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 .
Response to Amendment
The amendment filed 10/16/2025 has been entered. New claims 30-32 have been added. Claims 1-2, 4-8, 10-11, 14, 17-23, 25, 27, and 29-32 remain pending in the application, with claims 17-23, 25, and 27 being previously withdrawn from consideration.
Response to Arguments
Applicant’s arguments with respect to the independent claims 1, 29, 32, and claims dependent therefrom have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Newly cited reference Sutton (US20220071599) is now being relied upon for teaching the features argued upon.
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)(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.
Claims 1, 4, and 29-31 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sutton (US20220071599).
Regarding claim 1, Sutton teaches a method for acquiring physiological parameter(s) by an ultrasound device (70, 12) (Figs. 1 & 4-5, [0026], [0086], [0091], [0176-0184]), comprising:
acquiring, by the ultrasound device (70, 12), ultrasonic data of a target object, the ultrasonic data comprising at least an ultrasound image ([0051-0052], [0087-0088]);
performing, by the ultrasound device (70, 12), image recognition on the ultrasound image to acquire an image recognition result ([0041-0042], [0058], [0096], wherein identifying a relevant anatomical region within the acquired ultrasound image using an algorithm comprises performing image recognition on the ultrasound image, [0107], wherein identified anatomical regions such as the ventricles or mitral valve comprise the image recognition result);
acquiring, by the ultrasound device (70, 12), physiological parameter(s) corresponding to the image recognition result from a bedside device (28) or a device storing historical monitoring data, the physiological parameter(s) being detected by the bedside device (28) for the target object, wherein the bedside device (28) comprises at least one of: a patient monitor, a ventilator, an anesthesia machine, or a personal computer (Fig. 1, [0012], [0014], “identify a relevant anatomical region within the acquired ultrasound image data pertaining to the at least one physiological parameter”, wherein the identified (via image recognition) anatomical region in the ultrasound image which pertains to the physiological parameter comprises wherein the physiological parameter corresponds with the identified anatomical region or image recognition result, [0026], “The measurements may be acquired from signal outputs of one or more physiological parameter sensors with which the control unit is communicatively coupleable in use”, [0030], [0045-0046], [0071], “In some examples, the control unit may comprise a connection output for connecting for instance to a patient monitoring unit or system”, [0083], [0086], [0091], [0096], [0107], “In particular, first a relevant anatomical region within the acquired ultrasound data is identified, pertaining to the parameter of ejection fraction. In this case for instance, the relevant anatomical region may be both the left and right ventricle and the mitral valve”, [0109], “The physiological parameters acquired by the measurement acquisition module 18 may…be based on other non-ultrasound-derived physiological parameter measurements, for instance acquired using the one or more external attached sensors 28”, [0134], [0111], [0156], wherein the user is a patient and wherein heart rate monitors and blood pressure sensors (i.e. blood pressure cuffs) comprise patient monitoring units or systems); and
displaying (24), by the ultrasound device (70, 12), the acquired physiological parameter(s) and the ultrasound image (Fig. 4, [0030], [0034], [0069], “The ultrasound system may optionally further comprise a display unit, the display unit comprising a display panel, and wherein the control unit is adapted to communicate the generated control outputs to the display unit”, [0086-0087], [0122], wherein overlaying physiological parameters on the ultrasound image comprises displaying the acquired physiological parameters, and wherein figure 4 shows wherein the ultrasound system 70 includes the display unit 24 for displaying the ultrasound images and overlay).
Regarding claim 4, Sutton teaches the invention as claimed above in claim 1.
Sutton further teaches wherein the image recognition result includes an examination part of the target object, and the physiological parameter(s) corresponding to the image recognition result include(s): physiological parameter(s) corresponding to the examination part ([0107], “In particular, first a relevant anatomical region within the acquired ultrasound data is identified, pertaining to the parameter of ejection fraction. In this case for instance, the relevant anatomical region may be both the left and right ventricle and the mitral valve”, wherein the left and right ventricle and the mitral valve comprise the identified relevant anatomical region and image recognition result, and the physiological parameter being ejection fraction corresponds to the ventricles and mitral valve).
