DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This Office Action is responsive to the claims filed on 10/20/2025. Claims 7, 12, and 16 were previously cancelled. Claims 1, 2, 13, 15, and 17-20 have been amended. Claims 21-26 have been cancelled. Claims 1-6, 8-11, 13-15, 17-20, 27, and 28 are presently pending in this application.
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.
Claims 1, 8, 9, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 20190038260) in view of Sandy (US 20060058660) and Mihailescu (US 20160242744) and Buelow (US 20150126864) and Kiraly (US 20140228653).
Regarding claim 1, Lee teaches an ultrasonic probe (Paragraphs [0126]-[0129]; ultrasound probe #600, Fig. 5) electrically connectable (Paragraph [0127]; through first communication, for example, wired communication) to a display device (Paragraphs [0126]-[0129]; first electronic device #400… including a display #410, Fig. 5) configured to display an ultrasonic image (Paragraph [0128]; first electronic device 400 may acquire first data (for example, ultrasound scan data) by the connected probe #600 and display the acquired first data, for example, ultrasound scan image) and obtaining a vital sign (Paragraphs [0062] and [0090]; a blood glucose monitoring device, a heart rate monitoring device, a blood pressure measuring device, a body temperature measuring device, etc.; The sensor module #240 may measure, for example, physical quantity or detect an operational status of the electronic device #201, and may convert the measured or detected information into an electric signal) that is based on a vital sign signal obtained from a sensor (Paragraphs [0062] and [0090]; the electronic device may include at least one of various medical devices (e.g., various portable medical measuring devices (a blood glucose monitoring device, a heart rate monitoring device, a blood pressure measuring device, a body temperature measuring device, etc.); Additionally or alternatively, the sensor module 240 may include, for example, an E-nose sensor, an ElectroMyoGraphy (EMG) sensor, an ElectroEncephaloGram (EEG) sensor, an ElectroCardioGram (ECG) sensor; Fig. 2), the ultrasonic probe comprising:
an image capturing unit (Paragraphs [0097], [0126]-[0128], and [0161]; first electronic device #400 may acquire second data (for example, affected part image data) photographed by an internal camera; The camera module #291 and #670, Figs. 2 and 6) joined to or detachably attached to a cable (Paragraph [0127]; the first electronic device 400 may be connected with the probe 600 through first communication, for example, wired communication; Examiner notes the electronic device #400 comprising the camera module is connected to the probe through a wired communication), the image capturing unit comprising a first optical lens (Paragraph [0097]; may include… a lens) to capture an image of a nearby object (Paragraph [0161]; The camera module #670 may photograph a certain subject); and
a probe head (Paragraph [0127]; probe #600, Fig. 5) joined to or detachably attached to a cable (Paragraphs [0127] and [0134]; through first communication, for example, wired communication; According to various embodiments, when the electronic device #400 and the probe #600 are connected through a wired communication scheme, the electronic device #400 and the probe #600 may be connected based on at least some ports (for example, the data input/output port #411) of the communication interfaces; Fig. 11 shows probe #600 connected to a cable), the probe head being configured to transmit an ultrasonic beam toward a body surface of a subject (Paragraph [0129]; The probe #600 may radiate an ultrasound signal from a body surface of a target to a desired part within the body) and to receive a reflected wave from the body surface (Paragraph [0129]; and acquire a tomogram of soft tissues or an image of a blood flow based on information of the reflected ultrasound signal, for example, an ultrasound echo signal),
wherein the image capturing unit is configured to transmit a control signal (Paragraph [0150]; The user input unit 620 may receive user input for initiating the operation (for example, a function of connecting to or recognizing the probe 600, an ultrasound diagnosis function, and a data transmission/reception function) of the electronic device 400 according to various embodiments of the present disclosure and generate an input signal according to user input) to the display device (Paragraph [0258]; controller 680 may determine whether the screen mirroring function is selected) in accordance with an operation on an input interface (Paragraphs [0129] and [0149]; first electronic device 400 may include, for example, a smart phone and a tablet Personal Computer (PC). According to various embodiments, the first electronic device 400 may display various User Interfaces (UIs) or Graphical User Interfaces (GUIs); user input unit 620 may include at least one input device for detecting various user inputs) provided on a housing of the image capturing unit (Paragraph [0134]; the electronic device #400 may include… a housing (or a body) #420, Fig. 5),
wherein the control signal causes the display device to perform setting of the display device including display setting (Paragraph [0258]; controller #680 may determine whether the screen mirroring function is selected).
Lee does not explicitly teach the device is configured to display the vital sign;
and that the display device is a patient monitor configured to display measured waveforms of vital signs simultaneously with the photographic image acquired by the image capturing unit and/or the ultrasonic image;
that both the probe head and the image capturing unit are joined to or detachably attached to the first cable;
and that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject;
and the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via a second cable.
Sandy, however, teaches an ultrasonic probe (Paragraph [0009]; ultrasound scanning system; Paragraph [0030]; cardiac ultrasound monitoring system) electrically connectable to a display device (Paragraph [0032]; monitoring display 30, Fig. 3; Paragraph [0035]; combined display 48, Figs. 4 and 5) configured to display the vital sign (Paragraph [0033]; combined display 30 includes a hemodynamic display… includes selected hemodynamic measurements, including a pair of ECG traces 36, a pair of invasive blood pressure traces 38 and an oxygen saturation trace 40);
and that the display device is a patient monitor (Paragraphs [0028]; hemodynamic patient monitoring system; Paragraph [0032]; a combined ultrasound and hemodynamic anesthesia monitoring display 30, Fig. 3) configured to display measured waveforms of vital signs simultaneously with the photographic image acquired by the ultrasonic image (Paragraph [0033]; The hemodynamic data for the ECG trace 36, blood pressure trace 38 and oxygen saturation trace 40 is received from the anesthesia monitoring system, while the ultrasound image 32 and the thumb nail images 34 are received from the ultrasound monitoring system; Paragraph [0034]; monitored data and images are presented in a synchronized manner, Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Lee such that the display device is a patient monitor configured to display measured waveforms of vital signs simultaneously with the photographic image acquired by the ultrasonic image as taught by Sandy. This would have resulted in synchronization of the ultrasound images and the hemodynamic measurements allowing a clinician to review the combined monitoring results in a useful and time efficient manner (Sandy, Paragraph [0034]). Furthermore the synchronization of the ultrasound images and the patient waveforms allows a clinician to study the ultrasound images and the hemodynamic measurements at the time of the ultrasound images, as well as before and immediately following the ultrasound images (Sandy, Paragraph [0037]).
It is further unclear if the device of Lee in view of Sandy teaches that both the probe head and the image capturing unit are joined to or detachably attached to the first cable; and
that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject;
and the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via a second cable.
Mihailescu, however, teaches an ultrasonic probe (Paragraph [0012]; An ultrasound transducer, Fig. 11A) electrically connectable to a display device configured to display an ultrasonic image (Paragraph [0018]; A display can be operatively connected with the processor, the display configured for visualizing a three-dimensional (3-D) representation of the object created or refined from the determined spatial position and orientation and output from the ultrasound transducer), the ultrasonic probe comprising:
an image capturing unit (Paragraphs [0176] and [0179]; with tracking capability using ranging cameras mechanically registered to the ultrasound probe; The ranging camera is placed in camera housing shell 1106… A board 1108 accommodates the ranging and tracking components; Fig. 11A) joined to or detachably attached to a first cable (Paragraph [0180]; Whereas the cable 1116 makes the connection inside the tracking subsystem housing shell between the board 1108 and the connector 1115, the cable 1117 makes the connection inside the ultrasound probe housing shell 1101 between the connector 1115 and the board 1104; Fig. 11A), the image capturing unit comprising a first optical lens (Paragraph [0169]; a camera housing shell #1004 comprising a camera whose lenses #1005) to capture an image of a nearby object (Paragraph [0167]; the use of a ranging camera and/or a passive camera, which is attached to either one of the medical instruments or sensors, or it is positioned to observe the environment comprising the patient, medical instruments, and potentially, the local clinician); and
a probe head (Paragraph [0178]; The ultrasound transducer subsystem 1103 is inside the body of the probe… Dashed box 1104 is an abstract representation of such electronics; Fig. 11A) joined to or detachably attached to the first cable (Paragraph [0180]; the cable 1117 makes the connection inside the ultrasound probe housing shell 1101 between the connector 1115 and the board 1104; Fig. 11A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the arrangement of the image capturing unit with respect to the ultrasound probe of Lee in view of Sandy such that the image capturing unit and the probe head are connected, resulting in both the probe head and the image capturing unit being joined to or detachably attached to the first cable. This would help the device or a medical professional more accurately determine the physical position of the ultrasound probe with respect to the patient being imaged (Mihailescu, Paragraphs [0018]), and thus improve the ability for the device or a medical professional to give instructions on how to move the ultrasound probe (Mihailescu, [0217]). Furthermore, it would allow the on-board electronics to be able to communicate with other computing and visualization units (Mihailescu, Paragraph [0180]) and improve data transfer between the ultrasound transducer and image system to improve determining the positioning of the transducer.
The device of Lee in view of Sandy and Mihailescu further fails to teach that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject;
and the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via a second cable.
Buelow, however, teaches an ultrasonic probe (Paragraph [0043]; first image generating unit 2… being an ultrasound head, Fig. 1) electrically connectable to a display device configured to display an ultrasonic image (Paragraph [0057]; image generation apparatus 1 further comprises a display unit 17 for displaying the first and second images, Fig. 1; Paragraph [0062]; first image of deformable object… preferentially an ultrasound image) comprising:
an image capturing unit (Paragraph [0049]; marker position determination device 16 is an optical stereo camera system; Fig. 1);
a probe head (Paragraph [0043]; ultrasound head; Fig. 1, portion of the ultrasound unit in contact with the patient 5);
wherein the image capturing unit is configured to capture the photographic image (Paragraph [0051]; stereo camera system can record the positions of the markers on the membrane 6 and also record the location and orientation of the ultrasound head 2) of an abutment state of the probe head (Paragraph [0051]; location and the orientation, of the ultrasound head 2 relative to the membrane 6 at the time of imaging is determined.; The location and orientation of the ultrasound head is considered to be an abutment state of the probe head as understood in its broadest reasonable interpretation) with respect to the body surface of the subject (Paragraph [0055]; the determined surface of the object 5 in the second image and the reconstructed surface defined by the membrane 6 can be registered with respect to each other; The surface of the breast 5 is determined with respect to the probe in contact with the membrane 6 which is considered to read on the claimed limitation of capture the an abutment state of the probe head with respect to the body surface of the subject as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the image capturing unit of Lee in view of Sandy and Mihailescu such that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject as taught by Buelow because it would allow recording the current state of the breast shape at the time of the acquisition of an image of the breast (Buelow, Paragraph [0071]) and further store the position of the ultrasound probe with respect to the body part for later reference which would allow comparison the of position of features in the three-dimensional breast images acquired at different times (Buelow, Paragraph [0072]).
The device of Lee in view of Sandy, Mihailescu, and Buelow further fails to teach the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via a second cable.
Kiraly, however, teaches an ultrasonic probe (Paragraph [0027]; light weighted belt 20, Fig. 2 and 4; Paragraph [0031]; biosensor belt 400. Each source is surrounded by multiple detectors, and different sets of separately operated emitters and signal-receivers (e.g. miniature ultrasound transducers and receivers)) electrically connectable to a display device (Paragraph [0025]; portable computer device 10… with a display screen 12, Fig. 2; Paragraph [0031]; with a display screen 12) configured to display an ultrasonic image (Paragraph [0025]; it is capable of overlaying the mother's abdomen with a computer image, animation, ultrasound picture or real-time ultrasound video) and a vital sign that is based on a vital sign signal obtained from a sensor (Paragraph [0041]; portable device 10A provides outputs, which can include fetal heart rate, noise and artifact filtered EEG, ECG and/or integrated EEG signals), the ultrasonic probe comprising:
an image capturing unit (Paragraph [0029]; an imaging system 420, Fig. 4; Paragraph [0031]; a signal processing unit (CCD camera & intensifier-filter unit) 450, Fig. 5) joined to or detachably attached to a first cable (Paragraph [0026]; cord 42, Fig. 5), the image capturing unit comprising a first optical lens to capture an image of an object (Paragraph [0033]; The system 450 has optical fibers 140, a focusing lens 138); and
a probe head joined to or detachably attached to the first cable (Paragraph [0027]; light weighted belt 20, Fig. 2 and 4; Paragraph [0031]; the array 500 having… miniature ultrasound transducers and receivers), the probe head being configured to transmit an ultrasonic beam toward a body surface of a subject and to receive a reflected wave from the body surface (Paragraph [0046]; and multiple-point ultrasound transducers and/or light sources to launch ultrasound signals and/or light rays of specific wavelengths on the abdomen of the mother… reflected bodypart- or object-distance-specific ultrasound signal),
and wherein the image capturing unit and the ultrasonic probe are separate elements (Paragraph [0031]; biosensor belt 400… separately operated emitters and signal-receivers e.g. miniature ultrasound transducers and receivers; Paragraph [0029]; an imaging system 420, Fig. 4; Paragraph [0031]; a signal processing unit (CCD camera & intensifier-filter unit) 450, Fig. 5) connected to each other via the first cable (Fig. 5, cord 42), and commonly connected to the display device via a second cable (Paragraph [0031]; Fig. 5, conventional wires 452).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the image capturing unit and the ultrasonic probe of Lee in view of Sndy, Mihailescu, and Buelow to have been separate elements connected to each other via the first cable and commonly connected to the display device via a second cable as taught by Kiraly because it would have been known arrangement of connecting an imaging device and an ultrasound device to a display monitor that further would have allowed identifying the shape and position of the ultrasonic map with respect to the patient which would have further allowed overlaying the ultrasound image over the patient (Paragraph [0025] and [0043]).
Regarding claim 8, together Lee, Sandy, Mihailescu, Buelow, and Kiraly teach all of the limitations of claim 1 as noted above.
Lee further teaches the image capturing unit is configured to transmit the control signal for instructing a change of settings to both the display device (Paragraph [0258]; controller #680 may determine whether the screen mirroring function is selected) and the probe head (Abstract, Paragraphs [0139], [0202], and [0206]; control guide for the probe in response to reception of control information from the external device; may operate to output a direction indicator for moving the location of the probe 600 based on at least one of an affected part photographing screen and the probe 600) in accordance with the operation on the input interface provided on the housing of the image capturing unit (Paragraphs [0129] and [0149]; first electronic device 400 may include, for example, a smart phone and a tablet Personal Computer (PC). According to various embodiments, the first electronic device 400 may display various User Interfaces (UIs) or Graphical User Interfaces (GUIs); user input unit 620 may include at least one input device for detecting various user inputs; Paragraph [0134]; the electronic device #400 may include… a housing (or a body) #420, Fig. 5).
Regarding claim 9, together Lee, Sandy, Mihailescu, Buelow, and Kiraly teach all of the limitations of claim 1 as noted above. Lee further teaches the input interface is provided (Paragraph [0129]; first electronic device 400 may display various User Interfaces (UIs) or Graphical User Interfaces (GUIs)) on a side opposite (Paragraph [0260]; for example, a preview image (for example, a probe control image) as a real-time (or live) image) photographed by the camera (for example, a rear camera of the electronic device) to a side on which the first optical lens is provided (Paragraph [0097]; The camera module is, for example, a device for image and video capturing… may include one or more image sensors (e.g., a front sensor or a rear sensor), a lens).
