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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 9 is rejected because it recites newly amended limitations of the processing device configured to: “automatically select a patient or receive a selection of the patient from a user via a voice command” and “automatically select an ultrasound imaging exam type or receive a selection from the user of the ultrasound imaging exam type via a voice command”. It appears that the claim limitations recite a voice command that triggers a workflow wherein the processing device automatically selects a patient (for example “system, please start workflow X”). The specification appears to describe only embodiments of the system automatically selecting the patient or via a voice command such as “John Smith birthday 1/8/42” (See Paragraph 00159), and not a voice command that triggers an automatic workflow that then selects the patient. Therefore, the amended limitations are not supported by the instant specification, and fail to comply with the written description requirement.
Claims 10-20 are rejected because they inherit deficiencies by nature of its/their dependency on claim 9.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 is rejected because it recites newly amended limitations of the processing device configured to: “automatically select a patient or receive a selection of the patient from a user via a voice command” and “automatically select an ultrasound imaging exam type or receive a selection from the user of the ultrasound imaging exam type via a voice command”. It is unclear and therefore indefinite whether the claim limitation recites the processing device selects a patient via a voice command, such as “system, please select patient X”, or whether the claim limitation recites a voice command that triggers a workflow wherein the processing device automatically selects a patient (for example “system, please start workflow X”). The specification appears to describe only embodiments of the system automatically selecting the patient or via a voice command such as “John Smith birthday 1/8/42” (See Paragraph 00159), and not a voice command that triggers an automatic workflow. Therefore, for examination purposes, the examiner interprets the claim as the processing device selects the patient via a direct voice command. Similar reason is applied for the limitation of “automatically select an ultrasound imaging exam type”.
Claim 11 is rejected because it also recites “automatically select the exam”. This limitation depends from claim 9, and appears to conflict with claim 9, since as stated above, the selection of the exam is via voice command and not automatic by the processing device.
Claims 10 and 12-20 are rejected because they inherit deficiencies by nature of its/their dependency on claim 9.
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) 1-2, 4-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US20210353260A1 to Srinivasa Naidu et al. “Naidu”, in view of US2020/0170619 to “O’Brien”, further in view of US2021/0045717 to “Schwab”, and further in view of US20210041558 to “Akkaraju”.
Regarding claim 1, Naidu discloses an ultrasound system for performing an ultrasound imaging exam (Abstract, ultrasound imaging systems and methods for ultrasonically inspecting biological tissue), comprising:
an ultrasound imaging device (Fig. 1, Paragraph 0030, Ref. 101-j, ultrasound scanner; or Fig. 2 system 200, with ultrasound data acquisition unit and transducer or probe that generate images 232, see also Paragraphs 0035-36); and
a processing device in operative communication with the ultrasound imaging device (ultrasound system base, Fig. 2, Ref. 230 with data acquisition unit 210 and processor 223) and configured to:
initiate an ultrasound imaging application (Paragraph 0044, processor 223 may automatically set imaging parameters and send command to controller to change acoustic settings, which are the used in live imaging);
receive a selection of one or more user credentials (Paragraph 0032; in setting the ultrasound settings, a setting prediction model is used that requires user identification by means of voice input, a biometric scan, or scanning the user’s badge, which reads on the system receiving one or more user credentials)
automatically select a patient or receive a voice command from the user to select the patient (Paragraph 0032, system receives patient identification information; wherein patient information can be inputted by the user 0053; wherein an example of user input is a voice input, Paragraph 0051);
automatically select an ultrasound imaging preset or receive a voice command from the user to select the ultrasound imaging preset (automatic reconfiguration of the system based on predicted setting, using a settings prediction model, Paragraph 0032);
automatically select an ultrasound imaging depth or receive a voice command from the user to select the ultrasound imaging depth (automatic applying of acoustic settings based on predicted settings, wherein the settings include depth, Paragraph 0044);
automatically select an ultrasound imaging gain or receive a voice command from the user to select the ultrasound imaging gain (automatic reconfiguration of the system based on predicted setting, using a settings prediction model, Paragraph 0032; wherein one of the imaging parameters is gain, Paragraph 0036);
automatically select one or more time gain compensation (TGC) parameters or receive a voice command from the user to select the one or more TGC parameters (automatic applying of acoustic settings based on predicted settings, wherein the settings include depth, focus,…which is used to adjust other parameters such as TGC, Paragraph 0044);
automatically capture or receive a voice command to capture the one or more clinically relevant ultrasound images (automatically adjusting the settings, which are used in the subsequent round of the imaging, without additional user input, Paragraph 0032)
automatically upload the ultrasound imaging exam or receive a voice command from the user to upload the ultrasound imaging exam (transmit the images to the cloud for classification analysis, Paragraph 0047, wherein the classification results are fed back to the system for automatic reconfiguring of the system, Paragraph 0047, which would read as part of the automatic adjusting of parameters for live images as seen in Fig. 1, in a loop form, and therefore the uploading of the image to the cloud would be automatic), and
However, Naidu does not disclose automatically determine whether a sufficient amount of gel has been applied to the ultrasound imaging device, and upon determining that the sufficient amount of gel has not been applied to the ultrasound imaging device, provide an instruction to the user to apply more gel to the ultrasound imaging device.
