. These steps can be performed by looking at medical images, and section/categorizing sections that contain higher blood flow speed, and sections that contain slower blood flow speed. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No- The claim does not
contain additional elements. Therefore, the claim does not integrate the judicial
exception into a practical application.
Step 2B, Inventive Concept: No- The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Accordingly, claim 6 is directed to non-eligible patent subject matter and is
therefore rejected.
Regarding claim 7,
Step 1: Statutory category: a method of performing a computer tomography angiography is disclosed, therefore, is method.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes
The claim recites the limitations “wherein the determining the speed of the table further comprises determining a constant speed based on the blood flow speed at the specific locations”.
This limitation, as drafted, according to its broadest reasonable interpretation, recites a mental-process type abstract idea, which can practically be performed in the mind and/or with the with the aid of pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. These steps can be performed by calculating the blood flow speed using the images, and using that to determine the speed of the table. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No- The claim does not
contain additional elements. Therefore, the claim does not integrate the judicial
exception into a practical application.
Step 2B, Inventive Concept: No- The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Accordingly, claim 7 is directed to non-eligible patent subject matter and is
therefore rejected.
Regarding claim 8,
Step 1: Statutory category: a system for medical imaging is disclosed, therefore, a device is disclosed.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes
The claim recites the limitations “a computational model comprising instructions”, “an updated measurement of blood flow speed at least some of a plurality of specific locations in a portion of a body, or at least one other location in the portion of the body, or both”, “infer a blood flow speed throughout the portion of the body by executing the computational model”, “input cardiac physiological parameters (CPP) to the computational model”, “determine a contrast medium injection duration, or a speed of the table, or both, prior to a CT scan based on the inferred blood flow speed; and program the system to cause contrast medium to be injected for the determined contrast medium injection duration, or to move the table at the determined speed, or both, prior to the CT scan”.
This limitation, as drafted, according to its broadest reasonable interpretation, recites a mental-process type abstract idea, which can practically be performed in the mind and/or with the with the aid of pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. The blood flow speed can be calculated using known position and time in at least two different instances, using a pen and paper or a generic computer, or can be inferred and calculated by looking at images of blood flow and grouping the blood flow images with an estimated blood flow speed through the use of a model which associates the two. The computational model are merely algorithmic and mathematical expressions which can be used for calculations either using a pen or paper or a generic computer. Different cardiac physiological parameters can be used in the calculation of blood flow speed or to determine the duration of the contrast medium duration. The duration of the contrast medium can be selected based off the blood flow speed.
That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No- The claim additional recites “a computer tomography (CT) device comprising a table”, “a memory adapted to store”, “a processor”. However, these additional elements do not integrate the judicial
exception into a practical application.
Step 2B, Inventive Concept: No- The claim additionally recites a computer tomography (CT) device comprising a table, processor, a memory, however, these additional elements are generic components that is well known in the art to be used for CT imaging, and use of a processor operating a software to perform a judicial exception is not sufficient. Therefore, the claim does not integrate the judicial exception into a practical application.
Accordingly, claim 8 is directed to non-eligible patent subject matter and is therefore rejected.
Regarding claim 9,
Step 1: Statutory category: a system for medical imaging is disclosed, therefore, a device is disclosed.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes
The claim recites the limitation “determine a contrast injection protocol to provide a lowest bolus duration for the inferred blood flow speed and the speed of the table”.
This limitation, as drafted, according to its broadest reasonable interpretation, recites a mental-process type abstract idea, which can practically be performed in the mind and/or with the with the aid of pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. The a contrast injection protocol can be created such that there is a lowest bolus duration for the inferred blood flow speed and the speed of the table using a pen and paper or mentally. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No- The claim does not
contain additional elements. Therefore, the claim does not integrate the judicial
exception into a practical application.
Step 2B, Inventive Concept: No- The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Accordingly, claim 9 is directed to non-eligible patent subject matter and is
therefore rejected.
Regarding claim 10,
Step 1: Statutory category: a system for medical imaging is disclosed, therefore, a device is disclosed.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes
The claim recites the limitations “wherein the plurality of specific locations comprises locations of common stenosis”.
This limitation, as drafted, according to its broadest reasonable interpretation, recites a mental-process type abstract idea, which can practically be performed in the mind and/or with the with the aid of pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. The specific locations that contain common stenosis can be outlined in an image. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No- The claim does not
contain additional elements. Therefore, the claim does not integrate the judicial
exception into a practical application.
Step 2B, Inventive Concept: No- The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Accordingly, claim 10 is directed to non-eligible patent subject matter and is
therefore rejected.
Regarding claim 11,
Step 1: Statutory category: a system for medical imaging is disclosed, therefore, a device is disclosed.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes
The claim recites the limitations “to identify locations of stenosis based on an ultrasound scan. and to determine the plurality of specific locations from the identified locations”.
This limitation, as drafted, according to its broadest reasonable interpretation, recites a mental-process type abstract idea, which can practically be performed in the mind and/or with the with the aid of pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. The specific locations that contain stenosis can be outlined in in multiple images using pen and paper. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No- The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No- The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Accordingly, claim 11 is directed to non-eligible patent subject matter and is therefore rejected.
Regarding claim 12,
Step 1: Statutory category: a system for medical imaging is disclosed, therefore, a device is disclosed.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes
The claim recites the limitation “determine from the specific locations where a relative speed is increased based on the blood flow speed; and to determine from the specific locations where a relative speed is decreased based on the blood flow speed”.
