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 .
Claim Status:
Claims 20 and 21 are canceled.
Claims 1-19 and 22-24 are pending and examined below.
Information Disclosure Statement
The information disclosure statements (IDS’s) submitted on 09/23/2025, 10/02/2025, 10/09/2025,12/08/2025, and 12/31/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 6, 19, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US2017/0360401A1 to Rothberg et al. “Rothberg, in view of in view of US2012/0083692A1 to “Stoll”.
Regarding claim 1, Rothberg discloses a system (Paragraph 0201 and Fig. 5A, “ultrasound system) for acquiring ultrasound images (Paragraph 0203, ultrasound image 514, captured by the ultrasound device 502) of internal body organs (Paragraph 0004), comprising
a scanner (ultrasound device 502, Fig. 5A), and
at least one inertial measurement unit (IMU) associated therewith (Paragraph 0236, ultrasound device comprise one sensors such as inertial measurement units),
wherein the system is configured to issue instructions to the operator of the system that allow scans to be performed also by persons not trained for ultrasound scanning including a patient themself (Paragraphs 0142, system is for guiding operators that have little or no experience operating ultrasound devices, to capture medically relevant ultrasound images; wherein the guidance includes instructions and feedback to the operator for how to position the ultrasound device, Paragraphs 0144-145; See also Paragraphs 0151, 0203), and
wherein the scans are transmitted to a remote location for analysis by a healthcare professional (Paragraph 0218, “analysis by the physician…remotely”).
However, Rothberg does not disclose an image processing module adapted to audibly alert the user in case of insufficient coupling between the apparatus and the body.
Stoll teaches an image processing module (Paragraph 0060, processor 50; wherein as seen in Fig. 3, processor 50 is part of imaging apparatus/computer 42, that processes the ultrasound data into images, Paragraph 0058; therefore processor 50 would read on an image processing module). Stoll teaches the processor 50 is adapted to audibly alert the user in case of insufficient coupling between the apparatus and the body (Paragraph 0037 determining amount of compression from acquired images; Paragraph 0060, processor 50 is programmed for determining an amount of contact pressure applied by the transducer against a patient. The contact pressure is determined from ultrasound data. The processor 50 determines when the amount of contact pressure is sufficient; Paragraph 0044, user feedback is provided in the form of audio, visual, and/or tactile indication regarding the applied pressure by the user; wherein the pressure is the amount of contact pressure applied by the transducer against the patient, Paragraph 0060, which reads on coupling between transducer and the patient [body]; Paragraph 0048, a speaker or tactile output device is provided for control of the increase in pressure by providing user feedback; therefore since the processor 50 is programmed for determining when the amount of contact pressure is sufficient, and control increase in the transducer contact pressure, Paragraph 0059, it is inferred that when the speaker outputting audio feedback for increasing the pressure, as discussed in Paragraph 0048, there is insufficient contact pressure/coupling of the transducer with the patient/body. This reads on the claimed audibly alerting the user in case of insufficient coupling between the apparatus and the body).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Rothberg’s invention, wherein the system includes an image processing module adapted to audibly alert the user in case of insufficient coupling between the apparatus and the body, as taught by Stoll, in order to provide feedback to the user in regards to the applied pressure (Stoll, Paragraph 0044), such that an optimal contact force is applied via the ultrasound transducer to minimize imaging artifacts and maximize diagnostic yield (Stoll, Paragraph 0014).
Regarding claim 2, the modifications of Rothberg and Stoll disclose all the features of claim 1 above.
Rothberg discloses that after the operator has obtained the image, the image is stored on the computing device (Paragraph 0224), wherein the stored image may be analyzed by the computing device (Paragraph 0225). Rothberg further discloses that the analysis task can be off-loaded to external devices such as server 1518 or workstation 1520 via network 1516 (See Fig. 15B, Paragraph 0312).
Rothberg discloses the system may send an ultrasound image over the network 1516 to the server 1518 for analysis (e.g., to identify an anatomical feature in the ultrasound image and/or identify an instruction to provide the operator) and receive the results of the analysis from the server 1518 (Paragraph 0312). This reads on the claimed two-way communication between the operator and a non-monitored system (which is further supported as seen in Fig. 15B by the two-way arrow between the computing device 1302 and the workstation 1520 or server 1518).
Regarding claim 3, the modifications of Rothberg and Stoll disclose all the features of claim 2 above.
As disclosed in the claim 2 rejection above, Rothberg teaches the non-monitored system such as the server 1518 or workstation 1520 performs image analysis to identify an anatomical feature in the ultrasound image (Paragraph 0312). Rothberg further discloses the image processing is automated image processing to determine whether an ultrasound image contains the target anatomical view (Paragraph 0149). Therefore, the server/workstation would read on automated image analysis circuitry.
