DETAILED ACTION
Notices to Applicant
This communication is a First Action Non-Final on the merits. Claims 1-19 as filed 07/07/2025, are currently pending and have been considered below.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The present application is a continuation of and claims benefit under 35 U.S.C. §120 to U.S. Application No. 17/514,360, filed 10/29/2021, which is based upon and claims the benefit of priority from Japanese Patent Application No. 2020-183315, 10/30/2020.
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 2-3 and 7-17 are 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 2 recites the limitation, “processing circuitry configured to acquire estimated shape data indicating estimated a shape of a biological organ at a timing before treatment, and actual shape data indicating the shape of the biological organ at the timing before the treatment,” however, it is unclear the scope corresponding shapes of a biological organ at a timing before treatment. That is, the claim initially recites “a shape of a biological organ at a timing before treatment,” with estimated shape data then proceeds to recite “the shape of a biological organ at a timing before treatment,” with actual shape data, however it’s unclear as to whether “the shape” as recited in lines 5 and/or line 7 is the same or different shape as initially recited in lines 3-4. Accordingly, claims 2-3 and 7-17 are rejected as being indefinite.
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 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Claims 1 drawn to an X-ray CT apparatus, which is within the four statutory categories (i.e. machine).
Independent Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1 recites (additional elements bolded):
1. An X-ray CT apparatus, comprising: an X-ray tube configured to radiate X-rays; an X-ray detector configured to detect the X-rays; and processing circuitry configured to,
acquire estimated shape data indicating estimated a shape of a biological organ at a timing before treatment, and actual shape data, of CT image data based on the detected X- rays, indicating the shape of the biological organ at the timing before the treatment,
acquire a parameter related to the shape of the biological organ so that the estimated shape data becomes similar to the actual shape data, acquire treatment information, and
estimate, based on the treatment information, the parameter, and the estimated shape data or the actual shape data in a predetermined time phase at the timing before the treatment, a shape of the biological organ in the predetermined time phase at a timing after the treatment.
The claim limitations, as drafted, is a machine that, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people through rules or instructions but for the recitation of generic computer components/machinery. That is, other than reciting the above bolded language, nothing in the claim precludes the steps from managing personal behavior or interactions between people. For example, but for the above bolded language, acquire estimated shape data indicating estimated a shape of a biological organ at a timing before treatment, and actual shape data, of CT image data based on the detected X- rays, indicating the shape of the biological organ at the timing before the treatment, acquire a parameter related to the shape of the biological organ so that the estimated shape data becomes similar to the actual shape data, acquire treatment information, and estimate, based on the treatment information, the parameter, and the estimated shape data or the actual shape data in a predetermined time phase at the timing before the treatment, a shape of the biological organ in the predetermined time phase at a timing after the treatment in the context of this claim encompasses the rules or instructions for managing personal behavior or interactions between people for estimating biological organ data before and after treatment. If a claim limitation, under its broadest reasonable interpretation, covers rules or instructions for managing personal behavior or interactions between people but for the recitation of generic computer components/machinery, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Further, at least the claim limitations of estimate, based on the treatment information, the parameter, and the estimated shape data or the actual shape data in a predetermined time phase at the timing before the treatment, a shape of the biological organ in the predetermined time phase at a timing after the treatment in the context of this claim encompasses a user performing the limitation in the mind such that the claim also recites the abstract idea of a “Mental Process.” Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites the above bolded additional elements of using, for example, an “X-ray CT apparatus, comprising: an X-ray tube configured to radiate X-rays; an X-ray detector configured to detect the X-rays; and processing circuitry,” to perform the claim limitations. The additional elements in each of these steps are recited at a high-level of generality (i.e., an X-ray tube/detector configured to radiate and detect x-rays such as X-ray Computed Tomography (CT) device and processing circuitry such as a processor as it relates to a general purpose computer (Application Specification [0020], [0038])). As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer or other machinery used in its ordinary capacity, or merely uses a computer or other machinery used in its ordinary capacity as a tool to perform an abstract idea. See MPEP 2106.05(f)(2). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using, for example, “X-ray CT apparatus, comprising: an X-ray tube configured to radiate X-rays; an X-ray detector configured to detect the X-rays; and processing circuitry,” to perform the claim limitations amounts to no more than mere instructions to apply the exception using a generic computer component or other machinery. (i.e., an X-ray tube/detector configured to radiate and detect x-rays such as X-ray Computed Tomography (CT) device and processing circuitry such as a processor as it relates to a general purpose computer (Application Specification [0020], [0038])). Mere instructions to apply an exception using a generic computer component or other machinery used in its ordinary capacity cannot provide an inventive concept. See MPEP 2106.05(f)(2). The claim is not patent eligible.
