DETAILED ACTION
This office action is in response to the communication received on October 28, 2025 concerning application No. 16/938,515 filed on July 24, 2020.
Claims 1-17 and 28-34 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 10/28/2025 regarding the 35 USC 112b rejection have been fully considered. The amendments to the claims have been entered and overcome the 35 USC 112b rejection of claim 8 previously set forth. Examiner thanks applicant for pointing out the typographical error and amending the claims accordingly. Examiner notes the amendments have led to further 112b issues.
Applicant's arguments filed 10/28/2025 regarding the prior art rejection have been fully considered but they are not persuasive. In response to the applicant’s arguments that the prior art fails to teach “first and second linear transducer arrays forming a biplane transducer array”, examiner respectfully disagrees. Chiang which was relied upon as a secondary reference in the previous office action is now being relied upon to teach the argued limitation. Specifically, [0172] of Chiang discloses “figs. 39A and 39B illustrate an XY bi-plane probe consisting of two one dimensional, multi-element arrays”. This corresponds to the disclosure of the first and second linear transducer arrays discussed on pg. 52 of the present applications specification. Therefore the argued limitation is taught by Chiang. See the rejection below for further details on why it would have been obvious to combine the teachings of Chiang with Lundberg.
In response to the applicant’s arguments that the prior art fails to teach “a tilt control device to adjust a tilt angle of the biplane transducer array…in response to a control program that controls operating parameters of the tilt control device and the biplane transducer array”, examiner respectfully disagrees. [0033] of Lundberg disclose a number of cells (control program) for controlling the operation of setting the tilt and scan parameters, thereby controlling the tilt control device and operating parameters of the biplane transducer array of the system. For at least these reasons Lundberg teaches the argued limitation.
In response to the applicant’s arguments that the prior art fails to teach “a user adjusts the tilt angle of the biplane transducer array within the wearable transducer probe housing with at least one of a motion gesture or tap on the touchscreen display”, examiner respectfully disagrees. Park which was relied upon in the previous office action is being relied upon for teaching the argued limitation. Specifically, [0107] of Park discloses the user enters a user input for a tilt direction and a tilt amount of the probe 200 via the input interface 170. [0070] discloses the input interface 170 includes a touchpad or touch screen in which the user touches (taps) the touch screen to provide the input. While Park is not being relied upon for the teaching the probe housing is a wearable transducer probe housing, applying the teachings of Park to the system disclosed by Lundberg in view of Bar-Zion, Wurster, and Chiang results in the tilt angle of the biplane transducer array within the wearable transducer probe housing to be adjusted using a tap on the touchscreen. Therefore Park teaches the argued limitation recited above.
In response to applicants arguments that Chiang fails to teach the use of touch-actuated tilt access control, examiner notes Chiang is not being relied upon within the rejection for teaching the touch-actuated tilt access control.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 16/414,215, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior application does not disclose “a tilt control device to adjust a tilt angle of the biplane transducer array within the transducer probe housing, the tilt control device configured to orient the biplane transducer array to simultaneously image a parasternal long axis view and a parasternal short axis view of the heart” as recited in claim 1 of the present application. Accordingly, claims 1-17 and 28-30 are not entitled to the benefit of the prior application and the effective filing date of the present application is July 24, 2019.
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 28, 31, and 33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 28 recites the limitation “process image data to create the ultrasound image including at least two chambers of the heart and a second ultrasound imaging”, which is considered indefinite. It is not clear to the examiner whether the created ultrasound image and the second ultrasound image are the same as or different from the one or more ultrasound images of the heart displayed in claim 1. For the purpose of examination and this office action it is being interpreted that the ultrasound images of claim 28 are the same as the one or more ultrasound images of claim 1.
Claim 31 recites the limitation "the tilt axis of the biplane transducer array" in line 2. There is insufficient antecedent basis for this limitation in the claim. The claims from which claim 31 defend do not previously recite a tilt axis of the biplane transducer array.
