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 .
Election/Restrictions
Applicant’s election of Species B, claims 16-17 in the reply filed on 5/28/2026 is acknowledged. Claims 6-15 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species. Accordingly, claims 1-5 and 16-17 remain pending for examination.
Claim Objections
Claims 1-5 and 16-17 is/are objected to because of the following informalities:
Claim(s) 1 recite(s) the limitation “such that […]”. It is suggested to replace the phrase “such that” with the term —wherein— to ensure the positive recitation of all elements in the claim. The use of the phrase “such that” may be interpreted as a negative limitation in the claim, resulting in an interpretation of subsequent limitations (i.e., “such that the location and orientation of the ultrasound probe in space at the acquisition of each of the ultrasound images is known; and” in claim 1) as preferred or suggested limitations, and therefore may be excluded from examination.
Similarly claims 3 and 4 recite “such that” limitations that are suggested to be replaced with —wherein— to ensure the positive recitation of all elements in the claim.
Claims 1, 3-5 and 16 recite the limitation “and/or”, resulting in the creation of multiple interpretations of this and dependent claims based on the use of “and”, “or”, or both. Furthermore, claims 1, 3-5 and 16 do not appear to be proper Markush type claims. It is suggested to replace all instances of “and/or” with either “and” alone or “or” alone. For the purposes of examination, the broadest reasonable interpretation of the claim was implemented. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 3-4 and 17 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites “wherein the ultrasound probe includes a transducer and wherein the robotic system is configured to maintain an orientation of the transducer of the ultrasound probe such that it is substantially parallel to a tangent to a center of the subject's pelvis and/or an abdomen as the robotic system moves the ultrasound probe” which renders the claim indefinite. The limitation “substantially parallel to a tangent to a center of the subject's pelvis and/or an abdomen as the robotic system moves the ultrasound probe” is unclear, in part because the term “substantially” is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is no reasonable degree or range of how near ‘parallel to a tangent to a center’ the orientation must be. Furthermore, it is unclear what the ‘center’ of the ‘subject's pelvis and/or an abdomen’ is particularly referring to, because there is no definition of an explicit ‘center’ of either the pelvis or abdomen. It is not certain if the ‘center’ refers to an anatomical landmark, an anatomical feature, or some other aspect of the anatomy. It is suggested to amend the claim to clearly define the pattern of motion of the ultrasound probe by the robotic system. For the purposes of examination the broadest reasonable interpretation is any anatomical ‘center’ derived from ultrasound imaging data.
Claim 4 recites “wherein the robotic system is configured to maintain an orientation of the transducer of the ultrasound probe such that the ultrasound transducer is substantially directly facing a coronal plane of the subject's body at the subject's abdomen and/or pelvis as the robotic system moves the ultrasound probe” which renders the claim indefinite. The limitation “substantially directly facing a coronal plane of the subject's body at the subject's abdomen and/or pelvis as the robotic system moves the ultrasound probe” is unclear, in part because the term “substantially” is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is no reasonable degree or range of how near ‘directly facing a coronal plane’ the orientation must be. It is suggested to amend the claim to clearly define the pattern of motion of the ultrasound probe by the robotic system. For the purposes of examination the broadest reasonable interpretation of the orientation of the ultrasound imaging probe is applied to the limitation.
Claim 17 recites “subtract images that were acquired within the first set of ultrasound images from the images that were acquired within the second set of ultrasound images, such as to generate a set of subtraction images, […]” which renders the claim indefinite. The use of ‘images’ in each instance which are subtracted is unclear and may lack sufficient antecedent basis; it is unclear what ‘images’ are being acquired or how they are selected/extracted from either of the first or second set of ultrasound images. Furthermore, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase (i.e., generating a set of subtraction images each corresponding to a given location and orientation of the ultrasound probe) are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 3-5 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cannata et al. (US20200346046A1, 2020-11-05; hereinafter “Cannata”).
