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 .
Application has pending claims 1, 3-4, 7, and 9-12. Claims 2, 5-6, and 8 are canceled.
Response to Arguments
Applicant’s arguments, see Remarks page 5, filed 6/23/2026, with respect to claims 1 and 11-12 have been fully considered and are persuasive. Therefore, the previous 112(b) rejections have been withdrawn. However, upon further consideration a new 112(b) rejection is made in view of the amendments.
Applicant's arguments, see Remarks pages 5-7, filed 6/23/2026, have been fully considered but they are not persuasive. Applicant contends that Chui does not disclose or suggest selecting a particular one of the projection images for shape classification of a calcification image, much less selected the projection image obtained at the irradiation position closest to the detector-facing position. Examiner would like to point out, as similarly stated in the Non-Final, filed 03/23/2026, that Chui is not relied upon for these limitations. NAKYAMA is relied upon for disclosing the irradiation position closest to the detector-facing position (see NAKAYAMA FIG. 1, wherein the breast is against the radiation detection device for calcification detection), and Majid is relied upon for the shape classification (see Majid ¶138 and ¶277, wherein the lesion’s morphological features classify it as benign or malignant). The reference of Chui is solely to clarify that the calcification in NAKAYAMA’s tomographic images, is its own calcification image.
In addition, the contention that Chui is directed towards recognizing objects is unpersuasive, as Majid is the reference that is relied upon for the shape type classification. Therefore, this action is made FINAL.
Claim Objections
Claims 1 and 9-12 are objected to because of the following informalities: “the calcification image”. It is disclosed in claims 1 and 11-12 that the calcification image is detected, so it would be clearer if the limitation of “a/the calcification image” is corrected to “the detected calcification image”. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: “a calcification image”. It has already been disclosed in claim 1, so it should be corrected to “the calcification image” to draw antecedence to the calcification image of claim 1.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 11-12 are rejected under 112(b) to because of the following informalities: “detect a position of a calcification image”. It is unclear if the position is being detected or if the detection is for both the calcification image and the position. If it is just the position being detected, then “the detected calcification image” should be corrected to “the calcification image”. Additionally, it is unclear as to what position is being detected. Appropriate correction is required.
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 1, 4, and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hiroki NAKAYAMA US-20160249868-A1, hereinafter NAKAYAMA, in further view of Haili CHUI US-20210100518-A1, hereinafter CHUI, Majid MAHROOGHY US-20210035296-A1, hereinafter Majid, and William Scott Daughton US-20180293728-A1, hereinafter Daughton.
As per claim 1, NAKAYAMA discloses an image processing apparatus comprising (see NAKAYAMA ¶44 and FIGS 1-3, wherein the radiography device that captures images is disclosed):at least one processor configured to:detect a position of a calcification based on a plurality of tomographic images generated by reconstructing a series of projection images obtained by irradiating a breast with radiations from a plurality of irradiation positions having different irradiation angles (see NAKAYAMA ¶82, wherein tomographic images are generated from a plurality of projection images captured with the radiation emitting unit at different positions P1 to Pn as shown in FIG. 3. The tomosynthesis imaging is performed to find the detected calcification as clarified in ¶116-120);generate a region-of-interest image by cutting out (see NAKAYAMA ¶119-122, wherein the calcification is detected and the mutation site, where the calcification or tumor is found by the part-of-interest detection unit from a radiographic image, is extracted, or cut out), from one projection image selected from the series of projection images (see NAKAYAMA ¶115-118, wherein a mutation site within a radiographic image is detected from a low resolution and narrow angle image used (selected) to find the calcification, amongst the plurality of radiographic images) and obtained at an irradiation position closest to a position facing a detection surface of a radiation detector (see NAKAYAMA FIG. 1, wherein the breast is closest to the detection device to detect the calcification), a region including the detected calcification image at the detected position (see NAKAYAMA ¶119, wherein the calcification has been detected as the mutation site).
While NAKAYAMA detects calcifications using tomographic images, it fails to explicitly disclose where CHUI teaches:
detect a position of a calcification image based on a plurality of tomographic images generated by reconstructing a series of projection images obtained by irradiating a breast with radiations from a plurality of irradiation positions having different irradiation angles (see CHUI ¶26, wherein Tr images, which are tomographic reconstructed images, are reconstructed from a plurality of tomographic projection images Tp. The incorporated reference U.S. Pat. No. 7,577,282, which is incorporated by reference in its entirety, clarifies in col. 11 lines 38-59 that the Tr images are taken at different angles, or positions, using the x-ray imager. Further in CHUI ¶51-52 and FIG. 3, the detected calcifications from the Tr images are put into one synthesized image, i.e., a detected calcification image).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify NAKAYAMA’s apparatus by using CHUI’s teaching by including a calcification image to the calcification detection in order to further hone in on the calcification within the plurality of tomographic images.
However, NAKAYAMA, in combination with CHUI, fails to explicitly disclose where Majid discloses:classify a type of a shape of the detected calcification image included in the generated region-of-interest image into classes by inputting the generated region-of-interest image into a machine-learned model that has been trained to classify the type of the shape of the calcification image using a plurality of sample images (see Majid ¶138 and FIG. 3A, wherein the margin boundary comprises morphologic features, such as lesion shape, i.e., calcification, are classified using a classifier model, which is a machine learning model as disclosed in ¶89-90. Such morphologies comprise "smooth edges," "irregular and/or rough edges," and "those which may be predominantly round or ellipsoid, or any other shape which a lesion in a tissue may reasonably take.” Finally, see ¶277, wherein the lesion is classified as benign or malignant);
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify NAKAYAMA’s, in combination with CHUI, apparatus by using Majid’s teaching by including a machine-learned model to the calcification image in order to more rapidly classify a calcification image by using a machine learning model.
