DETAILED ACTION
This office action is in response to the communication received on 02/03/2026 concerning application no. 18/046,873 filed on 10/14/2022.
Claims 3, 5-6, 8-9, 12-13, 16-20, and 22-23 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 device provides a solution that distinguishing the stroma types and the assessment of cancer risk. App
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 stroma and assessment of the cancer risk, no such language is present in the independent claims. The image recognition algorithm is unpersuasive as the algorithm is merely “a procedure for solving a mathematical problem (as of finding the greatest common division) in a finite number of steps that frequently involves repetition of an operation.”1 MPEP 2106.05(I)(A) establishes “Courts have found that using a generic computer to perform generic computer functions to perform a judicial exception is not enough to qualify as 'significantly more'.” 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. 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”.2
Examiner respectfully maintains the rejection.
Applicant’s arguments with respect to claims 22-23 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. 13 is not entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3, 5-6, 8-9, 12-13, 16-20, and 22-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 22 recites “a volume ratio of a mammary gland content to the mammary gland region of the subject”. While paragraph 0076 establishes “Further, for example, JP2019-177050A discloses a method of measuring a mammary gland mass ratio Rm2 which is a ratio of a mammary gland mass to a mammary gland region of a subject from a mammography image, that is, a mammary gland content of a mammary gland tissue in a mammary gland concentration region in which mammary glands are concentrated by using a volume ratio”, the specification does not disclose the ratio being of a mammary gland content to the mammary gland region. Therefore, the claim contains subject matter which is not described in the specification in such a way as to reasonably convey to one with ordinary skill in the art that the inventor had possession of the claim invention at the time of filing.
Claim 8 recites “wherein the processor determines to perform analysis on the glandular tissue component region in a case where the volume ratio of the mammary gland content to the mammary gland region is higher than a predetermined mammary gland mass threshold value”. While paragraph 0076 establishes “Further, for example, JP2019-177050A discloses a method of measuring a mammary gland mass ratio Rm2 which is a ratio of a mammary gland mass to a mammary gland region of a subject from a mammography image, that is, a mammary gland content of a mammary gland tissue in a mammary gland concentration region in which mammary glands are concentrated by using a volume ratio”, the specification does not disclose the ratio being of a mammary gland content to the mammary gland region. Therefore, the claim contains subject matter which is not described in the specification in such a way as to reasonably convey to one with ordinary skill in the art that the inventor had possession of the claim invention at the time of filing.
Claim 23 recites “a volume ratio of a mammary gland content to the mammary gland region of the subject”. While paragraph 0076 establishes “Further, for example, JP2019-177050A discloses a method of measuring a mammary gland mass ratio Rm2 which is a ratio of a mammary gland mass to a mammary gland region of a subject from a mammography image, that is, a mammary gland content of a mammary gland tissue in a mammary gland concentration region in which mammary glands are concentrated by using a volume ratio”, the specification does not disclose the ratio being of a mammary gland content to the mammary gland region. Therefore, the claim contains subject matter which is not described in the specification in such a way as to reasonably convey to one with ordinary skill in the art that the inventor had possession of the claim invention at the time of filing.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(a) are also rejected because they inherit the deficiencies of the claims they respectively depend upon.
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 3, 5-6, 8-9, 12-13, 16-20, and 22-23 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 22 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 9 is indefinite for the following reasons:
Recites “wherein the processor calculates a ratio of the glandular tissue component region to the mammary gland region”. 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 12 is indefinite for the following reasons:
Recites “a breast region”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “breast region” is the same as the “breast region” established claim 22 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Claim 16 is indefinite for the following reasons:
Recites “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”. 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 18 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 in claim 22 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “wherein the processor displays an analysis result of the glandular tissue component region on the monitor”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the this is referring to the display of the calculated ratio in claim 22 or some other analysis result.
Applicant is encouraged to provide consistent and clear language.
Claim 23 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.
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.
Claims 9 and 16 are 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 9, recites “wherein the processor calculates a ratio of the glandular tissue component region to the mammary gland region.” Claim 9 depends on claim 22. Claim 22 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 9 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 9 is in improper dependent form for failing to further limit the subject matter of the claim upon which it depends.
Claim 16, recites “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.” Claim 16 depends on claim 22. Claim 22 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 16 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 16 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 3, 5-6, 8-9, 12-13, 16-20, 22-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
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: 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 “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”.