Regarding claim 13, Lee teaches an ultrasonic measurement system (Paragraph [0014]; A method and an apparatus for performing an ultrasound diagnosis based on an electronic device) comprising: a display device (Paragraphs [0126]-[0129]; first electronic device #400… including a display #410, Fig. 5) configured to display an ultrasonic image (Paragraph [0128]; first electronic device 400 may acquire first data (for example, ultrasound scan data) by the connected probe #600 and display the acquired first data, for example, ultrasound scan image) and obtaining a vital sign (Paragraphs [0062] and [0090]; a blood glucose monitoring device, a heart rate monitoring device, a blood pressure measuring device, a body temperature measuring device, etc.; The sensor module #240 may measure, for example, physical quantity or detect an operational status of the electronic device #201, and may convert the measured or detected information into an electric signal) that is based on a vital sign signal obtained from a sensor (Paragraphs [0062] and [0090]; the electronic device may include at least one of various medical devices (e.g., various portable medical measuring devices (a blood glucose monitoring device, a heart rate monitoring device, a blood pressure measuring device, a body temperature measuring device, etc.); Additionally or alternatively, the sensor module 240 may include, for example, an E-nose sensor, an ElectroMyoGraphy (EMG) sensor, an ElectroEncephaloGram (EEG) sensor, an ElectroCardioGram (ECG) sensor; Fig. 2); and
an ultrasonic probe (Paragraphs [0126]-[0129]; ultrasound probe #600, Fig. 5) electrically connectable (Paragraph [0127]; through first communication, for example, wired communication) to the display device (Paragraphs [0126]-[0129]; first electronic device #400… including a display #410, Fig. 5),
wherein the ultrasonic probe comprises:
an image capturing unit (Paragraphs [0097], [0126]-[0128], and [0161]; first electronic device #400 may acquire second data (for example, affected part image data) photographed by an internal camera; The camera module #291 and #670, Figs. 2 and 6) joined to or detachably attached to a cable (Paragraph [0127]; the first electronic device 400 may be connected with the probe 600 through first communication, for example, wired communication; Examiner notes the electronic device #400 comprising the camera module is connected to the probe through a wired communication), the image capturing unit comprising a first optical lens (Paragraph [0097]; may include… a lens) to capture an image of a nearby object (Paragraph [0161]; The camera module #670 may photograph a certain subject); and
a probe head (Paragraph [0127]; probe #600, Fig. 5) joined to or detachably attached to the cable (Paragraphs [0127] and [0134]; through first communication, for example, wired communication; According to various embodiments, when the electronic device #400 and the probe #600 are connected through a wired communication scheme, the electronic device #400 and the probe #600 may be connected based on at least some ports (for example, the data input/output port #411) of the communication interfaces; Fig. 11 shows probe #600 connected to a cable), the probe head being configured to transmit an ultrasonic beam toward a body surface of a subject (Paragraph [0129]; The probe #600 may radiate an ultrasound signal from a body surface of a target to a desired part within the body) and to receive a reflected wave from the body surface (Paragraph [0129]; and acquire a tomogram of soft tissues or an image of a blood flow based on information of the reflected ultrasound signal, for example, an ultrasound echo signal),
wherein the display device is configured to display the ultrasonic image based on the reflected wave received by the probe head (Paragraphs [0128] and [0157]; and display the acquired first data (for example, ultrasound scan image); acquiring data in the ultrasound diagnosis mode, displaying the data through a display; Fig. 11), and a photographic image captured by image capturing unit (Paragraphs [0128] and [0216]; and display the acquired second data (for example, a preview image); acquiring data in the ultrasound diagnosis mode, displaying the data through a display, Fig. 10), and
wherein the image capturing unit is configured to transmit a control signal (Paragraph [0150]; The user input unit 620 may receive user input for initiating the operation (for example, a function of connecting to or recognizing the probe 600, an ultrasound diagnosis function, and a data transmission/reception function) of the electronic device 400 according to various embodiments of the present disclosure and generate an input signal according to user input) to the display device (Paragraph [0258]; controller 680 may determine whether the screen mirroring function is selected) in accordance with an operation on an input interface (Paragraphs [0129] and [0149]; first electronic device 400 may include, for example, a smart phone and a tablet Personal Computer (PC). According to various embodiments, the first electronic device 400 may display various User Interfaces (UIs) or Graphical User Interfaces (GUIs); user input unit 620 may include at least one input device for detecting various user inputs) provided on a housing of the image capturing unit (Paragraph [0134]; the electronic device #400 may include… a housing (or a body) #420, Fig. 5),
wherein the control signal causes the display device to perform setting of the display device including display setting (Paragraph [0258]; controller #680 may determine whether the screen mirroring function is selected).
Lee does not explicitly teach that the device is configured to display the vital sign; and
that the display device is a patient monitor configured to display measured waveforms of vital signs simultaneously with the photographic image acquired by the image capturing unit and/or the ultrasonic image;
that both the probe head and the image capturing unit are joined to or detachably attached to the first cable; and
that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject; and
the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via a second cable.
Sandy, however, teaches an ultrasonic probe (Paragraph [0009]; ultrasound scanning system; Paragraph [0030]; cardiac ultrasound monitoring system) electrically connectable to a display device (Paragraph [0032]; monitoring display 30, Fig. 3; Paragraph [0035]; combined display 48, Figs. 4 and 5) configured to display the vital sign (Paragraph [0033]; combined display 30 includes a hemodynamic display… includes selected hemodynamic measurements, including a pair of ECG traces 36, a pair of invasive blood pressure traces 38 and an oxygen saturation trace 40);
and that the display device is a patient monitor (Paragraphs [0028]; hemodynamic patient monitoring system; Paragraph [0032]; a combined ultrasound and hemodynamic anesthesia monitoring display 30, Fig. 3) configured to display measured waveforms of vital signs simultaneously with the photographic image acquired by the ultrasonic image (Paragraph [0033]; The hemodynamic data for the ECG trace 36, blood pressure trace 38 and oxygen saturation trace 40 is received from the anesthesia monitoring system, while the ultrasound image 32 and the thumb nail images 34 are received from the ultrasound monitoring system; Paragraph [0034]; monitored data and images are presented in a synchronized manner, Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Lee such that the display device is a patient monitor configured to display measured waveforms of vital signs simultaneously with the photographic image acquired by the ultrasonic image as taught by Sandy. This would have resulted in synchronization of the ultrasound images and the hemodynamic measurements allowing a clinician to review the combined monitoring results in a useful and time efficient manner (Sandy, Paragraph [0034]). Furthermore the synchronization of the ultrasound images and the patient waveforms allows a clinician to study the ultrasound images and the hemodynamic measurements at the time of the ultrasound images, as well as before and immediately following the ultrasound images (Sandy, Paragraph [0037]).
It is further unclear if the device of Lee in view of Sandy teaches that both the probe head and the image capturing unit are joined to or detachably attached to the first cable;
and that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject; and
the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via a second cable.
Mihailescu, however, teaches an ultrasonic probe (Paragraph [0012]; An ultrasound transducer, Fig. 11A) electrically connectable to a display device configured to display an ultrasonic image (Paragraph [0018]; A display can be operatively connected with the processor, the display configured for visualizing a three-dimensional (3-D) representation of the object created or refined from the determined spatial position and orientation and output from the ultrasound transducer), the ultrasonic probe comprising:
an image capturing unit (Paragraphs [0176] and [0179]; with tracking capability using ranging cameras mechanically registered to the ultrasound probe; The ranging camera is placed in camera housing shell 1106… A board 1108 accommodates the ranging and tracking components; Fig. 11A) joined to or detachably attached to a first cable (Paragraph [0180]; Whereas the cable 1116 makes the connection inside the tracking subsystem housing shell between the board 1108 and the connector 1115, the cable 1117 makes the connection inside the ultrasound probe housing shell 1101 between the connector 1115 and the board 1104; Fig. 11A), the image capturing unit comprising a first optical lens (Paragraph [0169]; a camera housing shell #1004 comprising a camera whose lenses #1005) to capture an image of a nearby object (Paragraph [0167]; the use of a ranging camera and/or a passive camera, which is attached to either one of the medical instruments or sensors, or it is positioned to observe the environment comprising the patient, medical instruments, and potentially, the local clinician); and
a probe head (Paragraph [0178]; The ultrasound transducer subsystem 1103 is inside the body of the probe… Dashed box 1104 is an abstract representation of such electronics; Fig. 11A) joined to or detachably attached to the first cable (Paragraph [0180]; the cable 1117 makes the connection inside the ultrasound probe housing shell 1101 between the connector 1115 and the board 1104; Fig. 11A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the arrangement of the image capturing unit with respect to the ultrasound probe of Lee in view of Sandy such that the image capturing unit and the probe head are connected, resulting in both the probe head and the image capturing unit being joined to or detachably attached to the first cable. This would help the device or a medical professional more accurately determine the physical position of the ultrasound probe with respect to the patient being imaged (Mihailescu, Paragraphs [0018]), and thus improve the ability for the device or a medical professional to give instructions on how to move the ultrasound probe (Mihailescu, [0217]). Furthermore, it would allow the on-board electronics to be able to communicate with other computing and visualization units (Mihailescu, Paragraph [0180]) and improve data transfer between the ultrasound transducer and image system to improve determining the positioning of the transducer.
The device of Lee in view of Sandy and Mihailescu further fails to teach that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject; and
the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via a second cable.
Buelow, however, teaches an ultrasonic probe (Paragraph [0043]; first image generating unit 2… being an ultrasound head, Fig. 1) electrically connectable to a display device configured to display an ultrasonic image (Paragraph [0057]; image generation apparatus 1 further comprises a display unit 17 for displaying the first and second images, Fig. 1; Paragraph [0062]; first image of deformable object… preferentially an ultrasound image) comprising:
an image capturing unit (Paragraph [0049]; marker position determination device 16 is an optical stereo camera system; Fig. 1);
a probe head (Paragraph [0043]; ultrasound head; Fig. 1, portion of the ultrasound unit in contact with the patient 5);
wherein the image capturing unit is configured to capture the photographic image (Paragraph [0051]; stereo camera system can record the positions of the markers on the membrane 6 and also record the location and orientation of the ultrasound head 2) of an abutment state of the probe head (Paragraph [0051]; location and the orientation, of the ultrasound head 2 relative to the membrane 6 at the time of imaging is determined.; The location and orientation of the ultrasound head is considered to be an abutment state of the probe head as understood in its broadest reasonable interpretation) with respect to the body surface of the subject (Paragraph [0055]; the determined surface of the object 5 in the second image and the reconstructed surface defined by the membrane 6 can be registered with respect to each other; The surface of the breast 5 is determined with respect to the probe in contact with the membrane 6 which is considered to read on the claimed limitation of capture the an abutment state of the probe head with respect to the body surface of the subject as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the image capturing unit of Lee in view of Sandy and Mihailescu such that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject as taught by Buelow because it would allow recording the current state of the breast shape at the time of the acquisition of an image of the breast (Buelow, Paragraph [0071]) and further store the position of the ultrasound probe with respect to the body part for later reference which would allow comparison the of position of features in the three-dimensional breast images acquired at different times (Buelow, Paragraph [0072]).
The device of Lee in view of Sandy, Mihailescu, and Buelow further fails to teach that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject; and
the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via a second cable.
Kiraly, however, teaches an ultrasonic probe (Paragraph [0027]; light weighted belt 20, Fig. 2 and 4; Paragraph [0031]; biosensor belt 400. Each source is surrounded by multiple detectors, and different sets of separately operated emitters and signal-receivers (e.g. miniature ultrasound transducers and receivers)) electrically connectable to a display device (Paragraph [0025]; portable computer device 10… with a display screen 12, Fig. 2; Paragraph [0031]; with a display screen 12) configured to display an ultrasonic image (Paragraph [0025]; it is capable of overlaying the mother's abdomen with a computer image, animation, ultrasound picture or real-time ultrasound video) and a vital sign that is based on a vital sign signal obtained from a sensor (Paragraph [0041]; portable device 10A provides outputs, which can include fetal heart rate, noise and artifact filtered EEG, ECG and/or integrated EEG signals), the ultrasonic probe comprising:
an image capturing unit (Paragraph [0029]; an imaging system 420, Fig. 4; Paragraph [0031]; a signal processing unit (CCD camera & intensifier-filter unit) 450, Fig. 5) joined to or detachably attached to a first cable (Paragraph [0026]; cord 42, Fig. 5), the image capturing unit comprising a first optical lens to capture an image of an object (Paragraph [0033]; The system 450 has optical fibers 140, a focusing lens 138); and
a probe head joined to or detachably attached to the first cable (Paragraph [0027]; light weighted belt 20, Fig. 2 and 4; Paragraph [0031]; the array 500 having… miniature ultrasound transducers and receivers), the probe head being configured to transmit an ultrasonic beam toward a body surface of a subject and to receive a reflected wave from the body surface (Paragraph [0046]; and multiple-point ultrasound transducers and/or light sources to launch ultrasound signals and/or light rays of specific wavelengths on the abdomen of the mother… reflected bodypart- or object-distance-specific ultrasound signal),
and wherein the image capturing unit and the ultrasonic probe are separate elements (Paragraph [0031]; biosensor belt 400… separately operated emitters and signal-receivers e.g. miniature ultrasound transducers and receivers; Paragraph [0029]; an imaging system 420, Fig. 4; Paragraph [0031]; a signal processing unit (CCD camera & intensifier-filter unit) 450, Fig. 5) connected to each other via the first cable (Fig. 5, cord 42), and commonly connected to the display device via a second cable (Paragraph [0031]; Fig. 5, conventional wires 452).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the image capturing unit and the ultrasonic probe of Lee in view of Sndy, Mihailescu, and Buelow to have been separate elements connected to each other via the first cable and commonly connected to the display device via a second cable as taught by Kiraly because it would have been known arrangement of connecting an imaging device and an ultrasound device to a display monitor that further would have allowed identifying the shape and position of the ultrasonic map with respect to the patient which would have further allowed overlaying the ultrasound image over the patient (Paragraph [0025] and [0043]).
Claims 2 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Sandy, Mihailescu, Buelow, and Kiraly as applied to claim 1 above, and further in view of Hwang (US 7549961).
Regarding claim 2, together Lee, Sandy, Mihailescu, Buelow, and Kiraly teach all of the limitations of claim 1 as noted above.
The device of Lee in view of Sandy, Mihailescu, Buelow, and Kiraly does not explicitly teach a connector connectable to a connection port of the display device; and
a second cable connected to the connector and joined to or detachably attached to the image capturing unit.
Hwang, however, teaches an ultrasonic probe (Col. 7, Ln. 35-52; Scan head #103, Fig. 2) electrically connectable to a display device (Col. 4, Ln. 59-Col. 5, Ln. 3 and Col. 7, Ln. 25-35; Ultrasound scan head #103 of FIG. 2A is preferably attached to external controller #102; User interface 205 includes hardware and software components such that a user may interface with PDA/MDA #101 to monitor a patient's vital signs as well as to direct operation of ultrasound scan head 103 which may be attached to external controller 102 via interconnect 104; output on display #206; Figs. 1 and 2A; Examiner notes the combined PDA/MDA #101 and external interface controller #102 is considered to be a display device); the ultrasonic probe comprising a connector connectable to a connection port of the display device (Col. 8, Ln. 21-31 and Col. 12, Ln. 44-64; other hardware/software associated with external controller 102, such as ultrasound scan head 103 or sensors attached to patients for monitoring, using communication link 209 or through PCMCIA bus/peripheral interface 222; the optical acquisition unit that has been inserted in device #100); and
a second cable connected to the connector (Col. 5, Ln. 36-65 and Col. 8, Ln. 49-Col. 9, Ln. 23; may be transmitted to an external peripheral via interface 222; peripheral interface 222… Communication… may be via wireline) and joined to or detachably attached to the image capturing unit (Col. 12, Ln. 44-64; the medical technician inserts an optical acquisition unit, e.g., a video camera or other imaging device, into PDA/MDA 101).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Lee in view of Sandy, Mihailescu, Buelow, and Kiraly to include a connector connectable to a connection port of the display device and a second cable connected to the connector and joined to or detachably attached to the image capturing unit as taught by Hwang. This would have further allowed interfacing with a plurality of different devices (Hwang, Col. 8, Ln. 61-Col. 9, Ln. 23) and allow acquiring the anatomy and allow transfer of the acquired images in real-time to both display of PDA/MDA or to a remote expert (Col. 12, Ln. 44-64).
