DETAILED ACTION
This office action is in response to the communication received on March 12, 2026 concerning application No. 18/090,316 filed on December 22, 2022.
Claims 1-24 are currently pending.
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 .
Response to Arguments
Applicant's arguments filed 03/12/2026 regarding the 35 USC 112 rejection have been fully considered. The amendments to the claims have been entered and overcome the 35 USC 112b rejection of claim 4 previously set forth. Examiner notes the amendments to the claims have led to further 35 USC 112 issues.
Applicant’s arguments with respect to claim(s) 1-17 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The rejection relies upon newly cited reference Schneider to teach the newly filed claim amendments.
Applicant's arguments filed 03/12/2026 regarding the prior art rejection of claims 18-24 have been fully considered but they are not persuasive. In response to the applicant’s arguments that the prior art fails to teach “the transducer array generates both a parasternal long axis view and a parasternal short axis view of the heart shown on the touchscreen display in response to operation of a touch actuated user interface that receives a selection of an ultrasound examination preset and one or more related measurements selected from a touch actuated measurement menu”, examiner respectfully disagrees. As set forth in the previous office action, [0038] of Lundberg discloses the transducer generates both a parasternal long axis view and a parasternal short axis view of the heart shown on the display in response to operation of a user interface. The Bar-Zion and Chiang references are then relied upon for teaching the deficiencies of Lundberg. Specifically, [0007] and [0009]-[0011] of Bar-Zion disclose adjusting a position of the three receiving a selection of an ultrasound examination preset and one or more related measurements in order to adjust the position of the transducer array to generate the desired views. [0073]-[0075] and [0078]-[0080] of Chiang further disclose selecting the measurement from a touch actuated measurement menu. For at least these reasons the combination of Lundberg in view of Bar-Zion and Chiang teaches the argued limitation recited above.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 18-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 18 recites the limitation “actuating, during a bi-plane scanning operation, a transducer position control device including a plurality of at least three actuators in a transducer housing in which the transducer array is mounted to adjust a tilt position, a rotational position, and a rocking position in response to touchscreen operated control and thereby control a direction of a beam transmission axis of the transducer array relative to the heart such that the transducer array generates both a parasternal long axis view and a parasternal short axis view of the heart shown on the touchscreen display in response to operation of a touch actuated user interface that receives a selection of an ultrasound examination preset and one or more related measurements selected from a touch actuated measurements menu”, which is not described in the specification in such a way to reasonably convey the inventor had possession of the limitation at the time the application was filed. Specifically, it could not be found in the specification where the actuating of the transducer position control device is performed in response to a selection of one or more related measurements selected from a touch actuated measurements menu. Pgs. 101-102 and pg. 104 disclose selecting a measurement from a measurement menu in order to generate a measurement value but does not disclose actuating the transducer position control device in response to the measurement menu selection. For at least these reasons the newly filed claim amendment is considered new matter.
Claims dependent upon the rejected claims above, but not directly addressed, are also rejected because they inherit the indefiniteness of the claim(s) they respectively depend upon.
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.
Claim(s) 1-3, 5-6, and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bar-Zion et al. (US 20170105700, hereinafter Bar-Zion) in view of Chiang et al. (US 20140114190, hereinafter Chiang) and Schneider et al. (WO2015068073A1, hereinafter Schneider).