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 acquisition of information related to the breast composition and used that breast composition information to determine the analysis on a glandular tissue component region that involves the detection of the mammary gland region from the ultrasound image via image recognition and the extraction of the glandular tissue component by thresholding and extracting the glandular tissue component via a binary approach from the entire mammary gland region. This provides for the ratio determination. 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 calculated ratio is a display step that merely amounts to a post-solution insignificant activity. The use of 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 22 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 “determines to perform analysis on the glandular tissue component region in a case where the mammary gland category corresponding to the subject belongs to at least one mammary gland category among the mammary gland categories classified into the plurality of types”.
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 determination of if the analysis is needed based on if the category of the mammary gland is a high density with respect to the categories according to a thresholding . 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 determines”. 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 5 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - 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 “calculates the ratio of the mammary gland region to the breast region of the subject from a mammography 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 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 calculates”. 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 5 is ineligible.
Claim 6 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - 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 “determines to perform analysis on the glandular tissue component region in a case where the ratio of the mammary gland region to the breast region is higher than a predetermined mammary gland region threshold 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 determination for analysis based on the ratio of the mammary gland to the breast region to be higher than 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 determines”. 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 6 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 “determines to perform analysis on the glandular tissue component region in a case where the volume ratio of the mammary gland content to the mammary gland region is higher than a predetermined mammary gland mass threshold 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 determination for an analysis based on the ratio of the mammary gland mass to the mammary gland region volume being higher than a threshold. 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 determines”. 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 “calculates a ratio of the glandular tissue component region to the 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 calculation of the ratio of the glandular tissue component region to the 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 calculates”. 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 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 image analysis apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “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”.
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”. 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 image analysis apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “detects 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 detects”. 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 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 an ultrasound image analysis apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “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”.
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 calculates”. 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 image analysis apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “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”.
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 ratio based on mammary gland region volume and glandular tissue component region volume. 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 calculates”. The ultrasound image being a 3D ultrasound image is a data gathering step which is a form of 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 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 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 22 rejection.
Claim 18 recites the following elements: “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”. This claim element is a mere displaying step which amounts to a post-solution insignificant activity. The use of a monitor and a processer does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception and the post-solution insignificant activity. 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 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 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 18 rejection.
Claim 19 recites the following elements: “wherein the processor stores the analysis result of the glandular tissue component region in a tag associated with the ultrasound image”. This claim element is a mere 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 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 18 rejection.
Claim 20 recites the following elements: “an ultrasound probe; wherein the processor that 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”. This claim element is a mere data-gathering step which amounts to a pre-solution insignificant activity. The use of a ultrasound probe and a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception and the pre-solution insignificant activity. 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 20 is ineligible.
Claim 23 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 “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”.
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 acquisition of information related to the breast composition and used that breast composition information to determine the analysis on a glandular tissue component region that involves the detection of the mammary gland region from the ultrasound image via image recognition and the extraction of the glandular tissue component by thresholding and extracting the glandular tissue component via a binary approach from the entire mammary gland region. This provides for the ratio determination. 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 calculated ratio is a display step that 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 23 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 8, 18-20, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Arai et al. (PGPUB No. US 2020/0375562) as evidenced by Sherratt et al. ("Raised mammographic density: causative mechanisms and biological consequences", 2016) in view of Morita et al. (PGPUB No. US 2019/0304088) further in view of Sugiyama et al. (PGPUB No. US 2016/0110875).
Regarding claim 22, Arai teaches an ultrasound image analysis apparatus comprising:
a monitor (Fig. 2); and
a processor configured to (Paragraph 0220 teaches use of a processor):
acquire information related to a breast composition of a subject obtained by a mammography examination (Paragraph 0077 teaches that the radiography system has a mammography apparatus and a console. Paragraph 0078 teaches that images of the breast of the subject can be captured. See Fig. 2. Fig. 18 shows the image of the breast and Fig. 19 shows the breast with the plurality of mammary glands); 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 (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),
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 (Paragraph 0166 teaches that the control unit can assess if the information of the mammary gland is indicated can be assessed. If the result is yes, the ultrasound image is captured. If not, the ultrasound image is not captured. Paragraph 0193 teaches mammary gland identification can be captured by the ultrasound image. The mammary gland identification is performed after the ultrasound image is captured. Paragraph 0196 teaches image is analyzed and the capture of the image is assessed);
control the monitor to display the calculated ratio (Paragraph 0151 teaches the display of the mammary gland image with respect to the ratio provided in the context of a grid. See Fig. 12).
However, Arai is silent regarding an apparatus, comprising:
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;
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.
