DETAILED ACTION
This office action is in response to the communication received on 02/03/2026 concerning application no. 18/052,663 filed on 11/04/2022.
Claims 2-4, 7-22, and 24-25 are pending.
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 .
Response to Arguments
Applicant's arguments filed 02/03/2026 have been fully considered but they are not persuasive.
Regarding the 101 rejection, Applicant argues that the calculation cannot be performed in the mind as it is a pixel-level process and uses image recognition algorithms. Applicant argues that this is done for the binarization and isolation of the GTC.
Examiner respectfully disagrees. MPEP 716.01(c) establishes “Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).” Nothing in the claims establishes the use of image recognition algorithms. With respect to the binarization and isolation of the GTC, this can be performed mentally as is requires the mental determination of whether a given set of data is associated to the GTC or not. That is, the choice is binary and between the decisions of “yes” or “no”. Additionally, the use of a pixel-based approach does not preclude the performance of the mental process. MPEP 2106.04(a)(1) establishes that the “courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016) (holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper").” The assessment can be done by assessing the data via a mathematical assessment of its brightness with respect to other points of data and determining whether it is representative of the GTC or not. Furthermore, the step is a calculation step of a ratio. A ratio is merely the “the indicated quotient of two mathematical expressions” and “the relationship in quantity, amount, or size between two or more things”.1
Examiner respectfully maintains the rejection.
Applicant’s arguments with respect to claims 24-25 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.
Drawings
The drawings were received on 05/12/2025. These drawings are not accepted and not entered.
Specification
The substitute specification filed 05/12/2025 has not been entered because it does not conform to 37 CFR 1.125(b) and (c) because: The described Fig. 20 is not entered.
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 2-4, 7-22, and 24-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 24 is indefinite for the following reasons:
Recites “calculate a ratio of the extracted glandular tissue component region to the detected mammary gland region based on a number of occupied pixels of the detected mammary gland region and a number of occupied pixels of the extracted glandular tissue component region in the binarized mammary gland region”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the ratio is the GTC to the mammary gland region as the initial part of the claim element suggests or the mammary gland region to the GTC as the later part of the claim suggests. That is, the later part establishes it is based on the pixels of the mammary gland region and the GTC.
Applicant is encouraged to provide consistent and clear language.
Claim 7 is indefinite for the following reasons:
Recites “wherein the processor is further configured to calculate the ratio of the glandular tissue component region to the detected mammary gland region based on the number of occupied pixels of the detected mammary gland region and the number of occupied pixels of the glandular tissue component region in the ultrasound image”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if this is an additional calculation of the GTC ratio or is referring to the same calculation as the one established in claim 24 with the binarized pixels. If it is the later, see the 112(d) rejection below. If it is the former, it would be unclear what the performance of the calculation is utilizing as the pixels for the GTC and mammary gland region are the same.
Applicant is encouraged to provide consistent and clear language.
Claim 11 is indefinite for the following reasons:
Recites “a monitor”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “monitor” is the same as the “monitor” established claim 24 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Claim 12 is indefinite for the following reasons:
Recites “wherein the processor is further configured to calculate a ratio of the detected mammary gland region to the breast region and display the calculated ratio of the extracted glandular tissue component region to the detected mammary gland region on the monitor”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the calculated ratio of the GTC to the mammary gland region is displayed again after the display established in claim 24 or is referring to the same display. Additionally, it is unclear what relation the display has to the ratio of the detected gland region to the breast region.
Applicant is encouraged to provide consistent and clear language.
Claim 25 is indefinite for the following reasons:
Recites “calculating a ratio of the extracted glandular tissue component region to the detected mammary gland region based on a number of occupied pixels of the detected mammary gland region and a number of occupied pixels of the extracted glandular tissue component region in the binarized mammary gland region”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the ratio is the GTC to the mammary gland region as the initial part of the claim element suggests or the mammary gland region to the GTC as the later part of the claim suggests. That is, the later part establishes it is based on the pixels of the mammary gland region and the GTC.
Applicant is encouraged to provide consistent and clear language.
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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 7, recites “wherein the processor is further configured to calculate the ratio of the glandular tissue component region to the detected mammary gland region based on the number of occupied pixels of the detected mammary gland region and the number of occupied pixels of the glandular tissue component region in the ultrasound image.” Claim 7 depends on claim 24. Claim 24 recites “calculate a ratio of the extracted glandular tissue component region to the detected mammary gland region based on a number of occupied pixels of the detected mammary gland region and a number of occupied pixels of the extracted glandular tissue component region in the binarized mammary gland region”. The language of claim 7 fails to further limit the subject matter of the claim upon which it depends as both establish the calculation of the GTC ratio with respect to the occupied pixels of both the mammary gland region and the glandular tissue. Therefore, claim 7 is in improper dependent form for failing to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 2-4, 7-22, and 24-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 24 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 - The claims recite ultrasound image analysis apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “detect a mammary gland region from an ultrasound image obtained by imaging abreast of a subject, including a glandular tissue component region consisting of mammary ducts, lobules, and peripheral stroma tissue present between the lobules and the mammary ducts; extract the glandular tissue component region from the detected mammary gland region by binarizing the detected mammary gland region by using a predetermined brightness threshold value; calculate a ratio of the extracted glandular tissue component region to the detected mammary gland region based on a number of occupied pixels of the detected mammary gland region and a number of occupied pixels of the extracted glandular tissue component region in the binarized mammary gland region”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the detection of the mammary gland region from the ultrasound image and the extraction of the glandular tissue component region according to thresholding and determination of the ratio of the glandular tissue component region to the mammary gland. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “a monitor; and a processor configured to; and control the monitor to display the calculated ratio”. Display of the ratio is a display step is merely amounts to a post-solution insignificant activity. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional 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. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 24 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 - The claims recite an ultrasound image analysis apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “detect the mammary gland region by image recognition of the ultrasound image”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to performing an image recognition of an ultrasound image for the detection of a mammary gland region. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the processor is further configured to”. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional 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. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. 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 - The claims recite an ultrasound image analysis apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “detect a breast region located between a skin and a pectoral major muscle from the ultrasound image, recognize a front boundary line and a rear boundary line in the detected breast region, and detect a region between the front boundary line and the rear boundary line, as the detected mammary gland region”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the detection of breast region between skin and the pectoralis major muscle from an ultrasound image and the recognition of boundary lines in the breast region and the region in between the boundary lines. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the processor is further configured to”. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional 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. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. 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 - The claims recite an ultrasound image analysis apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “detect the mammary gland region from the ultrasound image by using deep learning”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the detection of mammary gland region from an ultrasound image. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the processor is further configured to” and “by using deep learning”. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional 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. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 4 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 - The claims recite an ultrasound image analysis apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “calculate the ratio of the glandular tissue component region to the detected mammary gland region based on the number of occupied pixels of the detected mammary gland region and the number of occupied pixels of the glandular tissue component region in the ultrasound image”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the calculation of a ratio based on the number of occupied pixels of the mammary gland region and the number of occupied pixels of the glandular tissue component region in an ultrasound image. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the processor is further configured to”. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional 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. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. 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 - The claims recite an ultrasound image analysis apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “detect the mammary gland region from each of a plurality of the ultrasound images obtained by imaging the breast of the subject at a plurality of predetermined locations of the breast of the subject, extract the glandular tissue component region from each of the detected mammary gland regions of the plurality of ultrasound images, and calculate the ratio of the glandular tissue component region to the detected mammary gland region in each of the plurality of ultrasound images”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the detection of the mammary gland region from multiple ultrasound images, extracting the component regions that include the mammary ducts, lobules, and peripheral stromata from each image, and the calculation of the ratio of the component region to the mammary gland region for each image. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the processor is further configured to”. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional 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. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. 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 - The claims recite an ultrasound image analysis apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “calculate an average value of ratios of the glandular tissue component regions to the mammary gland regions in the plurality of ultrasound images”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the averaging of the collected ratios of the component regions to the mammary gland regions. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the processor is further configured to”. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional 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. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. 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 - The claims recite an ultrasound image analysis apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “calculate the ratio of the glandular tissue component region to the detected mammary gland region based on a volume of the detected mammary gland region and a volume of the extracted glandular tissue component region”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the calculation of the ratio of the glandular tissue component region to the mammary gland region based on the volume that has been extracted. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the ultrasound image is a three-dimensional ultrasound image, and the processor is further configured to”. The collection of ultrasound image that is in 3D is a data-gathering step, which is a pre-solution insignificant activity. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional 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. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 10 is ineligible.
