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 .
Status of the Claims
Claims 1-20 were previously pending. Claims 14-16 have been amended. Claim 20 has been canceled. Claim 21 has been newly added. Thus claims 1-19, 21 are currently pending including independent claims 1, 18, 21.
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-19) in the reply filed on 09/27/2026 is acknowledged.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-5, 18-19, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duong (Luc Duong, Rui Liao, Hari Sundar, et al. "Curve-based 2D-3D registration of coronary vessels for image guided procedure", Proc. SPIE 7261, Medical Imaging 2009: Visualization, Image-Guided Procedures, and Modeling, 72610S (13 Mar 2009); https://doi.org/10.1117/12.811874).
Regarding claim 1, Duong discloses a method for image registration ([pg. 1, Abstract] register pre-operative volumetric data with intra-operative fluoroscopy for specific vessels occurring during the procedure), implemented on a computing device having at least one processor ([pg. 6, 3. Results, para. 1] The computation time is evaluated between 1.5 and 2.5 seconds on a Pentium M 2Ghz processor and includes visual display of intermediate registration results), the method comprising:
obtaining a first medical image and a second medical image of a target subject, the first medical image indicating blood vessels of the target subject, the second medical image indicating an interventional tool in the target subject ([pg. 2, 2.1 MSCT segmentation of the coronary arteries] the MSCT angiography is performed with a 64-slice MSCT scanner; [pg. 3, 2.2 2D-3D co-registration MSCT segmentation with 2D angiograms, para. 1-2] image-based navigation during PCI is provided using x-ray fluoroscopy…a short monoplane fluoroscopic sequence is acquired with either contrast agent injection or the presence of a radio opaque guide wire in one of the coronary branch);
determining an initial registration relationship between the first medical image and the second medical image ([pg. 3, 2.2 2D-3D co-registration MSCT segmentation with 2D angiograms, para. 1] MSCT volume is roughly aligned with respect to the fluoroscopic imaging system);
determining, based on a first physiological feature of the target subject at an acquisition time of the second medical image, a first motion state of the blood vessels at the acquisition time ([pg. 3, 2.2 2D-3D co-registration MSCT segmentation with 2D angiograms, para. 2] since ECG signal is recorded simultaneously with the fluoroscopic image acquisition, image frames from fluoroscopic sequence are automatically gated to match the acquisition cardiac phase of the MSCT volume (Fig. 3), corresponding acquisition cardiac phase from the MSCT volume is expressed using a percentage interval between two consecutives R-wave (R-R interval) from the QRS complex); and
determining a target registration relationship between the first medical image and the second medical image based on the initial registration relationship and the first motion state of the blood vessels (Fig. 3; [pg. 1, Abstract] this study incorporates automatic ECG gating for cardiac motion, respiratory motion is identified by rigid body registration of the vessels; [pg. 3, 2.2 2D-3D co-registration MSCT segmentation with 2D angiograms, para. 2] image frames from fluoroscopic sequence are automatically gated to match the acquisition cardiac phase of the MSCT volume (Fig. 3)…since cardiac motion is interleaved with the cycle of breathing motion pattern, the ECG-gated frames will contain only breathing motion with small and typically negligible vessel deformations).
Duong fails to explicitly disclose wherein the computing device has at least one storage device storing a set of instructions which is in communication with the processor.
However, It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine Duong with generic computer components including a storage device storing a set of instructions for the purpose of effectively implementing the method in an application setting such as during percutaneous coronary intervention procedures performed by cardiologists in clinical settings (See Duong: Abstract, 1. Introduction, 4. Conclusion).
Regarding claim 2, Duong discloses the method of claim 1 as applied above. Duong further discloses wherein the first medical image includes an angiography image collected before a surgery, and the second medical image includes a fluoroscopy image collected in the surgery ([pg. 2, 2.1 MSCT segmentation of the coronary arteries] the MSCT angiography is performed with a 64-slice MSCT scanner; [pg. 3, 2.2 2D-3D co-registration MSCT segmentation with 2D angiograms, para. 1-2] image-based navigation during PCI is provided using x-ray fluoroscopy…a short monoplane fluoroscopic sequence is acquired with either contrast agent injection or the presence of a radio opaque guide wire in one of the coronary branch).
