DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
Regarding independent claim 10, only one of steps (i)-(vi) is required since the broadest reasonable interpretation of the claim limitations has them listed as optional alternatives. That is, only one of the steps preceded by roman numerals is required because of the “and/or” conjunction with broadest reasonable interpretation being “or”.
Regarding claim 4, claim 4 incorporates all contents of Table 1 by reference with the claim language, “the tensor data comprises the data set out in Table 1”.
Claim Objections
Claim 9 is objected to because of the following informalities: each claim should be only one sentence with a single period at the end. However, claim 9 has a period at the end of step (f) and another at the end of (g). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9 and 12 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 9 recites the limitation "the matching plurality of segments" in line 5. There is insufficient antecedent basis for this limitation in the claim. One cannot know which matching plurality of segments are being referred to.
Claim 12 recites the limitation "the triangles" in line 1. There is insufficient antecedent basis for this limitation in the claim. One cannot know which triangles are being referred to.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5889524 A (Sheehan).
As per claim 10, Sheehan teaches a method for measuring a change in magnitude and/or direction of a heart chamber during a heart cycle (these limitations within the preamble are recited as intended use and are not required), wherein the method comprises the steps of:
(a) collecting a plurality of images associated with the heart chamber during the heart cycle (Sheehan:
Fig. 1: mainly 12; Fig. 2: mainly 42;
Col 7, lines 30-35: “In general, in a block 12 of FIG. 1, the data for a heart are acquired by imaging the heart in multiple planes whose location and orientation in three-dimensional space are known.”); and
(b) operating one or more processors to:
(i) generate two or more three-dimensional models of the chamber during the heart cycle using the plurality of images (Sheehan:
abstract: “An abstract model of a generalized left ventricle is generated that fits a wide range of sizes and shapes of this portion of the heart.”;
Fig. 1 (shown below): mainly 16);
(ii) overlay a mesh on each of the two or more three-dimensional models of the chamber (Sheehan:
abstract: “The abstract model includes an abstract control mesh in which the anatomic features are labeled and sharp (edge) characteristics are identified. Coordinates are assigned to the abstract control mesh, producing an initial embedded mesh”;
Col 5, lines 10-15: “An abstract control mesh is generated, which is designed to fit the left ventricle for any of a variety or wide range of normal and diseased hearts.”;
Fig. 1 (shown below): mainly 18);
(iii) divide the mesh into a plurality of segments (Sheehan:
abstract: “Coordinates are assigned to the abstract control mesh, producing an initial embedded mesh, which is then subdivided twice to increase its smoothness. The embedded subdivided mesh is rigidly aligned with the data set points of the patient's left ventricle, and in particular, with the anatomic features. Finally, the aligned subdivided mesh is optimally fit to the data set points and anatomic features, yielding the reconstructed surface of the organ.”;
col 5, lines 15-30: “The abstract control mesh contains a plurality of abstract features, each consisting of a set of vertices, edges, and/or faces corresponding to an anatomic landmark on the object. For example, anatomic landmarks for the left ventricle might include the mitral annulus, which is defined as a set of edges, the apex, which is defined as a point, and the septum, which is defined as a set of contiguous faces. The abstract vertices, edges, and faces are labeled according to their location relative to various abstract features, providing means for identifying locations on the object, e.g., on the left ventricle. When the abstract control mesh is fit to the input point data sets of an object such as the left ventricle”;
Fig. 1 (shown below): mainly 20;
Fig. 19 (shown below): mainly 152;
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(iv) measure the change in magnitude and/or direction of each of the plurality of segments during the heart cycle (Sheehan: These limitations are not required because they are recited as optional alternative step because of the “and/or” conjunction, below, with broadest reasonable interpretation being “or”);
(v) determine one or more vectors for each of the segments based on the change in magnitude and/or direction (Sheehan: These limitations are not required because they are recited as optional alternative step because of the “and/or” conjunction with broadest reasonable interpretation being “or”); and/or (only one of the steps preceded by roman numerals is required because of the “and/or” conjunction with broadest reasonable interpretation being “or”)
(vi) determine one or more tensors based on the one or more vectors for each of the segments; wherein the tensors represent volume and function of the heart chamber during the heart cycle (Sheehan: These limitations are not required because they are recited as optional alternative step because of the “and/or” conjunction, above, with broadest reasonable interpretation being “or”).
