DETAILED ACTION
Summary
Claims 1-20 are pending in the application. Claims 5, 10, and 18 are rejected under 35 USC 112(b). Claims 1-20 are rejected under 35 USC 101. Claims 1-4, 6-9, 11-18, and 19-20 are rejected under 35 USC 103.
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 .
Claim Objections
Claims 1, 6, and 10 are objected to because of the following informalities:
Claim 1 recites “a table configured to support a patient” in line 6. It should recites “a table configured to support the patient”.
Claim 6 recites “a table configured to support a patient” in line 6. It should recite “a table configured to support the patient”.
Claim 10 recites “a table configured to support a patient” in line 6. It should recite “a table configured to support the patient”.
Appropriate correction is required.
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 5, 10, and 18 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 5 recites “an anatomic dimensionless index (DICT)” in line 4. It is not clear if this is referring to the anatomic dimensionless index set forth in claim 1, or if this is setting forth a new anatomic dimensionless index. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 10 recites “an anatomic dimensionless index (DICT)” in line 4. It is not clear if this is referring to the anatomic dimensionless index set forth in claim 6, or if this is setting forth a new anatomic dimensionless index. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 18 recites “an anatomic dimensionless index (DICT)” in line 4. It is not clear if this is referring to the anatomic dimensionless index set forth in claim 14, or if this is setting forth a new anatomic dimensionless index. Clarification is required. For the purposes of examination, the former definition will be used.
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 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite mathematical concepts and mental processes. This judicial exception is not integrated into a practical application because the additional limitations are directed to insignificant extra-solution activities and are merely specifying a particular field of use. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because insignificant extra-solution activities and are merely specifying a particular field of use.
Regarding Claim 1, the limitations of determining an aortic valve area, a left ventricular outflow tract area, and a severity level of aortic valve stenosis are limitations which, by the broadest reasonable interpretation, encompass mathematical concepts and/or limitations that can practically be performed in the human mind and/or with the aid of pen/paper. A user, looking at a CT scan, can determine the aortic valve area and the left ventricular outflow tract area using only their mind or with the aid of pen/paper. Furthermore, a trained physician would be able to use the AVA, LVOT, and DI to determine a severity level using only their mind. The step of calculating is an anatomic dimensionless index is a mathematical concept, as the dimensionless index is obtained with a mathematical calculation.
The additional features do not integrate the abstract idea into a practical application. The step of performing a CT scan is directed to an insignificant pre-solution activity of gathering data. The use of CT scanner with a gantry, table, and computing device is a field of use limitation that just generally links the abstract idea of calculating a dimensionless index and determining AS severity to a particular technological environment. The use of a processor and a memory to perform the claimed abstract idea amount to no more than mere instructions to perform the abstract idea, and as such does not integrate the abstract idea into a practical application.
The claimed invention does not include additional elements, which viewed individually or as an ordered combination, amount to significantly more than the judicial exception. As detailed above, performing of the CT scan is directed to an insignificant pre-solution activity, the use of CT is a field of use limitation, and the use of a processor and memory are mere no more than mere instructions to perform the abstract idea. Furthermore, a CT scanner with a gantry and a table is well-understood, routine, and conventional, as evidenced by Toth et al. (U.S PGPub 2005/0089135 A1) (Fig. 5). The claim is not subject matter eligible.
Claim 2 recites an abstract idea without significantly more. The equation for calculating the dimensionless index is directed an abstract idea of a mathematical calculation. The claim contains no additional features which either integrate the abstract idea into a practical application, or amounts to significantly more than the abstract ide. The claim is not subject matter eligible.
Claim 3 recites an abstract idea without significantly more. The step of determining the severity is directed to a mental process. A user, looking at the AVA and DI values, can determine that the AS is severe using only their mind. The claim contains no additional limitations which either integrate the abstract idea into a practical application, or amount to significantly more than the judicial exception. The claim is not subject matter eligible.
Claim 4 recites an abstract idea without significantly more. The step of determining the severity is directed to a mental process. A user, looking at the AVA and DI values, can determine that the AS is moderate using only their mind. The claim contains no additional limitations which either integrate the abstract idea into a practical application, or amount to significantly more than the judicial exception. The claim is not subject matter eligible.