Regarding claim 1, Bar-Zion teaches a portable medical ultrasound imaging device (ultrasound system 10 in fig. 1) comprising:
a transducer probe housing a transducer array ([0123] “ultrasound measurement device 204 of ultrasound measurement assembly 200 includes an ultrasound transducer 230”. [0144] discloses the transducer includes an array);
a transducer position control device including at least one actuator ([0136]-[0138] discloses the device that controls the tilt and rotation of the transducer includes tilt actuator 236 and axial actuator 238) to adjust a position of the transducer array ([0138] discloses device controller 240 controls axial actuator 238 and tilt actuator 236 to adjust the position of the transducer array) having at least three degrees of motion including at least a tilt angle, a rotational position, and rocking position within the transducer probe housing ([0142] discloses the ultrasound transducer 230 is controlled to scan six degrees of freedom, which would include at least a tilt angle, a rotational position, and rocking position (lateral tilt));
a portable housing, the housing having a computer in the housing ([0065] discloses the controller is hosted by a general purpose computer and [0131] discloses the computer is a portable external computer. The housing of the portable external computer is considered the portable housing), the computer including at least one processor and at least one memory ([0066] discloses the controller includes a processor that is configured to access programmed instructions from a memory, meaning the computer has a processor and memory), a display that displays an ultrasound image ([0078] discloses “monitor 32 may display an ultrasound image”) and a touchscreen display user interface ([0076] discloses “user interface 30 may include…touch screens”) to control an orientation of the transducer array within the transducer probe housing ([0076] discloses a user can operate the controller 20 by way of an input device which includes a touch screen to perform instructions such as a begin or stop operation, operating parameters, or other instructions. These operations are seen as controlling an operation of the device controller 240 such as controlling the actuators to adjust the position of the transducer based on the operating parameters, thereby automatically adjusting a beam transmission axis of the transducer array as outlined in [0136]. Also see claims 1 and 16 “a controller that is configured to repeatedly steer and focus the ultrasound beam”); and
an ultrasound beamformer processing circuit that receives image data from the transducer array ([0070] discloses receive beamformer 24 which receives data from each ultrasound transducer element), the ultrasound beamformer processing circuit being communicably connected to the computer (fig. 1 shows that the receive beamformer 24 is connected to the controller 20).
Bar-Zion does not specifically teach the display is a touchscreen display, the touchscreen display is positioned on the housing and the touchscreen display includes a touch screen display user interface, wherein the touch screen display user interface displays information while scanning two imaging planes simultaneously during a bi-plane scanning operation.
However,
Chiang in a similar field of endeavor teaches the display is a touchscreen display ([0069] “a touch screen display 104”), the touchscreen display is positioned on the portable housing (fig. 9A shows that the display 104 is on the portable housing) and the touchscreen display includes a touch screen display user interface ([0070] “in an exemplary mode of operation, medical personnel…can employ simple single point gestures as user inputs to the multi-touch LCD touch screen of the touch screen display 104 for controlling one or more operational modes and/or functions of the medical ultrasound imaging equipment 100”), wherein the touch screen display user interface displays information while scanning two imaging planes simultaneously during a bi-plane scanning operation ([0178] “as depicted in fig. 44 A XY probe acquires real-time simultaneous images from two orthogonal planes”. Fig. 35 further discloses displaying information on the display while viewing the scan planes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the display disclosed by Bar-Zion to be a touchscreen display in order make the overall system more portable, as recognized by Chiang ([0010]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device disclosed by Bar-Zion to have the display be positioned on the housing in order to make the system more portable, as recognized by Chiang ([0002]).
It would have been obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of combining a touchscreen display with a touchscreen display user interface, wherein the touch screen display user interface displays information while scanning two imaging planes simultaneously during a bi-plane scanning operation as taught by Chiang to the display and user interface of Bar-Zion to allow for the predictable results of reducing the overall size of the system by materially reducing the number of elements, thereby making the system more portable.
Bar-Zion in view of Chiang does not specifically teach the orientation of the transducer array is displayed on the touchscreen display and the touchscreen display user interface displays while scanning two imaging planes simultaneously during a bi-plane scanning operation, a first and second graphical indicator whose displayed positioning respectively corresponds to a current position and orientation of the transducer array.