Claim 11 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 - The claims recite an ultrasound diagnostic apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “detect the mammary gland region from the ultrasound image”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the detection of the mammary gland region from the ultrasound image. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “a monitor that displays the ultrasound image obtained by imaging the breast of the subject; and the ultrasound image analysis apparatus according to claim 24, wherein the processor is further configured to display the calculated ratio of the glandular tissue component region to the detected mammary gland region on the monitor”. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional 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. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 11 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 - The claims recite an ultrasound diagnostic apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “calculate a ratio of the detected mammary gland region to the breast region and display the calculated ratio of the extracted glandular tissue component region to the detected mammary gland region on the monitor”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to acquiring data in the form of a ratio of the mammary gland with respect to the breast region from a mammography image. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the processor is further configured to”. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional 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. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 12 is 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 - The claims recite an ultrasound diagnostic apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein the processor is further configured to extract the glandular tissue component region in the detected mammary gland region only in a case where the calculated ratio of the extracted glandular tissue component region to the detected mammary gland region is higher than a set value”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to extraction of glandular tissue component region to the mammary gland region only based on a threshold value. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the processor is further configured to”. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional 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. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. 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 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 13 rejection.
Claim 14 recites the following elements: “wherein the processor is further configured to display a binarized image obtained by binarizing the detected mammary gland region on the monitor”. This claim element is a mere displaying step which amounts to a post-solution insignificant activity. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception. This post-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 14 is ineligible.
Claim 15 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 - The claims recite an ultrasound diagnostic apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein the predetermined brightness threshold value is a constant value”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the utilization of a threshold value that remains constant. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. 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 - The claims recite ultrasound image analysis apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “detect an edge of the glandular tissue component region in the ultrasound image, and automatically set the predetermined brightness threshold value based on a change in brightness value at the detected edge”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to detection of an edge of the glandular tissue component and setting the threshold based on the change in brightness. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the processor is further configured to”. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional 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. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. 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 - The claims recite an ultrasound diagnostic apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “create a histogram of brightness of the detected mammary gland region in the ultrasound image” and “wherein the predetermined brightness threshold value is set by a user based on the histogram, the binarized image, and the ultrasound image which are displayed on the monitor”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to creation of a histogram based on the data and the setting of a threshold based on the histogram, binarized image, and the ultrasound image. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the processor is further configured to display the created histogram on the monitor,” and “the histogram, the binarized image, and the ultrasound image which are displayed on the monitor”. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional 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. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. 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 - The claims recite an ultrasound diagnostic apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “generate a schematic diagram of the breast on which a plurality of predetermined locations are plotted”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to plotting of the predetermined location with respect to the breast. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the processor is further configured to” and “displays the schematic diagram on the monitor”. The display of the diagram is a displaying step which is a post-solution insignificant activity. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional 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. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. 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 - The claims recite an ultrasound diagnostic apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “guide a user to perform imaging of the ultrasound images at the plurality of predetermined locations”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to guide the user to perform imaging of the ultrasound images at the predetermined locations. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the processor is further configured to”. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional 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. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. 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 idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 11 rejection.
Claim 20 recites the following elements: “wherein the processor is further configured to store the calculated ratio of the glandular tissue component region to the detected mammary gland region in a tag associated with the ultrasound image”. This claim element is a mere data storage step which amounts to a post-solution insignificant activity. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception. This post-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 20 is ineligible.
Claim 21 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 11 rejection.
Claim 21 recites the following elements: “wherein the processor is further configured to display, on the monitor, a past ratio of the glandular tissue component region to the detected mammary gland region that is calculated based on the past ultrasound image of the subject, together with a latest ratio of the glandular tissue component region to the detected mammary gland region that is calculated based on the latest ultrasound image of the subject”. This claim element is a mere displaying step which amounts to a post-solution insignificant activity. The use of a processor and a monitor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception. This post-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 21 is ineligible.
Claim 22 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 11 rejection.
Claim 22 recites the following elements: “an ultrasound probe; and wherein the processor is further configured to generate the ultrasound image obtained by imaging the breast of the subject by transmitting and receiving an ultrasound beam to and from the subject using the ultrasound probe”. This claim element is a mere data-gathering step which amounts to a pre-solution insignificant activity. The use of ultrasound probe and processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 22 is ineligible.
Claim 25 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 - The claims recite a control method for an ultrasound image analysis apparatus and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “detecting a mammary gland region from an ultrasound image obtained by imaging a breast of a subject, including a glandular tissue component region consisting of mammary ducts, lobules, and peripheral stroma tissue present between the lobules and the mammary ducts; extracting the glandular tissue component region from the detected mammary gland region by with binarizing the detected mammary gland region by using a predetermined brightness threshold value; calculating a ratio of the extracted glandular tissue component region to the detected mammary gland region based on a number of occupied pixels of the detected mammary gland region and a number of occupied pixels of the extracted glandular tissue component region in the binarized mammary gland region”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the detection of the mammary gland region from the ultrasound image and the extraction of the glandular tissue component region according to thresholding and determination of the ratio of the glandular tissue component region to the mammary gland. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “controlling a monitor to display the calculated ratio”. Display of the ratio is a display step is merely amounts to a post-solution insignificant activity.
These additional 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. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 25 is ineligible.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-4, 7-8, 11, 18-20, 22, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Higashi et al. (PGPUB No. US 2023/0143350) as evidenced by Sherratt et al. ("Raised mammographic density: causative mechanisms and biological consequences", 2016) further in view of Sugiyama et al. (PGPUB No. US 2016/0110875).
Regarding claim 24, Higashi teaches an ultrasound image analysis apparatus comprising:
a monitor (Abstract teaches a display monitor); and
a processor (Paragraph 0031 teaches that the device includes a processor) configured to
detect a mammary gland region from an ultrasound image obtained by imaging abreast of a subject, including a glandular tissue component region consisting of mammary ducts, lobules, and peripheral stroma tissue present between the lobules and the mammary ducts (Paragraph 0037 teaches operation in ultrasound. Paragraph 0040 teaches that the overlooked areas can be determined by the apparatus. Paragraph 0116 teaches that the overlooked area is included in the mammary gland. See Fig. 5. It is inherent that a mammary gland comprises of mammary ducts, lobules, peripheral stromata, and edematous stroma2 );
calculate a ratio of the extracted glandular tissue component region to the detected mammary gland region based on a number of occupied pixels of the detected mammary gland region and a number of occupied pixels of the extracted glandular tissue component region in the binarized mammary gland region (Paragraph 0116 teaches the ratio of an overlooked area in the mammary gland to the mammary gland area. Paragraph 0117 teaches that the area of the mammary gland can be assessed based on the pixel number. Paragraph 0040 teaches that the overlooked region can be determined based on each pixel on the image data. Paragraph 0087 teaches the extraction of the overlooked region from non-candidate regions. Paragraph 0114 teaches that the score is based on the ratio and can be displayed); and
control the monitor to display the calculated ratio (Paragraph 0116 teaches the ratio of an overlooked area in the mammary gland to the mammary gland area. Paragraph 0117 teaches that the area of the mammary gland can be assessed based on the pixel number. Paragraph 0040 teaches that the overlooked region can be determined based on each pixel on the image data. Paragraph 0087 teaches the extraction of the overlooked region from non-candidate regions. Paragraph 0114 teaches that the score is based on the ratio and can be displayed).
However, Higashi is silent regarding an apparatus,
extract the glandular tissue component region from the detected mammary gland region by binarizing the detected mammary gland region by using a predetermined brightness threshold value;
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Sugiyama teaches an ultrasound image analysis apparatus, extract the glandular tissue component region from the detected mammary gland region by binarizing the detected mammary gland region by using a predetermined brightness threshold value (Paragraph 0201 teaches that the pixels can be thresholded based on brightness value. This assigns pixel value in a binary manner for the determination of the fat and mammary gland regions. See Figs. 26-27. Paragraph 0002 teaches the system operates with ultrasound).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Higashi with Sugiyama’s teaching of the binarizing of mammary gland tissue for the purpose of differentiation and the assessment of brightness value in the assessment of the anatomical regions. This modified apparatus would allow the user to improve level of precision of the mammary gland diagnosis (Paragraph 00071 of Sugiyama). Furthermore, the modification allows the assessment of the ROI of a breast and store the corresponding data (Paragraph 0036 of Sugiyama).
Regarding claim 2, modified Higashi teaches the ultrasound image analysis apparatus in claim 24, as discussed above.
Higashi further teaches an ultrasound image analysis apparatus, wherein the processor is further configured to detect the mammary gland region by image recognition of the ultrasound image (Paragraph 0037 teaches that ultrasound image data can be used and the image includes the mammary gland region. See Fig. 5. Paragraph 0117 teaches that the area of the mammary gland can be determined via the processing device).
Regarding claim 3, modified Higashi teaches the ultrasound image analysis apparatus in claim 2, as discussed above.
Higashi further teaches an ultrasound image analysis apparatus, wherein the processor (Paragraph 0031 teaches that the device includes a processor) is further configured to
detect a breast region located between a skin and a pectoral major muscle from the ultrasound image (Paragraph 0037 teaches that the mammogram images include the pectoralis major region and the mammary area as seen in Figs. 4-5. The mammary area is seen between the pectoralis major region and the skin),
recognize a front boundary line and a rear boundary line in the detected breast region, and detect a region between the front boundary line and the rear boundary line, as the detected mammary gland region (Paragraph 0037 teaches the mammary gland is determined in the area of the breast. Fig. 5 shows the mammary gland within the boundary defined by the pectoralis major and the outer skin boundary).