Regarding claim 1, Cannata teaches an apparatus for identifying abnormal tissue within a body of a subject, and for use with at least one ultrasound probe (“A method of treating tissue with an ultrasound therapy system,” [clm 1]; “the system may comprise onboard ultrasound, further configured to allow users to visualize, monitor and receive feedback for procedure sites […] including allowing ultrasound imaging and characterization (and various forms of), ultrasound guided planning and ultrasound guided treatment, all in real-time. The system may be configured to allow users to manually, semi-automated or in fully automated means image the patient” [0145]; [0086-0101, 0143-0192], [fig. 1A-1B]), the apparatus comprising:
a robotic system (“a therapy transducer 102, an imaging system 104, a display and control panel 106, a robotic positioning arm 108, and a cart 110.” [0094]; [fig. 1A]) comprising:
one or more robotic arms (“The robotic arm can be mounted to the mobile therapy cart on arm base […] The arm may be controlled through the histotripsy system software as well as a 12 inch touchscreen polyscope with a graphical user interface.” [0090]; [0086-0101], [fig. 1A-1B; see fig. 1A reproduced below]); and
an ultrasound probe supporting portion that is configured to hold the ultrasound probe (“The therapy head can comprise one of a select group of four histotripsy therapy transducers and an ultrasound imaging system/probe, coaxially located in the therapy transducer, with an encoded mechanism to rotate said imaging probe independent of the therapy transducer to known positions, […] The therapy head subsystem has an interface to the robotic arm includes a quick release mechanism to allow removing and/or changing the therapy head to allow cleaning, replacement and/or selection of an alternative therapy transducer design (e.g., of different number of elements and geometry)” [0091]; “an imaging system 104, a display and control panel 106, a robotic positioning arm 108, and a cart 110. The system can further “One or more robotic arms may also comprise various features to assist in maneuvering and modifying the arm position, manually or semi-manually, and of which said features may interface on or between the therapy transducer and the most distal joint of the robotic arm.” [0170]; [0086-0101, 0143-0192], [fig. 1A-1B; see fig. 1A reproduced below]);
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The robotic positioning arm 108 holds the ultrasound imaging probe 102 during an ultrasound procedure operated from the display and control panel 106 on cart 110 (Cannata [fig. 1A])
the robotic system being configured to maintain the ultrasound probe at a constant orientation in space as the robotic system moves the ultrasound probe (“Systems may be configured to include onboard integrated imaging hardware, software, sensors, probes and wetware, […] 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.” [0144]; “The robotic arm receives control signals and commands from the robotic control system, which may be housed in a Cart. The system may be configured to provide various functionalities, including but not limited to, position, tracking, patterns,” [0163]; “Tracking may be configured to comprise time-controlled tracking and/or distance-controlled tracking.” [0165]; The robotic arm may use distance-controlled positions/tracking to maintain the pose of the ultrasound probe and distance relative to the patient/cart movement during the procedure [0086-0101, 0143-0192], [fig. 1A-1B]); and
at least one computer processor (“A system is provided, comprising one or more ultrasound transducers […], and one or more computer processors configured to control power and position of said ultrasound transducers, wherein said one or more processors are configured to implement a treatment pattern” [0060]; “The mobile therapy cart architecture can comprise internal components, housed in a standard rack mount frame, […] robot controller, computer, router and modem, and an ultrasound imaging engine.” [0088]; [0143-0192], [fig. 1A-1B]) configured:
to drive the robotic system to acquire ultrasound images of the subject's pelvis and/or abdomen while moving relative to the subject's pelvis and/or abdomen, such that the location and orientation of the ultrasound probe in space at the acquisition of each of the ultrasound images is known (“the cart may be positioned to provide sufficient work-space and access to various anatomical locations on the patient (e.g., torso, abdomen, […] etc.), as well as providing work-space for other systems” [0097]; “the imaging solution may be able to move or adjust its position, […] 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.” [0144]; “The system may be configured to allow users to manually, semi-automated or in fully automated means image the patient (e.g., by hand or using a robotically-enabled imager).” [0145]; “The robotic arm receives control signals and commands from the robotic control system, which may be housed in a Cart. The system may be configured to provide various functionalities, including but not limited to, position, tracking, patterns” [0163]; “The therapy transducer may also comprise an integrated imaging probe or localization sensors, capable of displaying and determining transducer position within the treatment site and affording a direct field of view (or representation of) the treatment site, […] and as a function of its location within said treatment (e.g., tumor, healthy tissue surrounding, critical structures, adipose tissue, etc.).” [0196]; [0086-0101, 0143-0192], [fig. 1A-1B]); and