Claim 33 recites the limitation "the tilt axis direction" in line 2. There is insufficient antecedent basis for this limitation in the claim. The claims from which claim 31 defend do not previously recite a tilt axis direction.
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) 1-16, 28-29, and 31 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), Wurster et al. (US 4991604, hereinafter Wurster), Chiang et al. (US 20140114190, as set forth in the applicant 02/18/2022 IDS, hereinafter Chiang) and Park et al. (US 20180085090, hereinafter Park).
Regarding claim 1, Lundberg teaches a medical ultrasound cardiac imaging device ([0020] discloses ultrasound system 100 for imaging a human heart) comprising:
a transducer probe housing (the housing of the transducer elements 104 and transducer array 106 in fig. 1) including a biplane transducer array ([0037] discloses “ultrasound system 100 (fig. 1) to perform some type of biplane scan” and [0036] discloses “scanned substantially simultaneously along the two scan planes”, in order to simultaneously scan along the two scan planes the array must be a biplane array);
a tilt control device to adjust the tilt angle of the scan planes of the biplane transducer array within the transducer probe housing ([0033] discloses “the system 100 sets the…tilt…of multiplane scan for the planes”, the device within the system 100 that ultimately adjusts the tilt angle is considered the tilt control device) to orient the scan planes to simultaneously image a parasternal long axis view and a parasternal short axis view of a heart ([0038], “first a biplane acquisition from the parasternal window (trans-thoracic window) is performed to get PLAX and PSAX projections” and [0036] discloses “the object is scanned substantially simultaneously along the two scan planes based on the parameter values”. [0040] discloses the scan parameters for parasternal LAAX ad SAX views consist of a 90 degree rotation angle and a -5 degree tilt angle and [0046] further discloses the PLAX and PSAX planes are of the patient’s heart) in response to a control program that controls operating parameters of the tilt control device and the biplane transducer array ([0033] disclose a number of cells for controlling the operation of setting the tilt and scan parameters, thereby controlling the tilt control device and operating parameters of the biplane transducer array of the system);
a ultrasound device (ultrasound system 100 in fig. 1) having a computer in the ultrasound device, the computer (the electronic circuitry of system 100 in fig. 1) including at least one processor (processors 112, 116, 118, 120, 122) and at least one memory ([0022] discloses “the RF processor 112…stores the frame information” meaning the RF processor is a memory. Also memory 136 in fig. 1), a display (computer display 124 in fig. 1) configured to display an ultrasound image of the heart ([0026] discloses the produced image frames of the heart are displayed within the quadrants of the display. Claim 19 further discloses “displaying ultrasound images”), the display positioned on the ultrasound device (fig. 1 shows that the display is positioned on the ultrasound device 100); and
an ultrasound beamformer processing circuit that receives image data from the biplane transducer array ([0021] “the electrical signals are transmitted by the array transducer 106 to a receiver 108 and subsequently passed to the beamformer 110”), the ultrasound beamformer processing circuit being communicably connected to the computer to generate a cardiac output measurement (fig. 1 shows the beamformer 110 is connected to the rest of the electronic circuitry of system 100 and is therefore communicably connected to the computer. [0022] discloses the generated frames from the beamformer are added to the image buffer 114 and [0027] discloses the frames are processed to produce doppler data which represents the cardiac output measurement since doppler data measured flow of the blood through the heart).
Lundberg does not specifically teach the ultrasound device is a portable imaging device comprising a portable ultrasound device housing having a computer in the portable ultrasound device housing, the transducer probe housing is wearable and is configured to be attached to a patient for continuous cardiac monitoring.