Regarding claim 3, Duong discloses the method of claim 1 as applied above. Duong further discloses wherein the determining an initial registration relationship between the first medical image and the second medical image includes: determining centerlines of the blood vessels in the first medical image ([pg. 1, 1. Introduction, para. 2] MSCT is proposed to delineate in 3D the vessel centerline; see also Fig. 2);
determining a centerline of the interventional tool in the second medical image ([pg. 4, para. 2] the 2D centerline identified on the 2D image (i.e. fluoroscopy image); [pg. 3, 2.2 2D-3D co-registration MSCT segmentation with 2D angiograms, para. 3-4] This workflow is flexible enough to allow the outline of a radio opaque guide to be alternatively identified, when contrast agent is not flowing in the targeted vessel(s). Once the curve segments are identified on the 2D image, they are manually matched with their 3D MSCT segmented coronary (i.e. the radio opaque guide wire can be identified as a centerline)); and
determining the initial registration relationship based on the centerlines of the blood vessels and the centerline of the interventional tool ([pg. 4, para. 1] Registration between the curve identified in 2D and the segment selected on the 3D MSCT is performed using ICP algorithm, in order to estimate the transformation T, an energy minimization scheme is introduced estimating the distance between the 2D vessel and the projection of the 3D centerline).
Regarding claim 4, Duong discloses the method of claim 3 as applied above. Duong further discloses wherein the determining the initial registration relationship based on the centerlines of the blood vessels and the centerline of the interventional tool includes: obtaining projection data of the centerlines of the blood vessels by projecting the centerlines to a plane corresponding to the second medical image ([pg. 1, 1. Introduction, para. 2] MSCT is proposed to delineate in 3D the vessel centerline; see also Fig. 2; [pg. 4, para. 1] the 3D segmented centerline projected in the 2D image after transformation T (see Fig. 4));
determining a target centerline that matches the centerline of the interventional tool based on the projection data of the centerlines ([pg. 4, para. 2] the 2D centerline identified on the 2D image (i.e. fluoroscopy image); [pg. 3, 2.2 2D-3D co-registration MSCT segmentation with 2D angiograms, para. 3-4] This workflow is flexible enough to allow the outline of a radio opaque guide to be alternatively identified, when contrast agent is not flowing in the targeted vessel(s). Once the curve segments are identified on the 2D image, they are manually matched with their 3D MSCT segmented coronary (i.e. the radio opaque guide wire can be identified as a centerline)); and
determining the initial registration relationship by performing a registration operation on the target centerline and the centerline of the interventional tool ([pg. 4, para. 1] Registration between the curve identified in 2D and the segment selected on the 3D MSCT is performed using ICP algorithm, in order to estimate the transformation T, an energy minimization scheme is introduced estimating the distance between the 2D vessel and the projection of the 3D centerline…the cost function is defined as the sum of the distance transform values over the projection of the 3D centerline using the current pose).
Regarding claim 5, Duong discloses the method of claim 1 as applied above. Duong further discloses wherein the determining a first motion state of the blood vessels at the acquisition time includes: obtaining a mapping relationship between physiological phases and blood vessel motion states ([pg. 3, 2.2 2D-3D co-registration MSCT segmentation with 2D angiograms, para. 2] Since ECG signal is recorded simultaneously with the fluoroscopic image acquisition, image frames from fluoroscopic sequence are automatically gated to match the acquisition cardiac phase of the MSCT volume (Fig. 3)); and determining the first motion state of the blood vessels based on the first physiological feature and the mapping relationship ([pg. 3, 2.2 2D-3D co-registration MSCT segmentation with 2D angiograms, para. 2] Since cardiac motion is interleaved with the cycle of breathing motion pattern, the ECG-gated frames will contain only breathing motion, with small and typically negligible vessel deformations).
Regarding claim 18, Duong discloses everything claimed as applied above (see rejection of claim 1).
