DETAILED ACTION
1. The Office Action is in response to Application 19315694 filed on 09/01/2025. Claims 1-20 are pending.
Notice of Pre-AIA or AIA Status
2. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on 05/27/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 18505029 filed on 11/08/2023.
Priority # Filling Data Country
2021-100119 2021-06-16 JP
Claim Rejections - 35 USC § 112
5. 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.
6. Claim 3 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 pre-AIA the applicant regards as the invention.
For claim 3, it recites limitations of “the region” in “determine whether the medical image is an image that satisfies the determination criterion for the region included in the medical image”; However, it is not clear the region refers to which one since there are “the plurality of target regions: and also “a captured region” in independent claim 1.
Thus the scope of the claim is unclear.
7. Claim 9 is 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 pre-AIA the applicant regards as the invention.
For claim 9, it recites limitations of “a plurality of target regions” in “perform determination with respect to a plurality of target regions in a case where the medical image is captured using a white light source; and perform determination with respect to a selected target region among the plurality of target regions in a case where the medical image is captured using a light source that emits narrow-band light”; However, it is not clear “a plurality of target regions” is “the plurality of target regions” or “a plurality of target regions” in claim 2; are they the same or unrelated?
Thus the scope of the claim is unclear.
8. Claim 12 and its dependent claim 13 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 pre-AIA the applicant regards as the invention.
For claim 12, it recites limitations of “imaging with an endoscope for capturing the medical image” in “display, on the schematic diagram, a guide indicator for guiding imaging with an endoscope for capturing the medical image”; However, it is not clear who capture the image, the medical image processing apparatus (as in claim 1, A medical image processing apparatus comprising one or more processors, wherein the one or more processors are configured to: acquire a medical image of a subject) or an endoscope? What is the relationship between the medical image processing apparatus and the endoscope?
Thus the scope of the claim and its dependent claim 13 are unclear.
9. Claim 4 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 pre-AIA the applicant regards as the invention.
For claim 3, it recites limitations of “the information” in “maintain output of the information until all of the information indicating that the region is the captured region has been output”; However, it is not clear the information maintained refers to which information? Is it all the information indicating that the region is the captured region has been output? What is the difference between the information and all the information?
Thus the scope of the claim is unclear.
Claim Rejections - 35 USC § 102
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.
10. Claims 1-8, 10-11, 15-20 are rejected under 35 U.S.C. 102 (a) (2) as being anticipated by KIM et al. (US 20220207722).
Regarding claim 1, KIM teaches a medical image processing apparatus (fig. 2/fig. 7) comprising one or more processors (fig. 2, component 2000), wherein the one or more processors are configured to:
acquire a medical image (fig. 1, 1000, image acquisition device) of a subject (as shown in fig. 5, the human and the brain is a subject);
perform image recognition on the medical image using a trained model (as shown in fig. 7, training process P1000, the train neural network model and verify model are trained model);
based on a result of the image recognition, in response to a region included in the medical image satisfying a determination criterion, identify the region included in the medical image as a captured region (as shown in fig. 26, step S3753 and S3755; in which, target region is a captured region satisfying a determination criterion; paragraph 0630-0634, … mage quality determination process may include an operation of acquiring image segmentation information (S3751), an operation of acquiring a target region subject to quality determination (S3753), an operation of acquiring a morphological index of the target region (S3755), and an operation of comparing the morphological index of the target region to a reference value (S3757))… The operation of acquiring a target region subject to quality determination (S3753) may include specifying a target region subject to third image quality determination on the basis of the segmentation information);
and output information indicating that the region is the captured region with respect to a schematic diagram representing an organ. (as shown in fig. 26, step S3757; paragraph 0636… comparing the morphological index of the target region to a reference value (S3757) may include comparing the morphological index or the morphological value of the target region to a predetermined reference value. Here, the predetermined reference value may mean the average of the morphological values of the target region for a large number of ordinary people. The predetermined reference value may mean an index or measurement value related to the target region when medical information with a reliability above a certain level can be obtained upon disease determination based on the morphological index of the target region; the organ is shown in fig. 27, brain).