This limitation, as drafted, according to its broadest reasonable interpretation, recites a mental-process type abstract idea, which can practically be performed in the mind and/or with the with the aid of pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. These steps can be performed by looking at medical images, and section/categorizing sections that contain higher blood flow speed, and sections that contain slower blood flow speed. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No- The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No- The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Accordingly, claim 12 is directed to non-eligible patent subject matter and is therefore rejected.
Regarding claim 13,
Step 1: Statutory category: a system for medical imaging is disclosed, therefore, a device is disclosed.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes
This claim recites the limitation “wherein the instructions, when executed by the processor to determine the speed of the table further cause the processor to determine a constant speed based on the blood flow speed at the specific locations”.
This limitation, as drafted, according to its broadest reasonable interpretation, recites a mental-process type abstract idea, which can practically be performed in the mind and/or with the with the aid of pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. These steps can be performed by calculating the blood flow speed using the images, and using that to determine the speed of the table. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No- The claim does not
contain additional elements. Therefore, the claim does not integrate the judicial
exception into a practical application.
Step 2B, Inventive Concept: No- The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Accordingly, claim 13 is directed to non-eligible patent subject matter and is
therefore rejected.
Regarding claim 14,
Step 1: Statutory category: A tangible, non-transitory computer readable medium that stores instructions for a computational model is disclosed, therefore, a device is disclosed.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes
This claim recites the limitations “update a measurement of blood flow speed at least some of a plurality of specific locations in a portion of a body, or at least one other location in the portion of the body, or both”, “infer a blood flow speed throughout the portion of the body by executing the computational model”, “determine a contrast medium injection duration, or a speed of a table , or both, prior to a computer tomography (CT) scan based on the inferred blood flow speed”, “input cardiac physiological parameters (CPP) to the computational model”, “program a CT system to cause contrast medium to be injected for the determined contrast medium injection duration, or to move the table at the determined speed, or both, prior to the CT scan”.
This limitation, as drafted, according to its broadest reasonable interpretation, recites a mental-process type abstract idea, which can practically be performed in the mind and/or with the with the aid of pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. The blood flow speed can be calculated using known position and time in at least two different instances, using a pen and paper or a generic computer, or can be inferred and calculated by looking at images of blood flow and grouping the blood flow images with an estimated blood flow speed through the use of a model which associates the two. The computational model are merely algorithmic and mathematical expressions which can be used for calculations either using a pen or paper or a generic computer. Different cardiac physiological parameters can be used in the calculation of blood flow speed or to determine the duration of the contrast medium duration. The duration of the contrast medium can be selected based off the blood flow speed.
That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No
The claim further recites “provide the updated measurements of the blood flow speed to the computational model”. Providing updated measurements is a form of data gathering that is a form of a pre-solution insignificant activity.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No- The claim additionally recites a tangible, non-transitory computer readable medium, and a processor, however, these additional elements are generic components that is well known in the art to be used for CT imaging. Therefore, the claim does not integrate the judicial exception into a practical application. Accordingly, claim 14 is directed to non-eligible patent subject matter and is therefore rejected.
Regarding claim 15,
Step 1: Statutory category: A tangible, non-transitory computer readable medium that stores instructions for a computational model is disclosed, therefore, a device is disclosed.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes.
The claim recites the limitation “determine the contrast medium injection duration, further cause the processor to determine a contrast injection protocol to provide a lowest bolus duration for the inferred blood flow speed and the speed of the table”.
This limitation, as drafted, according to its broadest reasonable interpretation, recites a mental-process type abstract idea, which can practically be performed in the mind and/or with the with the aid of pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. The a contrast injection protocol can be created such that there is a lowest bolus duration for the inferred blood flow speed and the speed of the table using a pen and paper or mentally. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No- The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No- The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Accordingly, claim 15 is directed to non-eligible patent subject matter and is therefore rejected.
Regarding claim 16,
Step 1: Statutory category: A tangible, non-transitory computer readable medium that stores instructions for a computational model is disclosed, therefore, a device is disclosed.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes
The claim recites the limitations “wherein the specific locations comprise locations of common stenosis”.
This limitation, as drafted, according to its broadest reasonable interpretation, recites a mental-process type abstract idea, which can practically be performed in the mind and/or with the with the aid of pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. The specific locations that contain common stenosis can be outlined in an image. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No- The claim does not
contain additional elements. Therefore, the claim does not integrate the judicial
exception into a practical application.
Step 2B, Inventive Concept: No- The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Accordingly, claim 16 is directed to non-eligible patent subject matter and is
therefore rejected.
Regarding claim 17,
Step 1: Statutory category: A tangible, non-transitory computer readable medium that stores instructions for a computational model is disclosed, therefore, a device is disclosed.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes
The claim recites the limitations “determine from the specific locations where a relative speed is increased based on the blood flow speed; and to determine from the specific locations where a relative speed is decreased based on the blood flow speed”.
This limitation, as drafted, according to its broadest reasonable interpretation, recites a mental-process type abstract idea, which can practically be performed in the mind and/or with the with the aid of pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. These steps can be performed by looking at medical images, and section/categorizing sections that contain higher blood flow speed, and sections that contain slower blood flow speed. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No- The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No- The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Accordingly, claim 17 is directed to non-eligible patent subject matter and is therefore rejected.
Regarding claim 18,
Step 1: Statutory category: A tangible, non-transitory computer readable medium that stores instructions for a computational model is disclosed, therefore, a device is disclosed.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes
The claim recites the limitations “to determine the speed of the table further cause the processor to determine a constant speed based on the blood flow speed at the specific locations”.
This limitation, as drafted, according to its broadest reasonable interpretation, recites a mental-process type abstract idea, which can practically be performed in the mind and/or with the with the aid of pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. These steps can be performed by calculating the blood flow speed using the images, and using that to determine the speed of the table. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No- The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No- The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Accordingly, claim 18 is directed to non-eligible patent subject matter and is therefore rejected.