O’Brien teaches automatically determine whether a sufficient amount of gel has been applied to the ultrasound imaging device (See Fig. 2, Ref. 210, Paragraph 0062, determine and output gel sufficiency parameter for the gel on the skin), and upon determining that the sufficient amount of gel has not been applied to the ultrasound imaging device (Paragraph 0076, Fig. 2, Ref. 220, determines that an amount of the gel is insufficient based on the gel sufficiency parameter), provide an instruction to the user to apply more gel to the ultrasound imaging device (Paragraph 0088, gel needed indicator).
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 Naidu's invention, wherein the method includes automatically determine whether a sufficient amount of gel has been applied to the ultrasound imaging device, and upon determining that the sufficient amount of gel has not been applied to the ultrasound imaging device, provide an instruction to the user to apply more gel to the ultrasound imaging device, as taught by O’Brien, in order to improve transmission of energy emitted by the ultrasound device (Paragraph 0002).
However, the modifications of Naidu and O’Brien do not disclose automatically selecting an organization or receive a voice command from a user to select the organization; automatically select or receives a selection of an ultrasound imaging exam type; and automatically select an ultrasound imaging mode or receive a voice command from the user to select the ultrasound imaging mode.
Schwab teaches automatically selecting an organization or receive a voice command from a user to select the organization (Paragraph 0039, system identifies user and once positively identified, the controller access user information including name, department, and personal identification, wherein department reads on organization);
automatically select or receives a selection of an ultrasound imaging exam type (Paragraph 0034, system determines based on probe used, a particular exam type); automatically select an ultrasound imaging mode or receive a voice command from the user to select the ultrasound imaging mode (Paragraph 0034, system determines based on probe used, a particular imaging mode).
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 Naidu and O’Brien, wherein the processing device is configured to disclose automatically selecting an organization or receive a voice command from a user to select the organization; automatically select or receives a selection of an ultrasound imaging exam type; automatically select an ultrasound imaging mode or receive a voice command from the user to select the ultrasound imaging mode, as taught by Schwab, in order to automatically adjust parameters of an ultrasound exam based on information received about the user, and exam environment (Paragraph 0004).
However, the modifications of Naidu, O’Brien, and Schwab do not disclose guide the user to correctly place the ultrasound imaging device in order to capture one or more clinically relevant ultrasound images; automatically complete a portion or all of an ultrasound imaging worksheet or receive a voice command from the user to complete the portion or all of the ultrasound imaging worksheet; and associate a signature with the ultrasound imaging exam or request signature of the ultrasound imaging exam later.
Akkaraju teaches a guide the user to correctly place the ultrasound imaging device in order to capture one or more clinically relevant ultrasound images (Paragraph 0073, combination of text and symbols, e.g. arrows to guide the user to position the imaging probe for acquiring a view of the image); and
automatically complete a portion or all of an ultrasound imaging worksheet or receive a voice command from the user to complete the portion or all of the ultrasound imaging worksheet (Paragraph 0037, voice annotation and/or user-selected text may be added to a procedure, an image, or a review of the one or images).
associate a signature with the ultrasound imaging exam or request signature of the ultrasound imaging exam later (annotation or text can be associated with a procedure or an image, wherein the annotation or text is an attestation through digital signature, Paragraph 0078).
