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 .
Prior arts cited in this office action:
Sheeran et al. (US 20220401081 A1, hereinafter “Sheeran”)
Srinivasa Naidu et al. (US 20200297318 A1, hereinafter “Naidu”)
Milner et al. (US 20110137124 A1, hereinafter “Miller”)
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sheeran et al. (US 20220401081 A1, hereinafter “Sheeran”) in view of Srinivasa Naidu et al. (US 20200297318 A1, hereinafter “Naidu”) and in view of Milner et al. (US 20110137124 A1, hereinafter “Miller”).
Regarding claims 1 and 19:
Sheeran teaches a computer system implemented method of reducing a comet tail aberration in an image (Sheeran [0003], [0035]-[0036], where Sheeran teaches One challenge for clinicians in viewing and analyzing ultrasound images is distinguishing portions of the images that are representative of artifacts or image clutter from actual tissue structures. One type of artifact that can occur in ultrasound imaging is reverberation. Some reverberation artifacts arise when vibrations from structures in the imaging field induced by previous transmit events interfere with a later receive line), the method comprising:
receiving, by the computer system from an intracardiac echocardiography (ICE)
imaging system on a catheter coupled to the computer system, a first set of images, the first set of
images including at least one ICE image (Sheeran [0045], [0047], fig. 4 where Sheeran teaches In step 310, an ultrasound transducer is controlled to obtain a plurality of ultrasound images using a respective plurality of pulse repetition intervals (PRIs). In some embodiments, the ultrasound transducer comprises an external ultrasound probe that includes an array of ultrasound transducer elements… In step 320, the plurality of ultrasound images is analyzed to calculate an amount of reverberation artifacts in each of the plurality of ultrasound images);
automatically determining, by the computer system, a location in the first set of images (Sheeran [0007], [0042], [0059], [0063], the region or area of artifact is determined or calculated);
automatically determining, by the computer system, a presence of aberration in a region of interest (ROI) in the first set of images (Sheeran [0035], [0045], [0047], fig. 4 where Sheeran teaches In some embodiments, the amount of reverberation artifacts in an image can be quantified or inferred by removing or suppressing tissue in the image, and summing the remaining signal or intensity in the image. The summed remaining signal may represent or correlate to the amount of reverberation artifacts present in the image, and may also represent other artifacts); and
in response to determining the aberration is present in the ROI, automatically
changing, by the computer system, an imaging characteristic of the ICE imaging system to
affect an appearance of the aberration in the ROI in subsequent images generated by the
ICE imaging system using the changed imaging characteristic (Sheeran [0051] where Sheeran teaches In step 340, in response to selecting the PRI, the ultrasound transducer is controlled to obtain a reduced-reverberation ultrasound image at the selected PRI and wherein In FIG. 6, it can be seen that as the PRI 414 increases, the overall intensity or bright portions in the ultrasound images 412 decreases. Because the tissue has been suppressed in the ultrasound images 412, it may be inferred that the remaining portions are likely due to image clutter, such as reverberation artifacts. Thus, by increasing the PRI, more time is allowed for reverberation in the anatomy to dissipate, and less reverberation artifacts are visible”).
Sheeran fails to explicitly teach wherein the image is an image of an ablation catheter and the area of aberration is proximate the ablation catheter tip.
However, Srinivasa teaches a system configured to acquire ultrasound data from one or more regions of interest, which may include various tissues, organs, or other internal bodily structures. The ultrasound imaging system may include one or more processors and at least one model of a neural network, which may be implemented in hardware and/or software components. The neural network can be machine trained to identify one or more image artefacts, such as reverberations or mirror images, and output an indication of the presence and/or type of such artefacts (Srinivasa [0021], [0027]). Sheeran further discloses that although the present disclosure refers to synthetic aperture external ultrasound imaging using an external ultrasound probe, it will be understood that one or more aspects of the present disclosure can be implemented in any suitable ultrasound imaging probe or system, including external ultrasound probes and intraluminal ultrasound probes. For example, aspects of the present disclosure can be implemented in ultrasound imaging systems using a mechanically-scanned external ultrasound imaging probe, an intracardiac (ICE) echocardiography catheter and/or a transesophageal echocardiography (IEE) probe, a rotational intravascular ultrasound (IVUS) imaging catheter, a phased-array IVUS imaging catheter, a transthoracic echocardiography (TTE) imaging device, or any other suitable type of ultrasound imaging device (Sheeran [0032]). Furthermore, Milner teaches A number of factors can contribute to the optical aberrations, such as spherical aberration, coma, astigmatism, field curvature, chromatic aberration, distortion, and the like, in the Optical imaging catheter system (Milner [0029]).