In an analogous imaging field of endeavor, breast tissue analysis for medical diagnosis, Morita teaches an apparatus,
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 (Paragraph 0063 teaches the acquisition of the image data of the breast and the determination of the mammary gland content rate. The mammary gland content rate means the volume ratio of mammary gland tissues in each region);
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 (Paragraphs 0069-74 teaches that each pixel is assessed for the determination of whether it is reflective of the mammary gland content rate and the map is generated according for the entire breast region. Paragraph 0063 teaches that the mammary gland content rate means the volume ratio of mammary gland tissues in each region. Paragraph 0081 teaches that the extraction is according to the pixels that represent the mammary gland content rate. Paragraph 0094 teaches that the content rate can be compared to a threshold that is predetermined. If the content rate is above a threshold, the user can be warned of the high density and that the object of interest is difficult to see. Paragraphs 0130-31 teaches that in the case where it is difficult to see, the apparatus can perform tomosynthesis imaging for easy visibility); and
control the monitor to display the calculated ratio (Paragraph 0100 teaches the display of the mammary gland region).
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 Arai with Morita’s teaching of image analysis for the ratio being performed on a pixel level. 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).
However, Morita is silent regarding an apparatus, comprising:
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 apparatus, comprising:
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 the combination of Arai and Morita with Sugiyama’s teaching of the binarizing of mammary gland tissue for the purpose of differentiation. 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 8, modified Arai teaches the ultrasound image analysis apparatus in claim 22, as discussed above.
However, Arai is silent regarding an ultrasound image analysis apparatus, wherein the processor determines to perform analysis on the glandular tissue component region in a case where the volume ratio of the mammary gland content to the mammary gland region is higher than a predetermined mammary gland mass threshold value.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Morita teaches an ultrasound image analysis apparatus, wherein the processor determines to perform analysis on the glandular tissue component region in a case where the volume ratio of the mammary gland content to the mammary gland region is higher than a predetermined mammary gland mass threshold value (Paragraph 0063 teaches that the mammary gland content rate means the volume ratio of mammary gland tissues in each region. Paragraph 0094 teaches that the content rate can be compared to a threshold that is predetermined. If the content rate is above a threshold, the user can be warned of the high density and that the object of interest is difficult to see. Paragraphs 0130-31 teaches that in the case where it is difficult to see, the apparatus can perform tomosynthesis imaging for easy visibility).
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 Arai with Morita’s teaching of the performance of an image analysis in the case where the ratio of the mammary gland is higher than a threshold. 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).
Regarding claim 18, modified Arai teaches the ultrasound image analysis apparatus in claim 22, as discussed above.
Arai further teaches an ultrasound diagnostic apparatus comprising:
a monitor that displays an ultrasound image (Paragraph 0101 teaches the display unit. Paragraph 0193 teaches the display of the mammary gland information); and
the ultrasound image analysis apparatus according to claim 22 (See above),
wherein the processor displays an analysis result of the glandular tissue component region on the monitor (Paragraph 0193 teaches mammary gland identification can be captured by the ultrasound image and displayed. The mammary gland identification is performed after the ultrasound image is captured. See Figs. 19-20).
Regarding claim 19, modified Arai teaches the ultrasound diagnostic apparatus in claim 18, as discussed above.
Arai further teaches an ultrasound diagnostic apparatus, wherein the processor stores the analysis result of the glandular tissue component region in a tag associated with the ultrasound image (Paragraph 0125 teaches that the image storage system is a PACS system that is holding the ultrasound image data. Paragraph 0193 teaches mammary gland identification can be captured by the ultrasound image and displayed).
Regarding claim 20, modified Arai teaches the ultrasound diagnostic apparatus in claim 18, as discussed above.
Arai further teaches an ultrasound diagnostic apparatus, further comprising:
an ultrasound probe (Paragraph 0117 teaches the ultrasound probe);
wherein the processor that 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 (Paragraph 0005 teaches that the ultrasound apparatus is capturing image data of the breast. Paragraph 0121 teaches transmission and reception of ultrasound).
Regarding claim 23, Arai teaches 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 (Paragraph 0077 teaches that the radiography system has a mammography apparatus and a console. Paragraph 0078 teaches that images of the breast of the subject can be captured. See Fig. 2. Fig. 18 shows the image of the breast and Fig. 19 shows the breast with the plurality of mammary glands); 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 (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 stroma4), 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 (Paragraph 0166 teaches that the control unit can assess if the information of the mammary gland is indicated can be assessed. If the result is yes, the ultrasound image is captured. If not, the ultrasound image is not captured. Paragraph 0193 teaches mammary gland identification can be captured by the ultrasound image. The mammary gland identification is performed after the ultrasound image is captured. Paragraph 0196 teaches image is analyzed and the capture of the image is assessed);
controlling a monitor to display the calculated ratio (Paragraph 0151 teaches the display of the mammary gland image with respect to the ratio provided in the context of a grid. See Fig. 12).
