CTFR 18/990,890 CTFR 80687 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Response to Arguments 07-37 AIA Applicant's arguments filed 2/26/2026 have been fully considered but they are not persuasive. Applicant argues that the 112(b) rejection was not on “claim breadth” instead of “claim indefiniteness”. The language in claims 1, 12, and 20 recites “performing scan planning…based on size of the mammary gland” and “performing scan imaging…based on the scan planning”. With respect to the relationship between "scan planning" and the size of the mammary gland, it is not clear from the claim language how the "scan planning" is dependent on the size of the mammary gland from the claim language . As pointed out previously, Paragraph [0111] discloses the number of scans dependent on the size of the mammary gland. Therefore, the scan planning (which may involve number of scans as recited in claim 8) is dependent on the size of the mammary gland where a single scan is required for smaller mammary gland dimension and a more than one scan is required for larger mammary gland sizes. Dependent claims 5 and 16 are directed to recognizing the mammary gland edge and obtaining the size of the mammary gland based on the outer edge and claims 8 and 19 are directed to the scan planning which may include number of scans, scanning position and scanning stroke. Claim 11 recites “single scan” and “multi-scan” but no clear connection between the “single or multi-scan” and the size of the mammary gland, where smaller mammary gland size results in the single-scan and larger mammary gland size results in the “multi-scan” (as set forth in the specification). Therefore, none of the claims provide any clarity with respect to the how the scan planning (such as in claims 8, 11, and 19) is based on or is dependent on the size of the mammary glands (as in claims 5 and 16). Additionally, independent claim 20 does not provide any further clarifying claims with respect to the steps of scan planning and the steps of determining the size of the mammary glands. The “scan planning” steps based on “size of mammary gland” is the critical claim element of claims 1, 12, and 20 but the claim language does not clarify how the planning is dependent on the size of the mammary gland. For these reasons, the claim language is considered indefinite and the rejection is not based on “claim breadth”. It was suggested in the previous office action and the Interview Summary to provide further clarification to the language in claims 1, 12, and 20 with respect to the “scan planning” and how this step is executed as per the size of the mammary glands as the claims do not recite any clear relationship or dependency between the size of the mammary glands and the execution of the scan planning. The 112(b) rejection is maintained below. With respect to the Lalena reference which teaches adjusting of operating parameters or "scan planning" with respect to breast size, density and other features [0081], which parameters to use based on breast density value [0084], and adjust exposure parameters until satisfactory results are obtained [0083]. “Analysis of image content for the first or first several frames, using this information to determine parameters for the entire scan. After acquiring this image data, the system can determine the best parameters to use for the scan . The probe can acquire a number of frames while stationary at an initial position, before moving. These frames can then be analyzed to set parameters before further probe movement” [0080]. “A pre scan image could be displayed to the operator who can then adjust exposure parameters until satisfactory results are obtained”[0083]. Lalena teaches of obtaining the initial measurements of the patient in a B-mode and the region of interest in displayed and then this followed by dynamic imaging mode to track tissue over time [0048, 0054] using B-mode probe for initial scan [0092] and then followed by the separate secondary mode scan [0092, 0110]. Therefore, the reference teaches of adjusting operating parameters or execute scan planning based on breast size, density and other features as part of the pre-scan planning. This is all part of scan planning as it pertains to evaluating breast tissue and would therefore include the mammary glands as well. The Lalena reference teaches of breast size, density, and other features (which would necessarily include the mammary gland features as well) but does not explicitly teach of specifically mammary gland size and therefore the Koshino reference was used which is directed to scan planning based on determining size of GTC region relative to the mammary glands. Paragraphs [0171-0177] are directed to planning out a scan based on the mammary gland size and under broadest reasonable interpretation of the claim language, the combination of the references is directed to "scan planning" with respect to size of breast tissue which includes the mammary gland. The motivation to combine the references is based on the fact that the Koshino reference is specific to the mammary gland region to provide better diagnostics for cancer risk where the goal of the Lalena reference is also to improve image quality of the breast tissue (which would include the mammary gland region) with the goal for better diagnostics. Since the claim language does not clarify what is involved in the " scan planning" with respect to adjustment of scanning or operating parameters, duration, frequency relative to the size of the mammary gland , the combination of the references teaches the claim elements. The 103 rejection is therefore maintained and repeated below . Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 1-20 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. Claims 1, 12, and 20 recite the limitation, “performing scan planning on the scanning assembly based on the size of the mammary gland…performing scan imaging…based on the scan planning…”. The claims rely on the “based on” language with respect to the scan planning being dependent on the sized of the mammary gland and the scan imaging “based on” the scan planning. There is lack of clarity in the claims with respect to the “based on” language and specific parameters with respect to the size of the mammary gland that is relied upon to perform the desired type of scan planning and imaging. Upon review of the specification, “ scan planning corresponding to different sizes of mammary glands . As shown in FIG. 9 , in (a), the mammary gland size 910 is relatively small, and scan planning is a single scan ; that is, only one scan is performed in the range of a frame 920 . In (b), the mammary gland size 930 is relatively large compared with (a), and scan planning is two scans ; that is, one scan is performed in each of blocks 940 and 950 . Optionally, for an overlapping region of blocks 940 and 950 , the driving apparatus may drive the scanning probe not to scan in the overlapping region according to scan planning. In (c), the mammary gland size 960 is relatively the largest compared with (a) and (b), and scan planning is three scans ; that is, one scan is performed in each of blocks 970 , 980 and 990 . Optionally, for overlapping regions of blocks 970 , 980 and 990 , the driving apparatus may drive the scanning probe not to scan in the overlapping regions according to scan planning” [0111]. Therefore, in view of the above citation and figure 9, it is suggested claim language clarify the distinction between the sizes of the mammary glands resulting in the scan planning or the relationship between the different sizes of the mammary gland and the number of scans needed for the region of interest with respect to a single scan or multiple scans. The dependent claims do not provide additional clarity and therefore stand rejected under 112(b). Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim (s) 1, 3, 5-12, 14, and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lalena (2018/0055479) in view of Koshino (2023/0157662) . With respect to claims 1, 12, and 20, Lalena teaches of an ultrasound imaging system, method, and computer readable medium with computer program that includes the steps of pre-scanning the breast to generate a pre-scanned ultrasonic image of the breast [0079] in a first imaging mode received along sensing elements of a transducer probe and then the sensed data is analyzed and switching to a secondary imaging mode with the transducer probe at the same position [0012, 0013]. Lalena therefore teaches of performing scan planning on the scanning assembly in the first step or the pre-scan accounting for density of the breast and then performing scan imaging of the breast based on the pre-scan results [0079]. Lalena teaches of the scanning assembly or ABUS [0074, 0075] to include a frame or support 12 (fig. 7A), a scanning probe 26 and driving apparatus disposed in the frame and the driving apparatus driving the probe 26 to move within the frame to perform the ultrasonic scanning or where the probe 26 is mounted on the apparatus and a transport apparatus 30 moves probe 26 in a scanning direction [0076]. Lalena also teaches of the operator placing the scanning device over the anatomy and pressing a button or entering other instructions to start the exam and do horizontal and vertical sweeps or axial, sagittal and coronal scans [0074]. Lalena teaches of scan planning based on the size/density of the breast tissue [0078] but does not explicitly teach of scan planning based on the size of the mammary gland. In a related field of endeavor Koshino teaches of an ultrasound based breast imaging method and system for imaging the mammary gland region [0062, 0064, 0066, 0078, 0081]. Koshino teaches of detecting the breast region, detecting the mammary gland region [0112], based on brightness threshold value [0113] and the determine the number of occupied pixels of the mammary gland region in the ultrasound image [0115] and determining the size and shape of the mammary gland region M [0151, fig. 5, 6]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Koshino to modify Lalena to ensure better diagnostics such as estimating cancer risk of the mammary gland region with high accuracy [Koshino, 0156]. With respect to claims 3 and 14, Lalena in view of Koshino teaches of the use of probe 26 for performing pre-scanning or the scanning probe [Lalena, 0076, 0077, 0079] acquiring number of frames to monitor breast size, density, and other features [Lalena, 0079]. Lalena teaches of obtaining the initial