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 .
Information Disclosure Statements
The information disclosure statement (“IDS”) filed on 1/10/2024 were reviewed and the listed references were noted.
Drawings
The 10-page drawings have been considered and placed on record in the file.
Status of Claims
Claims 1-9 are pending
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
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 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter (an abstract idea without significantly more). The claims recite a method, a storage medium, and apparatuses for processing images by identifying regions, adding lines and points, and calculating an angle. With respect to analysis of Claim 1:
Step 1:
With regard to Step 1, the instant claim is directed to an apparatus; and therefore, the claim is directed to one of the statutory categories of inventions.
Step 2A, Prong One:
With regard to 2A, Prong One, the limitations of “ to specify, on a basis of a left atrium region, a left ventricle region, and an aortic valve region rendered in the three-dimensional medical image data, a three-chamber long-axis cross-sectional plane that traverses across these regions; to specify a mitral valve axis on a basis of a first annulus region included in a mitral valve region rendered in the three-dimensional medical image data and the three-chamber long-axis cross-sectional plane; to specify, from the three-chamber long-axis cross-sectional plane, an anterior leaflet region included in the mitral valve region and a second annulus region included in the aortic valve region; to specify an aortic valve axis on a basis of a positional relationship between the anterior leaflet region and the second annulus region on the three-chamber long-axis cross-sectional plane; and to calculate an angle based on the mitral valve axis and the aortic valve axis”, as drafted, recite an abstract idea, such as the combination of an apparatus and using mathematical calculations/drawings that, under their broadest reasonable interpretation, covers the performance of the limitation manually or in the mind of a medical professional. That is, a skilled technician or a doctor may specify different regions of the heart and draw axes on medical image data. The skilled technician or doctor may also calculate an angle based on the axes manually, using a pen and a paper, or even in the mind. This is the concept that falls under the combination of the groupings of abstract ideas of mental processes and mathematical calculations, i.e., a concept performed in the human mind, evaluation, judgement, and/or opinion of a technician/doctor through mathematical calculations to obtain an angle between axes.
Step 2A, Prong Two:
The 2019 PEG defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception. In the instant case, there are no additional elements/limitations in the claims, with the exception of the insignificant extra-solution activities, such as obtaining medical image data of a heart as input data. This limitation is regarded as insignificant extra-solution activity of acquiring medical image data, i.e., gathering input information, which may not be considered as an indication of integration of the judicial exception into a practical application. Accordingly, the above-mentioned additional element/limitation does not integrate the abstract idea into a practical application; and therefore, the claim recites an abstract idea. Additionally, the recited “processing circuitry”, in the claim, merely introduces a generic computer component to perform the abstract idea, and is not regarded as a specialized machine.
Step 2B:
Because the claims fail under Step 2A, the claims are further evaluated under Step 2B. The claims herein do not include additional elements that are sufficient to amount to significantly more than the judicial exception, because as discussed above with respect to integration of the abstract idea into practical application, the additional elements/limitations, amount to no more than insignificant routine and conventional elements. The abstract operation/purpose of the apparatus as listed in Claim 1, cannot provide an inventive concept. Therefore, independent Claim 1 is not patent eligible.
Furthermore, with regard to dependent claims 2-6, viewed individually, these additional elements/limitations, under their broadest reasonable interpretation, are regarded as either providing additional abstract idea (i.e., mathematical calculations or performing the limitations in the mind of a medical technician) or adding limitations that may not be considered as significantly more than the abstract idea; which do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Accordingly, they are not patent eligible.
With respect to analysis of Claim 7:
Step 1:
With regard to Step 1, the instant claim is directed to a method; and therefore, the claim is directed to one of the statutory categories of inventions.