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 Naidu, O’Brien, and Schwab, wherein the system is configured to guide the user to correctly place the ultrasound imaging device in order to capture one or more clinically relevant ultrasound images;
as taught by Akkaraju, in order to easily find clinically valid views of organs/tissue (Paragraph 0073). Further, 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 Naidu, O’Brien, and Schwab, wherein the system is configured to automatically complete a portion or all of an ultrasound imaging worksheet or receive a voice command from the user to complete the portion or all of the ultrasound imaging worksheet; and associate a signature with the ultrasound imaging exam or request signature of the ultrasound imaging exam later, as taught by Akkaraju, in order to allow hands free attestations and filling out of an imaging worksheet.
Regarding claim 2, the modifications of Naidu, O’Brien, Schwab, and Akkaraju discloses all the features of claim 1 above.
As disclosed in claim 1 above, Naidu teaches initiating the ultrasound imaging application with a voice input (Paragraph 0027, making a preselection of the settings to start the exam using user input, wherein user input can be a voice input, Paragraph 0032).
Regarding claim 4, the modifications of Naidu, O’Brien, Schwab, and Akkaraju discloses all the features of claim 1 above.
As disclosed in the claim 1 rejection above, Schwab teaches automatically selecting an organization or receive a voice command from a user to select the organization (Paragraph 0039, system identifies user and once positively identified, the controller access user information including name, department, and personal identification, wherein department reads on organization). This reads on selecting a default organization associated with the user.
Regarding claim 5, the modifications of Naidu, O’Brien, Schwab, and Akkaraju discloses all the features of claim 1 above.
As disclosed in the claim 1 rejection above, Naidu discloses automatically select the ultrasound imaging preset (automatic reconfiguration of the system based on predicted setting, using a settings prediction model, Paragraph 0032; wherein setting prediction model uses patient identification information, Paragraph 0032, such as through an EMR system, Paragraph 0061). This would read on retrieving an electronic medical record (EMR) of the patient and selecting the ultrasound imaging preset based on the EMR.
Regarding claim 6, the modifications of Naidu, O’Brien, Schwab, and Akkaraju discloses all the features of claim 1 above.
As disclosed in the claim 1 rejection above, and per the interpretation taken in the 35 U.S.C. 112(b) rejection above, Schwab teaches selecting the ultrasound imaging exam type based on the analysis of an image (Paragraph 0034, system determines based on probe used, a particular exam type; where in the probe used is determined by analyzed images, Paragraph 0034).
Regarding claim 7, the modifications of Naidu, O’Brien, Schwab, and Akkaraju discloses all the features of claim 1 above.
As disclosed in the claim 1 rejection above, Akkaraju discloses wherein completing the portion or all of the ultrasound imaging worksheet using a voice prompt (Paragraph 0037, voice annotation and/or user-selected text may be added to a procedure, an image, or a review of the one or images).
Regarding claim 8, the modifications of Naidu, O’Brien, Schwab, and Akkaraju discloses all the features of claim 1 above.
As disclosed in the claim 1 rejection above, Akkaraju discloses associate the signature with the ultrasound imaging exam based on a voice command from the user (voice annotation or text can be associated with a procedure or an image, wherein the annotation or text is an attestation through digital signature, Paragraph 0078).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naidu, in view of O’Brien, further in view of Schwab, and further in view of Akkaraju, as applied to claim 1 above, and further in view of US20130006112 to “Vardy”.
Regarding claim 3, the modifications of Naidu, O’Brien, Schwab, and Akkaraju discloses all the features of claim 1 above.
Naidu discloses wherein the processing device is configured to select the patient (Paragraph 0032, system receives patient identification information; wherein patient information can be inputted by the user 0053; wherein an example of user input is a voice input, Paragraph 0051).
However, Naidu, O’Brien, Schwab, and Akkaraju do not disclose wherein the patient is selected by receiving a scan of a barcode associated with the patient.
teaches wherein the patient is selected by receiving a scan of a barcode associated with the patient (Paragraph 0074, the user (is) required to select a subject/patient 504 this may be done by entering the subjects name and other personal details or by entering the patient's reference number either manually or for example via scanning a barcode or the like associated with a patient's file).
