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 Objections
Claim 13 is objected to because of the following informalities: in line 3 the “each two-dimensional image” should be changed to “each of the plurality of the two-dimensional images”. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: in line 3 the “each two-dimensional image” should be changed to “each of the plurality of the two-dimensional images”. 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 2-3, 5-9, 17, and 19 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.
Regarding claim 2, line 1 recites “a breast”. It is unclear if this is the same or a different breast from claim 1. For examination purposes it shall be considered the same.
Regarding claim 5, lines 1-2 recite “a volume of a mammary gland and a volume of the breast”. It is unclear if these are the same or different volumes from claim 1. For examination purposes they shall be considered the same.
Regarding claim 14, lines 1 and 8 recites “a position”. It is unclear if this is the same or different position recited in claim 12. For examination purposes, it shall be considered as the same.
Regarding claim 16 lines 1-2 recites “a breast”. It is unclear if this is the same or a different breast from claim 15. For examination purposes it shall be considered the same.
Further, line 2 recites “an ultrasonic image”. It is unclear if this is the same or a different US image from claim 15. For examination purposes it shall be considered the same.
Regarding claim 19, lines 1-2 recite “a volume of a mammary gland and a volume of the breast”. It is unclear if these are the same or different volumes from claim 15. For examination purposes they shall be considered the same.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(b) are also rejected because they inherit the indefiniteness of the claims they respectively depend upon.
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 and 20 are rejected under 35 U.S.C. 102(a)(1)as being anticipated by Wiskin et al., (US20160210774A1).
Regarding claim 1, Wiskin teaches A method for quantifying breast density (Abstract method for assessment of breast density), comprising:
performing ultrasonic scanning on a breast to acquire an ultrasonic image of the breast (fig. 1 breast images 105 generated from ultrasound [0027]);
determining a volume of a mammary gland ([0034] breast voxels that correspond to dense tissue is identified; [0020] this ‘dense’ tissue is parenchyma/fibroglandular tissue, which is considered as a mammary gland) and a volume of the breast based on the ultrasonic image ([0023] the breast density is estimated through 3d maps of breast speed; fig. 1 step 120 the breast voxels are separated from the dense tissue [0034] and [0028]); and
determining the breast density based on the volume of the mammary gland and the volume of the breast ([0020] breast density is determined by (total volume of ‘dense’ tissue)/(total volume of the breast)).
Regarding claim 20, Wiskin teaches a non-transitory computer-readable medium, having a computer program stored thereon, wherein the computer program has at least one code segment, and the at least one code segment is executable by a machine so that the machine performs steps of ([0043] the process flow described with respect to fig. 1 can be implemented in the form of computer-executable instructions such as program modules):
performing ultrasonic scanning on a breast to acquire an ultrasonic image of the breast (fig. 1 breast images 105 generated from ultrasound [0027]);
determining a volume of a mammary gland ([0034] breast voxels that correspond to dense tissue is identified; [0020] this ‘dense’ tissue is parenchyma/fibroglandular tissue, which is considered as a mammary gland) and a volume of the breast based on the ultrasonic image ([0023] the breast density is estimated through 3d maps of breast speed; fig. 1 step 120 the breast voxels are separated from the dense tissue [0034] and [0028]); and
determining the breast density based on the volume of the mammary gland and the volume of the breast ([0020] breast density is determined by (total volume of ‘dense’ tissue)/(total volume of the breast)).
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.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Wiskin as applied to claim 1, and further in view of Russell (US5873827A) and Wang et al., (US20140121520A1).
Regarding claim 2, Wiskin teaches the method of claim 1, wherein Wiskin teaches the performing ultrasonic scanning a breast to acquire an ultrasonic image of the breast(fig. 1 breast images 105 generated from ultrasound [0027]), but fails to explicitly disclose performing, via a scanning assembly, ultrasonic scanning on the breast, of which an outer edge is attached with at least one acoustically opaque marker, to acquire the ultrasonic image.
In the same ultrasound field of endeavor, Russel teaches performing, via a scanning assembly, ultrasonic scanning, of which an outer edge is attached with at least one acoustically opaque marker, to acquire the ultrasonic image (col. 2 lines 35-41 a surface marker is used for ultrasound examination and are acoustically opaque).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the method of Wiskin with the surface markers of Russell as both inventions relate to ultrasound imaging, and would yield to predictable result of a ultrasound method that includes the step of using ultrasound markers to one of ordinary skill in the art. One of ordinary skill would be able to perform such an combination, and the results of Wiskin incorporate surface ultrasonic markers are reasonably predictable. One of ordinary skill would also understand that since these are applied to the surface, and Wiskin’s target is of the breast, then the ultrasonic scanning would be on the breast, thus reading upon the limitation “performing, via a scanning assembly, ultrasonic scanning on the breast, of which an outer edge is attached with at least one acoustically opaque marker to acquire the ultrasonic image.