Step 2A, Prong One:
With regard to 2A, Prong One, the limitations of “specifying, on a basis of a left atrium region, a left ventricle region, and an aortic valve region rendered in the three-dimensional medical image data, a three-chamber long-axis cross-sectional plane that traverses across these regions; specifying a mitral valve axis on a basis of a first annulus region included in a mitral valve region rendered in the three-dimensional medical image data and the three-chamber long-axis cross-sectional plane; specifying, from the three-chamber long-axis cross-sectional plane, an anterior leaflet region included in the mitral valve region and a second annulus region included in the aortic valve region; specifying an aortic valve axis on a basis of a positional relationship between the anterior leaflet region and the second annulus region on the three-chamber long-axis cross-sectional plane; and calculating an angle based on the mitral valve axis and the aortic valve axis.”, as drafted, recite an abstract idea, such as the combination of a method and using mathematical calculations/drawings that, under their broadest reasonable interpretation, covers the performance of the limitation manually or in the mind of a medical professional. That is, a skilled technician or a doctor may specify different regions of the heart and draw axes on medical image data. The skilled technician or doctor may also calculate an angle based on the axes manually, using pen and paper, or even in the mind. This is the concept that falls under the combination of the groupings of abstract ideas of mental processes and mathematical calculations, i.e., a concept performed in the human mind, evaluation, judgement, and/or opinion of a technician/doctor through mathematical calculations to obtain an angle between axes.
Step 2A, Prong Two:
The 2019 PEG defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception. In the instant case, there are no additional steps/elements/limitations in the claims, with the exception of the insignificant extra-solution activities, such as obtaining medical image data of a heart as input data. This step is regarded as insignificant extra-solution activity of acquiring medical image data, i.e., gathering input information, which may not be considered as an indication of integration of the judicial exception into a practical application. Accordingly, the above-mentioned additional step/element/limitation does not integrate the abstract idea into a practical application; and therefore, the claim recites an abstract idea. Additionally, the recited “processing circuitry”, merely introduces a generic computer component to perform the abstract idea, and is not regarded as a specialized machine.
Step 2B:
Because the claims fail under Step 2A, the claims are further evaluated under Step 2B. The claims herein do not include additional steps/elements that are sufficient to amount to significantly more than the judicial exception, because as discussed above with respect to integration of the abstract idea into practical application, the additional steps/elements/limitations, amount to no more than insignificant routine and conventional elements. Mere instructions to apply an exception using generic components, such as the ones listed in Claim 7, cannot provide an inventive concept. Therefore, independent Claim 7 is not patent eligible.
With respect to analysis of Claim 9:
Step 1:
With regard to Step 9, the instant claim is directed to an apparatus; and therefore, the claim is directed to one of the statutory categories of inventions.
Step 2A, Prong One:
With regard to 2A, Prong One, the limitations of “to specify, on a basis of an atrium region, a ventricle region, and a second valve region rendered in the three-dimensional medical image data, a long-axis cross-sectional plane that traverses across these regions; to specify a first valve axis on a basis of a first annulus region included in a first valve region rendered in the three-dimensional medical image data and the long-axis cross-sectional plane; to specify, from the long-axis cross-sectional plane, an anterior leaflet region included in the first valve region and a second annulus region included in the second valve region; to specify a second valve axis on a basis of a positional relationship between the anterior leaflet region and the second annulus region on the long-axis cross-sectional plane; and to calculate an angle based on the first valve axis and the second valve axis”, as drafted, recite an abstract idea, such as the combination of an apparatus and using mathematical calculations/drawings that, under their broadest reasonable interpretation, covers the performance of the limitation manually or in the mind of a medical professional. That is, a skilled technician or a doctor may specify different regions of the heart and draw axes on medical image data. The skilled technician or doctor may also calculate an angle based on the axes manually, using pen and paper, or even in the mind. This is the concept that falls under the combination of the groupings of abstract ideas of mental processes and mathematical calculations, i.e., a concept performed in the human mind, evaluation, judgement, and/or opinion of a technician/doctor through mathematical calculations to obtain an angle between axes.
Step 2A, Prong Two:
The 2019 PEG defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception. In the instant case, there are no additional elements/limitations in the claims, with the exception of the insignificant extra-solution activities, such as obtaining medical image data of a heart as input data. This limitation is regarded as insignificant extra-solution activity of acquiring medical image data, i.e., gathering input information, which may not be considered as an indication of integration of the judicial exception into a practical application. Accordingly, the above-mentioned additional element/limitation does not integrate the abstract idea into a practical application; and therefore, the claims recite an abstract idea. Additionally, the recited “processing circuitry”, merely introduces a generic computer component to perform the abstract idea, and is not regarded as a specialized machine.