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 Naidu, O’Brien, Schwab, and Akkaraju, wherein the patient is selected by receiving a scan of a barcode associated with the patient, as taught by Vardy, in order to trigger the recognition of the subject and retrieve any data stored in the system’s database (Vardy, Paragraph 0074).
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naidu, in view of US2022/0071595 to Mienkina et al. “Mienkina”, further in view of Schwab, further in view of US2021/0350531 to Mclapudi et al. “Mclapudi”, and further in view of US20160338590 to Sagalovich et al. “Sagalovich”,
Regarding claim 9, Naidu discloses an ultrasound system for performing an ultrasound imaging exam (Abstract, ultrasound imaging systems and methods for ultrasonically inspecting biological tissue), comprising:
an ultrasound imaging device (Fig. 1, Paragraph 0030, Ref. 101-j, ultrasound scanner; or Fig. 2 system 200, with ultrasound data acquisition unit and transducer or probe that generate images 232, see also Paragraphs 0035-36); and
a processing device in operative communication with the ultrasound imaging device (ultrasound system base, Fig. 2, Ref. 230 with data acquisition unit 210 and processor 223) and configured to:
select a patient or receive a selection of the patient from a user via a voice command (Paragraph 0032, system receives patient identification information; wherein patient information can be inputted by the user 0053; wherein an example of user input is a voice input, Paragraph 0051);
select an ultrasound imaging exam type a selection from the user (Paragraph 0024, Figs. 10A-C, user selectable presets of imaging types, such as abdominal imaging, obstetric imaging, or gynecological imaging, wherein the system is an ultrasound imaging system, such as those sold by PHILIPS under the brand name EPIQ);
automatically select an ultrasound imaging preset (automatic reconfiguration of the system based on predicted setting, using a settings prediction model, Paragraph 0032), an ultrasound imaging depth (automatic applying of acoustic settings based on predicted settings, wherein the settings include depth, Paragraph 0044), an ultrasound imaging gain (automatic reconfiguration of the system based on predicted setting, using a settings prediction model, Paragraph 0032; wherein one of the imaging parameters is gain, Paragraph 0036), and/or one or more time gain compensation (TGC) parameters corresponding to the ultrasound;
capture one or more ultrasound images associated with the first scan of the ultrasound imaging (automatically adjusting the settings, which are used in the subsequent round of the imaging, without additional user input, Paragraph 0032); and
provide an option for the user to review the captured one or more ultrasound images (provide a display, Paragraph , for displaying previously acquired image data stored in memory, or the live, real-time image, Paragraph 0043).
However, Naidu does not disclose wherein the user input selection is via a voice command.
Mienkina teaches selecting examination types via user input by a user input device 130, wherein the user input device includes voice recognition (Paragraph 0034).
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 Naidu’s invention, wherein the user input selection is via a voice command, as taught by Mienkina, since using voice recognition/command is merely a simple substitution of one known method of user input for another (voice input) to obtain predictable results (inputting/selecting elements in the user interface).
Therefore, in the combination of Naidu and Mienkina, Naidu’s disclosure of selecting an ultrasound imaging exam type a selection from the user (Naidu, Paragraph 0024, Figs. 10A-C), in view of Mienkina, would be by voice input of the user input device 130 of Mienkina (Mienkina, Paragraph 0034).
However, the combination of Naidu and Mienkina do not disclose the processing device is configured to automatically select an ultrasound imaging mode.
Schwab teaches the processing device is configured to select an ultrasound imaging exam type or receive a selection from the user of the ultrasound imaging exam type (Paragraph 0034, system determines based on probe used, a particular exam type); and
automatically select an ultrasound imaging mode or receive a voice command from the user to select the ultrasound imaging mode (Paragraph 0034, system determines based on probe used, a particular imaging mode).
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 Naidu and Mienkina, wherein the processing device is configured to a automatically select an ultrasound imaging mode, as taught by Schwab, in order to automatically adjust parameters of an ultrasound exam based on information received about the user, and exam environment (Paragraph 0004).
