DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1-5, 7-10, 14, and 16-20 are objected to because of the following informalities:
In claim 1, line 7, “two or more frames” should read “two or more frames of the plurality of frames”.
In claim 2, line 3, “the examination object” should read “an examination object”.
In claim 3, lines 4-5, “the examination” should read “an examination”.
In claim 3, line 7, “examination” should read “the examination”.
In claim 4, line 8, “an ultrasound image” should read “the ultrasound image”.
In claim 5, line 2, “a common examination object” should read “the common examination object”.
In claim 7, lines 3-4, “a block image showing the divided block” should read “respective block images showing the divided blocks”.
In claims 8-9, “the block image” should read “the block images” or “each of the block images”.
In claims 10, lines 2-3, “an ultrasound image” should read “the ultrasound image”.
In claims 10, lines 4-5, “the displayed block image” should read “a displayed block image”.
In claims 10 and 20, lines 4-5, “a determined ultrasound image” should read “the determined ultrasound image”.
In claim 10, line 5, and claim 20, lines 3-4, “examination” should read “the examination”.
In claim 14, line 2, “the block” should read “a block”.
In claim 16, line 2, “the block image … the block” should read “each of the block images…a respective block”.
In claim 17, lines 2-3, “the block image” should read “the block images” or “each of the block images”.
In claim 18, line 7, “an operation” should read “the operation”.
In claim 19, line 2, “the block image” should read “each of the block images”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 and 12-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Although the claims fall within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter), claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection as judicial exceptions.
Regarding claim 1, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “distinguishably display positions on a time axis, where ultrasound image groups have been acquired, for each ultrasound image group which comprises two or more frames which include a common examination object among the plurality of frames,” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. In particular the displaying can be accomplished with the positions drawn on paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “ultrasonic diagnostic apparatus comprising a processing circuitry configured to: acquire ultrasound images of a plurality of frames by continuous scanning of a subject using an ultrasonic probe", which are steps of pre-solution data gathering and instructions to implement the abstract idea on a computer. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 1 is therefore non-statutory and not patent eligible.
Regarding claim 2, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “distinguish the examination object for each of the plurality of frames; and distinguishably display the positions on the time axis where the ultrasound image groups have been acquired, for each ultrasound image group, based on a result of distinguishing the examination object,” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. In particular the distinguishing can be done mentally and the displaying can be accomplished with the positions drawn on paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites the steps of “the processing circuitry is further configured to:”, which are instructions to implement the abstract idea on a computer. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 2 is therefore non-statutory and not patent eligible.
Regarding claim 3, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “calculate, for each frame in which the examination object has been distinguished, a degree of appropriateness indicating how appropriate the examination is; and determine, based on the calculated degrees of appropriateness, an ultrasound image for performing examination of the examination object,” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites the steps of “wherein the processing circuitry is further configured to:”, which are instructions to implement the abstract idea on a computer. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 3 is therefore non-statutory and not patent eligible.
Regarding claim 4, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “distinguish the examination object by dividing the ultrasound images of the plurality of frames into blocks each showing a common attribute;
calculate the degree of appropriateness for each of the divided blocks; and determine, for each of the divided blocks, based on the calculated degrees of appropriateness, an ultrasound image for performing examination of the examination object” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites the steps of “wherein the processing circuitry is further configured to:”, which are instructions to implement the abstract idea on a computer. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 4 is therefore non-statutory and not patent eligible.
Regarding claim 5, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “wherein the common attribute is a common examination object,” and “calculate a degree of certainty that a cross section corresponding to the examination object will be included in the ultrasound image; and divide, based on the calculated degrees of certainty, the ultrasound images of the plurality of frames into the blocks each showing the common examination object” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites the steps of “the processing circuitry is further configured to:”, which are instructions to implement the abstract idea on a computer. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 5 is therefore non-statutory and not patent eligible.
Regarding claim 6, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “wherein the common attribute is a common time phase,” and “divide, based on time, the ultrasound images of the plurality of frames into the blocks each showing a common time phase,” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites the steps of “the processing circuitry is further configured to:”, which are instructions to implement the abstract idea on a computer. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 6 is therefore non-statutory and not patent eligible.