However,
Bar-Zion in a similar field of endeavor teaches the ultrasound device is a portable imaging device ([0131] discloses the ultrasound measurement device 204 is connected to a portable external computer making the ultrasound device a portable imaging device) comprising a wearable transducer probe housing ([0061] discloses “ultrasound transducer 12 of continuous ultrasonic monitoring system 10 is configured to be attached to a surface of the skin of a patient”, making the transducer 12 a wearable transducer housing) including a transducer array ([0007] “ultrasound transducer including an array of ultrasonic transducer elements”) configured to be attached to a patient for continuous cardiac monitoring ([0060] discloses the system is for continuous ultrasonic monitoring and [0078] discloses imaging the heart, meaning the transducer 12 is configured to be attached to a patient and continuously monitor the heart (cardiac)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed in invention to have modified the device of Lundberg to have the ultrasound device be a portable imaging device comprising a portable ultrasound device housing having a computer in the portable ultrasound device housing and the transducer probe housing be wearable and be configured to be attached to a patient for continuous cardiac monitoring in order to maintain the target section within the acquired ultrasound image, as recognized by Bar-Zion ([0007]).
Lundberg in view of Br-Zion does not specifically teach the tilt control device having a plurality of at least three actuator elements that orient the biplane transducer array and wherein the at least three actuator elements are configured to extend to different distances relative to the wearable transducer probe housing.
However,
Wurster in a similar field of endeavor teaches a tilt control device having a plurality of at least three actuator elements that orient the transducer array (col. 6, lines 30-39, discloses “the transducer cup is mounted for pivotal movement about a center through a small angle Δα and Δβ in relation to the axes X and Y…the transducer cup can be moved up and down by means of at least three, preferably four screw-threaded rods 26 for example, there being driven for example by an electric motor” by changing the angle of the ultrasound cup the rods 26 adjust the tile angle of the transducer 1 which includes the array. The rods 26 and their corresponding motor are considered the actuators), wherein the at least three actuator elements are configured to extend to different distances relative to the transducer probe housing (fig. 3 shows the rods 26 (actuators), where the left rod is moving up and the right rod is moving down relative to the base plate (housing) holding the rods and transducer 1, meaning the actuators are configured to extend to different distances relative to the transducer housing).
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 tilt control device of Lundberg in view of Bar-Zion for the tilt control device of Wurster as recited above because it amounts to simple substitution of one known element for another to obtain the predictable results of imaging multiple views of the heart.
Lundberg in view of Bar-Zion and Wurster does not specifically teach the biplane transducer array is formed from a first and second linear transducer arrays and the display is a touchscreen display and the touchscreen display is positioned on the portable ultrasound device housing.
However,
Chiang in a similar field of endeavor teaches an transducer probe including a first and second linear transducer arrays that form a biplane transducer array ([0172] “figs. 39A and 39B illustrate an XY bi-plane probe consisting of two one dimensional, multi-element arrays”. This corresponds to the disclosure of the first and second linear transducer arrays discussed on pg. 52 of the present applications specification).
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 first and second linear transducer arrays forming a biplane transducer array of Chiang for the biplane transducer array of Lundberg in view of Bar-Zion and Wurster because it amounts to simple substitution of one known element for another to obtain the predictable results of generating a biplane image of the subject.
Chiang further teaches a touchscreen display ([0080] “touch screen display 104”) positioned on the portable housing (fig. 9A shows that the display 104 is on the portable housing), the touchscreen display provides a graphical user interface (GUI) configured to display a menu ([0154]-[0155] and fig. 32 disclose the display includes a GUI menu screen interface 3200 with touch actuated inputs).
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 Wurster to have the display be a touch screen display and the touch screen display be positioned on the portable ultrasound device housing, wherein the touchscreen display provides a graphical user interface (GUI) configured to display a menu in order to allow for the entire device to be transported to and from the hospital and/or field locations, while reducing the number of components of the device, as recognized by Chiang ([0002]-[0004]).
Lundberg in view of Bar-Zion, Wurster, and Chiang does not specifically teach the touchscreen display provides a selectable touch actuated tilt control such that a user adjusts the tilt angle of the biplane transducer array within the wearable transducer probe housing with at least one of a motion gesture or tap on the touchscreen display while displaying one or more ultrasound images of the heart generated by the biplane transducer array.