However, the combination of references is still silent regarding wherein the scanning assembly comprises a frame, the frame accommodates a scanning probe and a driving device, and the driving device drives the scanning probe to move within the frame to perform the ultrasonic scanning.
In the same ultrasound field of endeavor, Wang teaches wherein the scanning assembly comprises a frame (fig. 1 assembly 108), the frame accommodates a scanning probe (fig. 10 ultrasound probe 1004 [0054]) and a driving device (fig. 10 motor-driven pinions 1010 [0054]), and the driving device drives the scanning probe to move within the frame to perform the ultrasonic scanning ([0054] the motor driven pinions move the probe).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify modified Wiskin with the frame of Wang, as this would facilitate ultrasound scanning of the tissue volume (see Wang [0010]).
Regarding claim 3, modified Wiskin teaches the method of claim 2, but fails to explicitly disclose wherein the marker comprises a plurality of markers, and the plurality of markers are attached to the outer edge.
In the same ultrasound field of endeavor, Russel teaches wherein the marker comprises a plurality of markers, and the plurality of markers are attached to the outer edge (fig. 1 marker 10 comprises a spiral shaped member 12 that is defined by a plurality of spaced beads 13 col. 4 lines 54-56).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the method of Wiskin with the surface markers of Russell as both inventions relate to ultrasound imaging, and would yield to predictable result of a ultrasound method that includes the step of using ultrasound markers to one of ordinary skill in the art. One of ordinary skill would be able to perform such an combination, and the results of Wiskin incorporate surface ultrasonic markers are reasonably predictable. One of ordinary skill would understand that these markers would be applied to the surface of the breast of modified Wiskin, and thus read upon the limitation “the plurality of markers are attached to the outer edge of the breast”.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Wiskin as applied to claim 1, and further in view of Koshino (US20250268561A1).
Regarding claim 4, Wiskin teaches the method of claim 1, but is silent regarding wherein ultrasonic image comprises a plurality of two-dimensional images.
In the same ultrasound field of endeavor, Koshino teaches wherein ultrasonic image comprises a plurality of two-dimensional images ([0091] a plurality of two dimensional images are acquired).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the images of Wiskin with the two dimensional images of Koshino, as both inventions relate to ultrasonic images of a breast, and would yield the predictable result of an ultrasonic method that uses two dimensional ultrasonic images to one of ordinary skill in the art. One of ordinary skill would be able to perform such a substitution, and the results of the method Wiskin using two-dimensional ultrasonic images are reasonably predictable.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Wiskin in view of Koshino as applied to claim 4, and further in view of Ito (US20210161506A1), Zhang et al., (US20230018351A1).
Regarding claim 5, modified Wiskin teaches the method of claim 4, wherein Wiskin further teaches wherein the determination of a volume of a mammary gland and a volume of the breast based on the ultrasonic image comprises ([0020] total volume of dense tissue and total volume of the breast is determined to determine breast density; [0024] voxels are taken from sound images;[0027] the sound maps are generated with ultrasound) segmenting the image to acquire the mammary gland ([0041] the dense breast tissue is segmented) and the exterior of the breast ([0032] the breast tissue is segmented from exterior tissues)
determining the volume of the mammary gland based on the mammary gland ([0034] breast voxels that correspond to dense tissue is identified; [0020] this ‘dense’ tissue is parenchyma/fibroglandular tissue, which is considered as a mammary gland), and determining the volume of breast based on the exterior and the local coronal views(fig. 8A shows the coronal view of the speed images, and these images are used to identify breast voxels as they represent the speed map 110, which are used to determine volume [0041], and the breast voxels are separated from the exterior [0032])
However Wiskin fails to explicitly disclose the plurality of two-dimensional images.
In the same ultrasound field of endeavor, Koshino teaches the plurality of two-dimensional images ([0091] a plurality of two dimensional images are acquired).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the images of Wiskin with the two dimensional images of Koshino, as both inventions relate to ultrasonic images of a breast, and would yield the predictable result of an ultrasonic method that uses two dimensional ultrasonic images to one of ordinary skill in the art. One of ordinary skill would be able to perform such a substitution, and the results of the method Wiskin using two-dimensional ultrasonic images are reasonably predictable.
However the combination of references are silent regarding segmenting the image to acquire the mammary gland and chest wall of the breast.
