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 claim 17, thus application has pending claims 1-16.
Response to Arguments
Applicant’s arguments, see Remarks pages 6-7 of 9, filed 10/23/2025, with respect to the rejection(s) of claim(s) 1-5, 7-9, and 11-16 under U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Krishna, in combination with Li, as detailed below.
As such, the action is made FINAL.
Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Objections
Claim 3 objected to because of the following informalities: “…wherein the first location with compression comprises an output of the deep learning network.” Clearer language would be, “…the first location with the compression…”. Appropriate correction is required.
Claim 16 objected to because of the following informalities: “…the plurality of IVUS image corresponding…”. The language should be “…the plurality of IVUS images corresponding…”. 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 1-2, 9, 11, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Shimin Li US-20200226422-A1, hereinafter Li, in further view of Krishna Rocha-Singh US-10881541-B1, hereinafter Krishna.
As per claim 1, Li discloses a system, comprising:a processor circuit configured for communication with an external imaging device, wherein the processor circuit is configured to (see Li ¶78-79 and FIG. 1, wherein a processor circuit in connection with the imaging device is disclosed):receive, from the external imaging device, an external image comprising a blood vessel within a patient (see Li ¶75-76, wherein images of lumens, such as arteries, i.e., blood vessels, are disclosed. Additionally, Li ¶74 discloses that the image can be external).
While Li discloses determining, using the external image, a first location along the blood vessel with a restriction in blood flow (see Li ¶100, wherein plaque, i.e., an anatomical structure, is classified, or determined, within the artery that is causing restriction. The plaque is within the patient and different from the artery, i.e., blood vessel. See also ¶74, wherein imaging a patient is disclosed), Li fails to explicitly disclose where Krishna teaches:determining, using the external image, a first location along the blood vessel with a restriction in blood flow, wherein the restriction comprises compression of the blood vessel from outside of the blood vessel at the first location by an anatomical structure outside of the blood vessel (see Krishna FIG. 1A, wherein the restriction of the iliac artery is pointed out in the venogram, and col. 5 lines 40-50, wherein the compression is caused by an overriding arterial segment);generate a first graphical representation associated with the restriction (see Krishna FIG. 1A, wherein an arrow, i.e., graphical representation, is shown at the location of the compression);provide, to a display in communication with the processor circuit, a screen display comprising:the external image (see Krishna FIG. 1A, wherein a venogram is shown); andthe first graphical representation at the first location along the blood vessel in the external image and configured to identify the compression (see Krishna col. 5 lines 36-38 and FIG. 1A, wherein the venogram shows the compression of the iliac vein from the overriding arterial segment. The venogram is displayed to the clinician for assessment as suggested by col. 9 lines 64-66).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify Li’s system by using Krishna’s teaching by modifying the restriction to be the compression in the blood vessel in order to determine if the constriction within a blood vessel is caused by an external anatomical structure.
As per claim 2, Li, in combination with Krishna discloses the system of claim 1, wherein the external imaging device comprises an x-ray imaging device, and wherein the external image comprises an x-ray image (see Li ¶80, wherein the imaging system includes x-ray images).
As per claim 9, Li, in combination with Krishna, discloses the system of claim 1, wherein the external image comprises a first image (see Li FIG. 5F, wherein an OCT external image is shown),wherein the processor circuit is configured to receive a second image comprising at least one of the blood vessel or the anatomical structure (see Li ¶100-102, wherein multiple images of the artery is disclosed), andwherein the processor circuit is configured to determine the first location with the compression using the first image and the second image (see Li ¶104, wherein the ROI of the calcium plaque is determined using the OCT images and the angiography images, wherein Krishna further discloses that the restriction comprises a compression (see Krishna col. 5 lines 40-50 and FIG. 1A, wherein the compression is caused by an overriding arterial segment)).
As per claim 11, Li, in combination with Krishna, discloses the system of claim 9, wherein the first image comprises an x-ray image (see Li ¶80, wherein the data collection system includes x-ray images),wherein the second image comprises an intravascular ultrasound (IVUS) image (see Li ¶80, wherein the data collection system includes IVUS images),wherein the processor circuit is configured for communication with an IVUS catheter (see Li ¶79 and ¶83 and FIG. 1, wherein the processor circuit is connected to the IVUS probe), wherein the processor circuit is configured to receive the IVUS image from the IVUS catheter (see Li ¶85-86, wherein data collection from the IVUS probe, i.e., receiving IVUS images, is disclosed).