Claim 5 recites an abstract idea without significantly more. The equation for calculating the mean aortic valve gradient is an abstract idea of a mathematical calculation. The used of a computing device to perform the calculation amounts to n+o more than mere instructions to perform the abstract idea, and as such does not integrate the abstract idea into a practical application or amounts to significantly more than the abstract idea. The claim is not subject matter eligible.
Regarding Claim 6, the limitations of determining an aortic valve area, a left ventricular outflow tract area, and a severity level of aortic valve stenosis are limitations which, by the broadest reasonable interpretation, could be performed in the human mind. A user, looking at a CT scan, can determine the aortic valve area and the left ventricular outflow tract area using only their mind or with the aid of pen/paper. Furthermore, a trained physician would be able to use the AVA, LVOT, and DI to determine a severity level using only their mind. The step of calculating is an anatomic dimensionless index is a mathematical concept, as the dimensionless index is obtained with a mathematical calculation.
The additional features do not integrate the abstract idea into a practical application. The step of performing a CT scan is directed to an insignificant pre-solution activity of gathering data. The use of CT scanner with a gantry, table, and computing device is a field of use limitation that just generally links the abstract idea of calculating a dimensionless index and determining AS severity to a particular technological environment. The use of a processor and a memory to perform the claimed abstract idea amount to no more than mere instructions to perform the abstract idea, and as such does not integrate the abstract idea into a practical application.
The claimed invention does not include additional elements, which viewed individually or as an ordered combination, amount to significantly more than the judicial exception. As detailed above, performing of the CT scan is directed to an insignificant pre-solution activity, the use of CT is a field of use limitation, and the use of a processor and memory are no more than mere instructions to perform the abstract idea. Furthermore, a CT scanner with a gantry and a table is well-understood, routine, and conventional, as evidenced by Toth (U.S PGPub 2005/0089135 A1) (Fig. 5). The claim is not subject matter eligible.
Claim 7 recites an abstract idea without significantly more. The equation for calculating the dimensionless index is directed an abstract idea of a mathematical calculation. The claim contains no additional features which either integrate the abstract idea into a practical application, or amounts to significantly more than the abstract ide. The claim is not subject matter eligible.
Claim 8 recites an abstract idea without significantly more. The step of determining the severity is directed to a mental process. A user, looking at the AVA and DI values, can determine that the AS is severe using only their mind. The claim contains no additional limitations which either integrate the abstract idea into a practical application, or amount to significantly more than the judicial exception. The claim is not subject matter eligible.
Claim 9 recites an abstract idea without significantly more. The step of determining the severity is directed to a mental process. A user, looking at the AVA and DI values, can determine that the AS is moderate using only their mind. The claim contains no additional limitations which either integrate the abstract idea into a practical application, or amount to significantly more than the judicial exception. The claim is not subject matter eligible.
Claim 10 recites an abstract idea without significantly more. The equation for calculating the mean aortic valve gradient is an abstract idea of a mathematical calculation. The used of a computing device to perform the calculation amounts to no more than mere instructions to perform the abstract idea, and as such does not integrate the abstract idea into a practical application or amounts to significantly more than the abstract idea. The claim is not subject matter eligible.
Claim 11 does not integrate the abstract idea into a practical application. The use of a CT scanner with a gantry with a bore is directed to a field of use limitation which just generally links the abstract idea to a technological environment. The claimed invention does not include additional elements, which viewed individually or as an ordered combination, amount to significantly more than the judicial exception. As detailed above, using a gantry with a bore is a field of use limitation. Furthermore, a CT scanner with a gantry which contains a bore well-understood, routine, and conventional, as evidenced by Toth (U.S PGPub 2005/0089135 A1) (Fig. 5). The claim is not subject matter eligible.
Claim 12 does not integrate the abstract idea into a practical application. The use of a CT scanner with a table configured to move a patient through a bore is directed to a field of use limitation which just generally links the abstract idea to a technological environment. The claimed invention does not include additional elements, which viewed individually or as an ordered combination, amount to significantly more than the judicial exception. As detailed above, using a CT scanner with a table configured to move a patient into a bore is a field of use limitation. Furthermore, a CT scanner with a table configured to move a patient into a bore well-understood, routine, and conventional, as evidenced by Toth (U.S PGPub 2005/0089135 A1) (Fig. 5). The claim is not subject matter eligible.