Regarding claim 29, Sutton teaches an ultrasound device (70), comprising a transmitting circuit, a receiving circuit, an ultrasonic probe (104), a processor (122) and a display (24) (Figs. 4-5, [0177-0181], [0185], [0187], “Further, the system includes a transmit/receive (T/R) switch 116, which the microbeamformer 112 can be coupled to and which switches the array between transmission and reception modes…The controller 118 can include transmission circuitry arranged to drive the transducer elements of the array 106”, [0201-0202]), wherein:
the transmitting circuit is configured to control the ultrasonic probe (104) to transmit ultrasonic waves to a target object ([0185], [0187], [0189]);
the receiving circuit is configured to control the ultrasonic probe to receive ultrasonic echoes and obtain ultrasonic echo signals from the ultrasonic echoes ([0185], [0190], [0208], “The scan converter 132 arranges the echo signals in the spatial relationship from which they were received in a desired image format…The multi-planar reformatter will convert echoes that are received from points in a common plane in a volumetric region of the body into an ultrasound image of that plane”);
the processor (122, 130) is configured to perform ultrasonic imaging based on the ultrasonic echo signals to obtain an ultrasound image (Fig. 5, [0202], “The beamformed reception signals are coupled to a signal processor 122. The signal processor 122 can process the received echo signals”, [0207-0209]); and
the processor (122) is further configured to ([0024], “In some examples, the functionality of the different modules may be integrated and performed by a single element, for example by a single controller or processor…or processor within the ultrasound control unit”):
perform image recognition on the ultrasound image to acquire an image recognition result ([0014], [0017], [0042], [0096], [0115], wherein identified anatomical regions such as the mitral valve, ventricle, or heart comprise image recognition results, [0164], wherein identifying a relevant anatomical region within an ultrasound image using an algorithm comprises performing image recognition on the ultrasound image to acquire an image recognition result);
acquire physiological parameter(s) corresponding to the image recognition result from a bedside device (28) or a device storing historical monitoring data ([0012], [0014], [0026], [0045-0046], [0071], [0086], wherein the identified anatomical region being relevant and pertaining to the physiological parameter comprises wherein the physiological parameter(s) corresponds to the image recognition result, [0106-0107], i.e. the physiological parameter ejection fraction corresponds to the left and right ventricle and mitral valve identified within the ultrasound image, [0109], “The physiological parameters acquired by the measurement acquisition module 18 may…be based on other non-ultrasound-derived physiological parameter measurements, for instance acquired using the one or more external attached sensors 28”),
the physiological parameter(s) being detected by the bedside device (28) for the target object, wherein the bedside device (28) comprises at least one of: a patient monitor, a ventilator, an anesthesia machine, or a personal computer ([0046], [0071], “In some examples, the control unit may comprise a connection output for connecting for instance to a patient monitoring unit or system”, [0091], [0111], [0134], [0156], wherein the user is a patient and wherein heart rate monitors and blood pressure sensors (i.e. blood pressure cuffs) comprise patient monitoring units or systems); and
the display (24) is configured to display the acquired physiological parameter(s) and the ultrasound image (Fig. 4, [0030], [0034], [0069], “The ultrasound system may optionally further comprise a display unit, the display unit comprising a display panel, and wherein the control unit is adapted to communicate the generated control outputs to the display unit”, [0086-0087], [0122], wherein overlaying physiological parameters on the ultrasound image comprises displaying the acquired physiological parameters, and wherein figure 4 shows wherein the ultrasound system 70 includes the display unit 24 for displaying the ultrasound images and overlay).
Regarding claim 30, Sutton teaches the invention as claimed above in claim 1.
Sutton further teaches wherein the bedside device (28) further comprises an electrocardiographic module ([0045-0046], [0091], [0111], “ECG sensor device”).
Regarding claim 31, Sutton teaches the invention as claimed above in claim 29.
Sutton further teaches wherein the bedside device (28) further comprises an electrocardiographic module ([0045-0046], [0091], [0111], “ECG sensor device”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Sutton ‘599 (US20220071599) in view of Sutton ‘963 (US20220225963).