Regarding claim 4, modified Higashi teaches the ultrasound image analysis apparatus in claim 24, as discussed above.
Higashi further teaches an ultrasound image analysis apparatus, wherein the processor is further configured to detect the mammary gland region from the ultrasound image by using deep learning (Paragraph 0039 and 0080-81 teach the use of machine learning for identification of the overlooked areas and the environmental data. Paragraph 0116 teaches the ratio of an overlooked area in the mammary gland to the mammary gland area. Paragraph 0037 teaches that the image can be ultrasound).
Regarding claim 7, modified Higashi teaches the ultrasound image analysis apparatus in claim 24, as discussed above.
Higashi further teaches an ultrasound image analysis apparatus, wherein the processor is further configured to calculate the ratio of the glandular tissue component region to the detected mammary gland region based on the number of occupied pixels of the detected mammary gland region and the number of occupied pixels of the glandular tissue component region in the ultrasound image (Paragraph 0116 teaches the ratio of an overlooked area in the mammary gland to the mammary gland area. Paragraph 0117 teaches that the area of the mammary gland can be assessed based on the pixel number. Paragraph 0040 teaches that the overlooked region can be determined based on each pixel on the image data. Paragraph 0087 teaches the extraction of the overlooked region from non-candidate regions).
Regarding claim 8, modified Higashi teaches the ultrasound image analysis apparatus in claim 24, as discussed above.
Higashi further teaches an ultrasound image analysis apparatus, wherein the processor is further configured to
detect the mammary gland region from each of a plurality of the ultrasound images obtained by imaging the breast of the subject at a plurality of predetermined locations of the breast of the subject (Paragraph 0031 teaches that the device includes a processor. Paragraph 0037 teaches that ultrasound image data can be used and the image includes the mammary gland region. This includes multiples images. See Fig. 5. Paragraph 0117 teaches that the area of the mammary gland can be determined. Paragraph 0039 teaches that the machine learning can allow for the assessment of areas where the lesion is commonly overlooked to be considered when reading the environment),
extract the glandular tissue component region from each of the detected mammary gland regions of the plurality of ultrasound images (Paragraph 0040 teaches that the overlooked areas can be determined by the apparatus. Paragraph 0116 teaches that the overlooked area is included in the mammary gland. See Fig. 5. Paragraph 0037 teaches the operation with the mammography images), and
calculate the ratio of the glandular tissue component region to the detected mammary gland region in each of the plurality of ultrasound images (Paragraph 0116 teaches the ratio of an overlooked area in the mammary gland to the mammary gland area. Paragraph 0037 teaches the operation with the mammography images).
Regarding claim 11, modified Higashi teaches the an ultrasound image analysis apparatus in claim 24, as discussed above.
Higashi further teaches a ultrasound diagnostic apparatus, comprising:
a monitor that displays the ultrasound image obtained by imaging the breast of the subject (Abstract teaches that the images are displayed on the monitor. Fig. 9 shows the breast of a patient. Paragraph 0037 teaches that the images can be ultrasound images); and
the ultrasound image analysis apparatus according to claim 24 (See above),
wherein the processor (Paragraph 0031 teaches that the device includes a processor) is further configured to
detect the mammary gland region from the ultrasound image (Paragraph 0031 teaches that the device includes a processor. Paragraph 0037 teaches that ultrasound image data can be used and the image includes the mammary gland region. See Fig. 5. Paragraph 0117 teaches that the area of the mammary gland can be determined), and
display the calculated ratio of the glandular tissue component region to the detected mammary gland region on the monitor (Paragraph 0116 teaches the ratio of an overlooked area in the mammary gland to the mammary gland area as the score. Paragraph 0114 teaches that the score can be displayed).
Regarding claim 18, modified Higashi teaches the ultrasound diagnostic apparatus in claim 11, as discussed above.
Higashi further teaches a ultrasound diagnostic apparatus, wherein the processor is further configured to generate a schematic diagram of the breast on which a plurality of predetermined locations are plotted and displays the schematic diagram on the monitor (Paragraph 0034 teaches that the overlooked reasons can be performed with respect to the medical imaging data. See Fig. 9).
Regarding claim 19, modified Higashi teaches the ultrasound diagnostic apparatus in claim 18, as discussed above.
Higashi further teaches a ultrasound diagnostic apparatus, wherein the processor is further configured to guide a user to perform imaging of the ultrasound images at the plurality of predetermined locations (Paragraph 0034 teaches that the overlooked reasons can be performed with respect to the medical imaging data. This allows the radiologist to see which area should be scrutinized more carefully. See Fig. 9. Paragraphs 0072-73 teach the use of data acquiring units that are able to learn and acquire environmental information. Paragraph 0037 teaches that the medical imaging data can be ultrasound images).
Regarding claim 20, modified Higashi teaches the ultrasound diagnostic apparatus in claim 11, as discussed above.
Higashi further teaches a ultrasound diagnostic apparatus, wherein the processor is further configured to store the calculated ratio of the glandular tissue component region to the detected mammary gland region in a tag associated with the ultrasound image (Paragraph 0093 teaches that the memory can store the monitor related data and the environmental data. Paragraph 0116 teaches the ratio of an overlooked area in the mammary gland to the mammary gland area as the score. Paragraph 0114 teaches that the score can be displayed).
Regarding claim 22, modified Higashi teaches the ultrasound diagnostic apparatus in claim 11, as discussed above.
While Higashi teaches a data acquiring unit and utilization of ultrasound images (Paragraphs 0072-73 and 0037), Higashi is silent regarding an ultrasound diagnostic apparatus, further comprising:
an ultrasound probe; and
wherein the processor is further configured to generate the ultrasound image obtained by imaging the breast of the subject by transmitting and receiving an ultrasound beam to and from the subject using the ultrasound probe.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Sugiyama teaches an ultrasound diagnostic apparatus, further comprising:
an ultrasound probe (Paragraph 0048 teaches an ultrasound probe); and
wherein the processor is further configured to generate the ultrasound image obtained by imaging the breast of the subject by transmitting and receiving an ultrasound beam to and from the subject using the ultrasound probe (Paragraph 0051 teaches the use of an ultrasound probe that transmits and receives ultrasound with respect to patient anatomy).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Higashi with Sugiyama’s teaching of ultrasound imaging. This modified method would allow the user to improve level of precision of the mammary gland diagnosis (Paragraph 00071 of Sugiyama). Furthermore, the modification allows the assessment of the ROI of a breast and store the corresponding data (Paragraph 0036 of Sugiyama).
Regarding claim 25, Higashi teaches a control method for an ultrasound image analysis apparatus, the method comprising:
detecting a mammary gland region from an ultrasound image obtained by imaging a breast of a subject, including a glandular tissue component region consisting of mammary ducts, lobules, and peripheral stroma tissue present between the lobules and the mammary ducts (Paragraph 0037 teaches operation in ultrasound. Paragraph 0040 teaches that the overlooked areas can be determined by the apparatus. Paragraph 0116 teaches that the overlooked area is included in the mammary gland. See Fig. 5. It is inherent that a mammary gland comprises of mammary ducts, lobules, peripheral stromata, and edematous stroma3 );
calculating a ratio of the extracted glandular tissue component region to the detected mammary gland region based on a number of occupied pixels of the detected mammary gland region and a number of occupied pixels of the extracted glandular tissue component region in the binarized mammary gland region (Paragraph 0116 teaches the ratio of an overlooked area in the mammary gland to the mammary gland area. Paragraph 0117 teaches that the area of the mammary gland can be assessed based on the pixel number. Paragraph 0040 teaches that the overlooked region can be determined based on each pixel on the image data. Paragraph 0087 teaches the extraction of the overlooked region from non-candidate regions. Paragraph 0114 teaches that the score is based on the ratio and can be displayed); and
controlling a monitor to display the calculated ratio (Paragraph 0116 teaches the ratio of an overlooked area in the mammary gland to the mammary gland area. Paragraph 0117 teaches that the area of the mammary gland can be assessed based on the pixel number. Paragraph 0040 teaches that the overlooked region can be determined based on each pixel on the image data. Paragraph 0087 teaches the extraction of the overlooked region from non-candidate regions. Paragraph 0114 teaches that the score is based on the ratio and can be displayed).
However, Higashi is silent regarding a control method for an ultrasound image analysis apparatus, extracting the glandular tissue component region from the detected mammary gland region by with binarizing the detected mammary gland region by using a the predetermined brightness threshold value.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Sugiyama teaches a control method for an ultrasound image analysis apparatus, extracting the glandular tissue component region from the detected mammary gland region by with binarizing the detected mammary gland region by using a the predetermined brightness threshold value (Paragraph 0201 teaches that the pixels can be thresholded based on brightness value. This assigns pixel value in a binary manner for the determination of the fat and mammary gland regions. See Figs. 26-27. Paragraph 0002 teaches the system operates with ultrasound).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Higashi with Sugiyama’s teaching of the binarizing of mammary gland tissue for the purpose of differentiation. This modified method would allow the user to improve level of precision of the mammary gland diagnosis (Paragraph 00071 of Sugiyama). Furthermore, the modification allows the assessment of the ROI of a breast and store the corresponding data (Paragraph 0036 of Sugiyama).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Higashi et al. (PGPUB No. US 2023/0143350) further in view of Sugiyama et al. (PGPUB No. US 2016/0110875) further in view of Morita (PGPUB No. US 2019/0304088).