to identify abnormal tissue based upon the ultrasound images (“identifying a target tissue volume with the ultrasound therapy system;” [clm 1]; “wherein the target tissue volume is contoured to a tumor.” [clm 3]; “various image processing and characterization technologies may also be utilized to afford enhanced visualization and user decision making. These may be selected or commanded manually by the user or in an automated fashion by the system. The system may be configured to allow side by side, toggling, overlays, 3D reconstruction, segmentation, registration, multi-modal image fusion, […] as displayed in the various system user interfaces and displays. Examples may include locating, displaying and characterizing regions of interest, organ systems, potential treatment sites within, with on and/or surrounding organs or tissues, identifying critical structures such as ducts, […] tumors, tissue trauma/injury/disease, other organs, connective tissues, etc.,” [0143]; “The system may further include the ability to conduct image registration, including imaging and image data set registration to allow navigation and localization of the system to the patient, including the treatment site (e.g., tumor, critical structure, bony anatomy, anatomy and identifying features of, etc.)” [0156]; “The system may also be configured, through various aforementioned parameters and other parameters, to display real-time visualization of a bubble cloud in a spatial-temporal manner, including the resulting tissue effect peri/post-treatment from tissue/bubble cloud interaction, wherein the system can dynamically image and visualize, and display, the bubble cloud, and any changes to it (e.g., decreasing or increasing echogenicity), which may include intensity, shape, size, location, morphology, persistence, etc.” [0158]; “Overall, in no specific order of importance, the software may provide features and support to initialize and set up the system, […] imaging support for measuring/characterizing various dimensions within or around procedure and treatment sites (e.g., depth from one anatomical location to another, etc., pre-treatment assessments and protocols for measuring/characterizing in situ treatment site properties and conditions (e.g., acoustic cavitation/histotripsy thresholds and heterogeneity of), targeting and target alignment, calibration, marking/annotating, localizing/navigating, registering, guiding, providing and guiding through work-flows, procedure steps, executing treatment plans and protocols autonomously, autonomously and while under direct observation and viewing with real-time imaging as displayed through the software, including various views and viewports for viewing, communication tools (video, audio, sharing, etc.),” [0183]; The system may automatically segment and register anatomical regions of interest from ultrasound images [0086-0101, 0143-0192, 0243-0250], [fig. 1A-1B]).
Regarding claim 3, Cannata teaches the apparatus according to claim 1,
Cannata further teaching wherein the ultrasound probe includes a transducer (“Systems may be configured to include onboard integrated imaging hardware, software, sensors, probes and wetware, […] The aforementioned components may be also integrated into the system's Therapy sub-system components wherein probes, imaging arrays, or the like, and electrically, mechanically or electromechanically integrated into therapy transducers. This may afford, in part, the ability to have geometrically aligned imaging and therapy, with the therapy directly within the field of view, and in some cases in line, with imaging.” [0144]; “backscatter feedback can be monitored by any transducer or ultrasonic imager. By measuring feedback for the therapy transducer, an accessory transducer can send out interrogation pulses or be configured to passively detect cavitation.” [0147]; Ultrasound imaging probe comprises transducer(s) to transmit ultrasound pulses and detect reflections [0086-0101, 0143-0192, 0243-0250], [fig. 1A-1B]) and
wherein the robotic system is configured to maintain an orientation of the transducer of the ultrasound probe such that it is substantially parallel to a tangent to a center of the subject's pelvis and/or an abdomen as the robotic system moves the ultrasound probe (“the cart may be positioned to provide sufficient work-space and access to various anatomical locations on the patient (e.g., torso, abdomen, […] etc.), as well as providing work-space for other systems” [0097]; “Systems may be configured to include onboard integrated imaging hardware, software, sensors, probes and wetware, […] 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.” [0144]; “The robotic arm receives control signals and commands from the robotic control system, which may be housed in a Cart. The system may be configured to provide various functionalities, including but not limited to, position, tracking, patterns,” [0163]; “Tracking may be configured to comprise time-controlled tracking and/or distance-controlled tracking.” [0165]; [0086-0101, 0143-0192, 0243-0250], [fig. 1A-1B], [see claim 1 rejection]).