Regarding claim 2, Sutton ‘599 teaches the invention as claimed above in claim 1.
However, Sutton ‘599 fails to teach wherein when the ultrasound image at least comprises a grayscale image, performing image, by the ultrasound device, the image recognition on the ultrasound image to acquire the image recognition result comprises: performing, by the ultrasound device, the image recognition on the grayscale image to obtain the image recognition result; and when the ultrasound image comprises a grayscale image acquired under a grayscale imaging mode and an ultrasound image under a non-grayscale imaging mode, performing, by the ultrasound device, the image recognition on the ultrasound image comprises: performing, by the ultrasound device, the image recognition on a combination of the grayscale image and the ultrasound image under the non-grayscale imaging mode.
In an analogous ultrasound imaging including image recognition field of endeavor, Sutton ‘963 teaches such a feature. Sutton ‘963 teaches obtaining B-mode images and color Doppler ultrasound images (Abstract, [0021-0023], wherein B-mode images comprise grayscale images and color Doppler comprises non-grayscale images). Sutton ‘963 teaches determining whether a blood vessel is located in the image, thereby teaching performing image recognition for a blood vessel (Abstract, [0067]). Sutton ‘963 teaches the determination of a vessel being in the image may be based on image recognition of bony structures, and a convolution neural network may be trained to recognize structures ([0106], [0110]). Sutton ‘963 teaches performing image recognition on B-mode ultrasound images to identify/locate a vessel (Abstract, [0009-0010], [0016-0020], [0023], [0067], [0106], [0110]). Sutton ‘963 further teaches performing image recognition on color Doppler ultrasound images to identify/locate a vessel ([0021-0022], [0108-0110]). Moreover, Sutton ‘963 teaches performing image recognition using 2D duplex color Doppler data which comprises 2D color Doppler images overlaid onto B-mode images ([0024-0025], [0110], wherein duplex color Doppler data comprises a combination of grayscale b-mode images and non-grayscale color Doppler images).
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 invention of Sutton ‘599 to obtain and perform image recognition on b-mode images, color Doppler images, and duplex color Doppler images as taught by Sutton ‘963 (Abstract, [0009-0010], [0021-0025], [0067], [0106], [0110]). By performing image recognition on b-mode, color Doppler, or a combination of the two (duplex color Doppler), blood vessels may be recognized and identified/located as recognized by Sutton ‘963 (Abstract, [0010], [0021-0025], [0102], [0106-0110]). Sutton ‘599 modified by the teachings of Sutton to perform image recognition on B-mode, color Doppler, and Duplex ultrasound images/data would predictably result in performing image recognition on grayscale images (B-mode images) when the ultrasound image comprises a grayscale image (B-mode image) and performing image recognition on a combination of grayscale images (B-mode image) and non-grayscale images when the ultrasound image includes a grayscale image and non-grayscale image (duplex Color doppler). Sutton ‘963 teaches Duplex color Doppler data comprises 2D color Doppler images overlaid onto B-mode images (i.e. a combination of grayscale and non-grayscale images) ([0025], [0110]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sutton (US20220071599) in view of Dala-Krishna (US20090005679).
Regarding claim 5, Sutton teaches the invention as claimed above in claim 4.
Sutton further teaches wherein when the bedside device (28) comprises the patient monitor and the image recognition result is recognized as a section of a heart or a section of an abdomen, the physiological parameter(s) detected by the bedside device and acquired by the ultrasound device comprise(s) at least one of cardiac output, ejection fraction, stroke volume, and ventricular pressure and volume (Table 1, [0044], [0090], [0107], [0109-0110], [0115]).
However, Sutton fails to teach wherein the physiological parameter(s) detected by the bedside device and acquired by the ultrasound device comprise(s) at least one of electrocardiographic waveform parameter(s), respiratory wave parameter(s) and blood oxygen parameter(s).