Claim 13 does not integrate the claimed abstract idea into a practical application. Using a computing device to control the CT scanner to perform the CT scan is directed to an insignificant pre-solution activity of gathering data, and does not integrate the abstract idea into a practical application. The claim does not amount to significantly more than the practical application. As detailed above, using the computing device to perform a CT scan is directed to an insignificant pre-solution activity of gathering data. The claim is not patent eligible.
Regarding Claim 14, the limitations of determining an aortic valve area, a left ventricular outflow tract area, and a severity level of aortic valve stenosis are limitations which, by the broadest reasonable interpretation, are mathematical concepts and/or limitations that could practically be performed in the human mind and/or with the aid of pen/paper. A user, looking at a CT scan, can determine the aortic valve area and the left ventricular outflow tract area using only their mind or with the aid of pen/paper. Furthermore, a trained physician would be able to use the AVA, LVOT, and DI to determine a severity level using only their mind. The step of calculating is an anatomic dimensionless index is a mathematical concept, as the dimensionless index is obtained with a mathematical calculation.
The additional features do not integrate the abstract idea into a practical application. The step of performing a CT scan is directed to an insignificant pre-solution activity of gathering data. The use of CT scanner with a gantry, table, and computing device is a field of use limitation that just generally links the abstract idea of calculating a dimensionless index and determining AS severity to a particular technological environment. The use of a processor and a memory to perform the claimed abstract idea amount to no more than mere instructions to perform the abstract idea, and as such does not integrate the abstract idea into a practical application.
The claimed invention does not include additional elements, which viewed individually or as an ordered combination, amount to significantly more than the judicial exception. As detailed above, performing of the CT scan is directed to an insignificant pre-solution activity, the use of CT is a field of use limitation, and the use of a processor and memory are mere no more than mere instructions to perform the abstract idea. Furthermore, a CT scanner with a gantry and a table is well-understood, routine, and conventional, as evidenced by Toth (U.S PGPub 2005/0089135 A1) (Fig. 5). The claim is not subject matter eligible.
Claim 15 recites an abstract idea without significantly more. The equation for calculating the dimensionless index is directed an abstract idea of a mathematical calculation. The claim contains no additional features which either integrate the abstract idea into a practical application, or amounts to significantly more than the abstract idea. The use of a processor to perform the claimed abstract idea amount to no more than mere instructions to perform the abstract idea, and as such does not integrate the abstract idea into a practical application or amount to significantly more than the abstract idea. The claim is not patent eligible.
Claim 16 recites an abstract idea without significantly more. The step of determining the severity is directed to a mental process. A user, looking at the AVA and DI values, can determine that the AS is severe using only their mind. The claim contains no additional features which either integrate the abstract idea into a practical application, or amounts to significantly more than the abstract idea. The use of a processor to perform the claimed abstract idea amount to no more than mere instructions to perform the abstract idea, and as such does not integrate the abstract idea into a practical application or amount to significantly more than the abstract idea. The claim is not patent eligible.
Claim 17 recites an abstract idea without significantly more. The step of determining the severity is directed to a mental process. A user, looking at the AVA and DI values, can determine that the AS is moderate using only their mind. The claim contains no additional features which either integrate the abstract idea into a practical application, or amounts to significantly more than the abstract idea. The use of a processor to perform the claimed abstract idea amount to no more than mere instructions to perform the abstract idea, and as such does not integrate the abstract idea into a practical application or amount to significantly more than the abstract idea. The claim is not patent eligible.
Claim 18 recites an abstract idea without significantly more. The equation for calculating the mean aortic valve gradient is an abstract idea of a mathematical calculation. The use of a computing device to perform the calculation amounts to no more than mere instructions to perform the abstract idea, and as such does not integrate the abstract idea into a practical application or amounts to significantly more than the abstract idea. The claim is not subject matter eligible.
Claim 19 does not integrate the abstract idea into a practical application. The use of a CT scanner with a gantry with a bore is directed to a field of use limitation which just generally links the abstract idea to a technological environment. The claimed invention does not include additional elements, which viewed individually or as an ordered combination, amount to significantly more than the judicial exception. As detailed above, using a gantry with a bore id a field of use limitation. Furthermore, a CT scanner with a gantry which contains a bore well-understood, routine, and conventional, as evidenced by Toth (U.S PGPub 2005/0089135 A1) (Fig. 5). The claim is not subject matter eligible.