As per claim 13, Li, in combination Krishna, discloses the system of claim 1, wherein the processor circuit is configured to:determine a stent recommendation to treat the compression based on at least one of the external image or the first location of the blood vessel with the compression (see Li ¶162, wherein a stent recommendation is determined for treating a lesion/stenosis by selecting a placement within an artery. See also ¶100, wherein stenosis is the indication of plaque constriction. Krishna further discloses that the restriction comprises a compression (see Krishna col. 5 lines 40-50 and FIG. 1A, wherein the compression is caused by an overriding arterial segment)); andprovide the stent recommendation to the display (see Li ¶206 and FIG. 13A, wherein the display of the stent planning is disclosed).
As per claim 14, Li, in combination with Krishna, discloses the system of claim 13, wherein the processor circuit is configured to:determine a stent landing zone at a second location of the blood vessel based on at least one of the stent recommendation, the external image, or the first location with the compression (see Li ¶163, wherein the stent landing zone, different from the stent location recommendation is selected based on the MLS frames, i.e., the image. See also ¶78 and ¶92. Krishna further discloses that the restriction comprises a compression (see Krishna col. 5 lines 40-50 and FIG. 1A, wherein the compression is caused by an overriding arterial segment));generate a second graphical representation of the stent landing zone (see Li ¶208 and FIG. 13B, wherein the planning of the stent landing zone is created); andprovide the second graphical representation at the second location along the blood vessel in the external image (see Li ¶208-212 and FIG. 13B, wherein the stent landing zone at the blood vessel location is displayed to an end user).
As per claim 15, Li, in combination with Krishna, discloses the system of claim 13, wherein the processor circuit is configured to:determine a stent strength position at a third location of the blood vessel based on at least one of the stent landing zone, the stent recommendation, the external image, or the first location with the compression (see Li ¶162-164, wherein the shortest stent that provides maximal flow as well as size and type, i.e., stent strength, in their optimal placement is disclosed. Krishna further discloses that the restriction comprises a compression (see Krishna col. 5 lines 40-50 and FIG. 1A, wherein the compression is caused by an overriding arterial segment));generate a third graphical representation of the stent strength position (see Li ¶166 and FIG. 4A, wherein graphical display of the arterial representation is shown. See also FIG. 13B); andprovide the third graphical representation at the third location along the blood vessel in the external image (see Li ¶163-166 and ¶206-211 and FIG. 13B, wherein the graphical representation is displayed to an end user of the locations).
As per claim 16, Li, in combination with Krishna, discloses the system of claim 1, wherein the processor circuit is configured for communication with an intravascular ultrasound (IVUS) catheter (see Li ¶83, wherein an IVUS probe is disclosed),wherein the processor circuit is configured to:receive a plurality of IVUS images along a length of the blood vessel from the IVUS catheter, co-register the plurality of IVUS images with the external image (see Li ¶89 and more specifically ¶104-105, wherein the IVUS images are input, or received, and the image data, both IVUS and OCT images, are co-registered with angiography data);identify an IVUS image of the plurality of IVUS images corresponding to the first location with the compression (see Li ¶100, wherein the location of blood vessel restriction and further ¶105, wherein the IVUS image data of the blood vessel is identified and annotated. Krishna further discloses that the restriction comprises a compression (see Krishna col. 5 lines 40-50 and FIG. 1A, wherein the compression is caused by an overriding arterial segment)); andprovide the IVUS images to the display (see Li ¶105, wherein the image data is displayed).
Claim 3-7 is rejected under 35 U.S.C. 103 as being unpatentable over Li, in combination with Krishna, in further view of Briand Donald Luizzi US-20200155013-A1, hereinafter Luizzi.