Regarding claim 19, KIM teaches a medical image processing method (fig. 26) executed by a medical image processing apparatus (fig. 2/fig. 7) including a processor (fig. 2, component 2000), the method comprising:
acquire a medical image (fig. 1, 1000, image acquisition device) of a subject (as shown in fig. 5, the human and the brain is a subject);
perform image recognition on the medical image using a trained model (as shown in fig. 7, training process P1000, the train neural network model and verify model are trained model);
based on a result of the image recognition, in response to a region included in the medical image satisfying a determination criterion, identify the region included in the medical image as a captured region (as shown in fig. 26, step S3753 and S3755; in which, target region is a captured region satisfying a determination criterion; paragraph 0630-0634, … mage quality determination process may include an operation of acquiring image segmentation information (S3751), an operation of acquiring a target region subject to quality determination (S3753), an operation of acquiring a morphological index of the target region (S3755), and an operation of comparing the morphological index of the target region to a reference value (S3757))… The operation of acquiring a target region subject to quality determination (S3753) may include specifying a target region subject to third image quality determination on the basis of the segmentation information);
and output information indicating that the region is the captured region with respect to a schematic diagram representing an organ. (as shown in fig. 26, step S3757; paragraph 0636… comparing the morphological index of the target region to a reference value (S3757) may include comparing the morphological index or the morphological value of the target region to a predetermined reference value. Here, the predetermined reference value may mean the average of the morphological values of the target region for a large number of ordinary people. The predetermined reference value may mean an index or measurement value related to the target region when medical information with a reliability above a certain level can be obtained upon disease determination based on the morphological index of the target region; the organ is shown in fig. 27, brain).
Regarding claim 20, KIM teaches a non-transitory computer-readable recording medium storing a program (paragraph 0282, …. The first controller 2030 may be implemented as a central processing unit (CPU) or the like with hardware, software, or a combination thereof) for causing a processor (fig. 2, component 2000)of a medical image processing apparatus (fig. 2/fig. 7) to execute a medical image processing method (fig. 26/fig. 28), the program causing the processor to perform:
acquire a medical image (fig. 1, 1000, image acquisition device) of a subject (as shown in fig. 5, the human and the brain is a subject);
perform image recognition on the medical image using a trained model (as shown in fig. 7, training process P1000, the train neural network model and verify model are trained model);
based on a result of the image recognition, in response to a region included in the medical image satisfying a determination criterion, identify the region included in the medical image as a captured region (as shown in fig. 26, step S3753 and S3755; in which, target region is a captured region satisfying a determination criterion; paragraph 0630-0634, … mage quality determination process may include an operation of acquiring image segmentation information (S3751), an operation of acquiring a target region subject to quality determination (S3753), an operation of acquiring a morphological index of the target region (S3755), and an operation of comparing the morphological index of the target region to a reference value (S3757))… The operation of acquiring a target region subject to quality determination (S3753) may include specifying a target region subject to third image quality determination on the basis of the segmentation information);
and output information indicating that the region is the captured region with respect to a schematic diagram representing an organ. (as shown in fig. 26, step S3757; paragraph 0636… comparing the morphological index of the target region to a reference value (S3757) may include comparing the morphological index or the morphological value of the target region to a predetermined reference value. Here, the predetermined reference value may mean the average of the morphological values of the target region for a large number of ordinary people. The predetermined reference value may mean an index or measurement value related to the target region when medical information with a reliability above a certain level can be obtained upon disease determination based on the morphological index of the target region; the organ is shown in fig. 27, brain).
Regarding claim 2, KIM teaches the limitations recited in claim 1 as discussed above. In addition, KIM further discloses that determine whether any one of a plurality of target regions to be captured is included in the acquired medical image (fig. 26, step S3751-S3755; in which, there are a plurality of target region after image segmentation and it determine whether one of them is included; paragraph 0439, …. The brain atlas may include a plurality of brain regions including a first brain region and a second brain region. The training device may use an image in which a first region corresponding to the first brain region and a second region corresponding to the second brain region are labeled and may train the neural network model to acquire the first region and the second region by using the image as an input).
Regarding claim 3, KIM teaches the limitations recited in claim 2 as discussed above. In addition, KIM further discloses that in response to any one of the plurality of target regions being determined to be included in the medical image, determine whether the medical image is an image that satisfies the determination criterion for the region included in the medical image (fig. 19, step 3500-3700; in which, 3500 determines any one of the plurality of target regions being determined to be included in the medical image and 3700 determine whether the medical image is an image that satisfies the determination criterion for the region included in the medical image ; paragraph 0579, …. the first image quality determination unit 3710 may determine image quality on the basis of metadata information, the second image quality determination unit 3730 may determine image quality on the basis of noise information, the third image quality determination unit 3750 may determine image quality on the basis of segmentation information obtained through anatomical segmentation, and the fourth image quality determination unit 3770 may determine image quality on the basis of the relationship between segmentation information obtained through anatomical segmentation and complex information, e.g., noise information).
