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 2-4 and 16-18 are objected to because of the following informalities: each of the claims 2-4 and 16-18 recite “the computer processor”. However this should be read as “the at least one computer processor”. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: Regarding claim 4, claim 4 recites “maintaining the ultrasound probe in the hovering position over skin of the subject's pelvis and/or abdomen”. However this should be read as “maintaining the ultrasound probe in the hovering position over the skin of the subject's pelvis and/or abdomen”. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: Regarding claim 5, claim 5 recites “maintain the ultrasound probe in the hovering position over skin of the subject's pelvis and/or abdomen”. However this should be read as “maintain the ultrasound probe in the hovering position over the skin of the subject's pelvis and/or abdomen”. 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.
Claims 3, 13-18, and 20 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.
Regarding claim 3, claim 3 recites “drive the robotic system to acquire ultrasound images of the subject's pelvis and/or abdomen” and “driving the robotic system to acquire ultrasound images of the subject's pelvis and/or abdomen”. However claim 1 recites “drive the robotic system to acquire ultrasound images of the subject's pelvis and/or abdomen”. Therefore it is unclear if the ultrasound images in claim 3 are the same or different from the ultrasound images of claim 1. For examination purposes the claim will be interpreted as “drive the robotic system to acquire the ultrasound images of the subject's pelvis and/or abdomen” and “driving the robotic system to acquire the ultrasound images of the subject's pelvis and/or abdomen”
Regarding claim 13, claim 13 recites “wherein the flat base of the tray is shaped to define a flat base”. However the flat base has not been previously defined. For examination purposes the limitation will be read as “wherein a base of the tray is shaped to define a flat base”. Claim 14 is also rejected due to its dependency.
Regarding claim 15, claim 15 recites “enhance the abnormal tissue within ultrasound images”. However claim 1 recites “acquire ultrasound images of the subject's pelvis and/or abdomen”. Therefore it is unclear if the ultrasound images of claim 15 are the same or different from the acquired ultrasound images of the subject's pelvis and/or abdomen. For examination purposes the claim will be interpreted as “enhance the abnormal tissue within the ultrasound images of the subject's pelvis and/or abdomen”. Claims 16-18 are also rejected due to their dependency.
Regarding claim 20, claim 20 recites “wherein the one or more robotic arms comprise a double-parallelogram structure”. However claim 20 is dependent on claim 19 and claim 19 recites “wherein the one or more robotic arms comprise a double-parallelogram structure”. Therefore it is unclear if the double-parallelogram structure of claim 20 is the same or different from the double-parallelogram structure of claim 19. For examination purposes claim 20 will be interpreted as “wherein the one or more robotic arms comprise the double-parallelogram structure”.
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.
Claims 1, 4, 9, 11, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sumanaweera (US 20080021317).
Regarding claim 1, Sumanaweera discloses an apparatus for identifying abnormal tissue within a body of a subject, and for use with at least one ultrasound probe (Abstract – “A robotic mechanism positions a volume scanning transducer at multiple acoustic windows on a patient”, [0022] – “computer assisted diagnosis software for generating a wide field-of-view or for analyzing ultrasound data acquired by the ultrasound system”, [0065] – “For a specific computer assisted diagnosis example, abdominal aortic aneurysms (AAA) or patients at risk for AAA are detected”), the apparatus comprising:
a robotic system (Abstract – “A robotic mechanism”) comprising:
one or more robotic arms ([0021] – “One or more ultrasonic probes connect with one or more robotic manipulator arms”); and
an ultrasound probe supporting portion that is configured to hold the ultrasound probe ([0025] – “The robotic mechanism 12 includes a jaw, clamp, clip, latch, micro-manipulator or other component for connecting actively or passively with the transducer 14”); and
at least one computer processor configured:
to drive the robotic system to acquire ultrasound images of the subject's pelvis and/or abdomen while moving the ultrasound probe relative to the subject's pelvis and/or abdomen ([0050] – “The processor 24 controls the robotic mechanism 12 at least in part based on the geometry of the surface”, [0054] – “Once a map for scanning is provided, the processor 24 controls the robotic mechanism 12 to position the transducer 14 at the different or sequence of acoustic windows”, [0053] – “The acoustic windows may be associated with…a region of the abdomen”), and while maintaining the ultrasound probe in a hovering position over skin of the subject's pelvis and/or abdomen ([0042] – “the transducer 14 does not touch the bag 30, such as being maintained a fixed distance from the inside skin of the bag 30”, Fig. 3 shows the transducer 14 in the bag 30 therefore if the transducer is being maintained a fixed distance from the inside skin of the bag 30 it would be maintained in a hovering position over skin of the abdomen, [0053] – “The acoustic windows may be associated with holes, such as between ribs, or with generally open locations, such as a region of the abdomen”); and
to identify abnormal tissue based upon the ultrasound images ([0022] – “implements computer assisted diagnosis software for generating a wide field-of-view or for analyzing ultrasound data acquired by the ultrasound system”, [0065] – “For a specific computer assisted diagnosis example, abdominal aortic aneurysms (AAA) or patients at risk for AAA are detected”).