However,
Schneider in a similar field of endeavor teaches the orientation of the transducer array is displayed (pg. 1, lines 28-35, “graphical user interface that shows the relative position and orientation of the planes on a display screen…the orientation of one of the planes is fixed relative to the ultrasound probe” thereby providing the orientation of the transducer array on the display) and the touchscreen display user interface displays, while scanning two imaging planes simultaneously during a bi-plane scanning operation (pg. 2, lines 9-14, “real time images of both image planes are then displayed side-by-side on the display screen”, in order to display both images in real time the two imaging planes are scanned simultaneously, otherwise the images would not be displayed in real time), a first and second graphical indicator (pg. 11, line 17-pg. 12, line 6 and figure 4 disclose while displaying the two image planes L/R displaying an image orientation icon 400 which includes a first graphical indicator 406 and a second graphical indicator 408. Also see figs. 5a-5c which disclose the orientation icon) whose displayed positioning respectively corresponds to a current position and orientation of the transducer array (pg. 11, line 17-pg. 12, line 6 and figure 4 disclose the orientation icons corresponds to a specific side of the probe thereby indicating the orientation of the transducer array. pg. 1, lines 28-35, further disclose the display shows the relative position and orientation of the planes and that one of the planes is fixed relative to the ultrasound probe, thereby the display also shows the position and orientation of the transducer array of the ultrasound probe. Claim 1 discloses the probe is a two dimensional array transducer probe).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bar-Zion in view of Chiang to have the orientation of the transducer array is displayed on the touchscreen display and the touchscreen display user interface displays while scanning two imaging planes simultaneously during a bi-plane scanning operation, a first and second graphical indicator whose displayed positioning respectively corresponds to a current position and orientation of the transducer array in order to continuously and reliably visualize the object of interest being viewed, as recognized by Schneider (pg. 3, lines 1-9).
Regarding claim 2, Bar-Zion in view of Chiang and Schneider teaches the device of claim 1, as set forth above. Chiang further teaches the memory is a core memory and a graphics processor is connected to the core memory (fig. 17 shows the computer I/O and graphics chipset 1704 is connected to the core memory 1122 in the computer 106, the graphics chipset is considered the graphics processor) in the housing (fig. 1 shows the computer 106 is in the portable housing 102).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device disclosed by Bar-Zion in view of Chiang and Schneider to have the memory be a core memory and a graphics processor is connected to the core memory in order to process the data at a faster rate which would increase the efficiency of the procedure and provide faster results.
Regarding claim 3, Bar-Zion in view of Chiang and Schneider teaches the device of claim 1, as set forth above. Chiang further teaches the transducer array comprises a biplane transducer array ([0172] “an XY bi-plane probe consisting of two one dimensional, multi-element arrays”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the transducer array of Bar-Zion in view of Chiang and Schneider for the bi-plane transducer array of Chiang because it amounts to simple substitution of one known element for another to obtain the predictable results of obtaining multiple planes of data simultaneously, thereby improving the amount of data the device can process.
Regarding claim 5, Bar-Zion in view of Chiang and Schneider teaches the device of claim 1, as set forth above. Bar-Zion further teaches a backplane on which the transducer position control device is mounted (fig. 6 shows enclosure 205a/b on which device controller 240 and actuators are mounted).
Regarding claim 6, Bar-Zion in view of Chiang and Schneider teaches the device of claim 1, as set forth above. Bar-Zion further teaches the transducer position control device includes at least three contact points to control a central axis beam control direction of the transducer array ([0142] discloses the use of tilt actuator, axial actuator and additional mechanisms translate the ultrasound transducer to focus the ultrasound beam in six degrees of freedom. Each of the actuators and additional mechanisms is considered to have a contact point with the transducer to control its movement, therefore there is at least three contact points. Additionally see “Stewart platform mechanism” which would include at least three contact points).
Regarding claim 12, Bar-Zion in view of Chiang and Schneider teaches the device of claim 1, as set forth above. Chiang further teaches the transducer array comprises a plurality of transducer arrays ([0135] “the ultrasound probe 150 includes a transducer housing including one or more transducer arrays 152”), each operated by the ultrasound beamformer processing circuit ([0099] discloses the ultrasound engine 108 which is considered the beamformer processing circuit and operates the transducer array 152) that is positioned in the portable housing (fig. 9A shows the ultrasound engine 108 is in the portable housing) that comprises a tablet display device ([0005] discloses the housing is a tablet form factor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device disclosed by Bar-Zion in view of Chiang and Schneider to have the transducer array comprise a plurality of transducer arrays, each operated by the ultrasound beamformer processing circuit positioned in the portable housing that comprises a tablet in order to image multiple planes of data simultaneously, thereby improving the amount of data the device can process.