However, the modification of Naidu, Mienkina, and Schwab do not disclose guide a user to correctly place the ultrasound imaging device on the patient for capturing one or more ultrasound images associated with a first scan of the ultrasound imaging exam by using one or more of: one or more images, one or more videos, audio, and/or text that indicate how to place the ultrasound imaging device on the patient; a real-time quality indicator indicating a quality of recent ultrasound data collected by the ultrasound imaging device; and automatically capturing a multi-second cine of ultrasound images in response to the quality of the recent ultrasound data exceeding a first threshold; or receiving a command from the user to capture the one or more ultrasound images; and automatically advancing to guide the user to correctly place the ultrasound imaging device on the patient for capturing one or more ultrasound images associated with a second scan of the ultrasound imaging exam.
Mclapudi teaches guiding a user to correctly place the ultrasound imaging device on the patient for capturing one or more ultrasound images associated with a first scan of the ultrasound imaging exam by using one or more of: one or more images, one or more videos, audio, and/or text that indicate how to place the ultrasound imaging device on the patient (Paragraph 0069; the user guidance information may offer more specific suggestions in connection with changes to be made, such as changes in the position/orientation of the probe; the guidance is displayed to the user, Paragraph 0069, which reads on ore or more image text) a real-time quality indicator indicating a quality of recent ultrasound data collected by the ultrasound imaging device (Paragraph 0097, Fig. 6, generating Quality of image, Ref. 638, from acquired current ultrasound data set, Ref. 632); and
automatically capturing a multi-second cine of ultrasound images in response to the quality of the recent ultrasound data exceeding a first threshold (Paragraph 0085, operations of Fig. 5 are repeated to collect the best image for each scan plane, wherein a cine loop is acquired, images are reviewed and a quality is determined, and then second cine loop is acquired for a second scan plane and evaluated; the second cine loop after an ultrasound image from the first cine loop is evaluated as satisfactory would read on the claim); or capture the one or more ultrasound image (select image, Fig. 5, Ref. 506);
automatically advancing to guide the user to correctly place the ultrasound imaging device on the patient for capturing one or more ultrasound images associated with a second scan of the ultrasound imaging exam (Paragraph 0089 moving scan planes to acquire image from in a different scan plane after the image(s) acquired in the first scan plane has been deemed to be of best quality; wherein moving to a new best position can use the user guidance information discussed in Paragraph 0069).
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 Naidu, Mienkina, and Schwab, wherein the system is configured to guide a user to correctly place the ultrasound imaging device on the patient for capturing one or more ultrasound images associated with a first scan of the ultrasound imaging exam by using one or more of: one or more images, one or more videos, audio, and/or text that indicate how to place the ultrasound imaging device on the patient; provide a real-time quality indicator indicating a quality of recent ultrasound data collected by the ultrasound imaging device; automatically capturing a multi second cine of ultrasound images in response to the quality of the recent ultrasound data exceeding a first threshold; or receiving a command from the user to capture the one or more ultrasound images; and automatically advancing to guide the user to correctly place the ultrasound imaging device on the patient for capturing one or more ultrasound images associated with a second scan of the ultrasound imaging exam, as taught by Mclapudi, in order to obtain the best images for different scan planes (Paragraph 0089).
However, the modification of Naidu, Mienkina, Schwab, and Mclapudi do not disclose automatic anatomical and/or pathological labeling of one or more ultrasound images captured by ultrasound imaging device and provide a summary of the ultrasound imaging exam.
Sagalovich teaches automatic anatomical and/or pathological labeling(Paragraph 0239, anatomical labels applied to the display of 1, being the aortic area of the heart, 2 the pulmonary area of the patient’s heart, 3, Erb’s point of the patient’s heart) of one or more ultrasound images captured by ultrasound imaging device (wherein the image data is ultrasound image data, Paragraph 0118) and provide a summary of the ultrasound imaging exam (Paragraph 0229, displays the generated medical reports).
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 Naidu, Mienkina, Schwab, and Mclapudi, wherein the system is configured for automatic anatomical and/or pathological labeling of one or more ultrasound images captured by ultrasound imaging device and provide a summary of the ultrasound imaging exam, as taught by Sagalovich, in order to be able to view the generated reports and to be able to quickly orient locations in the medical image.