In the same ultrasound field of endeavor, Ito teaches segmenting the image to acquire the mammary gland and chest wall of the breast (fig. 3 the pectoralis major image 58 and the mammary gland 56 are separated by a boundary 60 [0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of segmenting the mammary gland and exterior tissues of modified Wiskin with the segmenting of the mammary gland and the chest wall of Ito, as this would support ultrasound diagnosis of breasts (see Ito [0006]). Further, one of ordinary skill in the art one understand that this modification would result in the exterior tissues being replaced with the chest wall (pectoralis major), and thus read upon the limitation segmenting each of the plurality of two-dimensional images to acquire the mammary gland and a chest wall of the breast; reconstructing each of the plurality of two-dimensional images to acquire a local coronal view of the breast; and determining the volume of the mammary gland based on the mammary gland, and determining the volume of the breast based on the chest wall and the local coronal views.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Wiskin in view of Koshino as applied to claim 4, and further in view of Highman et a., (US20210097677A1) and Karssemeijer et al., (US20120014578A1)
Regarding claim 10, modified Wiskin teaches the method of claim 4, but fails to explicitly disclose calculating a breast density map within an area of the breast based on a thickness of the mammary gland; and visualizing and displaying the breast density map.
In the same breast field of endeavor, Highman teaches calculating a breast density map within an area of the breast based on a thickness of the mammary gland ([0200] a density map is generated, and is based on the thickness of the dense tissue); and visualizing and displaying the breast density map ([0200] it is generated as a base image).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Wiskin with the density map of Highman, as this would allow for the information to be applied to CAD and enable accurate comparisons over time (see Highman [0054]).
However, Highman is silent regarding a distance from the skin to the chest wall.
In the same breast field of endeavor, Karssemeijer teaches a distance from the skin to the chest wall ([0082] thickness is take from the skin surface to the chest wall, with the total distance calculated as from the nipple to the chest wall).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the technique of calculating the thickness of a distance from skin to the chest wall as taught by Karssemeijer (and thus the density map) and apply it to the breast density map of the method of modified Wiskin as both inventions relate to breast imaging , and would yield the predictable result of also using the distance from the chest wall to the nipple/skin in tandem with the thickness of the mammary gland to calculate a density map to one of ordinary skill in the art. One of ordinary skill would be able to perform such an application, and the results of the method of modified Wiskin to include the distance from the skin to the chest wall are reasonably predictable. This would allow for users to normalize dense-tissue thickness measurement for variations in overall breast thickness and thereby improve accuracy.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Wiskin in view of Koshino, Highman, and Karssemeijer as applied to claim 10, and further in view of Erhard (US20160338660A1).
Regarding claim 11, modified Wiskin teaches the method of claim 10, but fails to explicitly disclose overlaying and displaying the breast density map on a coronal view of the breast.
In the same breast imaging field of endeavor, Erhard teaches overlaying and displaying the breast density map on a coronal view of the breast ([0019] the density can be presented color coded as an overlay; fig. 3 the breast parameter per subvolume is overlayed on the breast and is a coronal view of the breast[0038]; [0014] the parameter can be breast density).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Wiskin with the overlaying of the visuals on the breast, as this would improve mammographic images (see Erhard Abstract).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Wiskin in view of Koshino, Highman, and Karssemeijer as applied to claim 10, and further in view of Kato (US 20260000381 A1).
Regarding claim 12, modified Wiskin teaches the method of claim 10, but fails to explicitly disclose determining the thickness of the mammary gland and a position of the chest wall based on the ultrasonic image.
In the same ultrasound field of endeavor, Kato teaches determining the thickness of the mammary gland ([0058] the thickness calculation unit 26 calculates a thickness of the mammary gland region M in a depth direction) and a position of the chest wall based on the ultrasonic image (fig. 4 the mammary gland region extraction unit can recognize a pectoralis Major T from the ultrasound image [0054]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Wiskin with the image analysis of Kato, as this would provide a method to enable a user to easily consider a risk of breast cancer (see Kato [0010]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Wiskin.
Regarding claim 15, Wang teaches an ultrasonic imaging system, comprising:
a scanning assembly moving over the surface of a breast to acquire ultrasonic echo signals (fig. 3 scanning assembly 108 comprises ultrasound probe 302 that sweeps the linear array 304 across the breast [0047]);
a memory storing instructions (fig. 18 computer processor system 1810 would necessarily have a memory with instructions); and
a processor configured to execute the instructions to (fig. 18 computer processor system 1810);:
perform ultrasonic scanning on a breast to acquire an ultrasonic image of the breast (fig. 16 breast is scanned to generated the breast[0062]).