As per claim 11, Sheehan teaches the method of claim 10 wherein step (b) further comprises a user selecting a plurality of triangles within the mesh to generate a single segment within the mesh (Sheehan: These limitations are not required because they pertain to limitations recited as an optional alternative step above).
As per claim 12, Sheehan teaches the method of claim 10 wherein the triangles are contiguous or non-contiguous triangles (Sheehan: See arguments and citations offered in rejecting claim 10 above;
Figs. 10-13B: triangles are contiguous;
Col 5, lines 20-25: “contiguous faces”;
Col 13, lines 24-35: “FIG. 10 illustrates one abstract control mesh for the left ventricle…
Note that the faces "CAS", "BASl", "MASl", and "AAS" are contiguous or joined with faces "CIS", "BISl", "MISl", and "AIS", respectively, as the model is a continuous surface”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1 is rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0312527 A1 (Masumoto) in view of Sheehan.
As per claim 1, Masumoto teaches a method for measuring a change in magnitude and/or direction of movement of a heart chamber during a heart cycle (these limitations within the preamble are recited as intended use and are not required), wherein the method comprises the steps of:
(a) collecting a plurality of 2D images associated with the heart chamber during the heart cycle (Masumoto:
abstract: “A position obtainment means obtains the positions of points in the heart of a subject that are present in at least two three-dimensional volume datasets in a group of three-dimensional volume datasets that have been obtained, by imaging the heart of the subject at predetermined time intervals, the points anatomically corresponding to each other, and the at least two three-dimensional volume datasets having been obtained by imaging at different time from each other”;
para 9: “a volume data storage means for storing a group of three-dimensional volume datasets that have been obtained by imaging the heart of a subject at predetermined time intervals”;
para 42: “The volume data storage means 10 stores a group 110 of three-dimensional datasets, which includes a plurality of three-dimensional volume datasets 100 that have been obtained by imaging the heart of a subject at predetermined time intervals”;
para 43: “The three-dimensional volume dataset 100 is obtained by superposing, one on another, two-dimensional slice image datasets that are sequentially obtained along a direction perpendicular to the slice planes of a diagnosis target, such as a heart. The three-dimensional volume dataset 100 is generated by superposing, one on another, a plurality of tomographic images obtained by a CT apparatus, a MRI apparatus or the like”;
Note that 3D tomographic images are comprised of 2D image slices.);
(b) generating a plurality of segments of the heart chamber during the heart cycle using segment generation and assigning each of the plurality of segments to a surface of an anatomical position associated with the heart chamber (Masumoto:
Para 4: “Then, outlines Rl and R3 of the cardiac muscle wall (inner surface) at a cross section on a line intersecting the same position of long axis L are obtained”;
Para 21 (cited below): points of the heart, ventricle;
Paras 23, 27, 49, 50, 55 (cited below): ventricle;
para 47 (cited below): positions, points;
para 50: “The amount of motion of the wall is a difference between the diameter of the cardiac ventricle in diastole and that of the cardiac ventricle in systole.”