However, Arai is silent regarding a method,
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;
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.
In an analogous imaging field of endeavor, breast tissue analysis for medical diagnosis, Morita teaches a method,
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 (Paragraph 0063 teaches the acquisition of the image data of the breast and the determination of the mammary gland content rate. The mammary gland content rate means the volume ratio of mammary gland tissues in each region);
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 (Paragraphs 0069-74 teaches that each pixel is assessed for the determination of whether it is reflective of the mammary gland content rate and the map is generated according for the entire breast region. Paragraph 0063 teaches that the mammary gland content rate means the volume ratio of mammary gland tissues in each region. Paragraph 0081 teaches that the extraction is according to the pixels that represent the mammary gland content rate. Paragraph 0094 teaches that the content rate can be compared to a threshold that is predetermined. If the content rate is above a threshold, the user can be warned of the high density and that the object of interest is difficult to see. Paragraphs 0130-31 teaches that in the case where it is difficult to see, the apparatus can perform tomosynthesis imaging for easy visibility); and
controlling a monitor to display the calculated ratio (Paragraph 0100 teaches the display of the mammary gland region).
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 Arai with Morita’s teaching of image analysis for the ratio being performed on a pixel level. This modified method 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).
However, Morita is silent regarding a method,
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.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Sugiyama teaches a method,
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 (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 the combination of Arai and Morita 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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Arai et al. (PGPUB No. US 2020/0375562) as evidenced by Sherratt et al. ("Raised mammographic density: causative mechanisms and biological consequences", 2016) in view of Morita et al. (PGPUB No. US 2019/0304088) further in view of Sugiyama et al. (PGPUB No. US 2016/0110875) further in view of Keeley et al. (PGPUB No. US 2008/0015448).
Regarding claim 3, modified Arai teaches the ultrasound image analysis apparatus in claim 22, as discussed above.
However, the combination of Arai, Morita, and Sugiyama is silent regarding an ultrasound image analysis apparatus, wherein the processor determines to perform analysis on the glandular tissue component region in a case where the mammary gland category corresponding to the subject belongs to at least one mammary gland category among the mammary gland categories classified into the plurality of types.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Keely teaches an ultrasound image analysis apparatus, wherein the processor determines to perform analysis on the glandular tissue component region in a case where the mammary gland category corresponding to the subject belongs to at least one mammary gland category among the mammary gland categories classified into the plurality of types (Paragraph 0050 teaches the detection of increased density in the mammary gland. Paragraph 0103 teaches that the increased breast tissue density results in carcinoma formation. Paragraph 0022 teaches that the areas of the breast are thresholded for density and this allows for the assessment of qualitatively and/or quantitatively. The thresholding can also be correlated to the stage of cancer. The correlation can also assess malignancy or if the cancer is benign. The sub-signatures observed over a period of time are used diagnostic assessment by noting the qualitative and/or quantitative changes and/or rates of change).
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 Arai, Morita, and Sugiyama with Keely’s teaching of acquisition of a mammary gland category amongst a plurality of types based on density. This modified apparatus would allow the user to provide accurate and selective diagnosis of cancer, and provide diagnostic information complementary to conventional diagnostic methods (Abstract of Keely). Furthermore, the modification improves the accuracy, precision, and timing of cancer detection and the detection of suspected cancer at an early stage of development (Paragraph 0036 of Keely).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Arai et al. (PGPUB No. US 2020/0375562) as evidenced by Sherratt et al. ("Raised mammographic density: causative mechanisms and biological consequences", 2016) in view of Morita et al. (PGPUB No. US 2019/0304088) further in view of Sugiyama et al. (PGPUB No. US 2016/0110875) further in view of Ofuji (PGPUB No. US 2009/0086891).
Regarding claim 5, modified Arai teaches the ultrasound image analysis apparatus in claim 22, as discussed above.
However, the combination of Arai, Morita, and Sugiyama is silent regarding an ultrasound image analysis apparatus, wherein the processor calculates the ratio of the mammary gland region to the breast region of the subject from a mammography image.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Ofuji teaches an ultrasound image analysis apparatus, wherein the processor calculates the ratio of the mammary gland region to the breast region of the subject from a mammography image (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 0050 teaches that the breast image system is using a mammography apparatus. Paragraph 0059 teaches that the mammograms are read and assessed. See Figs. 1 and 5-6).