Regarding claim 19,
Step 1: Statutory category: a system for medical imaging is disclosed, therefore, a device is disclosed.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes
The claim recites the limitation “wherein the instructions, when executed by the processor further cause the processor to input to the computational model one or more of: ultrasound (US) blood flow speed data from the specific locations of a portion of the body; and low speed measurements at key-point locations of the body”
This limitation, as drafted, according to its broadest reasonable interpretation, recites a mental-process type abstract idea, which can practically be performed in the mind and/or with the with the aid of pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. A pen/paper or a generic computer can be used to input the ultrasound blood flow speed data from different locations and perform mathematical calculations. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No- The claim does not
contain additional elements. Therefore, the claim does not integrate the judicial
exception into a practical application.
Step 2B, Inventive Concept: No- The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Accordingly, claim 19 is directed to non-eligible patent subject matter and is
therefore rejected.
Regarding claim 20,
Step 1: Statutory category: A tangible, non-transitory computer readable medium that stores instructions for a computational model is disclosed, therefore, a device is disclosed.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes
The claim recites the limitation “wherein the instructions, when executed by the processor further cause the processor to input to the computational model one or more of: ultrasound (US) blood flow speed data from the specific locations of a portion of the body; and low speed measurements at key-point locations of the body”
This limitation, as drafted, according to its broadest reasonable interpretation, recites a mental-process type abstract idea, which can practically be performed in the mind and/or with the with the aid of pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. A pen/paper or a generic computer can be used to input the ultrasound blood flow speed data from different locations and perform mathematical calculations. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No- The claim does not
contain additional elements. Therefore, the claim does not integrate the judicial
exception into a practical application.
Step 2B, Inventive Concept: No- The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Accordingly, claim 20 is directed to non-eligible patent subject matter and is
therefore rejected.
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.
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, 2, 4-5, 8, 10, 14, 16, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US 20180071452 A1) in view of Wakai (US 20060233296 A1).
Regarding claim 1, Sharma teaches a method of performing a computer tomography (CT) scan (computed tomography (CT), [0032]), the method comprising:
providing the …measurements of the blood flow speed to a computational model (The computational model may include any suitable computational model that models the blood flow and contrast agent circulation of a patient to provide blood flow and contrast agent circulation parameters, such as, e.g., flow, velocities, contrast agent concentration, etc [0048];[0006]-[0008] and [0067], and [0100] discloses imaging patient to apply to computational model to predict blood flow and blood velocity);
inputting cardiac physiological parameters (CPP) to the computational model (the input training data may include patient characteristics, such as, e.g., arterial models, heart rate, blood pressure, weight, height, body surface area, age, gender, etc [0096]);
inferring, with a controller (and methods described herein may be implemented using digital circuitry, or using one or more computers using well-known computer processors, memory units, storage devices, computer software, and other components [0113]), a blood flow speed throughout the portion of the body executing the computational model ([0048], [0098], [0100] discloses inferring a blood flow speed in a portion of the body based on the computational model); and
determining contrast medium injection duration… prior to the CT scan based on the inferred blood flow speed ([0053]-[0054] discloses determining contrast medium duration based off the inferred blood flow speed/velocity; [0100] discloses determining administration parameters of the contrast medium injection duration; Medical imaging system 112 may be of any modality, such as, e.g., x-ray, magnetic resonance imaging (MRI), computed tomography (CT), ultrasound (US), single-photon emission computed tomography (SPECT), positron emission tomography (PET), or any other suitable modality or combination of modalities).
programming, with the controller (Systems, apparatuses, and methods described herein may be implemented using digital circuitry, or using one or more computers using well-known computer processors, memory units, storage devices, computer software, and other component [0113]), to cause contrast medium to be injected for the determined contrast medium injection duration (At step 210, the trigger time for imaging the patient is determined based on the administration parameters for administering the contrast agent using the computational model [0053]; or to move the table at the determined speed, or both, prior to the CT scan.
Sharma is silent regarding updating a measurement of blood flow speed at least some of a plurality of specific locations in a portion of a body, or at least one other location in the portion of the body, or both.
Waki is considered analogous to the instant application as “X-ray computer tomography apparatus”. Waki, fist also teaches:
a method of performing a computer tomography (CT) scan (X-ray computer tomography apparatus [0003]; blood flow [0035]).
Waki further teaches:
updating a measurement of blood flow speed (a first function of judging the velocity of blood flow based on an image obtained by the prep scanning [0034]; at least some of a plurality of specific locations in a portion of a body, or at least one other location in the portion of the body, or both (the blood flow measurements are taken along the body as the subject is scanned as disclosed in [0034]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Sharma to include updating a measurement of blood flow speed at least some of a plurality of specific locations in a portion of a body, or at least one other location in the portion of the body, or both, taught by Waki. Doing so would improve image quality, as suggested by Waki ([0050]).
Regarding claim 2, modified Sharma teaches the method of claim 1, as discussed above. Sharma further teaches prior to measuring blood flow, assessing a heart rate and a blood pressure of a patient ([0099] discloses that patient characteristics, including blood pressure and heart rate, may also be included prior to predicting blood flow. Patient Characteristics are under step 1112, and extracting features/measures of interests, are step 1116, snippet of fig. 11 reproduced below).
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Snippet of Fig. 11 reproduced above
Regarding claim 4, modified Sharma teaches the method of claim 1, as discussed above. Sharma further teaches wherein the specific locations comprise locations of common stenosis (locations and geometries of stenoses are disclosed in paragraph [0095]).