Para 55: “the function information obtainment means 30 obtains an amount of displacement of corresponding points, an amount of change in the thickness of the cardiac wall, a rate of increase in the thickness of the cardiac wall, an amount of motion of the cardiac wall or the like, as function information.”;
Note that the points on the ventricle wall surface are segments); and
(c) quantifying an angle and a displacement of each of the plurality of segments assigned to the surface of the anatomical position from an (Masumoto:
Abstract: “A function information obtainment means obtains, based on each of the positions of the points in the heart, which have been obtained by the position obtainment means, function information representing the function of the heart at each point within a three-dimensional space. A display means displays, based on the function information, the motion function of the heart at each of the points in an image that has the shape of the heart of the subject.”;
Para 10: “a position obtainment means for obtaining the positions of points in the heart that are present in at least two three-dimensional volume datasets in the group of three-dimensional volume datasets, the points anatomically corresponding to each other, and the at least two three-dimensional volume datasets having been obtained by imaging at different time from each other”;
Para 21: “The "function information representing the function of the heart" is an index for evaluating the motion function of the heart. For example, the function information is obtained from an amount of displacement when corresponding points of the heart have moved, the thickness of the cardiac wall, the diameter of the ventricle (cardiac ventricle) or the like.”;
Para 23: “The function information may represent a difference between the diameter of a cardiac ventricle in diastole and that of the cardiac ventricle in systole at each of the points”;
Para 24: “the function information may represent an amount of displacement between the corresponding points”;
Para 26: “the positions of points in a heart that are present in at least two three-dimensional volume datasets that have been obtained at different time from each other, the points anatomically corresponding to each other, are obtained…
evaluate the motion function of the heart so that the actual function of the heart”;
para 27: “the function of the heart may be evaluated by obtaining an amount of displacement of corresponding points in the heart…
a difference between the diameter of a cardiac ventricle in diastole and that of the cardiac ventricle in systole. Accordingly, it becomes possible to quantitatively express the motion function of the heart”;
para 47: “position-matching (positioning or registration) is performed between two three-dimensional volume datasets 100 that have been obtained in different phases…
Position-matching is performed in such a manner that the voxel value of the three-dimensional volume dataset in one phase (at time t) and that of the three-dimensional volume dataset in the other phase (at time t+ .DELTA.t) become the same. Accordingly, the positions of points in the heart that anatomically correspond to each other are obtained…
position-matching is sequentially performed between, at least two three-dimensional volume datasets that have been obtained in different phases. Accordingly, it is possible to obtain the positions of the anatomically corresponding points in the heart at least in two different phases”;
para 49: “The function information obtainment means 30 obtains, based on the position of each of anatomically corresponding points in the heart, function information representing the function of the heart by using at least two three-dimensional volume datasets 100. The motion function of the heart is evaluated based on the motion of the heart, which repeats relaxation and contraction…
The function of the heart can be evaluated based on an amount of displacement of corresponding points in the heart…
the function information is obtained from the amount of displacement of corresponding points in the heart in different phases”;
para 50: “as the function information, an amount of displacement of corresponding points in a cardiac wall…
The amount of motion of the wall is a difference between the diameter of the cardiac ventricle in diastole and that of the cardiac ventricle in systole”;
Para 51 (shown below): “color components r, g and b are assigned to each of points in the cardiac wall in such a manner that the color components r, g and b correspond to the sizes of components x, y and z of a three-dimensional vector representing displacement of the respective points.”: Note that a vector of displacement indicates magnitude and direction, which is an angle;
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Para 54: “the position obtainment means 20 obtains the positions of points in the heart, the points anatomically corresponding to each other and being present in each of three-dimensional volume datasets in the group 110 of three-dimensional volume datasets (step S101). The motion of the heart includes, twisting motion because of the presence of diastole and systole.”;
Para 55: “the function information obtainment means 30 obtains an amount of displacement of corresponding points, an amount of change in the thickness of the cardiac wall, a rate of increase in the thickness of the cardiac wall, an amount of motion of the cardiac wall or the like, as function information. These kinds of function information are obtained based on the positions of points in the heart that anatomically correspond to each other, the thickness of the cardiac muscle or the diameter of the cardiac ventricle in at least two three-dimensional volume datasets (step S102).”
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Masumoto is silent regarding end diastolic and end systolic (emphasis added).
Sheehan teaches end diastolic and end systolic (Sheehan:
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Col 7, lines 35-40: “end diastole and end systole in a block 14, producing an input data set that includes points representing the locations of the anatomic landmarks.”;
Col 10, lines 45-55: “an end diastole and an end systole will be selected for each of the image planes. The end diastole frames represent the left ventricle at the time of the greatest chamber area, and similarly, the image planes at end systole will be selected to represent the left ventricle when it has the smallest chamber area”;
Col 11, lines 30-40: “a model of the endocardial surface at both end diastole and end systole, representing the location of the endocardial surface at the two extreme chamber volume conditions during a cardiac cycle, is created using the data developed for each image plane at the end diastole and end systole times during the cardiac cycle. The second model is used in determining the range of motion for different portions of the left ventricle.”;
Col 14, lines 45-50: “The end diastolic frame is selected as the frame occurring on the R-wave of the electrocardiogram, or as the frame in which the left ventricular chamber area appears to be of maximal size. The end systolic frame is selected as the frame of minimal left ventricular chamber area.”).