Regarding claim 4, Cannata teaches the apparatus according to claim 1,
Cannata further teaching wherein the ultrasound probe includes a transducer (“Systems may be configured to include onboard integrated imaging hardware, software, sensors, probes and wetware, […] The aforementioned components may be also integrated into the system's Therapy sub-system components wherein probes, imaging arrays, or the like, and electrically, mechanically or electromechanically integrated into therapy transducers. This may afford, in part, the ability to have geometrically aligned imaging and therapy, with the therapy directly within the field of view, and in some cases in line, with imaging.” [0144]; “backscatter feedback can be monitored by any transducer or ultrasonic imager. By measuring feedback for the therapy transducer, an accessory transducer can send out interrogation pulses or be configured to passively detect cavitation.” [0147]; [0086-0101, 0143-0192, 0243-0250], [fig. 1A-1B], [see claim 3 rejection]) and
wherein the robotic system is configured to maintain an orientation of the transducer of the ultrasound probe such that the ultrasound transducer is substantially directly facing a coronal plane of the subject's body at the subject's abdomen and/or pelvis as the robotic system moves the ultrasound probe (“the cart may be positioned to provide sufficient work-space and access to various anatomical locations on the patient (e.g., torso, abdomen, […] etc.), as well as providing work-space for other systems” [0097]; “Systems may be configured to include onboard integrated imaging hardware, software, sensors, probes and wetware, […] 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.” [0144]; “The robotic arm receives control signals and commands from the robotic control system, which may be housed in a Cart. The system may be configured to provide various functionalities, including but not limited to, position, tracking, patterns,” [0163]; “Tracking may be configured to comprise time-controlled tracking and/or distance-controlled tracking.” [0165]; [0086-0101, 0143-0192, 0243-0250], [fig. 1A-1B], [see claim 1 rejection])
Regarding claim 5, Cannata teaches the apparatus according to claim 1,
Cannata further teaching wherein the computer processor is further configured to drive the ultrasound probe to apply ablative ultrasound energy to the abnormal tissue while moving the ultrasound probe relative to the subject's pelvis and/or abdomen, at a position and orientation of the ultrasound probe that is the same as the location and orientation of the ultrasound probe at acquisitions of the ultrasound images, in response to identifying the abnormal tissue (“identifying a target tissue volume with the ultrasound therapy system; dividing the target tissue volume into a plurality of treatment volumes with the ultrasound therapy system; positioning a focus of the ultrasound therapy system within a first of the plurality of treatment volumes; forming a cavitation bubble cloud at the focus;” [clm 1]; “Transducers may be designed and optimized for clinical applications (e.g., abdominal tumors, peripheral vascular disease, fat ablation, etc.) and desired outcomes (e.g., acoustic cavitation/histotripsy without thermal injury to intervening tissue)” [0142]; “The system may be configured to provide various functionalities, including but not limited to, position, tracking, patterns, triggering, and events/actions” [0163]; Target tissue volume is identified from ultrasound imaging, and therapy pulses for histotripsy are transmitted based on selecting the desired treatment regions [0086-0101, 0143-0192, 0243-0250], [fig. 1A-1B], [see claim 4 rejection]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being obvious over Cannata as applied to claim 1 above, in view of Schnorr (US20200395117A1, 2020-12-17; hereinafter “Schnorr”).
Regarding claim 2, Cannata teaches the apparatus according to claim 1, Cannata further teaching wherein the computer processor is configured to identify lesions based upon the ultrasound images (“the cart may be positioned to provide sufficient work-space and access to various anatomical locations on the patient (e.g., torso, abdomen, flank, head and neck, etc.),” [0097]; “The system may be configured to allow side by side, toggling, overlays, 3D reconstruction, segmentation, registration, multi-modal image fusion, image flow, […] Examples may include locating, displaying and characterizing regions of interest, organ systems, potential treatment sites within, with on and/or surrounding organs or tissues, identifying critical structures such as ducts, vessels, nerves, ureters, fissures, capsules, tumors, tissue trauma/injury/disease,” [0143]; [0086-0101, 0143-0192, 0243-0250], [fig. 1A-1B], [see claim 1 rejection]);
but Cannata may fail to explicitly teach identifying endometriosis lesions.