measurements of the patient in a B-mode and the region of interest in displayed and then this followed by dynamic imaging mode to track tissue over time [0048, 0054] using B-mode probe for initial scan [0092] and then followed by the separate secondary mode scan [0092, 0110]. With respect to claims 5 and 16, Lalena does not teach of pre-scanning the mammary gland. Koshino teaches of obtaining the size of the mammary gland by recognizing the mammary gland in the image, determining an outer edge or boundary line of the mammary gland [0081] and teaches of performing edge detection [0090] and obtaining the size of the mammary gland on the basis of the outer edge of the mammary gland with the GTC region ratio of the GTC region R1 to the mammary gland region M [0092, 0112, 0113] or the number of occupied pixels of all the GTC regions R1 existing in the mammary gland region M to the number of pixels of the entire mammary gland M [0094, 0115]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Koshino to modify Lalena to ensure better diagnostics such as estimating cancer risk of the mammary gland region with high accuracy [Koshino, 0156]. With respect to claims 6, 7, 17, and 18, Lalena does not explicitly teach of determining the depth of the scan. Koshino teaches of the depth of the scan imaging is a maximum value among chest wall depths or where the depth range of the ultrasound image is adjusted such that the entire breast of the subject such as the deep portion between the skin and the pectoralis major muscle of the subject is fitted into the screen and therefore achieving maximum depth value [0110]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Koshino to modify Lalena to ensure that the image detects a deep region between the skin and the pectoralis major muscle as the breast region and provide more accurate diagnostics [Koshino, 0080]. With respect to claims 8 and 19, Lalena in view of Koshino teaches of the scan planning to comprise plurality of scan positions [Lalena, 0012, 0013]. With respect to claims 9 and 10, Lalena in view of Koshino teaches of displaying the scan planning on a display where the pre-scan image is displayed to the operator who can adjust parameters on-the-fly or monitoring a scanning process in real time during the scan imaging, matching the scanning process and the scan planning or analyzing frame to set parameters before probe movement, dynamically adjusting based on sensed results and displaying the results [Lalena, 0079]. With respect to claim 11, Lalena in view of Koshino teaches of performing multi-scan or multiple scans during planning so that the driving apparatus does not drive the scanning probe to scan overlapping region between the plurality of scans where the scans are along different positions along the scan path including horizontal and vertical sweeps or axial, sagittal, and coronal scans [Lalena, 0074] . 07-21-aia AIA Claim (s) 2, 4, 13, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lalena in view of Koshino (‘662) and further in view of Koshino (2024/0000436). The previous references do not explicitly teach of the acquiring ultrasonic data to include nipple edge of the breast and data extending outward along the nipple edge to an edge of the mammary gland. In a similar field of endeavor Koshino ‘436 teaches of obtaining ultrasound scanning from end part to the other end part of the breast of the subject along one direction in a front view or a method of scanning from a nipple to a peripheral or edge part of the breast and scan a range from end part to the other end part of the breast [0067]. Koshino ‘436 therefore teaches of acquiring ultrasonic data in a plurality of angular directions including data of nipple edge of the breast and data extending outward along the nipple edge to an edge of the mammary gland and being uniformly distributed in a circumferential direction or scanning from the nipple to the peripheral part including a case of radially scanning from the nipple toward the peripheral part or a case of scanning by drawing a circle around the nipple in one direction using the nipple as the center [0068]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Koshino ‘436 to modify the previous teachings to ensure the user can check that the breast has been sufficiently scanned [Koshino ‘436, 0022] . Conclusion 07-39 AIA 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 BAISAKHI ROY whose telephone number is (571)272-7139. The examiner can normally be reached Monday-Friday 7-3 EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at 571-272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. 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BR /BAISAKHI ROY/Primary Examiner, Art Unit 3797 Application/Control Number: 18/990,890 Page 2 Art Unit: 3797 Application/Control Number: 18/990,890 Page 3 Art Unit: 3797 Application/Control Number: 18/990,890 Page 4 Art Unit: 3797 Application/Control Number: 18/990,890 Page 6 Art Unit: 3797 Application/Control Number: 18/990,890 Page 7 Art Unit: 3797 Application/Control Number: 18/990,890 Page 8 Art Unit: 3797 Application/Control Number: 18/990,890 Page 9 Art Unit: 3797 Application/Control Number: 18/990,890 Page 10 Art Unit: 3797
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