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 .
The IDS filed 01/03/2024 has been received and considered.
Claims 1 – 10, all of the claims pending in the application, have been rejected.
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 1 – 10 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 1 recites “acquire an analysis result of each of a plurality of algorithms for a medical image; cause a terminal of a user to display a screen in a display mode combining the analysis results of the algorithms”. According to the specification, algorithm A and algorithm B are defined on page 12, lines 11 – 16. Later in the specification, the analysis results of an algorithm C is mentioned and that it can also be displayed to the user on page 15, lines 27 – 34 and page 16, lines 1 – 7. However, there is no clear definition in the specification that defines what the results of algorithm C is supposed to represent. Figure 5 of the drawings also displays #403 which, according to the specification, represents an “unchecked” algorithm C. Without clearly defining what the results of algorithm C are supposed to represent, one skilled in the art would not be enabled to make and/or use the invention because claim 1 specifically states combining the analysis results of the algorithms, meaning all mention algorithms in the specification (i.e algorithms A, B, and C) would be needed.
Claims 2 – 9 are also rejected by virtue of their dependency to claim 1.
Claim 10, an independent system claim, is rejected for the same reasons as applied to claim 1.
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 1 – 10 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 1 requires processing circuitry with a particular configuration. The specification states that the storage circuity 120 is connected to the processing circuitry 110 and stores various kinds of information therein on page on page 9, lines 5 – 7 and further states that the processing circuitry1 110 is a processor that reads out each computer program from the storage circuitry 120 and executes the computer program to realize the function corresponding to the computer program. In other words, the processing circuitry 110 that has read out each computer program has each function illustrated in the processing circuitry 110 in FIG. 2 on page 9, lines 25 - 31. Even though the specification defines the various ways in which a processor can function, Examiner interprets (with respect to the diagram of Figure 2) that the processing circuitry and the storage circuitry are two separate components connected to each other meaning the processor is a distinct element from the storage media that would actually hold the instructions. Absent a hard-wired system such as an ASIC, a processor holds only a very limited number of instructions at any given point in time as a device (as opposed to a method where the instructions are understood to be serially fetched from a memory and executed by the processor). It is unclear at what point the processor would be configured as claimed, as a typical processor would hold nowhere near the number of instructions needed to perform the steps of claim 1. What state is the processor in when it is configured as claimed?
Claims 2 – 9 are also rejected by virtue of their dependency to claim 1.
Claim 10, an independent system claim, is rejected for the same reasons as applied to claim 1.
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 (i.e., changing from AIA to pre-AIA ) 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 – 4 and 9 – 10 as best understood are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US Publication No. 2024/0249407 A1 to JANG et al. (hereinafter JANG).
Claim 1
Regarding claim 1, JANG teaches a medical information processing apparatus comprising a processing circuitry configured to: acquire an analysis result of each of a plurality of algorithms for a medical image ("In this disclosure, the term “3D tomosynthesis images” may be interchangeably used with the term “3D image slices.” The “2D medical image” and the “3D image slice” can be differentiated in a sense that they are the results of different image making methods. Specifically, 3D tomosynthesis images are the input for the AI analysis. The lesion scores and lesions markings (e.g., contour or heatmap) acquired as a result of analyzing the 3D tomosynthesis images may be projected onto a guide image for effective visualization. Here, the guide image can be a 2D medical image or one of the 3D tomosynthesis images (i.e., 3D image slice) depending on which image is available at a customer site (i.e., at a user device).", Paragraph [0037]); and
cause a terminal of a user to display a screen in a display mode combining the analysis results of the algorithms ("In this disclosure, the term “interlocked” is intended to mean that the AI analysis results (i.e. lesion scores, markings, etc.) derived from 3D images are the same information to be projected onto their corresponding guide image.", Paragraph [0038]; " Examples of the user device 130 may include a smart phone, a tablet PC, a PC, a smart TV, a mobile phone, a personal digital assistant (PDA), a laptop computer, a media player, a micro server, a global positioning system (GPS) device, an e-book terminal, a digital broadcasting terminal, a navigation device, a kiosk, an MP3 player, a digital camera, home appliance, a camera-equipped device, and other mobile or non-mobile computing devices, but are not limited thereto. Also, the user device 130 may be a wearable device such as a wristwatch, glasses, a hair band, and a ring having a communication function and a data processing function. However, embodiments are not limited thereto", Paragraph [0042]), where Figure 7 shows the tool being displayed to the user with the results of the analysis "lesion score" for each 3D tomosynthesis slice acquired by the AI algorithms.