Regarding claim 5, modified Sharma teaches method of claim 1, as discussed above. Sharma further teaches, prior to the updating:
applying ultrasound to a portion of the body to provide an image of arterial blood flow by applying three-dimensional (3D) flow volumetry ultrasound ([0064] discloses applying three-dimensional flow volumetry ultrasound); and
measuring blood flow speed in an artery at a plurality of specific locations of the body (measuring blood flow in an artery in multiple location is disclosed in [0073]-[0074], and [0079]); .
Regarding claim 8, Sharma teaches a system for medical imaging, comprising:
a memory (memory [0017]) adapted to store:
a computational model comprising instructions (computational model [0048]; computer program instructions (e.g., code), which may be loaded into memory 104 and executed by processor 108 [0031]);
a processor, wherein the instructions, when executed by the processor (computational model [0048]; computer program instructions (e.g., code), which may be loaded into memory 104 and executed by processor 108 [0031]), cause the processor to:
input cardiac physiological parameters (CPP) to the computational model (the input training data may include patient characteristics, such as, e.g., arterial models, heart rate, blood pressure, weight, height, body surface area, age, gender, etc [0096]);
infer a blood flow speed throughout the portion of the body by executing the computational model ([0048], [0098], [0100] discloses inferring a blood flow speed in a portion of the body based on the computational model);
determine a contrast medium injection duration, or a speed of the table, or both, prior to a CT scan based on the inferred blood flow speed ([0053]-[0054] discloses determining contrast medium duration based off the inferred blood flow speed/velocity; [0100] discloses determining administration parameters of the contrast medium injection duration; Medical imaging system 112 may be of any modality, such as, e.g., x-ray, magnetic resonance imaging (MRI), computed tomography (CT), ultrasound (US), single-photon emission computed tomography (SPECT), positron emission tomography (PET), or any other suitable modality or combination of modalities [0032]).
program the system (Systems, apparatuses, and methods described herein may be implemented using digital circuitry, or using one or more computers using well-known computer processors, memory units, storage devices, computer software, and other component [0113]) to cause contrast medium to be injected for the determined contrast medium injection duration (At step 210, the trigger time for imaging the patient is determined based on the administration parameters for administering the contrast agent using the computational model [0053]), or to move the table at the determined speed, or both, prior to the CT scan.
While Sharma teaches operation with respect to x-ray and a CT scanner Medical imaging system 112 may be of any modality, such as, e.g., x-ray, magnetic resonance imaging (MRI), computed tomography (CT) [0032]), Sharma is silent regarding:
a computer tomography (CT) device comprising a table;
an updated measurement of blood flow speed at least some of a plurality of specific locations
Waki is considered analogous to the instant application as “X-ray computer tomography apparatus”. Waki teaches:
a computer tomography (CT) angiography (X-ray computer tomography apparatus [0003]) device comprising a table (a top plate 101 of the bed 10 [0029]);
an updated measurement of blood flow speed (a first function of judging the velocity of blood flow based on an image obtained by the prep scanning [0034]; steps Sa5 and Sa8, shown in fig. 2, disclose repeating measurements for each scan taken, as shown in fig. 2 and described in [0040]) at least one other location in the portion of the body (the blood flow measurements are taken along the body as the subject is scanned as disclosed in [0034]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Sharma to include a computer tomography (CT) device comprising a table, and an updated measurement of blood flow speed at least one other location in the portion of the body, as suggested by Waki. Doing so would improve image quality, as suggested by Waki ([0050]).
Regarding claim 10, modified Sharma teaches the system of claim 8, as modified above. Sharma, further teaches wherein the plurality of specific locations comprises locations of common stenosis (locations and geometries of stenoses are disclosed in paragraph [0095]).
Regarding claim 14, Sharma teaches a tangible, non-transitory computer readable medium (memory [0030]) that stores instructions for a computational model, which when executed by a processor(computational model [0048]; computer program instructions (e.g., code), which may be loaded into memory 104 and executed by processor 108 [0031]), cause the processor to:
provide the … measurements of the blood flow speed to the computational model (The computational model may include any suitable computational model that models the blood flow and contrast agent circulation of a patient to provide blood flow and contrast agent circulation parameters, such as, e.g., flow, velocities, contrast agent concentration, etc [0048];[0006]-[0008] and [0067], and [0100] discloses imaging patient to apply to computational model to predict blood flow and blood velocity);
input cardiac physiological parameters (CPP) to the computational model (the input training data may include patient characteristics, such as, e.g., arterial models, heart rate, blood pressure, weight, height, body surface area, age, gender, etc [0096]);
infer a blood flow speed throughout the portion of the body based on the computational model ([0048], [0098], [0100] discloses inferring a blood flow speed in a portion of the body based on the computational model);
determine a contrast medium injection duration prior to a …scan based on the inferred blood flow speed ([0053]-[0054] discloses determining contrast medium duration based off the inferred blood flow speed/velocity; [0100] discloses determining administration parameters of the contrast medium injection duration).
program a CT system to cause contrast medium to be injected for the determined contrast medium injection duration, or to move the table at the determined speed, or both, prior to the CT scan.
While Sharma teaches operation with respect to x-ray, Sharma is silent regarding update a measurement of blood flow speed at least some of a plurality of specific locations in a portion of a body, or at least one other location in the portion of the body, or both.