Regarding claim 4, the modifications of Rothberg and Stoll disclose all the features of claim 2 above.
Rothberg discloses wherein the two-way communications is visual (instruction provided in visual form as seen in Fig. 5B, Ref. 516; Paragraph 0203; additionally in a separate embodiment, the instructions can be audible instructions, Paragraph 0230).
Regarding claim 6, the modifications of Rothberg and Stoll disclose all the features of claim 2 above.
Rothberg discloses that after the operator has obtained the image, the image is stored on the computing device (Paragraph 0224), wherein the stored image may be analyzed by the computing device (Paragraph 0225). Rothberg further discloses that the analysis task can be off-loaded to external devices such as server 1518 or workstation 1520 via network 1516 (See Fig. 15B, Paragraph 0312).
Rothberg discloses the system may send an ultrasound image over the network 1516 to the server 1518 for analysis (e.g., to identify an anatomical feature in the ultrasound image and/or identify an instruction to provide the operator) and receive the results of the analysis from the server 1518 (Paragraph 0312). The results of the analysis would be whether the ultrasound contains an anatomical view, and additional instructions or confirmation about the positioning of the ultrasound device would be relayed back to the operator (Paragraphs 0227-0228).
Therefore, it would have been obvious to one of ordinary skill in the art that in the system of Rothberg and Stoll, that the output of the system is sent directly to a non-monitored system shortly after images are acquired, in order to provide the operator with confirmation that the ultrasound device is properly positioned, or if the image sent to the server/workstation did not contain the desired anatomical view, then instructions for properly positioning the ultrasound device such that the desired anatomical view can be obtained (Paragraphs 0227-0228).
Regarding claim 19, the modifications of Rothberg and Stoll discloses all the features of claim 1 above.
Rothberg discloses the communication link can a USB cable, Lightning cable (which reads on a wired communication link), or wireless communication link such as BLUETOOTH or Wi-Fi (Paragraph 0183).
Regarding claim 22, Rothberg discloses a system (Paragraph 0201 and Fig. 5A, “ultrasound system) for acquiring ultrasound images (Paragraph 0203, ultrasound image 514, captured by the ultrasound device 502) of internal body organs (Paragraph 0004), comprising
a scanner (ultrasound device 502, Fig. 5A), and
at least one inertial measurement unit (IMU) associated therewith (Paragraph 0236, ultrasound device comprise one sensors such as inertial measurement units).
However, Rothberg does not disclose an image processing module adapted to audibly alert the user in case of insufficient coupling between the apparatus and the body.
Stoll teaches an image processing module (Paragraph 0060, processor 50; wherein as seen in Fig. 3, processor 50 is part of imaging apparatus/computer 42, that processes the ultrasound data into images, Paragraph 0058; therefore processor 50 would read on an image processing module). Stoll teaches the processor 50 is adapted to audibly alert the user in case of insufficient coupling between the apparatus and the body (Paragraph 0037 determining amount of compression from acquired images; Paragraph 0060, processor 50 is programmed for determining an amount of contact pressure applied by the transducer against a patient. The contact pressure is determined from ultrasound data. The processor 50 determines when the amount of contact pressure is sufficient; Paragraph 0044, user feedback is provided in the form of audio, visual, and/or tactile indication regarding the applied pressure by the user; wherein the pressure is the amount of contact pressure applied by the transducer against the patient, Paragraph 0050, which reads on coupling between transducer and the patient [body]; Paragraph 0048, a speaker or tactile output device is provided for control of the increase in pressure by providing user feedback; therefore since the processor 50 is programmed for determining when the amount of contact pressure is sufficient, and control increase in the transducer contact pressure, Paragraph 0059, it is inferred that when the speaker outputting audio feedback for increasing the pressure, as discussed in Paragraph 0048, there is insufficient contact pressure/coupling of the transducer with the patient/body. This reads on the claimed audibly alerting the user in case of insufficient coupling between the apparatus and the body).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Rothberg’s invention, wherein the system includes an image processing module adapted to audibly alert the user in case of insufficient coupling between the apparatus and the body, as taught by Stoll, in order to provide feedback to the user in regards to the applied pressure (Stoll, Paragraph 0044), such that an optimal contact force is applied via the ultrasound transducer to minimize imaging artifacts and maximize diagnostic yield (Stoll, Paragraph 0014).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg, in view of Stoll, as applied in claim 2 above, and further in view of US2014/0282018A1 to Amble et al. “Amble”.
Regarding claim 5, the modifications of Rothberg and Stoll disclose all the features of claim 2 above.
However, the modifications of Rothberg and Stoll do not disclose two way video communication is enabled between the operator and the health care professional, enabling them to see each other while the operator is carrying out the scanning procedure to aid the health care professional in interpreting the images and to provide guidance if necessary.