Claim 20 does not integrate the claimed abstract idea into a practical application. Using a computing device to control the CT scanner to perform the CT scan is directed to an insignificant pre-solution activity of gathering data, and does not integrate the abstract idea into a practical application. The claim does not amount to significantly more than the practical application. As detailed above, using the computing device to perform a CT scan is directed to an insignificant pre-solution activity of gathering data. The claim is not patent eligible.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 6-9, 11-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Clavel et al. (Clavel, Marie-Annick, et al. "Aortic valve area calculation in aortic stenosis by CT and Doppler echocardiography." Cardiovascular Imaging 8.3 (2015): 248-257.) in view of Mantha et al. (Mantha, Yogamaya, et al. "Valvulo-arterial impedance and dimensionless index for risk stratifying patients with severe aortic stenosis." Frontiers in Cardiovascular Medicine 8 (2021): 742297.) and Toth et al. (U.S PGPub 2005/0089135 A1).
Regarding Claim 1, Clavel teaches a method of performing hemodynamic assessments of aortic valve stenosis by cardiac computed tomography (CT) scanning (Abstract), comprising:
performing a cardiac CT scan of a patient, using a CT scanner, (Pg. 249-250, MDCT imaging and measurements)
determining, via the CT scan (Pg. 249-250, MDCT imaging and measurements):
an aortic valve area (AVACT) of the patient; and (Pg. 250, Col 2, ¶ 1-2)
a left ventricular outflow tract area (LVOT AreaCT) of the patient; (Pg. 250, Col 2, ¶ 1-2).
Clavel fails to explicitly teach calculating an anatomic dimensionless index (DICT) based on the aortic valve area (AVACT) and the left ventricular outflow tract area (LVOT AreaCT); and determining, based on the aortic valve area (AVACT), the left ventricular outflow tract area (LVOT AreaCT), and the anatomic dimensionless index (DICT), a severity level of aortic valve stenosis (AS) of the patient.
Mantha teaches a method for hemodynamic assessment (Abstract). The system calculating an anatomic dimensionless index (DICT) based on the aortic valve area (AVACT) and the left ventricular outflow tract area (LVOT AreaCT) (Pg. 250, Fig. 1) (Dimensionless Index = LVOT-VTI/AV-VTI. One of ordinary skill would understand that Dimensionless Index = LVOT-VTI/AV-VTI = AVA/LVOT-CSA based on a simple algebraic rearrangement of the aortic valve area calculation (AVA = LVOT-VTI x LVOT-CSA/ AV-VTI), where AVA is equivalent to AVACT and LVOT-CSA is equivalent to LVOT AreaCT), and determining, based on the aortic valve area (AVACT), the left ventricular outflow tract area (LVOT AreaCT), and the anatomic dimensionless index (DICT), a severity level of aortic valve stenosis (AS) of the patient (Pg. 2, Table 1) (Pg. 3, Assessment of Aortic Stenosis and Hemodynamics).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Clavel, to calculate the dimensionless index and determine the severity level of aortic valve stenosis, as taught by Mantha, because this improves risk stratification and clinical decision making for treating a patient, as recognized by Mantha (Abstract).
The combination is silent regarding wherein the CT scanner comprises: a gantry comprising one or more X-ray generators; a table configured to support a patient; and a computing device comprising a processor and a memory; and using the computing device.
Toth teaches a system for computed tomography imaging (Abstract). This system has a CT scanner (Fig. 5) [0025] which contains a gantry (Fig. 5, 102) comprising one or more X-ray generators (Fig. 5, 104) [0045], a table configured to support a patient (Fig. 5, 136) [0047], and a computing device comprising a processor and a memory and using the computing device to control the system (Fig. 6, 126) [0016]+[0046]-[0047].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the computed tomography scanner of the combination with a CT scanner with a gantry and table, as taught by Toth, as the substitution for one known CT scanner with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a CT scanner with a gantry and table are reasonably predictable.
