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 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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Cannata et al (US Pub. 2024/0350153) in view of Lin et al (US Pub. 2025/0078277).
With respect to claim 1, Cannata discloses An ultrasound apparatus comprising processing circuitry configured to (see Figure 3A): receive ultrasound data from an ultrasound transducer, wherein the ultrasound transducer is for moving across a region of a patient or other subject to locate a target feature; generate a sequence of images from the ultrasound data, each image representing a view of the subject at a respective position of the transducer, (see figure 1B, and see paragraph 0050, wherein …navigating a combined imaging and treatment transducer assembly to a location on a patient enabling visualization of a region of interest; performing an ultrasound sweep using the imaging transducer of the combined imaging and treatment transducer assembly to capture a volume of ultrasound images…);
However, Cannata fails to explicitly disclose determine differences between images in the sequence and use the differences to determine a part of the sequence that corresponds to a sweep motion by the transducer and a part of the sequence that corresponds to a measurement motion by the transducer, as claimed.
Lin teaches determine differences between images in the sequence and use the differences to determine a part of the sequence that corresponds to a sweep motion by the transducer and a part of the sequence that corresponds to a measurement motion by the transducer, (see paragraph 0012, wherein …determining (302) which of the plurality of image frames in the CEUS sequence is an out-of-plane frame based on the comparing step and a criterion, generating an optimized set of CEUS frames by removing (304) a determined out-of-plane frame…[in this out-of-plane frame is read as “a sweep motion” and optimized set is read as “a measurement motion” images in the sequence), as claimed.
It would have been obvious to one ordinary skilled in the art at the effective date of invention to combine the two references as they are analogous because they are solving similar problem of image quality enhancement in ultrasound imagine. Teaching of Lin of getting the optimized images from the sequence of images by discarding the out of plane images can be incorporated into the Cannata system as suggested, (see Cannata, paragraph 0182, …goal of trimming the sweep is to remove any ultrasound images that do not contain clear data…), for suggestion, and modifying the system will yield an ultrasound with all the best quality images (see Lin paragraph 0007), for motivation.
With respect to claim 2, combination of Cannata and Lin further discloses wherein the processing circuitry is configured to use the differences between images to determine a part of the sequence that corresponds to a translation motion for centring or otherwise positioning the target feature on one on of the images prior to the measurement motion, (see Cannata paragraph 0007, wherein …The indicator is depicted upon movement of the therapy transducer to a location at which the focal point coincides with the survey point. The instructions when executed by the processor receive in input of a location of an intersection of a muscle layer and a fat layer in the live ultrasound images…), as claimed.
With respect to claim 3, combination of Cannata and Lin further discloses wherein the processing circuitry is configured to assign a location to the target feature based on a position of the transducer during the part of the sequence corresponding to the measurement motion, (see Cannata paragraph 0007, wherein …The indicator is depicted upon movement of the therapy transducer to a location at which the focal point coincides with the survey point. The instructions when executed by the processor receive in input of a location of an intersection of a muscle layer and a fat layer in the live ultrasound images…), as claimed.
With respect to claim 4, combination of Cannata and Lin further discloses wherein the processing apparatus is configured to process the sequence of ultrasound images to identify at least one anatomical feature in at least some of the images thereby to determine a position of the transducer with respect to the patient or other subject, (see Cannata paragraph 0123, wherein …In one aspect, the system allows the user to image and identify a region of interest, for example the liver, using integrated ultrasound…), as claimed.
With respect to claim 5, combination of Cannata and Lin further discloses wherein the at least one anatomical feature comprises at least one of a liver edge, blood vessel, a vascular structure, a branch point of a blood vessel or other vascular structure, a part of the liver or a liver segment, (see Cannata paragraph 0210, wherein … Adjustment of the focal point 726 may be required if the planned treatment volume cannot encompass the distal edge of the target tumor. The planned treatment volume may not be able to encompass the distal edge of the target tumor if moving the treatment head further would impinge on the patient's abdomen…), as claimed.
With respect to claim 6, combination of Cannata and Lin further discloses wherein the identifying of the at least one anatomical feature comprises matching at least one of the images in the sequence to at least one atlas, reference image or other reference data set, (see Cannata paragraph 0201, wherein … As described below, the value denoted in the indicators 730 can be adjusted by knobs 28, and thus the target contour 728 can be adjusted to more closely match the target contour 728 to the actual shape and size of the tumor or lesion to be treated…), as claimed.
With respect to claim 7, combination of Cannata and Lin further discloses wherein the at least one atlas, reference image or other reference data set comprises at least one liver plane, (see Cannata paragraph 0186, wherein … Finally, an image-based algorithm is engaged which seeks to match structures between the two image volumes… [one of the two images is read as “reference”), as claimed.
With respect to claim 8, combination of Cannata and Lin further discloses wherein the processing circuitry is configured to match the images to an ordered series of liver planes, (see Cannata paragraph 0135, wherein …this may include a linear pattern and pathway that traverses a spherical treatment volume in a series of axial slices (parallel to the imaging plane), beginning with the center slice within the treatment volume and progressing outward in the positive x-dimension (relative to the transducer array) until the entire +x-half of the spherical treatment volume is treated. The treatment then moves to the untreated slice adjacent to the center and treats the remaining half of the spherical volume in an analogous manner… [adjacent is read as the ordered series]), as claimed.
With respect to claim 9, combination of Cannata and Lin further discloses the measurement motion comprises at least a rotational motion, (see Cannata paragraph 0160, wherein …imaging probe 22 is configured to translate (extend) beyond the therapy transducer 18 by rotation of dial 38. In FIG. 2, the imaging probe 22 is depicted in its retracted position. An orientation and rotation tab 40 operatively connects to the imaging probe and enables 90 (degrees of) rotation of the imaging probe 22 relative to the therapy transducer 18…), as claimed.
