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 .
Response to Amendment
The amendment and written response filed 06/27/2025 have been entered and considered. Claims 1 and 12 have been amended.
Claim 20 has been withdrawn from consideration.
Claims 7, 10 and 12 have been cancelled.
Claims 1-6, 8-9, 11 and 13-21 are pending.
Response to Arguments
Applicant’s arguments, see remarks, filed 06/27/2025, with respect to the rejection of claims 1 and 21 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 Therefore, the rejection has been withdrawn.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 Cai, Olender and Gopinath et al (“Gopinath” hereinafter, U.S. Publication No. 2016/0171711 A1).
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 1-6, 8-9, 11 and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Cai et al (U.S. Publication No. 2015/0073279 A1) in view of Olender et al (“Olender” hereinafter, U.S. Publication No. 2020/0359911 A1) and further in view of Gopinath et al (“Gopinath” hereinafter, U.S. Publication No. 2016/0171711 A1).
As per claim 1, Cai discloses a method for processing intravascular ultrasound images (abstract: “A method for real-time displaying of cross-sectional images during an intravascular ultrasound (IVUS) imaging procedure”), the method comprising: collecting one or more ultrasound image of a blood vessel, wherein each of the one or more ultrasound images depict a wall of the blood vessel (figure 9: numeral 902: obtaining a set of cross-sectional IVUS images; paragraph [0034]: “the one more transducers 312 may be used to form an image of the walls of the blood vessel and tissue surrounding the blood vessel”); segmenting the ultrasound images with a processor (figure 1: processor 106 is used to estimate borders); and wherein segmenting includes identifying one or more of a lumen border of the blood vessel and media border for media within the blood vessel (paragraph [0065]: “a lumen border 612, obtained using a lumen border estimation algorithm, for one or more of the cross-sectional images 602 and 604. The border 612 may be determined by any suitable automated border estimation method or algorithm”; paragraph [0066]: “the external elastin media (EEM) border 613, can be determined using any suitable method”), displaying a first image of the one or more ultrasound image on a display device (figure 6); wherein the first image depicts the wall of the blood vessel (paragraph [0073] & figure 8A-8B).
However, Cai does not explicitly teach “the processor includes a deep neural network” and “displaying a visual representation of a calcification angle, calcium arc, or both on the display device”.
Olender teaches a wall area delineation (WAR) procedure: defining wall area using a lumen and outer border detection algorithm, and 2) automatic characterization of the WAR, e.g. using a convolutional neural network (CNN) algorithm (paragraph [0044]). Additionally, Olender teaches “displaying a visual representation of a calcification angle, calcium arc, or both on the display device (The region of the calcified issue in the last image of figure 23 is to be a thin band as described in paragraph [0115] (“when thin bands of calcified tissues were present”), and such thin band inside an arterial wall is to be an arc with an angle).
Cai and Oldender are combinable because they are from the same area of endeavor, ie. vessel imaging.
At the time of the invention, it would have been obvious to a person of ordinary skill in the art to modify Cai in light of Oldender’s neural network for identifying/segmenting borders in a vessel image. One would be motivated to do so because the deployment of neural network would greatly increase the accuracy and efficiency of image segmentation in the area of medical imaging.
However, Cai and Oldender does not explicitly teach the feature of “wherein the visual representation of the calcification angle, calcium arc or both is disposed on the first image radially outward of the lumen border and radially outward from a wall of the blood vessel on the first image”.
Gopinath in paragraph [0088] teaches visual representation of a calcified region with outer 1366 and inner 1368 boundaries in figure 13 as well as circumferential markers as shown in figure 12. The examiner notes such visual representation is radially outward of the lumen border and radially outward from a wall of the blood vessel on images as shown in figures 12 and 13.
Cai, Oldender and Gopinath are combinable because they are from the same area of endeavor, ie. vessel imaging.
At the time of the invention, it would have been obvious to a person of ordinary skill in the art to modify the combination of Cai and Oldender in light Gopinath’s teaching to visually depict the lumen walls and calcium inside a ring. One would be motivated to do so because it would allow the viewers to more easily identify the lumen walls and calcium in an image.
As per claim 2, the combination of Cai, Oldender and Gopinath teaches wherein segmenting includes identifying the lumen border (figure 6, paragraph [0059]-[0066]).
As per claim 3, the combination of Cai, Oldender and Gopinath teaches wherein segmenting includes identifying the media border (figure 6, paragraph [0066]: “the external elastin media (EEM) border 613 can be determined using any suitable method and displayed”).
As per claim 4, the combination of Cai, Oldender and and Gopinath teaches wherein the deep neural network is trained to identify the lumen border (as explained above, Oldender teaches the user of CNN for border detection).
As per claim 5, the combination of Cai, Oldender and and Gopinath teaches wherein the deep neural network is trained to identify the media border (as explained above, Oldender teaches the user of CNN for border detection).
As per claim 6, the combination of Cai, Oldender and and Gopinath teaches wherein the deep neural network is trained to identify the lumen border and is trained to identify the media border (as explained above, Oldender teaches the user of CNN for border detection).
As per claim 8, the combination of Cai, Oldender and and Gopinath teaches displaying a numerical indication of stenosis area for the first image on the display device (figure 6 and paragraph [0067] for “area stenosis” and “plaque burden”).
As per claim 9, the combination of Cai, Oldender and and Gopinath teaches displaying a numerical indication of plaque burden for the first image on the display device (paragraph [0067]).
As per claim 11, the combination of Cai, Oldender and and Gopinath teaches wherein the visual representation of the calcification angle includes an arc disposed along a boundary region of the first image (Oldender: figure 23, paragraph [0034]).
As per claim 13, the combination of Cai, Oldender and and Gopinath teaches wherein the visual representation of the calcification are includes an arc disposed along a boundary region of the first image (Oldender: figure 23, paragraph [34]).
As per claim 14, the combination of Cai, Oldender and and Gopinath teaches wherein segmenting includes identifying a cross- sectional area of the blood vessel, a cross-sectional area of the media, a calcification angle of a calcified lesion within the blood vessel, a side branch location, or combinations thereof (see figure 6 in Cai or figure 23 in Oldender).
As per claim 15, the combination of Cai, Oldender and and Gopinath teaches wherein segmenting includes identifying a calcification angle of a calcified lesion within the blood vessel (figure 23 in Oldender).
As per claim 16, the combination of Cai, Oldender and and Gopinath teaches displaying a visual representation of a calcification angle (see figure 23 in Oldender).
As per claim 17, the combination of Cai, Oldender and and Gopinath teaches wherein the visual representation of the calcification angle includes an arc disposed along a boundary region of the first cross-sectional image (see figure 23 in Oldender).
As per claim 18, the combination of Cai, Oldender and and Gopinath teaches displaying a visual representation of a calcification arc (see figure 23 in Oldender).
As per claim 19, the combination of Cai, Oldender and and Gopinath teaches wherein the visual representation of the calcification angle includes an arc disposed along a boundary region of the first cross-sectional image (see figure 23 in Oldender).
As per claim 21, see explanation in claim 1.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 TOM Y LU whose telephone number is (571)272-7393. The examiner can normally be reached Monday - Friday, 9AM - 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Matthew Bella can be reached at (571) 272 - 7778. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TOM Y LU/Primary Examiner, Art Unit 2667