Regarding claim 13, Bar-Zion in view of Chiang and Schneider teaches the device of claim 1, as set forth above. Bar-Zion further teaches the computer is programmed to control the transducer position control device in response to detected physiological landmarks within an ultrasound image detected by the transducer array ([0096]-[0099] discloses the controller initiates the continuous ultrasonic monitoring method which includes identifying a target section within the acquired images and repeatedly steering and focusing the ultrasound beam such that the target remains within a subsequently acquired image. The target is considered the detected physiological landmarks within the ultrasound image).
Regarding claim 14, Bar-Zion in view of Chiang and Schneider teaches the device of claim 13, as set forth above. Chiang further teaches the computer performs at least one measurement on the ultrasound image based at least in part on a first location of a first cursor on the display (claim 14 discloses, “performing by the computer at least one measurement on the ultrasound image based at least in part on the first cursor at the first location”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device disclosed by Bar-Zion in view of Chiang and Schneider to have the computer perform at least one measurement on the ultrasound image based at least in part on a first location of a first cursor on the display in order to allow the user to select which location of the image they want measurements to be taken of, thereby ensuring the measurements are acquired from the correct location.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bar-Zion in view of Chiang and Schneider as applied to claim 1 above, and further in view of Wurster et al. (US 4991604, hereinafter Wurster).
Regarding claim 4, Bar-Zion in view of Chiang and Schneider teaches the device of claim 1, as set forth above. Bar-Zion further teaches transducer position control device includes a linear actuator ([0141] discloses the axial actuator includes a linear actuator).
Bar-Zion in view of Chiang and Schneider does not specifically teach the transducer position control device includes a plurality of linear actuators.
However,
Wurster in a similar field of endeavor teaches a transducer position control device includes a plurality of linear actuators (fig. 2 and col. 5, lines 43-48 disclose three electric motors M_x, M_y and M_z which control rods 26 to move the transducer. Col. 6, lines 30-39 disclose each of the rods is driven by an electric motor moving up and down, therefore because the rods are being moved up and down the motors are considered linear motors (actuators)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the linear actuator of Bar-Zion in view of Chiang and Schneider for the plurality of linear actuators of Wurster because it amounts to simple substitution of one known element for another to obtain the predictable results of having a more fine-tuned adjustment of the position of the beam transmission axis.
Claim(s) 7-11 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bar-Zion in view of Chiang and Schneider as applied to claim 1 above, and further in view of Webb et al. (US 20230094631, hereinafter Webb).
Regarding claim 7, Bar-Zion in view of Chiang and Schneider teaches the device of Claim 1, as set forth above. Bar-Zion in view of Chiang and Schneider does not specifically teach the touchscreen display user interface displays a first ellipse relative to a second ellipse, the first ellipse being correlated with the rocking position of the transducer array.
However,
Webb in a similar field of endeavor teaches a touchscreen display user interface (claim 8 discloses the user interface is a touchscreen display) displays a first ellipse relative to a second ellipse ([0004] discloses a graphic user interface (display) includes a first indicator and a second indicator. Fig. 8 shows the first indicator 412 and the second indicator 414 are ellipses), the first ellipse being correlated with the rocking position of the transducer array ([0056] discloses the shapes of the indicators represent the ultrasound transducer array and their movements (positions) which include rocking. Therefore the first indicator (ellipse) is correlated with the rocking position of the transducer array).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device disclosed by Bar-Zion in view of Chiang and Schneider to have the touchscreen display user interface display a first ellipse relative to a second ellipse, the first ellipse being correlated with the rocking position of the transducer array in order to display to the user the current position and movement of the transducer array so the user can make adjustments as needed.