Regarding claim 4, Sumanaweera further discloses wherein the computer processor is configured to avoid movement and deformation of the skin and underlying body structures undergoing scanning by the ultrasound probe by maintaining the ultrasound probe in the hovering position over skin of the subject's pelvis and/or abdomen ([0042] – “the transducer 14 does not touch the bag 30, such as being maintained a fixed distance from the inside skin of the bag 30”, Fig. 3 shows the transducer 14 in the bag 30 therefore if the transducer is being maintained a fixed distance from the inside skin of the bag 30 it would be maintained in a hovering position over skin of the abdomen, [0060] – “Due to the pressure applied by the transducer 14 at each acoustic window, the volume represented by the ultrasound data may be warped or altered”, therefore by maintaining a fixed distance of the transducer from the inside skin of the bag 30 there wouldn’t be pressure applied by the transducer and therefore it avoids the volume being warped or altered).
Regarding claim 9, Sumanaweera further discloses wherein: the robotic system comprises a tray configured to be placed on the subject’s pelvis and/or abdomen, the tray defining internal channels ([0046] – “FIG. 5 shows different embodiments for the shape of the bag 30 from a top view…The helix, brick, toroid or other structure may allow for one robotic mechanism 12 to transition along rails for scanning at a plurality of acoustic windows”, [0043] – “the robotic mechanism 12 includes rails guiding the transducer 14 inside the bag 30”, the rails are interpreted as the tray, [0053] – “The acoustic windows may be associated with holes, such as between ribs, or with generally open locations, such as a region of the abdomen”),
the ultrasound probe supporting portion is configured to hold the ultrasound probe and to move the ultrasound probe along the internal channels defined by the tray ([0046] – “FIG. 5 shows different embodiments for the shape of the bag 30 from a top view… The helix, brick, toroid or other structure may allow for one robotic mechanism 12 to transition along rails for scanning at a plurality of acoustic windows”, [0043] – “the robotic mechanism 12 includes rails guiding the transducer 14 inside the bag 30”),
the at least one computer processor is configured to drive the robotic system to acquire the ultrasound images while moving along the internal channels defined by the tray ([0046] – “FIG. 5 shows different embodiments for the shape of the bag 30 from a top view… The helix, brick, toroid or other structure may allow for one robotic mechanism 12 to transition along rails for scanning at a plurality of acoustic windows”, [0004] – “Ultrasound data is acquired from the windows and combined into a wide field-of-view”, Fig. 1 processor 24), such that the location and orientation of the ultrasound probe at the acquisition of each of the ultrasound images relative to the subject's pelvis and/or abdomen is known ([0043] – “The transducer position and orientation in 3D space is determined either using the robotic mechanism's joint angle or locations or using independent position sensors”).
Regarding claim 11, Sumanaweera further discloses wherein the tray is shaped to define a curved tray configured to conform to a shape of the pelvis and/or abdomen of the subject, such that when placed on the subject's pelvis and/or abdomen the tray is coupled to skin of the subject generally without gaps between the tray and the subject's skin ([0043] – “the robotic mechanism 12 includes rails guiding the transducer 14 inside the bag 30, or any other mechanism capable of guiding the transducer 14 in three dimensions”, the rails guide the probe in three dimensions therefore it can be interpreted the rails are curved”, [0041] – “The bag 30 is an acoustically transparent pillow of Urethane or other material that conforms, at least in part, to the patient's body”, [0042] – “This pad is placed between the patient and the pillow for good acoustic coupling. Alternatively, gel is manually positioned on the patient prior to placing the bag 30 on the patient”).
Regarding claim 12, Sumanaweera further discloses wherein a surface of the tray that is placed on the pelvis and/or abdomen of the subject is made of an ultrasound transparent material ([0046] – “FIG. 5 shows different embodiments for the shape of the bag 30 from a top view…The helix, brick, toroid or other structure may allow for one robotic mechanism 12 to transition along rails for scanning at a plurality of acoustic windows”, [0043] – “the robotic mechanism 12 includes rails guiding the transducer 14 inside the bag 30”, [0041] – “The bag 30 is an acoustically transparent pillow of Urethane or other material that conforms, at least in part, to the patient's body”).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Sumanaweera (US 20080021317) as applied to claim 1 above, and further in view of Aleksandrovich (RU2307590C1) machine translation.