Regarding claim 7, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim and “distinguishably display the positions on the time axis by displaying a block image showing the divided block” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites the steps of “wherein the processing circuitry is configured to”, which are instructions to implement the abstract idea on a computer. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 7 is therefore non-statutory and not patent eligible.
Regarding claim 8, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “vary a display color of the block image according to the calculated degree of certainty” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites the steps of “wherein the processing circuitry is further configured to:”, which are instructions to implement the abstract idea on a computer. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 8 is therefore non-statutory and not patent eligible.
Regarding claim 9, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “display the block image in gradation according to the calculated degree of certainty,” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites the steps of “wherein the processing circuitry is further configured to:”, which are instructions to implement the abstract idea on a computer. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 9 is therefore non-statutory and not patent eligible.
Regarding claim 12, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “in a case where a plurality of examination objects are simultaneously included in the ultrasound images of the plurality of frames, divide the ultrasound images of the plurality of frames into the blocks individually for the plurality of examination objects, and display the block images of the plurality of examination objects in an overlapping manner or in a side-by-side manner,” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites the steps of “wherein the processing circuitry is further configured to:”, which are instructions to implement the abstract idea on a computer. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 12 is therefore non-statutory and not patent eligible.
Regarding claim 13, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “display a graph showing the calculated degree of certainty,” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites the steps of “wherein the processing circuitry is further configured to:”, which are instructions to implement the abstract idea on a computer. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 13 is therefore non-statutory and not patent eligible.
Regarding claim 14, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “contract the block based on detection values of the examination object included in the block; and calculate the degree of appropriateness for the contracted block,” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites the steps of “wherein the processing circuitry is further configured to:”, which are instructions to implement the abstract idea on a computer. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 14 is therefore non-statutory and not patent eligible.
Regarding claim 15, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “calculate the degree of appropriateness based on a detection value of the examination object,” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites the steps of “wherein the processing circuitry is further configured to:”, which are instructions to implement the abstract idea on a computer. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 15 is therefore non-statutory and not patent eligible.
Regarding claim 16, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “wherein the block image is an image schematically showing the block,” and “arrange and display the plurality of block images according to a time series,” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites the steps of “wherein the processing circuitry is further configured to:” and “display, on each block image, a frame of which the calculated degree of certainty is largest”, which are instructions to implement the abstract idea on a computer and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 16 is therefore non-statutory and not patent eligible.
Regarding claim 17, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “vary a display color of the block image according to the examination object,” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites the steps of “wherein the processing circuitry is further configured to:”, which are instructions to implement the abstract idea on a computer. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 17 is therefore non-statutory and not patent eligible.
Regarding claim 18, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites the steps of “wherein the block image is a thumbnail of the ultrasound image of each of the blocks, and the processing circuitry is further configured to display the thumbnail such that the thumbnail is selectable by an operation of a user, and display the ultrasound image corresponding to the thumbnail selected by an operation of the user”, which are instructions to implement the abstract idea on a computer and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 18 is therefore non-statutory and not patent eligible.
Regarding claim 19, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “wherein the block image is an image showing a head frame number and a tail frame number in the block,” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites no additional steps. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 19 is therefore non-statutory and not patent eligible.
Regarding claim 20, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites the steps of “wherein the processing circuitry is further configured to display, according to an operation of a user, a determined ultrasound image for performing examination of the examination object” which are instructions to implement the abstract idea on a computer and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 20 is therefore non-statutory and not patent eligible.
Regarding claim 21, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites the steps of “wherein the subject is a mother's body, and the examination object is a dimension of a fetus in the mother's body”, which are further limiting pre-solution data gathering. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 21 is therefore non-statutory and not patent eligible.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 7-8, 10-17, 19, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Canfield et al (US 20220071600), hereinafter Canfield.