Step 2B:
Because the claims fail under Step 2A, the claims are further evaluated under Step 2B. The claims herein do not include additional elements that are sufficient to amount to significantly more than the judicial exception, because as discussed above with respect to integration of the abstract idea into practical application, the additional elements/limitations, amount to no more than insignificant routine and conventional elements. The abstract operation/purpose of the apparatus as listed in Claim 9, cannot provide an inventive concept. Therefore, independent Claim 9 is not patent eligible.
Claim 8 is also rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter as follows.
Consider independent Claim 8, Claim 8 is directed to “A storage medium”. The specification only provides examples of “a storage medium” (See Page 4 of Applicant’s specification). The broadest reasonable interpretation of a claim drawn to a storage medium typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent. See Subject Matter Eligibility of Computer Readable Media, 1351 OG 212 (26 Jan 2010). See MPEP 2111.01. Signals are nothing but the physical characteristics of a form of energy, and as such is non-statutory natural phenomena. See, e.g., In re Nuitjen, 500 F. 3d 1246, 1357 (Fed. Cir. 2007) (slip. op. at 18) (“A transitory, propagating signal like Nuitjen’s is not a process, machine, manufacture, or composition of matter.’ … Thus, such a signal cannot be patentable subject matter.”). Thus, Claim 8 is rejected under 35 U.S.C. 101, because the claimed invention is directed to non-statutory subject matter. The instant rejection of claim 8 may be overcome if Applicant amends the claim to recite: “A non-transitory computer-readable storage medium storing therein a program for: …”.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kuhara et al. (US 10,203,385 B2), in view of Lutter et al. (“Transcatheter Mitral Valve Replacement (TMVR): annular or apical fixation?”), in further view of Huysmans et al. (US 2022/0096160 w/ EFD of April 29, 2020).
Regarding claim 1, Kuhara teaches “A medical image processing apparatus comprising processing circuitry configured: to obtain three-dimensional medical image data rendering a heart” (Kuhara, Column 3, lines 25-38 discloses; “The magnetic resonance apparatus of the present embodiment includes: a gantry which includes a static field magnet, a gradient coil and an RF coil to image an object; processing circuitry; and a memory that stores processor-executable instructions that, when executed by the processing circuitry, cause the processing circuitry to detect at least one position of an aortic valve and a pulmonary valve from three-dimensional image data including a heart of the object, as at least one characteristic region inside the heart, specify a position of an imaging cross-section substantially orthogonal to a bloodstream path inside the heart based on the position of the aortic valve or the pulmonary valve, and cause the gantry to image the imaging cross-section of the object at the specified position of the imaging cross-section.”), “to specify, on a basis of a left atrium region, a left ventricle region, and an aortic valve region rendered in the three-dimensional medical image data, a three-chamber long-axis cross-sectional plane that traverses across these regions” (Kuhara, Column 8, Lines 6-11 discloses; “Because an imaged picture of the cross-section passing through the respective center positions of the mitral valve, the left ventricular apex and the aortic valve can satisfactorily depict the left ventricle, the left atrium and the left ventricular outflow tract, it is called a three-chamber long axis plane (or three-chamber plane)”). Kuhara does not explicitly teach “to specify a mitral valve axis on a basis of a first annulus region included in a mitral valve region rendered in the three-dimensional medical image data and the three-chamber long-axis cross-sectional plane; to specify, from the three-chamber long-axis cross-sectional plane, an anterior leaflet region included in the mitral valve region and a second annulus region included in the aortic valve region; and to calculate an angle based on the mitral valve axis and the aortic valve axis”. Since Kuhara does not explicitly disclose these limitations, Examiner relies on the teachings of Lutter, in an analogous field of endeavor. Specifically, Lutter discloses, “to specify a mitral valve axis on a basis of a first annulus region included in a mitral valve region rendered in the three-dimensional medical image data and the three-chamber long-axis cross-sectional plane” (Lutter Pg 4, Figure 2 discloses; “L2: projection line of the mitral annulus. L4: central axis of the mitral annulus”). Examiner interprets “L4” of Lutter to be a mitral valve axis on a basis of an annulus region. Although not in a three-chamber long-axis cross-sectional plane, it would have been obvious to one skilled in the art before the effective filing date of the claimed invention to add this axis disclosed by Lutter to the three-chamber long-axis cross-sectional plane as disclosed by Kuhara. Lutter also discloses, “to specify, from the three-chamber long-axis cross-sectional plane, an anterior leaflet region included in the mitral valve region and a second annulus region included in the aortic valve region” (Lutter, Pg 6, “Discussion” & Figure 5 discloses; “In some TMVR implants, the anterior leaflet may displace the implants. As shown in Figure 5, the AML was pushed towards the aortic annulus which might be the cause of increased AMA after TMVR”). Examiner interprets Figure 5 of Lutter to specify an anterior leaflet region, and “Discussion” of Lutter to specify a second annulus region (“aortic annulus”). Lutter further discloses, “to calculate an angle based on the mitral valve axis and the aortic valve axis” (Lutter, Pg 3, “Measurements” & Figure 2 discloses; “The AMA was defined as the angle formed by the centre axis of the aortic annulus and the mitral annulus before implantation”).