With respect to claim 10, combination of Cannata and Lin further discloses the processing apparatus is configured to determine at least one of the rotational motion or the translational motion or the alignment motion based on differences between the images in the sequence, (see Cannata paragraph 0160, wherein …imaging probe 22 is configured to translate (extend) beyond the therapy transducer 18 by rotation of dial 38. In FIG. 2, the imaging probe 22 is depicted in its retracted position. An orientation and rotation tab 40 operatively connects to the imaging probe and enables 90 (degrees of) rotation of the imaging probe 22 relative to the therapy transducer 18…), as claimed.
With respect to claim 11, combination of Cannata and Lin further discloses the differences between images comprise differences in registrations, wherein the registrations are between the images in the sequence and one or more reference images, (see Cannata paragraph 0186, wherein …Finally, an image-based algorithm is engaged which seeks to match structures between the two image volumes. The result is a registration and ultimately a fusion of the ultrasound images from the ultrasound sweep and the pre-procedural or peri-procedural images as depicted in FIG. 28…), as claimed.
With respect to claim 12, combination of Cannata and Lin further discloses the identifying of at least one of the rotational motion or translational motion or alignment motion comprises comparing a measure of the differences between the images to a threshold, (see Lin paragraph 0059, wherein …Regardless of the type of criterion selected, a comparison to a threshold value, for example, will determine whether a particular frame should be discarded as being an OOP frame…), as claimed.
With respect to claim 13, combination of Cannata and Lin further discloses wherein the sweep motion comprises a linear or curved motion that is in a different direction to a linear or curved motion that may be included in the measurement motion, (see Cannata paragraph 0120, wherein … In other embodiments, the imaging solution may be able to move or adjust its position, including modifying angle, extension (e.g., distance from therapy transducer or patient), rotation (e.g., imaging plane in example of an ultrasound probe) and/or other parameters, including moving/adjusting dynamically while actively imaging. The imaging component or probe may be encoded so its orientation and position relative to another aspect of the system, such as the therapy transducer, and/or robotically-enabled positioning component may be determined…), as claimed.
With respect to claim 14, combination of Cannata and Lin further discloses wherein the processing circuitry is configured to use the differences between the images to determine a direction of motion of the transducer, (see Lin 0105, wherein … the measured similarity distance is compared to a pre-selected threshold criterion. The threshold criterion may be a value between 0 and 1 above which indicates a likelihood that the image frame is out-of-lane. Examples of the threshold criterion may be seen in the example graphs of FIGS. 10b and 11b as within a range of about 0.2 to 0.8, with a particular example of 0.5. Calculated similarity distances above the threshold criterion are determined to be out-of-plane frames), as claimed.
With respect to claim 15, combination of Cannata and Lin further discloses the differences between the images comprises at least one of a difference between shape, size, orientation of at least one feature in the images or a change in spacing or relative size or orientation of a plurality of features in the images, (see Cannata paragraph 0160, wherein … it is envisioned that a different shaped or sized treatment head 20 may be utilized when targeting treatment volumes and depths within the brain compared to, for example, abdominal locations such as liver or kidney…), as claimed.
With respect to claim 16, combination of Cannata and Lin further discloses at least one of: i) the target feature comprises a lesion or other pathology; ii) the measurement motion comprises a motion associated with a measurement procedure for measuring a size or other property of the target feature; ii) the apparatus further comprises the transducer. (see Cannata paragraph 0174, wherein, …. The coupling assembly 46 includes a conformal and flexible barrier film or membrane 48 that allows the coupling medium contained in the coupling assembly 46 while conforming to the shape and anatomy of the patient, and ensuring a suitable ultrasound coupling between the therapy transducer 18 (and the imaging probe 22), to the patient…), as claimed.
With respect to claim 17, combination of Cannata and Lin further discloses wherein the assigning of a location to the target feature comprises assigning the target feature to a liver segment of a plurality of liver segments arranged in accordance with the Couinard segmentation or other segmentation scheme, (see Cannata paragraph 0197, wherein …In other embodiments, the DICOM data comprising the pre-procedure imaging may also be modified in various manners, including various segmentations (organs, structures, unwanted tissue volumes, etc.), pre-plans comprising simulated contours and placement of, and/or other visualization features that may be used to inform targeting and localization and treatment planning in subsequent work-flow steps…), as claimed.
With respect to claim 18, combination of Cannata and Lin further discloses the processing circuitry is configured to apply a trained model to the ultrasound data or the images thereby to determine the differences between images and/or to determine the part of the sequence that corresponds to the sweep motion by the transducer and the part of the sequence that corresponds to the measurement motion, (see Lin figure 8 numerical 820 CNN), as claimed.
With respect to claim 19, combination of Cannata and Lin further discloses a user input device and the processing circuitry is configured to perform at least one of the following based on user input received via the user input device: i) record the start or end of a sweep motion or measurement motion; ii) confirm or reject an assigned location of the target feature; iii) accept or reject a candidate target feature; iv) record measurement data; or v) provide an output indicating that the transducer has returned to, or providing guidance as to how to return to, a previous sweep position or measurement position thereby to allow resumption of a sweep motion or measurement motion, (see Cannata figure 1A, a monitor and key board), as claimed.
Claim 20 is rejected for the same reasons as set forth in the rejections for claim 1, because claim 20 is claiming subject matter of similar scope as claimed in claim 1.
Conclusion
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/VIKKRAM BALI/ Primary Examiner, Art Unit 2663
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