In an analogous ultrasound imaging field of endeavor, Dala-Krishna teaches such a feature. Dala-Krishna teaches an ultrasound unit (40) coupled to an ECG unit ([0035-0036], [0104]). Dala-Krishna teaches acquiring ultrasound images of the heart (12) (Fig. 2, [0038]). Dala-Krishna teaches employing edge-detection image processing algorithms to recognize the heart and its surfaces, therefore teaching performing image recognition to identify heart structures ([0089], [0091], [0095]). Dala-Krishna teaches associating the ultrasound images with a sequence of ECG readings ([0036]). Moreover, Dala-Krishna teaches wherein the ultrasound unit may receive signals from the ECG sensor ([0050-0051]). Dala-Krishna therefore teaches detecting and acquiring by the ultrasound device at least electrocardiographic waveform parameters when the image recognition result is recognized as a section of a heart.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Sutton to detect and acquire ECG signals when imaging the heart as taught by Dala-Krishna (Fig. 2, [0035-0036], [0050-0051], [0089], [0091], [0095], [0104]). The ECG signals may be used to synchronize the ultrasound images with a heartbeat of the patient as recognized by Dala-Krishna ([0036], [0076], [0169]). Sutton similarly teaches wherein the bedside device may comprise an ECG sensor and thus wherein the physiological parameters detected and acquired may comprise ECG waveform readings ([0046], [0091], [0111]). Therefore, Sutton modified by the teachings of Dala-Krishna would predictably result in detecting and acquiring ECG waveform parameters when the heart is identified.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Sutton (US20220071599) in view of Oura (US20180214117).
Regarding claim 6, Sutton teaches the invention as claimed above in claim 4.
However, Sutton fails to teach wherein when the bedside device comprises the patient monitor and the image recognition result is recognized as a section of a brain, the physiological parameter(s) detected by the bedside device and acquired by the ultrasound device comprise(s) at least one of pressure parameter(s) and blood oxygen parameter(s).
In an analogous ultrasound imaging field of endeavor, Oura teaches such a feature. Oura teaches recognizing and discerning brain swelling using ultrasound (Abstract, Claim 1, [0030], [0087], [0118], [0125]). Oura further teaches a patient monitor connected to an ultrasound system (ultrasound transducer) configured to monitor parameters including oxygen saturation (SpO2) and blood pressure while the ultrasound system creates and displays brain displacement data (Claims 6 & 13). Oura therefore teaches when a bedside device comprises a patient monitor and an image recognition result is of the brain, the physiological parameters detected by the bedside device/patient monitor comprises at least one of a pressure parameter and blood oxygen parameter (SpO2).
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 invention of Sutton to monitor blood oxygenation and blood pressure while scanning the brain as taught by Oura (Figs. 3-4 & 16, Abstract, Claims 1, 6, & 13, [0030], [0087], [0118], [0125]). Intracranial pressure (ICP) may be caused by brain swelling ([0002], [0016]) and low blood pressure may cause long duration high ICP as recognized by Oura ([0056]), therefore monitoring and displaying blood pressure may be vital in analyzing intracranial blood pressure.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sutton (US20220071599) in view of Grunwald (US20160278869).
Regarding claim 7, Sutton teaches the invention as claimed above in claim 4.
However, Sutton fails to teach wherein when the bedside device comprises the patient monitor and the image recognition result is recognized as a section of blood vessels, the physiological parameter(s) detected by the bedside device and acquired by the ultrasound device comprise(s) at least one of blood pressure parameter(s), electrocardiographic waveform parameter(s) and blood oxygen parameter(s).
In an analogous ultrasound imaging field of endeavor, Grunwald teaches such a feature. Grunwald teaches a bedside device comprising an ECG data acquisition device (125) which provides ECG signals from the patient’s body (Fig. 1, [0038]). Grunwald teaches wherein the ECG signals are used to monitor the patient’s heart rate and presence of any heart rhythm abnormalities ([0133-0134]). Grunwald therefore teaches wherein the ECG data acquisition device (125) comprises a patient monitor since it monitors the patient as disclosed and shown in figure 1. Grunwald further teaches image recognition of objects in the ultrasound image (Fig. 11, [0099]). Grunwald teaches displaying an ultrasound image of a blood vessel alongside the acquired ECG signal/waveform by the ECG unit 125 (Fig. 17, Claim 5, [0131], [0138]). Grunwald therefore teaches capturing an ultrasound image of a blood vessel and when a blood vessel is detected and displayed, to further display a physiological parameter comprising an electrocardiographic waveform parameter detected by a bedside patient monitor comprising an ECG unit (125).