Regarding claim 9, modified Higashi teaches the ultrasound image analysis apparatus in claim 8, as discussed above.
However, the combination of Higashi and Sugiyama is silent regarding an ultrasound image analysis apparatus, wherein the processor is further configured to calculate an average value of ratios of the glandular tissue component regions to the mammary gland regions in the plurality of ultrasound images.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Morita teaches an ultrasound image analysis apparatus, wherein the processor is further configured to calculate an average value of ratios of the glandular tissue component regions to the mammary gland regions in the plurality of ultrasound images (Paragraph 0076 teaches that the control unit derives the average value of the mammary gland content rate for each pixel of the local region as the local mammary gland content rate. Paragraph 0063 teaches that the mammary gland content rate means the volume ratio of mammary gland tissues in each region. Paragraph 0081 teaches a plurality of the mammary gland concentrated regions can be assessed. Paragraph 0023 teaches multiple images can be acquired to acquire the whole mammary gland).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Higashi and Sugiyama with Morita’s teaching of averaging data. It would have been obvious to one with ordinary skill in the art that multiple sets of data regarding the ratio as taught by Higashi can be averaged. It is known that averaging is the expression of a set of data where the total value is divided by the number of sets of data. This summarizes the general significance of a set of unequal values. Given that Morita teaches averaging of data in the context of breast imaging and mammary glands particularly, one with ordinary skill in the art would be able to average the data collected in Higashi. This modified apparatus would allow the user to observe hidden or more difficult to see objects of interest in areas with high mammary gland concentration (Paragraph 0004 of Morita). Furthermore, the modification allows for careful observation of the object of interest (Paragraph 0006 of Morita).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Higashi et al. (PGPUB No. US 2023/0143350) further in view of Sugiyama et al. (PGPUB No. US 2016/0110875) further in view of Teboul (US Patent No. 5,709,206).
Regarding claim 10, modified Higashi teaches the ultrasound image analysis apparatus in claim 24, as discussed above.
Higashi further teaches an ultrasound image analysis apparatus, wherein the ultrasound image is a ultrasound image (Paragraph 0037 teaches that the images can be ultrasound-based), and
the processor is further configured to calculate the ratio of the glandular tissue component region to the detected mammary gland region based on a volume of the detected mammary gland region and a volume of the extracted glandular tissue component region (Paragraph 0116 teaches the ratio of an overlooked area in the mammary gland to the mammary gland area. Paragraph 0037 teaches that the image data can that can be used is CT image data. It is known that CT image data is volumetric data. Paragraph 0037 teaches that image data can be used and the image includes the mammary gland region. See Fig. 5. Paragraph 0117 teaches that the area of the mammary gland can be determined. Paragraph 0040 teaches that the overlooked areas can be determined by the apparatus. Paragraph 0116 teaches that the overlooked area is included in the mammary gland).
However, the combination of Higashi and Sugiyama is silent regarding an ultrasound image analysis apparatus, wherein the ultrasound image is a three-dimensional ultrasound image.
In an analogous imaging field of endeavor, regarding ultrasound-based analysis of breast tissue, Teboul teaches an ultrasound image analysis apparatus, wherein the ultrasound image is a three-dimensional ultrasound image (Abstract teaches the formation and utilization of a 3D image that is acquired via ultrasound imaging); and
assessment of breast tissue’s mammary gland via volumetric information (Abstract teaches the formation and utilization of a 3D image. Fig. 7 shows the performance of the imaging of the mammary gland. Col. 27, lines 55-65 teach the acquisition of the 3D view of the duct under investigation).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Higashi and Sugiyama with Teboul’s teaching of volumetric ultrasound imaging. As Higashi teaches that the system is able to operate with ultrasound image data and can operate with volumetric data in the form of CT images, it would be obvious to one with ordinary skill in the art that the image processing of Higashi can be implemented on the volumetric ultrasound information of Teboul. This modified apparatus would allow the user to accurately diagnose cancerous tissue in breast tissue (Col. 14, lines 17-24 of Teboul). Furthermore, the modification will improve long-term survival rates and allow early diagnosis (Col. 4, lines 7-10 of Teboul).
Claims 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Higashi et al. (PGPUB No. US 2023/0143350) further in view of Sugiyama et al. (PGPUB No. US 2016/0110875) further in view of Ofuji (PGPUB No. US 2009/0086891).
Regarding claim 12, modified Higashi teaches the ultrasound image analysis apparatus in claim 11, as discussed above.
However, the combination of Higashi and Sugiyama is silent regarding an ultrasound image analysis apparatus, wherein the processor is further configured to calculate a ratio of the detected mammary gland region to the breast region and display displays the calculated ratio of the extracted glandular tissue component region to the detected mammary gland region on the monitor.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Ofuji teaches an ultrasound diagnostic apparatus, wherein the processor is further configured to calculate a ratio of the detected mammary gland region to the breast region and display displays the calculated ratio of the extracted glandular tissue component region to the detected mammary gland region on the monitor (Paragraph 0018 teaches that the mammary gland content rate refers to the ratio of the portion of the mammary gland content rate to the breast region. Paragraph 0070 teaches that the display is in accordance to the mammary gland content rate. See Fig. 8).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Higashi and Sugiyama with Ofuji’s teaching of calculation and display of a ratio of the mammary gland region to the breast region. It would have been obvious to one with ordinary skill in the art that the ratio calculated according to Ofuji can be displayed as discussed by Higashi. As paragraph 0114 and 0116 of Higashi establish that the content rate can be displayed and determined in the form of a score. One with ordinary skill in the art would be able to implement the calculation of Ofuji and display that value. This is further evidence by the fact that Ofuji is organizing display data based on the content rate. This modified apparatus would allow the user to display mammograms based on the amounts of mammary glands included in the mammograms for image diagnosis assistance (Paragraph 0003 of Ofuji). Furthermore, the modification improves the accuracy for diagnosis (Paragraph 0081 of Ofuji).
Regarding claim 13, modified Higashi teaches the ultrasound diagnostic apparatus in claim 12, as discussed above.
Higashi further teaches an ultrasound diagnostic apparatus, wherein the processor is further configured to extract the glandular tissue component region in the detected mammary gland region only in a case where the calculated ratio of the extracted glandular tissue component region to the detected mammary gland region is higher than a set value (Paragraph 0085 teaches that the candidate pixels with the overlooked reasons is based on a thresholding. When the probability of the pixel is greater than the threshold, a candidate map is generated).
Regarding claim 14, modified Higashi teaches the ultrasound diagnostic apparatus in claim 13, as discussed above.
However, Higashi is silent regarding an ultrasound diagnostic apparatus, wherein the processor is further configured to display a binarized image obtained by binarizing the detected mammary gland region on the monitor.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Sugiyama teaches an ultrasound diagnostic apparatus, wherein the processor is further configured to display a binarized image obtained by binarizing the detected mammary gland region on the monitor (Paragraph 0201 teaches that the pixels can be thresholded based on brightness value. This assigns pixel value in a binary manner for the determination of the fat and mammary gland regions. See Figs. 26-27. Paragraph 0045 teaches that the display displays the image. Paragraph 0002 teaches the system operates with ultrasound).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Higashi with Sugiyama’s teaching of the binarizing of mammary gland tissue for the purpose of differentiation and display of the region. This modified apparatus would allow the user to improve level of precision of the mammary gland diagnosis (Paragraph 00071 of Sugiyama). Furthermore, the modification allows the assessment of the ROI of a breast and store the corresponding data (Paragraph 0036 of Sugiyama).
Regarding claim 15, modified Higashi teaches the ultrasound diagnostic apparatus in claim 14, as discussed above.
However, Higashi is silent regarding an ultrasound diagnostic apparatus, wherein the predetermined brightness threshold value is a constant value.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Sugiyama teaches an ultrasound diagnostic apparatus, wherein the predetermined brightness threshold value is a constant value (Paragraph 0200 teaches that the brightness values are thresholded by a threshold A and threshold B. See Fig. 26 that shows a fixed value relative to the scale).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Higashi with Sugiyama’s teaching of a constant threshold. This modified apparatus would allow the user to improve level of precision of the mammary gland diagnosis (Paragraph 00071 of Sugiyama). Furthermore, the modification allows the assessment of the ROI of a breast and store the corresponding data (Paragraph 0036 of Sugiyama).
Regarding claim 16, modified Higashi teaches the ultrasound diagnostic apparatus in claim 13, as discussed above.