Claims 3-5 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Sandy, Mihailescu, Buelow, Kiraly, and Hwang as applied to claim 2 above, and further in view of Takahashi (US 20050054227).
Regarding claim 3, together Lee, Sandy, Mihailescu, Buelow, Kiraly, and Hwang teach all of the limitations of claim 2 as noted above.
Together Lee, Sandy, Mihailescu, Buelow, Kiraly, and Hwang do not explicitly teach that the first cable and the second cable are arranged to extend from the image capturing unit in a gravity direction when the first optical lens is oriented in a horizontal direction.
Takahashi, however, teaches “an electronic apparatus … which is structured so that a plurality of connectors can be arranged efficiently while plugs are allowed to be connected easily thereto” (Abstract), and further teaches:
wherein the first cable (“audio/video output plug 13” Takahashi: [0041], Fig. 7) and the second cable (“USB plug 14” Takahashi: [0042], Fig. 7) are arranged to extend from the image capturing unit (“camera body 1” Takahashi: [0040], Fig. 7) in a gravity direction when the first optical lens (“In FIG. 5, Reference Numeral 1 denotes a camera body, and an image-taking lens 2 is provided on the front face thereof” Takahashi: [0033], Fig. 5) is oriented in a horizontal direction.
As shown in the annotated, rotated version Fig. 5 of Takahashi shown below, the first optical lens (“image-taking lens 2”) is oriented in a horizontal direction, as indicated by the horizontal arrow on the left side of the image, extending from the lens. As further shown in this figure, the first cable and second cable (when plugged in to connectors 10 and 11) will be arranged to extend from the camera in a gravity direction, as indicated by the vertical arrow at the bottom of the image, extending from the connectors.
PNG
media_image1.png
580
471
media_image1.png
Greyscale
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 ultrasound probe with integrated electronics disclosed by Lee in view of Sandy, Mihailescu, Buelow, and Hwang, by including the electronic apparatus and camera having connectors as taught by Takahashi. One of ordinary skill in the art would have been motivated to make this modification because like the image capturing unit described in the claimed invention, “apparatuses being frequently carried, such as image pickup apparatuses, have recently undergone progressive miniaturization, making it necessary to efficiently arrange the connectors. In addition, it is necessary that connectors should be arranged at positions not interfering with the use of the apparatus when it is used" (Takahashi: [0006]). Accordingly, "since connectors are required to be electrically connected inside, the connectors must be arranged on a circuit board in consideration of mounting efficiency. Furthermore, if the connectors are simply arranged close to one another on the circuit board, the plugs interfere with one another when the plugs are connected to the respective connectors. Hence, a certain amount of space is required between the connectors" (Takahashi: [0013]).
Regarding claim 4, together Lee, Sandy, Mihailescu, Buelow, Kiraly, and Hwang teach all of the limitations of claim 2 as noted above.
Together Lee, Sandy, Mihailescu, Buelow, Kiraly, and Hwang do not explicitly teach that the first cable and the second cable extend from the image capturing unit in a same direction that is different from an imaging direction of the first optical lens.
Takahashi, however, teaches “an electronic apparatus … which is structured so that a plurality of connectors can be arranged efficiently while plugs are allowed to be connected easily thereto” (Abstract), and further teaches:
wherein the first cable (“audio/video output plug 13” Takahashi: [0041], Fig. 7) and the second cable (“USB plug 14” Takahashi: [0042], Fig. 7) extend from the image capturing unit (“camera body 1” Takahashi: [0040], Fig. 7) in a same direction that is different (“audio/video output connector 10 and a USB connector 11 are disposed on a side face (first face) 1 a of the camera body 1” Takahashi: [0040], Fig. 7) from an imaging direction of the first optical lens (“In FIG. 5, Reference Numeral 1 denotes a camera body, and an image-taking lens 2 is provided on the front face thereof” Takahashi: [0033], Fig. 5).
As shown in Fig. 5, the lens 2 is provided on the front face of camera body 1, and takes an image in the same front-facing direction. As shown in Fig. 7, the first cable and second cable (represented by plugs 13 and 14) extend from the camera in the same direction (side-facing) that is different from the imaging direction of the lens (front-facing).
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 ultrasound probe with integrated electronics disclosed by Lee in view of Sandy, Mihailescu, Buelow, Kiraly, and Hwang, by including the electronic apparatus and camera having connectors as taught by Takahashi. One of ordinary skill in the art would have been motivated to make this modification because like the image capturing unit described in the claimed invention, “apparatuses being frequently carried, such as image pickup apparatuses, have recently undergone progressive miniaturization, making it necessary to efficiently arrange the connectors. In addition, it is necessary that connectors should be arranged at positions not interfering with the use of the apparatus when it is used" (Takahashi: [0006]). Accordingly, "since connectors are required to be electrically connected inside, the connectors must be arranged on a circuit board in consideration of mounting efficiency. Furthermore, if the connectors are simply arranged close to one another on the circuit board, the plugs interfere with one another when the plugs are connected to the respective connectors. Hence, a certain amount of space is required between the connectors" (Takahashi: [0013]).
Regarding claim 5, together Lee, Sandy, Mihailescu, Buelow, Kiraly, and Hwang teach all of the limitations of claim 2 as noted above.
Together Lee, Sandy, Mihailescu, Buelow, Kiraly, and Hwang do not explicitly teach that the first cable and the second cable extends from the image capturing unit such that the first cable and the second cable are arranged one behind the other when the first optical lens is viewed from the front.
Takahashi, however, teaches “an electronic apparatus … which is structured so that a plurality of connectors can be arranged efficiently while plugs are allowed to be connected easily thereto” (Abstract), and further teaches:
wherein the first cable (“audio/video output plug 13” Takahashi: [0041], Fig. 7) and the second cable (“USB plug 14” Takahashi: [0042], Fig. 7) extends from the image capturing unit (“camera body 1” Takahashi: [0040], Fig. 7) such that the first cable and the second cable are arranged one behind the other when the first optical lens (“In FIG. 5, Reference Numeral 1 denotes a camera body, and an image-taking lens 2 is provided on the front face thereof” Takahashi: [0033], Fig. 5) is viewed from the front.
When the first optical lens is view from the front (similar to the view that is shown in Fig. 5, but not exactly, as Fig. 5 does not show only the front face but also shows the side face), it becomes clear that the first cable and second cable will be arranged one behind the other once the cables are plugged in to their respective ports on the side face of the camera body. To explain further, when viewed from the front, the audio-video output plug 13 will be arranged directly in front of the USB plug 14.
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 ultrasound probe with integrated electronics disclosed by Lee in view of Sandy, Mihailescu, Buelow, Kiraly, and Hwang, by including the electronic apparatus and camera having connectors as taught by Takahashi. One of ordinary skill in the art would have been motivated to make this modification because like the image capturing unit described in the claimed invention, “apparatuses being frequently carried, such as image pickup apparatuses, have recently undergone progressive miniaturization, making it necessary to efficiently arrange the connectors. In addition, it is necessary that connectors should be arranged at positions not interfering with the use of the apparatus when it is used" (Takahashi: [0006]). Accordingly, "since connectors are required to be electrically connected inside, the connectors must be arranged on a circuit board in consideration of mounting efficiency. Furthermore, if the connectors are simply arranged close to one another on the circuit board, the plugs interfere with one another when the plugs are connected to the respective connectors. Hence, a certain amount of space is required between the connectors" (Takahashi: [0013]).
Regarding claim 10, together Lee, Sandy, Mihailescu, Buelow, Kiraly, and Hwang teach all of the limitations of claim 2 as noted above.
Together Lee, Sandy, Buelow, Mihailescu, Kiraly, and Hwang do not explicitly teach that the image capturing unit comprises three or more slots to which the first cable or the second cable is detachably attached.
Takahashi, however, teaches “an electronic apparatus … which is structured so that a plurality of connectors can be arranged efficiently while plugs are allowed to be connected easily thereto” (Abstract), and further teaches:
wherein the image capturing unit (“camera body 1” Takahashi: [0040], Fig. 7) comprises three or more slots (“an audio/video output connector 10 and a USB connector 11 are disposed on a side face (first face) 1 a of the camera body 1, and a DC input connector 12 is disposed on the rear face (second face) 1 b adjacent to the side face 1 a” Takahashi: [0040]) to which the first cable or the second cable is detachably attached (“Reference Numerals 13, 14 and 15 denote an audio/video output plug connected to the audio/video output connector 10, a USB plug connected to the USB connector 11 and a DC plug connected to the DC input connector 12, respectively” Takahashi: [0040]).
A first slot can be represented by the audio/video output connector 10, a second slot can be represented by the USB connector 11, and a third slot can be represented by a DC input connector 12, while the first cable is represented by the audio/video output plug 13 and the second cable is represented by the USB plug 14.
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 ultrasound probe with integrated electronics disclosed by Lee in view of Sandy, Mihailescu, Buelow, Kiraly, and Hwang, by including the electronic apparatus and camera having connectors as taught by Takahashi. One of ordinary skill in the art would have been motivated to make this modification because like the image capturing unit described in the claimed invention, “apparatuses being frequently carried, such as image pickup apparatuses, have recently undergone progressive miniaturization, making it necessary to efficiently arrange the connectors. In addition, it is necessary that connectors should be arranged at positions not interfering with the use of the apparatus when it is used" (Takahashi: [0006]). Accordingly, "since connectors are required to be electrically connected inside, the connectors must be arranged on a circuit board in consideration of mounting efficiency. Furthermore, if the connectors are simply arranged close to one another on the circuit board, the plugs interfere with one another when the plugs are connected to the respective connectors. Hence, a certain amount of space is required between the connectors" (Takahashi: [0013]).
Regarding claim 11, together Lee, Sandy, Mihailescu, Buelow, Kiraly, Hwang, and Takahashi teach all of the limitations of claim 10 as noted above.
Takahashi further teaches wherein one of the slots is provided on a side different from a side on which another one of the slots is provided (“an audio/video output connector 10 and a USB connector 11 are disposed on a side face (first face) 1 a of the camera body 1, and a DC input connector 12 is disposed on the rear face (second face) 1 b adjacent to the side face 1 a” Takahashi: [0040]).
As shown in Fig. 7, the DC input connector 12 is provided on a side different from a side on which the USB connector 11 is provided.
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 ultrasound probe with integrated electronics disclosed by Lee in view of Sandy, Mihailescu, Buelow, Kiraly, Hwang, and Takahashi, by including the electronic apparatus and camera having connectors as taught by Takahashi. One of ordinary skill in the art would have been motivated to make this modification because like the image capturing unit described in the claimed invention, “apparatuses being frequently carried, such as image pickup apparatuses, have recently undergone progressive miniaturization, making it necessary to efficiently arrange the connectors. In addition, it is necessary that connectors should be arranged at positions not interfering with the use of the apparatus when it is used" (Takahashi: [0006]). Accordingly, "since connectors are required to be electrically connected inside, the connectors must be arranged on a circuit board in consideration of mounting efficiency. Furthermore, if the connectors are simply arranged close to one another on the circuit board, the plugs interfere with one another when the plugs are connected to the respective connectors. Hence, a certain amount of space is required between the connectors" (Takahashi: [0013]).
Claims 6 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Sandy, Mihailescu, Buelow, and Kiraly as applied to claims 1 and 13 above, respectively, and further in view of Slayton (US 20070167709).
Regarding claim 6, together Lee, Sandy, Mihailescu, Buelow, and Kiraly teach all of the limitations of claim 1 as noted above.
Together Lee, Sandy, Mihailescu, Buelow, and Kiraly do not explicitly teach the probe head comprises a marker indicating a direction in which the probe head is to be abutted on the body surface of the subject.
Slayton, however, teaches a “non-invasive visual imaging system … wherein the imaging system procures an image of a transducer position during diagnostic or therapeutic treatment” (Abstract), and further teaches:
wherein the probe head comprises a marker (“positioning indicator 308”) indicating a direction in which the probe head is to be abutted on the body surface of the subject ("positioning indicator 308 comprises a series of marks which are suitably configured to facilitate the determination and assessment of the positional and/or orientation information of transducer 102 with respect to the patient" Slayton: [0052]; "positional image depicting the position and/or orientation of the transducer 602 on the surface of the treatment area at the time the transducer image is captured" Slayton: [0058]).
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 ultrasound probe with integrated electronics disclosed by Lee in view of Sandy, Mihailescu, Buelow, and Kiraly by including the visual imaging system for ultrasonic probe as taught by Slayton. One of ordinary skill in the art would have been motivated to make this modification because “by knowing the fixed distances of the triangulation marks, the software within central processing unit 108 can determine the position and distance of imaging device 116 with respect to transducer 102. Thus, as transducer 102 changes the angle of scan or otherwise the orientation with respect to the region of interest, the software within central processing unit 108 can suitably follow these changes in orientation and position. Accordingly, by knowing the orientation and geometry of transducer 102 with respect to the patient, positional and/or orientation information and ultrasonic imaging information can be suitably fused into a combined image,” thus providing the benefit of displaying both an ultrasonic image from a probe (transducer) and a photographic image from an imaging device.
Regarding claim 14, together Lee, Sandy, Mihailescu, Buelow, and Kiraly teach all of the limitations of claim 13 as noted above.
Together Lee, Sandy, Mihailescu, Buelow, and Kiraly do not explicitly teach the probe head comprises a marker indicating a direction in which the probe head is to be abutted on the body surface of the subject, and the display device is configured to detect characteristics of the ultrasonic probe from at least one of a color and a shape of the marker captured in the photographic image.
Slayton, however, teaches a “non-invasive visual imaging system … wherein the imaging system procures an image of a transducer position during diagnostic or therapeutic treatment” (Abstract), and further teaches:
wherein the probe head comprises a marker (“positioning indicator 308”) indicating a direction in which the probe head is to be abutted on the body surface of the subject ("positioning indicator 308 comprises a series of marks which are suitably configured to facilitate the determination and assessment of the positional and/or orientation information of transducer 102 with respect to the patient" Slayton: [0052]; "positional image depicting the position and/or orientation of the transducer 602 on the surface of the treatment area at the time the transducer image is captured" Slayton: [0058]), and
the display device is configured to detect characteristics of the ultrasonic probe ("Positioning indicator 308 is suitably configured to permit control system 100 to suitably correlate the geometry, i.e., position and orientation, of transducer 102 to the geometry of a corresponding ultrasonic image of the treatment region" Slayton: [0052]) from at least one of a color and a shape of the marker captured in the photographic image ("positioning indicator 308 can comprise triangulation marks, i.e., three marks configured in a triangular manner, configured at known distances apart to permit the software algorithm of central processing unit 108 to assess and determine the orientation and geometry of transducer 102 during operation" Slayton: [0052]).