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 invention of Sutton to display an ECG signal alongside the ultrasound image when the ultrasound image is of a blood vessel as taught by Grunwald (Fig. 17, Claim 5, [0099], [0131], [0138]). The monitored and displayed ECG signals may be used to monitor the patient’s heart rate and presence of any heart rhythm abnormalities during vascular (blood vessel) access as recognized by Grunwald ([0133-0134]). Sutton similarly teaches wherein the bedside device may comprise an ECG sensor and thus wherein the physiological parameters detected and acquired may comprise ECG waveform readings ([0046], [0091], [0111]). Thus, Sutton modified by the teachings of Grunwald would predictably result in acquiring and displaying, i.e. overlaying, of ECG waveforms when it is recognized or detected that the ultrasound image includes a blood vessel as Grunwald teaches to display an ECG waveform alongside an ultrasound image of a blood vessel (Fig. 17, [0131], [0138]) and performing image recognition of objects in the ultrasound image ([0099]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Sutton (US20220071599) in view of Huang (CN113040823; translation provided) and Maschke (US20080312519).
Regarding claim 8, Sutton teaches the invention as claimed above in claim 4.
Sutton further teaches wherein the bedside device comprises the patient monitor ([0046], [0071], “In some examples, the control unit may comprise a connection output for connecting for instance to a patient monitoring unit or system”, [0091], [0111], [0134], [0156], wherein the user is a patient and wherein heart rate monitors and blood pressure sensors (i.e. blood pressure cuffs) comprise patient monitoring units or systems).
However, Sutton fails to teach wherein when the bedside device comprises the patient monitor and the image recognition result is recognized as a section of lung(s), the physiological parameter(s) detected by the bedside device and acquired by the ultrasound device comprise(s) at least one of electrocardiographic waveform parameter(s) and respiratory wave parameter(s).
In an analogous ultrasound imaging and displaying of physiological parameters field of endeavor, Huang teaches such a feature. Huang teaches obtaining ultrasound images of the lung with an ultrasound imaging device (10) ([0004], [0006-0007], [0031-0034]). Huang teaches the ultrasound imaging equipment may communicate with monitoring equipment ([0026]). Huang further teaches obtaining monitoring data of a target object, the lungs ([0004-0005], [0008], [0022], [0031], [0033-0034], [0048], [0075-0080]). Huang teaches when the ultrasound image includes the lungs, the acquired monitoring data includes monitoring parameters such a respiratory rate, respiratory pressure, respiratory volume, tidal volume, and airway pressure ([0048], [0075-0080], “For example, when the ultrasound image of the target object includes a tissue grayscale image of the lungs, the monitoring data may be respiratory rate data, tidal volume data, blood pressure data and/or airway pressure data of the target object”, wherein these respiratory monitoring parameters comprise at least a respiratory wave parameter). Huang teaches displaying and combining of the ultrasound image of the lungs with monitoring data of the lungs ([0022], [0034]). Huang teaches by associating the ultrasound image with monitoring data, doctors may be provided with rich and accurate data/information, reducing examination time and improving work efficiency and accuracy ([0008], [0031], [0132]). Moreover, Huang teaches in this way, doctors may obtain all detection data related to the lungs at the same time, which is conducive to conducting examinations quickly and accurately, facilitates monitoring of the patient’s health status, and helps the doctor carry out subsequent targeted treatment of the patient ([0034]).