Regarding claim 2, Sumanaweera discloses all the elements of the claimed invention as cited in claim 1.
Sumanaweera further discloses wherein the computer processor is configured to identify […] lesions based upon the ultrasound images ([0022] – “implements computer assisted diagnosis software for generating a wide field-of-view or for analyzing ultrasound data acquired by the ultrasound system”, [0065] – “For a specific computer assisted diagnosis example, abdominal aortic aneurysms (AAA) or patients at risk for AAA are detected”).
Conversely Sumanaweera does not teach identify endometriosis lesions based upon the ultrasound images.
However Aleksandrovich discloses identify endometriosis lesions based upon the ultrasound images (pg. 5 second last para. – “During transabdominal and transvaginal ultrasound, it was found: the walls of the uterine cavity are contrasted with gas bubbles. The absence of echopositive contrast agent in the myometrium is noted. An echopositive contrast medium contoured the serous cover of the uterus, revealed a subserous myomatous node”).
Aleksandrovich is an analogous art considering it is in the field of abdominal ultrasound imaging.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sumanaweera to include the identification of endometriosis lesions of Aleksandrovich to achieve the same results. One would have motivation to combine because "the inventive method allows you to diagnose various forms and degrees of uterine endometriosis, to assess the state of postoperative myometrial scars, the size of the base of subserous myomatous nodes with passable fallopian tubes, in addition, it increases the diagnostic accuracy of ultrasound examination, does not harm the patient. The method is non-invasive and atraumatic, does not cause anaphylactic reactions" (Aleksandrovich – pg. 4).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Sumanaweera (US 20080021317) as applied to claim 1 above, and further in view of Crawford (US 20230011428).
Regarding claim 3, Sumanaweera discloses all the elements of the claimed invention as cited in claim 1.
Sumanaweera further discloses wherein the computer processor is configured to drive the robotic system to acquire ultrasound images of the subject's pelvis and/or abdomen ([0050] – “The processor 24 controls the robotic mechanism 12 at least in part based on the geometry of the surface”, [0054] – “Once a map for scanning is provided, the processor 24 controls the robotic mechanism 12 to position the transducer 14 at the different or sequence of acoustic windows”, [0053] – “The acoustic windows may be associated with…a region of the abdomen”), while maintaining the ultrasound probe in a hovering position over skin of the subject's pelvis and/or abdomen ([0042] – “the transducer 14 does not touch the bag 30, such as being maintained a fixed distance from the inside skin of the bag 30”, Fig. 3 shows the transducer 14 in the bag 30 therefore if the transducer is being maintained a fixed distance from the inside skin of the bag 30 it would be maintained in a hovering position over skin of the abdomen), by driving the robotic system to acquire ultrasound images of the subject's pelvis and/or abdomen ([0004] – “methods, systems and computer readable media for ultrasound imaging with robotic assistance”),
As cited above Sumanaweera teaches acquiring ultrasound images of the subject's pelvis and/or abdomen conversely Sumanaweera does not teach driving the robotic system to acquire ultrasound images […], while allowing light contact between the ultrasound probe and the skin of the subject[…].
However Crawford discloses driving the robotic system to acquire ultrasound images […], while allowing light contact between the ultrasound probe and the skin of the subject[…] (Abstract – “The US transducer is coupled to the end-effector and operative to output US imaging data of anatomical structure proximately located to the end-effector”, [0189] – “A 6-axis load cell at or near the leading edge of the robot arm may be used to sense pressure of the US transducer and/or end-effector against the patient and ensure that the US transducer stays in gentle contact with the skin”).
Crawford is an analogous art considering it is in the field of robotic movement of an ultrasound probe.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sumanaweera to include allowing light contact between the ultrasound probe and the skin of the subject of Crawford to achieve the same results. One would have motivation to combine because it would provide more comfort for the patient and provide clear images of the anatomical structures.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sumanaweera (US 20080021317) as applied to claim 1 above, and further in view of Overbeeke (US 20220054201).
Regarding claim 5, Sumanaweera discloses all the elements of the claimed invention as cited in claim 1.