Therefore, it would have been obvious to one of ordinary skill in the art before he effective filing date of the application to apply the general teaching of Sheeran in view of Srinivasa and in view of Milner to remove comet tail artifacts arising from reverberating object at any location in the image including the proximate ablation tip of the catheter, such as in the case of surgical ablation catheter tip, in order to differentiate between healthy tissues, damaged or diseased tissue, and the catheter effect on the tissue and/or to derive better images.
Regarding claim 2:
Sheeran in view of Srinivasa and in view of Milner teaches wherein changing the imaging characteristic comprises changing a scan parameter used to generate the first set of images (Sheeran [0032], [0045], [0047], where Sheeran teaches Change in the Pulse Repetition interval (PRI) which a scan parameter; Srinivasa [0007], [0025]).
Regarding claim 3:
Sheeran in view of Srinivasa and in view of Milner teaches wherein changing the scan parameter comprises changing transmission focus location of the ICE imaging system (Milner [0025], [0029], [0035]; Srinivasa [0007], [0025]).
Regarding claim 4:
Sheeran in view of Srinivasa and in view of Milner teaches wherein changing the scan parameter comprises changing a transmission frequency of the ICE imaging system (Sheeran [0032], [0045], [0047]; Srinivasa [0007], [0025] where combination teaches Change in the Pulse Repetition interval (PRI) which a scan frequency).
Regarding claim 5:
Sheeran in view of Srinivasa and in view of Milner teaches wherein changing a scan parameter comprises changing a transmission pulse of the ICE imaging system (Sheeran [0032], [0045], [0047]; Srinivasa [0007], [0025] where combination teaches Change in the Pulse Repetition interval (PRI) which a scan parameter).
Regarding claim 6:
Sheeran in view of Srinivasa and in view of Milner teaches wherein changing a scan parameter comprises changing a transmission pulse of the ICE imaging system (Sheeran [0032], [0045], [0047]; Srinivasa [0007], [0025] where combination teaches changing in the Pulse Repetition interval (PRI) which is a frequency).
Regarding claim 7:
Sheeran in view of Milner teaches wherein changing the imaging characteristic comprises changing a beamforming method of the ICE imaging system (Sheeran [0035]; Srinivasa [0007], [0025]; Milner [0029], [0034]).
Regarding claim 8:
Sheeran in view of Srinivasa and in view of Milner teaches wherein changing the imaging characteristic comprises changing a beamforming method tuned towards reverberation noise isolation (Sheeran [0035]; Srinivasa [0007], [0025];Milner [0029]-[0030], [0034] where the combination discloses converging of focusing the receive light to a point that would cause the image to avoid aberration (noise or artifacts)).
Regarding claim 9:
Sheeran in view of Srinivasa and in view of Milner teaches wherein changing the imaging characteristic comprises changing a beamforming method to a model-based approach that is tuned towards reverberation noise or wavefront isolation (Sheeran [0035]; Srinivasa [0007], [0025]; Milner [0029]-[0030], [0034], where the combination discloses converging of focusing the receive light to a point that would cause the image to avoid aberration (noise or artifacts) which can be any model based approach).
Regarding claim 10:
Sheeran in view of Srinivasa and in view of Milner teaches wherein the aberration is a noise artifact along an ultrasound scan line that extends beyond the tip of the ablation catheter(Srinivasa [0007], [0025]; Milner [0029]-[0030], [0034], fig. 6).
Regarding claim 11:
Sheeran in view of Srinivasa and in view of Milner teaches further comprising:
receiving a second set of images from the ICE imaging system that were generated
using the changed imaging characteristic, the second set of images including at least one
ICE image;
automatically determining in the ROI, in images in the second set of images, the
presence of the comet tail aberration;
determining if the aberration has been reduced; and
in response to determining that the aberration has not been reduced, automatically
changing a second imaging characteristic of the ICE imaging system to change the
appearance of the comet tail aberration in the ROI in subsequent images generated by the
ICE system using the second imaging characteristic (Sheeran [0004]-[0005], [0032], [0045], [0047]; Srinivasa [0007], [0025] where combination teaches change in the Pulse Repetition interval (PRI) which a scan frequency. Changing the pulse to obtain or to determine with pulse or pulse frequency that would result in obtaining the best picture quality free of artifact or aberration is a repetition and improvement process).
