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 .
Claim Objections
Claims 8, 9 objected to because of the following informalities: “…of any claim 1…”should read “…of claim 1…”. 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.
Claim(s) 1-7 and 11-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strommer et al. (IDS: US 20080091171 A1).
Regarding claims 1, 12, and 15, Strommer et al. disclose a medical system comprising: memory configured to store a three-dimensional (3D) model of a coronary vasculature of a patient; and processing circuitry communicatively coupled to the memory (3D model, [0030], navigation processor, [0078]) [processor implies processing circuitry and memory], the processing circuitry being configured to, a method comprising, and non-transitory computer-readable storage medium storing instructions, which, when executed, cause processing circuitry to (3D model, [0030], navigation processor, [0078]) [implementing using a processor implies instructions]: obtain first fluoroscopy with contrast imaging data from a first viewing angle and obtain second fluoroscopy with contrast imaging data from a second viewing angle, the second viewing angle being different than the first viewing angle (acquiring a plurality of two-dimensional (2D) images of the blood vessel from different perspectives, 2D images include representations of a proximal segment and a distal segment of the blood vessel, representation of the overall occluded vessel can be obtained by superimposing two 2D fluoroscopic images, each including a representation of another segment of the blood vessel, [0030], fluoroscopic dye injection is administered into occluded artery, [0035]) [dye = contrast]; determine the 3D model of the coronary vasculature of the patient based on the first fluoroscopy with contrast imaging data and the second fluoroscopy with contrast imaging data (A 3D model of an occluded blood vessel is generated, for example, by acquiring a plurality of two-dimensional (2D) images of the blood vessel from different perspectives and reconstructing the 3D model there from. The 2D images include representations of a proximal segment and a distal segment of the blood vessel, and do not include a representation of the occluded segment (since no blood flows there through). A representation of the overall occluded vessel can be obtained by superimposing two 2D fluoroscopic images, each including a representation of another segment of the blood vessel, [0030], Since at least two images are acquired for each dye injection, from at least two different perspectives, at least two superimposed images are obtained. A three-dimensional (3D) model of occlusion area 102 is generated, using the at least two superimposed images, by methods known in the art., [0043]); obtain additional imaging data, the additional imaging data comprising imaging data from one or more imagers other than a fluoroscopy imager (According to another embodiment of the disclosed technique, a Computed Tomography (CT) 3D model of the occlusion area may be obtained by employing a preoperative CT scan. The CT 3D model can be registered with the 3D model generated subsequent to the fluoroscopic dye injections, [0053]) update the 3D model based on the additional imaging data (These additional details may be superimposed on the acquired 3D model, after comparison with the CT 3D model, in order to enhance the acquired 3D model, [0053]); and output for display a representation of the updated 3D model (3D model 122 is displayed to a user during the procedure of advancing the guidewire through the blood vessel, [0051], Display 172 provides a visual representation of 3D model 182 and a visual representation of 3D center line 184 of the tubular organ, [0060]).
The above citations are not all from the same embodiment. It would have been obvious at the time of filing to one of ordinary skill in the art to combine the CT enhancement embodiment with the base embodiments as this was known at the time of filing, the combination would have predictable results, and as Strommer et al. indicate this will enhance the acquired 3D model ([0053]) so combining embodiments will result in a more complete model.
Regarding claims 2 and 13, Strommer et al. disclose the medical system and method of claims 1 and 12. Strommer et al. further indicate the additional imaging data comprises at least one of computed tomography (CT) imaging data, intravenous ultrasound (IVUS) imaging data, optical coherence tomography (OCT) imaging data, near infrared spectroscopy (NIRS) imaging data, ultrasound imaging data, magnetic resonance imaging (MRI) data, or positron emission tomography (PET) imaging data (CT 3D model, in order to enhance the acquired 3D model, [0053]).