Sumanaweera further discloses wherein the computer processor is configured to maintain the ultrasound probe in the hovering position over skin of the subject's pelvis and/or abdomen based upon the distance between the ultrasound probe and the skin ([0042] – “the transducer 14 does not touch the bag 30, such as being maintained a fixed distance from the inside skin of the bag 30”, Fig. 3 shows the transducer 14 in the bag 30 therefore if the transducer is being maintained a fixed distance from the inside skin of the bag 30 it would be maintained in a hovering position based upon the fixed distance over skin of the abdomen) […].
Conversely Sumanaweera does not teach further comprising a sensor configured to monitor a distance between the ultrasound probe and the skin, wherein the computer processor is configured to […] position over skin […] based upon the distance between the ultrasound probe and the skin as monitored by the sensor.
However Overbeeke discloses further comprising a sensor configured to monitor a distance between the ultrasound probe and the skin ([0118] – “distance sensor 35 arranged to measure a first distance D1 between the contact surface 3 a and the skin S…The first distance sensor 35 and the second distance sensor 36 are arranged at opposite sides of the ultrasound transducer 3”), wherein the computer processor is configured to […] position over skin […] based upon the distance between the ultrasound probe and the skin as monitored by the sensor ([0119] – “The processing device 6 is configured to provide a position control signal to adapt the position of the ultrasound transducer 3 on the basis of the first distance D1 and the second distance D2”).
Overbeeke is an analogous art considering it is in the field of robotic movement of an ultrasound probe.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Sumanaweera to incorporate the distance sensors of Overbeeke to achieve the same results. One would have motivation to combine because “arrangements to provide a contact force and/or position parameter are obtained that allow to automatically adjust a position of the ultrasound transducer 3 in order to adapt the contact force with which the ultrasound transducer 3 is pressed on the skin S and/or to adapt the position” (Overbeeke [0120]).
Claims 6, 7, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Sumanaweera (US 20080021317) as applied to claims 1 and 9 above, and further in view of Radicke (DE 102020209417A1) machine translation.
Regarding claim 6, Sumanaweera discloses all the elements of the claimed invention as cited in claim 1.
As cited above Sumanaweera discloses the robotic system is configured to maintain an orientation of the transducer of the ultrasound probe over the subject's pelvis and/or an abdomen
Conversely Sumanaweera does not teach 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.
However Radicke discloses wherein the ultrasound probe includes a transducer ([0022] – “the ultrasound probe's head in the holder is directed towards the surface of the patient's breast, so that ultrasound waves emanating from the ultrasound probe can be emitted into the breast tissue and ultrasound waves reflected from the tissue can be received by the ultrasound probe”) 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 ([0021] – “In a preferred embodiment, the ultrasound probe in the holder is oriented essentially transversely to a frontal plane of the patient and can be guided by mechanical guidance along the predetermined movement trajectory parallel to a sagittal plane of the patient on the compression element in order to acquire ultrasound data of a single layer”, [0065] – “prevents the ultrasound probe from deviating from a parallel alignment to a sagittal plane of the patient”, [0115] – “a movement pattern of the ultrasound probe 41…is determined and a control signal or a sequence of control signals is output to the robot arm 72…the freedom of movement of the ultrasound probe 41 can be restricted to one or two spatial directions by means of a mechanical guide 33 or the like”, one with ordinary skill in the art would find it obvious that if the guide frame 36 is placed above the abdomen to perform the imaging of Sumanaweera the transducer would be held in an orientation that is substantially parallel to a tangent to a center of the subject's abdomen).
Radicke is an analogous art considering it is in the field of robotic movement of an ultrasound probe.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Sumanaweera to incorporate the robotic system maintaining an orientation of the transducer of the ultrasound probe such that it is substantially parallel to a tangent to a plane of Radicke to achieve the same results. One would have motivation to combine because “the freedom of movement of the ultrasound probe 41 can be restricted to one or two spatial directions” (Radicke [0115]) therefore less processing is required to robotically control the position of the probe.
Regarding claim 7, Sumanaweera discloses all the elements of the claimed invention as cited in claim 1.
As cited above Sumanaweera discloses the robotic system is configured to maintain an orientation of the transducer of the ultrasound probe over the subject's pelvis and/or an abdomen
Conversely Sumanaweera does not teach 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 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.