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 ultrasound probe with integrated electronics disclosed by Lee in view of Sandy, Mihailescu, Kiraly, and Buelow by including the visual imaging system for ultrasonic probe as taught by Slayton. One of ordinary skill in the art would have been motivated to make this modification because “by knowing the fixed distances of the triangulation marks, the software within central processing unit 108 can determine the position and distance of imaging device 116 with respect to transducer 102. Thus, as transducer 102 changes the angle of scan or otherwise the orientation with respect to the region of interest, the software within central processing unit 108 can suitably follow these changes in orientation and position. Accordingly, by knowing the orientation and geometry of transducer 102 with respect to the patient, positional and/or orientation information and ultrasonic imaging information can be suitably fused into a combined image,” thus providing the benefit of displaying both an ultrasonic image from a probe (transducer) and a photographic image from an imaging device.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 20190038260) in view of Sandy (US 20060058660) and Buelow (US 20150126864) and Kiraly (US 20140228653).
Regarding claim 15, Lee teaches an ultrasonic probe (Paragraphs [0126]-[0129]; ultrasound probe #600, Fig. 5) comprising: a probe head (Paragraph [0127]; probe #600, Fig. 5) configured to abut on a body surface of a subject (Paragraph [0270]; of the probe 600 in contact with an affected part of the patient), to transmit an ultrasonic beam toward the body surface (Paragraph [0129]; The probe #600 may radiate an ultrasound signal from a body surface of a target to a desired part within the body), and to receive a reflected wave from the body surface (Paragraph [0129]; and acquire a tomogram of soft tissues or an image of a blood flow based on information of the reflected ultrasound signal, for example, an ultrasound echo signal); and
an image capturing unit (Paragraphs [0097], [0126]-[0128], and [0161]; first electronic device #400 may acquire second data (for example, affected part image data) photographed by an internal camera; The camera module #291 and #670, Figs. 2 and 6) that is connectable to the probe head by wire or by wireless (Paragraph [0127]; 400 may be connected (for example, paired) with the probe 600 through first communication, for example, wired communication or wireless communication) to transmit a control signal to the probe head (Paragraph [0138]; According to various embodiments, the electronic device 400 may process an operation related to starting a diagnosis, for example, acquire ultrasound data by controlling the probe 600), the image capturing unit comprising a first optical lens (Paragraph [0097]; may include… a lens) to capture an image of a nearby object (Paragraph [0161]; The camera module #670 may photograph a certain subject), the patient monitor (Paragraph [0131]; it may be assumed that the second electronic device 500 corresponds to a smart phone and a monitor, and the smart phone and the monitor exist in the same space) being configured to display an ultrasonic image (Paragraph [0131]; the smart phone may share and display the data through the connected monitor based on screen mirroring) and to obtain a vital sign (Paragraphs [0062] and [0090]; a blood glucose monitoring device, a heart rate monitoring device, a blood pressure measuring device, a body temperature measuring device, etc.; The sensor module #240 may measure, for example, physical quantity or detect an operational status of the electronic device #201, and may convert the measured or detected information into an electric signal) that is based on a vital sign signal obtained from a sensor (Paragraphs [0062] and [0090]; the electronic device may include at least one of various medical devices (e.g., various portable medical measuring devices (a blood glucose monitoring device, a heart rate monitoring device, a blood pressure measuring device, a body temperature measuring device, etc.); Additionally or alternatively, the sensor module 240 may include, for example, an E-nose sensor, an ElectroMyoGraphy (EMG) sensor, an ElectroEncephaloGram (EEG) sensor, an ElectroCardioGram (ECG) sensor; Fig. 2),
wherein the ultrasonic probe is configured to transmit a photographic image acquired by the image capturing unit (Paragraph [0269]; first electronic device 400 may photograph a control state of the probe 600 through the camera (for example, the camera module 670 or the rear camera) and transmit the photographed image to the second electronic device 500 in real time) and image information based on the reflected wave (Paragraph [0221]; second electronic device 500 may display ultrasound scan data based at least partially on the received data) to the patient monitor (Paragraph [0221]; second electronic device 500),
wherein the image capturing unit (Paragraph [0253]; controller 680 of the electronic device 400) is configured to transmit the control signal (Paragraph [0150]; user input unit 620 may receive user input for initiating the operation (for example, a function of connecting to or recognizing the probe 600, an ultrasound diagnosis function, and a data transmission/reception function) of the electronic device 400 according to various embodiments of the present disclosure and generate an input signal according to user input) to the patient monitor (Paragraph [0258]; controller 680 may determine whether the screen mirroring function is selected) in accordance with an operation on an input interface (Paragraph [0129]; first electronic device 400 may include, for example, a smart phone and a tablet Personal Computer (PC). According to various embodiments, the first electronic device 400 may display various User Interfaces (UIs) or Graphical User Interfaces (GUIs)) provided on a housing of the image capturing unit (Paragraph [0134]; electronic device 400 may include ..., a housing (or a body) 420),
wherein the control signal causes the patient monitor to perform setting of the patient monitor including display setting (Paragraph [0258]; controller 680 may determine whether the screen mirroring function is selected).
Lee does not explicitly teach the device is configured to display the vital sign;
that the patient monitor is configured to display measured waveforms of vital signs simultaneously with the photographic image acquired by the image capturing unit and/or the ultrasonic image; and
that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject; and
the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the patient monitor via a second cable.
Sandy, however, teaches an ultrasonic probe (Paragraph [0009]; ultrasound scanning system; Paragraph [0030]; cardiac ultrasound monitoring system) electrically connectable to a display device (Paragraph [0032]; monitoring display 30, Fig. 3; Paragraph [0035]; combined display 48, Figs. 4 and 5) configured to display the vital sign (Paragraph [0033]; combined display 30 includes a hemodynamic display… includes selected hemodynamic measurements, including a pair of ECG traces 36, a pair of invasive blood pressure traces 38 and an oxygen saturation trace 40);
and that the display device is a patient monitor (Paragraphs [0028]; hemodynamic patient monitoring system; Paragraph [0032]; a combined ultrasound and hemodynamic anesthesia monitoring display 30, Fig. 3) configured to display measured waveforms of vital signs simultaneously with the photographic image acquired by the ultrasonic image (Paragraph [0033]; The hemodynamic data for the ECG trace 36, blood pressure trace 38 and oxygen saturation trace 40 is received from the anesthesia monitoring system, while the ultrasound image 32 and the thumb nail images 34 are received from the ultrasound monitoring system; Paragraph [0034]; monitored data and images are presented in a synchronized manner, Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Lee such that the display device is a patient monitor configured to display measured waveforms of vital signs simultaneously with the photographic image acquired by the ultrasonic image as taught by Sandy. This would have resulted in synchronization of the ultrasound images and the hemodynamic measurements allowing a clinician to review the combined monitoring results in a useful and time efficient manner (Sandy, Paragraph [0034]). Furthermore the synchronization of the ultrasound images and the patient waveforms allows a clinician to study the ultrasound images and the hemodynamic measurements at the time of the ultrasound images, as well as before and immediately following the ultrasound images (Sandy, Paragraph [0037]).
The device of Lee in view of Sandy further fails to teach that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject; and
the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the patient monitor via a second cable.
Buelow, however, teaches an ultrasonic probe (Paragraph [0043]; first image generating unit 2… being an ultrasound head, Fig. 1) electrically connectable to a display device configured to display an ultrasonic image (Paragraph [0057]; image generation apparatus 1 further comprises a display unit 17 for displaying the first and second images, Fig. 1; Paragraph [0062]; first image of deformable object… preferentially an ultrasound image) comprising:
an image capturing unit (Paragraph [0049]; marker position determination device 16 is an optical stereo camera system; Fig. 1);
a probe head (Paragraph [0043]; ultrasound head; Fig. 1, portion of the ultrasound unit in contact with the patient 5);
wherein the image capturing unit is configured to capture the photographic image (Paragraph [0051]; stereo camera system can record the positions of the markers on the membrane 6 and also record the location and orientation of the ultrasound head 2) of an abutment state of the probe head (Paragraph [0051]; location and the orientation, of the ultrasound head 2 relative to the membrane 6 at the time of imaging is determined.; The location and orientation of the ultrasound head is considered to be an abutment state of the probe head as understood in its broadest reasonable interpretation) with respect to the body surface of the subject (Paragraph [0055]; the determined surface of the object 5 in the second image and the reconstructed surface defined by the membrane 6 can be registered with respect to each other; The surface of the breast 5 is determined with respect to the probe in contact with the membrane 6 which is considered to read on the claimed limitation of capture the an abutment state of the probe head with respect to the body surface of the subject as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the image capturing unit of Lee in view of Sandy such that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject as taught by Buelow because it would allow recording the current state of the breast shape at the time of the acquisition of an image of the breast (Buelow, Paragraph [0071]) and further store the position of the ultrasound probe with respect to the body part for later reference which would allow comparison the of position of features in the three-dimensional breast images acquired at different times (Buelow, Paragraph [0072]).
The device of Lee in view of Sandy and Buelow further fails to teach the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the patient monitor via a second cable.
Kiraly, however, teaches an ultrasonic probe (Paragraph [0027]; light weighted belt 20, Fig. 2 and 4; Paragraph [0031]; biosensor belt 400. Each source is surrounded by multiple detectors, and different sets of separately operated emitters and signal-receivers (e.g. miniature ultrasound transducers and receivers)) electrically connectable to a display device (Paragraph [0025]; portable computer device 10… with a display screen 12, Fig. 2; Paragraph [0031]; with a display screen 12) configured to display an ultrasonic image (Paragraph [0025]; it is capable of overlaying the mother's abdomen with a computer image, animation, ultrasound picture or real-time ultrasound video) and a vital sign that is based on a vital sign signal obtained from a sensor (Paragraph [0041]; portable device 10A provides outputs, which can include fetal heart rate, noise and artifact filtered EEG, ECG and/or integrated EEG signals), the ultrasonic probe comprising:
an image capturing unit (Paragraph [0029]; an imaging system 420, Fig. 4; Paragraph [0031]; a signal processing unit (CCD camera & intensifier-filter unit) 450, Fig. 5) joined to or detachably attached to a first cable (Paragraph [0026]; cord 42, Fig. 5), the image capturing unit comprising a first optical lens to capture an image of an object (Paragraph [0033]; The system 450 has optical fibers 140, a focusing lens 138); and
a probe head joined to or detachably attached to the first cable (Paragraph [0027]; light weighted belt 20, Fig. 2 and 4; Paragraph [0031]; the array 500 having… miniature ultrasound transducers and receivers), the probe head being configured to transmit an ultrasonic beam toward a body surface of a subject and to receive a reflected wave from the body surface (Paragraph [0046]; and multiple-point ultrasound transducers and/or light sources to launch ultrasound signals and/or light rays of specific wavelengths on the abdomen of the mother… reflected bodypart- or object-distance-specific ultrasound signal),
and wherein the image capturing unit and the ultrasonic probe are separate elements (Paragraph [0031]; biosensor belt 400… separately operated emitters and signal-receivers e.g. miniature ultrasound transducers and receivers; Paragraph [0029]; an imaging system 420, Fig. 4; Paragraph [0031]; a signal processing unit (CCD camera & intensifier-filter unit) 450, Fig. 5) connected to each other via the first cable (Fig. 5, cord 42), and commonly connected to the display device via a second cable (Paragraph [0031]; Fig. 5, conventional wires 452).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the image capturing unit and the ultrasonic probe of Lee in view of Sndy, Mihailescu, and Buelow to have been separate elements connected to each other via the first cable and commonly connected to the display device via a second cable as taught by Kiraly because it would have been known arrangement of connecting an imaging device and an ultrasound device to a display monitor that further would have allowed identifying the shape and position of the ultrasonic map with respect to the patient which would have further allowed overlaying the ultrasound image over the patient (Paragraph [0025] and [0043]).
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 20190038260) in view of Sandy (US 20060058660), Hwang (US 7549961), and Mihailescu (US 20160242744) and Buelow (US 20150126864) and Kiraly (US 20140228653).
Regarding claim 17, Lee teaches an ultrasonic probe (Paragraphs [0126]-[0129]; ultrasound probe #600, Fig. 5) electrically connectable (Paragraph [0127]; through first communication, for example, wired communication) to a display device (Paragraphs [0126]-[0129]; first electronic device #400… including a display #410, Fig. 5) configured to display an ultrasonic image (Paragraph [0128]; first electronic device 400 may acquire first data (for example, ultrasound scan data) by the connected probe #600 and display the acquired first data, for example, ultrasound scan image), the ultrasonic probe comprising:
an image capturing unit (Paragraphs [0097], [0126]-[0128], and [0161]; first electronic device #400 may acquire second data (for example, affected part image data) photographed by an internal camera; The camera module #291 and #670, Figs. 2 and 6) joined to or detachably attached to a cable (Paragraph [0127]; the first electronic device 400 may be connected with the probe 600 through first communication, for example, wired communication; Examiner notes the electronic device #400 comprising the camera module is connected to the probe through a wired communication), the image capturing unit comprising a first optical lens (Paragraph [0097]; may include… a lens) to capture an image of a nearby object (Paragraph [0161]; The camera module #670 may photograph a certain subject);
a probe head (Paragraph [0127]; probe #600, Fig. 5) joined to or detachably attached to the cable (Paragraphs [0127] and [0134]; through first communication, for example, wired communication; According to various embodiments, when the electronic device #400 and the probe #600 are connected through a wired communication scheme, the electronic device #400 and the probe #600 may be connected based on at least some ports (for example, the data input/output port #411) of the communication interfaces; Fig. 11 shows probe #600 connected to a cable), the probe head being configured to transmit an ultrasonic beam toward a body surface of a subject (Paragraph [0129]; The probe #600 may radiate an ultrasound signal from a body surface of a target to a desired part within the body) and to receive a reflected wave from the body surface (Paragraph [0129]; and acquire a tomogram of soft tissues or an image of a blood flow based on information of the reflected ultrasound signal, for example, an ultrasound echo signal).
Lee does not explicitly teach that both the probe head and the image capturing unit are joined to or detachably attached to the first cable;
a connector connectable to a connection port of the display device; and
a second cable connected to the connector and joined to or detachably attached to the image capturing unit,
wherein an image signal generated at the probe head is provided to the display device via the image capturing unit via the first cable, the image capturing unit, and the second cable;
wherein the display device is a patient monitor configured to display measured waveforms of vital signs simultaneously with the photographic image acquired by the image capturing unit and/or the ultrasonic image; and
that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject; and
the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via the second cable.
Sandy, however, teaches an ultrasonic probe (Paragraph [0009]; ultrasound scanning system; Paragraph [0030]; cardiac ultrasound monitoring system) electrically connectable to a display device (Paragraph [0032]; monitoring display 30, Fig. 3; Paragraph [0035]; combined display 48, Figs. 4 and 5) configured to display the vital sign (Paragraph [0033]; combined display 30 includes a hemodynamic display… includes selected hemodynamic measurements, including a pair of ECG traces 36, a pair of invasive blood pressure traces 38 and an oxygen saturation trace 40);
and that the display device is a patient monitor (Paragraphs [0028]; hemodynamic patient monitoring system; Paragraph [0032]; a combined ultrasound and hemodynamic anesthesia monitoring display 30, Fig. 3) configured to display measured waveforms of vital signs simultaneously with the photographic image acquired by the ultrasonic image (Paragraph [0033]; The hemodynamic data for the ECG trace 36, blood pressure trace 38 and oxygen saturation trace 40 is received from the anesthesia monitoring system, while the ultrasound image 32 and the thumb nail images 34 are received from the ultrasound monitoring system; Paragraph [0034]; monitored data and images are presented in a synchronized manner, Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Lee such that the display device is a patient monitor configured to display measured waveforms of vital signs simultaneously with the photographic image acquired by the ultrasonic image as taught by Sandy. This would have resulted in synchronization of the ultrasound images and the hemodynamic measurements allowing a clinician to review the combined monitoring results in a useful and time efficient manner (Sandy, Paragraph [0034]). Furthermore the synchronization of the ultrasound images and the patient waveforms allows a clinician to study the ultrasound images and the hemodynamic measurements at the time of the ultrasound images, as well as before and immediately following the ultrasound images (Sandy, Paragraph [0037]).