Amble et al. teaches a multi-site video based computer aided diagnostic system (Title) using ultrasound (Paragraph 0093). Amble teaches video conferencing between a Doctor of Veterinary Medicine (DVM), which would read on the operator, and Diplomat of the American College of Veterinary Radiology (DAVCR) which would read on the health care professional. During the video conference, the DAVCR can see the DVM carrying out the scanning procedure (See Fig. 4A; Paragraph 0096, “live feed of DVM’s actions”). The DAVCR may mark the ultrasound imaging, e.g., using an interface tool to denote an area of interest (Paragraph 0097) and the DAVCR is able to coach the DVM as they perform the examination by providing instructions to alter the acquisition characteristics of the examination (Paragraph 0100). This collectively reads on the claimed two way video communication that is enabled between the operator and the health care professional, enabling them to see each other while the operator is carrying out the scanning procedure to aid the health care professional in interpreting the images and to provide guidance if necessary. Examiner notes that although the example given by Amble is in terms of veterinary medicine and imaging, Amble does note that the patient may also be a human, and the methods in terms of human medical imaging (Paragraph 0031-32).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Rothberg and Stoll, wherein two way video communication is enabled between the operator and the health care professional, enabling them to see each other while the operator is carrying out the scanning procedure to aid the health care professional in interpreting the images and to provide guidance if necessary, as taught by Amble, in order to allow the operator to perform the ultrasound image instead of having to wait for an appointment so that a specialist performs the ultrasound imaging (Amble, Paragraph 0093).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg, in view of Stoll, as applied in claim 1 above, and further in view of US2012/0179039A1 to Pelissier et al. “Pelissier”.
Regarding claim 7, the modifications of Rothberg and Stoll disclose all the features of claim 1 above.
Rothberg discloses an overlay wherein the ultrasound scan/image is on top of the image of the scanner (See Fig. 5B, ultrasound image 514 overlaid on top of image 512; also see Fig. 6).
However, the modifications of Rothberg and Stoll do not explicitly disclose the image of the scanner is on top of the ultrasound scan.
Pelissier teaches overlaying an image of the scanner on top of the ultrasound scans to aid a healthcare professional in interpreting the images (overlaying a subject image video signal on an ultrasound image track as a picture-in-picture element, Paragraph 0076, wherein the subject image video signal are video signals captured by camera 24 which has a field of view that encompasses the probe 14, a portion of the subject, S, and the hand of the technician T, Paragraph 0072).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Rothberg and Stoll, wherein the image of the scanner is on top of the ultrasound scan, as taught by Pelissier, in order to allow supervising of the ultrasound apparatus operator (Pelissier, Paragraph 0126) and enable personnel untrained in formal descriptions of anatomy to acquire clinically useful ultrasound images (Pelissier, Paragraph 0121).
Claim(s) 8-10, 12, 14-15, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg, in view of Stoll, as applied to claim 1 above, and further in view of US2016/0314715A1 to Savitsky et al. “Savitsky”.
Regarding claim 8, the modifications of Rothberg and Stoll disclose all the features of claim 1 above.
Rothberg discloses components in, or associated with the housing (See Fig. 5A or 5B, ultrasound device 502 with a housing, unlabeled) including:
i) an ultrasound probe head (See Fig. 5A or 5B, portion of ultrasound housing touching the subject 501);
ii) the at least one IMU (Paragraph 0236), an accelerometer (Paragraph 0236) and a gyroscope (Paragraph 0236);
iii) electronic components for wired or wireless communication with remote terminals (communication link 112, Paragraph 0183; communication link 512, Paragraph 0201; for connection to network 1516, Paragraph 0312), and
iv) an internal or external power source (power management circuit that is part of the monolithic ultrasound device, Paragraph 0316, wherein the power management circuit is connected to an off-chip source for power, which reads on an external power source, Paragraph 0322).
However, the modifications of Rothberg and Stoll do not disclose the at least one IMU which comprises a three-axis accelerometer and a three-axis gyroscope.
Savitsky teaches a similar ultrasound system (Abstract) that is used for training an operator in operating the ultrasound probe for ultrasound imaging (Paragraphs 0026-27). Savitsky teaches at least one IMU which comprises a three-axis accelerometer and a three-axis gyroscope that is in, or associated with the housing (See Figs 1 or 4, and Paragraph 0037, sensor 118 is a low-cost IMU, comprising 3-axis accelerometer 130, and 3-axis gyroscope 132).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Rothberg and Stoll, wherein the IMU comprises a three-axis accelerometer and a three-axis gyroscope, as taught by Savitsky, in order to save on cost and use known off-the-shelf solutions that have a MEMS 3-xis accelerometer and 3-axis gyroscope incorporate with the IMU (Savitsky, Paragraph 0037).