Regarding claim 1, Canfield teaches an ultrasonic diagnostic apparatus (100) comprising a processing circuitry (110) configured to:
acquire ultrasound images of a plurality of frames (124) (“image acquisition…image frames 124” [0039], Fig. 1) (“The present disclosure describes imaging systems configured to generate index information to indicate which image frames in a plurality of image frames include one or more target anatomical features, such as a head or femur of a fetus…specific image frames (508) of the plurality of image frames” Abstract; Fig. 5) by continuous scanning of a subject using an ultrasonic probe (112) (“During an ultrasound exam, a user may scan a region of interest of a subject with an ultrasound transducer array.” [0021]; “FIG. 1 shows an example ultrasound system according to principles of the present disclosure. The ultrasound system 100 may include an ultrasound data acquisition unit 110. The ultrasound data acquisition unit 110 can include an ultrasound probe which includes an ultrasound sensor array 112 configured to transmit ultrasound pulses 114 into a region 116 of a subject, e.g., abdomen, and receive ultrasound echoes 118 responsive to the transmitted pulses.” [0028]; “the items of interest are various fetal anatomical features” [0045]); and
distinguishably display positions (502) on a time axis (horizontal axis in Fig. 5; “The horizontal axis labeled with image frame numbers 501” [0045], Fig. 5), where ultrasound image groups have been acquired (“The horizontal axis may be labeled with the image frame number, … and/or time of acquisition of the frame" [0043]), for each ultrasound image group which comprises two or more frames (for example, a group starting about the image frame 1519 and ending at frame 2163 in Fig. 5) which include a common examination object (504) (“a fetal head” [0046]; Fig. 5) among the plurality of frames (“For each image frame where one or more items of interest are present, one or more markers 502 in the form of bars with heights indicating the confidence level are displayed.” [0045]; “the selector 506 is placed on a marker 502 associated with a frame where a fetal head has been determined to be present.” [0046]; Fig. 5).
Regarding claim 2, Canfield teaches the ultrasonic diagnostic apparatus according to claim 1, wherein the processing circuitry is further configured to:
distinguish the examination object for each of the plurality of frames (“The vertical axis is labeled with the confidence level.” [0045]); and
distinguishably display the positions on the time axis where the ultrasound image groups have been acquired, for each ultrasound image group, based on a result of distinguishing the examination object (“The vertical axis is labeled with the confidence level. For each image frame where one or more items of interest are present, one or more markers 502 in the form of bars with heights indicating the confidence level are displayed. A different color bar is provided for each item of interest. Visual representation 500 further includes a legend 504 indicating which colors are associated with which items of interest. In the example illustrated in FIG. 5, the items of interest are various fetal anatomical features (e.g., umbilical cord, stomach, spine).” [0045]; Fig. 5).
Regarding claim 3, Canfield teaches the ultrasonic diagnostic apparatus according to claim 2, wherein the processing circuitry is further configured to:
calculate, for each frame in which the examination object has been distinguished, a degree of appropriateness indicating how appropriate the examination is (“which image frames from the plurality of ultrasound image frames where an item of interest is present are likely to be the most appropriate for taking measurements or diagnostic purposes, for example, a standard view defined by an ultrasound exam protocol.” [0035]; “the vertical axis represents the merit level of an item of interest present in the image frame or a sub-feature of an item of interest present in the frame… the merit level may be a measure of the quality of the image (e.g., resolution, conformity with a standard view). Visual representation 700 may be generated by display processor 158 based at least in part on output from image quality network 144. For appropriate frames (e.g., where a sub-feature is present), a marker 702 may indicate a merit level for one or more items of interest or sub-features thereof. In the example shown in FIG. 7, as indicated by legend 704, markers 702 are in the form of bars with heights corresponding to the merit levels of two different views of Item 2 are provided for appropriate frames. In some embodiments, merit levels below a certain threshold (e.g., 90%, 80%, 70%, 50%) may not be shown.” [0050]); and
determine, based on the calculated degrees of appropriateness, an ultrasound image for performing examination of the examination object (“The visual representation of the merit levels associated with each frame may provide the user with a visual overview as to which image frames from the plurality of ultrasound image frames where an item of interest is present are likely to be the most appropriate for taking measurements or diagnostic purposes, for example, a standard view defined by an ultrasound exam protocol.” [0035])
Regarding claim 4, Canfield teaches the ultrasonic diagnostic apparatus according to claim 3, wherein the processing circuitry is further configured to:
distinguish the examination object by dividing the ultrasound images of the plurality of frames into blocks each showing a common attribute (704);
calculate the degree of appropriateness for each of the divided blocks (Fig. 7); and
determine, for each of the divided blocks, based on the calculated degrees of appropriateness, an ultrasound image (708 or 710) for performing examination of the examination object (“data processor 126 may automatically provide image frames 708 and 710 associated with the highest merit levels for each view for display. In the example shown in FIG. 7, Views 1 and 2 correspond to two standard cardiac views: a four-chamber view of a heart (image frame 708) and a left ventricular outflow tract (image frame 710).” [0050]).