As per claim 3, while Li, in combination with Krishna, teach determining the first location of the blood vessel with the restriction using a deep learning network (see Li ¶106-108, wherein a convolutional neural network for classification and recognition of plaque within the artery is disclosed), it fails to explicitly disclose where Luizzi teaches:The system of claim 1, wherein, to determine the first location of the compression, the processor circuit is configured to provide the external image as an input to a deep learning network (see Luizzi ¶45-46, wherein the image data is given to a convolutional neural network for detection of the lumen border associated with veins, such as the iliac vein. Further, the image analysis can detect maximum and minimum area sites of veins for compression detection),wherein the first location with the compression comprises an output of the deep learning network (see Luizzi ¶73 and FIG. 5, wherein the vein model is generated corresponding based on the detected vein with the vascular disorder, such as compression as disclosed in ¶65).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify Li’s, in combination with Krishna, system by using Luizzi’s teaching by modifying the convolutional neural network to detect the location of the compression site in order to utilize machine learning to more quickly determine if the blood vessel is being compressed.
As per claim 4, Li, in combination with Krishna and Luizzi, discloses the system of claim 3, wherein the deep learning network comprises a convolutional neural network trained using a plurality of images with identified restrictions in blood flow caused by the compression of further blood vessels by further anatomical structures (see Li ¶110-111, wherein a training set of annotated and classified images for the MLS, which includes a neural network, is disclosed. These training sets includes the plaque constriction as disclosed in ¶100. See further ¶114, wherein the training phase of the MLS, which includes the classification of tissues, boundaries, regions, etc., is disclosed. See also ¶104 and FIGS. 3C and 5F).
As per claim 5, Li, in combination with Krishna and Luizzi, discloses the system of claim 3, wherein the output of the deep learning network comprises a classification of the first location with the compression as a first type of compression or a second type of compression (see Luizzi ¶35, wherein the identification of the May-Thurner Syndrome, i.e., second type of compression, from the images is disclosed. See further Luizzi ¶71-73, wherein the diagnosis of this disorder is done by the neural network).
As per claim 6, Li, in combination with Krishna and Luizzi, discloses the system of claim 5, wherein the anatomical structure comprises a ligament for the first type of compression such that the first location comprises the ligament compressing the blood vessel (since claim 5 discloses a first OR second type of restriction, only one need to be disclosed), andwherein the anatomical structure comprises a further blood vessel for the second type of compression such that the first location comprises a crossover by the further blood vessel compressing the blood vessel (see Luizzi ¶73, wherein the diagnosis of the vein model is associated with the cross-sectional area. See prior wherein the identification of the May-Thurner in this area is caused by the iliac artery compressing the iliac vein).
As per claim 7, Li, in combination with Krishna, discloses the system of claim 3, wherein the processor circuit is configured to segment anatomy within the image (see Li ¶97 and ¶108, wherein image segmentation of the body is disclosed. See more specifically ¶159, wherein an image of an artery is segmented).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Li, in combination with Krishna, in further view of Fergus MERRITT US-20220395333-A1, hereinafter MERRITT.
As per claim 10, Li, in combination with Krishna, fails to explicitly disclose where MERRITT teaches:The system of claim 9, wherein the first image comprises a first x-ray image obtained with contrast within the blood vessel, andwherein the second image comprises a second x-ray image obtained without contrast within the blood vessel (see MERRITT ¶69, wherein a first and second x-ray images, with and without contrast respectively, of the blood vessel are disclosed).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify Li’s, in combination with Krishna, system by using MERRITT’s teaching by including a no- and high-contrast image to the x-ray images in order to observe the blood vessel under the original and better imaging conditions.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Li, in combination with Krishna, in further view of Dr. Butros Venous Compression Syndrome NPL from the IDS dated 2/28/2023, hereinafter Butros.
As per claim 12, Li, in combination with Krishna, fails to explicitly disclose where Burtos teaches:
The system of claim 1, wherein the first graphical representation is color-coded on a severity of the compression (see Burtos page 7/11 and FIG. 6, wherein the DVT ultrasound identifies the compression. FIG 6(b) shows the absence of normal respiratory variation, suggestion compression).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify Li’s, in combination with Krishna, system by using Burtos’s teaching by including a color-coded severity to the compression in order to improve visualization on the area(s) most impacted by the compressions.
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