Regarding claim 12:
Sheeran in view of Srinivasa and in view of Milner teaches in response to a user input, changing a second imaging characteristic of the ICE imaging system to change the appearance of the comet tail aberration in the ROI in subsequent images generated by the ICE system using the second imaging characteristic (Sheeran [0004]-[0005], [0032], [0035], [0045], [0047]; Srinivasa [0007], [0025] where combination teaches Change in the Pulse Repetition interval (PRI) which a scan frequency. Changing the pulse to obtain or to determine with pulse or pulse frequency that would result in obtaining the best picture quality, free of artifacts or aberrations is a repetition and improvement process).
Regarding claim 13:
Sheeran in view of Srinivasa and in view of Milner teaches wherein automatically determining, by the computer system, the presence of the comet tail aberration in the ROI comprises accessing predetermined information of the ablation catheter characteristics (Milner [0029]-[0030], [0034], fig. 6; Srinivasa [0007], [0025] wherein the combination teaches determining which aberration among them that is more prevalent based on the ablation catheter characteristics and adjust the system to mitigate this particular aberration would have been obvious to one or ordinary skill in the art in order to better address the problem and be more efficient).
Regarding claim 14:
Sheeran in view of Srinivasa and in view of Milner teaches wherein automatically determining, by the computer system, the presence of the comet tail aberration in the ROI comprises using reverb wavefront modeling (Sheeran [0001], [0003]).
Regarding claim 15:
Sheeran in view of Srinivasa and in view of Milner teaches wherein automatically determining, by the computer system, the presence of the comet tail aberration in the ROI comprises comparing ICE images generated using two different frequencies (Sheeran [0032], [0045], [0047]; Srinivasa [0007], [0025]).
Regarding claim 16:
Sheeran in view of Srinivasa and in view of Milner teaches wherein automatically determining, by the computer system, the presence of the comet tail aberration in the ROI comprises comparing ICE images generated using two different imaging modes (Sheeran [0032], [0035]-[0035], [0045], [0047]; Srinivasa [0007], [0025] where combination teaches Change in the Pulse Repetition interval (PRI) which a scan parameter; In some embodiments, the image processor 24 is configured to generate images of different modes to be further analyzed or output to the display 30. For example, in some embodiments, the image processor can be configured to compile a B-mode image, such as a live B-mode image, of an anatomy of the patient. In other embodiments, the image processor 24 is configured to generate or compile an M-mode image. An M-mode image can be described as an image showing temporal changes in the imaged anatomy along a single scan line).
Regarding claim 17:
Sheeran in view of Srinivasa and in view of Milner teaches wherein automatically determining, by the computer system, the presence of the comet tail aberration in the ROI comprises using one or more morphological filters or other image segmentation methods (Srinivasa [0039], where the combination teaches for example, one or more layers 304 may be trained to recognize the edges and/or intensity levels of various features within each received image frame. One or more layers 304 may be trained to separate the image artefacts from other features having similar intensity levels).
Regarding claim 18:
Sheeran in view of Srinivasa and in view of Milner teaches wherein automatically determining, by the computer system, the presence of the comet tail aberration in the ROI comprises using a machine learning (ML) process (Srinivasa [0020]-[0021], [0039])
Regarding claim 20:
Sheeran in view of Srinivasa and in view of Milner teaches A computer system implemented method of reducing a comet tail aberration in an
image of an ablation catheter, the method comprising:
receive and display a first ICE image, wherein the first ICE image is generated with
first imaging characteristics;
determine a location of a catheter tip in the first ICE image;
determine a presence of a comet tail aberration, associated with the catheter tip, in
a region of interest (ROI) in the ICE image; in response to determining the presence of the comet tail aberration, initiate a dual frequency B-mode scanning sequence where a first frequency is used to generate a second ICE image in a first region of interest (ROI) that covers the catheter tip and a second region of interest (ROI) that includes a tissue ablation region.
This claim contains limitations that are similar to claims 1 and 19 rejected above and are therefore not allowable for the same reasons given above with regard to claims 1 and 19.
process the second ICE image to generate a smoothed ICE image, the smoothed
ICE image having smoothed boundaries between a background region, the first ROI, and
the second ROI; and display the smoothed second ICE image (Sheeran Abstract, [0002]-[0003]; Srinivasa [0005], [0008], [0049]).
Reducing or eliminating reverberation is considered by one skill in the art at performing smoothing on the image (see Li CN 106897687 for further clarification if needed).
Conclusion
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/WEDNEL CADEAU/Primary Examiner, Art Unit 2632 January 5, 2026