Regarding claim 8, Bar-Zion in view of Chiang, Schneider, and Webb teaches the device of Claim 7, as set forth above. Bar-Zion further teaches the computer executes one or more ultrasound imaging operations in response to an input from the touchscreen display wherein the transducer position control device automatically adjusts a beam transmission axis of the transducer array ([0076] discloses a user can operate the controller 20 by way of an input device which includes a touch screen to perform instructions such as a begin or stop operation, operating parameters, or other instructions. These operations are seen as controlling an operation of the device controller 240 such as controlling the actuators to adjust the position of the transducer based on the operating parameters, thereby automatically adjusting a beam transmission axis of the transducer array).
Regarding claim 9, Bar-Zion in view of Chiang, Schneider, and Webb teaches the device of claim 8, as set forth above. Bar-Zion further teaches the computer receives the input from the touch screen display to control an operation of the transducer position control device ([0076] discloses a user can operate the controller 20 by way of an input device which includes a touch screen to perform instructions such as a begin or stop operation, operating parameters, or other instructions. These operations are seen as controlling an operation of the device controller 240 such as controlling the actuators to adjust the position of the transducer based on the operating parameters, thereby controlling an operation of the transducer position control device) to adjust a position of the first ellipse relative to the second ellipse (by adjusting the transducer array based off of the input, a position of the first ellipse relative to the second ellipse would also change because the position of the transducer array is changing).
Regarding claim 10, Bar-Zion in view of Chiang, Schneider, and Webb teaches the device of claim 9, as set forth above. Chiang further teaches the input corresponds to a press gesture against the touchscreen display ([0007] discloses one of the gestures against the touchscreen display includes a press gesture).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the input disclosed by Bar-Zion in view of Chiang, Schneider, and Webb for the pressure gesture against a touchscreen display input of Chiang because it amounts to simple substitution of one known element for another to obtain the predictable results of having a user provide an input.
Regarding claim 11, Bar-Zion in view of Chiang, Schneider, and Webb teaches the device of claim 10, as set forth above. Bar-Zion further teaches receiving an input to manually adjust the tilt angle ([0136] discloses the tilt actuator may be operated by a user via a wired or wireless communication with device controller 240. By inputting commands to the device controller 240 the user is controlling the tilt actuators which in turn tile the ultrasound transducer 230 thereby adjusting the tilt angle).
Chiang further teaches the computer receives a second input from the touchscreen display (claim 3 discloses “receiving at the computer a second input from the touch screen display”).
Regarding claim 15, Bar-Zion in view of Chiang, Schneider, and Webb teaches the device of Claim 7, as set forth above. Bar-Zion further teaches the computer receives an input from a keyboard control panel or virtual control panel ([0076] discloses the input to the controller is input from a keyboard or keypad).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bar-Zion in view of Chiang and Schneider as applied to claim 1 above, and further in view of Lundberg et al. (US 20050281444, hereinafter Lundberg).
Regarding claim 16, Bar-Zion in view of Chiang and Schneider teaches the device of claim 1, as set forth above. Bar-Zion in view of Chiang and Schneider does not specifically teach the display shows a first image of an organ and a second image of the organ simultaneously, and wherein the transducer position control device simultaneously actuates a change in both the first image and the second image.
However,
Lundberg in a similar field of endeavor teaches a display shows a first image of an organ and a second image of the organ simultaneously (fig. 1 shows the computer display 124 displays multiple views of the heart simultaneously. Also display 400 in fig. 4 shows that multiple views of the heart are displayed simultaneously), and wherein the transducer position control device simultaneously actuates a change in both the first image and the second image ([0047] discloses the quadrants of display 400 show live images of the patient meaning when the system 100 causes the tilt and rotation of the scan planes to change the images corresponding to the scan planes will also simultaneously change).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device disclosed by Bar-Zion in view of Chiang and Schneider to have the display show a first image of an organ and a second image of the organ simultaneously, and wherein the transducer position control device simultaneously actuates a change in both the first image and the second image in order to show the most up to date images of the patient so the user can timely review the images, thereby making the device more efficient.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bar-Zion in view of Chiang and Schneider as applied to claim 1 above, and further in view of Abraham (US 20100174189).