Regarding claim 9, the modifications of Rothberg, Stoll, and Savitsky disclose all the features of claim 8 above.
Rothberg discloses v) an Analog Front End (AFE) that transmits and receives ultrasound signals by means of electronic components (timing and control circuit 1608, Paragraph 0332 that output either an “TX enable” signal to enable the operation of the TX circuit or an RX enable “signal to enable operation of the RX circuit”);
vi) a processor containing software (processor with software, Paragraph 0313);
vii) a user interface comprising a display screen and means to accept user's instructions (See Paragraph 0219, user interface; Display, see Paragraphs 0304, Figs. 3B-3C, Ref. 306, Fig. 5B, Ref. 508, Paragraph 0304; input/output device such as keyboard, mouse trackball, microphone, touch screen); and
viii) at least one memory device to store data and images processed by the software in the processor (non-transitory computer readable medium, to store processed ultrasound data, Paragraph 0184, wherein the processed ultrasound data is the captured ultrasound image, Paragraph 0224).
Regarding claim 10, the modifications of Rothberg, Stoll, and Savitsky disclose all the features of claim 9 above.
Rothberg discloses a remote terminal (See Fig. 5B, Computing device 504 that connects to ultrasound device 502 is a smartphone; See also Paragraphs 0184, 0201). Rothberg also discloses a speaker and a microphone (Paragraph 0304).
Regarding claim 12, the modifications of Rothberg, Stoll, and Savitsky disclose all the features of claim 9 above.
Rothberg discloses the computing device includes a processor (Paragraph 0074, also see fig. 15B), display, and touchscreen interface (See Fig. 5B, and Paragraph 0304; Fig. 15B), and memory (Fig. 15B). Rothberg further discloses a communication link to connect the scanner with the computing device (See Fig. 15B, Ref. 512, Paragraph 0201).
Rothberg discloses an Analog Front End (AFE) that transmits and receives ultrasound signals by means of electronic components (timing and control circuit 1608, Paragraph 0332 that output either an “TX enable” signal to enable the operation of the TX circuit or an RX enable “signal to enable operation of the RX circuit”) that is part of the ultrasound device/probe (Paragraph 0316). This reads on some of the other components v) - viii) are contained within the scanner and the remainder are located at a remote terminal.
Regarding claim 14, the modifications of Rothberg, Stoll, and Savitsky disclose all the features of claim 9 above.
Rothberg further discloses wherein the software is configured to:
produce ultrasound images (image processing using deep learning, Paragraph 0145, wherein the deep learning is implemented by software, Paragraph 0146);
analyze the data (analyze captured ultrasound image using deep learning techniques to determine whether the ultrasound image contains the target anatomical view, Paragraph 0145, wherein the deep learning is implemented by software, Paragraph 0146); and
effectively provide instructions how to move the scanner correctly in order to obtain satisfactory images (“techniques to guide an operator of an ultrasound device to capture medically relevant ultrasound images…embodied in a software application”, Paragraph 0005).
Regarding claim 15, the modifications of Rothberg, Stoll, and Savitsky disclose all the features of claim 14 above.
Rothberg discloses wherein instructions to the operator that are generated by the software are provided visually on the display screen or audibly from the speakers (instructions on the display screen, see Fig. 3A, Message 310; Fig. 3B, Fine instruction 312, Symbol 314, Message 316; Fig. 3C, Message 322; Fig. 5B, Instruction 516).
Regarding claim 17, the modifications of Rothberg, Stoll, and Savitsky disclose all the features of claim 14 above.
Stoll teaches wherein, if the processor determines, during a scan, that not enough pressure is being exerted on the skin (processor, Paragraph 0031; Paragraph 0037 determining amount of compression from acquired images), an instruction to increase the pressure is issued to the operator either visually on the display screen, e.g. by displaying a downward pointing arrow, and/or audibly from the speakers (Paragraph 0044, audio, visual, and/or tactile indication to instruct the user to increase the pressure, for example for example with a bar or graph including feedback on the rate to increase the pressure, wherein the pressure is contact pressure of the transducer, Abstract;).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Rothberg, Stoll, and Savitsky, wherein during a scan, that not enough pressure is being exerted on the skin, an instruction to increase the pressure is issued to the operator either visually on the display screen, e.g. by displaying a downward pointing arrow, and/or audibly from the speakers, as taught by Stoll, in order that an optimal contact force is applied via the ultrasound transducer to minimize imaging artifacts and maximize diagnostic yield (Stoll, Paragraph 0014).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg, in view of Stoll, and further in view of Savitsky, as applied to claim 9 above, and further in view of US6,126,608A to Kemme et al. “Kemme”.
Regarding claim 11, the modifications of Rothberg, Stoll, and Savitsky disclose all the features of claim 9 above.
