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 .
Applicant has canceled claims 2, 5-6, and 8. Thus claims 1, 3-4, 7, and 9-12 are pending.
Response to Arguments
Applicant’s arguments, see Remarks page 6, filed 12/29/2025, with respect to the rejection of amended claim independent claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of CHUI, in combination with NAKYAMA, Majid, and Daughton.
Applicant's arguments filed 12/29/2025, with respects to the teaching of NAKAYAMA, have been fully considered but they are not persuasive. Examiner respectfully disagrees that NAKAYAMA does not detect calcifications from tomographic images. As discussed in NAKAYAMA ¶116-120, tomosynthesis imaging is performed to find the detected calcification. As per the generation of the region of interest, while NAKAYAMA uses a part-of-interest unit to acquire the calcification, the region of interest generation step is clarified with the new rejection of CHUI as further detailed below. In addition, NAKAYAMA was not used for the disclosure of classifying calcification shape types. This limitation was instead disclosed by Majid in ¶138, wherein different morphologies, or shapes, are classified as smooth, irregular, ellipsoid, or so on. The morphologies of the margin boundaries are used to indicate if the lesion, or calcification, is cancerous/malignant, or benign as stated in ¶277.
Applicant's arguments filed 12/29/2025, with respects to the teaching of Majid, have been fully considered but they are not persuasive. Applicant argues that Majid does not handle x-ray tomosynthesis, reconstructed tomographic images, or calcification detection. Examiner would like to point out that Majid was used for neither of these teachings, as these limitations were disclosed by NAKAYAMA in ¶82, wherein reconstructed tomographic images are generated from a plurality of projection images captured with the radiation emitting unit, such as an x-ray defined in ¶44. Instead, Majid was used for the teaching of the classification of the shape type of a calcification. Additionally, Applicant argues that Majid does not perform, nor does it suggest, classification of the shape type itself as the classification target, as in the amended claims, which specify classifying calcification shape types into a plurality of classes. According the broadest reasonable interpretation, Majid does disclose a type of shape classification, as a lesion is classified as benign or malignant depending on the morphologies, or shape, of its margin boundary as disclosed in Majid ¶138 and ¶277.
Applicant’s arguments with respect to claims 2 and 4 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The limitations of claim 2, now incorporated into the amended independent claims 1 and 11-12, are taught by the new reference of CHUI, in combination with NAKAYAMA as detailed further below. Based on these facts, this action is made Non-Final.
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 recites the limitation “…including the detected calcification image from a projection image,” in pages 2-4 of the amended claims. However, in the new limitations of claims 1 and 11-12, “a series of projection images” has already been defined. In addition, the “calcification image,” as per the amended claims 1 and 11-12, state that it is based on a “tomographic image”. It is unclear whether the “detected calcification image” is from a new projection image, a projection image in the series of projection images, or a reconstructed tomographic image.
Additionally, claim 1 and 11-12 also recites the limitation “…obtained by irradiating a breast with radiations and imaging the breast” in pages 2-4 of the amended claims. However, in the new limitations of claims 1 and 11-12, a calcification image is detected by “reconstructing a series of projection images obtained by irradiating a breast with radiations.” It is unclear whether the breast of the generation step is the same as the breast of the detection step. For the purposes of examination, the Examiner will interpret these to be the same breast.
Lastly, claim 1 and 11-12 also recites the limitation “classify a type of a shape of a calcification image…” in pages 2-4 of the amended claims. However, it is unclear if this is a new calcification image or the detect calcification image. For purposes of examination, the Examiner is interpreting this to be the detect calcification image. Since the limitation recites “the detect calcification image,” the dependent claims of 4, 7, 9-10 should be corrected to recite similar language.
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 calcification 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 a region including the detected calcification 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. See also FIG. 1, wherein the breast is closest to the detection device), among a series of projection images obtained by irradiating a breast with radiations and imaging the breast (see NAKAYAMA ¶44-47, wherein several images of the radiation position of the breast is disclosed. See also NAKAYAMA ¶63, wherein the part-of-interest detection unit and the processor are disclosed. See further ¶66-67, wherein the part-of-interest detection unit acquires the mutation from the radiographic image generated by the image processing unit. See also ¶74, wherein a radiographic image is referred to as a projection image).
While NAKAYAMA detects calcifications using tomographic images, it fails to explicitly disclose where CHUI teaches:
detect 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 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);generate a region-of-interest image by cutting out a region including the detected calcification image from a projection image (see CHUI ¶43-44 and ¶50, wherein the regions including the object of interest, which includes calcifications, are recognized and stored, or extracted from the background, then added onto the synthesized calcification image as disclosed in ¶51-52 and 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 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 a calcification image included in the region-of-interest image into classes by inputting the 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 2, wherein the processor is configured to detect only the calcification image of which 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. 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 the type of the shape of the calcification image after performing noise removal processing or resolution enhancement processing, or both the noise removal processing and the resolution enhancement processing on the 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).
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
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