Regarding claim 10, the modification of Naidu, Mienkina, Schwab, Mclapudi, and Sagalovich all the features of claim 9 above.
Sagalovich teaches wherein the exam is assessing heart and lung function (Paragraph 0155, perform examination of the heart and lungs with an ultrasound device; also see Paragraph 0159).
Regarding claim 11, the modifications of Naidu, Mienkina, Schwab, Mclapudi, and Sagalovich disclose all the features of claim 10 above.
As disclosed in the claim 9 rejection above, Schwab discloses selecting the exam based on the image analysis of the probe and surround area. And as disclosed in the claim 10 rejection above, Sagalovich is directed towards obtaining measurements from the heart and lung area.
Therefore, 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 the system automatically select the exam assessing heart and lung function since the probe would be placed at the heart and lung region, and based on the teachings of Schwab, the system would analyze the probe and placement to select the exam.
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naidu, in view of Mienkina, further in view of Schwab, further in view of Mclapudi, and further in view of Sagalovich, as applied to claim 10 above, and further in view of US12,097,077 to “Bughrara”.
Regarding claim 12, the modifications of Naidu, Schwab, Mclapudi, and Sagalovich disclose all the features of claim 10 above.
However, the modifications of Naidu, Mienkina, Schwab, Mclapudi, and Sagalovich do not disclose wherein the ultrasound imaging exam comprises capturing one or more ultrasound images of an anterior-superior view of a right lung, a lateral-superior view of the right lung, a lateral-inferior view of the right lung, an anterior-superior view of a left lung, a lateral-superior view of the left lung, a lateral-inferior view of the left lung, a parasternal long axis view of a heart, or an apical four chamber view of the heart.
Bughrara teaches obtaining images of the heart and/or vena cava and/or lung (Col 3, first paragraph). Bughrara teaches obtaining an ultrasound image of an apical four chamber view of the heart (Col. 12, first paragraph).
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 Naidu, Mienkina, Schwab, Mclapudi, and Sagalovich, wherein the ultrasound imaging exam comprises capturing one or more ultrasound images of an anterior-superior view of a right lung, a lateral-superior view of the right lung, a lateral-inferior view of the right lung, an anterior-superior view of a left lung, a lateral-superior view of the left lung, a lateral-inferior view of the left lung, a parasternal long axis view of a heart, or an apical four chamber view of the heart, as taught by Bughrara, in order to detect a condition of the heart (Col. 4, Paragraph starting at line 6).
Regarding claim 13, the modifications of Naidu, Mienkina, Schwab, Mclapudi, and Sagalovich disclose all the features of claim 10 above.
However, the modifications of Naidu, Mienkina, Schwab, Mclapudi, and Sagalovich do not disclose wherein the first scan of the ultrasound imaging exam comprises capturing one or more ultrasound images of a lung and the second scan of the ultrasound imaging exam comprises capturing one or more ultrasound images of a heart.
Bughrara teaches wherein the first scan of the ultrasound imaging exam comprises capturing one or more ultrasound images of a lung and the second scan of the ultrasound imaging exam comprises capturing one or more ultrasound images of a heart (Col. 4, Last paragraph, capturing the ultrasound image of the heart, and also an image of the lung).
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 Naidu, Mienkina, Schwab, Mclapudi, and Sagalovich, wherein the first scan of the ultrasound imaging exam comprises capturing one or more ultrasound images of a lung and the second scan of the ultrasound imaging exam comprises capturing one or more ultrasound images of a heart, as taught by Bughrara, in order to compare with similar previous image to determine a condition of a phenotype that affects both the heart and lung (Col. 4, last paragraph into the first full paragraph of col. 5).
Regarding claim 14, the modifications of Naidu, Mienkina, Schwab, Mclapudi, and Sagalovich disclose all the features of claim 10 above.
As disclosed in the claim 9 rejection above, Sagalovich teaches anatomical labeling.
However, the modifications of Naidu, Mienkina, Schwab, Mclapudi, and Sagalovich do not disclose wherein the automatic anatomical and/or pathological labeling comprises labeling A lines, B lines, a pleural line, a right ventricle, a left ventricle, a right atrium, and/or a left atrium.