Regarding Claim 2, the combination of references teaches the invention substantially as claimed. Clavel fails to explicitly teaches wherein the anatomic dimensionless index, DICT, is calculated according to
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Mantha further teaches wherein the anatomic dimensionless index, DICT, is calculated according to
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(Pg. 250, Fig. 1) (Dimensionless Index = LVOT-VTI/AV-VTI. One of ordinary skill would understand that Dimensionless Index = LVOT-VTI/AV-VTI = AVA/LVOT-CSA based on a simple algebraic rearrangement of the aortic valve area calculation (AVA = LVOT-VTI x LVOT-CSA/ AV-VTI), where AVA is equivalent to AVACT and LVOT-CSA is equivalent to LVOT AreaCT).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Clavel, to calculate the dimensionless index, as taught by Mantha, because this improves risk stratification and clinical decision making for treating a patient, as recognized by Mantha (Abstract).
Regarding Claim 3, the combination of references teaches the invention substantially as claimed. Clavel fails to explicitly teach wherein the severity level of the AS of the patient is determined to be severe when the AVACT is less than 1.3 cm2 and the DICT is less than 0.25.
Mantha further teaches wherein the severity level of the AS of the patient is determined to be severe when the AVACT is less than 1.3 cm2 and the DICT is less than 0.25 (Pg. 6, Fig. 2B shows the AVA and DI when the stenosis is considered severe).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Clavel, to calculate the dimensionless index and determine the severity level of aortic valve stenosis using the index and AVA, as taught by Mantha, because this improves risk stratification and clinical decision making for treating a patient, as recognized by Mantha (Abstract).
Regarding Claim 4, the combination of references teaches the invention substantially as claimed. Clavel fails to explicitly teach wherein the severity level of the AS of the patient is determined to be moderate when the AVACT is between 1.3 cm2 and 2.0 cm2 and the DICT is between 0.25 and 0.45.
Mantha further teaches wherein the severity level of the AS of the patient is determined to be moderate when the AVACT is between 1.3 cm2 and 2.0 cm2 and the DICT is between 0.25 and 0.45 (Pg. 6, Fig. 2B shows the AVA and DI when the stenosis is considered moderate. The AVA is considered moderate at 1.37 cm2 (1.23+.14 cm2), which is greater than 1.3 cm2).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Clavel, to calculate the dimensionless index and determine the severity level of aortic valve stenosis using the index and AVA, as taught by Mantha, because this improves risk stratification and clinical decision making for treating a patient, as recognized by Mantha (Abstract).
Regarding Claim 6, Clavel teaches a system for performing hemodynamic assessments of aortic valve stenosis by cardiac computed tomography (CT) scanning (Abstract), comprising:
a CT scanner configured to perform a cardiac CT scan of a patient, (Pg. 249-250, MDCT imaging and measurements)
determine, via the CT scan (Pg. 249-250, MDCT imaging and measurements):
an aortic valve area (AVACT) of the patient; and (Pg. 250, Col 2, ¶ 1-2)
a left ventricular outflow tract area (LVOT AreaCT) of the patient; (Pg. 250, Col 2, ¶ 1-2).
Clavel fails to explicitly teach calculating an anatomic dimensionless index (DICT) based on the aortic valve area (AVACT) and the left ventricular outflow tract area (LVOT AreaCT); and determining, based on the aortic valve area (AVACT), the left ventricular outflow tract area (LVOT AreaCT), and the anatomic dimensionless index (DICT), a severity level of aortic valve stenosis (AS) of the patient.
Mantha teaches a method for hemodynamic assessment (Abstract). The system calculating an anatomic dimensionless index (DICT) based on the aortic valve area (AVACT) and the left ventricular outflow tract area (LVOT AreaCT) (Pg. 250, Fig. 1) (Dimensionless Index = LVOT-VTI/AV-VTI. One of ordinary skill would understand that Dimensionless Index = LVOT-VTI/AV-VTI = AVA/LVOT-CSA based on a simple algebraic rearrangement of the aortic valve area calculation (AVA = LVOT-VTI x LVOT-CSA/ AV-VTI), where AVA is equivalent to AVACT and LVOT-CSA is equivalent to LVOT AreaCT), and determining, based on the aortic valve area (AVACT), the left ventricular outflow tract area (LVOT AreaCT), and the anatomic dimensionless index (DICT), a severity level of aortic valve stenosis (AS) of the patient (Pg. 2, Table 1) (Pg. 3, Assessment of Aortic Stenosis and Hemodynamics).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Clavel, to calculate the dimensionless index and determine the severity level of aortic valve stenosis, as taught by Mantha, because this improves risk stratification and clinical decision making for treating a patient, as recognized by Mantha (Abstract).