Claim 2
Regarding claim 2, dependent on claim 1, JANG teaches the invention as claimed in claim 1.
JANG further teaches wherein the medical image is a three-dimensional image (Paragraph [0037]; "Specifically, 3D tomosynthesis images are the input for the AI analysis. The lesion scores and lesions markings (e.g., contour or heatmap) acquired as a result of analyzing the 3D tomosynthesis images may be projected onto a guide image for effective visualization), and
the processing circuitry is configured to cause the terminal to display on the screen, a range to which attention needs to be paid in the three-dimensional image, based on the analysis result of each of the algorithms (Figures 6 and 7), where the navigation tool (annotated in the red box in figure 6 below; figure 7) displays a range of scores corresponding to their respective image slice, to include the slice with the highest score corresponding to a lesion.
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Claim 3
Regarding claim 3, dependent on claim 2, JANG teaches the invention as claimed in claim 2.
JANG further teaches wherein the medical image is a three-dimensional image including a plurality of slice images ("In detail, since 3D tomosynthesis images include a plurality of 3D image slices, a slice number indicating the number of a 3D image slice currently displayed in the screen image 600 from among the plurality of 3D image slices may be displayed in the screen image 600. Also, the lesion score of the corresponding 3D image slice may be displayed together in the screen image 600.", Paragraph [0112]),
a tool for the user to designate one of the slice images is displayed on the screen (Figure 7; "FIG. 7 is a diagram illustrating an example of functions of a slice navigation tool according to an embodiment.", Paragraph [0116]; "The 3D tomosynthesis images include a plurality of 3D image slices, and a slice navigation tool 700 may be used to move to a 3D image slice desired by a user.", Paragraph [0117]), and
the processing circuitry is configured to perform display of a slice image together with the screen, the slice image being designated by the user with the tool ("The second program may perform navigation for 3D tomosynthesis images in the depth-wise direction through the slice navigation tool 700. The second program may display any one 3D image slice from among the plurality of 3D image slices based on a user input to the slice navigation tool 700.", Paragraph [0118]).
Claim 4
Regarding claim 4, dependent on claim 1, JANG teaches the invention as claimed in claim 1.
JANG further teaches wherein the processing circuitry is configured to cause the terminal to display the screen in the display mode combining the analysis results of algorithms selected by the user among the algorithms (Rejected as applied to claim 3), where the lesion score in Figure 7 is a result of the AI analysis algorithms.
Claim 9
Regarding claim 9, dependent on claim 1, JANG teaches the invention as claimed in claim 1.
JANG further teaches wherein the medical image is a two-dimensional image (Rejected as applied to claim 1), where the medical image can be 2D or a 3D image, and
the processing circuitry is configured to cause the terminal to display on the screen, a range to which attention needs to be paid in the two-dimensional image, based on the analysis result of each of the algorithms (Rejected as applied to claim 1), where the analysis can be projected onto a 2D image to be displayed by the user's device.
Claim 10, an independent system claim, is rejected for the same reasons as applied to claim 1.
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 (i.e., changing from AIA to pre-AIA ) 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 5 – 8 are rejected under 35 U.S.C. 103 as being unpatentable over US Publication No. 2024/0249407 A1 to JANG et al. (hereinafter JANG).
Claim 5
Regarding claim 5, dependent on claim 1, JANG teaches the invention as claimed in claim 1.