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 invention of Sutton to have the ultrasound system communicate with monitoring equipment and to acquire/display respiratory wave parameters such as respiratory rate when the ultrasound image includes the lung as taught by Huang ([0022], [0026], [0034], [0048], [0075-0080]). By acquiring and displaying monitoring data such as respiratory rate when imaging the lungs, examination may be faster and more accurate, monitoring of patient health may be facilitated, and carrying out subsequent targeted treatment of the patient may be improved as recognized by Huang ([0008], [0031], [0034], [0132]). Sutton modified by the teachings of Huang would predictably result in the ultrasound device communicating with monitoring equipment to acquire and display respiratory wave parameters when the ultrasound image includes a section of a lung.
However, the modified combination noted above fails to teach wherein the bedside device comprises the patient monitor and the ventilator.
In an analogous ultrasound imaging field of endeavor, Maschke teaches such a feature. Maschke teaches an all-in-one examination unit which has at least an ultrasonic device, patient monitor, and a ventilator (Abstract, [0002], [0028], [0034], Claims 18-19). Maschke teaches the examination unit can be used in acute and intensive diagnostics or in ambulances and may improve possibilities of on-site diagnosis for initiation of suitable measures for immediate treatment of patients at sites of emergency ([0002], [0020], [0048]). Maschke therefore teaches a bedside device (the all-in-one examination unit and/or ultrasonic device) comprising a patient monitor ([0034]) and a ventilator.
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 invention of Sutton to include a ventilator with the ultrasound device as taught by Maschke (Abstract, [0002], [0028], [0034], Claims 18-19). By having the ventilator with the ultrasound device, diagnosis may be performed with the ultrasound device and subsequent treatment may be provided to patients at times of emergency as recognized by Maschke ([0002], [0010], [0028]). Sutton modified by Huang and Maschke would predictably result wherein the bedside device comprises a patient monitor and a ventilator and therefore wherein when the bedside device comprises the patient monitor and the ventilator and the image recognition result is recognized as a section of lungs, a respiratory wave parameter is acquired (Huang above teaches acquiring a respiratory wave parameter).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Sutton (US20220071599) in view of Tsujino (US20030171668).
Regarding claim 11, Sutton teaches the invention as claimed above in claim 1.
However, Sutton fails to teach the invention further comprising: obtaining, by the ultrasound device, a user input including a physiological parameter to be added or deleted; when the user input indicates adding a physiological parameter, acquiring and displaying, by the ultrasound device, the physiological parameter to be added indicated by the user input; and when the user input indicates deleting, by the ultrasound device, a physiological parameter, deleting the physiological parameter to be deleted indicated by the user input from the displayed physiological parameter(s).
In an analogous ultrasound imaging field of endeavor, Tsujino teaches such a feature. Tsujino teaches an ultrasonic diagnosis apparatus (1) including a probe (2) for acquiring ultrasound images of a subject (Abstract, [0055-0056]). Tsujino teaches acquiring physical parameters based on acquired ultrasound images (Abstract, [0074-0076], [0152]). Tsujino further teaches displaying ultrasound images and the physical parameters, the physical parameters being superimposed thereon ([0068], [0133-0135], [0137]). Tsujino teaches a user can add or cancel various display items including physical parameters ([0138]). Moreover, Tsujino teaches only the specified or selected physical parameter items are displayed ([0138]). Tsujino therefore teaches obtaining a user input including a parameter to be added or deleted; and when a user indicates adding or specifying a parameter, displaying said parameter; and when a user indicates canceling of a parameter, deleting the parameter from the display.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Sutton to allow for user addition and removal of the display of parameters as taught by Tsujino ([0138]). By allowing a user to choose which parameter is displayed, the amount of information on display may be adjusted, thereby enabling a screen configuration comprehensible for users as recognized by Tsujino ([0138]). Sutton modified by the teachings of Tsujino to allow users to add or delete parameters for display would predictably further result in the acquiring of said parameters for display (in the case of adding a parameter) as one cannot display a parameter without first acquiring it.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Sutton (US20220071599) in view of Apperson (US20220160282).
Regarding claim 14, Sutton teaches the invention as claimed above in claim 1.
However, Sutton fails to teach wherein the physiological parameter(s) acquired by the ultrasound device from the bedside device and displayed by the ultrasound device is(are) simultaneously highlighted shown on the bedside device.
