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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-15 in the reply filed on 11/06/2025 is acknowledged.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/07/2025 has been made record of and considered by the examiner.
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.
Claim 14 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 recites the limitation "the abnormal region and monitor regions" in lines 2 and 3. There is no previous recitation of “abnormal region and monitor regions” in preceding claims 12 or 1, therefore, there is insufficient antecedent basis for this limitation in the claim. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-3, 5-7, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Abdel-Nasser (‘Temporal mammogram image registration using optimized curvilinear coordinates’), in further view of Ferl (US 2023/0005140 A1).
Consider claim 1, Abdel-Nasser discloses a system for aligning and registering a medical image with a reference medical image, the system comprising at least one processor in communication with at least one memory device (Abstract; Temporal mammogram image registration using optimized curvilinear coordinates), wherein the at least one processor is programmed to:
a. receive the medical image and a reference image (3; “A dataset of 100 temporal mammogram pairs”; reference and current/template);
b. convert the medical image to a binary image (3.1 Step 3; “The intensity values of mammograms were scaled to the range [0, 255] and a threshold of 18 was used to convert each mammogram to binary image (mask).”);
c. isolate an area of interest within the medical image to produce an isolated image (3.1 Step 4; “Given the resulted binary mask of step 3, we removed 1/8 of the number of the rows from the top and bottom borders and 1/8 of the number of the columns from the left and the right sides; this reduces the black boundaries surrounding the breast region.”);
d. remove at least one portion of the isolated image containing at least one (3.1 Step 5; “To eliminate the pectoral muscle”);
e. flip or rotate the segmented image into alignment with the reference image to produce an aligned image (3.1 Step 4; Left/Right alignment; 3.3; “In order to align the template mammogram with the coordinates of the reference mammogram, both of them are mapped to the curvilinear coordinate system … The optimal reference points are fed to the curvilinear mapping to transform the template mammogram to the coordinates of the reference mammogram.”); and
f. register the aligned image to the reference image to produce an aligned and registered image (3.3. Inverse mapping and registration; FIG. 8; “Fig. 8. An example of mammogram images registration using the proposed approach, (a) the reference mammogram, (b) the current mammogram and (c) the registered mammogram.”).
Abdel-Nasser fails to specifically disclose: d. remove at least one portion of the isolated image containing at least one user-selected tissue type to produce a segmented image.
In related art, Ferl discloses: a. receive the medical image and a reference image (Ferl ¶59; input images 205);
b. convert the medical image to a binary image (Ferl ¶62; binary converter #220);
c. isolate an area of interest within the medical image to produce an isolated image (Ferl ¶59; “the input images 205 are images depicting ROIs, in which an image region depicting the biological structure including heart, lung, and tumor is cropped from an original input image”);
d. remove at least one portion of the isolated image containing at least one user-selected tissue type to produce a segmented image (Ferl ¶55; “The user interface can be used to label each of the set of 3D image objects … a user using the user device 130 may assign a tissue label (e.g., the tumor, the liver, the heart) to each image object”; ¶56; “The classification subsystem 112 may use the trained machine learning model to identify whether the structural characteristics of a particular image object correspond to pre-identified structural characteristics associated with particular biological structure”; ¶154; “the user interface 2000 can be used to scroll through an entire stack of a plurality of 2D portions rendered from the 3D training image.”; ¶89, 90 FIG. 7A-B; “By using the second image mask, the second image filter 725 can generate a second set of filtered images 740. For each of the second set of filtered images 740, different parts of the filtered image can be identified for removal”);
e. flip or rotate the segmented image into alignment with the reference image to produce an aligned image (Ferl ¶63, 99; “The image registration operation (e.g., rotation, scale, translation, shear) may include associating the binary images to a reference image, in order to align the binary images into a single spatial coordinate system”); and
f. register the aligned image to the reference image to produce an aligned and registered image (Ferl ¶98-102 image registration subsystem 910).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the tissue selection of Ferl into the image registration method of Abdel-Nasser to remove the pectoralis or another selected tissue type. As stated by Abdel-Nasser, “Several works … have reported that the suppression of pectoral muscle improves the registration results (Abdel-Nasser 4.2).” As further stated by Ferl, “By using the second image mask, the second image filter 725 can generate a second set of filtered images 740. For each of the second set of filtered images 740, different parts of the filtered image can be identified for removal (Ferl ¶68-69).” The filtered image can be used in lieu of the image to separate the image object from the plurality of image objects, for example, an image depicting a large unknown mass may obscure other features within the image that may be relevant for diagnosis of diseases (Ferl ¶4, 10). Additionally, in view of the user-labelling and user interface which scrolls through tissue portions, the combination yields a predictable result.