Kuhara and Lutter are both considered to be analogous to the claimed invention because they are in the same field of using medical images of a heart to identify different regions of the heart. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kuhara to incorporate the teachings of Lutter in order to specify different regions and calculate an angle based on axes (as disclosed by Lutter) in a three-chamber long-axis cross-sectional plane (as disclosed by Kuhara). One of ordinary skill in the art would have been motivated to combine the previously described apparatus of Kuhara with the teachings of Lutter to get a more in-depth diagnostic analysis in a three-chamber long-axis cross-sectional plane of a heart. Accordingly, it would have been obvious to combine Kuhara and Lutter to obtain the above specified limitations.
In further regard to claim 1, the combination of Kuhara in view of Lutter does not explicitly teach “to specify an aortic valve axis on a basis of a positional relationship between the anterior leaflet region and the second annulus region on the three-chamber long-axis cross-sectional plane”. Since the combination of Kuhara and Lutter does not explicitly disclose this limitation, Examiner relies on the teachings of Huysmans, in an analogous field of endeavor. Specifically, Huysmans discloses, “to specify an aortic valve axis on a basis of a positional relationship between the anterior leaflet region and the second annulus region on the three-chamber long-axis cross-sectional plane” (Huysmans, Pg 5, Para. 0045 & 0046 discloses and Figure 5B; “For example, the plane of the aortic valve may be determined as the best-fit plane through the aortic cusps, or a plane through a plurality of points around the aortic valve. In one example, the plane may correspond to plane 522 of the heart 500 shown in FIG. 5B … For example, as shown in FIG. 5B, the plane 522 is translated or moved along an axis 524”). Examiner interprets “the anterior leaflet region” and “the second annulus region” to fall within “aortic cusps” and “a plurality of points around the aortic valve”.
The combination of Kuhara and Lutter in view of Huysmans are considered to be analogous to the claimed invention because they are all in the same field of using medical images of a heart to identify different regions of the heart. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Kuhara and Lutter to incorporate the teachings of Huysmans in order to specify an aortic axis based on the anterior leaflet region and the second annulus region (as disclosed by Huysmans) in a three-chamber long-axis cross-sectional plane (as disclosed by the combination of Kuhara and Lutter). One of ordinary skill in the art would have been motivated to combine the previously described apparatus of the combination of Kuhara and Lutter with the teachings of Huysmans to get a full diagnostic analysis in a three-chamber long-axis cross-sectional plane of a heart. Accordingly, it would have been obvious to combine the combination of Kuhara in view of Lutter and Huysmans to obtain the invention in claim 1.
Claim 7 recites a method with steps corresponding to the elements of the apparatus recited in Claim 1. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding apparatus claim. Additionally, the rationale and motivation to combine the Kuhara and Lutter references, presented in the rejection of claim 1, apply to this claim. Moreover, the rationale and motivation to combine the combination of Kuhara in view of Lutter and Huysmans references, presented in the rejection of claim 1, apply to this claim.
Claim 8 recites a computer-readable storage medium storing a program with instructions corresponding to the steps recited in claim 7. Therefore, the recited programming instructions of this claim are mapped to the proposed combination in the same manner as the corresponding steps in its corresponding method claim. Additionally, the rationale and motivation to combine the Kuhara and Lutter references, presented in the rejection of claim 7, apply to this claim. Moreover, the rationale and motivation to combine the combination of Kuhara in view of Lutter and Huysmans references, presented in the rejection of claim 7, apply to this claim. Finally, the combination of Kuhara and Lutter and Huysmans references discloses a computer readable storage medium (Huysmans, Pg. 9, Claim 14 discloses; “A non-transitory computer-readable medium having computer-executable instructions stored thereon, which, when executed by a processor of a computing device, cause the computing device to perform a method”).