Rothberg discloses the computing device includes a processor (Paragraph 0074, also see fig. 15B), display, and touchscreen interface (See Fig. 5B, and Paragraph 0304; Fig. 15B), and memory (Fig. 15B). Rothberg further discloses a communication link to connect the scanner with the computing device (See Fig. 15B, Ref. 512, Paragraph 0201).
However, the modifications of Rothberg, Stoll, and Savitsky do not disclose wherein the AFE is contained in the remote terminal.
Kemme discloses wherein the AFE is contained in the remote terminal (main unit 30 contains all the electronics necessary to create a diagnostic ultrasound instrument and comprises a single channel analog front-end 112, Col. 8, Paragraph starting at line 13; wherein the main unit is a portable device separate from the ultrasound probe, See Col 1, line 65 to Col. 2, line 11, and Fig. 1, Ref. 30 vs. Ref. 26).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Rothberg, Stoll, and Savitsky, wherein the AFE is contained in the remote terminal, as taught by Kemme, in order to have to have a low cost portable unit that contains all the electronics (Col. 8, Paragraph starting at line 13), and so that the scanhead/probe can be changed and customized for a particular purpose.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg, in view of Stoll, and further in view of Savitsky, as applied to claim 12 above, and further in view of Kemme.
Regarding claim 13, the modifications of Rothberg, Stoll, and Savitsky disclose all the features of claim 12 above.
Rothberg discloses the computing device includes a processor (Paragraph 0074, also see fig. 15B), display, and touchscreen interface (See Fig. 5B, and Paragraph 0304; Fig. 15B), and memory (Fig. 15B). Rothberg further discloses a communication link to connect the scanner with the computing device (See Fig. 15B, Ref. 512, Paragraph 0201).
However, the modifications of Rothberg, Stoll, and Savitsky do not disclose wherein the AFE is contained in the remote terminal.
Kemme discloses wherein the AFE is contained in the remote terminal (main unit 30 contains all the electronics necessary to create a diagnostic ultrasound instrument and comprises a single channel analog front-end 112, Col. 8, Paragraph starting at line 13; wherein the main unit is a portable device separate from the ultrasound probe, See Col 1, line 65 to Col. 2, line 11, and Fig. 1, Ref. 30 vs. Ref. 26).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Rothberg, Stoll, and Savitsky, wherein the AFE is contained in the remote terminal, as taught by Kemme, in order to have to have a low cost portable unit that contains all the electronics (Col. 8, Paragraph starting at line 13), and so that the scanhead/probe can be changed and customized for a particular purpose.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg, in view of Stoll, and further in view of Savitsky, as applied to claim 14 above, and further in view of Amble.
Regarding claim 16, the modifications of Rothberg, Stoll, and Savitsky disclose all the features of claim 14 above.
Rothberg discloses wherein instructions to the operator are provided visually on the display screen or audibly from the speakers
However, the modifications of Rothberg, Stoll, and Savitsky do not disclose wherein the instructions to the operator are provided visually on the display screen or audibly from the speakers by a trained health care professional located at a remote terminal.
Amble teaches wherein the instructions to the operator are provided visually on the display screen or audibly from the speakers by a trained health care professional located at a remote terminal (the DAVCR is able to coach the DVM as they perform the examination by providing instructions to alter the acquisition characteristics of the examination.”, Paragraph 0100; wherein the coaching is via video conferencing, Paragraph 0095, and at a minimum, the coaching would be audibly from the speakers).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Rothberg, Stoll, and Savitsky, wherein the instructions to the operator are provided visually on the display screen or audibly from the speakers by a trained health care professional located at a remote terminal, as taught by Amble, in order to alter the acquisition characteristics of the examination in real time (Amble, Paragraphs 0085, 0100).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg, in view of Stoll, and further in view of Savitsky, as applied to claim 14 above, and further in view of US2014/0037168 to Ishikawa et al. “Ishikawa”.
Regarding claim 18, the modifications of Rothberg, Stoll, and Savitsky disclose all the features of claim 17 above.
Ishikawa teaches wherein the processor determines that not enough pressure is being exerted on the skin by measuring the variance of the brightness of the image over some region of interest in the image and determining that the variance is smaller than a threshold value (Ishikawa teaches, Paragraph 0060, using the average luminance, and if the average luminance value is smaller than the predetermined threshold, it can be thought that the ultrasonic wave emitted to image the pixel has not reached the inside of the object. Therefore, it can be estimated that the point on the probe imaging surface 501 from which the ultrasonic wave has emerged is not in contact with the surface 503 (in a noncontact state); wherein luminance reads on a brightness of the image; further Ishikawa teaches that instead of using average luminance, the same comparison can be made using the variance of luminance values, Paragraph 0061).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Rothberg, Stoll, and Savitsky, wherein the processor determines that not enough pressure is being exerted on the skin by measuring the variance of the brightness of the image over some region of interest in the image and determining that the variance is smaller than a threshold value, as taught by Ishikawa, in order to determine a pattern of the contact state between the probe imaging surface and the surface of the object/patient (Ishikawa, Paragraph 0060).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg, in view of Stoll, as applied to claim 22 above, and further in view of US2016/0213349 to Groberman et al. “Groberman”.