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 Arai, Morita, and Sugiyama with Ofuji’s teaching of ratio of the mammary gland to the breast region based on a mammogram. 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 6, modified Arai teaches the ultrasound image analysis apparatus in claim 22, as discussed above.
However, the combination of Arai, Morita, and Sugiyama is silent regarding an ultrasound image analysis apparatus, wherein the processor determines to perform analysis on the glandular tissue component region in a case where the ratio of the mammary gland region to the breast region is higher than a predetermined mammary gland region threshold value.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Ofuji teaches an ultrasound image analysis apparatus, wherein the processor determines to perform analysis on the glandular tissue component region in a case where the ratio of the mammary gland region to the breast region is higher than a predetermined mammary gland region threshold value (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 0073 teaches that the content rates are assessed with respect to threshold values for classification. Paragraph 0078 teaches that the displaying is performed based on the classification type. Paragraph 0081 teaches this allows for the image reading for the mammograms accounts for content rates).
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 Arai, Morita, and Sugiyama with Ofuji’s teaching of the use of the ratio of the mammary gland to the breast tissue with respect to a threshold for image analysis. 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).
Claims 9, 12-13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Arai et al. (PGPUB No. US 2020/0375562) as evidenced by Sherratt et al. ("Raised mammographic density: causative mechanisms and biological consequences", 2016) in view of Morita et al. (PGPUB No. US 2019/0304088) further in view of Sugiyama et al. (PGPUB No. US 2016/0110875) further in view of Higashi et al. (PGPUB No. US 2023/0143350).
Regarding claim 9, modified Arai teaches the ultrasound image analysis apparatus in claim 22, as discussed above.
However, the combination of Arai, Morita, and Sugiyama is silent regarding an ultrasound image analysis apparatus, wherein the processor calculates a ratio of the glandular tissue component region to the mammary gland region.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Higashi teaches an ultrasound image analysis apparatus, wherein the processor calculates a ratio of the glandular tissue component region to the mammary gland region (Paragraph 0116 teaches the ratio of an overlooked area in the mammary gland to the mammary gland area).
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 Arai, Morita, and Sugiyama with Higashi’s teaching of the determination of a ratio of glandular tissue to a 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).
Regarding claim 12, modified Arai teaches the ultrasound image analysis apparatus in claim 9, as discussed above.
However, the combination of Arai, Morita, and Sugiyama is silent regarding an ultrasound image analysis apparatus, 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.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Higashi teaches an ultrasound image analysis apparatus, wherein the processor:
detects a breast region located between a skin and a pectoralis 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),
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 (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).
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 Arai, Morita, and Sugiyama with Higashi’s teaching of identification of the breast tissue and the mammary gland with respect to relative anatomy. 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 13, modified Arai teaches the ultrasound image analysis apparatus in claim 9, as discussed above.
However, the combination of Arai, Morita, and Sugiyama is silent regarding an ultrasound image analysis apparatus, wherein the processor detects the mammary gland region from the ultrasound image by using deep learning.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Higashi teaches an ultrasound image analysis apparatus, wherein, the processor detects 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).
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 Arai, Morita, and Sugiyama with Higashi’s teaching of the use of deep learning for region identification. 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 16, modified Arai teaches the ultrasound image analysis apparatus in claim 9, as discussed above.
However, the combination of Arai, Morita, and Sugiyama is silent regarding an ultrasound image analysis apparatus, 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.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Higashi teaches an ultrasound image analysis apparatus, 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 (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).
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 Arai, Morita, and Sugiyama with Higashi’s teaching of ratio of the image portions of interest based on pixel value. 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 17 is rejected under 35 U.S.C. 103 as being unpatentable over Arai et al. (PGPUB No. US 2020/0375562) as evidenced by Sherratt et al. ("Raised mammographic density: causative mechanisms and biological consequences", 2016) in view of Morita et al. (PGPUB No. US 2019/0304088) further in view of Sugiyama et al. (PGPUB No. US 2016/0110875) further in view of Higashi et al. (PGPUB No. US 2023/0143350) further in view of Teboul (US Patent No. 5,709,206).
Regarding claim 17, modified Arai teaches the ultrasound image analysis apparatus in claim 10, as discussed above.
However, the combination of Arai, Morita, and Sugiyama is silent regarding an ultrasound image analysis apparatus, 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.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Higashi teaches an ultrasound image analysis apparatus, 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 (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).
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 Arai, Morita, and Sugiyama with Higashi’s teaching of a ratio based on volumetric information. 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 (See below). 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).
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 Arai, Morita, Sugiyama, and Higashi with Teboul’s teaching of volumetric ultrasound imaging. 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).