The combination is silent regarding wherein the CT scanner comprises: a gantry comprising one or more X-ray generators; a table configured to support a patient; and a computing device comprising a processor and a memory; and using the computing device.
Toth teaches a system for computed tomography imaging (Abstract). This system has a CT scanner (Fig. 5) [0025] which contains a gantry (Fig. 5, 102) comprising one or more X-ray generators (Fig. 5, 104) [0045], a table configured to support a patient (Fig. 5, 136) [0047], and a computing device comprising a processor and a memory and using the computing device to control the system (Fig. 6, 126) [0016]+[0046]-[0047].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the computed tomography scanner of the combination with a CT scanner with a gantry and table, as taught by Toth, as the substitution for one known CT scanner with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a CT scanner with a gantry and table are reasonably predictable.
Regarding Claim 7, the combination of references teaches the invention substantially as claimed. Clavel fails to explicitly teaches wherein the computing device is configured to calculate the anatomic dimensionless index, DICT, according to
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Mantha further teaches wherein the anatomic dimensionless index, DICT, is calculated according to
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(Pg. 250, Fig. 1) (Dimensionless Index = LVOT-VTI/AV-VTI. One of ordinary skill would understand that Dimensionless Index = LVOT-VTI/AV-VTI = AVA/LVOT-CSA based on a simple algebraic rearrangement of the aortic valve area calculation (AVA = LVOT-VTI x LVOT-CSA/ AV-VTI), where AVA is equivalent to AVACT and LVOT-CSA is equivalent to LVOT AreaCT).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Clavel, to calculate the dimensionless index, as taught by Mantha, because this improves risk stratification and clinical decision making for treating a patient, as recognized by Mantha (Abstract).
Regarding Claim 8, the combination of references teaches the invention substantially as claimed. Clavel fails to explicitly teach wherein the computing device is configured to determine the severity level of the AS of the patient is to be severe when the AVACT is less than 1.3 cm2 and the DICT is less than 0.25.
Mantha further teaches wherein the severity level of the AS of the patient is determined to be severe when the AVACT is less than 1.3 cm2 and the DICT is less than 0.25 (Pg. 6, Fig. 2B shows the AVA and DI when the stenosis is considered severe).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Clavel, to calculate the dimensionless index and determine the severity level of aortic valve stenosis using the index and AVA, as taught by Mantha, because this improves risk stratification and clinical decision making for treating a patient, as recognized by Mantha (Abstract).
Regarding Claim 9, the combination of references teaches the invention substantially as claimed. Clavel fails to explicitly teach wherein the computing device is configured to determine the severity level of the AS of the patient to be moderate when the AVACT is between 1.3 cm2 and 2.0 cm2 and the DICT is between 0.25 and 0.45.
Mantha further teaches wherein the severity level of the AS of the patient is determined to be moderate when the AVACT is between 1.3 cm2 and 2.0 cm2 and the DICT is between 0.25 and 0.45 (Pg. 6, Fig. 2B shows the AVA and DI when the stenosis is considered moderate. The AVA is considered moderate at 1.37 cm2 (1.23+.14 cm2), which is greater than 1.3 cm2).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Clavel, to calculate the dimensionless index and determine the severity level of aortic valve stenosis using the index and AVA, as taught by Mantha, because this improves risk stratification and clinical decision making for treating a patient, as recognized by Mantha (Abstract).
Regarding Claim 11, the combination of references teaches the invention substantially as claimed. Clavel fails to explicitly teach wherein the gantry forms a bore through which one or more portions of the patient can pass.
Toth further teaches the system has a CT scanner (Fig. 5) [0025] which contains a gantry (Fig. 5, 102) with a bore through which one or more portions of the patient can pass (Fig. 5) [0017]+[0047].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the computed tomography scanner of the combination with a CT scanner with a gantry and a bore, as taught by Toth, as the substitution for one known CT scanner with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a CT scanner with a gantry and table are reasonably predictable.