However,
Park in a similar field of adjusting the angle of an ultrasound probe teaches a touchscreen display provides a selectable touch actuated tilt control such that a user adjusts the tilt angle of the transducer array with at least one or a motion gesture or tap on the touchscreen display ([0107] discloses the user enters a user input for a tilt direction and a tilt amount of the probe 200 via the input interface 170. [0070] discloses the input interface 170 includes a touchpad or touch screen in which the user touches (taps) the touch screen to provide the input) while displaying one or more ultrasound images of the heart generated by the transducer array ([0097] discloses the display displays the 2D ultrasound image during the procedure. [0017] discloses the probe is a transesophageal echocardiography probe, meaning the images of the target are of the heart).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed in invention to apply the known technique of having a tilt control such that a user controls the tilt angle with the tilt control of Park to the device of Lundberg in view of Bar-Zion, Wurster, and Chiang to allow for the predictable results of ensuring the region the user wants to image is being targeted, thereby increasing the accuracy of the procedure.
Regarding claim 2, Lundberg in view of Bar-Zion, Wurster, Chiang and Park teaches the device of claim 1, as set forth above. Lundberg further teaches the memory is a core memory (fig. 1 shows that the RF processor which is considered a memory as discussed above is found within the system 100 and is therefore considered a core memory).
Chiang further teaches a graphics processor that is connected to the core memory (fig. 17 shows that the computer I/O and graphics chipset 1704 is connected to the core memory 1122 in the computer 106, the graphics chipset 1704 is considered the graphics processor) in the portable ultrasound device 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 apply the known technique of having a graphics processor that is connected to the core memory in the portable ultrasound device housing of Chiang to the device of Lundberg in view of Bar-Zion, Wurster, Chiang and Park be to allow for the predictable results of being able to process more data at a faster rate which would increase the efficiency of the procedure and provide faster results.
Regarding claim 3, Lundberg in view of Bar-Zion, Wurster, Chiang and Park teaches the device of claim 1, as set forth above. Chiang further teaches the first and the second linear transducer arrays comprise a first linear transducer array and a second linear transducer array that is orthogonal to the first linear transducer array (fig. 40 shows the array 4012 of the biplane probe which include linear arrays 4002 and 4004 that are placed orthogonal to one another).
It would have been obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to substitute the first and second linear transducer arrays of Lundberg in view of Bar-Zion, Wurster, Chiang and Park for the first and the second linear transducer arrays comprise comprising orthogonal arrays of Chiang because it amounts to simple substitution of one known element for another to obtain the predictable results of obtaining multiple planes that are orthogonal to one another.
Regarding claim 4, Lundberg in view of Bar-Zion, Wurster, Chiang and Park teaches the device of claim 1, as set forth above. Wurster further teaches the plurality of at least three actuator elements are coupled to corresponding linear motors (col. 6, lines 30-39 discloses each of the rods is driven by an electric motor to move up and down, because the rods are being moved up and down the motors are considered linear motors. Fig. 2 and col. 5, lines 43-48 disclose the three electric motors M_x, M_y and M_z meaning each of the rods has its own corresponding motor) such that the at least three actuator elements can be extended to different distance to control an orientation axis of the biplane transducer array in response to the tilt control (fig. 3 shows the rods 26 (actuators) specifically, the left rod is moving up and the right rod is moving down to adjust the orientation of the transducer 1, additionally, col. 5, lines 43-48 teach the motors that control the rods are controlled in response to input signals (tilt control)).
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 tilt control device of Lundberg in view of Bar-Zion, Wurster, Chiang and Park for the three actuator elements of Wurster as recited above because it amounts to simple substitution of one known element for another to obtain the predictable results of imaging multiple views of the heart.
Regarding claim 5, Lundberg in view of Bar-Zion, Wurster, Chiang and Park teaches the device of claim 1, as set forth above. Wurster further teaches a backplane of the transducer array on which the plurality of at least three actuator elements of the tilt control device are mounted (fig. 3 shows that the rods 26 are mounted on to the transducer cup of transducer 1 which is considered to be the backplate of the transducer. Additionally, as set forth above Lundberg teaches the transducer is a 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 transducer array of Lundberg in view of Bar-Zion, Wurster, Chiang and Park to have a backplane of the transducer array on which the plurality of at least three actuator elements of the tilt control device are mounted in order to provide more support for the transducer array, thereby increasing the durability of the system.