Regarding claim 23, the modifications of Rothberg and Stoll disclose all the features of claim 22 above.
However, the modifications of Rothberg and Stoll do not explicitly disclose wherein the system is configured to issue an instruction including advice about how to improve coupling.
Groberman teaches a similar ultrasound transducer system (Doppler transducer, Abstract), with a pressure sensing module located at the surface of the transducer to determine if enough pressure is applied, using the ultrasound transducer, to the abdomen of a patient (Paragraph 0366). Groberman further teaches the system can direct the user, via a communication module, to move in a direction opposite to the directionality of the pressure in order to improve the signal (Paragraph 0366). The insufficient pressure applied from the probe to the abdomen reads on insufficient coupling of the ultrasound transducer to the abdomen. And the communication of shifting the applied pressure, would read on the claimed guidance or advice to improve the coupling.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Rothberg and Stoll, wherein the system is configured to issue an instruction including advice about how to improve coupling, as taught by Groberman, in order to improve the acquiring of the ultrasound signal (Paragraph 0366).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg, in view of Stoll, as applied to claim 22 above, and further in view of US2019/0328361 to Halmann et al. “Halmann”.
Regarding claim 24, the modifications of Rothberg and Stoll disclose all the features of claim 22 above.
However, the modifications of Rothberg and Stoll do not disclose wherein the system is adapted to alert the user in case of scanner speed outside of predetermined ranges.
Halmann teaches a similar ultrasound imaging system (Title). Halmann teaches wherein the system is adapted to alert the user in case of scanner speed outside of predetermined ranges (See Fig. 4, Ref. 408, Paragraph 0071, determine whether the imaging probe is being moved too slow or too fast during acquisition of the image data by comparing the speed of the probe to a lower speed limit and an upper speed limit; and Fig. 4, Ref. 410, Paragraph 0075, “a warning of the probe speed is presented to the operator of the imaging probe. The processor 116 can direct the display device 118 to visually present the warning, such as by displaying one or more graphical icons and/or text, activating a light, or the like…Responsive to the processor 116 determining that the probe 106 is moving too fast or too slow (relative to the limits), the processor 116 can direct the display device 118 to change a characteristic of the indicator 604, such as by changing the color of a portion of the indicator 604”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Rothberg's invention wherein the system as described by Rothberg and Stoll is adapted to alert the user in case of scanner speed outside of predetermined ranges, as taught by Halmann, since moving the probe too quickly or too slowly can negatively impact the quality and/or quantity of the image data that is acquired in one or more locations of the person (Halmann, Paragraph 0071).
Double Patenting
Claim 1-4, 6, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7, 8, and 34 of copending Application No. 17/920951 in view of US2017/0360401A1 to Rothberg et al. “Rothberg, and further in view of US2012/0083692 to Stoll et al. “Stoll”.
This is a provisional nonstatutory double patenting rejection.
Regarding claim 1, ‘951 discloses a system for acquiring ultrasound images of internal body organs (system for obtaining ultrasound images; of internal organs, Claim 34, lines 1-2), comprising
a scanner (Claim 34, line 3) and
at least one inertial measurement unit (IMU) associated therewith (Claim 34, line 4),
an image processing module (processor, Claim 34, line 6, configured to analyze the ultrasound image, Claim 34, line 8) adapted to audibly alert the user in case of insufficient coupling between the apparatus and the body (Claim 34, line 14-15, processor issues instructions about amount of pressure to be exerted on the skin based on analyzing of said ultrasound image data; Claim 8, generate an alert indicative of insufficient coupling between the scanner and the patient’s body)
wherein the system is configured to issue instructions to the operator of the system that allow scans to be performed (Claim 34, lines 20-30) also by persons not trained for ultrasound scanning including the patient themselves (Claim 34, lines 1-2).
However, claim 34 of the ‘951 co-pending application, and its dependent claims do not disclose wherein when the scans are performed by persons not trained for ultrasound scanning, the scans are transmitted to a remote location for analysis by a healthcare professional.
Rothberg teaches wherein when the scans are performed by untrained operators (Paragraphs 0142, system is for guiding operators that have little or no experience operating ultrasound devices, to capture medically relevant ultrasound images; wherein the guidance includes instructions and feedback to the operator for how to position the ultrasound device, Paragraphs 0144-145; See also Paragraphs 0151, 0203), the scans are transmitted to a remote location for analysis by a healthcare professional (Paragraph 0218, “analysis by the physician…remotely”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘951, wherein when the scans are performed by untrained operators, the scans are transmitted to a remote location for analysis by a healthcare professional, as taught by Rothberg, in order to allow a physician to be able to remotely monitor a condition of the subject (Rothberg, Paragraph 0218).