Regarding Claim 12, the combination of references teaches the invention substantially as claimed. Clavel fails to explicitly teach wherein the table is configured to move the one or more portions of the patient through the bore.
Toth further teaches wherein the table is configured to move the one or more portions of the patient through the bore (Fig. 5) [0047].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the computed tomography scanner of the combination with a CT scanner with a gantry and a bore, as taught by Toth, as the substitution for one known CT scanner with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a CT scanner with a gantry and table are reasonably predictable.
Regarding Claim 13, the combination of references teaches the invention substantially as claimed. Clavel fails to explicitly teach wherein the computing device is configured to cause the CT scanner to perform the cardiac CT scan of the patient.
Toth further teaches the computing device is configured to cause the CT scanner to perform the cardiac CT scan of the patient (Fig. 6, 126) [0016]+[0046]-[0047].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the computed tomography scanner of the combination with a CT scanner with a gantry and table, as taught by Toth, as the substitution for one known CT scanner with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a CT scanner with a gantry and table are reasonably predictable.
Regarding Claim 14, Clavel teaches a system for performing hemodynamic assessments of aortic valve stenosis by cardiac computed tomography (CT) scanning (Abstract), comprising:
a CT scanner configured to perform a cardiac CT scan of a patient, (Pg. 249-250, MDCT imaging and measurements)
determine, via the CT scan (Pg. 249-250, MDCT imaging and measurements):
an aortic valve area (AVACT) of the patient; and (Pg. 250, Col 2, ¶ 1-2)
a left ventricular outflow tract area (LVOT AreaCT) of the patient; (Pg. 250, Col 2, ¶ 1-2).
Clavel fails to explicitly teach calculating an anatomic dimensionless index (DICT) based on the aortic valve area (AVACT) and the left ventricular outflow tract area (LVOT AreaCT); and determining, based on the aortic valve area (AVACT), the left ventricular outflow tract area (LVOT AreaCT), and the anatomic dimensionless index (DICT), a severity level of aortic valve stenosis (AS) of the patient.
Mantha teaches a method for hemodynamic assessment (Abstract). The system calculating an anatomic dimensionless index (DICT) based on the aortic valve area (AVACT) and the left ventricular outflow tract area (LVOT AreaCT) (Pg. 250, Fig. 1) (Dimensionless Index = LVOT-VTI/AV-VTI. One of ordinary skill would understand that Dimensionless Index = LVOT-VTI/AV-VTI = AVA/LVOT-CSA based on a simple algebraic rearrangement of the aortic valve area calculation (AVA = LVOT-VTI x LVOT-CSA/ AV-VTI), where AVA is equivalent to AVACT and LVOT-CSA is equivalent to LVOT AreaCT), and determining, based on the aortic valve area (AVACT), the left ventricular outflow tract area (LVOT AreaCT), and the anatomic dimensionless index (DICT), a severity level of aortic valve stenosis (AS) of the patient (Pg. 2, Table 1) (Pg. 3, Assessment of Aortic Stenosis and Hemodynamics).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Clavel, to calculate the dimensionless index and determine the severity level of aortic valve stenosis, as taught by Mantha, because this improves risk stratification and clinical decision making for treating a patient, as recognized by Mantha (Abstract).
The combination is silent regarding wherein the CT scanner comprises: a gantry comprising one or more X-ray generators; a table configured to support a patient; and a computing device comprising a processor and a memory, wherein the memory is configured to store programming instructions that are executed by the processor.
Toth teaches a system for computed tomography imaging (Abstract). This system has a CT scanner (Fig. 5) [0025] which contains a gantry (Fig. 5, 102) comprising one or more X-ray generators (Fig. 5, 104) [0045], a table configured to support a patient (Fig. 5, 136) [0047], and a computing device comprising a processor and a memory, wherein the memory is configured to store programming instructions that are executed by the processor to control the system (Fig. 6, 126) [0016]+[0046]-[0047]+[0098].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the computed tomography scanner of the combination with a CT scanner with a gantry and table, as taught by Toth, as the substitution for one known CT scanner with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a CT scanner with a gantry and table are reasonably predictable.