Claims 2-3 and 7-17 are drawn to a medical image processing device, which is within the four statutory categories (i.e. machine).
Independent Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 2 recites (additional elements bolded):
2. A medical image processing device comprising: processing circuitry configured to acquire estimated shape data indicating estimated a shape of a biological organ at a timing before treatment, and actual shape data indicating the shape of the biological organ at the timing before the treatment,
acquire a parameter related to the shape of the biological organ so that the estimated shape data becomes similar to the actual shape data,
acquire treatment information,
estimate, based on the treatment information, the parameter, and the estimated shape data or the actual shape data in a predetermined time phase at the timing before the treatment, a shape of the biological organ in the predetermined time phase at a timing after the treatment.
The claim limitations, as drafted, is a machine that, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people through rules or instructions but for the recitation of generic computer components/machinery. That is, other than reciting the above bolded language, nothing in the claim precludes the steps from managing personal behavior or interactions between people. For example, but for the above bolded language, acquire estimated shape data indicating estimated a shape of a biological organ at a timing before treatment, and actual shape data indicating the shape of the biological organ at the timing before the treatment, acquire a parameter related to the shape of the biological organ so that the estimated shape data becomes similar to the actual shape data, acquire treatment information, estimate, based on the treatment information, the parameter, and the estimated shape data or the actual shape data in a predetermined time phase at the timing before the treatment, a shape of the biological organ in the predetermined time phase at a timing after the treatment in the context of this claim encompasses the rules or instructions for managing personal behavior or interactions between people for estimating biological organ data before and after treatment. If a claim limitation, under its broadest reasonable interpretation, covers rules or instructions for managing personal behavior or interactions between people but for the recitation of generic computer components/machinery, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Further, at least the claim limitations of estimate, based on the treatment information, the parameter, and the estimated shape data or the actual shape data in a predetermined time phase at the timing before the treatment, a shape of the biological organ in the predetermined time phase at a timing after the treatment in the context of this claim encompasses a user performing the limitation in the mind such that the claim also recites the abstract idea of a “Mental Process.” Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites the above bolded additional elements of using, for example, “processing circuitry,” to perform the claim limitations. The additional elements in each of these steps are recited at a high-level of generality (i.e., processing circuitry as it relates to a general purpose computer (Application Specification [0038])). As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer or other machinery used in its ordinary capacity, or merely uses a computer or other machinery used in its ordinary capacity as a tool to perform an abstract idea. See MPEP 2106.05(f)(2). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using, for example, “processing circuitry,” to perform the claim limitations amounts to no more than mere instructions to apply the exception using a generic computer component or other machinery (i.e., processing circuitry as it relates to a general purpose computer (Application Specification [0038])). Mere instructions to apply an exception using a generic computer component or other machinery used in its ordinary capacity cannot provide an inventive concept. See MPEP 2106.05(f)(2). The claim is not patent eligible.
Dependent claims 3 and 7-17 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore the dependent claims are rejected under 35 U.S.C. § 101.
Claims 4-6 are drawn to a medical image processing device, which is within the four statutory categories (i.e. machine).
Claim 18 is drawn to a medical image processing method, which is within the four statutory categories (i.e. method).
Claim 19 is drawn to a non-transitory computer readable medium, which is within the four statutory categories (i.e. manufacture).