Regarding claims 3 and 14, Strommer et al. disclose the medical system and method of claims 1 and 12. Strommer et al. further indicate the processing circuitry is further configured to: co-register at least one of the first fluoroscopy with contrast imaging data, the second fluoroscopy with contrast imaging data, or the 3D model with the additional imaging data; and output for display the additional imaging data and the at least one of the first fluoroscopy with contrast imaging data, the second fluoroscopy with contrast imaging data, or the representation of the updated 3D model (The CT 3D model can be registered with the 3D model generated subsequent to the fluoroscopic dye injections, [0053], Display 172 may further display 3D model 182 superimposed on a 2D image of the tubular organ, such as the superimposed image. Occlusion navigation processor 178 registers 3D model 182 with the MPS coordinate system of MPS 174. Display 172 provides a visual representation of the position and orientation 186 of the MPS sensor with respect to 3D model 182, [0060]).
Regarding claims 4 and 16, Strommer et al. disclose the medical system and method of claims 1 and 12. Strommer et al. further indicate as part of updating the 3D model, the processing circuitry is configured to: identify at least one area of the coronary vasculature of the patient; prompt a clinician to utilize additional equipment, the additional equipment being configured to determine additional information relating to the identified at least one area of vasculature of the patient; obtain the additional information; and update the 3D model based on the additional information (The user can then observe the determined boundary regions and adjust them, in case they do not seem to comply with the apparent boundary regions in the displayed image, [0041], “With reference to FIG. 3B, interpolation between boundary region 116 and boundary region 118, provides an estimate of a boundary region 120, depicted in dotted lines, of occluded segment 114. This interpolation can be performed by image processing of the superimposed image (e.g., by an image processor), or manually by the user (e.g., via a user input module). In the case where the superimposed image of occlusion area 102 is displayed to the user, boundary region 120 may be represented by a different representation than the representations of boundary region 116 and boundary region 118 (e.g., by a different color, a different line type, and the like). If the interpolation of the boundary regions is performed by an image processor, then the user can review the interpolated boundary region 120 of occluded segment 114 and adjust it, if necessary”, [0042]) [“apparent boundary regions” can be interpreted as “additional information”].
Regarding claims 5 and 17, Strommer et al. disclose the medical system and method of claims 1 and 12. Strommer et al. further indicate as part of at least one of determining the 3D model or updating the 3D model, the processing circuitry is configured to determine at least one of vessel morphology, plaque location, plaque type, vessel length, vessel diameter, fractional flow reserve (FFR) values, lesion dimensions, orientation of one or more lesions with respect to vessel walls, lipid composition, or SYNTAX scores (term "boundary region", refers to the area representing the blood vessel walls as they appear in the acquired 2D images, [0033]A boundary region 116 of proximal segment 110 and a boundary region 118 of distal segment 112, which appear in the superimposed image, are determined by using image processing techniques. For example, the image processing techniques can include edge detection or segmentation, in which certain segments or regions in the image, having properties distinct from their adjacent regions, are determined, [0041], If the interpolation of the boundary regions is performed by an image processor, then the user can review the interpolated boundary region 120 of occluded segment 114 and adjust it, if necessary, [0042], additional details may be, for example, the length of the occluded segment, the width of the occluded segment, the tortuosity of the occluded segment, [0053]) [boundary/edges of a vessel interpreted as vessel morphology].
Regarding claims 6 and 18, Strommer et al. disclose the medical system and method of claims 1 and 12. Strommer et al. further indicate as part of at least one of determining the 3D model or updating the 3D model, the processing circuitry is further configured to at least one of utilize at least one Digital Imaging and Communications in Medicine (DICOM) file or calibrate at least one measurement off at least one known device measurement reference (Medical positioning system 174 includes MPS transmitters 160, 162 and 164, reference sensor 180 and an MPS sensor (not shown), [0054], MPS 174 determines the position and orientation of the MPS sensor at a plurality of positions along the occluded tubular organ in a 3D coordinate system (hereinafter, the MPS coordinate system), relative to MPS transmitters 160, 162 and 164, and reference sensor 180, [0055]) [MPS and reference sensor interpreted as known device measurement reference].