Consider claim 2, Abdel-Nasser, as modified by Ferl, discloses the claimed invention wherein the medical image is selected from a longitudinal series of medical images and the reference image comprises an initial medical image of the series (Abdel-Nasser Abstract; Ferl ¶59).
Consider claim 3, Abdel, as modified by Ferl, discloses the claimed invention wherein the medical image is selected from a dataset comprising a plurality of medical images obtained from a plurality of subjects and the reference image comprises a user-selected medical image from the dataset (Abdel-Nasser 1 Database; Ferl ¶99).
See MPEP 2144.04(III): “In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958) (Appellant argued that claims to a permanent mold casting apparatus for molding trunk pistons were allowable over the prior art because the claimed invention combined "old permanent-mold structures together with a timer and solenoid which automatically actuates the known pressure valve system to release the inner core after a predetermined time has elapsed." The court held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art.).”
Consider claim 5, Abdel-Nasser, as modified by Ferl, discloses the claimed invention wherein the medical image further comprises a craniocaudal view or a mediolateral oblique view (Abdel-Nasser 2.5, FIG. 5).
Consider claim 6, Abdel-Nasser, as modified by Ferl, discloses the claimed invention wherein the area of interest of the medical image comprises a portion of the medical image containing a breast region (Abdel-Nasser Abstract, FIGs. 1, 3).
Consider claim 7, Abdel-Nasser, as modified by Ferl, discloses the claimed invention wherein the area of interest is isolated by fitting a rectangle of minimal dimension around the breast region (Abdel-Nasser 3.1; Ferl ¶59, ¶110 definition of bounding box).
Consider claim 13, Abdel-Nasser, as modified by Ferl, discloses the claimed invention wherein the at least one processor is further programmed to:
a. identify an abnormal region within one medical image from the longitudinal series of medical images (Ferl ¶56, 59);
b. identify a monitor region for each medical image of the longitudinal series of medical images, wherein the monitor region of each medical image is matched to the abnormal region of the one medical image (Ferl ¶59, 151); and
c. display a series of monitor images to a user, the series of monitor images comprising the longitudinal series of medical images demarcated with each corresponding abnormal region or monitor region (Ferl ¶154, FIGs. 20A-C).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Abdel-Nasser, in view of Ferl, as applied to claims 1-3, 5-7, and 13 above, and further in view of Kreeger (US 2020/0054300 A1).
Consider claim 4, Abdel-Nasser, as modified by Kerl, fails to specifically disclose the claimed invention wherein the medical image is selected from a digital mammogram image and at least a portion of a digital 3D tomosynthesis image.
In related art, Kreeger discloses wherein the medical image is selected from a digital mammogram image and at least a portion of a digital 3D tomosynthesis image (Kreeger ¶36-37, 46, 75).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the combination of Kreeger into the registration method of Abdel-Nasser, as modified by Ferl, to display medical images with more information to aid in accurate diagnosis (Abdel-Nasser Conclusion; Kreeger ¶36-37, 46, 75).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Abdel-Nasser, in view of Ferl, as applied to claims 1-3, 5-7, and 13 above, and further in view of Lee (‘Automated mammographic breast density estimation using a fully convolutional network’).
Consider claim 8, Abdel-Nasser, as modified by Ferl, fails to specifically disclose wherein the at least one user-selected tissue type removed from the isolated image comprises soft tissues outside of the breast region within craniocaudal views, pectoral muscle tissue within mediolateral oblique views, and any combination thereof.