Independent Claim 4 as well as substantially similar independent claims 18 and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 4 recites (additional elements bolded)::
4. A medical image processing device comprising: processing circuitry configured to acquire estimated shape data indicating estimated a shape of a biological organ at a timing before treatment, and actual shape data indicating the shape of the biological organ at the timing before the treatment,
acquire a parameter related to the shape of the biological organ so that the estimated shape data becomes similar to the actual shape data,
acquire treatment information,
acquire shape data indicating a shape of the biological organ in a predetermined time phase at a timing after the treatment, and
estimate, based on the treatment information, the parameter, and the estimated shape data or the actual shape data in a predetermined time phase at the timing before the treatment, a shape of the biological organ at the timing after the treatment over a plurality of time phases
The claim limitations of claims 4, 18, and 19, as drafted, is a machine/method/manufacture that, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people through rules or instructions but for the recitation of generic computer components/machinery. That is, other than reciting the above bolded language, nothing in the claim precludes the steps from managing personal behavior or interactions between people. For example, but for the above bolded language, acquire estimated shape data indicating estimated a shape of a biological organ at a timing before treatment, and actual shape data indicating the shape of the biological organ at the timing before the treatment, acquire a parameter related to the shape of the biological organ so that the estimated shape data becomes similar to the actual shape data, acquire treatment information, acquire shape data indicating a shape of the biological organ in a predetermined time phase at a timing after the treatment, and estimate, based on the treatment information, the parameter, and the estimated shape data or the actual shape data in a predetermined time phase at the timing before the treatment, a shape of the biological organ at the timing after the treatment over a plurality of time phases in the context of this claim encompasses the rules or instructions for managing personal behavior or interactions between people for estimating biological organ data before and after treatment. If a claim limitation, under its broadest reasonable interpretation, covers rules or instructions for managing personal behavior or interactions between people but for the recitation of generic computer components/machinery, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Further, at least the claim limitations of estimate, based on the treatment information, the parameter, and the estimated shape data or the actual shape data in a predetermined time phase at the timing before the treatment, a shape of the biological organ at the timing after the treatment over a plurality of time phases in the context of this claim encompasses a user performing the limitation in the mind such that the claim also recites the abstract idea of a “Mental Process.” Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites the above bolded additional elements of using, for example, “processing circuitry,” (claim 4) or “a non-transitory computer readable medium,” (claim 19) to perform the claim limitations. The additional elements in each of these steps are recited at a high-level of generality (i.e., processing circuitry and non-transitory computer readable medium as storage circuitry for a computer program as it relates to a general purpose computer (Application Specification [0030], [0038])). As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer or other machinery used in its ordinary capacity, or merely uses a computer or other machinery used in its ordinary capacity as a tool to perform an abstract idea. See MPEP 2106.05(f)(2). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Claim 18 does not recite any additional elements. The claim are directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using, for example, “processing circuitry,” (claim 4) or “a non-transitory computer readable medium,” (claim 19) to perform the claim limitations amounts to no more than mere instructions to apply the exception using a generic computer component or other machinery (i.e., processing circuitry and non-transitory computer readable medium as storage circuitry for a computer program as it relates to a general purpose computer (Application Specification [0030], [0038])). Mere instructions to apply an exception using a generic computer component or other machinery used in its ordinary capacity cannot provide an inventive concept. See MPEP 2106.05(f)(2). Claim 18 does not recite any additional elements. The claims are not patent eligible.
Dependent claims 5-6, which depend upon claim 4 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore the dependent claims are rejected under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. 2016/0246938 A1 (hereinafter “Sipiorski et al.”).
RE: Claim 1 Sipiorski et al. teaches the claimed:
1. An X-ray CT apparatus, comprising: an X-ray tube configured to radiate X-rays;
an X-ray detector configured to detect the X-rays; and processing circuitry configured to, acquire estimated shape data indicating estimated a shape of a biological organ at a timing before treatment, and actual shape data, of CT image data based on the detected X- rays, indicating the shape of the biological organ at the timing before the treatment ((Sipiorski et al., [0025]) (calcification details may be observed and determined from a prior 3D rotational data scan (i.e., a diagnostic imaging scan) of the heart. The equipment and processing utilized to conduct the diagnostic imaging scan ( diagnostic imaging equipment 220) may, in an embodiment, transmit the calcification details to the valve clip prediction processor 210. The diagnostic imaging scan may include, but is not limited to, one or more of a rotational 3D data scan, a computed tomography (CT) scan, an MRI, an XA scan, and an Ultrasound));
acquire a parameter related to the shape of the biological organ so that the estimated shape data becomes similar to the actual shape data ((Sipiorski et al., [0026]) (The equipment may include an ultrasound transducer in a probe for collecting Doppler information of the heart, including various geometric measurements; The Doppler information may provide tissue density information for the leaflets 130, 140 of the valve 100, such as whether the tissue is hard, soft, thick, thin, or other characteristics of interest));
acquire treatment information ((Sipiorski et al., [0024]) (for predicting an optimal position for a valve clip to be placed and/or an optimal type of valve clip to be used, for repairing the mitral valve; These contributing parameters are inputted to the valve clip prediction processor 210 from various sources. The contributing parameters may include, but are not limited to, calcification details, information from a 3D or4D model of the valve, valve clip properties, and prior flow simulation)), and
estimate, based on the treatment information, the parameter, and the estimated shape data or the actual shape data in a predetermined time phase at the timing before the treatment, a shape of the biological organ in the predetermined time phase at a timing after the treatment ((Sipiorski et al., [0036]) (The simulation may be CPD-simulated to predict at least one of the optimal clip type (e.g. dimension, mass, etc.) and optimal clip position. The simulation may be transmitted to a user interface and displayed in a 3D rotational image and/or as a 2D image. The predicted optimal clip type and position for its placement may be shown overlaid in the image among the displayed valve)).