However Radicke discloses wherein the ultrasound probe includes a transducer ([0022] – “the ultrasound probe's head in the holder is directed towards the surface of the patient's breast, so that ultrasound waves emanating from the ultrasound probe can be emitted into the breast tissue and ultrasound waves reflected from the tissue can be received by the ultrasound probe”) 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 ([0021] – “In a preferred embodiment, the ultrasound probe in the holder is oriented essentially transversely to a frontal plane of the patient and can be guided by mechanical guidance along the predetermined movement trajectory parallel to a sagittal plane of the patient on the compression element in order to acquire ultrasound data of a single layer”, [0065] – “prevents the ultrasound probe from deviating from a parallel alignment to a sagittal plane of the patient”, [0115] – “a movement pattern of the ultrasound probe 41…is determined and a control signal or a sequence of control signals is output to the robot arm 72…the freedom of movement of the ultrasound probe 41 can be restricted to one or two spatial directions by means of a mechanical guide 33 or the like”, one with ordinary skill in the art would find it obvious that if the guide frame 36 is placed above the abdomen to perform the imaging of Sumanaweera the transducer would be held in an orientation that is substantially parallel to a tangent to a center of the subject's abdomen).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Sumanaweera to incorporate the robotic system maintaining an orientation of the transducer of the ultrasound probe such that it is substantially directly facing a coronal plane of the subject's body of Radicke to achieve the same results. One would have motivation to combine because “the freedom of movement of the ultrasound probe 41 can be restricted to one or two spatial directions” (Radicke [0115]) therefore less processing is required to robotically control the position of the probe.
Regarding claim 13, Sumanaweera discloses all the elements of the claimed invention as cited in claims 1 and 9.
Conversely Sumanaweera does not teach wherein the ultrasound probe includes a transducer, and wherein the flat base of the tray is shaped to define a flat base, the flat base configured to maintain an orientation of the transducer of the ultrasound probe such that the transducer is substantially parallel to a tangent to a center of the subject's pelvis and/or abdomen as the robotic system moves the ultrasound probe.
However Radicke discloses wherein the ultrasound probe includes a transducer ([0022] – “the ultrasound probe's head in the holder is directed towards the surface of the patient's breast, so that ultrasound waves emanating from the ultrasound probe can be emitted into the breast tissue and ultrasound waves reflected from the tissue can be received by the ultrasound probe”), and wherein the flat base of the tray is shaped to define a flat base (Fig. 1 ultrasound recording device 30 includes compression element 31 and frame 36, the frame 36 is not disclosed to be flexible and the frame and compression element are shown to be flat in Fig. 1), the flat base configured to maintain an orientation of the transducer of the ultrasound probe such that the transducer is substantially parallel to a tangent to a center of the subject's pelvis and/or abdomen as the robotic system moves the ultrasound probe ([0021] – “In a preferred embodiment, the ultrasound probe in the holder is oriented essentially transversely to a frontal plane of the patient and can be guided by mechanical guidance along the predetermined movement trajectory parallel to a sagittal plane of the patient on the compression element in order to acquire ultrasound data of a single layer”, [0065] – “prevents the ultrasound probe from deviating from a parallel alignment to a sagittal plane of the patient”, [0115] – “a movement pattern of the ultrasound probe 41…is determined and a control signal or a sequence of control signals is output to the robot arm 72…the freedom of movement of the ultrasound probe 41 can be restricted to one or two spatial directions by means of a mechanical guide 33 or the like”, one with ordinary skill in the art would find it obvious that if the guide frame 36 is placed above the center of the abdomen to perform the imaging of Sumanaweera the transducer would be held in an orientation that is substantially parallel to a tangent to a center of the subject's abdomen).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Sumanaweera to incorporate the robotic system maintaining an orientation of the transducer of the ultrasound probe such that it is substantially directly facing a coronal plane of the subject's body of Radicke to achieve the same results. One would have motivation to combine because “the freedom of movement of the ultrasound probe 41 can be restricted to one or two spatial directions” (Radicke [0115]) therefore less processing is required to robotically control the position of the probe.
Regarding claim 14, Sumanaweera and Radicke disclose all the elements of the claimed invention as cited in claims 1, 9, and 13.
Sumanaweera further discloses further comprising a water-filled compartment ([0041] – “a fluid-filled flexible bag 30…The fluid is de-gassed water doped with PED (polyethelene glycol) or other liquid.”).
Conversely Sumanaweera does not teach the flat base of the tray.
However Radicke discloses the flat base of the tray (Fig. 1 ultrasound recording device 30 includes compression element 31 and frame 36, the frame 36 is not disclosed to be flexible and the frame and compression element are shown to be flat in Fig. 1).