In an analogous acquiring of physiological parameters field of endeavor, Apperson teaches such a feature. Apperson teaches an ECG device (106) configured to obtain and display ECG signals (Fig. 1, Abstract, [0024]). Apperson teaches the ECG device (106) may also include an ECG monitor and/or a display (156, 1204) ([0030], [0049], [0095-0097]). Apperson teaches the ECG device (106) may change the color or highlight the ECG waveform/signal to indicate the ECG signal may be noisy ([0095-0096]). Apperson therefore teaches highlighting a physiological parameter (ECG signal) on a bedside device (ECG 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 invention of Sutton to highlight the ECG signal on the ECG device as taught by Apperson ([0096]). The highlighting or changing of color of the ECG waveform may indicate the ECG is noisy as recognized by Apperson ([0096]). Sutton similarly teaches wherein the bedside device may comprise an ECG sensor and thus wherein the physiological parameters detected and acquired may comprise ECG waveform readings ([0046], [0091], [0111]). Sutton modified by the teachings of Apperson would predictably result wherein the ECG reading acquired and displayed by the ultrasound device via the ECG device may simultaneously be highlighted on the bedside ECG device for indicating noise.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Sutton (US20220071599) in view of Lu (US20210330285).
Regarding claim 32, Sutton teaches a method for acquiring physiological parameter(s) by an ultrasound device (70, 12) (Figs. 1 & 4-5, [0026], [0086], [0091], [0176-0184]), comprising:
acquiring, by the ultrasound device (70, 12), ultrasonic data of a target object, the ultrasonic data comprising at least an ultrasound image ([0051-0052], [0087-0088]);
performing, by the ultrasound device (70, 12), image recognition on the ultrasound image to acquire an image recognition result ([0041-0042], [0058], [0096], wherein identifying a relevant anatomical region within the acquired ultrasound image using an algorithm comprises performing image recognition on the ultrasound image, [0107], wherein identified anatomical regions such as the ventricles or mitral valve comprise the image recognition result); and
acquiring, by the ultrasound device (70, 12), physiological parameter(s) corresponding to the image recognition result from a bedside device (28) or a device storing historical monitoring data, the physiological parameter(s) being detected by the bedside device (28) for the target object (Fig. 1, [0012], [0014], “identify a relevant anatomical region within the acquired ultrasound image data pertaining to the at least one physiological parameter”, wherein the identified (via image recognition) anatomical region in the ultrasound image which pertains to the physiological parameter comprises wherein the physiological parameter corresponds with the identified anatomical region or image recognition result, [0026], “The measurements may be acquired from signal outputs of one or more physiological parameter sensors with which the control unit is communicatively coupleable in use”, [0030], [0045-0046], [0071], “In some examples, the control unit may comprise a connection output for connecting for instance to a patient monitoring unit or system”, [0083], [0086], [0091], [0096], [0107], “In particular, first a relevant anatomical region within the acquired ultrasound data is identified, pertaining to the parameter of ejection fraction. In this case for instance, the relevant anatomical region may be both the left and right ventricle and the mitral valve”, [0109], “The physiological parameters acquired by the measurement acquisition module 18 may…be based on other non-ultrasound-derived physiological parameter measurements, for instance acquired using the one or more external attached sensors 28”, [0134], [0111], [0156], wherein the user is a patient and wherein heart rate monitors and blood pressure sensors (i.e. blood pressure cuffs) comprise bedside devices);
wherein when the target object is coupled to more than one bedside device, the physiological parameter(s) corresponds to the image recognition result from the bedside device (Claim 8, [0026], “The measurements may be acquired from signal outputs of one or more physiological parameter sensors with which the control unit is communicatively coupleable in use”, [0045], [0086], “one or more auxiliary physiological parameter sensors 28”, [0091], [0014], “identify a relevant anatomical region within the acquired ultrasound image data pertaining to the at least one physiological parameter”).
Sutton further teaches wherein the physiological parameter(s) may be derived from ultrasound images or based on signals received from other sources (28), i.e. bedside devices or patient monitors described above ([0026], [0045], [0109]).