Regarding claim 6, Lundberg in view of Bar-Zion, Wurster, Chiang and Park teaches the device of claim 5, as set forth above. Wurster further teaches the tilt control device includes at least three contact points on the backplane to control a central axis beam control direction of the transducer (fig. 3 shows that each of the rods 26 make contact with the backplane (transducer cup of transducer 1) and col. 6, lines 30-39 discloses there are three rods meaning there are three points of contact that move the transducer cup about a center. By moving the transducer about a center and as shown in fig. 3 the central axis beam of the transducer is moved in order to scan object 19).
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 tilt control device of Lundberg in view of Bar-Zion, Wurster, Chiang and Park for the tilt control device of Wurster as recited above because it amounts to simple substitution of one known element for another to obtain the predictable results of imaging multiple views of the heart.
Regarding claim 7, Lundberg in view of Bar-Zion, Wurster, Chiang and Park teaches the device of claim 1, as set forth above. Chiang further teaches the GUI on the touchscreen display comprises a plurality of icons that are displayed on the touchscreen display to control a plurality of imaging operations including tissue Doppler imaging and color flow imaging ([0073] and fig. 4a disclose the GUI of the touchscreen display 104 includes a plurality of icons (multipoint gestures) to control doppler and color controls. [0104] further discloses the operations performed by the microprocessor include Doppler processing and Color Flow processing)
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, Wurster, Chiang and Park to have the GUI on the touchscreen display comprises a plurality of icons that are displayed on the touchscreen display to control a plurality of imaging operations including tissue Doppler imaging and color flow imaging of Chiang because it allows for the predictable results of reducing the number of components needed to operate the device, thereby making the device easier to transport.
Regarding claim 8, Lundberg in view of Bar-Zion, Wurster, Chiang and Park teaches the device of claim 7, as set forth above. Chiang further teaches the computer acts in response to an input from the touchscreen display to select an ultrasound imaging plane that is orthogonal to a tilt axis of the biplane transducer array ([0137] discloses the user selects ultrasound data including images (planes) and in response displays them. The displaying of the image is computer (electronic circuitry of the system) acting in response to the selection. [0176] and [0178] discloses the bi-plane probe is used for forming orthogonal plane images, meaning the selected image is a plane that is orthogonal to the tilt axis).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed in invention to apply the known technique of having the computer acts in response to an input from the touchscreen display to select an ultrasound imaging plane that is orthogonal to a tilt axis of the biplane transducer array of Chiang to the device of Lundberg in view of Bar-Zion, Wurster, Chiang, and Park to allow for the predictable results of ensuring the region the user wants to image is being displayed, thereby increasing the accuracy of the procedure.
Park further teaches the computer is connected to the tilt control device that adjusts the probe tilting elements in response to touch actuation of the tilt control ([0107] discloses the user enters a user input for a tilt direction and a tilt amount of the probe 200 via the input interface 170. [0108] discloses the tilt of the probe is adjusted based on the user input entered. Fig. 1 shows the computer (electronic circuitry of system 100) is connected to the tilt controller (input interface 170)). As set forth above, Wurster teaches the probe tilting elements are at least three actuator elements.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed in invention to apply the known technique of having the computer be connected to the tilt control device that adjusts the at probe tilting elements in response to touch actuation of the tilt control of Park to the device of Lundberg in view of Bar-Zion, Wurster, Chiang, and Park to allow for the predictable results more rapidly adjusting the tilt of the probe by directing the connecting the controller to the implementer, thereby making the procedure more efficient.