It is not clear if together Lee and Sandy teach that both the probe head and the image capturing unit are joined to or detachably attached to the first cable;
a connector connectable to a connection port of the display device; and
a second cable connected to the connector and joined to or detachably attached to the image capturing unit,
wherein an image signal generated at the probe head is provided to the display device via the image capturing unit via the first cable, the image capturing unit, and the second cable; and
that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject;
and the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via the second cable.
Hwang, however, teaches an ultrasonic probe (Col. 7, Ln. 35-52; Scan head #103, Fig. 2) electrically connectable to a display device (Col. 4, Ln. 59-Col. 5, Ln. 3 and Col. 7, Ln. 25-35; Ultrasound scan head #103 of FIG. 2A is preferably attached to external controller #102; User interface 205 includes hardware and software components such that a user may interface with PDA/MDA #101 to monitor a patient's vital signs as well as to direct operation of ultrasound scan head 103 which may be attached to external controller 102 via interconnect 104; output on display #206; Figs. 1 and 2A; Examiner notes the combined PDA/MDA #101 and external interface controller #102 is considered to be a display device) configured to display an ultrasonic image and a vital sign that is based on a vital sign signal obtained from a sensor (Col. 8, Ln. 61-Col. 9, Ln. 10; While PDA/MDA 101 monitors a patient's vital signs, ultrasound scan head 103 may simultaneously acquire ultrasound imaging data and transfer this data from scan head 103 to external controller 102 via interconnect 104 for display on PDA/MDA 101);
a connector connectable to a connection port of the display device (Col. 8, Ln. 21-31 and Col. 12, Ln. 44-64; other hardware/software associated with external controller 102, such as ultrasound scan head 103 or sensors attached to patients for monitoring, using communication link 209 or through PCMCIA bus/peripheral interface 222; the optical acquisition unit that has been inserted in device #100); and a second cable connected to the connector (Col. 5, Ln. 36-65 and Col. 8, Ln. 49-Col. 9, Ln. 23; may be transmitted to an external peripheral via interface 222; peripheral interface 222… Communication… may be via wireline) and joined to or detachably attached to the image capturing unit (Col. 12, Ln. 44-64; the medical technician inserts an optical acquisition unit, e.g., a video camera or other imaging device, into PDA/MDA 101).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Lee in view of Sandy such that the display device to include a connector connectable to a connection port of the display device and a second cable connected to the connector and joined to or detachably attached to the image capturing unit as taught by Hwang. The unified device of embodiments is small, portable and suitable for mobile applications (Hwang, Col. 2, Ln. 12-23). This would have further allowed interfacing with a plurality of different devices (Hwang, Col. 8, Ln. 61-Col. 9, Ln. 23) and allow acquiring the anatomy and allow transfer of the acquired images in real-time to both display of PDA/MDA or to a remote expert (Col. 12, Ln. 44-64).
It is not clear if together Lee, Sandy, and Hwang teach that both the probe head and the image capturing unit are joined to or detachably attached to the first cable; and an arrangement of cables such that an image signal generated at the probe head is provided to the display device via the image capturing unit via the first cable, the image capturing unit, and the second cable; and
that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject;
the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via the second cable.
Mihailescu, however, teaches an ultrasonic probe (Paragraph [0012]; An ultrasound transducer, Fig. 11A) electrically connectable to a display device configured to display an ultrasonic image (Paragraph [0018]; A display can be operatively connected with the processor, the display configured for visualizing a three-dimensional (3-D) representation of the object created or refined from the determined spatial position and orientation and output from the ultrasound transducer), the ultrasonic probe comprising:
an image capturing unit (Paragraphs [0176] and [0179]; with tracking capability using ranging cameras mechanically registered to the ultrasound probe; The ranging camera is placed in camera housing shell 1106… A board 1108 accommodates the ranging and tracking components; Fig. 11A) joined to or detachably attached to a first cable (Paragraph [0180]; Whereas the cable 1116 makes the connection inside the tracking subsystem housing shell between the board 1108 and the connector 1115, the cable 1117 makes the connection inside the ultrasound probe housing shell 1101 between the connector 1115 and the board 1104; Fig. 11A), the image capturing unit comprising a first optical lens (Paragraph [0169]; a camera housing shell #1004 comprising a camera whose lenses #1005) to capture an image of a nearby object (Paragraph [0167]; the use of a ranging camera and/or a passive camera, which is attached to either one of the medical instruments or sensors, or it is positioned to observe the environment comprising the patient, medical instruments, and potentially, the local clinician); a second cable (Paragraph [0180]; The tracking subsystem board 1108 can be connected directly to read-out electronics or a computing unit through a cable 1114; Fig. 11A); and
a probe head (Paragraph [0178]; The ultrasound transducer subsystem 1103 is inside the body of the probe… Dashed box 1104 is an abstract representation of such electronics; Fig. 11A) joined to or detachably attached to the first cable (Paragraph [0180]; the cable 1117 makes the connection inside the ultrasound probe housing shell 1101 between the connector 1115 and the board 1104; Fig. 11A); and
an image signal generated at the probe head (Paragraph [0180]; the board 1108 can be connected to the electronics inside the ultrasound probe housing shell 1101; Fig. 11A) is provided to the display device via the image capturing unit (Paragraph [0179]; A board 1108 accommodates the ranging and tracking components; Fig. 11A) via the first cable (Paragraph [0180]; a computing unit through a cable 1114), the image capturing unit (Paragraph [0179]; A board 1108 accommodates the ranging and tracking components; Fig. 11A), and the second cable (Paragraphs [0178] and [0180]; the connection inside the tracking subsystem housing shell between the board 1108 and the connector 1115, the cable 1117 makes the connection inside the ultrasound probe housing shell 1101 between the connector 1115 and the board 1104; he ultrasound transducer subsystem 1103 is inside the body of the probe…; Dashed box 1104 is an abstract representation of such electronics; Fig. 11A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the arrangement of the image capturing unit with respect to the ultrasound probe of Lee in view of Sandy and Hwang such that the image capturing unit and the probe head are connected, resulting in both the probe head and the image capturing unit being joined to or detachably attached to the first cable and such that an image signal generated at the probe head is provided to the display device via the image capturing unit via the first cable, the image capturing unit, and the second cable. This would help the device or a medical professional more accurately determine the physical position of the ultrasound probe with respect to the patient being imaged (Mihailescu, Paragraphs [0018]), and thus improve the ability for the device or a medical professional to give instructions on how to move the ultrasound probe (Mihailescu, [0217]). Furthermore, it would allow the on-board electronics to be able to communicate with other computing and visualization units (Mihailescu, Paragraph [0180]) and improve data transfer between the ultrasound transducer and image system to improve determining the positioning of the transducer.
The device of Lee in view of Sandy, Hwang, and Mihailescu further fails to teach that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject; and
the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via the second cable.
Buelow, however, teaches an ultrasonic probe (Paragraph [0043]; first image generating unit 2… being an ultrasound head, Fig. 1) electrically connectable to a display device configured to display an ultrasonic image (Paragraph [0057]; image generation apparatus 1 further comprises a display unit 17 for displaying the first and second images, Fig. 1; Paragraph [0062]; first image of deformable object… preferentially an ultrasound image) comprising:
an image capturing unit (Paragraph [0049]; marker position determination device 16 is an optical stereo camera system; Fig. 1);
a probe head (Paragraph [0043]; ultrasound head; Fig. 1, portion of the ultrasound unit in contact with the patient 5);
wherein the image capturing unit is configured to capture the photographic image (Paragraph [0051]; stereo camera system can record the positions of the markers on the membrane 6 and also record the location and orientation of the ultrasound head 2) of an abutment state of the probe head (Paragraph [0051]; location and the orientation, of the ultrasound head 2 relative to the membrane 6 at the time of imaging is determined.; The location and orientation of the ultrasound head is considered to be an abutment state of the probe head as understood in its broadest reasonable interpretation) with respect to the body surface of the subject (Paragraph [0055]; the determined surface of the object 5 in the second image and the reconstructed surface defined by the membrane 6 can be registered with respect to each other; The surface of the breast 5 is determined with respect to the probe in contact with the membrane 6 which is considered to read on the claimed limitation of capture the an abutment state of the probe head with respect to the body surface of the subject as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the image capturing unit of Lee in view of Sandy, Hwang, and Mihailescu such that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject as taught by Buelow because it would allow recording the current state of the breast shape at the time of the acquisition of an image of the breast (Buelow, Paragraph [0071]) and further store the position of the ultrasound probe with respect to the body part for later reference which would allow comparison the of position of features in the three-dimensional breast images acquired at different times (Buelow, Paragraph [0072]).
The device of Lee in view of Sandy, Hwang, Mihailescu, and Buelow further fails to teach the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via the second cable.
Kiraly, however, teaches an ultrasonic probe (Paragraph [0027]; light weighted belt 20, Fig. 2 and 4; Paragraph [0031]; biosensor belt 400. Each source is surrounded by multiple detectors, and different sets of separately operated emitters and signal-receivers (e.g. miniature ultrasound transducers and receivers)) electrically connectable to a display device (Paragraph [0025]; portable computer device 10… with a display screen 12, Fig. 2; Paragraph [0031]; with a display screen 12) configured to display an ultrasonic image (Paragraph [0025]; it is capable of overlaying the mother's abdomen with a computer image, animation, ultrasound picture or real-time ultrasound video) and a vital sign that is based on a vital sign signal obtained from a sensor (Paragraph [0041]; portable device 10A provides outputs, which can include fetal heart rate, noise and artifact filtered EEG, ECG and/or integrated EEG signals), the ultrasonic probe comprising:
an image capturing unit (Paragraph [0029]; an imaging system 420, Fig. 4; Paragraph [0031]; a signal processing unit (CCD camera & intensifier-filter unit) 450, Fig. 5) joined to or detachably attached to a first cable (Paragraph [0026]; cord 42, Fig. 5), the image capturing unit comprising a first optical lens to capture an image of an object (Paragraph [0033]; The system 450 has optical fibers 140, a focusing lens 138); and
a probe head joined to or detachably attached to the first cable (Paragraph [0027]; light weighted belt 20, Fig. 2 and 4; Paragraph [0031]; the array 500 having… miniature ultrasound transducers and receivers), the probe head being configured to transmit an ultrasonic beam toward a body surface of a subject and to receive a reflected wave from the body surface (Paragraph [0046]; and multiple-point ultrasound transducers and/or light sources to launch ultrasound signals and/or light rays of specific wavelengths on the abdomen of the mother… reflected bodypart- or object-distance-specific ultrasound signal),
and wherein the image capturing unit and the ultrasonic probe are separate elements (Paragraph [0031]; biosensor belt 400… separately operated emitters and signal-receivers e.g. miniature ultrasound transducers and receivers; Paragraph [0029]; an imaging system 420, Fig. 4; Paragraph [0031]; a signal processing unit (CCD camera & intensifier-filter unit) 450, Fig. 5) connected to each other via the first cable (Fig. 5, cord 42), and commonly connected to the display device via a second cable (Paragraph [0031]; Fig. 5, conventional wires 452).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the image capturing unit and the ultrasonic probe of Lee in view of Sndy, Mihailescu, and Buelow to have been separate elements connected to each other via the first cable and commonly connected to the display device via a second cable as taught by Kiraly because it would have been known arrangement of connecting an imaging device and an ultrasound device to a display monitor that further would have allowed identifying the shape and position of the ultrasonic map with respect to the patient which would have further allowed overlaying the ultrasound image over the patient (Paragraph [0025] and [0043]).
Regarding claim 18, Lee teaches an ultrasonic measurement system (Paragraph [0014]; A method and an apparatus for performing an ultrasound diagnosis based on an electronic device) comprising:
a display device (Paragraphs [0126]-[0129]; first electronic device #400… including a display #410, Fig. 5) configured to display an ultrasonic image (Paragraph [0128]; first electronic device 400 may acquire first data (for example, ultrasound scan data) by the connected probe #600 and display the acquired first data, for example, ultrasound scan image);
an ultrasonic probe (Paragraphs [0126]-[0129]; ultrasound probe #600, Fig. 5) electrically connectable (Paragraph [0127]; through first communication, for example, wired communication) to the display device (Paragraphs [0126]-[0129]; first electronic device #400… including a display #410, Fig. 5), wherein the ultrasonic probe comprises:
an image capturing unit (Paragraphs [0097], [0126]-[0128], and [0161]; first electronic device #400 may acquire second data (for example, affected part image data) photographed by an internal camera; The camera module #291 and #670, Figs. 2 and 6) joined to or detachably attached to a cable (Paragraph [0127]; the first electronic device 400 may be connected with the probe 600 through first communication, for example, wired communication; Examiner notes the electronic device #400 comprising the camera module is connected to the probe through a wired communication), the image capturing unit comprising a first optical lens (Paragraph [0097]; may include… a lens) to capture an image of a nearby object (Paragraph [0161]; The camera module #670 may photograph a certain subject); and
a probe head (Paragraph [0127]; probe #600, Fig. 5) joined to or detachably attached to the cable (Paragraphs [0127] and [0134]; through first communication, for example, wired communication; According to various embodiments, when the electronic device #400 and the probe #600 are connected through a wired communication scheme, the electronic device #400 and the probe #600 may be connected based on at least some ports (for example, the data input/output port #411) of the communication interfaces; Fig. 11 shows probe #600 connected to a cable), the probe head being configured to transmit an ultrasonic beam toward a body surface of a subject (Paragraph [0129]; The probe #600 may radiate an ultrasound signal from a body surface of a target to a desired part within the body) and to receive a reflected wave from the body surface (Paragraph [0129]; and acquire a tomogram of soft tissues or an image of a blood flow based on information of the reflected ultrasound signal, for example, an ultrasound echo signal);
wherein the display device is configured to display the ultrasonic image based on the reflected wave received by the probe head (Paragraphs [0128] and [0157]; and display the acquired first data (for example, ultrasound scan image), and a photographic image captured by the image capturing unit (Paragraphs [0128] and [0216]; and display the acquired second data (for example, a preview image); acquiring data in the ultrasound diagnosis mode, displaying the data through a display, Fig. 10).
Lee does not explicitly teach that both the probe head and the image capturing unit are joined to or detachably attached to the first cable;
a connector connectable to a connection port of the display device; and
a second cable connected to the connector and joined to or detachably attached to the image capturing unit,
wherein an image signal generated at the probe head is provided to the display device via the image capturing unit via the first cable, the image capturing unit, and the second cable; and
wherein the display device is a patient monitor configured to display measured waveforms of vital signs simultaneously with the photographic image acquired by the image capturing unit and/or the ultrasonic image; and
that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject;
and the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via the second cable.