Waki is considered analogous to the instant application as “X-ray computer tomography apparatus”. Waki teaches:
computer tomography (CT) (X-ray computer tomography apparatus [0003]; blood flow [0035]);
update a measurement of blood flow speed (a first function of judging the velocity of blood flow based on an image obtained by the prep scanning [0034]; steps Sa5 and Sa8, shown in fig. 2, disclose repeating measurements for each scan taken, as shown in fig. 2 and described in [0040]) at least one other location in the portion of the body (the blood flow measurements are taken along the body as the subject is scanned as disclosed in [0034]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Sharma to substitute X-ray imaging with CT angiography, and to include update a measurement of blood flow speed at least one other location in the portion of the body, as taught by Waki. Doing so would improve image quality, as suggested by Waki ([0050]).
Regarding claim 16, modified Sharma teaches the tangible, non-transitory computer readable medium of claim 14, as discussed above. Sharma further teaches wherein the plurality of specific locations comprises locations of common stenosis (locations and geometries of stenoses are disclosed in paragraph [0095]).
Regarding claim 19, modified Sharma teaches system of claim 8, as discussed above. Sharma further teaches wherein the instructions, when executed by the processor further cause the processor to input to the computational model one or more of: ultrasound (US) blood flow speed data from the specific locations of a portion of the body (A time-varying velocity profile (or flow rate profile) can be consistently determined in a clinical setting, and is often part of the diagnostic workflow (e.g., a 2D/3D phase-contrast MRI or Doppler ultrasound). The parameters of the lumped model of the heart can be computed based on non-invasively acquired flow rate and pressure values [0067]).
Regarding claim 20, modified Sharma teaches the tangible, non-transitory computer readable medium of claim 14, as discussed above. Sharma further teaches wherein the instructions, when executed by the processor further cause the processor to input to the computational model one or more of: ultrasound (US) blood flow speed data from the specific locations of a portion of the body (A time-varying velocity profile (or flow rate profile) can be consistently determined in a clinical setting, and is often part of the diagnostic workflow (e.g., a 2D/3D phase-contrast MRI or Doppler ultrasound). The parameters of the lumped model of the heart can be computed based on non-invasively acquired flow rate and pressure values [0067]).
Claims 3, 9, 11, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US 20180071452 A1) in view of Wakai (US 20060233296 A1) and Fleischmann, Dominik, and Karl Hittmair.("Mathematical analysis of arterial enhancement and optimization of bolus geometry for CT angiography using the discrete fourier transform." Journal of computer assisted tomography 23.3 (1999): 474-484, Hereinafter “Fleischmann”)
Regarding claim 3, modified Sharma teaches the method of claim 1, as discussed above. Sharma, however, does not teach wherein the determining the contrast medium injection duration further comprises determining a contrast injection protocol to provide a lowest bolus duration for the inferred blood flow speed and the speed of the table.
Fleischmann is considered analogous to the instant application as CT angiography is disclosed (title).
Fleishmann teaches the determining the contrast medium injection duration further comprises determining a contrast injection protocol to provide a lowest bolus duration for the inferred blood flow speed and the speed of the table (a pharmacokinetic model might be used to determined the adequacy of a selected contrast medium injection protocol to achieve a desired enhancement (7) and subsequently change or accept the injection parameters selected. Compared with such an iterative tailoring attempt, a purely mathematical approach, taking advantage of the "black box" concept and the powerful deconvolution properties of Fourier analysis, which allows us to directly calculate the respective injection protocol to any desired arterial enhancement from knowledge of the patient function, is a much more straightforward concept, Page 480, Col. 2, right column, paragraph 3; “Clinical Implementation: Bolus Injection, CTA Technique, and Subjects” on pages 477-478 discloses that all CT angiography examines were performed with a known table speed).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Sharma to include the determining the contrast medium injection duration further comprises determining a contrast injection protocol to provide a lowest bolus duration for the inferred blood flow speed and the speed of the table, as taught by Fleishmann. Doing so would to optimize arterial enhancement in CTA as suggested by Fleishmann (Page 474, abstract).
Regarding claim 9, modified Sharma teaches the system of claim 8, as discussed above. Sharma further teaches wherein the instructions (processor for executing instructions [0113]), when executed by the processor (processor 108 [0031]), to determine the contrast medium injection duration ([0053]-[0054] discloses determining contrast medium duration based off the inferred blood flow speed/velocity; [0100] discloses determining administration parameters of the contrast medium injection duration). Sharma, however, does not teach the processor to determine a contrast injection protocol to provide a lowest bolus duration for the inferred blood flow speed and the speed of the table.
Fleischmann is considered analogous to the instant application as CT angiography is disclosed (title).
Fleischmann teaches:
determine a contrast injection protocol to provide a lowest bolus duration for the inferred blood flow speed and the speed of the table (a pharmacokinetic model might be used to determined the adequacy of a selected contrast medium injection protocol to achieve a desired enhancement (7) and subsequently change or accept the injection parameters selected. Compared with such an iterative tailoring attempt, a purely mathematical approach, taking advantage of the "black box" concept and the powerful deconvolution properties of Fourier analysis, which allows us to directly calculate the respective injection protocol to any desired arterial enhancement from knowledge of the patient function, is a much more straightforward concept, Page 480, Col. 2, right column, paragraph 3; “Clinical Implementation: Bolus Injection, CTA Technique, and Subjects” on pages 477-478 discloses that all CT angiography examines were performed with a known table speed).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Sharma to modify the instructions, when executed by the processor, to include determine a contrast injection protocol to provide a lowest bolus duration for the inferred blood flow speed and the speed of the table, as taught by Fleishmann. Doing so would to optimize arterial enhancement in CTA as suggested by Fleishmann (Page 474, abstract).