Regarding claim 9, Lundberg in view of Bar-Zion, Wurster, Chiang, and Park teaches the device of claim 8, as set forth above. Bar-Zion further teaches the computer receives the input from the touchscreen display to control a cardiac monitoring operation of the tilt 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 tilt actuator 236 such as turning the actuator on and off. [0020] discloses the ultrasound system is for imaging the heart, therefore the operation is a cardiac monitoring operation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed in invention to have modified the device of Lundberg in view of Bar-Zion, Wurster, Chiang, and Park to have the computer receive the input from the touchscreen display to control a cardiac monitoring operation of the tilt control device in order to have the user control the operation of the device, as recognized by Bar-Zion ([0076]).
Regarding claim 10, Lundberg in view of Bar-Zion, Wurster, Chiang, and Park 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 of the touchscreen display includes a press gesture).
Regarding claim 11, Lundberg in view of Bar-Zion, Wurster, Chiang, and Park teaches the device of claim 10, as set forth above. Park further teaches the computer receives an second input from the touchscreen display to manually adjust the tilt angle ([0107] discloses the user enters a user input for a tilt direction and a tilt amount of the probe 200 via the input interface 170. [0108] discloses the tilt of the probe is adjusted based on the user input entered. By entering the tilt direction the computer (electronic circuitry of system 100 in fig. 1) receives an input to manually adjust the tilt angle).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed in invention to apply the known technique of having the computer receive an input from the touchscreen display to manually adjust the tilt angle of Park to the device of Lundberg in view of Bar-Zion, Wurster, Chiang and Park to allow for the predictable results of ensuring the region the user wants to image is being targeted, thereby increasing the accuracy of the procedure.
Regarding claim 12, Lundberg in view of Bar-Zion, Wurster, Chiang, and Park teaches the device of claim 1, as set forth above. Chiang further teaches the biplane transducer array comprises a plurality of transducer arrays ([0135], “the ultrasound probe 150 includes a transducer housing including one or more transducer arrays 152” and [0172] disclose the probe includes two multi-element arrays. Fig. 40 discloses the biplane array 4012 contains arrays 4002 and 4004), each transducer array in the plurality of transducer arrays being operated by a probe beamformer processing circuit ([0099] discloses that the ultrasound engine 108 which is considered the beamformer controls the transducer array) in the portable ultrasound device housing (fig. 9A shows that the ultrasound engine 108 is in the portable housing) that comprises a tablet ([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 Lundberg in view of Bar-Zion, Wurster, Chiang, and Park to have the biplane transducer array comprise a plurality of transducer arrays because it would allow for the predictable results of being able to image for information at the same time, which would increase the efficiency of the procedure.
Regarding claim 13, Lundberg in view of Bar-Zion, Wurster, Chiang, and Park teaches the device of claim 1, as set forth above. Lundberg further teaches the transducer array generates image data of the one or more parasternal views of the heart ([0038] “biplane acquisition from the parasternal window” and fig. 4 shows the images of the parasternal views of the heart).
Bar-Zion further teaches the computer is programmed to control the tilt control device to periodically monitor the heart ([0142]-[0143] disclose the scanning mechanisms may be automatically controlled by a scanner which is controlled by controllers 240, 20 to continuously monitor a target object such as an organ and ([0078] discloses the monitoring is of a heart)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed in invention to have modified the device of Lundberg in view of Bar-Zion, Wurster, Chiang, and Park to have the computer be programmed to control the tilt control device to periodically monitor the heart in order to continuously monitor the target location, as recognized by Bar-Zion ([0142]).
Regarding claim 14, Lundberg in view of Bar-Zion, Wurster, Chiang, and Park 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” and [0080] disclose the described methods can be used to quantify measurements of the heart).
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, Wurster, Chiang, and Park 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 of Chiang because it allows for the predictable results of allowing the user select what location of the image they want measurements to be taken from.
Regarding claim 15, Lundberg in view of Bar-Zion, Wurster, Chiang, and Park teaches the device of claim 7, as set forth above. Lundberg further teaches the computer receives an input from a keyboard control panel or a virtual control panel ([0048] discloses the user input receives input through the use of a mouse by selecting different scan planes to be viewed which is an example of a virtual control panel. By providing an input to the user interface 134 the system which represents the computer is receiving an input).
