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 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 1-10 and 12-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract without significantly more.
Step 1: Statutory Category: Yes, the claim is directed to a method and is therefore a process.
Step 2A, Prong 1, Judicial Exception: Yes. The claim recites the limitation “determining a volume of a mammary gland and a volume of the breast based on registering the first coronal view and the second local coronal view; and determining the breast density based on the volume of the mammary gland and the volume of the breast”.
This limitation, as drafted, is a process step, that, under its BRI, covers an abstract idea, more specifically a mathematical concept. That is, the listed claim recites a mathematical calculation that is a mathematical operation or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic equation such as exponentiation. Accordingly, the claim recites a mathematical concept-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No; The claim further recites “A method for quantifying breast density, comprising: performing ultrasonic scanning on a breast to acquire ultrasonic images of the breast; acquiring, based on the ultrasonic images, a first local coronal view having a first set of markers acquiring, based on the ultrasonic images, a second local coronal view having a second set of markers that is different than the first set of markers; registering the first local coronal view and the second local coronal view based on the first set of markers and the second set of markers”.
These elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No, similar to Step 2A Prong 2, the additional elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. In light of the above, claim 1 is ineligible.
Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes, for the same reasons as claim 1,
Step 2A, Prong 1, Judicial Exception: Yes, for the same reasons as claim 1.
Step 2A, Prong 2, Integrated into Practical Application: No, the claim additionally recites “wherein the performing ultrasonic scanning on the breast to acquire the ultrasonic images of the breast comprises: performing, via a scanning assembly, ultrasonic scanning on the breast, of which an outer edge is attached with at least one marker of the first set of marker or the second set of markers, to acquire the ultrasonic images, 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.”
These elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No, similar to Step 2A Prong 2, the additional elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. In light of the above, claim 2 is ineligible
Claim 3 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes, for the same reasons as claim 1,
Step 2A, Prong 1, Judicial Exception: Yes, for the same reasons as claim 1,
Step 2A, Prong 2, Integrated into Practical Application: No, the claim additionally recites the limitation “wherein the at least one marker comprises a plurality of markers, and the plurality of markers are attached to the outer edge of the breast.”
These elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No, similar to Step 2A Prong 2, the additional elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. In light of the above, claim 3 is ineligible
Claim 4 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes, for the same reasons as claim 1,
Step 2A, Prong 1, Judicial Exception: Yes, for the same reasons as claim 1,
Step 2A, Prong 2, Integrated into Practical Application: No, the claim additionally recites the limitation “wherein the ultrasonic images comprise a plurality of two-dimensional images.”
These elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No, similar to Step 2A Prong 2, the additional elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. In light of the above, claim 4 is ineligible
Claim 5 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes, for the same reasons as claim 1,
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites “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 first local coronal view and the second local coronal view.” This limitation, as drafted, is a process step, that, under its BRI, covers an abstract idea, more specifically a mathematical concept. That is, the listed claim recites a mathematical calculation that is a mathematical operation or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic equation such as exponentiation. Accordingly, the claim recites a mathematical concept-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No, the claim additionally recites the limitation “wherein the determination of the volume of the mammary gland and the volume of the breast based on the ultrasonic images comprises: 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 the first local coronal view and the second local coronal view of the breast”.
These elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No, similar to Step 2A Prong 2, the additional elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. In light of the above, claim 5 is ineligible.