In related art, Lee discloses the claimed invention wherein the at least one user-selected tissue type removed from the isolated image comprises soft tissues outside of the breast region within craniocaudal views, pectoral muscle tissue within mediolateral oblique views, and any combination thereof (Lee 2B Establishing Ground Truth, FIG. 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the manual segmentation of Lee into the teachings of Abdel-Nasser, as modified by Ferl, to more accurately remove irrelevant tissue (Abdel-Nasser 3.1, 4.2; Lee 1).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Abdel-Nasser, in view of Ferl, as applied to claims 1-3, 5-7, and 13 above, and further in view of Sonka (Image processing, analysis and machine vision, Section 4.3 Local pre-processing).
Consider claim 10, Abdel Nasser, as modified by Ferl and Lee, discloses wherein the at least one processor is further programmed to automatically determine the pectoral muscle tissue by binarizing the medical image, applying a (Abdel-Nasser 3.1; Lee 2B).
While disclosing edge processing algorithms, Abdel-Nasser, as modified by Ferl and Lee, fails to specifically disclose applying a Canny algorithm to detect an edge.
In related art, Sonka discloses applying a Canny algorithm to detect an edge (4.3 Local Pre-processing; 4.3.5 Canny edge detection).
KSR Rationale E: Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the Canny detection algorithm of Sonka into the teachings of Abdel-Nasser as modified by Ferl and Lee, to detect edges in the image. A Canny edge detector is “obvious to try”- chosen from a finite number of identified, predictable solutions, with a reasonable expectation of success.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Abdel-Nasser, in view of Ferl, as applied to claims 1-3, 5-7, and 13 above, and further in view of Sanjay-Gopal (‘A regional registration technique for automated interval change analysis of breast lesions on mammograms’), further in view of Bediz (US 2016/0019690 A1).
Consider claim 11, Abdel-Nasser, as modified by Ferl, fail to specifically disclose the claimed invention wherein the at least one processor is further programmed to produce the aligned image by:
a. finding a width ratio between the segmented image and the reference image;
b. obtaining an alignment angle between a line along the top of the segmented image and a line connecting the top left corner and the largest horizontal (x) point of the breast tissue within the segmented image; and
c. rotating the segmented image to align the alignment angle with a corresponding alignment angle of the reference image.
In related art, Sanjay-Gopal discloses:
a. finding a width ratio between the segmented image and the reference image (Sanjay-Gopal II.A);
b. obtaining an alignment angle and the largest horizontal (x) point of the breast tissue within the segmented image (Sanjay-Gopal II.A, nipple as origin); and
c. rotating the segmented image to align the alignment angle with a corresponding alignment angle of the reference image (Sanjay-Gopal II.A; FIG. 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the scaling registration technique of Sanjay-Gopal into the registration method of Abdel-Nasser, as modified by Ferl, to accurately register the current and prior mammograms (Abdel-Nasser 2).
In related art, Bediz discloses:
b. obtaining an alignment angle between a line along the top of the segmented image and a line connecting the top left corner and the largest horizontal (x) point of the breast tissue within the segmented image (Bediz ¶5, 59 step 260 FIG. 2A); and
c. rotating the segmented image to align the alignment angle with a corresponding alignment angle of the reference image (Bediz ¶60 step 270 FIG. 2A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the alignment technique of Bediz into the registration method of Abdel-Nasser, as modified by Ferl and Sanjay-Gopal, to accurately register the current and prior mammograms (Abdel-Nasser 2).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Abdel-Nasser, in view of Ferl, as applied to claims 1-3, 5-7, and 13 above, and further in view of Sanjay-Gopal (‘A regional registration technique for automated interval change analysis of breast lesions on mammograms’).
Consider claim 12, Abdel-Nasser, as modified by Ferl, fails to specifically disclose the claimed invention wherein the at least one processor is further programmed to register the aligned image to the reference image by adjusting a ratio in image width pixelwise between the aligned image and the reference image.