However, Higashi is silent regarding an ultrasound diagnostic apparatus, wherein the processor is further configured to detect an edge of the glandular tissue component region in the ultrasound image, and automatically set the predetermined brightness threshold value based on a change in brightness value at the detected edge.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Sugiyama teaches an ultrasound diagnostic apparatus, wherein the processor is further configured to detect an edge of the glandular tissue component region in the ultrasound image, and automatically set the predetermined brightness threshold value based on a change in brightness value at the detected edge (Paragraph 0002 teaches the system operates with ultrasound. Paragraph 0200 teaches the thresholding for the extraction of the mammary gland parenchyma and the value of the chest wall. Paragraphs 0201-03 teach the edge detection methods that are used. The values within the threshold ranges are used in the identification of the mammary gland parenchyma. See Figs. 26-27).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Higashi with Sugiyama’s teaching of edge detection and extraction of the mammary gland information based on the threshold in relation to the edge. This modified apparatus would allow the user to improve level of precision of the mammary gland diagnosis (Paragraph 00071 of Sugiyama). Furthermore, the modification allows the assessment of the ROI of a breast and store the corresponding data (Paragraph 0036 of Sugiyama).
Regarding claim 17, modified Higashi teaches the ultrasound diagnostic apparatus in claim 14, as discussed above.
However, Higashi is silent regarding an ultrasound diagnostic apparatus, wherein the processor is further configured to
create a histogram of brightness of the detected mammary gland region in the ultrasound image and display the created histogram on the monitor,
wherein the predetermined brightness threshold value is set by a user based on the histogram, the binarized image, and the ultrasound image which are displayed on the monitor.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Sugiyama teaches an ultrasound diagnostic apparatus, wherein the processor is further configured to
create a histogram of brightness of the detected mammary gland region in the ultrasound image and display the created histogram on the monitor (Paragraph 0199 teaches that the histogram of the mammography can be generated. See Fig. 26. Paragraph 0002 teaches the system operates with ultrasound. Paragraph 0200 teaches the display and extraction of mammary gland information based on the brightness values),
wherein the predetermined brightness threshold value is set by a user based on the histogram, the binarized image, and the ultrasound image which are displayed on the monitor (Paragraph 0201 teaches that the pixels can be thresholded based on brightness value. This assigns pixel value in a binary manner for the determination of the fat and mammary gland regions. See Figs. 26-27. The thresholding can be done with respect to organized data in the form of a histogram. Paragraph 0045 teaches that the display displays the image. Paragraph 0002 teaches the system operates with ultrasound).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Higashi with Sugiyama’s teaching of the creation and use of a histogram for thresholding. This modified apparatus would allow the user to improve level of precision of the mammary gland diagnosis (Paragraph 00071 of Sugiyama). Furthermore, the modification allows the assessment of the ROI of a breast and store the corresponding data (Paragraph 0036 of Sugiyama).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Higashi et al. (PGPUB No. US 2023/0143350) further in view of Sugiyama et al. (PGPUB No. US 2016/0110875) further in view of Fujita et al. (PGPUB No. US 2009/0264758).
Regarding claim 21, modified Higashi teaches the ultrasound diagnostic apparatus in claim 11, as discussed above.
Higashi further teaches an ultrasound image analysis, that displays the calculated ratio of the glandular tissue component region to the detected mammary gland region on the monitor (Paragraph 0116 teaches the ratio of an overlooked area in the mammary gland to the mammary gland area as the score. Paragraph 0114 teaches that the score can be displayed).
However, the combination of Higashi and Sugiyama is silent regarding an ultrasound diagnostic apparatus, wherein the processor is further configured to display past data of a prior ultrasound image in relation to the current data that is based on the latest ultrasound image.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Fujita teaches an ultrasound diagnostic apparatus, wherein the processor is further configured to display past data of a prior ultrasound image in relation to the current data that is based on the latest ultrasound image (Paragraph 0023 teaches that current image can be displayed in parallel to a past image. This will allow the diagnosis of cancer or any disturbance to the tissue. Figs. 1 and 8 show the current images in conjunction with the past image. Paragraph 0014 notes that the breast contains mammary glands and Abstract teaches that this is display for an ultrasound breast diagnosis system. Paragraph 00544 teaches that the display allows for the measurement and sturdy of areas of interest. Abstract teaches that the past and current images are able to be interpreted together).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Higashi and Sugiyama with Fujita’s teaching of simultaneous display of ultrasound image data of the breast with mammary gland tissue. As Higashi teaches the calculating of a ratio of the glandular tissue component region to the mammary gland region based on ultrasound image information and that the ratio can be displayed, it would have been obvious to one with ordinary skill in the art, in light of Fujita, that past image data’s value can also be displayed in conjunction with the current ratio value. Such a simultaneous display of the ratio would allow the user to assess the progress of the diagnosis of the breast tissue. This modified apparatus would allow the user to diagnose the presence of a lesion in a breast and have a suitable means of screening for breast cancer (Paragraph 0001 of Fujita). Furthermore, the modification allows for any disturbance in the tissue to be detected (Paragraph 0023 of Fujita).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 2-4, 7-8, 10-11, 20, 22, and 25 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2-9, 12, 13, 16-20 and 22-23 of copending Application No. 18/046,873 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending Application No. 18/046,873 anticipates the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 24, Claim 22 of Application No. 18/046,873 teaches an ultrasound image analysis apparatus comprising:
a monitor; and a processor configured to detect a mammary gland region from an ultrasound image obtained by imaging abreast of a subject, including a glandular tissue component region consisting of mammary ducts, lobules, and peripheral stroma tissue present between the lobules and the mammary ducts; extract the glandular tissue component region from the detected mammary gland region by binarizing the detected mammary gland region by using a predetermined brightness threshold value; calculate a ratio of the extracted glandular tissue component region to the detected mammary gland region based on a number of occupied pixels of the detected mammary gland region and a number of occupied pixels of the extracted glandular tissue component region in the binarized mammary gland region; and control the monitor to display the calculated ratio (Claim 22 recites: An ultrasound image analysis apparatus comprising: a monitor; and a processor configured to: acquire information related to a breast composition of a subject obtained by a mammography examination, the information related to the breast composition of the subject being at least one of: a mammary gland category corresponding to the subject among mammary gland categories classified into a plurality of types according to a mammary gland density, a ratio of a mammary gland region to a breast region of the subject, and a volume ratio of a mammary gland content to the mammary gland region of the subject; and determine whether or not to perform analysis on a glandular tissue component region in the mammary gland region based on the acquired information related to the breast composition, the glandular tissue component region consisting of mammary ducts, lobules, and peripheral stroma tissue present between the lobules and the mammary ducts, wherein the processor is further configured to: detect the mammary gland region from an ultrasound image obtained by imaging a breast of the subject by image recognition of the ultrasound image; extract the glandular tissue component region from the detected mammary gland region by binarizing the detected mammary gland region by using a predetermined brightness threshold value; calculate a ratio of the extracted glandular tissue component region to the detected mammary gland region based on a number of occupied pixels of the detected mammary gland region and a number of occupied pixels of the extracted glandular tissue component region in the binarized mammary gland region; and control the monitor to display the calculated ratio).
Regarding claim 2, Application No. 18/046,873 teaches the ultrasound image analysis apparatus in claim 24, as discussed above.
Claim 22 of Application No. 18/046,873 further teaches an ultrasound image analysis apparatus, wherein the processor is further configured to detect the mammary gland region by image recognition of the ultrasound image (Claim 22 recites: An ultrasound image analysis apparatus comprising: a monitor; and a processor configured to: acquire information related to a breast composition of a subject obtained by a mammography examination, the information related to the breast composition of the subject being at least one of: a mammary gland category corresponding to the subject among mammary gland categories classified into a plurality of types according to a mammary gland density, a ratio of a mammary gland region to a breast region of the subject, and a volume ratio of a mammary gland content to the mammary gland region of the subject; and determine whether or not to perform analysis on a glandular tissue component region in the mammary gland region based on the acquired information related to the breast composition, the glandular tissue component region consisting of mammary ducts, lobules, and peripheral stroma tissue present between the lobules and the mammary ducts, wherein the processor is further configured to: detect the mammary gland region from an ultrasound image obtained by imaging a breast of the subject by image recognition of the ultrasound image; extract the glandular tissue component region from the detected mammary gland region by binarizing the detected mammary gland region by using a predetermined brightness threshold value; calculate a ratio of the extracted glandular tissue component region to the detected mammary gland region based on a number of occupied pixels of the detected mammary gland region and a number of occupied pixels of the extracted glandular tissue component region in the binarized mammary gland region; and control the monitor to display the calculated ratio).
Regarding claim 3, Application No. 18/046,873 teaches the ultrasound image analysis apparatus in claim 2, as discussed above.
Claim 12 of Application No. 18/046,873 further teaches an ultrasound image analysis apparatus according to claim 2, wherein the processor is further configured to detect a breast region located between a skin and a pectoralis major muscle from the ultrasound image, recognize a front boundary line and a rear boundary line in the detected breast region, and detect a region between the front boundary line and the rear boundary line, as the detected mammary gland region (Claim 12 recites: The ultrasound image analysis apparatus according to claim 9, wherein the processor detects a breast region located between a skin and a pectoralis major muscle from the ultrasound image, recognizes a front boundary line and a rear boundary line in the detected breast region, and detects a region between the front boundary line and the rear boundary line, as the mammary gland region).