Claim 6 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes, for the same reasons as claim 1,
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites “acquiring the volume of the mammary gland based on the mask of the mammary gland”. This limitation, as drafted, is a process step, that, under its BRI, covers an abstract idea, more specifically a mathematical concept. That is, the listed claim recites a mathematical calculation that is a mathematical operation or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic equation such as exponentiation. Accordingly, the claim recites a mathematical concept-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No, the claim recites “segmenting the mammary gland from each of the plurality of two-dimensional images to acquire a segmentation mask of the mammary gland; registering the plurality of segmentation masks of the mammary gland on the plurality of two-dimensional images based on a registration parameter used for registering the plurality of the first local coronal view and the second local coronal view of the breast to acquire a mask of the mammary gland”
These elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No, similar to Step 2A Prong 2, the additional elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. In light of the above, claim 6 is ineligible
Claim 7 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes, for the same reasons as claim 1,
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites “determining a breast boundary based on the positions of the markers;”. This limitation, as drafted, is a process step that, under its broadest reasonably interpretation (BRI), covers an abstract idea, more specifically a process that can be performed in the human mind. That is, nothing in the listed claim elements precludes the step from practically being performed in the mind and/or performed with the aid of a pen and paper, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Further, the claim recites “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.” This limitation, as drafted, is a process step, that, under its BRI, covers an abstract idea, more specifically a mathematical concept. That is, the listed claim recites a mathematical calculation that is a mathematical operation or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic equation such as exponentiation. Accordingly, the claim recites a mathematical concept-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No, the claim recites “wherein the determination of the volume of the breast based on the chest wall and the first local coronal view and the second local coronal view comprises: detecting a nipple and markers on each of the plurality of the first local coronal view and the second local coronal view; registering the plurality of the first local coronal view and the second local coronal view based on positions of the nipple and the markers on each of the first local coronal view and the second local coronal view to acquire an overall coronal view of the breast.”
These elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No, similar to Step 2A Prong 2, the additional elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. In light of the above, claim 7 is ineligible
Claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes, for the same reasons as claim 1,
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites “determining a position of the chest wall.” This limitation, as drafted, is a process step that, under its broadest reasonably interpretation (BRI), covers an abstract idea, more specifically a process that can be performed in the human mind. That is, nothing in the listed claim elements precludes the step from practically being performed in the mind and/or performed with the aid of a pen and paper, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No, the claim does not recite additional elements.
Step 2B, Inventive Concept: Similarly to Step 2A Prong 2, the claim does not recite any additional elements. In light of the above, claim 8 is ineligible.
Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes, for the same reasons as claim 1,
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites “acquiring a position of the chest wall based on the mask of the chest wall”.
This limitation, as drafted, is a process step that, under its broadest reasonably interpretation (BRI), covers an abstract idea, more specifically a process that can be performed in the human mind. That is, nothing in the listed claim elements precludes the step from practically being performed in the mind and/or performed with the aid of a pen and paper, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No, the claim further recites “segmenting the chest wall from each of the plurality of two-dimensional images to acquire a segmentation mask of the chest wall; registering the plurality of segmentation masks of the chest wall on the plurality of two- dimensional images based on a registration parameter used for registering the plurality of the first local coronal view and the second local coronal view of the breast to acquire a mask of the chest wall”.
These elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No, similar to Step 2A Prong 2, the additional elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. In light of the above, claim 9 is ineligible
Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes, for the same reasons as claim 1,
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites “calculating a breast density map within an area of the breast based on a thickness of the mammary gland and a distance from the skin to a chest wall”.
This limitation, as drafted, is a process step that, under its broadest reasonably interpretation (BRI), covers an abstract idea, more specifically a process that can be performed in the human mind. That is, nothing in the listed claim elements precludes the step from practically being performed in the mind and/or performed with the aid of a pen and paper, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No, the claim further recites “visualizing and displaying the breast density map.”
These elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No, similar to Step 2A Prong 2, the additional elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. In light of the above, claim 10 is ineligible.
Claim 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes, for the same reasons as claim 1,
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites “determining the thickness of the mammary gland and a position of the chest wall based on the ultrasonic images.”
This limitation, as drafted, is a process step that, under its broadest reasonably interpretation (BRI), covers an abstract idea, more specifically a process that can be performed in the human mind. That is, nothing in the listed claim elements precludes the step from practically being performed in the mind and/or performed with the aid of a pen and paper, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No, the claim does not recite any further claim limitations.