Regarding claim 19, Duong discloses everything claimed as applied above (see rejection of claim 2).
Regarding claim 21, Duong discloses everything claimed as applied above (see rejection of claim 1).
Allowable Subject Matter
Claims 6-17 are 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 6, Duong discloses the method of claim 5 as applied above. Duong fails to disclose wherein the mapping relationship is determined by: obtaining sample medical images of the target subject and a sample physiological feature corresponding to each sample medical image, the sample medical images being collected sequentially over at least one physiological cycle and indicating the blood vessels of the target subject; determining relative motions of the blood vessels between pairs of adjacent sample medical images among the sample medical images; and determining the mapping relationship based on the sample physiological feature and the relative motions of the blood vessels.
Similar reasoning applies to claims 7-9 which are dependent on claim 6.
Regarding claim 10, Duong discloses the method of claim 5 as applied above. Duong fails to disclose wherein the mapping relationship is determined based on sample medical images of a sample subject different from the target subject, the sample medical images being collected sequentially over at least one physiological cycle and indicating blood vessels of the sample subject.
Regarding claim 11, Duong discloses the method of claim 1 as applied above. Duong fails to disclose wherein the determining a target registration relationship based on the initial registration relationship and the first motion state of the blood vessels includes: generating a first auxiliary registration relationship between the first medical image and the second medical image based on the first motion state of the blood vessels; determining a first weight for the initial registration relationship and a second weight for the first auxiliary registration relationship based on the second medical image; determining the target registration relationship based on the first auxiliary registration relationship, the initial registration relationship, the first weight, and the second weight.
Similar reasoning applies to claims 12-14 which are dependent on claim 11.
Regarding claim 15, Duong discloses the method of claim 1 as applied above. Duong fails to disclose wherein the determining a target registration relationship comprises: obtaining a second physiological feature of the target subject at the acquisition time of the second medial image; determining a second motion state of the blood vessels based on the second physiological feature; and determining the target registration relationship based on the initial registration relationship, the first motion state, and the second motion state.
Regarding claim 16, Duong discloses the method of claim 1 as applied above. Duong fails to disclose wherein the second medical image is collected during a surgery, and the determining the target registration relationship comprises: obtaining monitoring information of the body of the target subject during the surgery; in response to detecting a rigid motion of the body of the target subject based on the monitoring information, updating the initial registration relationship based on the detected rigid motion; determining the target registration relationship based on the updated initial registration relationship and the first motion state.
Regarding claim 17, Duong discloses the method of claim 1 as applied above. Duong fails to disclose wherein the determining a first motion state comprises: obtaining a first physiological curve of the target subject in a pre-scan and sample medical images of the target subject collected sequentially over multiple physiological cycles in the pre-scan; obtaining a second physiological curve of the target subject during a period including the acquisition time of the second medical image; identifying a target portion in the first physiological curve that matches the second physiological curve; and determining the first motion state based on the sample medical images corresponding to the target portion in the first physiological curve.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Vizitiu (US 20230380787 A1) discloses overlaying angiographic image over a real-time fluoroscopic image based on alignment data including detecting cardiac cycle phases.
Xu (US 20130195338 A1) discloses registering 3D images with 2D fluoroscopic x-ray images and segmenting a medical instrument depicted in the 2D image and identifying centerlines.
Aben (US 20150131886 A1) discloses co-registering angiography and intravascular images including detecting cardiac cycles.
Rivest-Henault (D. Rivest-Henault, H. Sundar and M. Cheriet, "Nonrigid 2D/3D Registration of Coronary Artery Models With Live Fluoroscopy for Guidance of Cardiac Interventions," in IEEE Transactions on Medical Imaging, vol. 31, no. 8, pp. 1557-1572, Aug. 2012, doi: 10.1109/TMI.2012.2195009.) discloses 2D-3D nonrigid registration method to align 3D centerlines of arteries with fluoroscopic images for use in image-guided procedures.
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/CAROLINE E. DEPALMA/Examiner, Art Unit 2675
/SJ Park/Primary Examiner, Art Unit 2675