Regarding claim 11, modified Sharma teaches the system of claim 8, as discussed above. Sharma further teaches wherein the instructions, when executed by the processor to train the computational model (training the computational model is disclosed in [0095]), further cause the processor to identify locations of stenosis (locations and geometries of stenoses are disclosed in paragraph by training the computational model [0095]) based on an ultrasound scan (The medical imaging data may be any medical images of the patient depicting the interior of the patient, such as, e.g., x-ray, MRI, ultrasound, etc [0064]) , and to determine the plurality of specific locations from the identified locations (locations and geometries of stenoses are disclosed in paragraph [0095]).
Regarding claim 15, modified Sharma teaches he tangible, non-transitory computer readable medium of claim 14, wherein the instructions, when executed by the processor when executed by the processor to determine the contrast medium injection duration, as noted above. Sharma, however, does not teach the processor to determine a contrast injection protocol to provide a lowest bolus duration for the inferred blood flow speed and the speed of the table.
Fleischmann is considered analogous to the instant application as CT angiography is disclosed (title).
Fleishmann teaches determine the contrast medium injection duration further comprises determining a contrast injection protocol to provide a lowest bolus duration for the inferred blood flow speed and the speed of the table (a pharmacokinetic model might be used to determined the adequacy of a selected contrast medium injection protocol to achieve a desired enhancement (7) and subsequently change or accept the injection parameters selected. Compared with such an iterative tailoring attempt, a purely mathematical approach, taking advantage of the "black box" concept and the powerful deconvolution properties of Fourier analysis, which allows us to directly calculate the respective injection protocol to any desired arterial enhancement from knowledge of the patient function, is a much more straightforward concept, Page 480, Col. 2, right column, paragraph 3; “Clinical Implementation: Bolus Injection, CTA Technique, and Subjects” on pages 477-478 discloses that all CT angiography examines were performed with a known table speed).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Sharma to include determine a contrast medium injection duration further comprises determining a contrast injection protocol to provide a lowest bolus duration for the inferred blood flow speed and the speed of the table, as taught by Fleishmann. Doing so would to optimize arterial enhancement in CTA as suggested by Fleishmann (Page 474, abstract).
Claims 6, 7, 12, 13, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US 20180071452 A1) in view of Wakai (US 20060233296 A1) and Russinger et al (US 20060140336 A1, hereinafter “Russinger”).
Regarding claim 6, modified Sharma teaches the method of claim 1, as discussed above. Sharma, however, does not teach wherein the determining the speed of the table further comprises determining from the specific locations where a relative speed is increased based on the blood flow speed, and determining from the specific locations where a relative speed is decreased based on the blood flow speed.
Russinger is considered analogous to the instant application as “Method for imaging with the aid of a multirow computed tomograph” is disclosed (title).
Russinger teaches:
wherein the determining the speed of the table further comprises determining from the specific locations where a relative speed is increased based on the blood flow speed (matching of the scanning speed to the propagation speed of the contrast medium in the scanning direction [0012]; matching of the scanning speed is performed in a way known per se by changing the feed rate of the patient positioning table [0013]; the contrast medium flow is detected locally once or several times as the examination is being carried out. The scanning speed is then matched in each case to the contrast medium flow or the propagation speed determined therefrom. This can be performed once, or else—in the case of a number of measurements of the propagation speed that are offset in time and space—after each individual determination [0014]), and determining from the specific locations where a relative speed is decreased based on the blood flow speed ([0012] and [0013] discloses that the propagation speed of the table i.e. the relative speed is dependent to the rate of the blood flow in the same direction; [0022] and [0042] further discloses the relationship between flow and table speed).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Sharma to include wherein the determining the speed of the table further comprises determining from the specific locations where a relative speed is increased based on the blood flow speed, and determining from the specific locations where a relative speed is decreased based on the blood flow speed, as taught by Russinger. This would allow for the scanning speed to be optimally matched at any time to the flow of contrast medium in the scanning direction, as suggested by Russinger ([0022])
Regarding claim 7, modified Sharma teaches the method of claim 1, as discussed above. Sharma, however does not teach wherein the determining the speed of the table further comprises determining a constant speed based on the blood flow speed at the specific locations.
Russinger is considered analogous to the instant application as “Method for imaging with the aid of a multirow computed tomograph” is disclosed (title).
Russinger teaches:
wherein the determining the speed of the table further comprises determining a constant speed based on the blood flow speed at the specific locations ([0012]-[0014] discloses that the propagation speed of the table i.e. the relative speed is dependent to the rate of the blood flow in the same direction/location; [0022] and [0042] further discloses the relationship between flow and table speed).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Sharma to include wherein the determining the speed of the table further comprises determining a constant speed based on the blood flow speed at the specific locations, as taught by Russinger. This would allow for the scanning speed to be optimally matched at any time to the flow of contrast medium in the scanning direction, as suggested by Russinger ([0022])
Regarding claim 12, modified Sharma teaches the system of claim 8, as discussed above. Sharma, however, does not teach wherein the instructions, when executed by the processor to determine the speed of the table further cause the processor to: determine from the specific locations where a relative speed is increased based on the blood flow speed; and to determine from the specific locations where a relative speed is decreased based on the blood flow speed.
Waki, however teaches wherein the instructions, when executed by the processor (computing device and processor disclosed in [0024]) to determine the speed of the table ([0013] discloses determining the speed of the table).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Sharma to include wherein the instructions, when executed by the processor to determine the speed of the table, as taught by Waki. Doing so would improve image quality, as suggested by Waki ([0050]).
The combined invention, still does not teach determine from the specific locations where a relative speed is increased based on the blood flow speed; and to determine from the specific locations where a relative speed is decreased based on the blood flow speed.
Russinger is considered analogous to the instant application as “Method for imaging with the aid of a multirow computed tomograph” is disclosed (title).