Regarding claim 4, Application No. 18/046,873 teaches the ultrasound image analysis apparatus in claim 24, as discussed above.
Claim 13 of Application No. 18/046,873 further teaches an ultrasound image analysis apparatus, wherein the processor is further configured to detect the mammary gland region from the ultrasound image by using deep learning (Claim 13 recites: The ultrasound image analysis apparatus according to claim 9, wherein the processor detects the mammary gland region from the ultrasound image by using deep learning).
Regarding claim 7, modified Application No. 18/046,873 teaches the ultrasound image analysis apparatus in claim 24, as discussed above.
Claim 16 of Application No. 18/046,873 further teaches an ultrasound image analysis apparatus, wherein the processor is further configured to calculate the ratio of the glandular tissue component region to the detected mammary gland region based on the number of occupied pixels of the detected mammary gland region and the number of occupied pixels of the glandular tissue component region in the ultrasound image (Claim 16 recites: The ultrasound image analysis apparatus according to claim 9,
wherein the processor calculates the ratio of the glandular tissue component region to the mammary gland region based on the number of occupied pixels of the mammary gland region and the number of occupied pixels of the glandular tissue component region in the ultrasound image).
Regarding claim 8, Application No. 18/046,873 teaches the ultrasound image analysis apparatus in claim 24, as discussed above.
Claim 22 of Application No. 18/046,873 further teaches an ultrasound image analysis apparatus, wherein the processor is further configured to detect the mammary gland region from each of a plurality of the ultrasound images obtained by imaging the breast of the subject at a plurality of predetermined locations of the breast of the subject, extract the glandular tissue component region from each of the detected mammary gland regions of the plurality of ultrasound images, and calculate the ratio of the glandular tissue component region to the detected mammary gland region in each of the plurality of ultrasound images (Claim 22 recites: An ultrasound image analysis apparatus comprising: a monitor; and a processor configured to: acquire information related to a breast composition of a subject obtained by a mammography examination, the information related to the breast composition of the subject being at least one of: a mammary gland category corresponding to the subject among mammary gland categories classified into a plurality of types according to a mammary gland density, a ratio of a mammary gland region to a breast region of the subject, and a volume ratio of a mammary gland content to the mammary gland region of the subject; and determine whether or not to perform analysis on a glandular tissue component region in the mammary gland region based on the acquired information related to the breast composition, the glandular tissue component region consisting of mammary ducts, lobules, and peripheral stroma tissue present between the lobules and the mammary ducts, wherein the processor is further configured to: detect the mammary gland region from an ultrasound image obtained by imaging a breast of the subject by image recognition of the ultrasound image; extract the glandular tissue component region from the detected mammary gland region by binarizing the detected mammary gland region by using a predetermined brightness threshold value; calculate a ratio of the extracted glandular tissue component region to the detected mammary gland region based on a number of occupied pixels of the detected mammary gland region and a number of occupied pixels of the extracted glandular tissue component region in the binarized mammary gland region; and control the monitor to display the calculated ratio).
Regarding claim 10, Application No. 18/046,873 teaches the ultrasound image analysis apparatus in claim 24, as discussed above.
Claim 17 of Application No. 18/046,873 further teaches an ultrasound image analysis apparatus, wherein the ultrasound image is a three-dimensional ultrasound image, and the processor is further configured to calculate the ratio of the glandular tissue component region to the detected mammary gland region based on a volume of the detected mammary gland region and a volume of the extracted glandular tissue component region (Claim 17 recites: The ultrasound image analysis apparatus according to claim 9, wherein the ultrasound image is a three-dimensional ultrasound image, and the processor calculates the ratio of the glandular tissue component region to the mammary gland region based on a volume of the detected mammary gland region and a volume of the extracted glandular tissue component region).
Regarding claim 11, Application No. 18/046,873 teaches the ultrasound image analysis apparatus in claim 24, as discussed above.
Claim 18 of Application No. 18/046,873 further teaches an ultrasound image analysis apparatus, a monitor that displays the ultrasound image obtained by imaging the breast of the subject; and the ultrasound image analysis apparatus according to and the ultrasound image analysis apparatus according to claim 24, wherein the processor is further configured to detect the mammary gland region from the ultrasound image, and display the calculated ratio of the glandular tissue component region to the detected mammary gland region on the monitor (Claim 18 recites: An ultrasound diagnostic apparatus comprising: a monitor that displays an ultrasound image; and the ultrasound image analysis apparatus according to claim 22, wherein the processor displays an analysis result of the glandular tissue component region on the monitor. Claim 22 recites: An ultrasound image analysis apparatus comprising: a monitor; and a processor configured to: acquire information related to a breast composition of a subject obtained by a mammography examination, the information related to the breast composition of the subject being at least one of: a mammary gland category corresponding to the subject among mammary gland categories classified into a plurality of types according to a mammary gland density, a ratio of a mammary gland region to a breast region of the subject, and a volume ratio of a mammary gland content to the mammary gland region of the subject; and determine whether or not to perform analysis on a glandular tissue component region in the mammary gland region based on the acquired information related to the breast composition, the glandular tissue component region consisting of mammary ducts, lobules, and peripheral stroma tissue present between the lobules and the mammary ducts, wherein the processor is further configured to: detect the mammary gland region from an ultrasound image obtained by imaging a breast of the subject by image recognition of the ultrasound image; extract the glandular tissue component region from the detected mammary gland region by binarizing the detected mammary gland region by using a predetermined brightness threshold value; calculate a ratio of the extracted glandular tissue component region to the detected mammary gland region based on a number of occupied pixels of the detected mammary gland region and a number of occupied pixels of the extracted glandular tissue component region in the binarized mammary gland region; and control the monitor to display the calculated ratio).
Regarding claim 20, Application No. 18/046,873 teaches the ultrasound image analysis apparatus in claim 11, as discussed above.
Claim 19 of Application No. 18/046,873 further teaches an ultrasound image analysis apparatus, wherein the processor is further configured to store the calculated ratio of the glandular tissue component region to the detected mammary gland region in a tag associated with the ultrasound image (Claim 19 recites: The ultrasound diagnostic apparatus according to claim 18, wherein the processor stores the analysis result of the glandular tissue component region in a tag associated with the ultrasound image).
Regarding claim 22, Application No. 18/046,873 teaches the ultrasound image analysis apparatus in claim 11, as discussed above.
Claim 20 of Application No. 18/046,873 further teaches an ultrasound image analysis apparatus, further comprising an ultrasound probe; and wherein the processor is further configured to generate the ultrasound image obtained by imaging the breast of the subject by transmitting and receiving an ultrasound beam to and from the subject using the ultrasound probe (Claim 20 recites: The ultrasound diagnostic apparatus according to claim 18, further comprising: an ultrasound probe; wherein the processor generates the ultrasound image obtained by imaging the breast of the subject by transmitting and receiving an ultrasound beam to and from the subject using the ultrasound probe).
Regarding claim 25, Application No. 18/046,873 teaches a control method for an ultrasound image analysis apparatus, the method comprising: detecting a mammary gland region from an ultrasound image obtained by imaging a breast of a subject, including a glandular tissue component region consisting of mammary ducts, lobules, and peripheral stroma tissue present between the lobules and the mammary ducts to or higher than the predetermined brightness threshold value; extracting the glandular tissue component region from the detected mammary gland region by with binarizing the detected mammary gland region by using a the predetermined brightness threshold value; calculating a ratio of the extracted glandular tissue component region to the detected mammary gland region based on a number of occupied pixels of the detected mammary gland region and a number of occupied pixels of the extracted glandular tissue component region in the binarized mammary gland region; and controlling a monitor to display the calculated ratio (Claim 23 recites: A control method for an ultrasound image analysis apparatus, the method comprising: acquiring information related to a breast composition of a subject obtained by a mammography examination, the information related to the breast composition of the subject being at least one of: a mammary gland category corresponding to the subject among mammary gland categories classified into a plurality of types according to a mammary gland density, a ratio of a mammary gland region to a breast region of the subject, and a volume ratio of a mammary gland content to the mammary gland region of the subject; and determining whether or not to perform analysis on a glandular tissue component region in the mammary gland region based on the acquired information related to the breast composition, , the glandular tissue component region consisting of mammary ducts, lobules, and peripheral stroma tissue present between the lobules and the mammary ducts, wherein the method further comprises: detecting the mammary gland region from an ultrasound image obtained by imaging a breast of the subject by image recognition of the ultrasound image; extracting the glandular tissue component region from the detected mammary gland region by binarizing the detected mammary gland region by using a predetermined brightness threshold value; calculating a ratio of the extracted glandular tissue component region to the detected mammary gland region based on a number of occupied pixels of the detected mammary gland region and a number of occupied pixels of the extracted glandular tissue component region in the binarized mammary gland region; and controlling a monitor to display the calculated ratio).