Sandy, however, teaches an ultrasonic probe (Paragraph [0009]; ultrasound scanning system; Paragraph [0030]; cardiac ultrasound monitoring system) electrically connectable to a display device (Paragraph [0032]; monitoring display 30, Fig. 3; Paragraph [0035]; combined display 48, Figs. 4 and 5) configured to display the vital sign (Paragraph [0033]; combined display 30 includes a hemodynamic display… includes selected hemodynamic measurements, including a pair of ECG traces 36, a pair of invasive blood pressure traces 38 and an oxygen saturation trace 40);
and that the display device is a patient monitor (Paragraphs [0028]; hemodynamic patient monitoring system; Paragraph [0032]; a combined ultrasound and hemodynamic anesthesia monitoring display 30, Fig. 3) configured to display measured waveforms of vital signs simultaneously with the photographic image acquired by the ultrasonic image (Paragraph [0033]; The hemodynamic data for the ECG trace 36, blood pressure trace 38 and oxygen saturation trace 40 is received from the anesthesia monitoring system, while the ultrasound image 32 and the thumb nail images 34 are received from the ultrasound monitoring system; Paragraph [0034]; monitored data and images are presented in a synchronized manner, Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Lee such that the display device is a patient monitor configured to display measured waveforms of vital signs simultaneously with the photographic image acquired by the ultrasonic image as taught by Sandy. This would have resulted in synchronization of the ultrasound images and the hemodynamic measurements allowing a clinician to review the combined monitoring results in a useful and time efficient manner (Sandy, Paragraph [0034]). Furthermore the synchronization of the ultrasound images and the patient waveforms allows a clinician to study the ultrasound images and the hemodynamic measurements at the time of the ultrasound images, as well as before and immediately following the ultrasound images (Sandy, Paragraph [0037]).
Together Lee and Sandy do not explicitly teach that both the probe head and the image capturing unit are joined to or detachably attached to the first cable;
a connector connectable to a connection port of the display device; and
a second cable connected to the connector and joined to or detachably attached to the image capturing unit,
wherein an image signal generated at the probe head is provided to the display device via the image capturing unit via the first cable, the image capturing unit, and the second cable; and
that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject; and
the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via the second cable.
Hwang, however, teaches an ultrasonic probe (Col. 7, Ln. 35-52; Scan head #103, Fig. 2) electrically connectable to a display device (Col. 4, Ln. 59-Col. 5, Ln. 3 and Col. 7, Ln. 25-35; Ultrasound scan head #103 of FIG. 2A is preferably attached to external controller #102; User interface 205 includes hardware and software components such that a user may interface with PDA/MDA #101 to monitor a patient's vital signs as well as to direct operation of ultrasound scan head 103 which may be attached to external controller 102 via interconnect 104; output on display #206; Figs. 1 and 2A; Examiner notes the combined PDA/MDA #101 and external interface controller #102 is considered to be a display device) configured to display an ultrasonic image and a vital sign that is based on a vital sign signal obtained from a sensor (Col. 8, Ln. 61-Col. 9, Ln. 10; While PDA/MDA 101 monitors a patient's vital signs, ultrasound scan head 103 may simultaneously acquire ultrasound imaging data and transfer this data from scan head 103 to external controller 102 via interconnect 104 for display on PDA/MDA 101);
a connector connectable to a connection port of the display device (Col. 8, Ln. 21-31 and Col. 12, Ln. 44-64; other hardware/software associated with external controller 102, such as ultrasound scan head 103 or sensors attached to patients for monitoring, using communication link 209 or through PCMCIA bus/peripheral interface 222; the optical acquisition unit that has been inserted in device #100); and a second cable connected to the connector (Col. 5, Ln. 36-65 and Col. 8, Ln. 49-Col. 9, Ln. 23; may be transmitted to an external peripheral via interface 222; peripheral interface 222… Communication… may be via wireline) and joined to or detachably attached to the image capturing unit (Col. 12, Ln. 44-64; the medical technician inserts an optical acquisition unit, e.g., a video camera or other imaging device, into PDA/MDA 101).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Lee in view of Sandy to include a connector connectable to a connection port of the display device and a second cable connected to the connector and joined to or detachably attached to the image capturing unit as taught by Hwang. The unified device of embodiments is small, portable and suitable for mobile applications (Hwang, Col. 2, Ln. 12-23). This would have further allowed interfacing with a plurality of different devices (Hwang, Col. 8, Ln. 61-Col. 9, Ln. 23) and allow acquiring the anatomy and allow transfer of the acquired images in real-time to both display of PDA/MDA or to a remote expert (Col. 12, Ln. 44-64).
It is not clear if together Lee, Sandy, and Hwang teach that both the probe head and the image capturing unit are joined to or detachably attached to the first cable; and an arrangement of cables such that an image signal generated at the probe head is provided to the display device via the image capturing unit via the first cable, the image capturing unit, and the second cable; and
that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject.
Mihailescu, however, teaches an ultrasonic probe (Paragraph [0012]; An ultrasound transducer, Fig. 11A) electrically connectable to a display device configured to display an ultrasonic image (Paragraph [0018]; A display can be operatively connected with the processor, the display configured for visualizing a three-dimensional (3-D) representation of the object created or refined from the determined spatial position and orientation and output from the ultrasound transducer), the ultrasonic probe comprising:
an image capturing unit (Paragraphs [0176] and [0179]; with tracking capability using ranging cameras mechanically registered to the ultrasound probe; The ranging camera is placed in camera housing shell 1106… A board 1108 accommodates the ranging and tracking components; Fig. 11A) joined to or detachably attached to a first cable (Paragraph [0180]; Whereas the cable 1116 makes the connection inside the tracking subsystem housing shell between the board 1108 and the connector 1115, the cable 1117 makes the connection inside the ultrasound probe housing shell 1101 between the connector 1115 and the board 1104; Fig. 11A), the image capturing unit comprising a first optical lens (Paragraph [0169]; a camera housing shell #1004 comprising a camera whose lenses #1005) to capture an image of a nearby object (Paragraph [0167]; the use of a ranging camera and/or a passive camera, which is attached to either one of the medical instruments or sensors, or it is positioned to observe the environment comprising the patient, medical instruments, and potentially, the local clinician); a second cable (Paragraph [0180]; The tracking subsystem board 1108 can be connected directly to read-out electronics or a computing unit through a cable 1114; Fig. 11A); and
a probe head (Paragraph [0178]; The ultrasound transducer subsystem 1103 is inside the body of the probe… Dashed box 1104 is an abstract representation of such electronics; Fig. 11A) joined to or detachably attached to the first cable (Paragraph [0180]; the cable 1117 makes the connection inside the ultrasound probe housing shell 1101 between the connector 1115 and the board 1104; Fig. 11A); and
an image signal generated at the probe head (Paragraph [0180]; the board 1108 can be connected to the electronics inside the ultrasound probe housing shell 1101; Fig. 11A) is provided to the display device via the image capturing unit (Paragraph [0179]; A board 1108 accommodates the ranging and tracking components; Fig. 11A) via the first cable (Paragraph [0180]; a computing unit through a cable 1114), the image capturing unit (Paragraph [0179]; A board 1108 accommodates the ranging and tracking components; Fig. 11A), and the second cable (Paragraphs [0178] and [0180]; the connection inside the tracking subsystem housing shell between the board 1108 and the connector 1115, the cable 1117 makes the connection inside the ultrasound probe housing shell 1101 between the connector 1115 and the board 1104; he ultrasound transducer subsystem 1103 is inside the body of the probe…; Dashed box 1104 is an abstract representation of such electronics; Fig. 11A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the arrangement of the image capturing unit with respect to the ultrasound probe of Lee in view of Sandy and Hwang such that the image capturing unit and the probe head are connected, resulting in both the probe head and the image capturing unit being joined to or detachably attached to the first cable and such that an image signal generated at the probe head is provided to the display device via the image capturing unit via the first cable, the image capturing unit, and the second cable. This would help the device or a medical professional more accurately determine the physical position of the ultrasound probe with respect to the patient being imaged (Mihailescu, Paragraphs [0018]), and thus improve the ability for the device or a medical professional to give instructions on how to move the ultrasound probe (Mihailescu, [0217]). Furthermore, it would allow the on-board electronics to be able to communicate with other computing and visualization units (Mihailescu, Paragraph [0180]) and improve data transfer between the ultrasound transducer and image system to improve determining the positioning of the transducer.
The device of Lee in view of Sandy, Hwang, and Mihailescu further fails to teach that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject; and
the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via the second cable.
Buelow, however, teaches an ultrasonic probe (Paragraph [0043]; first image generating unit 2… being an ultrasound head, Fig. 1) electrically connectable to a display device configured to display an ultrasonic image (Paragraph [0057]; image generation apparatus 1 further comprises a display unit 17 for displaying the first and second images, Fig. 1; Paragraph [0062]; first image of deformable object… preferentially an ultrasound image) comprising:
an image capturing unit (Paragraph [0049]; marker position determination device 16 is an optical stereo camera system; Fig. 1);
a probe head (Paragraph [0043]; ultrasound head; Fig. 1, portion of the ultrasound unit in contact with the patient 5);
wherein the image capturing unit is configured to capture the photographic image (Paragraph [0051]; stereo camera system can record the positions of the markers on the membrane 6 and also record the location and orientation of the ultrasound head 2) of an abutment state of the probe head (Paragraph [0051]; location and the orientation, of the ultrasound head 2 relative to the membrane 6 at the time of imaging is determined.; The location and orientation of the ultrasound head is considered to be an abutment state of the probe head as understood in its broadest reasonable interpretation) with respect to the body surface of the subject (Paragraph [0055]; the determined surface of the object 5 in the second image and the reconstructed surface defined by the membrane 6 can be registered with respect to each other; The surface of the breast 5 is determined with respect to the probe in contact with the membrane 6 which is considered to read on the claimed limitation of capture the an abutment state of the probe head with respect to the body surface of the subject as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the image capturing unit of Lee in view of Sandy, Hwang, and Mihailescu such that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject as taught by Buelow because it would allow recording the current state of the breast shape at the time of the acquisition of an image of the breast (Buelow, Paragraph [0071]) and further store the position of the ultrasound probe with respect to the body part for later reference which would allow comparison the of position of features in the three-dimensional breast images acquired at different times (Buelow, Paragraph [0072]).
The device of Lee in view of Sandy, Hwang, and Mihailescu further fails to teach the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via the second cable.
Kiraly, however, teaches an ultrasonic probe (Paragraph [0027]; light weighted belt 20, Fig. 2 and 4; Paragraph [0031]; biosensor belt 400. Each source is surrounded by multiple detectors, and different sets of separately operated emitters and signal-receivers (e.g. miniature ultrasound transducers and receivers)) electrically connectable to a display device (Paragraph [0025]; portable computer device 10… with a display screen 12, Fig. 2; Paragraph [0031]; with a display screen 12) configured to display an ultrasonic image (Paragraph [0025]; it is capable of overlaying the mother's abdomen with a computer image, animation, ultrasound picture or real-time ultrasound video) and a vital sign that is based on a vital sign signal obtained from a sensor (Paragraph [0041]; portable device 10A provides outputs, which can include fetal heart rate, noise and artifact filtered EEG, ECG and/or integrated EEG signals), the ultrasonic probe comprising:
an image capturing unit (Paragraph [0029]; an imaging system 420, Fig. 4; Paragraph [0031]; a signal processing unit (CCD camera & intensifier-filter unit) 450, Fig. 5) joined to or detachably attached to a first cable (Paragraph [0026]; cord 42, Fig. 5), the image capturing unit comprising a first optical lens to capture an image of an object (Paragraph [0033]; The system 450 has optical fibers 140, a focusing lens 138); and
a probe head joined to or detachably attached to the first cable (Paragraph [0027]; light weighted belt 20, Fig. 2 and 4; Paragraph [0031]; the array 500 having… miniature ultrasound transducers and receivers), the probe head being configured to transmit an ultrasonic beam toward a body surface of a subject and to receive a reflected wave from the body surface (Paragraph [0046]; and multiple-point ultrasound transducers and/or light sources to launch ultrasound signals and/or light rays of specific wavelengths on the abdomen of the mother… reflected bodypart- or object-distance-specific ultrasound signal),
and wherein the image capturing unit and the ultrasonic probe are separate elements (Paragraph [0031]; biosensor belt 400… separately operated emitters and signal-receivers e.g. miniature ultrasound transducers and receivers; Paragraph [0029]; an imaging system 420, Fig. 4; Paragraph [0031]; a signal processing unit (CCD camera & intensifier-filter unit) 450, Fig. 5) connected to each other via the first cable (Fig. 5, cord 42), and commonly connected to the display device via a second cable (Paragraph [0031]; Fig. 5, conventional wires 452).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the image capturing unit and the ultrasonic probe of Lee in view of Sndy, Mihailescu, and Buelow to have been separate elements connected to each other via the first cable and commonly connected to the display device via a second cable as taught by Kiraly because it would have been known arrangement of connecting an imaging device and an ultrasound device to a display monitor that further would have allowed identifying the shape and position of the ultrasonic map with respect to the patient which would have further allowed overlaying the ultrasound image over the patient (Paragraph [0025] and [0043]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 20190038260) in view of Sandy (US 20060058660), Hwang (US 7549961), and Buelow (US 20150126864) and Kiraly (US 20140228653).
Regarding claim 19, Lee teaches an ultrasonic probe (Paragraphs [0126]-[0129]; ultrasound probe #600, Fig. 5) comprising: a probe head (Paragraph [0127]; probe #600, Fig. 5) configured to abut on a body surface of a subject (Paragraph [0270]; of the probe 600 in contact with an affected part of the patient), to transmit an ultrasonic beam toward the body surface (Paragraph [0129]; The probe #600 may radiate an ultrasound signal from a body surface of a target to a desired part within the body), and to receive a reflected wave from the body surface (Paragraph [0129]; and acquire a tomogram of soft tissues or an image of a blood flow based on information of the reflected ultrasound signal, for example, an ultrasound echo signal); and
an image capturing unit (Paragraphs [0097], [0126]-[0128], and [0161]; first electronic device #400 may acquire second data (for example, affected part image data) photographed by an internal camera; The camera module #291 and #670, Figs. 2 and 6) that is configured to transmit a control signal to the probe head via (Abstract, Paragraphs [0139], [0202], and [0206]; control guide for the probe in response to reception of control information from the external device; may operate to output a direction indicator for moving the location of the probe 600 based on at least one of an affected part photographing screen and the probe 600), the image capturing unit comprising a first optical lens (Paragraph [0097]; may include… a lens) to capture an image of a nearby object (Paragraph [0161]; The camera module #670 may photograph a certain subject), a patient monitor being configured to display an ultrasonic image (Paragraph [0128]; first electronic device 400 may acquire first data (for example, ultrasound scan data) by the connected probe #600 and display the acquired first data, for example, ultrasound scan image) and obtaining a vital sign (Paragraphs [0062] and [0090]; a blood glucose monitoring device, a heart rate monitoring device, a blood pressure measuring device, a body temperature measuring device, etc.; The sensor module #240 may measure, for example, physical quantity or detect an operational status of the electronic device #201, and may convert the measured or detected information into an electric signal) that is based on a vital sign signal obtained from a sensor (Paragraphs [0062] and [0090]; the electronic device may include at least one of various medical devices (e.g., various portable medical measuring devices (a blood glucose monitoring device, a heart rate monitoring device, a blood pressure measuring device, a body temperature measuring device, etc.); Additionally or alternatively, the sensor module 240 may include, for example, an E-nose sensor, an ElectroMyoGraphy (EMG) sensor, an ElectroEncephaloGram (EEG) sensor, an ElectroCardioGram (ECG) sensor; Fig. 2);
wherein the ultrasonic probe is configured to transmit a photographic image acquired by the image capturing unit (Paragraph [0269]; first electronic device 400 may photograph a control state of the probe 600 through the camera (for example, the camera module 670 or the rear camera) and transmit the photographed image to the second electronic device 500 in real time) and image information based on the reflected wave (Paragraph [0221]; second electronic device 500 may display ultrasound scan data based at least partially on the received data) to the patient monitor (Paragraph [0221]; second electronic device 500),
wherein the control signal causes the patient monitor to perform setting of the patient monitor including display setting (Paragraph [0258]; controller 680 may determine whether the screen mirroring function is selected).