However, in the same field of endeavor, Schnorr teaches an apparatus for identifying abnormal tissue within a body of a subject, and for use with at least one ultrasound probe (“The reference image may be processed according to one or more adaptive processing frameworks for de-speckling or noise processing of ultrasound images” [abst]; “A system for digital image processing in assisted reproductive technologies,” [clm 1]; “said ANN system and method for pre-processing or processing one or more imaging modalities in the provision of ART for the diagnosis, treatment and clinical management of clinical infertility. In various embodiments, the imaging modality preferably comprises ultrasound […] the images comprise reproductive anatomy, including but not limited to a cell, fallopian tube, ovary, ovum, ova, follicle, cyst, uterus, uterine lining, endometrial thickness, uterine wall, eggs, blood vessels, or the like” [0024]; [0070-0104], [fig. 1A]);
Schnorr further teaching wherein the computer processor is configured to identify endometriosis lesions based upon the ultrasound images (“the said system and method enables object detection, localization, counting, and tracking over time of one or more reproductive anatomy from one or more US images. In various embodiments, the reproductive anatomy includes but is not limited to a(n): ovary, cyst, cystic ovary, polycystic ovary, […] uterus, endometrial pattern, endometrial thickness, or the like.” [0026]; “a chosen CNN architecture and method enable the detection, recognition, annotation, segmentation, or classification of a(n): ovary, cyst, cystic ovary, polycystic ovary, follicle, antral follicle, or the like.” [0110]; The trained network applied by the system analyzes ultrasound images of the reproductive anatomy and may perform object detection to detect cysts (i.e., identify endometriosis lesions), and may further count and track cysts and other tissue features over time [0070-0104], [fig. 1A]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to combine the apparatus for identifying abnormal tissue taught by Cannata by identifying endometriosis lesions as taught by Schnorr. Imaging modalities such as US that form images with coherent energy suffer from speckle noise, which can impair the performance for automated operations such as computer aided diagnostics (CAD) to differentiate benign and malignant lesion tissues for cancer diagnosis (Schnorr [0008]). This feedback and monitoring technique may permit early observation of changes resulting from the acoustic cavitation/histotripsy process and can identify changes in tissue before substantial or complete tissue effect (e.g., erosion occurs) (Cannata [0150]). Computer aided diagnostics (CAD) based on deep learning (DL) has the potential to improve the performance of assisted reproductive technology (ART) (Schnorr [0011]).
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being obvious over Cannata as applied to claim 1 above, in view of Chang (US20110208061A1, 2011-08-25; hereinafter “Chang”).
Regarding claim 16, Cannata teaches the apparatus according to claim 1,
Cannata further teaching wherein the apparatus is for use with a contrast agent configured to enhance the abnormal tissue within ultrasound images (“Imaging modalities may comprise various ultrasound, x-ray, CT, MRI, PET, fluoroscopy, optical, contrast or agent enhanced versions, and/or various combinations of.” [0143]; “imaging feedback and monitoring can include monitoring changes in: backscatter from bubble clouds; speckle reduction in backscatter; backscatter speckle statistics; mechanical properties of tissue (i.e., elastography); tissue perfusion (i.e., ultrasound contrast);” [0146]; [0086-0101, 0143-0192, 0243-0250], [fig. 1A-1B]), and
wherein the computer processor is configured:
prior to the contrast agent having been administered to the subject, to drive the robotic system to acquire a first set of ultrasound images of the subject's pelvis and/or abdomen by moving the ultrasound probe while maintaining the probe at the constant orientation at the acquisition of each of the ultrasound images belonging to the first set of ultrasound images (“Systems may be configured to include onboard integrated imaging hardware, software, sensors, probes and wetware, […] 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.” [0144]; “The robotic arm receives control signals and commands from the robotic control system, which may be housed in a Cart. The system may be configured to provide various functionalities, including but not limited to, position, tracking, patterns,” [0163]; Ultrasound imaging may be performed without contrast agent applied [0086-0101, 0143-0192, 0243-0250], [fig. 1A-1B], [see claim 1 rejection]);
subsequent to the contrast agent having been administered to the subject, to drive the robotic system to acquire a second set of ultrasound images of the subject's pelvis and/or abdomen by moving the ultrasound probe while maintaining the probe at the constant orientation at the acquisition of each of the ultrasound images belonging to the second set of ultrasound images is known (“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.” [0144]; “imaging feedback and monitoring can include monitoring changes in: backscatter from bubble clouds; speckle reduction in backscatter; backscatter speckle statistics; mechanical properties of tissue (i.e., elastography); tissue perfusion (i.e., ultrasound contrast);” [0146]; Ultrasound images may be obtained after contrast agent is used [0086-0101, 0143-0192, 0243-0250], [fig. 1A-1B]);
but Cannata may fail to explicitly teach analyzing the first and second sets of ultrasound images.