RE: Claim 2 Sipiorski et al. teaches the claimed:
2. A medical image processing device comprising: processing circuitry configured to acquire estimated shape data indicating estimated a shape of a biological organ at a timing before treatment, and actual shape data indicating the shape of the biological organ at the timing before the treatment ((Sipiorski et al., [0025]) (calcification details may be observed and determined from a prior 3D rotational data scan (i.e., a diagnostic imaging scan) of the heart. The equipment and processing utilized to conduct the diagnostic imaging scan ( diagnostic imaging equipment 220) may, in an embodiment, transmit the calcification details to the valve clip prediction processor 210. The diagnostic imaging scan may include, but is not limited to, one or more of a rotational 3D data scan, a computed tomography (CT) scan, an MRI, an XA scan, and an Ultrasound));
acquire a parameter related to the shape of the biological organ so that the estimated shape data becomes similar to the actual shape data ((Sipiorski et al., [0026]) (The equipment may include an ultrasound transducer in a probe for collecting Doppler information of the heart, including various geometric measurements; The Doppler information may provide tissue density information for the leaflets 130, 140 of the valve 100, such as whether the tissue is hard, soft, thick, thin, or other characteristics of interest));
acquire treatment information ((Sipiorski et al., [0024]) (for predicting an optimal position for a valve clip to be placed and/or an optimal type of valve clip to be used, for repairing the mitral valve; These contributing parameters are inputted to the valve clip prediction processor 210 from various sources. The contributing parameters may include, but are not limited to, calcification details, information from a 3D or4D model of the valve, valve clip properties, and prior flow simulation)), and
estimate, based on the treatment information, the parameter, and the estimated shape data or the actual shape data in a predetermined time phase at the timing before the treatment, a shape of the biological organ in the predetermined time phase at a timing after the treatment ((Sipiorski et al., [0036]) (The simulation may be CPD-simulated to predict at least one of the optimal clip type (e.g. dimension, mass, etc.) and optimal clip position. The simulation may be transmitted to a user interface and displayed in a 3D rotational image and/or as a 2D image. The predicted optimal clip type and position for its placement may be shown overlaid in the image among the displayed valve)).
RE: Claim 3 Sipiorski et al. teaches the claimed:
3. The medical image processing device according to claim 2, wherein the processing circuitry calculates, as the parameter related to the shape, a parameter indicating at least one of hardness, a thickness, a fiber direction, a length, a width, a connecting position, and number of the biological organ based on the estimated shape data and the actual shape data ((Sipiorski et al., [0024], [0026]) (contributing parameters may include, but are not limited to, calcification details, information from a 3D or 4D model of the valve, valve clip properties, and prior flow simulations; The equipment may include an ultrasound transducer in a probe for collecting Doppler information of the heart, including various geometric measurements; The Doppler information may provide tissue density information for the leaflets of the valve, such as whether the tissue is hard, soft, thick, thin, or other characteristics of interest. Doppler information may also include location and size specifics of the valve and valve leaflets)), and
estimates the shape of the biological organ in the predetermined time phase at the timing after the treatment based on the parameter indicating at least one of the above items and the estimated shape data in the predetermined time phase ((Sipiorski et al., [0006]) (conduct the simulation of the blood flow for the mitral valve based on one or more of the one or more received parameters; compare results of the simulation with the defined one or more metrics; reconduct the simulation of the blood flow for the mitral valve based on a re-parameterization of one or more of the one or more received parameters if the comparison indicates an unacceptable simulation result)).