Lee does not explicitly teach a connector connectable to a connection port of the patient monitor; and
a second cable connected to the connector and joined to or detachably attached to the image capturing unit; and
wherein the patient monitor is configured to display measured values and/or measured waveforms of vital signs simultaneously with the photographic image acquired by the image capturing unit and/or the ultrasonic image; and
that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject; and
wherein the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the patient monitor via the second cable.
Sandy, however, teaches an ultrasonic probe (Paragraph [0009]; ultrasound scanning system; Paragraph [0030]; cardiac ultrasound monitoring system) electrically connectable to a display device (Paragraph [0032]; monitoring display 30, Fig. 3; Paragraph [0035]; combined display 48, Figs. 4 and 5) configured to display the vital sign (Paragraph [0033]; combined display 30 includes a hemodynamic display… includes selected hemodynamic measurements, including a pair of ECG traces 36, a pair of invasive blood pressure traces 38 and an oxygen saturation trace 40);
and that the display device is a patient monitor (Paragraphs [0028]; hemodynamic patient monitoring system; Paragraph [0032]; a combined ultrasound and hemodynamic anesthesia monitoring display 30, Fig. 3) configured to display measured waveforms of vital signs simultaneously with the photographic image acquired by the ultrasonic image (Paragraph [0033]; The hemodynamic data for the ECG trace 36, blood pressure trace 38 and oxygen saturation trace 40 is received from the anesthesia monitoring system, while the ultrasound image 32 and the thumb nail images 34 are received from the ultrasound monitoring system; Paragraph [0034]; monitored data and images are presented in a synchronized manner, Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Lee such that the display device is a patient monitor configured to display measured waveforms of vital signs simultaneously with the photographic image acquired by the ultrasonic image as taught by Sandy. This would have resulted in synchronization of the ultrasound images and the hemodynamic measurements allowing a clinician to review the combined monitoring results in a useful and time efficient manner (Sandy, Paragraph [0034]). Furthermore the synchronization of the ultrasound images and the patient waveforms allows a clinician to study the ultrasound images and the hemodynamic measurements at the time of the ultrasound images, as well as before and immediately following the ultrasound images (Sandy, Paragraph [0037]).
Together Lee and Sandy do not explicitly teach a connector connectable to a connection port of the patient monitor; and
a second cable connected to the connector and joined to or detachably attached to the image capturing unit; and
that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject; and
wherein the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the patient monitor via the second cable.
Hwang, however, teaches an ultrasonic probe (Col. 7, Ln. 35-52; Scan head #103, Fig. 2) electrically connectable to a display device (Col. 4, Ln. 59-Col. 5, Ln. 3 and Col. 7, Ln. 25-35; Ultrasound scan head #103 of FIG. 2A is preferably attached to external controller #102; User interface 205 includes hardware and software components such that a user may interface with PDA/MDA #101 to monitor a patient's vital signs as well as to direct operation of ultrasound scan head 103 which may be attached to external controller 102 via interconnect 104; output on display #206; Figs. 1 and 2A; Examiner notes the combined PDA/MDA #101 and external interface controller #102 is considered to be a display device) configured to display an ultrasonic image and a vital sign that is based on a vital sign signal obtained from a sensor (Col. 8, Ln. 61-Col. 9, Ln. 10; While PDA/MDA 101 monitors a patient's vital signs, ultrasound scan head 103 may simultaneously acquire ultrasound imaging data and transfer this data from scan head 103 to external controller 102 via interconnect 104 for display on PDA/MDA 101);
an image capturing unit (Col. 12, Ln. 44-64; When image acquisition is to be performed, the medical technician inserts an optical acquisition unit, e.g., a video camera or other imaging device, into PDA/MDA 101); and
a connector connectable to a connection port of the display device (Col. 8, Ln. 21-31 and Col. 12, Ln. 44-64; other hardware/software associated with external controller 102, such as ultrasound scan head 103 or sensors attached to patients for monitoring, using communication link 209 or through PCMCIA bus/peripheral interface 222; the optical acquisition unit that has been inserted in device #100); and a second cable connected to the connector (Col. 5, Ln. 36-65 and Col. 8, Ln. 49-Col. 9, Ln. 23; may be transmitted to an external peripheral via interface 222; peripheral interface 222… Communication… may be via wireline) and joined to or detachably attached to the image capturing unit (Col. 12, Ln. 44-64; the medical technician inserts an optical acquisition unit, e.g., a video camera or other imaging device, into PDA/MDA 101).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Lee in view of Sandy to include a connector connectable to a connection port of the display device and a second cable connected to the connector and joined to or detachably attached to the image capturing unit as taught by Hwang. The unified device of embodiments is small, portable and suitable for mobile applications (Hwang, Col. 2, Ln. 12-23). This would have further allowed interfacing with a plurality of different devices (Hwang, Col. 8, Ln. 61-Col. 9, Ln. 23) and allow acquiring the anatomy and allow transfer of the acquired images in real-time to both display of PDA/MDA or to a remote expert (Col. 12, Ln. 44-64).
The device of Lee in view of Sandy and Hwang further fails to teach that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject; and
wherein the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the patient monitor via the second cable.
Buelow, however, teaches an ultrasonic probe (Paragraph [0043]; first image generating unit 2… being an ultrasound head, Fig. 1) electrically connectable to a display device configured to display an ultrasonic image (Paragraph [0057]; image generation apparatus 1 further comprises a display unit 17 for displaying the first and second images, Fig. 1; Paragraph [0062]; first image of deformable object… preferentially an ultrasound image) comprising:
an image capturing unit (Paragraph [0049]; marker position determination device 16 is an optical stereo camera system; Fig. 1);
a probe head (Paragraph [0043]; ultrasound head; Fig. 1, portion of the ultrasound unit in contact with the patient 5);
wherein the image capturing unit is configured to capture the photographic image (Paragraph [0051]; stereo camera system can record the positions of the markers on the membrane 6 and also record the location and orientation of the ultrasound head 2) of an abutment state of the probe head (Paragraph [0051]; location and the orientation, of the ultrasound head 2 relative to the membrane 6 at the time of imaging is determined.; The location and orientation of the ultrasound head is considered to be an abutment state of the probe head as understood in its broadest reasonable interpretation) with respect to the body surface of the subject (Paragraph [0055]; the determined surface of the object 5 in the second image and the reconstructed surface defined by the membrane 6 can be registered with respect to each other; The surface of the breast 5 is determined with respect to the probe in contact with the membrane 6 which is considered to read on the claimed limitation of capture the an abutment state of the probe head with respect to the body surface of the subject as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the image capturing unit of Lee in view of Sandy and Hwang such that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject as taught by Buelow because it would allow recording the current state of the breast shape at the time of the acquisition of an image of the breast (Buelow, Paragraph [0071]) and further store the position of the ultrasound probe with respect to the body part for later reference which would allow comparison the of position of features in the three-dimensional breast images acquired at different times (Buelow, Paragraph [0072]).
The device of Lee in view of Sandy, Hwang, and Buelow further fails to teach the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the patient monitor via the second cable.
Kiraly, however, teaches an ultrasonic probe (Paragraph [0027]; light weighted belt 20, Fig. 2 and 4; Paragraph [0031]; biosensor belt 400. Each source is surrounded by multiple detectors, and different sets of separately operated emitters and signal-receivers (e.g. miniature ultrasound transducers and receivers)) electrically connectable to a display device (Paragraph [0025]; portable computer device 10… with a display screen 12, Fig. 2; Paragraph [0031]; with a display screen 12) configured to display an ultrasonic image (Paragraph [0025]; it is capable of overlaying the mother's abdomen with a computer image, animation, ultrasound picture or real-time ultrasound video) and a vital sign that is based on a vital sign signal obtained from a sensor (Paragraph [0041]; portable device 10A provides outputs, which can include fetal heart rate, noise and artifact filtered EEG, ECG and/or integrated EEG signals), the ultrasonic probe comprising:
an image capturing unit (Paragraph [0029]; an imaging system 420, Fig. 4; Paragraph [0031]; a signal processing unit (CCD camera & intensifier-filter unit) 450, Fig. 5) joined to or detachably attached to a first cable (Paragraph [0026]; cord 42, Fig. 5), the image capturing unit comprising a first optical lens to capture an image of an object (Paragraph [0033]; The system 450 has optical fibers 140, a focusing lens 138); and
a probe head joined to or detachably attached to the first cable (Paragraph [0027]; light weighted belt 20, Fig. 2 and 4; Paragraph [0031]; the array 500 having… miniature ultrasound transducers and receivers), the probe head being configured to transmit an ultrasonic beam toward a body surface of a subject and to receive a reflected wave from the body surface (Paragraph [0046]; and multiple-point ultrasound transducers and/or light sources to launch ultrasound signals and/or light rays of specific wavelengths on the abdomen of the mother… reflected bodypart- or object-distance-specific ultrasound signal),
and wherein the image capturing unit and the ultrasonic probe are separate elements (Paragraph [0031]; biosensor belt 400… separately operated emitters and signal-receivers e.g. miniature ultrasound transducers and receivers; Paragraph [0029]; an imaging system 420, Fig. 4; Paragraph [0031]; a signal processing unit (CCD camera & intensifier-filter unit) 450, Fig. 5) connected to each other via the first cable (Fig. 5, cord 42), and commonly connected to the display device via a second cable (Paragraph [0031]; Fig. 5, conventional wires 452).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the image capturing unit and the ultrasonic probe of Lee in view of Sndy, Mihailescu, and Buelow to have been separate elements connected to each other via the first cable and commonly connected to the display device via a second cable as taught by Kiraly because it would have been known arrangement of connecting an imaging device and an ultrasound device to a display monitor that further would have allowed identifying the shape and position of the ultrasonic map with respect to the patient which would have further allowed overlaying the ultrasound image over the patient (Paragraph [0025] and [0043]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 20190038260) in view of Sandy (US 20060058660), Hwang (US 7549961), Mihailescu (US 20160242744), Anderson (US 20130182107), and Buelow (US 20150126864), and Kiraly (US 20140228653).
Regarding claim 20, Lee teaches an ultrasonic probe (Paragraphs [0126]-[0129]; ultrasound probe #600, Fig. 5) electrically connectable (Paragraph [0127]; through first communication, for example, wired communication) to a display device (Paragraphs [0126]-[0129]; first electronic device #400… including a display #410, Fig. 5) configured to display an ultrasonic image (Paragraph [0128]; first electronic device 400 may acquire first data (for example, ultrasound scan data) by the connected probe #600 and display the acquired first data, for example, ultrasound scan image) and obtaining a vital sign (Paragraphs [0062] and [0090]; a blood glucose monitoring device, a heart rate monitoring device, a blood pressure measuring device, a body temperature measuring device, etc.; The sensor module #240 may measure, for example, physical quantity or detect an operational status of the electronic device #201, and may convert the measured or detected information into an electric signal) that is based on a vital sign signal obtained from a sensor (Paragraphs [0062] and [0090]; the electronic device may include at least one of various medical devices (e.g., various portable medical measuring devices (a blood glucose monitoring device, a heart rate monitoring device, a blood pressure measuring device, a body temperature measuring device, etc.); Additionally or alternatively, the sensor module 240 may include, for example, an E-nose sensor, an ElectroMyoGraphy (EMG) sensor, an ElectroEncephaloGram (EEG) sensor, an ElectroCardioGram (ECG) sensor; Fig. 2), the ultrasonic probe comprising:
an image capturing unit (Paragraphs [0097], [0126]-[0128], and [0161]; first electronic device #400 may acquire second data (for example, affected part image data) joined to or detachably attached to a cable (Paragraph [0127]; the first electronic device 400 may be connected with the probe 600 through first communication, for example, wired communication; Examiner notes the electronic device #400 comprising the camera module is connected to the probe through a wired communication), the image capturing unit comprising a first optical lens (Paragraph [0097]; may include… a lens) to capture an image of a nearby object (Paragraph [0161]; The camera module #670 may photograph a certain subject); and
a probe head (Paragraph [0127]; probe #600, Fig. 5) joined to or detachably attached to the cable (Paragraphs [0127] and [0134]; through first communication, for example, wired communication; According to various embodiments, when the electronic device #400 and the probe #600 are connected through a wired communication scheme, the electronic device #400 and the probe #600 may be connected based on at least some ports (for example, the data input/output port #411) of the communication interfaces; Fig. 11 shows probe #600 connected to a cable), the probe head being configured to transmit an ultrasonic beam toward a body surface of a subject (Paragraph [0129]; The probe #600 may radiate an ultrasound signal from a body surface of a target to a desired part within the body) and to receive a reflected wave from the body surface (Paragraph [0129]; and acquire a tomogram of soft tissues or an image of a blood flow based on information of the reflected ultrasound signal, for example, an ultrasound echo signal), wherein the image capturing unit is configured to transmit a control signal (Paragraph [0150]; The user input unit 620 may receive user input for initiating the operation (for example, a function of connecting to or recognizing the probe 600, an ultrasound diagnosis function, and a data transmission/reception function) of the electronic device 400 according to various embodiments of the present disclosure and generate an input signal according to user input) to the display device (Paragraph [0258]; controller 680 may determine whether the screen mirroring function is selected) in accordance with an operation on an input interface (Paragraphs [0129] and [0149]; first electronic device 400 may include, for example, a smart phone and a tablet Personal Computer (PC). According to various embodiments, the first electronic device 400 may display various User Interfaces (UIs) or Graphical User Interfaces (GUIs); user input unit 620 may include at least one input device for detecting various user inputs) provided on a housing of the image capturing unit (Paragraph [0134]; the electronic device #400 may include… a housing (or a body) #420, Fig. 5).
Lee does not explicitly teach that both the probe head and the image capturing unit are joined to or detachably attached to the first cable;
the device is configured to display the vital sign; and
wherein the control signal causes the display device to perform an alarm cancellation and display measured waveforms of the vital signs simultaneously with the image acquired by the image capturing unit and/or the ultrasonic image; and
that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject; and
the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via a second cable.
Sandy, however, teaches an ultrasonic probe (Paragraph [0009]; ultrasound scanning system; Paragraph [0030]; cardiac ultrasound monitoring system) electrically connectable to a display device (Paragraph [0032]; monitoring display 30, Fig. 3; Paragraph [0035]; combined display 48, Figs. 4 and 5) configured to display the vital sign (Paragraph [0033]; combined display 30 includes a hemodynamic display… includes selected hemodynamic measurements, including a pair of ECG traces 36, a pair of invasive blood pressure traces 38 and an oxygen saturation trace 40);
and that the display device is a patient monitor (Paragraphs [0028]; hemodynamic patient monitoring system; Paragraph [0032]; a combined ultrasound and hemodynamic anesthesia monitoring display 30, Fig. 3); and a control signal (Paragraph [0032]; The thumb nail images 34 allow the operator to select between different views available from the ultrasound system; Paragraph [0038]; Since the ultrasound monitoring system 44 and the anesthesia monitoring system 46 receive the common synchronization signal 50, the ultrasound images and hemodynamic measurements stored at the central database 52 are synchronized with each other) causes the display device to display measured waveforms of vital signs simultaneously with the photographic image acquired by the ultrasonic image (Paragraph [0033]; The hemodynamic data for the ECG trace 36, blood pressure trace 38 and oxygen saturation trace 40 is received from the anesthesia monitoring system, while the ultrasound image 32 and the thumb nail images 34 are received from the ultrasound monitoring system; Paragraph [0034]; monitored data and images are presented in a synchronized manner, Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Lee such that the display device is a patient monitor; and a control signal causes the display device to display measured waveforms of vital signs simultaneously with the photographic image acquired by the ultrasonic image as taught by Sandy. This would have resulted in synchronization of the ultrasound images and the hemodynamic measurements allowing a clinician to review the combined monitoring results in a useful and time efficient manner (Sandy, Paragraph [0034]). Furthermore the synchronization of the ultrasound images and the patient waveforms allows a clinician to study the ultrasound images and the hemodynamic measurements at the time of the ultrasound images, as well as before and immediately following the ultrasound images (Sandy, Paragraph [0037]).
