DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-8, in the reply filed on 6/24/2026 is acknowledged.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(2) as being clearly anticipated by Dubin et al. (US20170112439A1, 2017-04-27; hereinafter “Dubin”).
Regarding claim 1, Dubin teaches an ultrasound system (“A system for measuring physiological parameters of a patient, the system comprising: a portable measurement system, operable to acquire physiological measurement from an examined body location of the patient;” [clm 1]; “the portable measurement system comprises an ultrasonic transducer which is operable to acquire the physiological measurement which comprises ultrasonic sound waves reflected from a body of the patient” [clm 5]; [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B]) comprising:
an ultrasound probe operated by an operator (“the portable measurement system comprises an ultrasonic transducer” [clm 5]; “portable measurement system 210 may include an ultrasonic transducer (e.g. a piezoelectric transducer) which is operable to acquire the physiological measurement which includes ultrasonic sound waves reflected from a body of the patient.” [0100]; “that user 102 and patient 103 are located at patient location 100.” [0167]; [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B; see fig. 3, 7 reproduced below]);
a mobile information terminal positioned close to the ultrasound probe and operated by the operator (“System 200 further includes camera 220, synchronization module 230 and communication module 240,” [0079]; “user 102 operates system 200 as a diagnostic device, as further detailed below. In some cases, user 102 also operates an optional patient workstation 114, as further detailed below. […] It is to be noted that in some cases, patient workstation 114 can be incorporated within system 200.” [0104]; Patient workstation 114 and system 200 together (i.e., mobile information terminal) are used with the separate portable measurement system 210 (i.e., ultrasound probe) during a medical examination [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B; see fig. 3, 7 reproduced below]); and
a remote apparatus positioned at a remote location with respect to the ultrasound probe and the portable information terminal (“Different kinds of systems may serve as the remote system 300 to which system 200 transmits data […] For example, the remote system to which system 200 transmits data (e.g. system 400) may be a server, a personal computer, a smart phone, a television set, a non-volatile storage system, and so on.” [0102]; “The acquired data can be transmitted (directly from system 200 or through patient workstation 114) to trained personnel workstation 122 located at trained personnel location 120 and/or to an optional central system 130.” [0173]; Trained personnel workstation 122 (i.e., remote apparatus) may be located remotely from the patient location [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B; see fig. 7 reproduced below]),
wherein the ultrasound probe includes
a transducer array (“the portable measurement system comprises an ultrasonic transducer” [clm 5]; “an ultrasonic transducer (e.g. a piezoelectric transducer) which is operable to acquire the physiological measurement which includes ultrasonic sound waves reflected from a body of the patient” [0100]; [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B; see fig. 3 reproduced below]),
a transmission and reception circuit configured to transmit an ultrasonic wave from the transducer array and generate a sound ray signal based on a reception signal acquired by the transducer array (“portable measurement system 210 may include an ultrasonic transducer (e.g. a piezoelectric transducer) which is operable to acquire the physiological measurement which includes ultrasonic sound waves reflected from a body of the patient. Processor 250 may be operable, in such case, to execute the calculations involved in processing the data collected by the ultrasonic transducer, in order to provide a visual representation of the examined location. Optionally, processor 250 may also be configured to control the electrical currents sent to the transducer probe to emit ultrasonic sound waves” [0100]; [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B; see fig. 3 reproduced below]), and
a probe side processor (“portable measurement system 210 may include one or more physiological measurement sensors 211, as well as additional components such as one or more of the following modules: communication module 212, […] processor 214,” [0075]; “Processor 250 may be operable, in such case, to execute the calculations involved in processing the data collected by the ultrasonic transducer, in order to provide a visual representation of the examined location.” [0100]; “any combination of one to four of components 210, 220, 230, 240 and 250 (which do not include both sensor 210 and camera 220) may be integrated into a computerized system having other capabilities” [0103]; The processor 214 (i.e., probe side processor) may integrate the image processing function of processor 250 to generate ultrasound images [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B; see fig. 3 reproduced below]) configured to
generate an ultrasound image based on the sound ray signal generated by the transmission and reception circuit (“Processor 250 may be operable, in such case, to execute the calculations involved in processing the data collected by the ultrasonic transducer, in order to provide a visual representation of the examined location.” [0100]; [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B; see fig. 3 reproduced below]), and
wirelessly transmit the ultrasound image (“portable measurement system 210 may include one or more physiological measurement sensors 211, as well as additional components such as one or more of the following modules: communication module 212,” [0075]; “any transmission and/or communication of data between any two units, modules, systems, processors etc. of any one of the systems discussed above may be executed in a wired manner, in a wireless manner, or as a combination of both.” [0181]; Portable measurement system may wirelessly transmit ultrasound data to the patient workstation 114/system 200 [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B; see fig. 3 reproduced below]),