One with ordinary skill in the art would find it obvious in view of Sumanaweera combined with Radicke to the flat base tray of Radicke inside the bag of Sumanaweera so that the water and the acoustically transparent pillow material of the bag are located between the subject's pelvis and/or abdomen and the flat base of the tray. This would allow the probe to maintain its orientation so that ultrasound probe only has to be moved in one or two spatial directions while maintaining acoustically coupled to skin of the abdomen which is not entirely flat.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Sumanaweera to incorporate the flat base of the tray of Radicke to achieve the same results. One would have motivation to combine because “the freedom of movement of the ultrasound probe 41 can be restricted to one or two spatial directions” (Radicke [0115]) therefore less processing is required to robotically control the position of the probe.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Sumanaweera (US 20080021317) as applied to claim 1 above, and further in view of Salcudean (US 6425865).
Regarding claim 8, Sumanaweera discloses all the elements of the claimed invention as cited in claim 1.
Conversely Sumanaweera does not teach wherein the robotic system is configured to maintain the ultrasound probe at a constant orientation in space as the robotic system moves the ultrasound probe.
However Salcudean discloses wherein the robotic system is configured to maintain the ultrasound probe at a constant orientation in space as the robotic system moves the ultrasound probe (Col. 11 lines 15-19 – “the ultrasound probe orientation can be fixed to a set value, while its translational components are controlled by the ultrasound machine operator 50 via the hand controller 2. This keeps the probe in a constant orientation”).
Salcudean is an analogous art considering it is in the field of robotic movement of an ultrasound probe.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Sumanaweera to incorporate the robotic system maintaining the ultrasound probe at a constant orientation as the robotic system moves the ultrasound probe of Salcudean to achieve the same results. One would have motivation to combine because it “allows the operator to translate the probe for fine motions with greater ease.” (Salcudean col. 11 lines 19-21).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Sumanaweera (US 20080021317) as applied to claim 9 above, and further in view of Demene (US 20240057969).
Regarding claim 10, Sumanaweera discloses all the elements of the claimed invention as cited in claims 1 and 9.
Conversely Sumanaweera does not teach wherein the tray is configured to be attached to the subject, such that the tray moves with the subject.
However Demene discloses wherein the tray is configured to be attached to the subject, such that the tray moves with the subject ([0052]-[0053] – “filling a cavity formed by the opening of the head pad with an ultrasound gel; fastening the ultrasound probe on the head pad so that the ultrasound probe is in ultrasonic contact with a fontanel of the infant”).
Demene is an analogous art considering it is in the field of placing a pad/pillow on a curved surface of the body for ultrasonic coupling.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Sumanaweera to incorporate the tray being attached to the subject of Demene to achieve the same results. One would have motivation to combine because it would prevent the pad/pillow with rails of Sumanaweera from moving and therefore allow imaging to be continuously done at a precise location.
Claims 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Sumanaweera (US 20080021317) as applied to claim 1 above, and further in view of Berlin (US 20190192229).
Regarding claim 15, Sumanaweera discloses all the elements of the claimed invention as cited in claim 1.
Sumanaweera further discloses drive the robotic system to acquire a first set of ultrasound images of the subject's pelvis and/or abdomen while moving the ultrasound probe (Abstract – “A robotic mechanism positions a volume scanning transducer at multiple acoustic windows on a patient. Ultrasound data is acquired from the windows and combined into a wide field-of-view”, [0053] – “The acoustic windows may be associated with holes, such as between ribs, or with generally open locations, such as a region of the abdomen”);
drive the robotic system to acquire a second set of ultrasound images of the subject's pelvis and/or abdomen while moving the ultrasound probe (Abstract – “A robotic mechanism positions a volume scanning transducer at multiple acoustic windows on a patient. Ultrasound data is acquired from the windows and combined into a wide field-of-view”, [0053] – “The acoustic windows may be associated with holes, such as between ribs, or with generally open locations, such as a region of the abdomen”);
Conversely Sumanaweera does not teach wherein the apparatus is for use with a contrast agent configured to enhance the abnormal tissue within ultrasound images, and wherein the computer processor is configured:
prior to the contrast agent having been administered to the subject, […] acquire a first set of ultrasound images […];
subsequent to the contrast agent having been administered to the subject, to […] acquire a second set of ultrasound images […]; and
to identify the abnormal tissue by analyzing the first and second sets of ultrasound images.
However Berlin discloses wherein the apparatus is for use with a contrast agent configured to enhance the abnormal tissue within ultrasound images ([0065] – “ultrasound imaging…All signal present is from tissue and would ideally be suppressed in the contrast-mode view to render contrast agent accumulation in the lesion more prominent for a practitioner to reliably identify”), and wherein the computer processor is configured:
prior to the contrast agent having been administered to the subject, […] acquire a first set of ultrasound images […] ([0107] – “a frame prior to contrast agent arrival is used to build a model of the background signal”);
subsequent to the contrast agent having been administered to the subject, to […] acquire a second set of ultrasound images […] ([0107] – “FIG. 17B shows a schematic image representation 1710 of the tissue after contrast agent arrival”); and
to identify the abnormal tissue by analyzing the first and second sets of ultrasound images ([0108] – “Use of occlusion-compensated background removal (the results of which are shown in the schematic image representation 1730 of FIG. 17D) permits visualization of tissue perfusion”).