RE: Claim 4 Sipiorski et al. teaches the claimed:
4. A medical image processing device comprising: processing circuitry configured to acquire estimated shape data indicating estimated a shape of a biological organ at a timing before treatment, and actual shape data indicating the shape of the biological organ at the timing before the treatment ((Sipiorski et al., [0025]) (calcification details may be observed and determined from a prior 3D rotational data scan (i.e., a diagnostic imaging scan) of the heart. The equipment and processing utilized to conduct the diagnostic imaging scan ( diagnostic imaging equipment 220) may, in an embodiment, transmit the calcification details to the valve clip prediction processor 210. The diagnostic imaging scan may include, but is not limited to, one or more of a rotational 3D data scan, a computed tomography (CT) scan, an MRI, an XA scan, and an Ultrasound));
acquire a parameter related to the shape of the biological organ so that the estimated shape data becomes similar to the actual shape data ((Sipiorski et al., [0026]) (The equipment may include an ultrasound transducer in a probe for collecting Doppler information of the heart, including various geometric measurements; The Doppler information may provide tissue density information for the leaflets 130, 140 of the valve 100, such as whether the tissue is hard, soft, thick, thin, or other characteristics of interest));
acquire treatment information ((Sipiorski et al., [0024]) (for predicting an optimal position for a valve clip to be placed and/or an optimal type of valve clip to be used, for repairing the mitral valve; These contributing parameters are inputted to the valve clip prediction processor 210 from various sources. The contributing parameters may include, but are not limited to, calcification details, information from a 3D or 4D model of the valve, valve clip properties, and prior flow simulation)), and
acquire shape data indicating a shape of the biological organ in a predetermined time phase at a timing after the treatment ((Sipiorski et al., [0024], [0031]) (These contributing parameters are inputted to the valve clip prediction processor from various sources. The contributing parameters may include, but are not limited to, calcification details, information from a 3D or4D model of the valve, valve clip properties, and prior flow simulation; The one or more metrics may be based on the clinical situation and may be entered by a physician, lab technician, user, or the like, and transmitted to the valve clip prediction processor 210 from one or more computing devices)),
estimate, based on the treatment information, the parameter, and the estimated shape data or the actual shape data in a predetermined time phase at the timing before the treatment, a shape of the biological organ at the timing after the treatment over a plurality of time phases ((Sipiorski et al., [0036]) (The simulation may be CPD-simulated to predict at least one of the optimal clip type (e.g. dimension, mass, etc.) and optimal clip position. The simulation may be transmitted to a user interface and displayed in a 3D rotational image and/or as a 2D image. The predicted optimal clip type and position for its placement may be shown overlaid in the image among the displayed valve)).
RE: Claim 5 Sipiorski et al. teaches the claimed:
5. The medical image processing device according to claim 4, wherein the processing circuitry acquires a parameter related to movement of the biological organ based on the estimated shape data and the actual shape data ((Sipiorski et al., [0026]) (Color Doppler information can suggest fluid dynamics about the valve 100 for location purposes. The valve clip prediction processor 210 may generate a 3D model of the valve 100 based on the collected Doppler information. A 4D model may also be generated, adding a time component for fluid transfer relative to time about the 3D model)), and
estimates the shape of the biological organ at the timing after the treatment over the plurality of the time phases based on the shape data and the parameter related to movement of the biological organ ((Sipiorski et al., [0036]) (The simulation may be CPD-simulated to predict at least one of the optimal clip type (e.g. dimension, mass, etc.) and optimal clip position. The simulation may be transmitted to a user interface and displayed in a 3D rotational image and/or as a 2D image. The predicted optimal clip type and position for its placement may be shown overlaid in the image among the displayed valve)).
RE: Claim 6 Sipiorski et al. teaches the claimed:
6. The medical image processing device according to claim 5, wherein the processing circuitry acquires, as the parameter related to movement, a parameter indicating at least one of hardness, a volume, and a degree of smoothness of a surface of the biological organ, and viscosity, a flow speed, and a total quantity of a fluid flowing in the biological organ based on the estimated shape data and the actual shape data ((Sipiorski et al., [0024], [0026]) (contributing parameters may include, but are not limited to, calcification details, information from a 3D or 4D model of the valve, valve clip properties, and prior flow simulations; The equipment may include an ultrasound transducer in a probe for collecting Doppler information of the heart, including various geometric measurements; The Doppler information may provide tissue density information for the leaflets of the valve, such as whether the tissue is hard, soft, thick, thin, or other characteristics of interest. Doppler information may also include location and size specifics of the valve and valve leaflets)), and
estimates the shape of the biological organ at the timing after the treatment over the time phases based on the shape data and the parameter indicating at least one of the above items ((Sipiorski et al., [0006]) (conduct the simulation of the blood flow for the mitral valve based on one or more of the one or more received parameters; compare results of the simulation with the defined one or more metrics; reconduct the simulation of the blood flow for the mitral valve based on a re-parameterization of one or more of the one or more received parameters if the comparison indicates an unacceptable simulation result)).