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 8-9, 12-13, 16-20, and 22-23 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-4, 7-22, and 24-25 of copending Application No. Application No. 18/052,663 in view of Arai et al. (PGPUB No. US 2020/0375562) in view of Morita et al. (PGPUB No. US 2019/0304088).
This is a provisional nonstatutory double patenting rejection.
Regarding claim 22, Claim 24 of Application No. 18/052,663 teaches a ultrasound image analysis apparatus comprising: a monitor; and a processor configured to: 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 (Claim 24 recites: 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).
However, the claims of Application No. 18/052,663 is silent regarding an ultrasound image analysis apparatus, 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, wherein the processor is further configured to, in a case where it is determined to perform analysis.
In an analogous imaging field of endeavor, regarding ultrasound-based analysis of breast tissue, Arai teaches an ultrasound image analysis apparatus teaches an ultrasound image analysis apparatus, acquire information related to a breast composition of a subject obtained by a mammography examination (Paragraph 0077 teaches that the radiography system has a mammography apparatus and a console. Paragraph 0078 teaches that images of the breast of the subject can be captured. See Fig. 2. Fig. 18 shows the image of the breast and Fig. 19 shows the breast with the plurality of mammary glands);
determine whether or not to perform analysis on a glandular tissue component region in a mammary gland region based on the acquired information related to the breast composition (Paragraph 0166 teaches that the control unit can assess if the information of the mammary gland is indicated can be assessed. If the result is yes, the ultrasound image is captured. If not, the ultrasound image is not captured. Paragraph 0193 teaches mammary gland identification can be captured by the ultrasound image. The mammary gland identification is performed after the ultrasound image is captured),
wherein the processor is further configured to, in a case where it is determined to perform analysis (Paragraph 0166 teaches that the control unit can assess if the information of the mammary gland is indicated can be assessed. If the result is yes, the ultrasound image is captured. If not, the ultrasound image is not captured. Paragraph 0193 teaches mammary gland identification can be captured by the ultrasound image. The mammary gland identification is performed after the ultrasound image is captured).
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. 18/052,663 with Arai’s teaching of the determination of whether or not to perform analysis on a glandular tissue region based on breast composition. This modified apparatus would allow a user to maintain compression while acquire image data (Paragraph 0005 of Arai). Furthermore, the user can easily understand the positional correspondence between the imaging and compression systems (Paragraph 0007 of Arai). Additionally, the determination on whether or not to perform the analysis can result in fewer unnecessary or unsuccessful analyses being performed and thereby saving computational and electrical resources.
In an analogous imaging field of endeavor, breast tissue analysis for medical diagnosis, Morita teaches an apparatus, 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 (Paragraph 0063 teaches the acquisition of the image data of the breast and the determination of the mammary gland content rate. The mammary gland content rate means the volume ratio of mammary gland tissues in each region).
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. 18/052,663 and Arai with Morita’s teaching of image analysis for the ratio being performed on a pixel level. 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).
Regarding claim 8, modified Application No. 18/052,663 teaches the ultrasound image analysis in claim 22, as discussed above.
However, the combination of Application No. 18/052,663 and Arai is silent regarding an ultrasound image analysis system, wherein the processor determines to perform analysis on the glandular tissue component region in a case where the volume ratio of the mammary gland content to the mammary gland region is higher than a predetermined mammary gland mass threshold value.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Morita teaches an ultrasound image analysis system, wherein the processor determines to perform analysis on the glandular tissue component region in a case where the volume ratio of the mammary gland content to the mammary gland region is higher than a predetermined mammary gland mass threshold value (Paragraph 0063 teaches that the mammary gland content rate means the volume ratio of mammary gland tissues in each region. Paragraph 0094 teaches that the content rate can be compared to a threshold that is predetermined. If the content rate is above a threshold, the user can be warned of the high density and that the object of interest is difficult to see. Paragraphs 0130-31 teaches that in the case where it is difficult to see, the apparatus can perform tomosynthesis imaging for easy visibility).
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. 18/052,663 and Arai with Morita’s teaching of the performance of an image analysis in the case where the ratio of the mammary gland is higher than a threshold. 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).
Regarding claim 9, Application No. 18/052,663 teaches the ultrasound image analysis apparatus in claim 22, as discussed above.
Claim 24 of Application No. 18/052,663 further teaches an ultrasound image analysis apparatus, wherein the processor calculates a ratio of the glandular tissue component region to the mammary gland region (Claim 24 recites: 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).