Regarding claim 9, the combination of Kuhara in view of Lutter in further view of Huysmans discloses, “A medical image processing apparatus comprising processing circuitry configured: to obtain three-dimensional medical image data” (Kuhara, Column 3, lines 25-38 discloses; “The magnetic resonance apparatus of the present embodiment includes: a gantry which includes a static field magnet, a gradient coil and an RF coil to image an object; processing circuitry; and a memory that stores processor-executable instructions that, when executed by the processing circuitry, cause the processing circuitry to detect at least one position of an aortic valve and a pulmonary valve from three-dimensional image data including a heart of the object, as at least one characteristic region inside the heart, specify a position of an imaging cross-section substantially orthogonal to a bloodstream path inside the heart based on the position of the aortic valve or the pulmonary valve, and cause the gantry to image the imaging cross-section of the object at the specified position of the imaging cross-section.”), “rendering an atrium, a ventricle, a first valve positioned between the atrium and the ventricle, and a second valve positioned between the ventricle and an artery; to specify, on a basis of an atrium region, a ventricle region, and a second valve region rendered in the three-dimensional medical image data, a long-axis cross-sectional plane that traverses across these regions” (Kuhara, Column 8, Lines 6-11 discloses; “Because an imaged picture of the cross-section passing through the respective center positions of the mitral valve, the left ventricular apex and the aortic valve can satisfactorily depict the left ventricle, the left atrium and the left ventricular outflow tract, it is called a three-chamber long axis plane (or three-chamber plane)”). “to specify a first valve axis on a basis of a first annulus region included in a first valve region rendered in the three-dimensional medical image data and the long-axis cross-sectional plane” (Lutter Pg 4, Figure 2 discloses; “L2: projection line of the mitral annulus. L4: central axis of the mitral annulus”). Examiner interprets “L4” of Lutter to be a first valve axis on a basis of a first annulus region. Although not in a three-chamber long-axis cross-sectional plane, it would have been obvious to one skilled in the art before the effective filing date of the claimed invention to add this axis disclosed by Lutter to the three-chamber long-axis cross-sectional plane as disclosed by Kuhara. The combination of Kuhara in view of Lutter in further view of Huysmans also discloses, “to specify, from the long-axis cross-sectional plane, an anterior leaflet region included in the first valve region and a second annulus region included in the second valve region” (Lutter, Pg 6, “Discussion” & Figure 5 discloses; “In some TMVR implants, the anterior leaflet may displace the implants. As shown in Figure 5, the AML was pushed towards the aortic annulus which might be the cause of increased AMA after TMVR”). Examiner interprets Figure 5 of Lutter to specify an anterior leaflet region, and “Discussion” of Lutter to specify a second annulus region (“aortic annulus”). The combination of Kuhara in view of Lutter in further view of Huysmans further discloses, “to specify a second valve axis on a basis of a positional relationship between the anterior leaflet region and the second annulus region on the long-axis cross-sectional plane” (Huysmans, Pg 5, Para. 0045 & 0046 discloses and Figure 5B; “For example, the plane of the aortic valve may be determined as the best-fit plane through the aortic cusps, or a plane through a plurality of points around the aortic valve. In one example, the plane may correspond to plane 522 of the heart 500 shown in FIG. 5B … For example, as shown in FIG. 5B, the plane 522 is translated or moved along an axis 524”). Examiner interprets “the anterior leaflet region” and “the second annulus region” to fall within “aortic cusps” and “a plurality of points around the aortic valve”. Finally, the combination of Kuhara in view of Lutter in further view of Huysmans discloses, “to calculate an angle based on the first valve axis and the second valve axis” (Lutter, Pg 3, “Measurements” & Figure 2 discloses; “The AMA was defined as the angle formed by the centre axis of the aortic annulus and the mitral annulus before implantation”). The proposed combination as well as the motivation for combining the Kuhara, Lutter and Huysmans references presented in the rejection of claim 1, apply to claim 9 and are incorporated herein by reference. Thus, the method recited in claim 9 is met by Kuhara, Lutter and Huysmans.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kuhara in view of Lutter in further view of Huysmans and still in view of Peters et al. (US 2023/0126342 A1 w/ EFD of April 16, 2020).