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System for measuring physiological parameters of a patient including portable measurement system 210, standalone smartphone 290, and remote system 300 (Dubin [fig. 3])
wherein the mobile information terminal includes
a camera unit configured to acquire a view image obtained by imaging a scanning point of the ultrasound probe in a subject (“an external camera operable to capture visible light, oriented toward the examined body location; […] an orientation image which is based on the positioning image, the orientation image comprising at least a part of the portable measurement system adjacent to the examined body location,” [clm 1]; “System 200 further includes camera 220, […] Camera 220 (also referred to as “external camera 220”) is external to sensor 210, in the sense that it is physically separated from sensor 210. External camera 220 is preferably movable irrespectively of sensor 210. Camera 220 is operable to capture visible light, and to generate images based on light it captures.” [0079]; “the camera of a smartphone (or another portable computer such as a tablet computer, denoted 290) may be used as camera 220,” [0104]; The smartphone camera (i.e., camera unit) captures images of the portable measurement system in use relative to the patient during a medical examination [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B; see fig. 7 reproduced below]), and
a terminal side processor configured to wirelessly transmit the view image acquired by the camera unit (“System 200 also includes communication module 240, which is operable to obtain the physiological measurement and the positioning image.” [0091]; “system 200 may include processor 250 which is operable to receive some or all of the physiological measurement acquired by portable measurement system 210 from the examined body location, and to process it.” [0096]; “the camera of a smartphone (or another portable computer such as a tablet computer, denoted 290) may be used as camera 220, the processor of the smartphone may be used as synchronization module 230 (and possibly also as processor 250), and a communication module of the smartphone (e.g. the cellular communication module, the Wi-Fi communication module, or the Bluetooth communication module) may be used as communication module 240.” [0104]; “The acquired data can be transmitted (directly from system 200 or through patient workstation 114) to trained personnel workstation 122 located at trained personnel location 120 and/or to an optional central system 130.” [0173]; Communication module 240 and processor 250 may receive positioning image/orientation image (i.e., view image) from the camera 220 and transmit the images/data to a remote system [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B; see fig. 7 reproduced below]),
wherein the remote apparatus includes a remote monitor (“trained personnel workstation 122 can be any computer, including a personnel computer, a portable computer, a cellular handset or an apparatus with appropriate processing capabilities, including a computer” [0174]; “patient workstation 114, trained personnel workstation 122 and central system 130 can include a display (e.g. LCD screen), and a keyboard or any other suitable input/output devices.” [0180]; The trained personnel workstation 122 may include a display [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B; see fig. 7 reproduced below]), and
a remote apparatus side processor configured to wirelessly communicate with at least the terminal side processor (“System 400 includes at least communication module 410, processor 430 and user interface output 440,” [0138]; “The acquired data can be transmitted (directly from system 200 or through patient workstation 114) to trained personnel workstation 122 located at trained personnel location 120 and/or to an optional central system 130.” [0173]; “trained personnel workstation 122 can be any computer, including a personnel computer, a portable computer, a cellular handset or an apparatus with appropriate processing capabilities,” [0174]; “trained personnel 124 can provide feedback to user 102, for example by transmitting data back to patient workstation 114. Such feedback can include, for example, analysis of the received data, request to receive more data, medical treatment instructions, invitation to further examination, etc.” [0180]; [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B; see fig. 7 reproduced below]),
wherein the remote apparatus side processor is further configured to
synchronize the ultrasound image wirelessly transmitted from the ultrasound probe and the view image wirelessly transmitted from the mobile information terminal captured at the same timing with each other by referring to a time stamp of the ultrasound image and a time stamp of the view image (“Synchronization module 230 is operable to receive a triggering indication, and in response to the triggering indication to associate the positioning image captured by camera 220 to the physiological measurement acquired by portable measurement system 210. […] Optionally, synchronization module 230 may be separated from portable measurement system 210 and from camera 220.” [0084]; “synchronization module 230 (or another component of system 200) may add metadata to one or more of: the orientation image, the physiological measurement record, and the association data. Such metadata may include for example positioning data (e.g. based on GPS measurement), time stamp,” [0113]; “system 400 may be used for receiving (and possibly processing) of any of the types of physiological measurements discussed with respect to system 200” [0146]; “the processor is operable to retrieve from the tangible memory the physiological measurement records, and to synchronize providing information of the different physiological measurement records with the displaying of the video, based on the association data.” [0161]; “the system used at the trained patient location 120 may be another system, which does not necessarily have all the capabilities of system 400 (e.g. it may not necessarily have to be operable to use synchronized data, as discussed with respect to system 400)” [0315]; The processor at trained personnel location may synchronize physiological measurement record (e.g., ultrasound image) and orientation image (i.e., view image) [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B; see fig. 7 reproduced below]), and