Regarding claims 7 and 19, Strommer et al. disclose the medical system and method of claims 1 and 12. Strommer et al. further indicate the processing circuitry is configured to update the 3D model during a percutaneous coronary intervention (PCI) procedure (A medical procedure is performed on the occluded blood vessel, during which a guidewire is inserted into the blood vessel and passes through the occluded segment. In order to avoid the risk of localized arterial wall dissection or coronary perforation by the guidewire tip, the guidewire is to be advanced through the center of the occluded segment, along 3D center line 126. Thus, 3D center line 126 represents a 3D safe trajectory, through which the guidewire is to be advanced. With reference to FIG. 2A, the guidewire can approach occluded segment 114 from the proximal end thereof, passing first through proximal segment 110. Alternatively, the guidewire can approach occluded segment 114 from the distal end thereof, passing first through distal segment 112, [0049], The guidewire reaches an end of the occluded section (not shown) and is advanced through the occluded segment of the blood vessel (similar to occluded segment 114 of FIG. 2A). Representations of an MPS sensor position 128 and an MPS sensor orientation 130 are presented with respect to 3D model 122, [0050], Occlusion navigation processor 178 generates a 3D model 182 of the tubular organ, using the superimposed 2D images. Occlusion navigation processor 178 further determines an estimate for a 3D center line 184 of the tubular organ, according to 3D model 182. 3D center line 184 passes through the proximal segment, the occluded segment, and the distal segment of the occluded tubular organ, [0060], user of system 150 inserts guidewire 156 into the tubular organ and advances it toward the occluded segment thereof, [0061], When guidewire distal tip 158 reaches the distal segment of the occluded tubular organ, the user can then pass a catheter over the guidewire, for treating the occluded blood vessel. Such a catheter may be a Guided Measurement Catheter (GMC), a diagnostic catheter (e.g., Ultra Sound imaging catheter), or an ablation catheter. For example, the user can perform angioplasty, by inserting a balloon catheter into the blood vessel, and inflating the balloon within the occluded segment, in order to dilate the occluded blood vessel, [0065]) [procedures involving guidewire such as balloon catheter interpreted as percutaneous coronary intervention]
Regarding claim 11, Strommer et al. disclose the medical system of claim 1. Strommer et al. further indicate as part of updating the 3D model the processing circuitry is further configured to: obtain additional fluoroscopy with contrast imaging data; and update the 3D model based on the additional fluoroscopy with contrast imaging data (A first fluoroscopic dye injection is administered to the occluded tubular organ, for example, by a physician. Medical imaging system 168 acquires a plurality of first-injection 2D images of the tubular organ from a plurality of different perspectives. The difference between the plurality of perspectives (i.e., the angular difference between the vectorial direction of the optical axis in each perspective) is at least 30.degree.. Subsequent to the second injection, medical imaging system 168 acquires a plurality of second-injection 2D images of the occlusion area from different perspectives, showing the presence of the fluoroscopic dye in the blood vessels in the heart of patient 152 (see FIG. 2C). In these images, the distal segment is visible, since blood containing the fluoroscopic dye flows there through, [0056], Occlusion navigation processor 178 generates a 3D model 182 of the tubular organ, using the superimposed 2D images, [0060]).
Claim(s) 8 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strommer et al. (IDS: US 20080091171 A1) as applied to claims 1 and 12 above, further in view of Mori et al. (US 20190184199 A1).
Regarding claims 8 and 20, Strommer et al. disclose the medical system and method of claims 1 and 12. Strommer et al. do not disclose as part of updating the 3D model, the processing circuitry is configured to: obtain third fluoroscopy with contrast imaging data during a percutaneous coronary intervention (PCI) procedure, the third fluoroscopy with contrast imaging data having a lower frame rate than at least one of the first fluoroscopy with contrast imaging data or the second fluoroscopy with contrast imaging data; and update the 3D model based on the third fluoroscopy with contrast imaging data.