Regarding claim 5, Canfield teaches the ultrasonic diagnostic apparatus according to claim 4, wherein the common attribute is a common examination object (“a heart” [0050]), and
the processing circuitry is further configured to: calculate a degree of certainty (“Merit” Fig. 7; “a marker 702 may indicate a merit level for one or more items of interest or sub-features thereof. In the example shown in FIG. 7, as indicated by legend 704, markers 702 are in the form of bars with heights corresponding to the merit levels of two different views of Item 2 are provided for appropriate frames. In some embodiments, merit levels below a certain threshold (e.g., 90%, 80%, 70%, 50%) may not be shown.” [0050]) that a cross section corresponding to the examination object (“two standard cardiac views” [0050], Fig. 7) will be included in the ultrasound image; and
divide, based on the calculated degrees of certainty, the ultrasound images of the plurality of frames into the blocks each showing the common examination object (“Views 1 and 2 correspond to two standard cardiac views: a four-chamber view of a heart (image frame 708) and a left ventricular outflow tract (image frame 710).” [0050], Fig. 7).
Regarding claim 7, Canfield teaches the ultrasonic diagnostic apparatus according to claim 5, wherein the processing circuitry is further configured to:
distinguishably display the positions on the time axis by displaying a block image (“A different color bar”) showing the divided block (“For each image frame where one or more items of interest are present, one or more markers 502 in the form of bars with heights indicating the confidence level are displayed. A different color bar is provided for each item of interest. Visual representation 500 further includes a legend 504 indicating which colors are associated with which items of interest. In the example illustrated in FIG. 5, the items of interest are various fetal anatomical features (e.g., umbilical cord, stomach, spine).” [0045]; Fig. 5).
Regarding claim 8, Canfield teaches the ultrasonic diagnostic apparatus according to claim 7, wherein the processing circuitry is further configured to vary a display color of the block image according to the calculated degree of certainty (“the markers 402 could be squares having different colors representative of the confidence level, and an overlay pattern (e.g., stripes, dots, crosshatch) on the squares could indicate the item of interest. Frames where there is no confidence that any item of interest is present may not have a marker.” [0043]).
Regarding claim 10, Canfield teaches the ultrasonic diagnostic apparatus according to claim 7, wherein the processing circuitry is further configured to replace, as an ultrasound image for performing examination of the examination object (“data processor 126 may automatically provide image frames 708 and 710 associated with the highest merit levels” [0050]; Fig. 7. The replacing takes place when a user selects a frame first and then the data processor 126 automatically provides image frames), an ultrasound image of a frame selected by a user from the displayed block image (“As shown in FIG. 5, a user may interact with the visual representation 500 by providing an input (e.g., user input 166) via a user control, such as user controls 168 shown in FIG. 2. The user may control the location of a selector 506 via the user controls (e.g., trackball, mouse, arrow keys, touch screen). The selector 506 may be placed over a marker 502 associated with a particular frame. In response to the input (e.g., placement of the selector 506), the user interface may provide the corresponding image frame 508 on a display. As shown in the example in FIG. 5, the selector 506 is placed on a marker 502 associated with a frame where a fetal head has been determined to be present. The input by the user may be provided to the data processor 126 and a corresponding image frame 508 from image frames 124 may be provided by the data processor 126 to display processor 158 which may display image frame 508 above the visual representation 500.” [0046]; “Similar to the example shown in FIG. 5, the user may then select an image frame to view from the visual representation 700.” [0050])
with a determined ultrasound image for performing examination of the examination object (“Alternatively, data processor 126 may automatically provide image frames 708 and 710 associated with the highest merit levels for each view for display. In the example shown in FIG. 7, Views 1 and 2 correspond to two standard cardiac views: a four-chamber view of a heart (image frame 708) and a left ventricular outflow tract (image frame 710).” [0050]).