However, in the same field of endeavor, Chang teaches an apparatus for identifying abnormal tissue within a body of a subject, and for use with at least one ultrasound probe (“An ultrasonic diagnostic imaging system for identifying a lesion in a region of interest” [clm 1]; “the probe is commanded to acquire an ultrasonic image” [0017]; [fig. 1]);
Chang further teaching wherein the apparatus is for use with a contrast agent configured to enhance the abnormal tissue within ultrasound images (“a sequence of spatial data sets detecting the rise and fall of an amount of contrast agent which perfuses the region of interest;” [clm 1]; “This invention relates to medical diagnostic ultrasound systems and, in particular, to ultrasound systems which perform contrast-enhanced imaging studies to identify and characterize lesions” [0001]; [0017-0025], [fig. 1, 3]), and
wherein the computer processor (“Control of the ultrasound system and of various control setting for imaging such as probe selection is effected by user manipulation of the controls of a control panel 20 which is coupled to and applies its control through the central controller 28.” [0018]; “The two dimensional image signals from the contrast signal processor 38, the B mode processor 36 and the Doppler processor 40,” [0022]; [fig. 1]) is configured:
prior to the contrast agent having been administered to the subject, to drive the robotic system to acquire a first set of ultrasound images of the subject's pelvis and/or abdomen by moving the ultrasound probe while maintaining the probe at the constant orientation at the acquisition of each of the ultrasound images belonging to the first set of ultrasound images (“Such a perfusion curve 60 may be formed of a succession of echo signals acquired from a particular point in the body as a contrast agent arrives at the point at time t0, rises to a maximum intensity as the amount of contrast builds up, then decreases as the contrast agent washes out of that point of the vasculature.” [0023]; “The first step 70 is to acquire ultrasound image data as the contrast agent washes into and out of the region of the body being examined. […] Images are acquired as the contrast agent washes into and out of the region of the body being studied so that all of the points in the suspect area are rapidly sampled for the presence of contrast agent. The acquired data is stored for analysis. The image data is reviewed to identify a region of interest (ROI) for analysis as step 72.” [0024]; Ultrasound images are taken of the abdomen prior to the administration of contrast agent at t0 (i.e., first set of ultrasound images) and throughout the examination as contrast washes into and out of the tissue [0017-0028], [fig. 1-3]);
subsequent to the contrast agent having been administered to the subject, to drive the robotic system to acquire a second set of ultrasound images of the subject's pelvis and/or abdomen by moving the ultrasound probe while maintaining the probe at the constant orientation at the acquisition of each of the ultrasound images belonging to the second set of ultrasound images is known (“Filtered echo signals of a contrast agent, such as microbubbles, are coupled to a contrast signal processor 38. Contrast agents are often used to more clearly delineate blood vessels, or to perform perfusion studies of the microvasculature of tissue […] The contrast signal processor 38 preferably separates echoes returned from harmonic contrast agents by the pulse inversion technique” [0020]; “Such a perfusion curve 60 may be formed of a succession of echo signals acquired from a particular point in the body as a contrast agent arrives at the point at time t0, rises to a maximum intensity as the amount of contrast builds up, then decreases as the contrast agent washes out of that point of the vasculature.” [0023]; “time-intensity curve levels are set as indicated in step 76 which define three successive periods of time, a wash-in period as the contrast agent builds up, an enhancement period as a maximal level of contrast agent is sustained at each point, and a wash-out period as the contrast agent flows out of the ROI points. […] Parametric images may then be formed of each of the time period times” [0024]; “Three parametric images may be formed of these time period parameters, one where each image pixel is encoded in accordance with its wash-in time period value, another where each pixel is encoded with its enhancement time period value, and a third where each pixel is encoded with its wash-out time period value.” [0026]; Ultrasound images are taken after contrast agent has arrived at the tissue region of interest [0017-0028], [fig. 1-3]); and
to identify the abnormal tissue by analyzing the first and second sets of ultrasound images (“Parametric images may then be formed of each of the time period times as stated in step 78. One or more of the parametric images of the time periods are'then used to delineate a lesion or its boundary in step 80.” [0024]; “Abnormal tissue is characterized by a relatively fast wash-in (short rise time period), a fast enhancement (short enhancement time period), and a fast wash-out (short fall time period). The clinician can observe the time periods in an area of normal tissue outside the lesion and then observe the time periods inside a suspected lesion in the color-coded image, or the quantification of the three time periods at normal and suspect image locations. The comparison will indicate the differences between normal and abnormal tissue.” [0026]; The ultrasound images before and after contrast agent is introduced of the tissue region of interest are compared to detect lesions [0017-0028], [fig. 1, 3]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to combine the apparatus for identifying abnormal tissue taught by Cannata by analyzing the first and second sets of ultrasound images using contrast agent as taught by Chang. Since a contrast agent can be applied in a bolus injection, and can also be disrupted by relatively intense ultrasound and allowed to reperfuse tissue, temporal characteristics of the arrival and departure of the contrast agent can also be measured and used for diagnosis. These parameters include the peak and the slope of the curves, each indicating a different characteristic of the tissue perfusion (Chang [0003]). It is known that lesions will develop their own unique microvasculature to provide a flow of blood to pathology such as cancerous lesions. Consequently the parameters of the time-intensity curve have been used to try to, first, identify a lesion and then to distinguish the lesion from surrounding normal tissue. It is desirable to more definitively locate a lesion in a contrast agent exam so that its size, shape, and particularly its border can be precisely located for subsequent treatment procedures such as hyperthermic and radiofrequency ablation therapy (Chang [0006]). By measuring backscatter feedback for the therapy transducer using an ultrasonic imager, the nature of the feedback received can be used to adjust acoustic parameters (and associated system parameters) to optimize the drug delivery and/or tissue erosion process (Cannata [0147]).