display the ultrasound image and the view image synchronized with each other on the remote monitor (“For example, the information gathered and processed by system 200 may be reviewed by a trained medical expert,” [0102]; “User interface output 440 configured to display the at least one matching orientation image in combination with providing information of the selected physiological measurement record.” [0152]; “The acquired data can be transmitted (directly from system 200 or through patient workstation 114) to trained personnel workstation 122 located at trained personnel location 120” [0173]; “A trained personnel 124 […] located at trained personnel location 120, can retrieve and review the acquired data (e.g. as discussed with respect to system 400), for example using trained personnel workstation 122.” [0179]; Trained personnel may review the synchronized ultrasound image and orientation image using the display included with trained personnel workstation [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B; see fig. 7 reproduced below]).
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System architecture for performing a self-guided medical examination, wherein trained personnel may understand the conditions of patient location where physiological measurement is executed to determine whether the examination was carried out correctly (Dubin [fig. 7])
Regarding claim 2, Dubin teaches the ultrasound system according to claim 1,
Dubin further teaching wherein the terminal side processor is further configured to synchronize the ultrasound image and the view image captured at the same timing with each other by referring to the time stamp of the ultrasound image and the time stamp of the view image (“Synchronization module 230 is operable to receive a triggering indication, and in response to the triggering indication to associate the positioning image captured by camera 220 to the physiological measurement acquired by portable measurement system 210. […] Optionally, synchronization module 230 may be separated from portable measurement system 210 and from camera 220.” [0084]; “synchronization module 230 (or another component of system 200) may add metadata to one or more of: the orientation image, the physiological measurement record, and the association data. Such metadata may include for example positioning data (e.g. based on GPS measurement), time stamp,” [0113]; “the processor is operable to retrieve from the tangible memory the physiological measurement records, and to synchronize providing information of the different physiological measurement records with the displaying of the video, based on the association data.” [0161]; “the system used at the trained patient location 120 may be another system, which does not necessarily have all the capabilities of system 400 (e.g. it may not necessarily have to be operable to use synchronized data, as discussed with respect to system 400)” [0315]; [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B], [see claim 1 rejection]).
Regarding claim 3, Dubin teaches the ultrasound system according to claim 1,
Dubin further teaching wherein the mobile information terminal includes a terminal monitor (“system 200 may include a display 260 (also referred to as monitor 260) which is operable to display various types of visual information,” [0107]; [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B; see fig. 3 reproduced below], [see claim 1 rejection]),
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Standalone smartphone may feature a display (Dubin [fig. 3])
wherein the remote apparatus side processor is further configured to wirelessly transmit the ultrasound image and the view image synchronized with each other to the mobile information terminal (“trained personnel 124 can provide feedback to user 102, for example by transmitting data back to patient workstation 114. Such feedback can include, for example, analysis of the received data, request to receive more data, medical treatment instructions, invitation to further examination, etc.” [0180]; [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B], [see claim 1 rejection]), and
wherein the terminal side processor is further configured to display the ultrasound image and the view image wirelessly transmitted from the remote apparatus side processor on the terminal monitor (“system 200 may include a display 260 (also referred to as monitor 260) which is operable to display various types of visual information, such as […] images and/or videos captured by camera 220, processed versions of such images and/or videos, positioning images, orientation images, instructions regarding the way in which system 200 should be operated by a user and/or operator thereof, a graphic user interface (GUI) which utilizes association between images and physiological measures and/or physiological measurement records, and so on.” [0107]; “system 200 may include a monitor (e.g. display 260) operable to display to the user positioning instructions indicating a body location for measurement. The instructions may be textual, visual, and may relate to an image acquired by the external camera 220 or by another camera of system 200” [0127]; [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B], [see claim 1 rejection]).