Step 2B, Inventive Concept: No, the claim does not recite any additional claim limitations, and is therefore ineligible.
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes, for the same reasons as claim 1,
Step 2A, Prong 1, Judicial Exception: Yes the claim recites “and acquiring the thickness of the mammary gland from calculation based on the mask of the mammary gland”.
This limitation, as drafted, is a process step, that, under its BRI, covers an abstract idea, more specifically a mathematical concept. That is, the listed claim recites a mathematical calculation that is a mathematical operation or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic equation such as exponentiation. Accordingly, the claim recites a mathematical concept-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No, the claim further recites “segmenting the mammary gland from each of the plurality of two-dimensional images to acquire a segmentation mask of the mammary gland; registering the plurality of segmentation masks of the mammary gland on the plurality of two-dimensional images based on a registration parameter used for registering a plurality of the first local coronal view and the second local coronal view of the breast to acquire a mask of the mammary gland”.
These elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No, similar to Step 2A Prong 2, the additional elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. In light of the above, claim 13 is ineligible.
Claim 14 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes, for the same reasons as claim 1,
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites “acquiring the position of the chest wall based on the mask of the chest wall.”
This limitation, as drafted, is a process step, that, under its BRI, covers an abstract idea, more specifically a mathematical concept. That is, the listed claim recites a mathematical calculation that is a mathematical operation or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic equation such as exponentiation. Accordingly, the claim recites a mathematical concept-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No, the claim further recites “wherein the determination of [[a]]the position of the chest wall based on the ultrasonic images comprises: segmenting the chest wall from each of the plurality of two-dimensional images to acquire a segmentation mask of the chest wall; registering the plurality of segmentation masks on the plurality of two-dimensional images based on a registration parameter used for registering a plurality of the first local coronal view and the second local coronal view of the breast to acquire a mask of the chest wall;”
These elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No, similar to Step 2A Prong 2, the additional elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. In light of the above, claim 14 is ineligible.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract without significantly more.
Step 1: Statutory Category: Yes, the claim is directed to a system and is therefore a machine.
Step 2A, Prong 1, Judicial Exception: Yes. The claim recites the limitation “determine a volume of a mammary gland and a volume of the breast based on registering the first coronal view and the second local coronal view; and determine the breast density based on the volume of the mammary gland and the volume of the breast”.
This limitation, as drafted, is a process step, that, under its BRI, covers an abstract idea, more specifically a mathematical concept. That is, the listed claim recites a mathematical calculation that is a mathematical operation or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic equation such as exponentiation. Accordingly, the claim recites a mathematical concept-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No; The claim further recites “An ultrasonic imaging system, comprising: a scanning assembly moving over the surface of a breast to acquire ultrasonic echo signals; a memory storing instructions; and a processor configured to execute the instructions to: perform ultrasonic scanning on a breast to acquire ultrasonic images of the breast; acquire, based on the ultrasonic images, a first local coronal view having a first set of markers acquire, based on the ultrasonic images, a second local coronal view having a second set of markers that is different than the first set of markers; register the first local coronal view and the second local coronal view based on the first set of markers and the second set of markers”.
These elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No, similar to Step 2A Prong 2, the additional elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. In light of the above, claim 15 is ineligible.
Claim 16 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes, for the same reasons as claim 15,
Step 2A, Prong 1, Judicial Exception: Yes, for the same reasons as claim 15.
Step 2A, Prong 2, Integrated into Practical Application: No, the claim additionally recites “wherein the performing ultrasonic scanning on the breast to acquire the ultrasonic images of the breast comprises: performing, via a scanning assembly, ultrasonic scanning on the breast, of which an outer edge is attached with at least one marker of the first set of marker or the second set of markers, to acquire the ultrasonic images, 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.”
These elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No, similar to Step 2A Prong 2, the additional elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. In light of the above, claim 16 is ineligible
Claim 17 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes, for the same reasons as claim 17,
Step 2A, Prong 1, Judicial Exception: Yes, for the same reasons as claim 17,
Step 2A, Prong 2, Integrated into Practical Application: No, the claim additionally recites the limitation “wherein the at least one marker comprises a plurality of markers, and the plurality of markers are attached to the outer edge of the breast.”
These elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No, similar to Step 2A Prong 2, the additional elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. In light of the above, claim 17 is ineligible
Claim 18 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes, for the same reasons as claim 18,
Step 2A, Prong 1, Judicial Exception: Yes, for the same reasons as claim 18,
Step 2A, Prong 2, Integrated into Practical Application: No, the claim additionally recites the limitation “wherein the ultrasonic images comprise a plurality of two-dimensional images.”
These elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No, similar to Step 2A Prong 2, the additional elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. In light of the above, claim 18 is ineligible
Claim 19 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes, for the same reasons as claim 19,
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites “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 first local coronal view and the second local coronal view.” This limitation, as drafted, is a process step, that, under its BRI, covers an abstract idea, more specifically a mathematical concept. That is, the listed claim recites a mathematical calculation that is a mathematical operation or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic equation such as exponentiation. Accordingly, the claim recites a mathematical concept-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No, the claim additionally recites the limitation “wherein the determination of the volume of the mammary gland and the volume of the breast based on the ultrasonic images comprises: 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 the first local coronal view and the second local coronal view of the breast”.
These elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No, similar to Step 2A Prong 2, the additional elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. In light of the above, claim 19 is ineligible.
Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract without significantly more.
Step 1: Statutory Category: Yes, the claim is directed to a non-transitory computer readable medium and is therefore a machine.
Step 2A, Prong 1, Judicial Exception: Yes. The claim recites the limitation “determining a volume of a mammary gland and a volume of the breast based on registering the first coronal view and the second local coronal view; and determining the breast density based on the volume of the mammary gland and the volume of the breast”.
This limitation, as drafted, is a process step, that, under its BRI, covers an abstract idea, more specifically a mathematical concept. That is, the listed claim recites a mathematical calculation that is a mathematical operation or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic equation such as exponentiation. Accordingly, the claim recites a mathematical concept-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No; The claim further recites “A method for quantifying breast density, comprising: performing ultrasonic scanning on a breast to acquire ultrasonic images of the breast; acquiring, based on the ultrasonic images, a first local coronal view having a first set of markers acquiring, based on the ultrasonic images, a second local coronal view having a second set of markers that is different than the first set of markers; registering the first local coronal view and the second local coronal view based on the first set of markers and the second set of markers”.
These elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No, similar to Step 2A Prong 2, the additional elements merely recites insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. In light of the above, claim 20 is ineligible.
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 1 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wiskin et al., (US20160210774A1) in view of Zhang et al., (US20070038085A1) in further view of Leproux et al., “Automated 3D whole-breast ultrasound imaging: results of a clinical pilot study” Proc. SPIE 7629, Medical Imaging 2010: Ultrasonic Imaging, Tomography, and Therapy, 762902 (12 Mar 2010) (hereinafter “Leproux”)and Tokuda et al., (US20170000581A1).
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 ultrasonic images of the breast (fig. 1 breast images 105 generated from ultrasound [0027]);
acquiring, based on the ultrasonic images, a first local coronal view (fig 2A [0036])
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 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)).
However, Wiskin is silent regarding acquiring, based on the ultrasonic images, a first local coronal view; acquiring, based on the ultrasonic images, a second local coronal view; registering the first local coronal view and the second local coronal view based on the first set of markers and the second set of markers
However in the same ultrasound imaging field of endeavor, Zhang, teaches acquiring, based on the ultrasonic images, a first local coronal view; acquiring, based on the ultrasonic images, a second local coronal view being different than the first view; ([0103] a first and second volume of a breast is scanned, and first and second coronal views are different.).