However Wang is silent regarding determine a volume of a mammary gland and a volume of the breast based on the ultrasonic image; and determine the breast density based on the volume of the mammary gland and the volume of the breast.
In the same ultrasound field of endeavor, Wiskin teaches determining a volume of a mammary gland ([0034] breast voxels that correspond to dense tissue is identified; [0020] this ‘dense’ tissue is parenchyma/fibroglandular tissue, which is considered as a mammary gland) and a volume of the breast based on the ultrasonic image ([0023] the breast density is estimated through 3d maps of breast speed; fig. 1 step 120 the breast voxels are separated from the dense tissue [0034] and [0028]); and determining the breast density based on the volume of the mammary gland and the volume of the breast ([0020] breast density is determined by (total volume of ‘dense’ tissue)/(total volume of the breast)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Wang with the method Wiskin, as this would improve breast care by providing patients with accurate breast health information (see Wiskin [0019]).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Wiskin as applied to claim 15, and further in view of Russell.
Regarding claim 16, modified Wang teaches the system of claim 15, wherein Wang further teaches wherein the scanning assembly comprises a frame (fig. 1 assembly 108), the frame accommodates a scanning probe (fig. 10 ultrasound probe 1004 [0054]) and a driving device (fig. 10 motor-driven pinions 1010 [0054]), and the driving device drives the scanning probe to move within the frame to perform the ultrasonic scanning ([0054] the motor driven pinions move the probe).
However, modified Wang fails to explicitly disclose performing, via a scanning assembly, ultrasonic scanning, of which an outer edge is attached with at least one acoustically opaque marker, to acquire the ultrasonic image.
In the same ultrasound field of endeavor, Russell teaches performing, via a scanning assembly, ultrasonic scanning, of which an outer edge is attached with at least one acoustically opaque marker, to acquire the ultrasonic image (col. 2 lines 35-41 a surface marker is used for ultrasound examination and are acoustically opaque).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the method of Wiskin with the surface markers of Russell as both inventions relate to ultrasound imaging, and would yield to predictable result of a ultrasound method that includes the step of using ultrasound markers to one of ordinary skill in the art. One of ordinary skill would be able to perform such an combination, and the results of Wiskin incorporate surface ultrasonic markers are reasonably predictable. One of ordinary skill would also understand that since these are applied to the surface, and Wang’s target is of the breast, then the ultrasonic scanning would be on the breast, thus reading upon the limitation “performing, via a scanning assembly, ultrasonic scanning on the breast, of which an outer edge is attached with at least one acoustically opaque marker to acquire the ultrasonic image.
Regarding claim 17, modified Wiskin teaches the system of claim 16, but fails to explicitly disclose wherein the marker comprises a plurality of markers, and the plurality of markers are attached to the outer edge.
In the same ultrasound field of endeavor, Russell teaches wherein the marker comprises a plurality of markers, and the plurality of markers are attached to the outer edge (fig. 1 marker 10 comprises a spiral shaped member 12 that is defined by a plurality of spaced beads 13 col. 4 lines 54-56).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the system of Wiskin with the surface markers of Russell as both inventions relate to ultrasound imaging, and would yield to predictable result of a ultrasound method that includes the step of using ultrasound markers to one of ordinary skill in the art. One of ordinary skill would be able to perform such an combination, and the results of modified Wang incorporating surface ultrasonic markers are reasonably predictable. One of ordinary skill would understand that these markers would be applied to the surface of the breast of modified Wang, and thus read upon the limitation “the plurality of markers are attached to the outer edge of the breast”.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Wiskin as applied to claim 15, and further in view of Koshino.
Regarding claim 18, Wang teaches the system of claim 15, but is silent regarding wherein ultrasonic image comprises a plurality of two-dimensional images.
In the same ultrasound field of endeavor, Koshino teaches wherein ultrasonic image comprises a plurality of two-dimensional images ([0091] a plurality of two dimensional images are acquired).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the images of modified Wang with the two dimensional images of Koshino, as both inventions relate to ultrasonic images of a breast, and would yield the predictable result of an ultrasonic method that uses two dimensional ultrasonic images to one of ordinary skill in the art. One of ordinary skill would be able to perform such a substitution, and the results of the method Wiskin using two-dimensional ultrasonic images are reasonably predictable.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Wiskin and Koshino as applied to claim 18, and further in view of Ito and Zhang.
Regarding claim 19, modified Wang teaches the method of claim 4, but fails to explicitly disclose wherein the determination of a volume of a mammary gland and a volume of the breast based on the ultrasonic image segmenting the image to acquire the mammary gland and the exterior of the breast determining the volume of the mammary gland based on the mammary gland and determining the volume of breast based on the exterior and the local coronal views.