Russinger teaches:
determine from the specific locations where a relative speed is increased based on the blood flow speed (matching of the scanning speed to the propagation speed of the contrast medium in the scanning direction [0012]; matching of the scanning speed is performed in a way known per se by changing the feed rate of the patient positioning table [0013]; the contrast medium flow is detected locally once or several times as the examination is being carried out. The scanning speed is then matched in each case to the contrast medium flow or the propagation speed determined therefrom. This can be performed once, or else—in the case of a number of measurements of the propagation speed that are offset in time and space—after each individual determination [0014]); and
to determine from the specific locations where a relative speed is decreased based on the blood flow speed ([0012] and [0013] discloses that the propagation speed of the table i.e. the relative speed is dependent to the rate of the blood flow in the same direction; [0022] and [0042] further discloses the relationship between flow and table speed).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Sharma to include determine from the specific locations where a relative speed is increased based on the blood flow speed; and to determine from the specific locations where a relative speed is decreased based on the blood flow speed, as taught by Russinger. This would allow for the scanning speed to be optimally matched at any time to the flow of contrast medium in the scanning direction, as suggested by Russinger ([0022]).
Regarding claim 13, modified Sharma teaches the system of claim 8, as discussed above. Sharma, however, does not teach wherein the instructions, when executed by the processor to determine the speed of the table further cause the processor to determine a constant speed based on the blood flow speed at the specific locations.
Waki, however, teaches wherein the instructions, when executed by the processor (computing device and processor disclosed in [0024]) to determine the speed of the table ([0013] discloses determining the speed of the table).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Sharma to include wherein the instructions, when executed by the processor to determine the speed of the table, as taught by Waki. Doing so would improve image quality, as suggested by Waki ([0050]).
The combined invention still, however, does not teach the processor to determine a constant speed based on the blood flow speed at the specific locations
Russinger is considered analogous to the instant application as “Method for imaging with the aid of a multirow computed tomograph” is disclosed (title).
Russinger teaches:
the processor to determine a constant speed based on the blood flow speed at the specific locations ([0012]-[0014] discloses that the propagation speed of the table i.e. the relative speed is dependent to the rate of the blood flow in the same direction/location; [0022] and [0042] further discloses the relationship between flow and table speed).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Sharma to include the processor to determine a constant speed based on the blood flow speed at the specific locations, as taught by Russinger. This would allow for the scanning speed to be optimally matched at any time to the flow of contrast medium in the scanning direction, as suggested by Russinger ([0022]).
Regarding claim 17, modified Sharma teaches he tangible, non-transitory computer readable medium of claim 14, when executed by the processor to determine the speed of the table further, as discussed above. Sharma, however does not teach determine from the specific locations where a relative speed is increased based on the blood flow speed; and to determine from the specific locations where a relative speed is decreased based on the blood flow speed.
Russinger is considered analogous to the instant application as “Method for imaging with the aid of a multirow computed tomograph” is disclosed (title).
Russinger teaches:
determine from the specific locations where a relative speed is increased based on the blood flow speed (matching of the scanning speed to the propagation speed of the contrast medium in the scanning direction [0012]; matching of the scanning speed is performed in a way known per se by changing the feed rate of the patient positioning table [0013]; the contrast medium flow is detected locally once or several times as the examination is being carried out. The scanning speed is then matched in each case to the contrast medium flow or the propagation speed determined therefrom. This can be performed once, or else—in the case of a number of measurements of the propagation speed that are offset in time and space—after each individual determination [0014]); and
to determine from the specific locations where a relative speed is decreased based on the blood flow speed ([0012] and [0013] discloses that the propagation speed of the table i.e. the relative speed is dependent to the rate of the blood flow in the same direction; [0022] and [0042] further discloses the relationship between flow and table speed).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Sharma to include determine from the specific locations where a relative speed is increased based on the blood flow speed; and to determine from the specific locations where a relative speed is decreased based on the blood flow speed, as taught by Russinger. This would allow for the scanning speed to be optimally matched at any time to the flow of contrast medium in the scanning direction, as suggested by Russinger ([0022]).
Regarding claim 18, modified Sharma teaches he tangible, non-transitory computer readable medium of claim 14, when executed by the processor to determine the speed of the table, as discussed above. Sharma, however, does not teach determine the speed of the table further cause the processor to determine a constant speed based on the blood flow speed at the specific locations determining a constant speed based on the blood flow speed at the specific locations ([0012]-[0014] discloses that the propagation speed of the table i.e. the relative speed is dependent to the rate of the blood flow in the same direction/location; [0022] and [0042] further discloses the relationship between flow and table speed).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Sharma to include wherein the determining the speed of the table further comprises determine a constant speed based on the blood flow speed at the specific locations, as taught by Russinger. This would allow for the scanning speed to be optimally matched at any time to the flow of contrast medium in the scanning direction, as suggested by Russinger ([0022]).
Response to Arguments
Applicant's arguments filed 12/22/2025 have been fully considered but they are not persuasive.
Regarding the 35 USC 101 rejection, of claims 1-18, the applicant argues the following:
“At the outset, the Office Action concedes blood flow speed can be estimated ''through the use of a model which associates the two." The Examiner has not identified what "model" is being used in this calculation. Assuming the model is one of the models used in carrying various embodiments of the present teachings... So, and noting the Examiner hasn't defined what model is being used, the inventors, who clearly have ordinary skill in the art, have filed a patent application noting that execution of the model cannot be performed by hand.” on pages 7-8.