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 acquiring different coronal scans of the same breast as taught by Zhang to the method of Wiskin as both inventions relate to ultrasound imaging of the breast, and would yield the predictable result of a method of quantifying breast density that includes acquiring two coronal views of the breast to one of ordinary skill in the art. One of ordinary skill would be able to perform such a technique, and the results of Wiskin acquiring two coronal views of the breast are reasonably predictable. This would facilitate identification of correspond breast tissue regions across multiple acquisitions.
However, the combination of references are silent regarding registering the first and second images.
In the same ultrasound field of endeavor, Leproux teaches registering the first and second images (pg 7, the volumes of the breast are registered together).
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 acquiring the coronal views of modified Wiskin by registering those coronal views as taught by Leproux, as this would help interpretation of the ultrasound anatomical data (see Leproux page 8).
However, the combination of references fails to teach a second set of markers that is different than the first set of markers.
In the same image registration field of endeavor, Tokuda teaches a second set of markers that is different than the first set of markers ([0008] two clusters of markers that comprise a different number size/shape/material and are used in registration).
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 registering the first and second coronal views of modified Wiskin to have distinguishing marker sets that have different characteristics as taught by Tokuda, as this would facilitate automated methods for registering images (see Tokuda [0007]). One of ordinary skill would understand that such modification would have enabled improved identification of corresponding marker locations and resulted in the coronal views having markers, and registering them based on the first and second set markers.
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 ultrasonic images of the breast (fig. 1 breast images 105 generated from ultrasound [0027]);
acquiring, based on the ultrasonic images, a first local coronal view (fig 2A [0036])
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 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)).
However, Wiskin is silent regarding acquiring, based on the ultrasonic images, a first local coronal view; acquiring, based on the ultrasonic images, a second local coronal view.
However in the same ultrasound imaging field of endeavor, Zhang, teaches acquiring, based on the ultrasonic images, a first local coronal view; acquiring, based on the ultrasonic images, a second local coronal view being different than the first view; ([0103] a first and second volume of a breast is scanned, and first and second coronal views are different.).
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 acquiring different coronal scans of the same breast as taught by Zhang to the method of Wiskin as both inventions relate to ultrasound imaging of the breast, and would yield the predictable result of a method of quantifying breast density that includes acquiring two coronal views of the breast to one of ordinary skill in the art. One of ordinary skill would be able to perform such a technique, and the results of Wiskin acquiring two coronal views of the breast are reasonably predictable. This would facilitate identification of correspond breast tissue regions across multiple acquisitions.
However, the combination of references are silent regarding registering the first and second images.
In the same ultrasound field of endeavor, Leproux teaches registering the first and second images (pg 7, the volumes of the breast are registered together).
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 acquiring the coronal views of modified Wiskin by registering those coronal views as taught by Leproux, as this would help interpretation of the ultrasound anatomical data (see Leproux page 8).
However, the combination of references fails to teach a second set of markers that is different than the first set of markers.
In the same image registration field of endeavor, Tokuda teaches a second set of markers that is different than the first set of markers ([0008] two clusters of markers that comprise a different number size/shape/material and are used in registration).
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 registering the first and second coronal views of modified Wiskin to have distinguishing marker sets that have different characteristics as taught by Tokuda, as this would facilitate automated methods for registering images (see Tokuda [0007]). One of ordinary skill would understand that such modification would have enabled improved identification of corresponding marker locations and resulted in the coronal views having markers, and registering them based on the first and second set markers.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Wiskin, Zhang, Leproux, and Tokuda as applied to claim 1, and further in view of Russell (US5873827A) and Wang et al., (US20140121520A1).
Regarding claim 2, modified Wiskin teaches the method of claim 1, wherein Wiskin teaches the performing ultrasonic scanning the breast to acquire the ultrasonic images 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 images.