RE: Claim 7 Sipiorski et al. teaches the claimed:
7. The medical image processing device according to claim 2, wherein the processing circuitry acquires the parameter used for estimating the estimated shape data, wherein an evaluation value, which is calculated based on the estimated shape data and the actual shape data, satisfies a standard determined in advance ((Sipiorski et al., [0006]) (receive one or more parameters that influence a simulation of blood flow for a mitral valve; define one or more metrics for an acceptable simulation result; conduct the simulation of the blood flow for the mitral valve based on one or more of the one or more received parameters)).
RE: Claim 8 Sipiorski et al. teaches the claimed:
8. The medical image processing device according to claim 7, wherein the processing circuitry acquires the parameter used for estimating the estimated shape data, wherein the estimated shape data is similar to the actual shape data ((Sipiorski et al., [0006]) (compare results of the simulation with the defined one or more metrics; determine at least at least one of a valve clip position and a valve clip type based on the acceptable simulation result from one of the conducted simulation and a re-conducted simulation)).
RE: Claim 9 Sipiorski et al. teaches the claimed:
9. The medical image processing device according to claim 7, wherein the processing circuitry acquires the parameter used for estimating the estimated shape data, wherein a difference between the estimated shape data and the actual shape data is equal to or smaller than a threshold ((Sipiorski et al., [0006]) (re-conduct the simulation of the blood flow for the mitral valve based on a re-parameterization of one or more of the one or more received parameters if the comparison indicates an unacceptable simulation result, wherein the re-conducting is performed until the acceptable simulation result is accomplished as determined by a comparison of the results of the re-conducting simulation with the defined one or more metrics)).
RE: Claim 10 Sipiorski et al. teaches the claimed:
10, The medical image processing device according to claim 7, wherein the processing circuitry acquires the evaluation value based on a point and a plane constituting the estimated shape data, and a point and a plane constituting the actual shape data ((Sipiorski et al., [0029]) (at least five clip positions are considered as input for the CFD calculation: left, lower left, center, lower right, and right; although more or fewer clip positions can be used)),
RE: Claim 11 Sipiorski et al. teaches the claimed:
11. The medical image processing device according to claim 7, wherein the processing circuitry repeatedly changes the parameter used for estimating the estimated shape data until the evaluation value satisfies the standard ((Sipiorski et al., [0006]) (re-conduct the simulation of the blood flow for the mitral valve based on a re-parameterization of one or more of the one or more received parameters if the comparison indicates an unacceptable simulation result, wherein the re-conducting is performed until the acceptable simulation result is accomplished as determined by a comparison of the results of the re-conducting simulation with the defined one or more metrics)).
RE: Claim 12 Sipiorski et al. teaches the claimed:
12. The medical image processing device according to claim 8, wherein the processing circuitry repeatedly changes the parameter used for estimating the estimated shape data until the estimated shape data becomes similar to the actual shape data ((Sipiorski et al., [0006]) (re-conduct the simulation of the blood flow for the mitral valve based on a re-parameterization of one or more of the one or more received parameters if the comparison indicates an unacceptable simulation result, wherein the re-conducting is performed until the acceptable simulation result is accomplished as determined by a comparison of the results of the re-conducting simulation with the defined one or more metrics)).
RE: Claim 13 Sipiorski et al. teaches the claimed:
13. The medical image processing device according to claim 9, wherein the processing circuitry repeatedly changes the parameter used for estimating the estimated shape data until the difference becomes equal to or smaller than the threshold ((Sipiorski et al., [0006]) (re-conduct the simulation of the blood flow for the mitral valve based on a re-parameterization of one or more of the one or more received parameters if the comparison indicates an unacceptable simulation result, wherein the re-conducting is performed until the acceptable simulation result is accomplished as determined by a comparison of the results of the re-conducting simulation with the defined one or more metrics)).
RE: Claim 14 Sipiorski et al. teaches the claimed:
14. The medical image processing device according to claim 2, wherein the processing circuitry acquires a plurality of pieces of the estimated shape data by estimating the pieces of estimated shape data using a plurality of different parameters, and acquires the parameter used for estimating the shape of the biological organ based on the pieces of estimated shape data and the actual shape data ((Sipiorski et al., [0006]) (conduct the simulation of the blood flow for the mitral valve based on one or more of the one or more received parameters; compare results of the simulation with the defined one or more metrics; reconduct the simulation of the blood flow for the mitral valve based on a re-parameterization of one or more of the one or more received parameters if the comparison indicates an unacceptable simulation result)).