Regarding claim 11, Canfield teaches the ultrasonic diagnostic apparatus according to claim 7, wherein the processing circuitry is further configured to:
divide the ultrasound images (162) of the plurality of frames into the blocks in real time during the scanning (“in real time as an ultrasound scan is being performed” [0038] FIG. 2; “Visual representations described herein may be dynamically generated and displayed in real time. That is, indexing information, confidence levels, merit levels, and/or measurements may be determined in real time and visual representations of those determinations may be provided to a user during image acquisition. As shown in the example illustrated in FIG. 9, an initial visual representation 900A for a scan including image frame 908A is displayed. As additional image frames, such as image frame 908B, are acquired during an ultrasound exam, visual representation 900A is updated as shown in visual representation 900B to include markers 902 indicating confidence levels for each image frame as it is acquired. Additional items of interest are also added to the legend 904 as they are located.” [0054]); and
display the block image (140) together with the ultrasound image (162) in real time during the scanning (“the user interface 160 can be configured to display the ultrasound images 162 in real time as an ultrasound scan is being performed, along with one or more visual representations 140, which may be overlaid on the images and/or displayed separately. The visual representations 140 can include index information, confidence levels, merit levels, and/or measurements in the form of annotations, color-mapping, percentages, and/or bars.” [0038] FIG. 2).
Regarding claim 12, Canfield teaches the ultrasonic diagnostic apparatus according to claim 7, wherein the processing circuitry is further configured to, in a case where a plurality of examination objects (504) are simultaneously included in the ultrasound images of the plurality of frames (seen in Fig. 5), divide the ultrasound images of the plurality of frames into the blocks individually for the plurality of examination objects (“colors are associated with … items of interest” [0045]), and display the block images of the plurality of examination objects in an overlapping manner or in a side-by-side manner (“Visual representation 500 further includes a legend 504 indicating which colors are associated with which items of interest. In the example illustrated in FIG. 5, the items of interest are various fetal anatomical features (e.g., umbilical cord, stomach, spine).” [0045]; “As shown in the example in FIG. 5, the selector 506 is placed on a marker 502 associated with a frame where a fetal head has been determined to be present.” [0046])
Regarding claim 13, Canfield teaches the ultrasonic diagnostic apparatus according to claim 7, wherein the processing circuitry is further configured to display a graph showing the calculated degree of certainty (“Confidence” Fig. 4; “FIG. 5 illustrates an example of how a user may interact with a visual representation, such as visual representation 500 of confidence levels. The visual representation 500 may be generated by the display processor 158 based at least in part on output from neural network 128. The visual representation 500 may be provided on a display, such as display 164 shown in FIG. 2. The visual representation 500 may be similar to visual representation 400 of confidence levels. The visual representation 500 includes a horizontal axis and a vertical axis…The vertical axis is labeled with the confidence level.” [0045]).
Regarding claim 14, Canfield teaches the ultrasonic diagnostic apparatus according to claim 7, wherein the processing circuitry is further configured to:
contract the block based on detection values of the examination object included in the block (“the input 166 may include an instruction to raise or lower a threshold for a confidence level or merit level or adjust one or more image acquisition settings.” [0039] “Frames where there is no confidence that any item of interest is present may not have a marker… confidence levels below a certain threshold (e.g., 90%, 80%, 70%, 50%) may not be shown. The threshold may be pre-set in a system (e.g., system 100) or may be indicated by a user via a user input (e.g., input 166).” [0043]); and
calculate the degree of appropriateness for the contracted block (“the image quality network 144 may generate a merit level based on the probability that the correct imaging plane for a specified anatomical measurement and/or standard view is included in an image frame. The probability may be based, at least in part, on the confidence levels for each of the landmarks (e.g., items of interest, sub-features) generated by the neural network 128.” [0059]; Display processor 158 may use the outputs 127, 145, and 149 of networks 128, 144, and 148 to generate visual representations of the indexing information, confidence levels, merit levels, and/or measurements. The visual representations may be output to the display 164.” [0070]; Fig. 7).