However in the same ultrasound field of endeavor, Wiskin teaches wherein the determination of a volume of a mammary gland and a volume of the breast based on the ultrasonic image comprises ([0020] total volume of dense tissue and total volume of the breast is determined to determine breast density; [0024] voxels are taken from sound images;[0027] the sound maps are generated with ultrasound) segmenting the image to acquire the mammary gland ([0041] the dense breast tissue is segmented) and the exterior of the breast ([0032] the breast tissue is segmented from exterior tissues) determining the volume of the mammary gland based on the mammary gland ([0034] breast voxels that correspond to dense tissue is identified; [0020] this ‘dense’ tissue is parenchyma/fibroglandular tissue, which is considered as a mammary gland), and determining the volume of breast based on the exterior and the local coronal views(fig. 8A shows the coronal view of the speed images, and these images are used to identify breast voxels as they represent the speed map 110, which are used to determine volume [0041], and the breast voxels are separated from the exterior [0032]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Wang with the method of Wiskin, as this would improve breast care by providing patients with accurate breast health information (see Wiskin [0019]).
However Wiskin fails to explicitly disclose the plurality of two-dimensional images.
In the same ultrasound field of endeavor, Koshino teaches the plurality of two-dimensional images ([0091] a plurality of two dimensional images are acquired).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the images of Wiskin with the two dimensional images of Koshino, as both inventions relate to ultrasonic images of a breast, and would yield the predictable result of an ultrasonic method that uses two dimensional ultrasonic images to one of ordinary skill in the art. One of ordinary skill would be able to perform such a substitution, and the results of the method Wiskin using two-dimensional ultrasonic images are reasonably predictable.
However the combination of references are silent regarding segmenting the image to acquire the mammary gland and chest wall of the breast.
In the same ultrasound field of endeavor, Ito teaches segmenting the image to acquire the mammary gland and chest wall of the breast (fig. 3 the pectoralis major image 58 and the mammary gland 56 are separated by a boundary 60 [0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of segmenting the mammary gland and exterior tissues of modified Wiskin with the segmenting of the mammary gland and the chest wall of Ito, as this would support ultrasound diagnosis of breasts (see Ito [0006]). Further, one of ordinary skill in the art one understand that this modification would result in the exterior tissues being replaced with the chest wall (pectoralis major), and thus read upon the limitation segmenting each of the plurality of two-dimensional images to acquire the mammary gland and a chest wall of the breast; reconstructing each of the plurality of two-dimensional images to acquire a local coronal view of the breast; and determining the volume of the mammary gland based on the mammary gland, and determining the volume of the breast based on the chest wall and the local coronal views.
Allowable Subject Matter
Claims 6-9 13, and 14 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 6, the prior art of record, whether considered individually or in combination, fails to teach or suggest the specific manner in which the claims segment from a plurality of two-dimensional images the mammary gland in order to acquire a plurality segmentation mask of the mammary gland, and the for each of the plurality of segmentation masks, register them to the two-dimensional images based on a register parameter used for registering the plurality of local coronal views to acquire the volume of the mammary gland based on the mask of the mammary gland.
In particular, while the prior art teaches segmentation and registration as separate processing steps, they fail to teach or even suggest cross dependency, wherein parameters used to register coronal views are reused to register segmentation masks derived from the two-dimensional views. This specific process establishes a relationship between coronal-view registration and segmentation that is absent from the prior art. Therefore claim 6 contains allowable subject matter.
Regarding claim 7, the prior art of record, whether considered individually or in combination, fails to teach or suggest detecting a nipple and markers on each of the plurality of local coronal views; registering the plurality of local coronal views based on positions of the nipple and the markers on each of the local coronal views to acquire an overall coronal view of the breast; determining a breast boundary based on the positions of the markers; and acquiring the volume of the breast based on the breast boundary and a distance from the skin to the chest wall within the breast boundary.
Specifically, while markers and anatomical markers are known, the prior does not disclose or suggest the claimed marker-driven coronal registration process that results in an overall coronal view from which breast volume is computed using both boundary geometry and the length from the chest wall to that nipple. The claimed combination of nipple based alignment, marker based boundary determination, and length from the chest wall to the nipple that is absent from the prior art. Therefore claim 7 contains allowable subject matter.
The remaining claims reference but not discussed above still contain allowable subject matter for the same reason as above, as they are dependent on such claims and necessarily contain the same allowable subject material as the claim in which they depend on.
Conclusion
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/MICHAEL YIMING FANG/ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798