Regarding claim 17, Bar-Zion in view of Chiang and Schneider teaches the device of claim 1, as set forth above. Bar-Zion in view of Chiang and Schneider does not specifically teach the transducer position control device comprises a MEMS actuator.
However,
Abraham in a similar field of endeavor teaches a transducer position control device comprising a MEMS actuator ([0041] discloses the motors of fig. 2 are used to move the transducer element array and [0115] discloses the motors of fig. 2 are MEMS).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device disclosed by Bar-Zion in view of Chiang and Schneider to have the transducer position control device comprise a MEMS actuator in order to more efficiently move the probe in all six degrees of freedom.
Claim(s) 18-20 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundberg et al. (US 20050281444, hereinafter Lundberg) in view of Bar-Zion et al. (US 20170105700, hereinafter Bar-Zion) and Chiang et al. (US 20140114190, hereinafter Chiang).
Regarding claim 18, Lundberg teaches a method for ultrasound monitoring of a patient (Abstract) comprising:
operating an ultrasound device (ultrasound system 100 in fig. 1) wherein a computer (the electronic circuitry of system 100 in fig. 1) controls an image processing operation including actuation of a transducer array to generate images of a region of interest in a heart of a patient ([0041]-[0042] discloses scanning an object using an ultrasound probe to generate images. [0046] discloses the patient’s heart is imaged and [0020] discloses the myocardium is the region of interest. [0020] further teaches the transducer is an array transducer), the transducer array being coupled to the patient to monitor the region of interest in the heart of the patient during a monitoring period ([0041]-[0042] discloses the ultrasound probe (transducer) scans an object. [0046] discloses the patient’s heart is imaged and [0020] discloses the myocardium of the heart is imaged which is considered the region. [0043] discloses the images are obtained during a patient examination, the time period of the patient examination is considered the monitoring period. Additionally by placing the transducer on the patient during the patient examination the transducer is being coupled to the patient); and
actuating, during a bi-plane scanning operation ([0029] discloses the scanning operation is a bi-plane scan), a transducer position control device to adjust a tilt position and a rotational position in response to an operated control ([0029] discloses the user designates the rotation and tilt angle of the planes using the user interface) and thereby control a direction of a beam transmission axis of the transducer array relative to the heart ([0033] discloses the system 100 sets the tilt of the multiplane scan for the planes, the device within the system 100 that ultimately adjusts the tilt angle is considered the transducer position control device. [0040] discloses the tilt is determined relative to the heart of the patient) such that the transducer array generates both a parasternal long axis view and a parasternal short axis view of the heart shown on the display in response to operation of a user interface ([0038] “the user may select and populate cells 502 and 510 of the template to designate acquiring scan data for both biplane and tri-plane recordings…first a biplane acquisition from the parasternal window (trans-thoracic window) is performed to get PLAX and PSAX projections”. The user is further able to select and populate the cells where the views of the heart are shown in response to operation of a user interface [0048]).
Lundberg does not specifically teach the computer controls are touchscreen operated, the transducer position control device includes a plurality of at least three actuators in a transducer housing in which the transducer array is mounted and the control device is actuated to adjust a tilt position, a rotational position, and a rocking position in response to touch screen operated control on a touch actuated user interface that receives a selection of an ultrasound examination preset and one or more related measurements.