RE: Claim 15 Sipiorski et al. teaches the claimed:
15. The medical image processing device according to claim 2, wherein the processing circuitry acquires the estimated shape data indicating estimated a shape of a mitral valve as the biological organ, and the actual shape data indicating the shape of the mitral valve ((Sipiorski et al., [0005], [0025]) (a simulation of the blood flow for the mitral valve is used to calculate the optimal position for the valve clip as well as the optimal type of clip to be used; calcification details may be observed and determined from a prior 3D rotational data scan (i.e., a diagnostic imaging scan) of the heart. The equipment and processing utilized to conduct the diagnostic imaging scan ( diagnostic imaging equipment 220) may, in an embodiment, transmit the calcification details to the valve clip prediction processor 210. The diagnostic imaging scan may include, but is not limited to, one or more of a rotational 3D data scan, a computed tomography (CT) scan, an MRI, an XA scan, and an Ultrasound)); and
estimates the shape of the mitral valve at the timing after the treatment ((Sipiorski et al., [0005], [0036]) (a simulation of the blood flow for the mitral valve is used to calculate the optimal position for the valve clip as well as the optimal type of clip to be used; The simulation may be CPD-simulated to predict at least one of the optimal clip type (e.g. dimension, mass, etc.) and optimal clip position. The simulation may be transmitted to a user interface and displayed in a 3D rotational image and/or as a 2D image. The predicted optimal clip type and position for its placement may be shown overlaid in the image among the displayed valve)).
RE: Claim 16 Sipiorski et al. teaches the claimed:
16. The medical image processing device according to claim 11, wherein the processing circuitry further controls a display to display a plurality of parameters respectively used for estimating a plurality of pieces of the estimated shape data, and a plurality of the evaluation values based on the respective pieces of estimated shape data and the actual shape data ((Sipiorski et al., [0006]) (A user interface in communication with the processor is configured to display data relating to the at least one of the valve clip position and the valve clip type)).
RE: Claim 17 Sipiorski et al. teaches the claimed:
17. The medical image processing device according to claim 2, wherein the processing circuitry acquire, as treatment information, a treatment parameter related to a clip set in advance based on a known size, weight, tension of the clip ((Sipiorski et al., [0027]) (valve clip data from one or more databases or other sources may be inputted to the valve clip prediction processor. The valve clip data may include valve clip properties, such as but not limited to size and mass, that may be provided for various types of valve clips that may be designed and built by one or more manufacturers)).
RE: Claim 18 Sipiorski et al. teaches the claimed:
18. A medical image processing method comprising: acquiring estimated shape data indicating estimated a shape of a biological organ at a timing before treatment, and actual shape data indicating the shape of the biological organ at the timing before the treatment ((Sipiorski et al., [0025]) (calcification details may be observed and determined from a prior 3D rotational data scan (i.e., a diagnostic imaging scan) of the heart. The equipment and processing utilized to conduct the diagnostic imaging scan ( diagnostic imaging equipment 220) may, in an embodiment, transmit the calcification details to the valve clip prediction processor 210. The diagnostic imaging scan may include, but is not limited to, one or more of a rotational 3D data scan, a computed tomography (CT) scan, an MRI, an XA scan, and an Ultrasound));
acquiring a parameter related to the shape of the biological organ so that the estimated shape data becomes similar to the actual shape data ((Sipiorski et al., [0026]) (The equipment may include an ultrasound transducer in a probe for collecting Doppler information of the heart, including various geometric measurements; The Doppler information may provide tissue density information for the leaflets 130, 140 of the valve 100, such as whether the tissue is hard, soft, thick, thin, or other characteristics of interest));
acquiring treatment information ((Sipiorski et al., [0024]) (for predicting an optimal position for a valve clip to be placed and/or an optimal type of valve clip to be used, for repairing the mitral valve; These contributing parameters are inputted to the valve clip prediction processor 210 from various sources. The contributing parameters may include, but are not limited to, calcification details, information from a 3D or 4D model of the valve, valve clip properties, and prior flow simulation)), and
acquiring shape data indicating a shape of the biological organ in a predetermined time phase at a timing after the treatment ((Sipiorski et al., [0024], [0031]) (These contributing parameters are inputted to the valve clip prediction processor from various sources. The contributing parameters may include, but are not limited to, calcification details, information from a 3D or4D model of the valve, valve clip properties, and prior flow simulation; The one or more metrics may be based on the clinical situation and may be entered by a physician, lab technician, user, or the like, and transmitted to the valve clip prediction processor 210 from one or more computing devices)),
estimating, based on the treatment information, the parameter, and the estimated shape data or the actual shape data in a predetermined time phase at the timing before the treatment, a shape of the biological organ at the timing after the treatment over a plurality of time phases ((Sipiorski et al., [0036]) (The simulation may be CPD-simulated to predict at least one of the optimal clip type (e.g. dimension, mass, etc.) and optimal clip position. The simulation may be transmitted to a user interface and displayed in a 3D rotational image and/or as a 2D image. The predicted optimal clip type and position for its placement may be shown overlaid in the image among the displayed valve)).