Berlin is an analogous art considering it is in the field of ultrasound imaging to identify tissue abnormalities.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Sumanaweera to incorporate the pre and post contrast imaging of Berlin to achieve the same results. One would have motivation to combine because it “permits visualization of tissue perfusion” within ultrasound images (Berlin [0108]).
Regarding claim 16, Sumanaweera and Berlin disclose all the elements of the claimed invention as cited in claims 1 and 15.
Sumanaweera further discloses wherein, by avoiding movement and deformation of the skin and underlying body structures undergoing scanning by the probe, the computer processor is configured to minimize changes in position and shape of the skin and underlying body structures between the acquisitions of the first and second sets of ultrasound images of the subject's pelvis and/or abdomen ([0042] – “the transducer 14 does not touch the bag 30, such as being maintained a fixed distance from the inside skin of the bag 30”, Fig. 3 shows the transducer 14 in the bag 30 therefore if the transducer is being maintained a fixed distance from the inside skin of the bag 30 it would be maintained in a hovering position over skin of the abdomen, [0060] – “Due to the pressure applied by the transducer 14 at each acoustic window, the volume represented by the ultrasound data may be warped or altered”, therefore by maintaining a fixed distance of the transducer from the inside skin of the bag 30 there wouldn’t be pressure applied by the transducer and therefore it avoids the volume being warped or altered).
Regarding claim 17, Sumanaweera and Berlin disclose all the elements of the claimed invention as cited in claims 1 and 15.
Conversely Sumanaweera does not teach 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.
However Berlin discloses 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 ([0107] – “a frame prior to contrast agent arrival is used to build a model of the background signal, which is then subtracted from later-arriving frames”, [0047] – “The image frames received are typically registered with one another (aligned) in multiple dimensions in step 220”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Sumanaweera to incorporate the subtraction images of Berlin to achieve the same results. One would have motivation to combine because it “permits visualization of tissue perfusion” within ultrasound images (Berlin [0108]).
Regarding claim 18, Sumanaweera and Berlin disclose all the elements of the claimed invention as cited in claims 1, 15, and 17.
Sumanaweera further discloses wherein, by avoiding movement and deformation of the skin and underlying body structures undergoing scanning by the probe, the computer processor is configured to minimize changes in position and shape of the skin and underlying body structures between the acquisitions of the first and second sets of ultrasound images of the subject's pelvis and/or abdomen, […] ([0042] – “the transducer 14 does not touch the bag 30, such as being maintained a fixed distance from the inside skin of the bag 30”, Fig. 3 shows the transducer 14 in the bag 30 therefore if the transducer is being maintained a fixed distance from the inside skin of the bag 30 it would be maintained in a hovering position over skin of the abdomen, [0060] – “Due to the pressure applied by the transducer 14 at each acoustic window, the volume represented by the ultrasound data may be warped or altered”, therefore by maintaining a fixed distance of the transducer from the inside skin of the bag 30 there wouldn’t be pressure applied by the transducer and therefore it avoids the volume being warped or altered).
Conversely Sumanaweera does not teach thereby enhance accuracy of the subtraction images.
However Berlin discloses the subtraction images ([0107] – “a frame prior to contrast agent arrival is used to build a model of the background signal, which is then subtracted from later-arriving frames”, [0074] – “obtaining post-contrast binding images from the same location and imaging perspective”).
One with ordinary skill in the art would find it obvious in view of Berlin combined with Sumanaweera that the hovering of the probe of Sumanaweera would minimize changes in position and shape of the skin between acquisitions of the pre-contrast image and the post-contrast image that are taken at the same location at different times of Berlin and thereby enhance accuracy of the subtraction images of Berlin.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Sumanaweera to incorporate the subtraction images of Berlin to achieve the same results. One would have motivation to combine because it “permits visualization of tissue perfusion” within ultrasound images (Berlin [0108]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Sumanaweera (US 20080021317) as applied to claim 1 above, and further in view of Hourtash (US 20180214225).
Regarding claim 19, Sumanaweera discloses all the elements of the claimed invention as cited in claim 1.
As cited above Sumanaweera discloses robotic system moving the ultrasound probe
Conversely Sumanaweera does not teach wherein the one or more robotic arms comprise a double-parallelogram structure configured to maintain the […device] at a constant orientation in space as the robotic system moves the […device].