Regarding claim 4, KIM teaches the limitations recited in claim 1 as discussed above. In addition, KIM further discloses that maintain output of the information until all of the information indicating that the region is the captured region has been output (fig. 21, S3713-S3717; in which, non-image information is all other kinds of the information indicating that the region; paragraph 0584, …. acquiring non-image information (S3713) may include acquiring medical image information from the medical image. The operation of acquiring non-image information (S3713) may include acquiring non-image information from the medical image. Here, the non-image information may include file structure information of the medical image or patient information input to the medical image).
Regarding claim 5, KIM teaches the limitations recited in claim 1 as discussed above. In addition, KIM further discloses that perform determination based on a different determination criterion respectively for each of a plurality of regions (as shown in fig. 20, there are different determination criterion respectively for each of a plurality of regions including 3710 (first) 3730 (second), 3750 (third) and 3770 (fourth) criterion).
Regarding claim 6, KIM teaches the limitations recited in claim 1 as discussed above. In addition, KIM further discloses that the determination criterion is based on a plurality of indices (fig. 26, S3757; paragraph 0630, comparing the morphological index of the target region to a reference value (S3757)).
Regarding claim 7, KIM teaches the limitations recited in claim 6 as discussed above. In addition, KIM further discloses that wherein the plurality of indices include at least one of out-of-focus/blurring determination, brightness determination, boundary visibility determination, cardia visibility determination, cardia distance determination, peristalsis determination, fold determination, treatment determination, or composition determination (paragraph 0333, … perform preprocessing such as alignment of the medical image, normalization of brightness or intensity of the medical image, and noise removal).
Regarding claim 8, KIM teaches the limitations recited in claim 1 as discussed above. In addition, KIM further discloses that perform determination using different trained models respectively for each of a plurality of regions included in the medical image (as shown in fig. 17, there are first neural network model and second neural network model and verify model for each of a plurality of regions included in the medical image).
Regarding claim 10, KIM teaches the limitations recited in claim 1 as discussed above. In addition, KIM further discloses that display, on the schematic diagram the information indicating the captured region at a position corresponding to the captured region (as shown in fig. 32-fig. 38).
Regarding claim 11, KIM teaches the limitations recited in claim 1 as discussed above. In addition, KIM further discloses that in response to the medical image being determined to be an image satisfying the determination criterion for the region included in the medical image, change a display mode of the information indicating that the region is the captured region (paragraph 1107-1108, … to change and output previously output morphological index-based information on the basis of the corrected morphological value or the corrected morphological index… morphological value or a morphological index computed according to a reference scan condition acquired from a user may be changed. Based on this change, the image analysis device 2000 may be implemented to modify and output a brain volume percentage graph G1 based on the changed morphological value or morphological index through the output module 2050).
Regarding claim 15, KIM teaches the limitations recited in claim 1 as discussed above. In addition, KIM further discloses that in response to the medical image being determined, with respect to all of a plurality of target regions, to be an image satisfying a respective determination criterion of each of the plurality of target regions (fig. 28), display information indicating that imaging of all of the plurality of target regions has been completed on a display (as shown in fig. 34, list of regions means that all of the plurality of target regions has been completed on a display).
Regarding claim 16, KIM teaches the limitations recited in claim 1 as discussed above. In addition, KIM further discloses that in response to the medical image being determined to be an image satisfying the determination criterion for the region included in the medical image, perform a storage process of storing the medical image in a memory (paragraph 0264, … medical images may be stored in a server or memory of the image analysis device 2000).
Regarding claim 17, KIM teaches the limitations recited in claim 1 as discussed above. In addition, KIM further discloses that wherein the region included in the medical image is selected from at least an esophagogastric junction, a lesser curvature J-turn immediately below a cardia, a greater curvature U-turn immediately below the cardia, a lesser curvature posterior wall J-turn from an angulus or a lower body part, a pyloric ring from a prepyloric region, and a greater curvature in the lower body part from above (paragraph 0262, … various embodiments disclosed in the present application may be applied to any suitable body part other than the brain (e.g., lung, breast, heart, joint, blood vessel, etc.); which includes at least an esophagogastric junction, a lesser curvature J-turn immediately below a cardia, a greater curvature U-turn immediately below the cardia, a lesser curvature posterior wall J-turn from an angulus or a lower body part, a pyloric ring from a prepyloric region, and a greater curvature in the lower body part from above).