However,
Bar-Zion in a similar field of endeavor teaches touchscreen operated computer controls ([0076] discloses “user interface 30 may include…touch screens…that enable a user to input one or more instructions to controller 20”), a transducer position control device that includes a plurality of at least three actuators ([0142] discloses motorized controllable orientation adjusting mechanism that includes a tilt actuator, axial actuator and additional control mechanisms, which reads on at least three actuators) in a transducer housing in which the transducer array is mounted (fig. 6 shows the control device 240 (position control device) is within the ultrasound measurement assembly 200 (transducer housing) and the transducer 230 (transducer array) is mount there within), and the control device is actuated to adjust a tilt position, a rotational position, and a rocking position in response to touch screen operated control on a touch actuated user interface ([0142] discloses the ultrasound transducer 230 is controlled to scan six degrees of freedom, which would include at least a tilt angle, a rotational position, and rocking position (lateral tilt). [0076] discloses a user can operate the controller 20 by way of an input device which includes a touch screen to perform instructions such as a begin or stop operation, operating parameters, or other instructions. These operations are seen as controlling an operation of the device controller 240 such as controlling the actuators to adjust the position of the transducer based on the operating parameters, thereby automatically adjusting a beam transmission axis of the transducer array as outlined in [0136]. Also see claims 1 and 16 “a controller that is configured to repeatedly steer and focus the ultrasound beam”) that receives a selection of an ultrasound examination preset and one or more related measurements ([0007] discloses “the ultrasonic transducer elements being operable to steer and focus an ultrasound beam to a selectable location and to receive an ultrasound signal from the selectable location”. [0009]-[0011] further discloses receiving a selection of a hemodynamic parameter in order to calculate a measurement of a flow rate of blood in the target section).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device disclosed by Lundberg to have the transducer position control device include a plurality of at least three actuators in a transducer housing in which the transducer array is mounted in order to make the transducer self-sufficient so that it can be used with a plurality of ultrasound systems, specifically systems that do not contain position control devices.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device disclosed by Lundberg to have the computer controls be touchscreen operated and the control device be actuated to adjust a tilt position, a rotational position, and a rocking position in response to touch screen operated control on a touch actuated user interface that receives a selection of an ultrasound examination preset and one or more related measurements in order to make the device be more portable and have the adjustments be input by the user using a more streamlined process, thereby making the device more efficient.
Lundberg in view of Bar-Zion does not specifically teach the ultrasound device is an ultrasound touchscreen display device where the images are generated on the touchscreen display and the measurement is selected from a touch actuated measurements menu.
However,
Chiang in a similar field of endeavor teaches the ultrasound device is a touchscreen display device (Abstract and [0069] “a touch screen display 104”) and displays the ultrasound images ([0080] and fig. 6A disclose the ultrasound image is displayed in the display 104) and has the measurement selected from a touch actuated measurements menu ([0073]-[0075] and [0078]-[0080] discloses selecting a touch control from the touch screen display 104 to perform a measurement).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the display disclosed by Lundberg in view of Bar-Zion to be a touchscreen display that display the ultrasound images and has the measurement selected from a touch actuated measurements menu in order make the overall system more portable, as recognized by Chiang ([0010]).
Regarding claim 19, Lundberg in view of Bar-Zion and Chiang teaches the method of claim 18. Lundberg further teaches the transducer comprises a biplane probe that generates two images of the heart ([0037] discloses “the ultrasound system 100 (fig. 1) to perform some type of biplane scan”. Display 124 in fig. 1 further shows that two images of the heart are generated).
Regarding claim 20, Lundberg in view of Bar-Zion and Chiang teaches the method of claim 19. Lundberg further teaches the ultrasound device generates at least one image that comprises a parasternal view of the heart ([0046] and fig. 4 disclose images of the parasternal view of the heart are generated and displayed).
Regarding claim 22, Lundberg in view of Bar-Zion and Chiang teaches the method of claim 18. Bar-Zion further teaches the ultrasound device comprises a input device having a touchscreen display, the tilt control device being operable in response to a touch gesture on the touchscreen display ([0076] discloses a user can operate the controller 20 by way of an input device which includes a touch screen to perform instructions such as a begin or stop operation, operating parameters, or other instructions. These operations are seen as controlling an operation of the device controller 240 such as turning the actuators on and off or controlling the actuators to adjust the position of the transducer based on the operating parameters).