Regarding claim 16, Lundberg in view of Bar-Zion, Wurster, Chiang, and Park teaches the device of claim 1, as set forth above. Lundberg further teaches the display shows a first image of the heart and a second image of the heart simultaneously (fig. 1 shows that the computer display 124 displays multiple views of the heart simultaneously. Also display 400 of fig. 4 shows that multiple views of the heart are displayed simultaneously), and wherein the tilt 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 that as the tilt control device moves the transducer array which causes the images to change the images being displayed on the display will also change).
Regarding claim 28, Lundberg in view of Bar-Zion, Wurster, Chiang, and Park teaches the device of claim 1, as set forth above. Lundberg further teaches the processor is configured to process image data to create the ultrasound image including at least two chambers of the heart and a second ultrasound image including at least four chambers of the heart ([0026] “the frames processed by the display processor 116 may produce an apical 4-chamber view of the heart…frames processed by the display processor 118 may produce an apical 2-chamber view of the heart”).
Regarding claim 29, Lundberg in view of Bar-Zion, Wurster, Chiang, and Park teaches the device of claim 1, as set forth above.
Bar-Zion further teaches the tilt control device automatically controls the tilt angle to monitor a condition of the heart ([0140] discloses the orientation of the transducer 230 is automatically controlled by axial actuator 238 and tilt actuator 236 and [0078] discloses the heart is the anatomical structure being imaged).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed in invention to apply the known technique of having the tilt control device automatically control the tilt angle to monitor a condition of the heart of Bar-Zion to the device of Lundberg in view of Bar-Zion, Wurster, Chiang, and Park to allow for the predictable results of performing the procedure without interference from the operator or allowing an unskilled operator to perform the procedure, thereby increasing the efficiency of the procedure.
Regarding claim 31, Lundberg in view of Bar-Zion, Wurster, Chiang, and Park teaches the device of claim 1, as set forth above. Bar-Zion further teaches an automated tilt axis control program is used to control the tilt axis of the biplane transducer array and beam steering direction of the first and second linear transducer arrays ([0140] and [0145] disclose the orientation (tilt axis) of the ultrasound transducer is controlled automatically by the ultrasound measurement device (control program). By controlling the tilt axis of the array the beam steering direction of the first and second linear transducer arrays is also being controlled. .
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed in invention to apply the known technique of having an automated tilt axis control program be used to control the tilt axis of the biplane transducer array and beam steering direction of the first and second linear transducer arrays of Bar-Zion to the device of Lundberg in view of Bar-Zion, Wurster, Chiang, and Park to allow for the predictable results of performing the procedure without interference from the operator or allowing an unskilled operator to perform the procedure, thereby increasing the efficiency of the procedure.
Claim 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundberg in view of Bar-Zion, Wurster, Chiang and Park as applied to claim 1 above, and further in view of Abraham (US 20100174189).
Regarding claim 17, Lundberg in view of Bar-Zion, Wurster, Chiang, and Park teaches the device of claim 1, as set forth above. Lundberg in view of Bar-Zion, Wurster, Chiang, and Park do not specifically teach the tilt control device comprises at least one MEMS actuator.
However,
Abraham in a similar field of endeavor teaches the tilt control device comprises a MEMS actuator ([0041] discloses the motors of fig. 2 are used to move the transducer element array and [0115] discloses that the motors of fig. 2 can be MEMS).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed in invention to substitute the tilt control device of Lundberg in view of Bar-Zion, Wurster, Chiang, and Park for the MEMS actuator of Abraham because it amounts to simple substitution of one known element for another to obtain the predictable results or more efficiently moving the probe in all six degrees of freedom.
Claims 30 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundberg in view of Bar-Zion, Wurster, Chiang, and Park as applied to claim 1 above, and further in view of Moro (US 20140275976).