Regarding claim 18, KIM teaches the limitations recited in claim 1 as discussed above. In addition, KIM further discloses that wherein the region included in the medical image is selected from at least a rectum, an anus, a splenic flexure, a hepatic flexure, a duodenal entrance, and an ileocecal region (paragraph 0262, … various embodiments disclosed in the present application may be applied to any suitable body part other than the brain (e.g., lung, breast, heart, joint, blood vessel, etc.); which includes at least a rectum, an anus, a splenic flexure, a hepatic flexure, a duodenal entrance, and an ileocecal region).
Claim Rejections - 35 USC § 103
11. 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 of this title, 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.
12. Claim 9, 14 are rejected are rejected under 35 U.S.C. 103 as being unpatentable over KIM et al. (US 20220207722) and in view of YANO (US 20140354788).
Regarding claim 9, KIM teaches the limitations recited in claim 1 as discussed above. In addition, KIM further discloses that perform determination with respect to a plurality of target regions (fig. 18, there are a plurality of target regions in the medical image) and perform determination with respect to a selected target region among the plurality of target regions (fig. 28, S3775-S3777, the ROI is a selected target region among the plurality of target regions).
It is noticed that KIM does not disclose explicitly of perform determination with respect to a plurality of target regions and perform determination with respect to a selected target region among the plurality of target region based on the light source is a white light source or a narrow-band light.
YANO discloses of perform determination with respect to a plurality of target regions in a case where the medical image is captured using a white light source (fig. 10, when in white light (as shown in fig. 9, component 60, white light source), a plurality of target regions is determined (all pixels); and perform determination with respect to a selected target region among the plurality of target region where the medical image is captured using a narrow-band light (as shown in fig. 10, when in narrow band light (as shown fig. 9, component 61, special light source) a selected target region among the plurality of target region is determined (every other lines)) .
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to incorporate the technology that perform determination with respect to a plurality of target regions and perform determination with respect to a selected target region among the plurality of target region based on the light source is a white light source or a narrow-band light as a modification to the apparatus for the benefit of that effectively processing image (paragraph 0088).
Regarding claim 14, KIM teaches the limitations recited in claim 1 as discussed above. In addition, KIM further discloses that display the schematic diagram in a first display mode and display the schematic diagram in a second display mode (paragraph 1107-1108, … to change and output previously output morphological index-based information on the basis of the corrected morphological value or the corrected morphological index… morphological value or a morphological index computed according to a reference scan condition acquired from a user may be changed. Based on this change, the image analysis device 2000 may be implemented to modify and output a brain volume percentage graph G1 based on the changed morphological value or morphological index through the output module 2050).
It is noticed that KIM does not disclose explicitly of display the schematic diagram in different mode based on the light source is a white light source or a narrow-band light.
YANO discloses of display the schematic diagram in different mode based on the light source is a white light source or a narrow-band light (fig. 10, when in white light (as shown in fig. 9, component 60, white light source), it is display in first mode (all pixels); and display in second mode where the medical image is captured using a narrow-band light (as shown in fig. 10, when in narrow band light (as shown fig. 9, component 61, special light source) a selected target region among the plurality of target region is determined (every other lines)) .
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to incorporate the technology that display the schematic diagram in different mode based on the light source is a white light source or a narrow-band light as a modification to the method for the benefit of that effectively processing image (paragraph 0088).
13. Claim 12 is rejected are rejected under 35 U.S.C. 103 as being unpatentable over KIM et al. (US 20220207722) and in view of Mikkaichi et al. (US 20070167967).
Regarding claim 12, KIM teaches the limitations recited in claim 1 as discussed above. In addition, KIM further discloses that display, on the schematic diagram, a guide indicator (fig. 37, the zoom in /out are guide indicator ).
It is noticed that KIM does not disclose explicitly of guiding imaging with an endoscope for capturing the medical image.
Mikkaichi discloses of guiding imaging with an endoscope for capturing the medical image (fig. 10, as shown in fig. 9, 61/60 are guide indicator; paragraph 0039, … the direction indicated by the indicator 61 (or indicator 60) is confirmed by checking an image of the endoscope 1, thereby making it possible to recognize an approximate direction of the target site with guidance to the image of the endoscope 1) .
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to incorporate the technology that guiding imaging with an endoscope for capturing the medical image as a modification to the apparatus for the benefit of that effectively and accurately acquire image (paragraph 0039).
15. Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See form 892.
16. Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZAIHAN JIANG whose telephone number is (571)272-1399. The examiner can normally be reached on flexible.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sath Perungavoor can be reached on (571)272-7455. The fax phone number for the organization where this application or proceeding is assigned is 571-270-0655.
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/ZAIHAN JIANG/Primary Examiner, Art Unit 2488
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