Chiang further teaches a user input device that is a tablet ([0005] “a tablet form factor, and a touch screen display”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device disclosed by Lundberg in view of Bar-Zion and Chiang to have the input device be a tablet in order for medical personnel to easily transport the equipment between the hospital and/or field locations, as recognized by Chiang.
Regarding claim 23, Lundberg in view of Bar-Zion and Chiang teaches the method of claim 18. Bar-Zion further teaches automatically controlling the tilt and rotation by adjusting a tilt angle and a rotational position of the transducer array relative to the transducer housing during an ultrasound imaging procedure ([0096]-[0099] discloses the controller initiates the continuous ultrasonic monitoring method which includes identifying a target section within the acquired images and repeatedly steering and focusing the ultrasound beam such that the target remains within a subsequently acquired image. [0140] discloses the orientation (tilt and rotation) of the transducer is adjusted by adjusting the axial actuator which adjusts the rotation of the transducer and the tilt actuator which adjusts the tilt of the transducer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device disclosed by Lundberg in view of Bar-Zion and Chiang to automatically control the tilt and rotation by adjusting a tilt angle and a rotational position of the transducer array relative to the transducer housing during an ultrasound imaging procedure in order to continuously monitor the target section, as recognized by Bar-Zion ([0099]).
Chiang further teaches an automatic ejection fraction measurement of the heart is generated ([0178] discloses ejection fraction measurements are performed after auto-border detection).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device disclosed by Lundberg in view of Bar-Zion and Chiang to have an automatic ejection fraction measurement of the heart be generated in order to ensure on-axis views of the heart are obtained, as recognized by Chiang ([0178]).
Claim(s) 21 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundberg in view of Bar-Zion and Chiang as applied to claim 19 above, and further in view of Webb et al. (US 20230094631, hereinafter Webb).
Regarding claim 21, Lundberg in view of Bar-Zion and Chiang teaches the method of claim 19. Lundberg further teaches a first image includes at least two chambers of the heart or at least four chambers of the heart ([0026] discloses the processed frames produce an image that includes either a 4-chamber view or 2-chamber view).
Bar-Zion further teaches the ultrasound device detects physiological landmarks of the heart (Abstract, “identify a target section of an object inside the body of the patient” and [0078] discloses the image includes the patient heart).
Lundberg in view of Bar-Zion and Chiang does not specifically teach displaying a first ellipse positioned relative to a second ellipse, the relative position correlated with the beam transmission axis that is controlled by the transducer position control device, the first ellipse being within the second ellipse to align the view.
However,
Webb in a similar field of endeavor teaches displaying a first ellipse positioned relative to a second ellipse, the relative position correlated with the beam transmission axis ([0004] discloses a graphic user interface (display) includes a first indicator and a second indicator. The first indicator representing the current pose of the ultrasound transducer, meaning the relative position is correlated with the beam transmission axis. Fig. 8 shows the first indicator 412 and the second indicator 414 are ellipses and are positioned relative to each other), the first ellipse being within the second ellipse to align the view (318 and 321 in fig. 6 shows that the first ellipse is within the second ellipse).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device disclosed by Lundberg in view of Bar-Zion and Chiang to display a first ellipse positioned relative to a second ellipse, the relative position correlated with the beam transmission axis that is controlled by the transducer position control device, the first ellipse being within the second ellipse to align the view in order to display to the user the current position and movement of the transducer array so the user can make adjustments as needed.
Regarding claim 24, Lundberg in view of Bar-Zion, Chiang, and Webb teaches the method of claim 21. Bar-Zion further teaches coupling the transducer array to the patient with a coupling element ([0125] discloses adhesive path 201 is configured to hold the measurement assembly 200 to the skin of the patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device disclosed by Lundberg in view of Bar-Zion, Chiang, and Webb to have the coupled the transducer to the patient with a coupling element in order to ensure that the probe stays in contact with the skin of the patient, as recognized by Bar-Zion ([0125]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ANDREW W BEGEMAN/Examiner, Art Unit 3798
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