Mori et al. teach obtain third fluoroscopy with contrast imaging data during a percutaneous coronary intervention (PCI) procedure, the third fluoroscopy with contrast imaging data having a lower frame rate than at least one of the first fluoroscopy with contrast imaging data or the second fluoroscopy with contrast imaging data; and update the 3D model based on the third fluoroscopy with contrast imaging data (As described above, the fluoroscopic image TI is captured even in a stage in which irradiation of the therapeutic beam B is not performed (for example, the preparation stage), or even in a stage in which irradiation of the therapeutic beam B is performed (for example, the therapy stage). However, the frame rate of capturing the fluoroscopic image TI in the preparation stage may be different from the frame rate of capturing the fluoroscopic image TI in the therapy stage. For example, the frame rate of capturing the fluoroscopic image TI in the preparation stage may be set to be lower than the frame rate of capturing the fluoroscopic image TI in the therapy stage, [0090], In the present embodiment, the frame rate of capturing the fluoroscopic image TI in the preparation stage is set to be lower than the frame rate of capturing the fluoroscopic image TI in the therapy stage, [0102]).
As Strommer et al. teaches updating the 3D model based on the fluoroscopy with contrast imaging data above, the combination together of Strommer et al. and Mori et al. teaches update the 3D model based on the third fluoroscopy with contrast imaging data.
Strommer et al. and Mori et al. are in the same art of fluoroscopy images (Strommer et al., [0056]; Mori et al., [0090]). The combination of Mori et al. with the invention of Strommer et al. will enable obtaining images with different frame rates. It would have been obvious at the time of filing to one of ordinary skill in the art to combine the frame rate of Mori et al. with the invention of Strommer et al. as this was known at the time of filing, the combination would have predictable results, and as Mori et al. indicate “Therefore, compared to a case in which the preparation stage and the therapy stage have a common frame rate, the exposure dose of a patient in the preparation stage can be reduced” ([0102]) which will result in an improved patient experience when inventions are combined.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strommer et al. (IDS: US 20080091171 A1) as applied to claim 1 above, further in view of Ohnmacht et al. (US 20180221566 A1).
Regarding claim 9, Strommer et al. disclose the medical system of claim 1. Strommer et al. do not disclose the processing circuitry is further configured to: determine a scaled model for each device used during a percutaneous coronary intervention (PCI) procedure; and output for display a representation of the scaled model for each device used during the PCI procedure.
Ohnmacht et al. teach determine a scaled model for each device used during a percutaneous coronary intervention (PCI) procedure (The anatomical structures may include, but are not limited to, bone, the heart, the liver, other organs, fissures, diseased tissue, such as, for example, chronic obstructive pulmonary disease (COPD) lung tissue, and blood vessels. Accordingly, the anatomical structures may be any structure within the body of patient 10 that should be avoided, if possible, by percutaneous device (e.g., percutaneous needle 650). Additionally, the atlas model(s) may include weighted information related to the acceptability of a planned trajectory or planned ablation procedure to determine the optimal plan. This weighted information may include, but is not limited to, information regarding which anatomical structure(s) cannot be crossed by a medical device, information regarding avoid anatomical structure(s) by at least a given distance, and information regarding the heat sink effect of anatomical structure(s) so that ablation location and amount may be adjusted, [0204], The images in the image dataset may be fluoroscopic images, ultrasound images, to computed tomography (CT) images, fused computed tomography—positron emission tomography (CT/PET) images, magnetic resonance imaging (MRI) images, etc., [0217]); and output for display a representation of the scaled model for each device used during the PCI procedure (The extended trajectory displays the potential extension of the medical device so that it may be confirmed that potential extension of the medical device will sample and/or treat the target tissue and will not hit one or more anatomical structures. The displayed extended trajectory may also aid in ensuring that a sufficient sample is taken and/or that the treatment may be properly placed in the target tissue, [0203], “Thus as shown in FIG. 20E at step 1034, one or more atlas models is matched to image dataset 400 of patient 10 wherein the matching may comprise deforming the atlas model(s) to the image dataset 400 and/or registering the atlas model(s) to patient 10. At step 1036, navigation system 70 identifies anatomical structure(s) to be avoided by the trajectory of the percutaneous device. At step 1038, navigation system 70 may calculate and display a trajectory of the percutaneous device from the confirmed location of the target tissue to a corresponding entry point on the body of patient 10. This trajectory may avoid some or all of the anatomical structures. Accordingly, if a physician or other healthcare professional inserts percutaneous device, such as percutaneous needle 650, following this trajectory, percutaneous device may avoid some or all of the anatomical structures thereby preventing damage to the anatomical structure(s)”, [0205]).