Regarding claim 15, Canfield teaches the ultrasonic diagnostic apparatus according to claim 14, wherein the processing circuitry is further configured to
calculate the degree of appropriateness based on a detection value of the examination object (“the image quality network 144 may generate a merit level based on the probability that the correct imaging plane for a specified anatomical measurement and/or standard view is included in an image frame. The probability may be based, at least in part, on the confidence levels for each of the landmarks (e.g., items of interest, sub-features) generated by the neural network 128.” [0059]).
Regarding claim 16, Canfield teaches the ultrasonic diagnostic apparatus according to claim 7, wherein the block image is an image (302) schematically showing the block (“The markers 302 may allow a user to quickly see which image frames include particular items of interest.” [0042]), and
the processing circuitry is further configured to arrange and display the plurality of block images according to a time series (“The horizontal axis may be labeled with the image frame number, file name of the image frame, and/or time of acquisition of the frame (not shown).” [0042]), and display, on each block image, a frame (908A, 908B) (“As additional image frames, such as image frame 908B, are acquired during an ultrasound exam, visual representation 900A is updated as shown in visual representation 900B to include markers 902 indicating confidence levels for each image frame as it is acquired." [0054] Fig. 9) of which the calculated degree of certainty is largest (“For frames where no items of interest are present, no markers 302 may be present. Whether an item of interest is present may be based on whether an associated confidence level associated with the item of interest was above a threshold value (e.g., 90%, 80%, 70%, 50%).” The system is capable to display a frame of which the calculated degree of certainty is largest by setting the appropriate threshold value).
Regarding claim 17, Canfield teaches the ultrasonic diagnostic apparatus according to claim 7, wherein the processing circuitry is further configured to vary a display color of the block image according to the examination object (seen in Fig. 5) (“Visual representation 500 further includes a legend 504 indicating which colors are associated with which items of interest. In the example illustrated in FIG. 5, the items of interest are various fetal anatomical features (e.g., umbilical cord, stomach, spine).” [0045]).
Regarding claim 19, Canfield teaches the ultrasonic diagnostic apparatus according to claim 7, wherein the block image is an image (501) showing a head frame number (1519) and a tail frame number (2163) in the block (“The horizontal axis labeled with image frame numbers 501. The image frame numbers 501 may indicate the frame number in a cineloop or in a file of image frames.” [0045]; Fig. 5).
Regarding claim 21, Canfield teaches the ultrasonic diagnostic apparatus according to claim 1, wherein the subject is a mother's body, and
the examination object is a dimension (802) of a fetus in the mother's body (“In the example illustrated in FIG. 5, the items of interest are various fetal anatomical features (e.g., umbilical cord, stomach, spine). [0045]; As discussed above, once an image frame is displayed, a user may make measurements on the displayed image (e.g., image frames 708 and/or 710 shown in FIG. 7). In some embodiments, the data processor 126 may automatically acquire measurements of one or more items of interest in an image frame. For example, as shown in FIG. 8, the image measurement network 148 may acquire a biparietal diameter 802 of a fetal skull from image frame 800. The measurements (e.g., diameter 802) may be stored as annotations of image frame 800 in local memory 125.” [0052]).
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Canfield as applied to claim 4, and further in view of Maeda (US 20200046316), hereinafter, Maeda.
Regarding claim 6, Canfield teaches the ultrasonic diagnostic apparatus according to claim 4.
Canfield does not teach that the common attribute is a common time phase, and
the processing circuitry is further configured to divide, based on time, the ultrasound images of the plurality of frames into the blocks each showing a common time phase.