Regarding claim 12, Application No. 18/052,663 teaches the ultrasound image analysis apparatus in claim 9, as discussed above.
Claim 3 of Application No. 18/052,663 further teaches an ultrasound image analysis apparatus, 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 (Claim 3 recites: The 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).
Regarding claim 13, Application No. 18/052,663 teaches the ultrasound image analysis apparatus in claim 9, as discussed above.
Claim 4 of Application No. 18/052,663 further teaches an ultrasound image analysis apparatus, wherein the processor detects the mammary gland region from the ultrasound image by using deep learning (Claim 4 recites: 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 by using deep learning).
Regarding claim 16, Application No. 18/052,663 teaches the ultrasound image analysis apparatus in claim 9, as discussed above.
Claim 7 of Application No. 18/052,663 further teaches an ultrasound image analysis apparatus, 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 (Claim 7 recites: The ultrasound image analysis apparatus according to claim 24, 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).
Regarding claim 17, Application No. 18/052,663 teaches the ultrasound image analysis apparatus in claim 9, as discussed above.
Claim 10 of Application No. 18/052,663 further teaches an ultrasound image analysis apparatus, 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 (Claim 10 recites: The ultrasound image analysis apparatus according to claim 24, 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).
Regarding claim 18, Application No. 18/052,663 teaches the ultrasound image analysis apparatus in claim 22, as discussed above.
Claim 11 of Application No. 18/052,663 further teaches 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 11 recites: An ultrasound diagnostic apparatus comprising: 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).
Regarding claim 19, Application No. 18/052,663 teaches the ultrasound diagnostic apparatus in claim 18, as discussed above.
Claim 20 of Application No. 18/052,663 further teaches an ultrasound diagnostic apparatus, wherein the processor stores the analysis result of the glandular tissue component region in a tag associated with the ultrasound image (Claim 20 recites: The ultrasound diagnostic apparatus according to claim 11, 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).
Regarding claim 20, Application No. 18/052,663 teaches the ultrasound diagnostic apparatus in claim 18, as discussed above.
Claim 22 of Application No. 18/052,663 further teaches an ultrasound diagnostic apparatus, 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 (Claim 22 recites: The ultrasound diagnostic apparatus according to claim 11, 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).
Regarding claim 23, Claim 25 of Application No. 18/052,663 teaches a control method for an ultrasound image analysis apparatus, the method comprising:
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 25 recites: 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).
However, the claims of Application No. 18/052,663 is silent 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 a mammary gland region based on the acquired information related to the breast composition,
wherein the method further comprises, in a case where it is determined to perform analysis.
In an analogous imaging field of endeavor, regarding ultrasound-based analysis of breast tissue, Arai teaches a method, acquiring information related to a breast composition of a subject obtained by a mammography examination (Paragraph 0077 teaches that the radiography system has a mammography apparatus and a console. Paragraph 0078 teaches that images of the breast of the subject can be captured. See Fig. 2. Fig. 18 shows the image of the breast and Fig. 19 shows the breast with the plurality of mammary glands);
determining whether or not to perform analysis on a glandular tissue component region in a mammary gland region based on the acquired information related to the breast composition (Paragraph 0166 teaches that the control unit can assess if the information of the mammary gland is indicated can be assessed. If the result is yes, the ultrasound image is captured. If not, the ultrasound image is not captured. Paragraph 0193 teaches mammary gland identification can be captured by the ultrasound image. The mammary gland identification is performed after the ultrasound image is captured),
wherein the method further comprises, in a case where it is determined to perform analysis (Paragraph 0166 teaches that the control unit can assess if the information of the mammary gland is indicated can be assessed. If the result is yes, the ultrasound image is captured. If not, the ultrasound image is not captured. Paragraph 0193 teaches mammary gland identification can be captured by the ultrasound image. The mammary gland identification is performed after the ultrasound image is captured).
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. 18/052,663 with Arai’s teaching of the determination of whether or not to perform analysis on a glandular tissue region based on breast composition. This modified apparatus would allow a user to maintain compression while acquire image data (Paragraph 0005 of Arai). Furthermore, the user can easily understand the positional correspondence between the imaging and compression systems (Paragraph 0007 of Arai). Additionally, the determination on whether or not to perform the analysis can result in fewer unnecessary or unsuccessful analyses being performed and thereby saving computational and electrical resources.
In an analogous imaging field of endeavor, breast tissue analysis for medical diagnosis, Morita teaches an method, 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 (Paragraph 0063 teaches the acquisition of the image data of the breast and the determination of the mammary gland content rate. The mammary gland content rate means the volume ratio of mammary gland tissues in each region).