Bughrara teaches determining A-Line and B-line pattern (Col. 23, Paragraph starting at line 15).
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 Naidu, Mienkina, Schwab, Mclapudi, and Sagalovich, wherein the automatic anatomical and/or pathological labeling comprises labeling A lines, B lines, a pleural line, a right ventricle, a left ventricle, a right atrium, and/or a left atrium, as taught by Sagalovich, in view of Bughrara, in order to determine conditions that are associated with A-Line, like dry lungs, and those with B-line patterns (Col. 24, Paragraph starting at line 37).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naidu, in view of Mienkina, further in view of Schwab, further in view of Mclapudi, and further in view of Sagalovich, as applied to claim 9 above, and further in view of US2011/0172536 to Do et al “Do”.
Regarding claim 15, the modifications of Naidu, Mienkina, Schwab, Mclapudi, and Sagalovich disclose all the features of claim 9 above.
However, the modifications of Naidu, Mienkina, Schwab, Mclapudi, and Sagalovich do not disclose wherein the processing device is further configured to disable capturing the one or more ultrasound images associated with the first scan of the ultrasound imaging exam when the quality of the recent ultrasound data does not exceed a second threshold.
Do teaches a similar ultrasound diagnostic imaging system (Abstract). Do teaches stopping a heart image acquisition if the images are not of the desired diagnostic quality (Paragraph 0027, this would read on the images being below a quality threshold).
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 Naidu, Mienkina, Schwab, Mclapudi, and Sagalovich, wherein the processing device is further configured to disable capturing the one or more ultrasound images associated with the first scan of the ultrasound imaging exam when the quality of the recent ultrasound data does not exceed a second threshold, as taught by Do, in order to stop a low quality acquisition, and be able to repeat the acquisition until acceptable data is acquired (Paragraph 0027).
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naidu, in view of Mienkina, further in view of Schwab, further in view of Mclapudi, and further in view of Sagalovich, as applied to claim 9 above, and further in view of US2023/0148998 to Owen et al. “Owen”.
Regarding claims 16 and 17, the modifications of Naidu, Mienkina, Schwab, Mclapudi, and Sagalovich disclose all the features of claim 9 above.
However, the modifications of Naidu, Mienkina, Schwab, Mclapudi, and Sagalovich do not disclose wherein the processing device is configured, when providing the summary of the ultrasound imaging exam, to provide a single score for the ultrasound imaging exam and the single score is based on one or more of: a number of scans completed; whether or not a plurality of scans are auto-captured, or if the plurality of scans are manually captured, an average quality score for the plurality of scans; and which of a plurality of automatic calculations are calculated.
Owen teaches a single quality score of the ultrasound images (Paragraph 0032, average image quality score). Owen teaches the average image quality score is the average of the ultrasound image frames acquired prior to a particular current image, such as from a prior set, which would read on the score being a number of scans completed.
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 Naidu, Mienkina, Schwab, Mclapudi, and Sagalovich, wherein the processing device is configured, when providing the summary of the ultrasound imaging exam, to provide a single score for the ultrasound imaging exam and the single score is based on one or more of: a number of scans completed; whether or not a plurality of scans are auto-captured, or if the plurality of scans are manually captured, an average quality score for the plurality of scans; and which of a plurality of automatic calculations are calculated, as taught by Owen, in order to compare a current image acquisition to the quality of the all the images acquired before it (Paragraph 0032).
Claim(s) 18, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naidu, in view of Mienkina, further in view of Schwab, further in view of Mclapudi, and further in view of Sagalovich, as applied to claim 9 above, and further in view of Sokulin et al. “Sokulin”.
Regarding claims 18 and 20, the modifications of Naidu, Mienkina, Schwab, Mclapudi, and Sagalovich disclose all the features of claim 9 above.
However, the modifications of Naidu, Mienkina, Schwab, Mclapudi, and Sagalovich do not disclose wherein the processing device is configured, when providing the summary of the ultrasound imaging exam, to provide a count of scans automatically captured and a count of scans missing or display progress through a plurality of scans of the ultrasound imaging exam.