However, Sutton fails to explicitly teach wherein the method further comprises determining, by the ultrasound device based on the image recognition result, the bedside device from which the physiological parameter(s) is(are) to be acquired, and acquiring the corresponding physiological parameter(s) from the determined bedside device.
In an analogous ultrasound imaging field of endeavor, Lu teaches such a feature. Lu teaches an ultrasound system (100), including an ultrasound imaging device (110) and display (112), configured to estimate physiological parameters (Fig. 1, [0018-0019]). Lu teaches wherein the physiological parameters are estimated based on the received ultrasound images ([0025]). Moreover, Lu teaches wherein the estimation of physiological parameters is performed by using image recognition to recognize anatomical structures ([0016], [0026]). Lu teaches displaying ultrasound images with relevant information, i.e. the physiological parameters, on the display (112) ([0021], [0077]). Lu therefore teaches acquiring and displaying physiological parameters which correspond with an ultrasound image recognition result. Because Sutton teaches wherein the invention may comprise multiple bedside devices or sensors (Claim 8, [0026-0027], [0045-0046], [0086], [0091]) and wherein the physiological parameters may be acquired by other sources (i.e. bedside devices/sensors) rather than derived from ultrasound image data (like taught by Lu) ([0026], [0045], [0109]), Sutton modified by the teachings of Lu may predictably result in selecting one of the sensors which correspond with the image recognition result and to acquire and display said physiological parameter.
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 invention of Sutton to acquire and display physiological parameters corresponding to an ultrasound image recognition result as taught by Lu ([0016], [0021], [0026-0027], [0077]). While Lu teaches deriving the physiological parameters from the ultrasound image data, Sutton teaches wherein the physiological parameters may be obtained from other sources instead, i.e. bedside devices/sensors ([0026], [0045], [0109]). Moreover, Sutton teaches wherein there may be more than one, i.e. multiple, bedside devices/sensors ([0026], [0045], [0086], [0091], [0109]). Thus, in the case in which Sutton teaches a plurality of bedside devices or sensors, Sutton modified by the teachings of Lu to acquire and display physiological parameters corresponding to the image recognition result would predictably result in determining which bedside device from which the physiological parameter is to be acquired and to display/overlay said parameter on the ultrasound image.
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter:
Within the context of claim 10, the prior art of record does not teach or reasonably suggest to the ordinarily skilled artisan “when the blood vessels are identified as arterial vessels, the physiological parameter(s) detected by the bedside device and acquired by the ultrasound device comprise(s) arterial pressure parameter(s); and when the blood vessels are identified as venous vessels, the physiological parameter(s) detected by the bedside device and acquired by the ultrasound device comprise(s) venous pressure parameter(s)”.
The most relevant prior arts cited are Sutton (US20220225963), Wu (CN102078202), and Tomoeda (US20180242945). Sutton teaches performing grayscale imaging of blood vessels using B-mode imaging and non-grayscale imaging using color Doppler (Abstract, [0021-0023]). Moreover, Sutton teaches performing image recognition to identify and locate blood vessels on color Doppler ultrasound images and 2D duplex color Doppler ultrasound images which comprise Doppler images overlaid onto B-mode images ([0024-0025], [0110]). Wu teaches using pulse wave Doppler (PWD) to determine whether a blood vessel is an artery or vein after obtaining B-mode images ([0005]) and also performing pulse Doppler spectrum analysis for the determination ([0059-0062]). Tomoeda teaches determining arterial pressure based on B-mode images ([0117-0121]) and wherein an noninvasive ultrasound probe (20a) may measure venous pressure ([0095-0102]). Sutton, Wu, and Tomoeda however fail to teach wherein a bedside device comprising at least one of an patient monitor, a ventilator, an anesthesia machine, or a personal computer detects arterial/venous pressure after identification of the vessel as arterial/venous. Moreover, the prior arts cited fail to teach wherein an ultrasound device acquires the arterial/venous pressure parameter(s) from said bedside device.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TOMMY T LY/ Examiner, Art Unit 3797
/SERKAN AKAR/ Primary Examiner, Art Unit 3797