Strommer et al. and Ohnmacht et al. are in the same art of fluoroscopy images (Strommer et al., [0056]; Ohnmacht et al., [0125], [0217]). The combination of Ohnmacht et al. with the invention of Strommer et al. will enable scaling the model. It would have been obvious at the time of filing to one of ordinary skill in the art to combine the scaling of Ohnmacht et al. with the invention of Strommer et al. as this was known at the time of filing, the combination would have predictable results, and as Ohnmacht et al. indicate this will ensure treatment may be properly placed in the target tissue ([0203]), which will result in an improved patient experience when inventions are combined.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strommer et al. (IDS: US 20080091171 A1) as applied to claim 1 above, further in view of Kuo et al. (US 20230334659 A1).
Regarding claim 10, Strommer et al. disclose the medical system of claim 1. Strommer et al. do not disclose as part of at least one of determining the 3D model or updating the 3D model, the processing circuitry is configured to execute an artificial intelligence algorithm.
Kuo et al. teach as part of at least one of determining the 3D model or updating the 3D model, the processing circuitry is configured to execute an artificial intelligence algorithm (The co-registration system receives CT imaging data which is used to construct a three-dimensional model of a patient’s vasculature. The system also receives two or more x-ray angiography images of the patient’s vasculature obtained at two different angles. The x-ray angiography images are then used to create an additional three-dimensional model of the vasculature. The system then identifies common landmark features in both the x-ray angiography-based model and the CT-based model to create a mapping between the two models, [0006], In one aspect, the system may receive multiple x-ray fluoroscopy images of the patient’s vasculature at any angle while an intravascular device moves through the vasculature collecting data. The intravascular data is mapped to the fluoroscopy images associating the intravascular data with locations along a two-dimensional path. The two-dimensional path and its associated intravascular data is projected onto the three-dimensional angiography-based model and then mapped to the CT-based model. The intravascular data may then be displayed along the corresponding vessel in the three-dimensional CT-based model, [0007], Any or all of the previously mentioned angiography-based data 1650 may be calculated through any suitable method. For example, the data may be determined via image processing or artificial intelligence techniques, [0156], The vessels shown in the angiography image 1600 may be identified with any of the previously mentioned image processing or artificial intelligence methods, [0158], At step 1545, the method 1500 includes co-registering the determined metrics from the x-ray angiography image to the CT-based 3D model. The step 1545 will also be described with reference to FIG. 17. As illustrated in FIG. 17 and described in steps 1535 and 1540, the angiography-based three-dimensional model 1700 may include all of the angiography-based data 1650 obtained at step 1535. In other words, each position of the three-dimensional model 1700 may have associated angiography-based data 1650. Using the feature mapping generated at step 1525 which links locations within the angiography-based model 1700 and the CT-based model 1705, the same angiography-based data 1650 associated with positions along the three-dimensional model 1700 may be associated with the same positions on the CT-based three-dimensional model 1705, [0162]).
Strommer et al. and Kuo et al. are in the same art of fluoroscopy images (Strommer et al., [0056]; Kuo et al., abstract). The combination of Kuo et al. with the invention of Strommer et al. will enable using an artificial intelligence algorithm. It would have been obvious at the time of filing to one of ordinary skill in the art to combine the artificial intelligence algorithm of Kuo et al. with the invention of Strommer et al. as this was known at the time of filing, the combination would have predictable results, and as Kuo et al. indicate “The diagnostic system 100 may be used for many different medical procedures, such as but not limited to diagnostic procedures, planning treatment, guiding treatment (e.g., during deployment of a treatment device), and evaluating the efficacy of treatment after it has been performed” ([0039]) suggesting an expansion of hospital applicability when inventions are combined.
Conclusion
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/MICHELLE M ENTEZARI HAUSMANN/Primary Examiner, Art Unit 2671
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