However, ‘the modifications of claim 34 of the ‘951 co-pending application, and its dependent claims, and Rothberg do not disclose wherein the alert for insufficient coupling is an audible alert.
Stoll teaches wherein the alert for insufficient coupling is an audible alert (Paragraph 0044, user feedback is provided in the form of audio, visual, and/or tactile indication regarding the applied pressure by the user; wherein the pressure is the amount of contact pressure applied by the transducer against the patient, Paragraph 0060, which reads on coupling between transducer and the patient [body]; Paragraph 0048, a speaker or tactile output device is provided for control of the increase in pressure by providing user feedback; processor 50 is programmed for determining when the amount of contact pressure is sufficient, and control the increase in the transducer contact pressure, Paragraph 0059, therefore it is inferred that when the speaker outputs audio feedback for increasing the pressure, as discussed in Paragraph 0048, the processor has determined that there is insufficient contact pressure/coupling of the transducer with the patient/body; the audio feedback from the speaker would read on the audible alert).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by ‘951 and Rothberg, wherein the alert is an audible alert, as taught by Stoll, in order to provide feedback to the user without having to look at a display.
The following is mapping between dependent claims 2-4, 6, and 19 of the instant application to the claims of the co-pending application:
Instant Application
Co-pending ‘951
2: wherein the system is configured to allow two-way communication between the operator and a remote individual or non- monitored system
8+34+ Rothberg+Stoll: the system may send an ultrasound image over the network 1516 to the server 1518 for analysis (e.g., to identify an anatomical feature in the ultrasound image and/or identify an instruction to provide the operator) and receive the results of the analysis from the server 1518 [Paragraph 0312]
3: wherein the non-monitored system comprises automated, image analysis circuitry
8+34+ Rothberg+Stoll: the non-monitored system such as the server 1518 or workstation 1520 performs image analysis to identify an anatomical feature in the ultrasound image [Paragraph 0312]; the image processing is automated image processing to determine whether an ultrasound image contains the target anatomical view [Paragraph 0149].
4: wherein the two-way communication is selected from audio, visual, and video communication, and combinations thereof
8+34+ Rothberg+Stoll: instruction provided in visual form as seen in Fig. 5B, Ref. 516; Paragraph 0203; additionally in a separate embodiment, the instructions can be audible instructions, [Paragraph 0230]
6: wherein the system is configured such that the output of the system is sent directly to a remote healthcare professional and/or to a non-monitored system in real time, or shortly after images are acquired
8+34+ Rothberg+Stoll: after the operator has obtained the image, the image is stored on the computing device (Paragraph 0224), the analysis task can be off-loaded to external devices such as server 1518 or workstation 1520 via network 1516 (See Fig. 15B, Paragraph 0312).
19
7+8+34+Rothberg
Claim 5 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 34 of copending Application No. 17/920951 in view of Rothberg, and further in view of Stoll, as applied in claim 1, and further in view of US2014/0282018A1 to Amble et al. “Amble”.
This is a provisional nonstatutory double patenting rejection.
Regarding claim 5, ‘951, Rothberg, and Stoll disclose all the features of claim 2 above.
However, the modifications of ‘951, Rothberg, and Stoll do not disclose two way video communication is enabled between the operator and the health care professional, enabling them to see each other while the operator is carrying out the scanning procedure to aid the health care professional in interpreting the images and to provide guidance if necessary.
Amble teaches a multi-site video based computer aided diagnostic system (Title) using ultrasound (Paragraph 0093). Amble teaches video conferencing between a Doctor of Veterinary Medicine (DVM), which would read on the operator, and Diplomat of the American College of Veterinary Radiology (DAVCR) which would read on the health care professional. During the video conference, the DAVCR can see the DVM carrying out the scanning procedure (See Fig. 4A; Paragraph 0096, “live feed of DVM’s actions”). The DAVCR may mark the ultrasound imaging, e.g., using an interface tool to denote an area of interest (Paragraph 0097) and the DAVCR is able to coach the DVM as they perform the examination by providing instructions to alter the acquisition characteristics of the examination (Paragraph 0100). This collectively reads on the claimed two way video communication that is enabled between the operator and the health care professional, enabling them to see each other while the operator is carrying out the scanning procedure to aid the health care professional in interpreting the images and to provide guidance if necessary. Examiner notes that although the example given by Amble is in terms of veterinary medicine and imaging, Amble does note that the patient may also be a human, and the methods in terms of human medical imaging (Paragraph 0031-32).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘951, Rothberg, and Stoll, wherein two way video communication is enabled between the operator and the health care professional, enabling them to see each other while the operator is carrying out the scanning procedure to aid the health care professional in interpreting the images and to provide guidance if necessary, as taught by Amble, in order to allow the operator to perform the ultrasound image instead of having to wait for an appointment so that a specialist performs the ultrasound imaging (Amble, Paragraph 0093).