Claim 9 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over 2-9, 12, 13, 16-20 and 22-23 of copending Application No. 18/046,873 in view of Morita (PGPUB No. US 2019/0304088).
This is a provisional nonstatutory double patenting rejection.
Regarding claim 9, modified Application No. 18/046,873 teaches the ultrasound image analysis apparatus in claim 8, as discussed above.
However, the claims of Application No. 18/046,873 is silent regarding an ultrasound image analysis apparatus, wherein the processor is further configured to calculate an average value of ratios of the glandular tissue component regions to the mammary gland regions in the plurality of ultrasound images.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Morita teaches an ultrasound image analysis apparatus, wherein the processor is further configured to calculate an average value of ratios of the glandular tissue component regions to the mammary gland regions in the plurality of ultrasound images (Paragraph 0076 teaches that the control unit derives the average value of the mammary gland content rate for each pixel of the local region as the local mammary gland content rate. Paragraph 0063 teaches that the mammary gland content rate means the volume ratio of mammary gland tissues in each region. Paragraph 0081 teaches a plurality of the mammary gland concentrated regions can be assessed. Paragraph 0023 teaches multiple images can be acquired to acquire the whole mammary gland).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Application No. 18/046,873 with Morita’s teaching of averaging data. It would have been obvious to one with ordinary skill in the art that multiple sets of data regarding the ratio as taught by Application No. 18/046,873 can be averaged. It is known that averaging is the expression of a set of data where the total value is divided by the number of sets of data. This summarizes the general significance of a set of unequal values. Given that Morita teaches averaging of data in the context of breast imaging and mammary glands particularly, one with ordinary skill in the art would be able to average the data collected in Application No. 18/046,873. This modified apparatus would allow the user to observe hidden or more difficult to see objects of interest in areas with high mammary gland concentration (Paragraph 0004 of Morita). Furthermore, the modification allows for careful observation of the object of interest (Paragraph 0006 of Morita).
Claim 18-19 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over 2-9, 12, 13, 16-20 and 22-23 of copending Application No. 18/046,873 in view of Higashi et al. (PGPUB No. US 2023/0143350).
This is a provisional nonstatutory double patenting rejection.
Regarding claim 18, modified Application No. 18/046,873 teaches the ultrasound diagnostic apparatus in claim 11, as discussed above.
However, the claims of Application No. 18/046,873 is silent regarding an ultrasound diagnostic apparatus, wherein the processor is further configured to generate a schematic diagram of the breast on which a plurality of predetermined locations are plotted and displays the schematic diagram on the monitor.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Higashi teaches an ultrasound diagnostic apparatus, wherein the processor is further configured to generate a schematic diagram of the breast on which a plurality of predetermined locations are plotted and displays the schematic diagram on the monitor (Paragraph 0034 teaches that the overlooked reasons can be performed with respect to the medical imaging data. See Fig. 9).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Application No. 18/046,873 with Higashi’s teaching of the display of a schematic diagram of the breast with the predetermined locations. This modified apparatus would allow the user to assess and identify areas that are likely to be overlooked (Paragraphs 0009-11 of Higashi). Furthermore, the modification defines the visibility on the display and helps identify lesions (Paragraph 0006 of Higashi).
Regarding claim 19, modified Application No. 18/046,873 teaches the ultrasound diagnostic apparatus in claim 18, as discussed above.
However, the claims of Application No. 18/046,873 is silent regarding an ultrasound diagnostic apparatus, wherein the processor is further configured to guide a user to perform imaging of the ultrasound images at the plurality of predetermined locations.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Higashi teaches an ultrasound diagnostic apparatus, wherein the processor is further configured to guide a user to perform imaging of the ultrasound images at the plurality of predetermined locations (Paragraph 0034 teaches that the overlooked reasons can be performed with respect to the medical imaging data. This allows the radiologist to see which area should be scrutinized more carefully. See Fig. 9. Paragraphs 0072-73 teach the use of data acquiring units that are able to learn and acquire environmental information. Paragraph 0037 teaches that the medical imaging data can be ultrasound images).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Application No. 18/046,873 with Higashi’s teaching of the guidance to a user to perform imaging of the ultrasound images at the predetermined locations. This modified apparatus would allow the user to assess and identify areas that are likely to be overlooked (Paragraphs 0009-11 of Higashi). Furthermore, the modification defines the visibility on the display and helps identify lesions (Paragraph 0006 of Higashi).
Claim 12-13 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over 2-9, 12, 13, 16-20 and 22-23 of copending Application No. 18/046,873 in view of Higashi et al. (PGPUB No. US 2023/0143350) further in view of Ofuji (PGPUB No. US 2009/0086891).
This is a provisional nonstatutory double patenting rejection.
Regarding claim 12, modified Application No. 18/046,873 teaches the ultrasound diagnostic apparatus in claim 11, as discussed above.
However, the combination of Application No. 18/046,873 and Higashi are silent regarding an ultrasound image analysis apparatus, wherein the processor is further configured to calculate a ratio of the detected mammary gland region to the breast region and display the calculated ratio of the extracted glandular tissue component region to the detected mammary gland region on the monitor.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Ofuji teaches an ultrasound image analysis apparatus, wherein the processor is further configured to calculate a ratio of the detected mammary gland region to the breast region and display the calculated ratio of the extracted glandular tissue component region to the detected mammary gland region on the monitor (Paragraph 0018 teaches that the mammary gland content rate refers to the ratio of the portion of the mammary gland content rate to the breast region. Paragraph 0070 teaches that the display is in accordance to the mammary gland content rate. See Fig. 8).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Application No. 18/046,873 and Higashi with Ofuji’s teaching of calculation and display of a ratio of the mammary gland region to the breast region. It would have been obvious to one with ordinary skill in the art that the ratio calculated according to Ofuji can be displayed as discussed by Higashi. As paragraph 0114 and 0116 of Higashi establish that the content rate can be displayed and determined in the form of a score. One with ordinary skill in the art would be able to implement the calculation of Ofuji and display that value. This is further evidence by the fact that Ofuji is organizing display data based on the content rate. This modified apparatus would allow the user to display mammograms based on the amounts of mammary glands included in the mammograms for image diagnosis assistance (Paragraph 0003 of Ofuji). Furthermore, the modification improves the accuracy for diagnosis (Paragraph 0081 of Ofuji).
Regarding claim 13, modified Application No. 18/046,873 teaches the ultrasound diagnostic apparatus in claim 12, as discussed above.
However, the claims of Application No. 18/046,873 are silent regarding an ultrasound image analysis apparatus, wherein the processor is further configured to extract the glandular tissue component region in the detected mammary gland region only in a case where the calculated ratio of the extracted glandular tissue component region to the detected mammary gland region is higher than a set value.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Higashi teaches an ultrasound diagnostic apparatus, wherein the processor is further configured to extract the glandular tissue component region in the detected mammary gland region only in a case where the calculated ratio of the extracted glandular tissue component region to the detected mammary gland region is higher than a set value (Paragraph 0085 teaches that the candidate pixels with the overlooked reasons is based on a thresholding. When the probability of the pixel is greater than the threshold, a candidate map is generated).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Application No. 18/046,873 with Higashi’s teaching of extracting the glandular tissue based on a ratio being higher than a set value. This modified method would allow the user to assess and identify areas that are likely to be overlooked (Paragraphs 0009-11 of Higashi). Furthermore, the modification defines the visibility on the display and helps identify lesions (Paragraph 0006 of Higashi).
Claim 14-17 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over 2-9, 12, 13, 16-20 and 22-23 of copending Application No. 18/046,873 in view of Higashi et al. (PGPUB No. US 2023/0143350) further in view of Ofuji (PGPUB No. US 2009/0086891) further in view of Sugiyama et al. (PGPUB No. US 2016/0110875).
This is a provisional nonstatutory double patenting rejection.
Regarding claim 14, modified Application No. 18/046,873 teaches the ultrasound diagnostic apparatus in claim 13, as discussed above.
However, the combination of Application No. 18/046,873, Higashi, and Ofuji are silent regarding an ultrasound image analysis apparatus, wherein the processor is further configured to display a binarized image obtained by binarizing the detected mammary gland region on the monitor.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Sugiyama teaches an ultrasound diagnostic apparatus, wherein the processor is further configured to display a binarized image obtained by binarizing the detected mammary gland region on the monitor (Paragraph 0201 teaches that the pixels can be thresholded based on brightness value. This assigns pixel value in a binary manner for the determination of the fat and mammary gland regions. See Figs. 26-27. Paragraph 0045 teaches that the display displays the image. Paragraph 0002 teaches the system operates with ultrasound).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Application No. 18/046,873, Higashi, and Ofuji with Sugiyama’s teaching of the binarizing of mammary gland tissue for the purpose of differentiation and display of the region. This modified apparatus would allow the user to improve level of precision of the mammary gland diagnosis (Paragraph 00071 of Sugiyama). Furthermore, the modification allows the assessment of the ROI of a breast and store the corresponding data (Paragraph 0036 of Sugiyama).