Regarding Claim 15, the combination of references teaches the invention substantially as claimed. Clavel fails to explicitly teaches wherein the programming instructions, when executed by the processor, are further configured to calculate the anatomic dimensionless index, DICT, according to
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Mantha further teaches wherein the anatomic dimensionless index, DICT, is calculated according to
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(Pg. 250, Fig. 1) (Dimensionless Index = LVOT-VTI/AV-VTI. One of ordinary skill would understand that Dimensionless Index = LVOT-VTI/AV-VTI = AVA/LVOT-CSA based on a simple algebraic rearrangement of the aortic valve area calculation (AVA = LVOT-VTI x LVOT-CSA/ AV-VTI), where AVA is equivalent to AVACT and LVOT-CSA is equivalent to LVOT AreaCT).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Clavel, to calculate the dimensionless index, as taught by Mantha, because this improves risk stratification and clinical decision making for treating a patient, as recognized by Mantha (Abstract).
Regarding Claim 16, the combination of references teaches the invention substantially as claimed. Clavel fails to explicitly teach the programming instructions, when executed by the processor, are further configured to determine the severity level of the AS of the patient is to be severe when the AVACT is less than 1.3 cm2 and the DICT is less than 0.25.
Mantha further teaches wherein the severity level of the AS of the patient is determined to be severe when the AVACT is less than 1.3 cm2 and the DICT is less than 0.25 (Pg. 6, Fig. 2B shows the AVA and DI when the stenosis is considered severe).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Clavel, to calculate the dimensionless index and determine the severity level of aortic valve stenosis using the index and AVA, as taught by Mantha, because this improves risk stratification and clinical decision making for treating a patient, as recognized by Mantha (Abstract).
Regarding Claim 17, the combination of references teaches the invention substantially as claimed. Clavel fails to explicitly teach the programming instructions, when executed by the processor, are further configured to determine the severity level of the AS of the patient to be moderate when the AVACT is between 1.3 cm2 and 2.0 cm2 and the DICT is between 0.25 and 0.45.
Mantha further teaches wherein the severity level of the AS of the patient is determined to be moderate when the AVACT is between 1.3 cm2 and 2.0 cm2 and the DICT is between 0.25 and 0.45 (Pg. 6, Fig. 2B shows the AVA and DI when the stenosis is considered moderate. The AVA is considered moderate at 1.37 cm2 (1.23+ .14 cm2), which is greater than 1.3 cm2).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Clavel, to calculate the dimensionless index and determine the severity level of aortic valve stenosis using the index and AVA, as taught by Mantha, because this improves risk stratification and clinical decision making for treating a patient, as recognized by Mantha (Abstract).
Regarding Claim 19, the combination of references teaches the invention substantially as claimed. Clavel fails to explicitly teach wherein the gantry forms a bore through which one or more portions of the patient can pass.
Toth further teaches the system has a CT scanner (Fig. 5) [0025] which contains a gantry (Fig. 5, 102) with a bore through which one or more portions of the patient can pass (Fig. 5) [0017]+[0047].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the computed tomography scanner of the combination with a CT scanner with a gantry and a bore, as taught by Toth, as the substitution for one known CT scanner with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a CT scanner with a gantry and table are reasonably predictable.
Regarding Claim 20, the combination of references teaches the invention substantially as claimed. Clavel fails to explicitly teach the programming instructions, when executed by the processor, are further configured to cause the processor to perform the cardiac CT scan of the patient.
Toth further teaches the computing device is configured to cause the CT scanner to perform the cardiac CT scan of the patient (Fig. 6, 126) [0016]+[0046]-[0047].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the computed tomography scanner of the combination with a CT scanner with a gantry and table, as taught by Toth, as the substitution for one known CT scanner with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a CT scanner with a gantry and table are reasonably predictable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Keshavarz Motamed et al. (US 2025/0099058 A1), which teaches a method for assessing aortic valve calcification.
Weber et al. (Weber, Marcel, et al. "TAVR outcome after reclassification of aortic valve stenosis by using a hybrid continuity equation that combines computed tomography and echocardiography data." Catheterization and Cardiovascular Interventions 96.4 (2020): 958-967.), which teaches a method of using CT in evaluating aortic stenosis.
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/SEAN D MATTSON/ Primary Examiner, Art Unit 3798