Sokulin teaches the controller identifies the number of ultrasound images missing relative to the protocol and displays it on the display, which conversely would also show the amount that was acquired relative to the protocol (Paragraph 0074). Sokulin further teaches a graphical icon can also be indicative of the ratio of the images acquired relative to the protocol (Paragraph 0074), which would read on a progress icon for the completion of the protocol.
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 Naidu, Mienkina, Schwab, Mclapudi, and Sagalovich, wherein the processing device is configured, when providing the summary of the ultrasound imaging exam, to provide a count of scans automatically captured and a count of scans missing or display progress through a plurality of scans of the ultrasound imaging exam, as taught by Sokulin, in order to provide a status for the completeness of the protocol.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naidu, in view of Mienkina, further in view of Schwab, further in view of Mclapudi, and further in view of Sagalovich, as applied to claim 10 above, and further in view of US2021/0315541 to “Poland”.
Regarding claim 19, the modifications of Naidu, Mienkina, Schwab, Mclapudi, and Sagalovich disclose all the features of claim 10 above.
However, the modifications of Naidu, Mienkina, Schwab, Mclapudi, and Sagalovich do not disclose calculating and displaying: a left ventricular diameter, a left atrial diameter, a right ventricular diameter, a right atrial diameter, and an ejection fraction based on an apical four chamber scan; the left ventricular diameter, the left atrial diameter, and the right ventricular diameter based on a parasternal long axis scan; and a number of B lines based on each of a plurality of lung scans
Poland teaches acquiring assessment results (Paragraph 0078) from the ultrasound images, wherein the assessment includes ejection fraction and anterolateral diameter (Paragraph 0078).
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 Naidu, Mienkina, Schwab, Mclapudi, and Sagalovich, wherein a left ventricular diameter, a left atrial diameter, a right ventricular diameter, a right atrial diameter, and an ejection fraction based on an apical four chamber scan; the left ventricular diameter, the left atrial diameter, and the right ventricular diameter based on a parasternal long axis scan; and a number of B lines based on each of a plurality of lung scans, as taught by Sokulin, in order to provide an assessment result without having to show the actual ultrasound image to alleviate memory use of the device (Paragraph 0006).
Response to Arguments
Applicant's arguments filed 02/10/2026 have been fully considered but they are not persuasive. More specifically, applicant argues on Pages 9-11 of Arguments, that none of the prior art references teach using voice inputs for all the cited features in claim 1, and that Naidu only teaches voice commands for user identification and tissue identification. The examiner respectfully disagrees. Naidu also teaches in cited Paragraph 0053 that patient identification inputs, which are used to select a patient, can be provided to the system by user inputs, and as stated in Paragraph 0051, user inputs used by the system can include voice input of the operator. Although Naidu provided an example of using voice input as user input for tissue classification, one of ordinary skill in the art would understand that voice input could be used as user input, in portions of Naidu that recited a user input, since its merely substituting one known/established user input method with another. Therefore, Naidu does also teach using a voice input from the user/operator to select the patient. Regarding the other selection inputs of claim 1, the examiner agrees that Naidu cannot be used to teach voice inputs for these additional selection inputs. However, the claim limitations claim “automatically select” or “receive a voice command”. For the ultrasound imaging preset, ultrasound imaging depth, ultrasound imaging gain, and time gain compensation, Naidu teaches automatically configuring these parameters based on the cited paragraphs as cited in the previous office action, in conjunction with cited paragraph 0032, regarding the automatic reconfiguration of the system based on predicted setting, using a settings prediction model. Additionally, prior art to Schwab teaches automatically selecting an organization (Schwab, Paragraph 0039, by automatically accessing user information such as department, once a user has been identified) and also automatically determining the imaging mode (Schwab, Paragraph 0034, the system determines the imaging mode based on the probe used). Therefore, for claim 1, the combination of Naidu, in view of O’Brien, further in view of Schwab, and further in view of Akkaraju teaches all the claim limitations of claim 1, and claim 1 remains rejected. Claims 2-8 also remain rejected, since they depend from claim 1 directly, or indirectly, and arguments directed towards claims 2-8 are the same as for claim 1.
Arguments for claims 9-20 are moot since independent claim 9 includes newly amended limitations that were not considered previously for claim 9.
Conclusion
THIS ACTION IS MADE FINAL. 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 RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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