RE: Claim 19 Sipiorski et al. teaches the claimed:
19. A non-transitory computer readable medium comprising instructions that cause a computer to execute: acquiring estimated shape data indicating estimated a shape of a biological organ at a timing before treatment, and actual shape data indicating the shape of the biological organ at the timing before the treatment ((Sipiorski et al., [0025], [0033]) (calcification details may be observed and determined from a prior 3D rotational data scan (i.e., a diagnostic imaging scan) of the heart. The equipment and processing utilized to conduct the diagnostic imaging scan ( diagnostic imaging equipment 220) may, in an embodiment, transmit the calcification details to the valve clip prediction processor 210. The diagnostic imaging scan may include, but is not limited to, one or more of a rotational 3D data scan, a computed tomography (CT) scan, an MRI, an XA scan, and an Ultrasound; The computer system 710 also includes a system memory 730 coupled to the bus 721 for storing information and instructions to be executed by processors 720. The system memory 730 may include computer readable storage media in the form of volatile and/or nonvolatile memory, such as read only memory (ROM) 731 and/or random access memory (RAM)));
acquiring a parameter related to the shape of the biological organ so that the estimated shape data becomes similar to the actual shape data ((Sipiorski et al., [0025]) (calcification details may be observed and determined from a prior 3D rotational data scan (i.e., a diagnostic imaging scan) of the heart. The equipment and processing utilized to conduct the diagnostic imaging scan ( diagnostic imaging equipment 220) may, in an embodiment, transmit the calcification details to the valve clip prediction processor 210. The diagnostic imaging scan may include, but is not limited to, one or more of a rotational 3D data scan, a computed tomography (CT) scan, an MRI, an XA scan, and an Ultrasound));
acquiring a parameter related to the shape of the biological organ so that the estimated shape data becomes similar to the actual shape data ((Sipiorski et al., [0026]) (The equipment may include an ultrasound transducer in a probe for collecting Doppler information of the heart, including various geometric measurements; The Doppler information may provide tissue density information for the leaflets 130, 140 of the valve 100, such as whether the tissue is hard, soft, thick, thin, or other characteristics of interest));
acquiring treatment information ((Sipiorski et al., [0024]) (for predicting an optimal position for a valve clip to be placed and/or an optimal type of valve clip to be used, for repairing the mitral valve; These contributing parameters are inputted to the valve clip prediction processor 210 from various sources. The contributing parameters may include, but are not limited to, calcification details, information from a 3D or 4D model of the valve, valve clip properties, and prior flow simulation)), and
acquiring shape data indicating a shape of the biological organ in a predetermined time phase at a timing after the treatment ((Sipiorski et al., [0024], [0031]) (These contributing parameters are inputted to the valve clip prediction processor from various sources. The contributing parameters may include, but are not limited to, calcification details, information from a 3D or4D model of the valve, valve clip properties, and prior flow simulation; The one or more metrics may be based on the clinical situation and may be entered by a physician, lab technician, user, or the like, and transmitted to the valve clip prediction processor 210 from one or more computing devices)),
estimating, based on the treatment information, the parameter, and the estimated shape data or the actual shape data in a predetermined time phase at the timing before the treatment, a shape of the biological organ at the timing after the treatment over a plurality of time phases ((Sipiorski et al., [0036]) (The simulation may be CPD-simulated to predict at least one of the optimal clip type (e.g. dimension, mass, etc.) and optimal clip position. The simulation may be transmitted to a user interface and displayed in a 3D rotational image and/or as a 2D image. The predicted optimal clip type and position for its placement may be shown overlaid in the image among the displayed valve)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2012/0232386 A1 teaches valve treatment simulation performed from patient specific imaging data for therapy planning (Abstract);
US 2019/0095589 A1 teaches a system and method for selecting, modeling and analyzing various surgical treatments of mitral valves through simulation based on imaging and Doppler ultrasound data acquired from the mitral valve (Abstract); and
US 2004/0153128 teaches creating a computerized interactive model of a heart based on the patient data and may simulate at least one proposed cardiac intervention by adding or deleting features to the model, and determining the effects of the proposed cardiac simulation upon the entire model, and may be repeated to allow the user to determine an optimal cardiac intervention (Abstract).
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/A.M.B./Examiner, Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682
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