Regarding claim 4, Dubin teaches the ultrasound system according to claim 1,
Dubin further teaching wherein the remote apparatus side processor is further configured to wirelessly communicate with both the probe side processor and the terminal side processor (“any transmission and/or communication of data between any two units, modules, systems, processors etc. of any one of the systems discussed above may be executed in a wired manner, in a wireless manner, or as a combination of both.” [0181]; [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B], [see claim 1 rejection]), and
wherein the probe side processor is further configured to wirelessly transmit the ultrasound image to both the mobile information terminal and the remote apparatus (“portable measurement system 210 may include one or more physiological measurement sensors 211, as well as additional components such as one or more of the following modules: communication module 212,” [0075]; “any transmission and/or communication of data between any two units, modules, systems, processors etc. of any one of the systems discussed above may be executed in a wired manner, in a wireless manner, or as a combination of both.” [0181]; [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B], [see claim 1 rejection]).
Regarding claim 5, Dubin teaches the ultrasound system according to claim 1,
Dubin further teaching wherein the probe side processor is further configured to wirelessly transmit the ultrasound image to the mobile information terminal (“portable measurement system 210 may include one or more physiological measurement sensors 211, as well as additional components such as one or more of the following modules: communication module 212,” [0075]; “any transmission and/or communication of data between any two units, modules, systems, processors etc. of any one of the systems discussed above may be executed in a wired manner, in a wireless manner, or as a combination of both.” [0181]; [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B], [see claim 1 rejection]), and
wherein the terminal side processor is further configured to wirelessly transmit the ultrasound image wirelessly transmitted from the probe side processor and the view image acquired by the camera unit to the remote apparatus (“System 200 also includes communication module 240, which is operable to obtain the physiological measurement and the positioning image.” [0091]; “system 200 may include processor 250 which is operable to receive some or all of the physiological measurement acquired by portable measurement system 210 from the examined body location, and to process it.” [0096]; “the camera of a smartphone (or another portable computer such as a tablet computer, denoted 290) may be used as camera 220, the processor of the smartphone may be used as synchronization module 230 (and possibly also as processor 250), and a communication module of the smartphone (e.g. the cellular communication module, the Wi-Fi communication module, or the Bluetooth communication module) may be used as communication module 240.” [0104]; “The acquired data can be transmitted (directly from system 200 or through patient workstation 114) to trained personnel workstation 122 located at trained personnel location 120 and/or to an optional central system 130.” [0173]; [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B], [see claim 1 rejection]).
Regarding claim 6, Dubin teaches the ultrasound system according to claim 3,
Dubin further teaching wherein the remote apparatus includes an input device (“system 400 may include a user interface input 450 for receiving information from an operator of system 400. User interface input 450 may be a physical user interface (e.g. including physical buttons, switches, etc.), a software user interface (e.g. an API), a touchscreen user interface (e.g. using a display of UI 440), and so on. Among other optional functionalities, UI input 450 may be used in order to enable a user of system 400 to review a physiological measurement of a patient and an orientation image associated with that physiological measurement” [0155]; [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B]),
wherein the remote apparatus side processor is further configured to wirelessly transmit external input information input through the input device to the mobile information terminal (“system 400 may include a user interface input 450 for receiving information from an operator of system 400. […] UI input 450 may be used in order to enable a user of system 400 to review a physiological measurement of a patient and an orientation image associated with that physiological measurement. Thereby, the user can associate the physiological measurement to the examined body location near which the sensor was located.” [0155]; “patient workstation 114, trained personnel workstation 122 and central system 130 can include a display (e.g. LCD screen), and a keyboard or any other suitable input/output devices. In some cases, trained personnel 124 can provide feedback to user 102, for example by transmitting data back to patient workstation 114. Such feedback can include, for example, analysis of the received data, request to receive more data, medical treatment instructions, invitation to further examination, etc.” [0180]; [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B], [see claim 1 rejection]), and
wherein the terminal side processor is further configured to display the external input information wirelessly transmitted from the remote apparatus side processor on the terminal monitor (“system 200 may include a monitor (e.g. display 260) operable to display to the user positioning instructions indicating a body location for measurement. The instructions may be textual, visual, and may relate to an image acquired by the external camera 220 or by another camera of system 200” [0127]; “patient workstation 114, trained personnel workstation 122 and central system 130 can include a display (e.g. LCD screen), and a keyboard or any other suitable input/output devices. In some cases, trained personnel 124 can provide feedback to user 102, for example by transmitting data back to patient workstation 114. Such feedback can include, for example, analysis of the received data, request to receive more data, medical treatment instructions, invitation to further examination, etc.” [0180]; [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B], [see claim 3 rejection]).