Regarding claim 2, the combination of Kuhara in view of Lutter in further view of Huysmans teaches the medical image processing apparatus according to claim 1, “wherein the processing circuitry is configured to specify the three-chamber long-axis cross-sectional plane” (Kuhara, Column 8, Lines 6-11 discloses; “Because an imaged picture of the cross-section passing through the respective center positions of the mitral valve, the left ventricular apex and the aortic valve can satisfactorily depict the left ventricle, the left atrium and the left ventricular outflow tract, it is called a three-chamber long axis plane (or three-chamber plane)”). The combination of Kuhara, Lutter, and Huysmans does not explicitly teach “on a basis of center-of-gravity coordinates of the left atrium region, coordinates of a tip end of the left ventricle region, and center-of-gravity coordinates of the aortic valve region”. Since the combination of Kuhara, Lutter, and Huysmans does not explicitly disclose these limitations, Examiner relies on the teachings of Peters, in an analogous field of endeavor. Specifically, Peters discloses, “on a basis of center-of-gravity coordinates of the left atrium region, coordinates of a tip end of the left ventricle region, and center-of-gravity coordinates of the aortic valve region” (Peters, Pg. 4, Para. 0066 discloses; “Purely by way of example, where the 3D image is an image of a heart, a 2D image of a desired target view can use several “landmarks” such as the LV apex, a center point of some valves, or centers of gravity of some heart chambers”). Examiner interprets “centers of gravity of some heart chambers” to include that of the left atrium and “center point of some valves” to include that of the aortic valve.
The combination of Kuhara in view of Lutter in further view of Huysmans and Peters are both considered to be analogous to the claimed invention because they are in the same field of using medical images of a heart to identify different regions of the heart. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Kuhara, Lutter, and Huysmans to incorporate the teachings of Peters in order to base the three-chamber long-axis cross-sectional plane (as disclosed by the combination of Kuhara, Lutter, and Huysmans) on the center of gravity of different heart chambers (as disclosed by Peters). Using these known methods in the art would yield predictable results. One of ordinary skill in the art would have been motivated to combine the previously described apparatus of the combination of Kuhara, Lutter, and Huysmans with the teachings of Peters to get the best view of the three chambers of the heart, which would be based on centers of gravities. Accordingly, it would have been obvious to combine the combination of Kuhara in view of Lutter in further view of Huysmans and Peters to obtain the invention in claim 2.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kuhara in view of Lutter in further view of Huysmans and still in view of Loghin et al. (“Role of Imaging in Novel Mitral Technologies – Echocardiography and Computed Tomography”)
Regarding claim 3, the combination of Kuhara in view of Lutter in further view of Huysmans teaches “to derive a straight line that passes through two intersection points at which the three-chamber long-axis cross-sectional plane intersects the first annulus region” (Lutter Pg 4, Figure 2 discloses; “L2: projection line of the mitral annulus. L4: central axis of the mitral annulus” and Kuhara, Column 8, Lines 6-11 discloses; “Because an imaged picture of the cross-section passing through the respective center positions of the mitral valve, the left ventricular apex and the aortic valve can satisfactorily depict the left ventricle, the left atrium and the left ventricular outflow tract, it is called a three-chamber long axis plane (or three-chamber plane)”). It is inherent that the mitral annulus of Lutter would intersect the three-chamber long-axis cross-sectional plane of Kuhara. The combination of Kuhara in view of Lutter in further view of Huysmans does not explicitly disclose “to specify a straight line that is orthogonal to the straight line and passes through a middle point between sets of coordinates of the two intersection points, as the mitral valve axis”. Since the combination of Kuhara, Lutter, and Huysmans does not explicitly disclose these limitations, Examiner relies on the teachings of Loghin, in an analogous field of endeavor. Specifically, Loghin discloses, “to specify a straight line that is orthogonal to the straight line and passes through a middle point between sets of coordinates of the two intersection points, as the mitral valve axis” (Loghin Pg. 2, “Mitral Valve – Functional Anatomy” discloses; “The mitral annulus “trajectory”, defined as a vector orthogonal to the annulus “plane””). Examiner interprets the “mitral valve axis” to be the same as “mitral annulus trajectory”.