Claim 22-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7, 8, and 34 of copending Application No. 17/920951 in view of US2012/0083692 to Stoll et al. “Stoll”.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 22, ‘951 discloses a system for acquiring ultrasound images of internal body organs (system for obtaining ultrasound images; of internal organs, Claim 34, lines 1-2), comprising a scanner (Claim 34, line 3), at least one inertial measurement unit (IMU) associated therewith (Claim 34, line 4), and an image processing module (processor, Claim 34, line 6, configured to analyze the ultrasound image, Claim 34, line 8) adapted to alert the user in case of insufficient coupling between the apparatus and the body (Claim 34, line 14-15, processor issues instructions about amount of pressure to be exerted on the skin based on analyzing of said ultrasound image data; Claim 8, generate an alert indicative of insufficient coupling between the scanner and the patient’s body).
However, ‘the modifications of claim 34 of the ‘951 co-pending application, and its dependent claims, do not disclose wherein the alert for insufficient coupling is an audible alert.
Stoll teaches wherein the alert for insufficient coupling is an audible alert (Paragraph 0044, user feedback is provided in the form of audio, visual, and/or tactile indication regarding the applied pressure by the user; wherein the pressure is the amount of contact pressure applied by the transducer against the patient, Paragraph 0060, which reads on coupling between transducer and the patient [body]; Paragraph 0048, a speaker or tactile output device is provided for control of the increase in pressure by providing user feedback; processor 50 is programmed for determining when the amount of contact pressure is sufficient, and control the increase in the transducer contact pressure, Paragraph 0059, therefore it is inferred that when the speaker outputs audio feedback for increasing the pressure, as discussed in Paragraph 0048, the processor has determined that there is insufficient contact pressure/coupling of the transducer with the patient/body; the audio feedback from the speaker would read on the audible alert).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘51, wherein the alert is an audible alert, as taught by Stoll, in order to provide feedback to the user without having to look at a display.
The following is mapping between dependent claims 23 and 24 of the instant application to the claims of the co-pending application:
23
8+34+Stoll
24
8+9+34+Stoll
*Examiner notes that there is no double patenting rejection for claims 7-18.
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive. Applicant has amended claim 1 and 22 such that the “alert” of claim 1 is now “audibly alert”, which narrows the scope. Therefore, a new grounds of rejection has been issued, as a final rejection. However, the grounds of rejection uses prior art that has been previously presented, and the examiner will address all applicable arguments. Applicant argues that Rothberg, in view of Ishikawa, and Baym do not teach “an image processing module adapted to audibly alert the user in case of insufficient coupling between the apparatus and the body. " The examiner agrees, however applicant has made the same argument regarding claim 17 and 18, which includes prior art to Stoll. The examiner disagrees with the argument that Stoll does not teach the amended limitation.
Stoll teaches an image processing module (Paragraph 0060, processor 50) that is programmed for determining an amount of contact pressure applied by the transducer against a patient. The contact pressure is determined from ultrasound data. The processor 50 determines when the amount of contact pressure is sufficient (Paragraph 0060). Stoll further teaches (Paragraph 0044) user feedback is provided in the form of audio, visual, and/or tactile indication regarding the applied pressure by the user; wherein the pressure is the amount of contact pressure applied by the transducer against the patient (Paragraph 0060), which reads on coupling between transducer and the patient [body]. Stoll provides an example (Paragraph 0048) of a speaker or tactile output device is provided for control of the increase in pressure by providing user feedback. Therefore since the processor 50 is programmed for determining when the amount of contact pressure is sufficient, and control increase in the transducer contact pressure, Paragraph 0059, it is inferred that when the speaker outputting audio feedback for increasing the pressure, as discussed in Paragraph 0048, there is insufficient contact pressure/coupling of the transducer with the patient/body. This reads on the claimed audibly alerting the user in case of insufficient coupling between the apparatus and the body.
Applicant additionally argues (Pages 10-11) that the newly amended claims that include the amendment of the “alert” in claims 1 and 22 to audibly alert would overcome the double patenting rejection. The examiner disagrees and prior art to Stoll is used for the provisional non-statutory obvious type double patenting rejections for claims 1 and 22. Therefore claims 1 and 22 remain rejected under double patenting. Claims 2-6, 19, and 22-24 remain rejected since their double patenting rejection mappings remain the same, except for the addition of Stoll, due to their dependency on either claims 1 or 22.
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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/MT/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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