However, in the ultrasound diagnostic devices field of endeavor, Maeda discloses ultrasound diagnostic apparatus, program, and method of operating ultrasound diagnosis apparatus, which is analogous art. Maeda teaches that the common attribute is a common time phase (“distinct time phases” [0065]; “the time phase of the diastole acquired in S602” [0082]; Figs. 2, 6).
Therefore, based on Maeda’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Canfield to have the common attribute that is a common time phase, and the processing circuitry that is further configured to divide, based on time, the ultrasound images of the plurality of frames into the blocks each showing a common time phase, as taught by Maeda, in order to examine an amount of temporal change at each coordinate of interest in the ultrasound images.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Canfield as applied to claim 8, and further in view of Liao et al (US 20230368379), hereinafter, Liao.
Regarding claim 9, Canfield teaches the ultrasonic diagnostic apparatus according to claim 8.
Canfield does not teach that the processing circuitry is further configured to display the block image in gradation according to the calculated degree of certainty.
However, in the ultrasound diagnostic devices field of endeavor, Liao discloses image processing method and apparatus, which is analogous art. Liao teaches that the processing circuitry is further configured to display the image in gradation according to the calculated degree of certainty (“Image 1714 to image 1744 shown on the fifth line are used for indicating artificial intelligence segmented images, such as images outputted by the foregoing region division model, which can provide more detailed sampling information. For example, color A represents a tumor tissue, color B represents a muscular tissue, color C represents a normal mucosa tissue, and color D represents an adipose tissue. In an implementation, the darker the color is, the higher the confidence is.” [0182]).
Therefore, based on Liao’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Canfield to employ the processing circuitry that is further configured to display the image in gradation according to the calculated degree of certainty, as taught by Liao, in order to simplify selecting higher quality images that meet examination requirements. In the invention of Canfield and Liao, the image is the block image.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Canfield as applied to claim 7, and further in view of Urabe et al (US 20170024883), hereinafter, Urabe.
Regarding claim 18, Canfield teaches the ultrasonic diagnostic apparatus according to claim 7.
Canfield does not teach that the block image is a thumbnail of the ultrasound image of each of the blocks, and the processing circuitry is further configured to display the thumbnail such that the thumbnail is selectable by an operation of a user, and display the ultrasound image corresponding to the thumbnail selected by an operation of the user.
However, in the ultrasound diagnostic devices field of endeavor, Urabe discloses ultrasound image processing apparatus and medium, which is analogous art. Urabe teaches that the block image is a thumbnail of the ultrasound image of each of the blocks (“thumbnails” [0125]), and
the processing circuitry is further configured to display the thumbnail such that the thumbnail is selectable by an operation of a user (“in addition to the cine slider, cine markers and the same type range part may be displayed so as to be associated with the thumb nails.” [0125]. It would be reasonable to make thumbnails selectable when range part is displayed to be associated with the thumbnails so that a user could see corresponding images within the range [0125]), and display the ultrasound image corresponding to the thumbnail selected by an operation of the user (“a cine screen 200 includes the ultrasound image part 210 for one ultrasound image and the cine slider part 220 is displayed as shown in FIG. 7. However, this is not limitative in any way. For example, the cine screen 200 may include thumbnails of a predetermined number of cine frames in the front and behind the cine frame shown in the ultrasound image part 210, in the order of generation, separately from the ultrasound image part 210. Further, if the cine marker and the same type range part correspond to the image data of these thumb nails, in addition to the cine slider, cine markers and the same type range part may be displayed so as to be associated with the thumb nails.” [0125]).
Therefore, based on Urabe’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Canfield to employ the block image that is a thumbnail of the ultrasound image of each of the blocks, and the processing circuitry that is further configured to display the thumbnail such that the thumbnail is selectable by an operation of a user, and display the ultrasound image corresponding to the thumbnail selected by an operation of the user, as taught by Urabe, in order to simplify image review to identify ultrasound images that meet examination requirements.
Conclusion
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/ALEXEI BYKHOVSKI/
Primary Examiner, Art Unit 3798