In response, the examiner asserts that the blood flow speed can be calculated using known position and time in at least two different instances, using a pen and paper or a generic computer. The examiner further notes that computational models are merely algorithmic and mathematical expressions that can be performed mentally or via pen and paper, as noted in the 35 USC 101 rejection above. The claims merely recite that a computational model is used for “inferring, with a controller, a blood flow speed throughout the portion of the body by executing the computational model”, and does not recite any other particulars of the computational model that would require extensive computation. A blood flow speed can be calculated with a pen and paper by divided distance over time just using two points of data, for example, and can be performed mentally. Accordingly, this argument is not persuasive.
“Clearly, the ultrasound imaging systems described in the filed application require at the very least a controller and processors (i.e., a computer), which the inventors have identified as being improved by the present teachings, accordingly is not a "generic computer."… So, in direct contrast to the assertions regarding the facility with which the model can be executed by hand, or by a "generic" computer, the inventors, who again are of at least ordinary skill in the art, have clearly disclosed this is not the case”- page 8
In response, the examiner asserts that the steps can be completed using pen and paper (in particular, calculating blood flow speed and making a determination of contrast medium injection duration, or a speed of a table, or both, prior to the CT scan based on the inferred blood flow speed: and programming). The claim does not any additional information on how the contrast medium injection is determined, the claim merely recites that it is “based on the inferred blood flow speed”. A generic computer was stated as the mental process steps can take place either in a computer environment or calculated mentally using a pen and paper. Accordingly, this argument is not persuasive.
“In direct response to the first contention in the rejection that the claims are not directed to a practical application, Applicants direct attention to paragraphs [0003] –[0006] of the filed application in the Background of the application, which disclose… In describing the improvement of the present teachings to the technical field, paragraph [0052] of the filed application states:… So, according to the inventors of the present application, who have at least ordinary skill in the all of the present teachings, not only does the claimed subject matter provide a clear improvement to the described known CT systems (which include a computer), but also provides clear improvement to the technical field of contrast based” pages 9-13.
In response, the examiner asserts that there is no practical application that is stated in the claim language. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., paragraphs [0003]-[0006], and [0052] , and any additional background information in the specification cited) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claims recite “with the controller, to cause contrast medium to be injected for the determined contrast medium injection duration, or to move the table at the determined speed, or both, prior to the CT scan”. There is no practical application that is stated in the claim, only that the contrast medium injection duration or the table speed is determined. Accordingly, this argument is not persuasive.
“So, in the present case where the treatment of the patient involves diagnostic imaging with a CT scanner, the claims most-certainly affirmatively recite an action that effects a particular medical procedure (and thus treatment) that is instrumental in the identifying and treating a disease or medical condition”. Page 14
In response, the examiner respectfully disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., action that effects a particular medical procedure (and thus treatment) that is instrumental in the identifying and treating a disease or medical condition) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Accordingly, this argument is not persuasive.
“Applicants first note the quoted portion in the paragraph above states a desired result. Applicants claims recite a method that is used in an effort to attain those results. Moreover, and as noted in the filed application, execution of the computational model of the present application cannot be practically done mentally, but requires a trained computational model executed by a processor in an ultrasound system. Finally, Applicants note that in the Response under Rule 111, multiple legal challenges to the alleged ineligibility of the claimed subject matter spanning five full pages of arguments and support were provided”. Pages 14-15.
In response the examiner states that all of the hardware presented in the claims are generic hardware components that are either used for data/computer processing or for obtaining data. The examiner further asserts that the court cases previously mentioned in the remarks follow a specific fact pattern that is different from the instant application, and does not apply to the instant application. Accordingly, this argument is not persuasive.
Accordingly, the arguments are not persuasive and the 35 USC 101 of claims 1-18 are maintained.
Regarding the 35 USC 103 argument of claim 1, applicant argues on pages 17-20 that “At 408, the inferred BFS data are used to determine the contrast injection duration, or table feed speed, or both, for the current patient. In accordance with a representative embodiment, the contrast injection duration and the table feed speed (constant or variable) are stored in a look-up table for various injector volume speeds, table feed speeds, and detector width used in the scan of the current patient. Specifically, for a given set of BFS data gathered for the current patient, the lookup table provides table feed speed, or injector volume speed, or both, for a particular detector width used in the scan…Applicants respectfully submit that conspicuously absent from the portions of Sharma, et al. to which Applicants are directed is the duration of the contrast agent…Plainly, there ls no disclosure or description of how the duration of the injection is determined, as it is only described as a variable in the injection curve” on pages 17-20. In response, the examiner respectfully disagrees. The examiner first states that claim 1 merely states that “determining contrast medium injection duration, or a speed of a table, or both, prior to the CT scan based on the inferred blood flow speed”. There is no look up table, calculation, or any particular method in how the contrast medium injection duration is calculated. Examiner further asserts that the features upon which applicant relies (i.e “, the contrast injection duration and the table feed speed (constant or variable) are stored in a look-up table for various injector volume speeds, table feed speeds, and detector width used in the scan of the current patient” ) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Further, paragraphs [0053]-[0054], and [0076] of Sharma discloses determining the administration characteristics of the contrast agent, which includes the duration and the concentration which are then administered. Paragraph [0076] further discloses that the duration and the time delay of the contrast agent is modeled. Paragraph [0048] also discloses that the contrast agent circulation parameters, such as, e.g., flow, velocities, contrast agent concentration, etc. are included in the computational model, as outlined in the rejection above. Accordingly, this argument is not persuasive and the rejection is maintained.
Applicant arguments on pages 20-21 are premised upon the assertion that claims 8 and 14 are allowable for the same reasons as stated for claim 1, and that claims 2-7, 9-13, and 15-20 are allowable as they are dependent on allowable claims the examiner respectfully disagrees for the reasons discussed above. Accordingly, this argument is not persuasive and the rejection is maintained.
Conclusion
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/N.B./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798