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. 18/052,663 and Arai with Morita’s teaching of image analysis for the ratio being performed on a pixel level. This modified method 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 3 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-4, 7-22, and 24-25 of copending Application No. Application No. 18/052,663 in view of Arai et al. (PGPUB No. US 2020/0375562) in view of Morita et al. (PGPUB No. US 2019/0304088) further in view of Keeley et al. (PGPUB No. US 2008/0015448).
This is a provisional nonstatutory double patenting rejection.
Regarding claim 3, modified Application No. 18/052,663 teaches the ultrasound image analysis in claim 22, as discussed above.
However, the combination of Application No. 18/052,663, Arai, and Morita is silent regarding an ultrasound image analysis system, wherein the processor determines to perform analysis on the glandular tissue component region in a case where the mammary gland category corresponding to the subject belongs to at least one mammary gland category among the mammary gland categories classified into the plurality of types.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Keely teaches an ultrasound image analysis system, wherein the processor determines to perform analysis on the glandular tissue component region in a case where the mammary gland category corresponding to the subject belongs to at least one mammary gland category among the mammary gland categories classified into the plurality of types (Paragraph 0050 teaches the detection of increased density in the mammary gland. Paragraph 0103 teaches that the increased breast tissue density results in carcinoma formation. Paragraph 0022 teaches that the areas of the breast are thresholded for density and this allows for the assessment of qualitatively and/or quantitatively. The thresholding can also be correlated to the stage of cancer. The correlation can also assess malignancy or if the cancer is benign. The sub-signatures observed over a period of time are used diagnostic assessment by noting the qualitative and/or quantitative changes and/or rates of change).
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. 18/052,663, Arai, and Morita with Keely’s teaching of performing image analysis based on the category of the gland that has been determined based on density. This modified apparatus would allow the user to provide accurate and selective diagnosis of cancer, and provide diagnostic information complementary to conventional diagnostic methods (Abstract of Keely). Furthermore, the modification improves the accuracy, precision, and timing of cancer detection and the detection of suspected cancer at an early stage of development (Paragraph 0036 of Keely).
Claim 5-6 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-4, 7-22, and 24-25 of copending Application No. Application No. 18/052,663 in view of Arai et al. (PGPUB No. US 2020/0375562) in view of Morita et al. (PGPUB No. US 2019/0304088) in view of Ofuji (PGPUB No. US 2009/0086891).
This is a provisional nonstatutory double patenting rejection.
Regarding claim 5, modified Application No. 18/052,663 teaches the ultrasound image analysis in claim 22, as discussed above.
However, the combination of Application No. 18/052,663, Arai, and Morita is silent regarding an ultrasound image analysis system, wherein the processor calculates the ratio of the mammary gland region to the breast region of the subject from a mammography image.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Ofuji teaches an ultrasound image analysis system, wherein the processor calculates the ratio of the mammary gland region to the breast region of the subject from a mammography image (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 0050 teaches that the breast image system is using a mammography apparatus. Paragraph 0059 teaches that the mammograms are read and assessed. See Figs. 1 and 5-6).
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. 18/052,663, Arai, and Morita with Ofuji’s teaching of ratio of the mammary gland to the breast region based on a mammogram. 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 6, modified Application No. 18/052,663 teaches the ultrasound image analysis in claim 22, as discussed above.
However, the combination of Application No. 18/052,663, Arai, and Morita is silent regarding an ultrasound image analysis system, wherein the processor determines to perform analysis on the glandular tissue component region in a case where the ratio of the mammary gland region to the breast region is higher than a predetermined mammary gland region threshold value.
In an analogous imaging field of endeavor, regarding breast tissue analysis for medical diagnosis, Ofuji teaches an ultrasound image analysis system, wherein the processor determines to perform analysis on the glandular tissue component region in a case where the ratio of the mammary gland region to the breast region is higher than a predetermined mammary gland region threshold value (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 0073 teaches that the content rates are assessed with respect to threshold values for classification. Paragraph 0078 teaches that the displaying is performed based on the classification type. Paragraph 0081 teaches this allows for the image reading for the mammograms accounts for content rates).
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. 18/052,663, Arai, and Morita with Ofuji’s teaching of the use of the ratio of the mammary gland to the breast tissue with respect to a threshold for image analysis. 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).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADIL PARTAP S VIRK whose telephone number is (571)272-8569. The examiner can normally be reached Mon-Fri 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached on 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798
1 https://www.merriam-webster.com/dictionary/algorithm
2 Link: https://www.merriam-webster.com/dictionary/ratio
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”
4 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”