Lee and Sandy do not explicitly teach that both the probe head and the image capturing unit are joined to or detachably attached to the first cable;
the device is configured to display the vital sign; and
wherein the control signal causes the display device to perform an alarm cancellation; and
that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject; and
the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via a second cable.
Hwang, however, teaches an ultrasonic probe (Col. 7, Ln. 35-52; Scan head #103, Fig. 2) electrically connectable to a display device (Col. 4, Ln. 59-Col. 5, Ln. 3 and Col. 7, Ln. 25-35; Ultrasound scan head #103 of FIG. 2A is preferably attached to external controller #102; User interface 205 includes hardware and software components such that a user may interface with PDA/MDA #101 to monitor a patient's vital signs as well as to direct operation of ultrasound scan head 103 which may be attached to external controller 102 via interconnect 104; output on display #206; Figs. 1 and 2A; Examiner notes the combined PDA/MDA #101 and external interface controller #102 is considered to be a display device) configured to display an ultrasonic image and a vital sign that is based on a vital sign signal obtained from a sensor (Col. 8, Ln. 61-Col. 9, Ln. 10; While PDA/MDA 101 monitors a patient's vital signs, ultrasound scan head 103 may simultaneously acquire ultrasound imaging data and transfer this data from scan head 103 to external controller 102 via interconnect 104 for display on PDA/MDA 101);
an image capturing unit (Col. 12, Ln. 44-64; When image acquisition is to be performed, the medical technician inserts an optical acquisition unit, e.g., a video camera or other imaging device, into PDA/MDA 101).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Lee in view of Sandy to include a connector connectable to a connection port of the display device and a second cable connected to the connector and joined to or detachably attached to the image capturing unit as taught by Hwang. The unified device of embodiments is small, portable and suitable for mobile applications (Hwang, Col. 2, Ln. 12-23). This would have further allowed interfacing with a plurality of different devices (Hwang, Col. 8, Ln. 61-Col. 9, Ln. 23) and allow acquiring the anatomy and allow transfer of the acquired images in real-time to both display of PDA/MDA or to a remote expert (Col. 12, Ln. 44-64).
Together Lee, Sandy, and Hwang do not explicitly teach that both the probe head and the image capturing unit are joined to or detachably attached to the first cable; and wherein the control signal causes the display device to perform an alarm cancellation; and
that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject; and
the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via a second cable.
Mihailescu, however, teaches an ultrasonic probe (Paragraph [0012]; An ultrasound transducer, Fig. 11A) electrically connectable to a display device configured to display an ultrasonic image (Paragraph [0018]; A display can be operatively connected with the processor, the display configured for visualizing a three-dimensional (3-D) representation of the object created or refined from the determined spatial position and orientation and output from the ultrasound transducer), the ultrasonic probe comprising:
an image capturing unit (Paragraphs [0176] and [0179]; with tracking capability using ranging cameras mechanically registered to the ultrasound probe; The ranging camera is placed in camera housing shell 1106… A board 1108 accommodates the ranging and tracking components; Fig. 11A) joined to or detachably attached to a first cable (Paragraph [0180]; Whereas the cable 1116 makes the connection inside the tracking subsystem housing shell between the board 1108 and the connector 1115, the cable 1117 makes the connection inside the ultrasound probe housing shell 1101 between the connector 1115 and the board 1104; Fig. 11A), the image capturing unit comprising a first optical lens (Paragraph [0169]; a camera housing shell #1004 comprising a camera whose lenses #1005) to capture an image of a nearby object (Paragraph [0167]; the use of a ranging camera and/or a passive camera, which is attached to either one of the medical instruments or sensors, or it is positioned to observe the environment comprising the patient, medical instruments, and potentially, the local clinician); and
a probe head (Paragraph [0178]; The ultrasound transducer subsystem 1103 is inside the body of the probe… Dashed box 1104 is an abstract representation of such electronics; Fig. 11A) joined to or detachably attached to the first cable (Paragraph [0180]; the cable 1117 makes the connection inside the ultrasound probe housing shell 1101 between the connector 1115 and the board 1104; Fig. 11A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the arrangement of the image capturing unit with respect to the ultrasound probe of Lee in view of Sandy and Hwang such that the image capturing unit and the probe head are connected, resulting in both the probe head and the image capturing unit being joined to or detachably attached to the first cable. This would help the device or a medical professional more accurately determine the physical position of the ultrasound probe with respect to the patient being imaged (Mihailescu, Paragraphs [0018]), and thus improve the ability for the device or a medical professional to give instructions on how to move the ultrasound probe (Mihailescu, [0217]). Furthermore, it would allow the on-board electronics to be able to communicate with other computing and visualization units (Mihailescu, Paragraph [0180]) and improve data transfer between the ultrasound transducer and image system to improve determining the positioning of the transducer.
Together Lee, Sandy, Hwang, and Mihailescu do not explicitly teach the control signal causes the display device to perform an alarm cancellation; and
that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject; and
the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via a second cable.
Anderson, however, teaches, a patient monitor (Paragraph [0009]; Some embodiments are directed to a system for monitoring a patient that includes a video camera):
wherein the control signal causes the display device to perform an alarm cancellation (Paragraph [0110]; control specifies how an alarm, once triggered, is ended. Options are manual, which requires the user to acknowledge the alarm; Examiner notes this option is included as part of the monitoring device).
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 ultrasound probe with integrated electronics disclosed by Lee in view of Sandy, Hwang, and Mihailescu, by including the control signal causes the display device to perform an alarm cancellation as taught by Anderson. One of ordinary skill in the art would have been motivated to make this modification because it would allow alerting a medical professional and then further allowing the medical professional to stop the alarm once alerted. More generally, alarms on information notification devices in the medical setting provide the benefit of conferring valuable information to practitioners about a patient’s status (“operating status is monitored, and if an abnormality is detected, an alarm is immediately generated and the details of the abnormality are displayed on a display device”). However, “the continuous sound of the alarm is noisy and annoys others,” thus providing the need for efficient alarm cancellation.
The device of Lee in view of Sandy, Hwang, Mihailescu, and Anderson further fails to teach that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject; and
the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via a second cable.
Buelow, however, teaches an ultrasonic probe (Paragraph [0043]; first image generating unit 2… being an ultrasound head, Fig. 1) electrically connectable to a display device configured to display an ultrasonic image (Paragraph [0057]; image generation apparatus 1 further comprises a display unit 17 for displaying the first and second images, Fig. 1; Paragraph [0062]; first image of deformable object… preferentially an ultrasound image) comprising:
an image capturing unit (Paragraph [0049]; marker position determination device 16 is an optical stereo camera system; Fig. 1);
a probe head (Paragraph [0043]; ultrasound head; Fig. 1, portion of the ultrasound unit in contact with the patient 5);
wherein the image capturing unit is configured to capture the photographic image (Paragraph [0051]; stereo camera system can record the positions of the markers on the membrane 6 and also record the location and orientation of the ultrasound head 2) of an abutment state of the probe head (Paragraph [0051]; location and the orientation, of the ultrasound head 2 relative to the membrane 6 at the time of imaging is determined.; The location and orientation of the ultrasound head is considered to be an abutment state of the probe head as understood in its broadest reasonable interpretation) with respect to the body surface of the subject (Paragraph [0055]; the determined surface of the object 5 in the second image and the reconstructed surface defined by the membrane 6 can be registered with respect to each other; The surface of the breast 5 is determined with respect to the probe in contact with the membrane 6 which is considered to read on the claimed limitation of capture the an abutment state of the probe head with respect to the body surface of the subject as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the image capturing unit of Lee in view of Sandy, Hwang, Mihailescu, and Anderson such that the image capturing unit is configured to capture the photographic image of an abutment state of the probe head with respect to the body surface of the subject as taught by Buelow because it would allow recording the current state of the breast shape at the time of the acquisition of an image of the breast (Buelow, Paragraph [0071]) and further store the position of the ultrasound probe with respect to the body part for later reference which would allow comparison the of position of features in the three-dimensional breast images acquired at different times (Buelow, Paragraph [0072]).
The device of Lee in view of Sandy, Hwang, Mihailescu, and Anderson further fails to teach the image capturing unit and the ultrasonic probe are separate elements connected to each other via the first cable, and commonly connected to the display device via a second cable.
Kiraly, however, teaches an ultrasonic probe (Paragraph [0027]; light weighted belt 20, Fig. 2 and 4; Paragraph [0031]; biosensor belt 400. Each source is surrounded by multiple detectors, and different sets of separately operated emitters and signal-receivers (e.g. miniature ultrasound transducers and receivers)) electrically connectable to a display device (Paragraph [0025]; portable computer device 10… with a display screen 12, Fig. 2; Paragraph [0031]; with a display screen 12) configured to display an ultrasonic image (Paragraph [0025]; it is capable of overlaying the mother's abdomen with a computer image, animation, ultrasound picture or real-time ultrasound video) and a vital sign that is based on a vital sign signal obtained from a sensor (Paragraph [0041]; portable device 10A provides outputs, which can include fetal heart rate, noise and artifact filtered EEG, ECG and/or integrated EEG signals), the ultrasonic probe comprising:
an image capturing unit (Paragraph [0029]; an imaging system 420, Fig. 4; Paragraph [0031]; a signal processing unit (CCD camera & intensifier-filter unit) 450, Fig. 5) joined to or detachably attached to a first cable (Paragraph [0026]; cord 42, Fig. 5), the image capturing unit comprising a first optical lens to capture an image of an object (Paragraph [0033]; The system 450 has optical fibers 140, a focusing lens 138); and
a probe head joined to or detachably attached to the first cable (Paragraph [0027]; light weighted belt 20, Fig. 2 and 4; Paragraph [0031]; the array 500 having… miniature ultrasound transducers and receivers), the probe head being configured to transmit an ultrasonic beam toward a body surface of a subject and to receive a reflected wave from the body surface (Paragraph [0046]; and multiple-point ultrasound transducers and/or light sources to launch ultrasound signals and/or light rays of specific wavelengths on the abdomen of the mother… reflected bodypart- or object-distance-specific ultrasound signal),
and wherein the image capturing unit and the ultrasonic probe are separate elements (Paragraph [0031]; biosensor belt 400… separately operated emitters and signal-receivers e.g. miniature ultrasound transducers and receivers; Paragraph [0029]; an imaging system 420, Fig. 4; Paragraph [0031]; a signal processing unit (CCD camera & intensifier-filter unit) 450, Fig. 5) connected to each other via the first cable (Fig. 5, cord 42), and commonly connected to the display device via a second cable (Paragraph [0031]; Fig. 5, conventional wires 452).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the image capturing unit and the ultrasonic probe of Lee in view of Sndy, Mihailescu, and Buelow to have been separate elements connected to each other via the first cable and commonly connected to the display device via a second cable as taught by Kiraly because it would have been known arrangement of connecting an imaging device and an ultrasound device to a display monitor that further would have allowed identifying the shape and position of the ultrasonic map with respect to the patient which would have further allowed overlaying the ultrasound image over the patient (Paragraph [0025] and [0043]).
Claim 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Sandy, Mihailescu, Buelow, and Kiraly as applied to claim 1 above; and Lee in view of Sandy, Mihailescu, Buelow, Slayton, and Kiraly as applied to claim 14 above, respectively, and further in view of Murai (US 20150126865).
Regarding claim 27, together Lee, Sandy, Mihailescu, Buelow, and Kiraly teach all of the limitations of claim 1 as noted above.
The device of Lee in view of Sandy, Mihailescu, Buelow, and Kiraly does not explicitly teach the probe head comprises a marker which has a color or shape indicating an operation of the probe head.
Murai, however, teaches probe head (Paragraph [0046]; ultrasonic probe 50; Fig. 2a) comprising a marker (Paragraph [0048]; notification section 58, Fig. 2C; Paragraph [0128]; optical measurement direction marker 72… may be realized by an LED or the like so as to function as the notification section 58, Fig. 12A) which has a color or shape (Paragraph [0058]; notification section 58 performs one or a plurality of kinds of notification according to a notification pattern… combination of a blinking pattern, color; displayed by replacing the size of the index value) indicating an operation of the probe head (Paragraph [0073]; second light emitting section 56 and the notification section 58, the operator understands that the position adjustment has been completed, a blood vessel has been detected, and the ultrasonic probe 50 has been placed at an appropriate position for ultrasonic measurement; Paragraph [0106]; , the processing unit 200 starts a control based on the ultrasonic measurement pattern for the notification section 58 (step S28), and starts a control to make the first light emitting section 54 emit light according to the ultrasonic measurement pattern (step S30)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the probe head of Lee in view of Sandy, Mihailescu, and Buelow to have comprised a marker which has a color or shape indicating an operation of the probe head as taught by Murai because it would have allowed an operator to determine when the probe is located at the target tissue by seeing the color of the notification of the marker, and thus increase the ease of performing the ultrasound procedure (Murai, Paragraph [0110]).
Regarding claim 28, together Lee, Sandy, Mihailescu, Buelow, Kiraly, and Slayton teach all of the limitations of claim 14 as noted above.
The device of Lee in view of Sandy, Mihailescu, Buelow, Kiraly, and Slayton does not explicitly teach the probe head comprises a marker which has a color or shape indicating an operation of the probe head.
Murai, however, teaches probe head (Paragraph [0046]; ultrasonic probe 50; Fig. 2a) comprising a marker (Paragraph [0048]; notification section 58, Fig. 2C; Paragraph [0128]; optical measurement direction marker 72… may be realized by an LED or the like so as to function as the notification section 58, Fig. 12A) which has a color or shape (Paragraph [0058]; notification section 58 performs one or a plurality of kinds of notification according to a notification pattern… combination of a blinking pattern, color; displayed by replacing the size of the index value) indicating an operation of the probe head (Paragraph [0073]; second light emitting section 56 and the notification section 58, the operator understands that the position adjustment has been completed, a blood vessel has been detected, and the ultrasonic probe 50 has been placed at an appropriate position for ultrasonic measurement; Paragraph [0106]; , the processing unit 200 starts a control based on the ultrasonic measurement pattern for the notification section 58 (step S28), and starts a control to make the first light emitting section 54 emit light according to the ultrasonic measurement pattern (step S30)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the marker of the probe head of Lee in view of Sandy, Mihailescu, Buelow and Kiraly to have a color or shape indicating an operation of the probe head as taught by Murai because it would have allowed an operator to determine when the probe is located at the target tissue by seeing the color of the notification of the marker, and thus increase the ease of performing the ultrasound procedure (Murai, Paragraph [0110]).
Response to Arguments
Claim Rejections under – 35 U.S.C. § 103
Applicant’s arguments with respect to the previous 35 U.S.C. § 103 rejections have been considered but are moot in view of the updated grounds of rejection necessitated by amendments.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dean N Edun whose telephone number is (571)270-3745. The examiner can normally be reached M-F 8am-5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anh Tuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEAN N EDUN/Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
01/26/26