DETAILED ACTION
Allowable Subject Matter
Claims 3-4, 14-15 and 25-26 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all of the limitations of the base claim and any intervening claims, provided that all remaining rejections are withdrawn.
The prior art of record, alone or in combination, fails to fairly teach or suggest these limitations, including the concept of a method for automatic segmentation of structures of interest of an organ in an MR image, comprising: creating a weighted active shape model (wASM); registering model points of the structures in an MR atlas image to a target image that is the MR image to be segmented, as initial model points of the structures in the target image; and iteratively fitting the wASM to the target image, starting from the initial model points, until the shape converges, wherein the final shape is the segmentation of the structures of interest, wherein the wASM is created from a set of CT images in which the structures of interest are visible, wherein the set of CT images comprises microCT ( CT) image volumes, wherein in each CT image volume, the structures of interest are manually segmented to create a surface for each structure while maintaining point-to- point correspondence between volumes, wherein said creating the wASM comprises: establishing a point correspondence between surfaces of the structures that are manually segmented in each CT; registering the surfaces to each other with seven degrees of a freedom similarity transformation by using the points; and computing eigenvectors of the registered points' covariance matrix, wherein said establishing the point correspondence between the structure surfaces comprises: mapping the set of CT image volumes to one of the CT image volumes chosen as a reference volume by using a non-rigid registration; and registering the surface of each CT image volume to the surface of the reference volume, so as to establish the correspondence between each point on the reference surface with the closest point in each of the registered CT image surfaces.
For example, Xu (US PGPub 2008/0037848) teaches segmentation of the corpus callosum in MR brain images via an active shape model (ASM) with confidence weighting to iteratively adjust an initial contour to define a boundary of the corpus callosum in an MR image. ¶ 0018 teaches training the MR atlas image/models and ¶ 0020-0021 fitting the model to the target image. ¶ 0021 teaches that the model contour is undergoes adjusting and fitting iteratively until the contour converges to a final position as the segmentation. Noble (“Image-Guidance Enables New Methods for Customizing Cochlear Implant Stimulation Strategies”) Noble teaches a method of weighted Active Shape Model segmentation which trains the wASM via CT images, see pg. 822, Sections B and C. None of the closest prior art teaches or suggests all of the limitations of the above-mentioned claims. The claim language goes beyond the similarities of these devices and Applicant’s invention and a combination could not reasonably be made without impermissible hindsight. The differences here are viewed as allowable over the prior art.
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 1-33 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. The term “MR image” contains an abbreviation without corresponding definition in the claims. As such the metes and bounds of the term are uncertain.
Claims 2-5, 13-16 and 24-27 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. The term “CT image” contains an abbreviation without corresponding definition in the claims. As such the metes and bounds of the term are uncertain.
Claims 3-4, 14-15 and 25-26 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. The following amendment should be made: “a seven degrees of [[a]] freedom similarity transformation”
Claims 5, 16 and 27 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. The following amendment should be made: “performing wASM segmentation on [[its]] a corresponding CT image”
Claims 7-8, 18-19 and 29-30 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.
The claims recite, “wherein the affine transformations are performed by registering the whole images and then a number of regions of interest (ROIs) that are empirically chosen around the organ and have enough content to permit registration, wherein the number of ROIs includes a number of large- to small-sized ROIs; and wherein after the affine transformations are computed, the nonrigid registration is performed between the ROIs of the MR atlas image and the target image.”
It is not clear what the metes and bounds are of the following terms:
“Empirically” in the context, “a number of regions of interest (ROIs) that are empirically chosen.”
“Enough” in “enough content to permit registration”
“Large-to-small” in “a number of large- to small-sized ROIs”
Additionally, it is not clear what the metes and bounds are of the phrase, “registering the whole images and then a number of regions of interest (ROIs) that are empirically chosen around the organ and have enough content to permit registration”. It is not clear if the claims are requiring two separate registration steps successively. It is also not clear what the meaning is of the phrase “have enough content to permit registration,” for example if this is referring to the ROIs or to the whole images, or to both.
Claims 9, 20 and 31 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. The following amendment should be made: “[[the]] an initial registration transformation”
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, 6-8, 10, 12, 17-19, 21, 23, 28-30 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xu (US PGPub 2008/0037848).
Regarding claim 1, Xu discloses a method for automatic segmentation of structures of interest of an organ in an MR image, comprising: (Xu teaches segmentation of the corpus callosum in MR brain images via an active shape model (ASM) with confidence weighting to iteratively adjust an initial contour to define a boundary of the corpus callosum in an MR image.)
creating a weighted active shape model (wASM); (¶ 0016 teaches an Active Shape Model (ASM) which is adjusted by confidence weighting boundary movement.)
registering model points of the structures in an MR atlas image to a target image that is the MR image to be segmented, as initial model points of the structures in the target image; and (¶ 0018 teaches training the MR atlas image/models and ¶ 0020-0021 fitting the model to the target image.)
iteratively fitting the wASM to the target image, starting from the initial model points, until the shape converges, wherein the final shape is the segmentation of the structures of interest. (¶ 0021 teaches that the model contour is undergoes adjusting and fitting iteratively until the contour converges to a final position as the segmentation.)
Xu does not expressly disclose that all of its above-cited teachings on are expressly disclosed as occurring in the same embodiment. That is, despite the reference being clear that these functions are disclosed, there is no express disclosure that the details are all found in the same embodiment. Instead, the reference presents some of the individual detailed disclosures as ‘according to some embodiments.’ It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the various teachings to provide a single system capable of the variety of tasks which are disclosed. In view of these teachings, this cannot be considered a non-obvious improvement over the prior art. Using known engineering design, no “fundamental” operating principle of the teachings are changed; they continue to perform the same functions as originally taught prior to being combined.