The combination of Kuhara in view of Lutter in further view of Huysmans and Loghin are both considered to be analogous to the claimed invention because they are in the same field of using medical images of a heart to identify different regions of the heart. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Kuhara, Lutter, and Huysmans to incorporate the teachings of Loghin in order to use the three-chamber long-axis cross-sectional plane (as disclosed by the combination of Kuhara, Lutter, and Huysmans) to specify a mitral valve axis that is orthogonal to the mitral annulus (as disclosed by Peters). Using these known methods in the art would yield predictable results. One of ordinary skill in the art would have been motivated to combine the previously described apparatus of the combination of Kuhara, Lutter, and Huysmans with the teachings of Loghin to specify a mitral valve axis in the three-chamber long-axis cross-sectional plane. Accordingly, it would have been obvious to combine the combination of Kuhara in view of Lutter in further view of Huysmans and Loghin to obtain the invention in claim 3.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kuhara in view of Lutter in further view of Huysmans and still in view of Ruile et al. (“Fusion of Pre- and Post- Procedural Computed Tomography Angiography in Transcatheter Aortic Valve Implantation Patients: Evaluation of Prosthesis Position and its Influence on New Conduction Disturbances”)
Regarding claim 6, the combination of Kuhara in view of Lutter in further view of Huysmans teaches, “the processing circuitry is configured to specify the mitral valve axis, on the basis of the first annulus region included in the mitral valve region rendered in the three-dimensional medical image data and the three-chamber long-axis cross-sectional plane” (Lutter Pg 4, Figure 2 discloses; “L2: projection line of the mitral annulus. L4: central axis of the mitral annulus” and Kuhara, Column 8, Lines 6-11 discloses; “Because an imaged picture of the cross-section passing through the respective center positions of the mitral valve, the left ventricular apex and the aortic valve can satisfactorily depict the left ventricle, the left atrium and the left ventricular outflow tract, it is called a three-chamber long axis plane (or three-chamber plane)”). The combination of Kuhara in view of Lutter in further view of Huysmans does not explicitly disclose, “the mitral valve region corresponding to a situation where equipment is placed on a mitral valve and including a region where the mitral valve was present prior to the placement of the equipment”. Since the combination of Kuhara, Lutter, and Huysmans does not explicitly disclose these limitations, Examiner relies on the teachings of Ruile, in an analogous field of endeavor. Specifically, Ruile discloses, “(Ruile, Abstract discloses; “The purpose of this study was to evaluate prosthesis position by fusion of pre- and post-transcatheter aortic valve implantation (TAVI) computed tomography angiography (CTA) images and to investigate its influence on the occurrence of new conduction disturbances (CD)” and “Fusion imaging of pre- and post-TAVI-CTA allows for the exact evaluation of THV position in relation to the native annulus plane”). Figure 1 of Ruile also discloses the fusion of the pre-op and post-op images, in which the implant and native valve are visible. It is inherent that this image processing technique can be applied to the mitral valve as well as the aortic valve, as disclosed by Ruile.
The combination of Kuhara in view of Lutter in further view of Huysmans and Ruile are both considered to be analogous to the claimed invention because they are in the same field of using medical images of a heart to identify different regions of the heart for potential diagnosis. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Kuhara, Lutter, and Huysmans to incorporate the teachings of Ruile in order to use the three-chamber long-axis cross-sectional plane (as disclosed by the combination of Kuhara, Lutter, and Huysmans) to picture the native mitral valve along with equipment pictured on the mitral valve (as disclosed by Ruile). Using these known methods in the art would yield predictable results. One of ordinary skill in the art would have been motivated to combine the previously described apparatus of the combination of Kuhara, Lutter, and Huysmans with the teachings of Ruile to evaluate the position and placement of mitral valve equipment in comparison to the native valve. Accordingly, it would have been obvious to combine the combination of Kuhara in view of Lutter in further view of Huysmans and Loghin to obtain the invention in claim 6.
Allowable Subject Matter
Claims 4 and 5 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/JUSTIN M OAKES/Examiner, Art Unit 2662
/Siamak Harandi/Primary Examiner, Art Unit 2662