However, NAKAYAMA, in combination with CHUI and Majid, fails to explicitly disclose where Daughton discloses:display a classification result of the type of the shape of the calcification image on a display device (see Daughton ¶140, wherein the shape of each calcification in a cluster is disclosed. See further ¶142, wherein a cancer score is based on the classified clusters of calcifications and then displayed).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify NAKAYAMA’s, in combination with CHUI and Majid, apparatus by using Daughton’s teaching by including a display to the classification result in order to have the user to see and know the type of shape related to the image.
As per claim 4, NAKAYAMA, in combination with CHUI, Majid, and Zhang, discloses the image processing apparatus according to claim 1, wherein the detected calcification image of which is a calcification image having a signal value is equal to or smaller than a certain value (see NAKAYAMA ¶66, wherein a first size threshold is disclosed. See further NAKAYAMA ¶115, wherein the part-of-interest detection unit selects the mutation site where size detection is a first size, which can be equal to or less than 10 pixels in the radiographic image with the mutation site. The combination of CHUI discloses a calcification image which focuses on the calcification).
As per claim 10, NAKAYAMA, in combination with Majid and Daughton, discloses the image processing apparatus according to claim 1, wherein the processor is configured to determine whether the calcification image represents benignancy or malignancy, or determine a degree of malignancy represented by the calcification image, based on the classification result (see Majid ¶144, wherein the algorithm is able to determine if the mass is benign or malign in the ROI image. See also ¶258-261, ¶369, and FIGS. 13-16. See also ¶234, which in the principal component analysis (PCA), which contains a processor, in capable of this decision).
As per claims 11-12, the rationale provided in claim 1 is incorporated herein. In addition, NAKAYAMA discloses a non-transitory computer-readable storage medium (see NAKAYAMA ¶30, wherein a storage medium is disclosed) as per claim 12.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over NAKAYAMA, in combination with CHUI, Majid, and Daughton, in further view of Hiroshi Hashimoto US-20170200267-A1, hereinafter Hashimoto.
As per claim 3, NAKAYAMA, in combination with CHUI, Majid, and Daughton, fails to explicitly disclose where Hashimoto teaches:The image processing apparatus according to claim 2, wherein the processor is configured to individually generate the region-of-interest image for each of a plurality of the calcification images in a case where the plurality of calcification images are detected (see Hashimoto ¶49-54 and FIG. 4, wherein the calcification image is acquired and then the microcalcifications in the calcification image are grouped into candidate regions. See ¶69, wherein a plurality of images is disclosed for the microcalcification candidate detection processing).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify NAKAYAMA’s, in combination with CHUI, Majid, and Daughton, apparatus by using Hashimoto’s teaching by generating region-of-interest images to the calcification images in order to segment the calcification images to the areas wherein the calcification is detected.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over NAKAYAMA, in combination with CHUI, Majid, and Daughton, in further view of XIANG-CHUN YU CN-111680687-A, hereinafter YU.
As per claim 7, NAKAYAMA, in combination with CHUI, Majid, and Daughton, fails to disclose where YU teaches: The image processing apparatus according to claim 1, wherein the processor is configured to classify a type of the shape of the detected calcification image included in the region-of-interest image after performing noise removal processing or resolution enhancement processing, or both the noise removal processing and the resolution enhancement processing, on the generated region-of-interest image (see YU page 4/18 step S1, wherein the breast image is denoised to improve the image quality. See further page 5/18 step S4, wherein the ROI is classified to be normal or abnormal based on the calcification information, size and texture, as disclosed on page 2/18).
While YU does not explicitly disclose a generated region-of-interest image, it would have been obvious to use the generated region-of-interest image from NAKAYAMA in its place for noise removal, as NAKAYAMA’s region-of-interest image is used for calcification detection. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify NAKAYAMA’s, in combination with CHUI, Majid, and Daughton, apparatus by using YU’s teaching by including noise removal to the calcification image in order to obtain a clearer image so as to improve the detection results.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over NAKAYAMA, in combination with CHUI, Majid, and Daughton, in further view of Dong-xu HAN CN-113808101-A, hereinafter HAN.
As per claim 9, NAKAYAMA, in combination with CHUI, Majid, and Daughton, fails to disclose where HAN teaches:The image processing apparatus according to claim 1, wherein the processor is configured to highlight and display the calcification image having a specific shape based on the classification result (see HAN page 6/21, wherein the calcification point boundary shape is calculated. See further HAN page 7/21 and FIGS. 3-4, wherein the calcification areas are displayed as brighter regions, as shown in FIG. 4, or with a box around them, as shown in FIG. 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify NAKAYAMA’s, in combination with CHUI, Majid, and Daughton, apparatus by using HAN’s teaching by including a highlight and display to the shape determination result in order to more easily identify the calcification in the image.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradley Obas Felix whose telephone number is (703)756-1314. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vincent Rudolph can be reached at 5712728243. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY O FELIX/Examiner, Art Unit 2671
/VINCENT RUDOLPH/Supervisory Patent Examiner, Art Unit 2671
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