In the same ultrasound field of endeavor, Russel teaches performing, via a scanning assembly, ultrasonic scanning on the breast, of which an outer edge is attached with at least one marker of the first set or marker, to acquire the ultrasonic images. (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 modified 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 Wiskin incorporate surface ultrasonic markers are reasonably predictable. One of ordinary skill would also understand that since these are applied to the surface, and modified 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 at least one 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 at least one 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 modified 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 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 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, Zhang, Leproux, and Tokuda as applied to claim 1, and further in view of Koshino (US20250268561A1).
Regarding claim 4, modified Wiskin teaches the method of claim 1, but is silent regarding wherein ultrasonic images comprise a plurality of two-dimensional images.
In the same ultrasound field of endeavor, Koshino teaches wherein ultrasonic images comprise 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 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 modified Wiskin using two-dimensional ultrasonic images are reasonably predictable.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over modified Wiskin Zhang, Leproux, and Tokuda 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 the first local coronal view and the second 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 first local coronal view and the second local coronal view.
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 images (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 and in further view Zhang, Leproux, and Tokuda.
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]).
However, the combination of references is silent regarding acquiring, based on the ultrasonic images, a first local coronal view; acquiring, based on the ultrasonic images, a second local coronal view; registering the first local coronal view and the second local coronal view based on the first set of markers and the second set of markers
However in the same ultrasound imaging field of endeavor, Zhang, teaches acquiring, based on the ultrasonic images, a first local coronal view; acquiring, based on the ultrasonic images, a second local coronal view being different than the first view; ([0103] a first and second volume of a breast is scanned, and first and second coronal views are different.).
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 acquiring different coronal scans of the same breast as taught by Zhang to the method of Wiskin as both inventions relate to ultrasound imaging of the breast, and would yield the predictable result of a method of quantifying breast density that includes acquiring two coronal views of the breast to one of ordinary skill in the art. One of ordinary skill would be able to perform such a technique, and the results of Wiskin acquiring two coronal views of the breast are reasonably predictable. This would facilitate identification of correspond breast tissue regions across multiple acquisitions.
However, the combination of references are silent regarding registering the first and second images.
In the same ultrasound field of endeavor, Leproux teaches registering the first and second images (pg 7, the volumes of the breast are registered together).
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 acquiring the coronal views of modified Wiskin by registering those coronal views as taught by Leproux, as this would help interpretation of the ultrasound anatomical data (see Leproux page 8).
However, the combination of references fails to teach a second set of markers that is different than the first set of markers.
In the same image registration field of endeavor, Tokuda teaches a second set of markers that is different than the first set of markers ([0008] two clusters of markers that comprise a different number size/shape/material and are used in registration).
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 registering the first and second coronal views of modified Wiskin to have distinguishing marker sets that have different characteristics as taught by Tokuda, as this would facilitate automated methods for registering images (see Tokuda [0007]). One of ordinary skill would understand that such modification would have enabled improved identification of corresponding marker locations and resulted in the coronal views having markers, and registering them based on the first and second set markers.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Wiskin, Zhang, Leproux, and Tokuda 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 marker of the first set of 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 marker of the first set of 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 modified Wang 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 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 Wang 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 at least one 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 Wang 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, Zhang, Leproux, and Tokuda 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 images comprise a plurality of two-dimensional images.
In the same ultrasound field of endeavor, Koshino teaches wherein ultrasonic images comprise 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 Wang 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, Zhang, Leproux, and Koshino as applied to claim 18, and further in view of Ito and Zhang.
Regarding claim 19, modified Wang teaches the system of claim 18, but fials to explicitly disclose wherein the determination of a volume of a mammary gland and a volume of the breast based on the ultrasonic image comprises 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])
However the combination of references fail 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 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.
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 the first local coronal view and the second 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 first local coronal view and the second local coronal view.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Now Wiskin, Zhang, Leproux, and Tokuda have been used to teach claim 1.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MICHAEL YIMING FANG/ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798
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