Regarding claim 6, the above combination discloses the method of claim 1, wherein said registering the model points of the structures in the atlas image to the target image is performed by affine transformations followed by a nonrigid registration. (See affine transformations and nonrigid registration at ¶ 0025.)
Regarding claim 7, the above combination discloses the method of claim 6, wherein the affine transformations are performed by registering the whole images and then a number of regions of interest (ROIs) that are empirically chosen around the organ and have enough content to permit registration, wherein the number of ROIs includes a number of large- to small-sized ROIs; and wherein after the affine transformations are computed, the nonrigid registration is performed between the ROIs of the MR atlas image and the target image. (See affine transformations of whole image of bounding box of contour at ¶ 0025 and see ¶ 0028 regarding regions of interest/nodes for the registration. See rejection of claim 6 regarding registration.)
Regarding claim 8, the above combination discloses the method of claim 7, wherein the position of the initial model points on the target image are obtained by projecting the points from the MR atlas image using a concatenation of the affine and nonrigid transformations. (¶ 0025 and 0031 teach scaling and rotation, affine and nonrigid transformations, concatenated together to accomplish registration.)
Regarding claim 10, the above combination discloses the method of claim 1, wherein the organ includes cochlea, brain, heart, or other organs of a living subject, wherein the structures of interest comprise anatomical structures in the organ. (Xu teaches segmenting the brain.)
Claims 12, 17-19 and 21 are system claims corresponding to the method of claims 1, 6-8 and 10. Xu discloses a system (abstract). Remaining limitations are rejected similarly. See detailed analysis above.
Claims 23, 28-30 and 32 are the non-transitory computer-readable medium claims corresponding to the method of claims 1, 6-8 and 10. Xu discloses a computer-readable medium (¶ 0039). Remaining limitations are rejected similarly. See detailed analysis above.
Claim(s) 2, 5, 9, 11, 13, 16, 20, 22, 24, 27, 31 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xu (US PGPub 2008/0037848) in view of Noble (“Image-Guidance Enables New Methods for Customizing Cochlear Implant Stimulation Strategies”).
Regarding claim 5, the above combination discloses the method of claim 1, including that the model points of the structures in the MR atlas image are obtained by performing wASM segmentation on its corresponding MR image. (See rejection of claim 1)
aligning the MR image to the MR atlas image with a rigid-body registration; and (¶ 0018 teaches aligning the MR image to the MR atlas image, a rigid-body registration.)
projecting the model points from the MR image to the MR atlas image. (¶ 0018 details projection of the constituent MR images to the MR atlas image/model.)
In the field of active shape modeling Noble teaches that said image model points of the structures in the atlas image are obtained with a CT image. (Noble teaches a method of weighted Active Shape Model segmentation which trains the wASM via CT images, see pg. 822, Sections B and C.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined Xu’s active shape modeling with Noble’s active shape modeling. Xu teaches building a weighted active shape model with MR images and using the model for segmentation. Noble teaches building a weighted active shape model with CT images, also to be used for segmentation. The combination constitutes the repeatable and predictable result of simply applying Noble’s teaching for building the active shape model with CT images. CT and MR are both well-known and widely-used medical imaging modalities for capturing the outline of an organ. Simply generating a model with imaging of one modality rather than another cannot be considered a non-obvious improvement in view of the relevant prior art here. Using known engineering design, no “fundamental” operating principle of the teachings are changed; they continue to perform the same functions as originally taught prior to being combined.
Regarding claim 2, the above combination discloses the method of claim 1, wherein the wASM is created from a set of CT images in which the structures of interest are visible, wherein the set of CT images comprises microCT (CT) image volumes, wherein in each CT image volume, the structures of interest are manually segmented to create a surface for each structure while maintaining point-to- point correspondence between volumes. (Noble, Pg. 821, Section A. Overview, ¶ 2 and 3.)
Regarding claim 9, the above combination discloses the method of claim 1, wherein said iteratively fitting the wASM to the target image comprises at each iteration, adjusting every model point from the last wASM fitting to its new candidate position, wherein if said model point is an edge point, a search is performed along the surface normal of said model point, and the new candidate point is chosen to be a point with the largest gradient magnitude along the surface normal over a range from said model point, and wherein if said model point is a nonedge point, its initial position, which is the position of this corresponding point projected from the MR atlas image using the initial registration transformation, is used as the new candidate point; and fitting the wASM to the new candidate points in the weighted-least-squares scheme. (Xu ¶ 0021 and 0035 regarding iteratively fitting the wASM. Noble’s weighted Active Shape Model segmentation iteratively converges via each new candidate point chosen to be a point with the largest gradient magnitude along the surface normal, see pg. 822, Sections B and C. Also see paragraph spanning pgs. 821 and 822.)
Regarding claim 11, the above combination discloses the method of claim 10, wherein the anatomical structures comprise intracochlear anatomy (ICA). (Noble teaches segmenting the intracochlear anatomy, see Abstract.)
Claims 16, 20 and 22 are system claims corresponding to the method of claims 5, 9 and 11. Xu discloses a system (abstract). Remaining limitations are rejected similarly. See detailed analysis above.
Claims 27, 31 and 33 are the non-transitory computer-readable medium claims corresponding to the method of claims 5, 9 and 11. Xu discloses a computer-readable medium (¶ 0039). Remaining limitations are rejected similarly. See detailed analysis above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Raphael Schwartz whose telephone number is (571)270-3822. The examiner can normally be reached Monday to Friday 9am-5pm CT.
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/RAPHAEL SCHWARTZ/ Examiner, Art Unit 2671