Regarding claim 7, Dubin teaches the ultrasound system according to claim 1,
Dubin further teaching wherein the terminal side processor and the remote apparatus side processor are further configured to perform wireless communication of voice data between each other in two directions (“system 200 may include a monitor (e.g. display 260) operable to display to the user positioning instructions indicating a body location for measurement. The instructions may be textual, visual, and may relate to an image acquired by the external camera 220 or by another camera of system 200 (e.g. 270). It is noted that such instructions may also be provided using a speaker,” [0127]; “The term “user interface output” pertains to the type of user information which emits information (such as a speaker, a display, and so on).” [0152]; “patient workstation 114, trained personnel workstation 122 and central system 130 can include a display (e.g. LCD screen), and a keyboard or any other suitable input/output devices. In some cases, trained personnel 124 can provide feedback to user 102, for example by transmitting data back to patient workstation 114. Such feedback can include, for example, analysis of the received data, request to receive more data, medical treatment instructions, invitation to further examination, etc.” [0180]; [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B], [see claim 1 rejection]).
Regarding claim 8, Dubin teaches the ultrasound system according to claim 1,
Dubin further teaching wherein the mobile information terminal is mountable on a head of the operator who operates the ultrasound probe and the mobile information terminal (“external camera 220 may also be wore by a user (usually other than the patient, but not necessarily so). For example, a camera which is installed on glasses (such as Google-Glass™) or on another type of optical head-mounted display (OHMD, e.g. augmented reality glasses) may be used.” [0105]; [0069-0162, 0167-0184], [fig. 1-5, 7, 17A-17B]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pedersen et al. (US20090306509A1, 2009-12-10) teaches a freehand 3-D imaging system includes an integrated sensor configuration that provides position and orientation of each 2D imaging plane used for 3-D reconstruction without the need for external references. The position sensors communicate with the imaging system using either wired and wireless means [abst]. The position sensor(s) are of a type that acquires data along a single or multiple axes, including, but not limited to, optical sensors; the position sensor(s) may comprise a light-sensitive image capture device for converting the optical image output from the lens into said position signal such as, for example a charge coupled device camera and digital signal processor [0026].
Caluser et al. (EP2790587B1, 2018-04-11) teaches three dimensional mapping display ("TDMD") diagnostic ultrasound system in which ultrasound probe position registration is automated, the position of each pixel in the ultrasound image in reference to preselected anatomical references is calculated, and specified information is stored on command [0001].
Hershey et al. (US20140171799A1, 2014-06-19) teaches an ultrasound device coupled with an ultrasound probe and configured to acquire ultrasound images of a subject. The system further includes at least one of a plurality of digital cameras or a plurality of digital scanners configured to acquire scene information including images of the ultrasound probe with the subject during an image scan [abst].
Edwards et al. (US20170231508A1, 2017-08-17) teaches medical devices, and more particularly, to synchronization of functions within one or a plurality of medical devices [0002].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James F. McDonald III whose telephone number is (571)272-7296. The examiner can normally be reached M-F; 8AM-6PM EST.
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JAMES FRANKLIN MCDONALD III
Examiner
Art Unit 3797
/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797
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