However Hourtash discloses wherein the one or more robotic arms comprise a double-parallelogram structure ([0044] – “Such systems may utilize a double parallelogram linkage which constrains movement of the linkages such that the shaft of the instrument supported by the manipulator pivots about a remote center point”) configured to maintain the […device] at a constant orientation in space as the robotic system moves the […device] ([0006] – “robotic manipulator arms are included for moving an endoscope or other image capture device”, [0045] – “The present invention allows a user, such as a physician's assistant, to quickly and easily reconfigure the manipulator arm, while maintaining the desired end effector state, optionally even during movement of the end effector during a surgical procedure”).
Hourtash is an analogous art considering it is in the field of robotic movement of an imaging device.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Sumanaweera to incorporate the double-parallelogram structure of Hourtash to achieve the same results. One would have motivation to combine because it “Such a manipulator structure can constrain movement of the instrument so that the instrument shaft pivots about a remote center of spherical rotation positioned in space along the length of the rigid shaft” (Hourtash [0007]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Sumanaweera (US 20080021317) and Hourtash (US 20180214225) as applied to claim 19 above, and further in view of Radicke (DE 102020209417A1) machine translation.
Regarding claim 20, Sumanaweera and Hourtash disclose all the elements of the claimed invention as cited in claims 1 and 19.
As cited above Sumanaweera discloses robotic system moving the ultrasound probe
Conversely Sumanaweera does not teach wherein the ultrasound probe includes a transducer, wherein the one or more robotic arms comprise a double-parallelogram structure 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 abdomen as the robotic system moves the ultrasound probe.
However Hourtash discloses wherein the one or more robotic arms comprise a double-parallelogram structure ([0044] – “Such systems may utilize a double parallelogram linkage which constrains movement of the linkages such that the shaft of the instrument supported by the manipulator pivots about a remote center point”) configured to maintain the […device] at a […constant orientation in space] as the robotic system moves the […device] ([0006] – “robotic manipulator arms are included for moving an endoscope or other image capture device”, [0045] – “The present invention allows a user, such as a physician's assistant, to quickly and easily reconfigure the manipulator arm, while maintaining the desired end effector state, optionally even during movement of the end effector during a surgical procedure”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Sumanaweera to incorporate the double-parallelogram structure of Hourtash to achieve the same results. One would have motivation to combine because it “Such a manipulator structure can constrain movement of the instrument so that the instrument shaft pivots about a remote center of spherical rotation positioned in space along the length of the rigid shaft” (Hourtash [0007]).
Conversely Sumanaweera and Hourtash do not teach wherein the ultrasound probe includes a transducer, […] 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 abdomen as the robotic system moves the ultrasound probe.
However Radicke discloses wherein the ultrasound probe includes a transducer ([0022] – “the ultrasound probe's head in the holder is directed towards the surface of the patient's breast, so that ultrasound waves emanating from the ultrasound probe can be emitted into the breast tissue and ultrasound waves reflected from the tissue can be received by the ultrasound probe”), […] 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 abdomen as the robotic system moves the ultrasound probe ([0021] – “In a preferred embodiment, the ultrasound probe in the holder is oriented essentially transversely to a frontal plane of the patient and can be guided by mechanical guidance along the predetermined movement trajectory parallel to a sagittal plane of the patient on the compression element in order to acquire ultrasound data of a single layer”, [0065] – “prevents the ultrasound probe from deviating from a parallel alignment to a sagittal plane of the patient”, [0115] – “a movement pattern of the ultrasound probe 41…is determined and a control signal or a sequence of control signals is output to the robot arm 72…the freedom of movement of the ultrasound probe 41 can be restricted to one or two spatial directions by means of a mechanical guide 33 or the like”, one with ordinary skill in the art would find it obvious that if the guide frame 36 is placed above the abdomen to perform the imaging of Sumanaweera the transducer would be held in an orientation that is substantially parallel to a tangent to a center of the subject's abdomen).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Sumanaweera to incorporate the robotic system maintaining an orientation of the transducer of the ultrasound probe such that it is substantially parallel to a tangent to a plane of Radicke to achieve the same results. One would have motivation to combine because “the freedom of movement of the ultrasound probe 41 can be restricted to one or two spatial directions” (Radicke [0115]) therefore less processing is required to robotically control the position of the probe.
Conclusion
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/R.C.L. Examiner, Art Unit 3797 /MICHAEL T ROZANSKI/ Primary Examiner, Art Unit 3797
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