Thus, it would have been obvious for one of ordinary skill in the art, prior to filing, to implement the teachings of Sheehan into Masumoto since both Masumoto and Sheehan suggest a practical solution and field of endeavor of segmenting heart ventricles, determining surface points, and determining range of motion between systole and diastole in general and Sheehan additionally provides teachings that can be incorporated into Masumoto in that the systole and diastole are specifically end-systole and end diastole as for “representing the location of the endocardial surface at the two extreme chamber volume conditions during a cardiac cycle” (Sheehan: Col 11, lines 30-40). The teachings of Sheehan can be incorporated into Masumoto in that he systole and diastole are specifically end-systole and end diastole. Furthermore, one of ordinary skill in the art could have combined the elements as claimed by known methods and, in combination, each component functions the same as it does separately. One of ordinary skill in the art would have recognized that the results of the combination would be predictable.
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Masumoto in view of Sheehan as applied to claim 1 above, and further in view of US 20140071125 A1 (Burlina).
As per claim 2, Masumoto in view of Sheehan teaches the method of claim 1 further comprising:
(d) determining a plurality of vectors for each of the plurality of segments based on the change in magnitude and direction (Masumoto: See arguments and citations offered in rejecting claim 1 above: para 51: “Specifically, color components r, g and b are assigned to each of points in the cardiac wall in such a manner that the color components r, g and b correspond to the sizes of components x, y and z of a three-dimensional vector representing displacement of the respective points.”); and
(e) determining a (Masumoto: See arguments and citations offered in rejecting claim 1 above;
Para 51 (shown above): “color components r, g and b are assigned to each of points in the cardiac wall in such a manner that the color components r, g and b correspond to the sizes of components x, y and z of a three-dimensional vector representing displacement of the respective points.”: Note that a vector of displacement indicates magnitude and direction, which is an angle).
Masumoto in view of Sheehan does not teach tensor.
Burlina teaches determining a tensor data based on the plurality of vectors (Burlina: para 645: “computing displacement vectors for voxels of the time-sequential series of frames with an energy function that includes a first-order brightness-constancy function that penalizes differences in voxel values between adjacent image frames, and a spatiotemporal smoothness function that penalizes tensor gradient in flow vectors at each voxel based on magnitudes of the gradients”;
[0159] A structure tensor, also referred to as a second-moment matrix, is a matrix derived from the gradient of a function. The structure tensor summarizes the predominant directions of the gradient in a specified neighborhood of a point, and a degree to which those directions are coherent.
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Thus, it would have been obvious for one of ordinary skill in the art, prior to filing, to implement the teachings of Burlina into Masumoto in view of Sheehan since both Masumoto in view of Sheehan and Burlina suggest a practical solution and field of endeavor of a determining heart health and a displacement vector in general and Burlina additionally provides teachings that can be incorporated into Masumoto in view of Sheehan in that a tensor comprises the vectors as “to detect the location of thin tissue” (Burlina: para 158) since “The structure tensor summarizes the predominant directions of the gradient in a specified neighborhood of a point, and a degree to which those directions are coherent” (Burlina: para 159). The teachings of Burlina can be incorporated into Masumoto in view of Sheehan in that a tensor comprises the vectors. Furthermore, one of ordinary skill in the art could have combined the elements as claimed by known methods and, in combination, each component functions the same as it does separately. One of ordinary skill in the art would have recognized that the results of the combination would be predictable.
Allowable Subject Matter
Claims 3-8 are 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.
The following is a statement of reasons for the indication of allowable subject matter: Limitations pertaining to “the tensor data include surface area, contraction coefficient, and length of tensor which represents volume and function of the heart chamber during the heart cycle”, in conjunction with other limitations present in the claim 3 and intervening and base claims, distinguish over the prior art.
The following is a statement of reasons for the indication of allowable subject matter: Limitations pertaining to “the tensor data comprises the data set out in Table 1”, in conjunction with other limitations present in the claim 4 and intervening and base claims, distinguish over the prior art. Note that claim 4 incorporates all contents of Table 1 by reference with the claim language, “the tensor data comprises the data set out in Table 1”.
Claim 9 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Atiba Fitzpatrick whose telephone number is (571) 270-5255. The examiner can normally be reached on M-F 10:00am-6pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Bee can be reached on (571) 270-5183. The fax phone number for Atiba Fitzpatrick is (571) 270-6255.
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Atiba Fitzpatrick
/ATIBA O FITZPATRICK/
Primary Examiner, Art Unit 2677