Regarding claim 30, Lundberg in view of Bar-Zion, Wurster, Chiang, and Park teaches the device of claim 1, as set forth above. Chiang further teaches the computer actuates an ejection fraction measurement ([0178] discloses a process of calculating the ejection fraction (EF), “EF is calculated”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed in invention to have modified the device of Lundberg in view of Bar-Zion, Wurster, Chiang, and Park to actuate an ejection fraction measurement in order see how the characteristics of the heart have changed over time, thereby improving the outcome of the procedure.
Lundberg in view of Bar-Zion, Wurster, Chiang, and Park do not specifically teach the computer determines at least one of a cardiac index and a diastolic filling time (DFT) of the heart or combinations thereof.
However,
Moro in a similar field of endeavor teaches determining a diastolic filling time of the heart ([0044] discloses the diastolic filling period is measured).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed in invention to have modified the device of Lundberg in view of Bar-Zion, Wurster, Chiang, and Park to determine a diastolic filling time of the heart in order to further identify heart issues of patients, as recognized by Moro ([0022]).
Regarding claim 34, Lundberg in view of Bar-Zion, Wurster, Chiang, and Park teaches the device of claim 1, as set forth above. Lundberg in view of Bar-Zion, Wurster, Chiang, and Park do not specifically teach the cardiac output measurement comprises diastolic filling time.
However,
Moro in a similar field of endeavor teaches determining a diastolic filling time of the heart ([0044] discloses the diastolic filling period is measured).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed in invention to have modified the device of Lundberg in view of Bar-Zion, Wurster, Chiang, and Park to determine a diastolic filling time of the heart in order to further identify heart issues of patients, as recognized by Moro ([0022]).
Claim 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundberg in view of Bar-Zion, Wurster, Chiang and Park as applied to claim 1 above, and further in view of Mo et al. (US 20060079778, hereinafter Mo).
Regarding claim 32, Lundberg in view of Bar-Zion, Wurster, Chiang, and Park teaches the device of claim 1, as set forth above. Lundberg in view of Bar-Zion, Wurster, Chiang, and Park do not specifically teach a machine learning program is used to control a beam direction of the biplane transducer array.
However,
Mo in a similar field of endeavor teaches a machine learning program is used to control a beam direction of the biplane transducer array ([0097] “use a neural-network-trained fuzzy logic controller to automatically identify, for a given application type (e.g., carotid), the main vessel (e.g., carotid artery) location in the B-mode image, and determine its spatial orientation based upon which the best beam steer angle and Doppler angle can be computed. The system will further automatically position a tracking sample volume gate of appropriate size at or near the center of the lumen of a moving vessel”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed in invention to apply the known technique of having a machine learning program is used to control a beam direction of the biplane transducer array of Mo to the device of Lundberg in view of Bar-Zion, Wurster, Chiang, and Park to allow for the predictable results of increasing the efficiency of the procedure by reducing the need of the user to determine where to aim the beam of the biplane transducer array.
Claim 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundberg in view of Bar-Zion, Wurster, Chiang and Park as applied to claim 1 above, and further in view of Anderson (US 20080287783).
Regarding claim 33, Lundberg in view of Bar-Zion, Wurster, Chiang, and Park teaches the device of claim 1, as set forth above. Lundberg in view of Bar-Zion, Wurster, Chiang, and Park do not specifically teach a touch actuated gesture selects a manual touchscreen control of the tilt axis direction or an automated operation to control the tilt axis direction.
However,
Anderson in a similar field of endeavor teaches a touch actuated gesture selects a manual touchscreen control of the tilt axis direction or an automated operation to control the tilt axis direction (Claim 6 discloses , “the controller is operable to receive an instructions via an input device representative of a selection between a manual steering mode and an automatic steering mode”. [0045] discloses the input device is a touch screen capable of receiving user directive, therefore the input gesture is touch actuated).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed in invention to apply the known technique of having a touch actuated gesture selects a manual touchscreen control of the tilt axis direction or an automated operation to control the tilt axis direction of Anderson to the device of Lundberg in view of Bar-Zion, Wurster, Chiang, and Park to allow for the predictable results of providing additional controls to the user to ensure the system is performing appropriately, thereby increasing the reliability/accuracy of the system.
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