DETAILED ACTION
Summary
Claims 1-20 are pending in the application. 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 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 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.
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 the 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 the 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 the 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.
Response to Arguments
Applicant's arguments filed 5/5/2026 have been fully considered but they are not persuasive.
The Applicant argues the claim does not recite an abstract idea. The Applicant states that determining the aortic valve area and the left ventricular outflow area cannot be performed in the human mind, as the measurements cannot be eyeballed, and instead require specific computations to accurately determine the respective areas. The Examiner disagrees. By the broadest reasonable interpretation, an “eyeballed” estimate of the areas would read on the claims. There are no image processing, multiplanar reconstruction, or contour tracing recited in the claims. A user, looking at the CT image, could estimate the respective areas using only their mind/with the aid of a pen and paper. The Applicant continues to argue the claim does not teach a mathematical concept. The Examiner disagrees. The calculation of the dimensionless index is a mathematical calculation. While there are other elements in the claim, those features are not considered until step 2A, prong 2. The claim recites an abstract idea.
The Applicant continues to argue that the combination of references provides an improvement in medical diagnostic technology. “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements” (MPEP 2106.05(a)). In this case, the improvement is directed to the judicial exception, not the additional limitations. The disclosed improvement is based on the improved ability to analyze aortic valve severity (See at least [0075]). As detailed above, the calculation of the areas, the calculation of the dimensionless index, and the determination of aortic valve are all directed to the judicial exception. While the claim generally recites obtaining a CT image, this is not reflective of the improvement as the claim is completely silent regarding the scenarios in which the CT scan is an improvement (e.g. low flow, limited acoustic window, etc.), and instead is a mere data gathering step. The improvement is exclusively reflected in the judicial exception, and the improvement does not integrate the abstract idea into a practical application.
The Applicant continues to argue that the claimed invention is integrated in a judicial exception as the CT scanner is a particular machine, integral to the claim. The Examiner notes “It is noted that while the application of a judicial exception by or with a particular machine is an important clue, it is not a stand-alone test for eligibility” (MPEP 2106.05(b)). In this case, the claimed CT machine does not integrate the abstract idea into a practical application. The CT scanner is claimed at a high level of generality (i.e. the CT scanner only includes a gantry and a table). Furthermore, the claimed CT scanner is only nominally connected to the execution of the claimed method. The CT scanner performing a CT scan is a routine data gathering step, as every use of the abstract idea needs the acquired data (i.e. the CT image). Example 29 is not relevant in this case, as that example contains no judicial exception. In this case, as discussed above, there is a judicial exception present.
Applicant argues that the combined system is integrated into a practical application. The Examiner disagrees. As detailed above, the additional components (i.e. the CT scanner) is only nominally connected to the claimed abstract idea, and amounts to no more than an insignificant pre-solution activity of gathering data. Furthermore, contrary to the Applicant’s assertion, the claim is neither a treatment nor a prophylaxis, and is instead a diagnostic process. The claim is not integrated into a practical application.
The Applicant argues that the claims that the combined system is significantly more than the judicial exception. The Applicant argues that the test is not whether the CT scanner is conventional in isolation, but rather whether the combined system is conventional. The Examiner disagrees. “Another consideration when determining whether a claim recites significantly more than a judicial exception is whether the additional element(s) are well-understood, routine, conventional activities previously known to the industry.” (MPEP 2106.05(d)). The only additional elements in the claim is the CT scanner. As the Toth reference shows the CT scanner is conventional, the claim is not significantly more than the judicial exception. The claim is not subject matter eligible, and the rejection under 35 USC 101 is maintained.
Applicant argues that the combination of Clavel, Mantha, and Toth does not teach the claimed invention. The Examiner disagrees. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Clavel teaches the continuity equation (Pg. 250, Col 2), and calculating the AVA and LVOT from CT images. Mantha teaches the dimensionless index is a known value that is equivalent to AVA/LVOT (Fig. 1). When viewed together, one of ordinary skill would recognize that the DI of Mantha could be calculated using the measure CT values as taught by Clavel. Mantha stating that the LVOT need not be used from calculating a DI is not a teaching away as “(d)isclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).” (MPEP 2123(II)), and one of ordinary skill in the art would recognize from Mantha that the LVOT could be used for calculating the DI.
The Applicant argues that the algebraic rearrangement is not supported by the prior art. The Examiner disagrees. The argument is that dimensionless index, as taught by Mantha, is equal to LVOT-VTI/AV-VTI and also equal to AVA/LVOT-CSA (See figure 1). As such, when viewed with the teachings of Clavel, one of ordinary skill could use the values obtained by Clavel to obtain the dimensionless index as taught by Mantha. The Examiner further notes that AVAecho and AVACT being different values does not suggest that the dimensionless index calculated using the different modalities would also be different.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Mantha teaches that the dimensionless index improves risk stratification and improved clinical decision making (Abstract). As noted above, Mantha teaches the DI could also be AVA/LVOT-CSA. When viewed with Clavel, one of ordinary skill would have been motivated to use the CT values calculated by Clavel to achieve the improvement of using a DI, as taught by Mantha. The Examiner disagrees that the Mantha improvement is a “general teaching”, as Mantha explicitly sets forth the nexus between improved risk stratification and the dimensionless index in the Abstract.
The claims are obvious over the prior art, and the rejection under 35 USC 103 is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN D MATTSON whose telephone number is (408)918-7613. The examiner can normally be reached Monday - Friday 9 AM - 5 PM PST.
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/SEAN D MATTSON/Primary Examiner, Art Unit 3798