JANG further teaches wherein the processing circuitry is configured to cause the terminal to display the screen representing any of an OR operation result, an AND operation result, and an XOR operation result as the display mode combining the analysis results of the algorithms.
Official notice is taken that low-level computer operations largely consist of these Boolean operations (i.e. OR, AND, and XOR operators) that would be executed in order for analysis functions to output a result. Consider https://en.wikipedia.org/wiki/List_of_x86_instructions (AND, OR, XOR part of original 8086 instruction set). Therefore, to output a result, to a user’s display device in this situation, the AI algorithms would have had to use one or multiple of these operators for the analysis. It 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 to have used machine learning algorithms in which Boolean algebra was used in order for the computer to function properly and output the analysis result like a lesion score or lesion markings, as described in paragraph [0037] of JANG.
Claim 6
Regarding claim 6, dependent on claim 2, JANG teaches the invention as claimed in claim 2.
JANG further teaches wherein the processing circuitry is configured to cause the terminal to display the screen in the display mode using a color according to a score representing the analysis result of each of the algorithms ("The lesion scores and lesions markings (e.g., contour or heatmap) acquired as a result of analyzing the 3D tomosynthesis images may be projected onto a guide image for effective visualization.", Paragraph [0037]), where it is obvious to one skilled in the art that the heat map results correlate to a color representing that respective score, more commonly referred to as a "color-coded grid".
It is recognized that the citations and evidence provided above are derived from potentially different embodiments of a single reference. Nevertheless, it 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 to employ combinations and sub-combinations of these complementary embodiments, because JANG teaches the use of heatmaps which are known to use color visualization to display analysis results.
Claim 7
Regarding claim 7, dependent on claim 2, JANG teaches the invention as claimed in claim 2.
JANG further teaches wherein the processing circuitry is configured to cause the terminal to display the screen in the display mode using a graph in which a body axis direction of a subject and a score representing the analysis result of each of the algorithms are associated (Rejected as applied to claim 2), where it would be obvious that the imaging device would be moving in a certain direction when capturing the image slices while producing an analysis result with respect to each image.
It is recognized that the citations and evidence provided above are derived from potentially different embodiments of a single reference. Nevertheless, it 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 to employ combinations and sub-combinations of these complementary embodiments, because JANG teaches the use of contour and heatmaps and it would have been obvious to project a heatmap graph with the included labeled axis’s, resulting from AI analysis, onto an image to be displayed to the user, as disclosed in paragraph [0037]).
Claim 8
Regarding claim 8, dependent on claim 2, JANG teaches the invention as claimed in claim 2.
JANG further teaches wherein the processing circuitry is configured to cause the terminal to display the screen in the display mode using a heat map in which a score representing the analysis result of a first algorithm among the algorithms and a score representing the analysis result of a second algorithm among the algorithms are associated (Rejected as applied to claim 6), where it would have been obvious to have the results represented by the vertical and horizontal axis of the contour or heat map, for example the lesion score and lesion marking results as disclosed in Paragraph [0037]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ronde Miller whose telephone number is (703) 756-5686 The examiner can normally be reached Monday-Friday 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Gregory Morse can be reached on (571) 272-3838. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RONDE LEE MILLER/Examiner, Art Unit 2663
/GREGORY A MORSE/Supervisory Patent Examiner, Art Unit 2698
1 Note that MPEP 2181(I)(a) identifies “circuitry” as normally referring to structure rather than being a means-plus-function limitation. The term is interpreted to have the same meaning as in the Mass. Inst. of Tech. v. Abacus Software cited in that section in lieu of being a means-plus-function limitation. Note that that decision states:
We conclude that Microsoft has not overcome the presumption that the “aesthetic correction circuitry” limitation is not a means-plus-function limitation.
Microsoft urges that “circuitry” should be limited to hardware whereas MIT urged below that it should include both hardware and software. We conclude that the term “aesthetic correction circuitry” is clearly limited to hardware.