In related art, Sanjay-Gopal discloses wherein the at least one processor is further programmed to register the aligned image to the reference image by adjusting a ratio in image width pixelwise between the aligned image and the reference image (II. A. Regional registration and mammogram correspondence, FIG. 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the scaling registration technique of Sanjay-Gopal into the registration method of Abdel-Nasser, as modified by Ferl, to accurately register the current and prior mammograms (Abdel-Nasser 2).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Abdel-Nasser, in view of Ferl and Sanjay-Gopal, as applied to claim 12 above, and further in view of Kreeger (US 2020/0054300 A1).
Consider claim 14, Abdel-Nasser, as modified by Kerl and Sanjay-Gopal, fails to specifically disclose the claimed invention wherein the at least one processor is further programmed to display magnified views of the abnormal region and monitor regions to the user.
In related art, Kreeger discloses displaying magnified views of the abnormal region and monitor regions to the user (Kreeger ¶50, FIG. 4, ¶68-71).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the magnification of selected ROIs of Kreeger into the registration method of Abdel-Nasser, as modified by Ferl and Sanjay-Gopal, to graphically communicate abnormality/regions to be monitored to the user (Ferl ¶149).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Abdel-Nasser, in view of Ferl, as applied to claims 1-3, 5-7, and 13 above, and further in view of Hartman (US 2007/0076938 A1).
Consider claim 15, Abdel-Nasser, as modified by Ferl, fails to specifically disclose:
a. identify text within the medical image; and
b. determine a view of the binary image based on the identified text, wherein the view is a craniocaudal view or a mediolateral oblique view.
In related art, Hartman discloses:
a. identify text within the medical image (Hartman ¶76, 78); and
b. determine a view of the binary image based on the identified text, wherein the view is a craniocaudal view or a mediolateral oblique view (Hartman ¶78, 81).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the automated orientation identification of Hartman into the registration method of Abdel-Nasser, as modified by Ferl, to more efficiently identify image orientation (Abdel-Nasser 3.1). For example, according to Hartman, “where the letters “R,” “C,” “C” or the set of letters “RCC” are identified, the film view is identified as the Right Cranial Caudal view (Hartman ¶78).”
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Abdel-Nasser, in view of Ferl, as applied to claims 1-3, 5-7, and 13 above, and further in view of Jiang (‘Predicting the onset of breast cancer using mammogram imaging data with irregular boundary’).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). See MPEP 2144.8, “When a single prior art reference which discloses a genus encompassing the claimed species or subgenus but does not expressly disclose the particular claimed species or subgenus, Office personnel should attempt to find additional prior art to show that the differences between the prior art primary reference and the claimed invention as a whole would have been obvious.”
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Consider claim 8, Abdel-Nasser, as modified by Ferl, discloses wherein the at least one user-selected tissue type removed from the isolated image comprises (Abdel-Nasser 3.1), and any combination thereof.
In related art, Jiang discloses wherein the at least one user-selected tissue type removed from the isolated image comprises soft tissues outside of the breast region within craniocaudal views (Jiang 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the removal procedures of Jiang into the teachings of Abdel-Nasser, as modified by Ferl, to denoise the image (Abdel-Nasser 3.1; Jiang 4).
Consider claim 9, Abdel-Nasser, as modified by Ferl and Jiang, discloses the claimed invention wherein the at least one processor is further programmed to automatically determine the soft tissues outside the breast region based on a union of discontinuities on a boundary of the breast area and deviations from a semi-circular shape, wherein the semicircular shape is selected to approximate the boundary of the breast area (Jiang 2.1, 2.2).
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Marias: ‘A Registration Framework for the Comparison of Mammogram Sequences.’
Basheer: ‘Pre-Processing Algorithms on Digital Mammograms.’
Handbook of Medical Image Processing: Chapter 8 Image Registration.
US 2010/0220905 A1 discloses an image diagnosis support apparatus, right and left breast image position corresponding method and program.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY HYTREK whose telephone number is (703)756-4562. The examiner can normally be reached M-F 9:00-5:00.
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/ASHLEY HYTREK/ Examiner, Art Unit 2665
/Stephen R Koziol/ Supervisory Patent Examiner, Art Unit 2665