Regarding claim 15, modified Application No. 18/046,873 teaches the ultrasound diagnostic apparatus in claim 14, as discussed above.
However, the combination of Application No. 18/046,873, Higashi, and Ofuji are silent regarding an ultrasound image analysis apparatus, wherein the brightness threshold value is a constant value.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Sugiyama teaches an ultrasound diagnostic apparatus, wherein the brightness threshold value is a constant value (Paragraph 0200 teaches that the brightness values are thresholded by a threshold A and threshold B. See Fig. 26 that shows a fixed value relative to the scale).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Application No. 18/046,873, Higashi, and Ofuji with Sugiyama’s teaching of a constant threshold. This modified apparatus would allow the user to improve level of precision of the mammary gland diagnosis (Paragraph 00071 of Sugiyama). Furthermore, the modification allows the assessment of the ROI of a breast and store the corresponding data (Paragraph 0036 of Sugiyama).
Regarding claim 16, modified Application No. 18/046,873 teaches the ultrasound image analysis apparatus of claim 13, as discussed above.
However, the combination of Application No. 18/046,873, Higashi, and Ofuji are silent regarding an ultrasound image analysis apparatus, wherein the processor is further configured to detect an edge of the glandular tissue component region in the ultrasound image, and automatically set the predetermined brightness threshold value based on a change in brightness value at the detected edge.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Sugiyama teaches an ultrasound diagnostic apparatus, wherein the processor is further configured to detect an edge of the glandular tissue component region in the ultrasound image, and automatically set the predetermined brightness threshold value based on a change in brightness value at the detected edge (Paragraph 0002 teaches the system operates with ultrasound. Paragraph 0200 teaches the thresholding for the extraction of the mammary gland parenchyma and the value of the chest wall. Paragraphs 0201-03 teach the edge detection methods that are used. The values within the threshold ranges are used in the identification of the mammary gland parenchyma. See Figs. 26-27).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Application No. 18/046,873, Higashi, and Ofuji with Sugiyama’s teaching of edge detection and extraction of the mammary gland information based on the threshold in relation to the edge. This modified apparatus would allow the user to improve level of precision of the mammary gland diagnosis (Paragraph 00071 of Sugiyama). Furthermore, the modification allows the assessment of the ROI of a breast and store the corresponding data (Paragraph 0036 of Sugiyama).
Regarding claim 17, modified Application No. 18/046,873 teaches the ultrasound image analysis apparatus of claim 14, as discussed above.
However, the combination of Application No. 18/046,873, Higashi, and Ofuji are silent regarding an ultrasound image analysis apparatus, wherein the processor is further configured to
create a histogram of brightness of the detected mammary gland region in the ultrasound image and display the created histogram on the monitor,
wherein the predetermined brightness threshold value is set by a user based on the histogram, the binarized image, and the ultrasound image which are displayed on the monitor.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Sugiyama teaches an ultrasound diagnostic apparatus, wherein the processor is further configured to
create a histogram of brightness of the detected mammary gland region in the ultrasound image and display the created histogram on the monitor (Paragraph 0199 teaches that the histogram of the mammography can be generated. See Fig. 26. Paragraph 0002 teaches the system operates with ultrasound. Paragraph 0200 teaches the display and extraction of mammary gland information based on the brightness values),
wherein the predetermined brightness threshold value is set by a user based on the histogram, the binarized image, and the ultrasound image which are displayed on the monitor.
(Paragraph 0201 teaches that the pixels can be thresholded based on brightness value. This assigns pixel value in a binary manner for the determination of the fat and mammary gland regions. See Figs. 26-27. The thresholding can be done with respect to organized data in the form of a histogram. Paragraph 0045 teaches that the display displays the image. Paragraph 0002 teaches the system operates with ultrasound).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Application No. 18/046,873, Higashi, and Ofuji with Sugiyama’s teaching of the creation and use of a histogram for thresholding. It would have been obvious to one with ordinary skill in the art that the histogram calculated according to Sugiyama can be displayed as discussed by Higashi. As paragraph 0114 and 0116 of Higashi establish that the content rate can be displayed and determined in the form of a score. One with ordinary skill in the art would be able to implement the calculation of Ofuji and display those values in the form of a histogram. This modified apparatus would allow the user to improve level of precision of the mammary gland diagnosis (Paragraph 00071 of Sugiyama). Furthermore, the modification allows the assessment of the ROI of a breast and store the corresponding data (Paragraph 0036 of Sugiyama).
Claim 21 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over 2-9, 12, 13, 16-20 and 22-23 of copending Application No. 18/046,873 in view of Higashi et al. (PGPUB No. US 2023/0143350) further in view of Fujita et al. (PGPUB No. US 2009/0264758).
This is a provisional nonstatutory double patenting rejection.
Regarding claim 21, modified Application No. 18/046,873 teaches the ultrasound image analysis apparatus of claim 11, as discussed above.
However, Application No. 18/046,873 is silent regarding an ultrasound image analysis apparatus, wherein the processor is further configured to display, on the monitor, a past ratio of the glandular tissue component region to the detected mammary gland region that is calculated based on the past ultrasound image of the subject, together with a latest ratio of the glandular tissue component region to the detected mammary gland region that is calculated based on the latest ultrasound image of the subject.
Higashi further teaches an ultrasound image analysis, that displays the calculated ratio of the glandular tissue component region to the detected mammary gland region on the monitor (Paragraph 0116 teaches the ratio of an overlooked area in the mammary gland to the mammary gland area as the score. Paragraph 0114 teaches that the score can be displayed).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Application No. 18/046,873 with Higashi’s teaching of the display of the glandular tissue region ratio to the mammary gland region. This modified apparatus would allow the user to assess and identify areas that are likely to be overlooked (Paragraphs 0009-11 of Higashi). Furthermore, the modification defines the visibility on the display and helps identify lesions (Paragraph 0006 of Higashi).
However, the combination of Application No. 18/046,873 and Higashi is silent regarding an ultrasound image analysis apparatus, wherein the processor is further configured to display past data of a prior ultrasound image in relation to the current data that is based on the latest ultrasound image.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Fujita teaches an ultrasound image analysis apparatus, wherein the processor is further configured to display past data of a prior ultrasound image in relation to the current data that is based on the latest ultrasound image of a mammary gland (Paragraph 0023 teaches that current image can be displayed in parallel to a past image. This will allow the diagnosis of cancer or any disturbance to the tissue. Figs. 1 and 8 show the current images in conjunction with the past image. Paragraph 0014 notes that the breast contains mammary glands and Abstract teaches that this is display for an ultrasound breast diagnosis system. Paragraph 00544 teaches that the display allows for the measurement and sturdy of areas of interest. Abstract teaches that the past and current images are able to be interpreted together).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Application No. 18/046,873 and Higashi with Fujita’s teaching of simultaneous display of ultrasound image data of the breast with mammary gland tissue. As Higashi teaches the calculating of a ratio of the glandular tissue component region to the mammary gland region based on ultrasound image information and that the ratio can be displayed, it would have been obvious to one with ordinary skill in the art, in light of Fujita, that past image data’s value can also be displayed in conjunction with the current ratio value. Such a simultaneous display of the ratio would allow the user to assess the progress of the diagnosis of the breast tissue. This modified apparatus would allow the user to diagnose the presence of a lesion in a breast and have a suitable means of screening for breast cancer (Paragraph 0001 of Fujita). Furthermore, the modification allows for any disturbance in the tissue to be detected (Paragraph 0023 of Fujita).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Collins et al. (PGPUB No. US 2011/0026791): Teaches pixel based binarization of breast image data with consideration for the GTC.
Kendall et al. (PGPUB No. US 2010/0310183): Teaches pixel based binarization of breast image data with consideration for the GTC.
Fukuda (PGPUB No. US 2014/0094696): Teaches pixel based binarization of breast image data with consideration for the GTC.
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 extension fee 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 date of this final action.
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/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798
1 Link: https://www.merriam-webster.com/dictionary/ratio
2 Fig. 1 of Sherratt shows a medical diagram of a breast that comprises the stroma, duct, and lobules. Paragraph 2 of “Breast architecture and composition” section states “External to the ductal/lobular structure lies the stromal connective tissue. This provides a solid underpinning for the epithelium. It is constructed of fibroblastic cells that synthesise collagenous supportive ECM. The stroma is fairly thick around the ducts but much thinner around the secretory alveoli. Stromal-epithelial trees are surrounded by adipocytes to fill out the spaces, which together create the bag-like architecture of breast tissue”
3 Fig. 1 of Sherratt shows a medical diagram of a breast that comprises the stroma, duct, and lobules. Paragraph 2 of “Breast architecture and composition” section states “External to the ductal/lobular structure lies the stromal connective tissue. This provides a solid underpinning for the epithelium. It is constructed of fibroblastic cells that synthesise collagenous supportive ECM. The stroma is fairly thick around the ducts but much thinner around the secretory alveoli. Stromal-epithelial trees are surrounded by adipocytes to fill out the spaces, which together create the bag-like architecture of breast tissue”
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