Regarding claim 17, Cannata and Chang teach the apparatus according to claim 16,
Chang further teaching wherein the computer processor is configured to subtract images that were acquired within the first set of ultrasound images from the images that were acquired within the second set of ultrasound images, such as to generate a set of subtraction images, each of the subtraction images corresponding to a given location and orientation of the ultrasound probe in space (“Consequently the parameters of the time-intensity curve have been used to try to, first, identify a lesion and then to distinguish the lesion from surrounding normal tissue. One way this may be done is to compute and parametrically image the perfusion curve parameters of the lesion and of the normal tissue, then compare the results. Such measurements and comparisons have been used with varying results to identify and distinguish the area, shape and size of lesions.” [0006]; “benign lesions tend to have longer enhancement and slower fall time periods than malignant lesions, the latter tending to have shorter enhancement and faster fall time periods than benign lesions. By observing the appearance of the normal tissue background in comparison with the lesion during the time period, an indication of possible malignancy is provided.” [0027]; [0017-0028], [fig. 1, 3], [see claim 16 rejection]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to combine the apparatus for identifying abnormal tissue taught by Cannata by analyzing the first and second sets of ultrasound images using contrast agent as taught by Chang. Since a contrast agent can be applied in a bolus injection, and can also be disrupted by relatively intense ultrasound and allowed to reperfuse tissue, temporal characteristics of the arrival and departure of the contrast agent can also be measured and used for diagnosis. These parameters include the peak and the slope of the curves, each indicating a different characteristic of the tissue perfusion (Chang [0003]). Boundary delineation is useful in planning and assessing treatment such as radiofrequency ablation or hyperthermic treatment with high intensity ultrasound, for instance (Chang [0028]). By measuring backscatter feedback for the therapy transducer using an ultrasonic imager, the nature of the feedback received can be used to adjust acoustic parameters (and associated system parameters) to optimize the drug delivery and/or tissue erosion process (Cannata [0147]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Berlin et al. (US20190192229A1, 2019-06-27) teaches a system and method for guiding a surgical instrument based on information obtained using enhanced contrast-mode ultrasound [abst]. The exemplary system 100 includes a transducer/probe 120, which is shown held against the tissue in an appropriate orientation using freehand guidance or a mechanical device (e.g. a robotic manipulator) [0043].
Dayton et al. (US20180000444A1, 2018-01-04) teaches an apparatus for preclinical ultrasound imaging of a subject may comprise a platform on which a subject (e.g., a rodent) is positionable, and at least one motion stage for controlling a spatial position of at least one ultrasound transducer relative to the platform in order to acquire ultrasound image data of the subject [0007].
Stopek (WO2021178961A1, 2021-09-10) teaches optimized systems and methods that provide targeted, efficacious histotripsy in a variety of different regions and under a variety of different conditions without causing undesired tissue damage to intervening/non-target tissues or structures [abst].
Vaezy et al. (US20050038340A1, 2005-02-17) teaches the use of contrast agents to enhance localization of a vascular system and to facilitate and enhance a therapeutic treatment provided using high intensity ultrasound [0003].
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JAMES FRANKLIN MCDONALD III
Examiner
Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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