DETAILED ACTION
This Office action is responsive to communications filed on 04/27/2026. Claims 1, 5, 12, 15, 18, & 20 have been amended. Claims 4, 14 canceled. Presently, Claims 1-3, 5-13, 15-20 remain pending and are hereinafter examined on the merits.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/27/2026 has been entered.
Response to Arguments
Previous rejections under 35 USC § 112(b) are withdrawn in view of the amendments filed on 04/27/2026.
The Applicant’s arguments with respect to rejections under 35 USC § 101 have been fully, considered, but are not persuasive.
Firstly, the Applicant cites the August 2025 Deputy Commission Memorandum for the principles that examiners should not exceed the mental process category to limitation that cannot practically be performed in the human mind. In response, the memo was only intended as a reminder with respect to the emerging technologies. This reminder memo is not intended to announce any new practice or procedure and is meant to be consistent with existing guidance. The Examiner agrees with these principles outlined by the reminder memo and is applied herein.
The rejection set forth identifies the limitations directed to identifying anatomical features, identifying a scanning view using trained models, and determining completeness of scans as reciting a mental process and mathematical concepts. The Applicant argues that the claims must be considered as a whole and that the claims cannot be practically performed in the human mind because they occur during an ultrasound examination. However, the rejection does not characterize the claims as a whole as a mental process. Rather the rejection explicitly identified the specific limitations that recite abstract ideas as both mental and mathematical concepts, and then evaluates the remining claims elements under Step 2A Prong two and Step 2B. The fact that the claims additionally recite ultrasound image acquisition and display related operations does not remove the identified abstract concepts from the claims.
The Applicant reliance on the requirement that the claims must be considered as a whole is unavailing because the rejection evaluates the claims as a whole after identifying the judicial exception. See the 35 USC 101 rejection below. The Applicant further argues that the claims cannot be practically performed in the human mind because the claim recites capturing the ultrasound imagery during an examination and generating supplemented image during the examination. This argument is not commensurate within the basis of the rejection. Rather the identified abstract limitations are directed to recognizing anatomical features, scanning views, and evaluating scan completeness, which as recited amount to nothing more than forms of observation, evaluation, classification, and judgement. The additional limitations related to image acquisition and display were separately addressed as additional elements.
The Applicant argues that identifying a scanning view and determining relative completeness using trained models cannot be practically performed in the human mind. Again, the rejection relied on mental and mathematical concepts, which is not address by the Applicant. The claims; however, do not recite an specific model architecture, training techniques, mathematical formulation, or specialized processing. Upon review of the specification, the specification does not appear to provide this either. The claims broadly recite applying trained models to identify the result of classification and evaluation and therefore remain abstract. Recitations of a trained model, without further technological details as addressed above, does not by itself confer eligibility.
The Applicant contends that the claims provide a technological solution to a technological problem because the ultrasound images are supplemented with anatomical feature information, scanning view information, and completeness information. However, the claims do not recite any technological improvement to ultrasound image acquisition, ultrasound beamforming, image reconstruction, probe operations, displaying means, or computer functionality or even machine-learning technology. Instead, the claims use conventional ultrasound image acquisition as input to perform an analysis and present resulting information. Providing information to the user as its recited constitutes an informational result rather than a technological improvement to the underlying ultrasound system.
The Applicants arguments that the claimed features remedy shortcomings of ultrasound systems and improve utility of the ultrasound system is not persuasive because the claims doe not recite any technological mechanism by which such improvements are achieved. The Applicant’s argument that the claimed operations occur during an ultrasound examination does not establish a practical application. The claim language itself does not impose any specialized technological improvements of “during examination” beyond the mere recitation of that term. “during an examination” simply denotes the steps are performed while the procedure is ongoing; it does not specify any technological requirement that would preclude the abstract idea identified in PRONG ONE. Therefore, the real-time nature of the claimed steps does not transform the identified abstract idea in PRONG ONE into a technological improvement. Thus, a reliance on the need for high precision does not negate its nature of being directed to data-gathering.
The Applicant also relies on the addition of determination relative completeness of scans and including completeness information in supplemented images. However, the determining completeness remains evaluative judgement based on image information/data, and displaying the resulting completeness information constitutes presentation of the analysis result. These limitations do not meaningfully limit the judicial expiation or even provide an inventive concept.
The 35 USC § 101 rejection is maintained.
The Applicant’s arguments with respect to rejections under 35 USC § 102 have been fully, considered, but are not persuasive.
The rejection does not rely on Mienkina’s structural overlay template 250 alone as the claim “identification information of the scanning view”. Rather the rejection cites Mienkina’s disclosure that the system automatically detects a target view corresponding to the acquired ultrasound image view and present information associated with the detected view, including the visual indicators, identifies, and markers, and a 3D model indicating the location or plane of the acquired view. The claims merely require that the supplement ultrasound images include identification information of the scanning view, and do not require any particular format, or presentation of the information. Applicant’s arguments improperly import limitations form the specification regarding how the scanning view information is presented whereas the claims are “broader”.
Applicant argues the Mienkina is concerned with matching an image view to a target view rather than identifying the scanning view. This argument is not persuasive because the rejection relies on Mienkina’s disclosure that the system automatically determined which target view corresponds to the acquired ultrasound image. Identifying a target view corresponding to the acquired ultrasound image constitutes identifying a scanning view under the broadest reasonable interpretation of the claim language.
The Applicant’s argument regarding the structural overlay template attacks a feature that was not solely relied upon to teach the claim identification information. The rejection relies on the combined disclosure of view detection, related indicators, marks and modeling associated with the detected view. Thus, even if the template 250 alone were not considered identification information, the rejection remains supported by the broader teachings of Mienkina in view of the broad claim limitations.
The Applicant’s argument that Mienkina only provides binary checks for individual features and therefore does not determine relative completeness scans is also unpersuasive. As explain in the rejection, Mienkina evaluates protocol adherence for a detected target view by determining which required anatomical features are present and which are absent. The resulting assessment reflect the degree to which the scan satisfies the requirements for the detected view. The claims do not require a numerical completeness score, percentage, ranking, or metric. Under the broadest reasonable interpretation, information identifying present and missing required features for a view constitutes information including the relative completeness of the scan for that view.
For these reasons, the 35 USC § 102 rejection is maintained.
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 1-3, 5-13, 15-20 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 1: recites:
“identify a scanning view captured during the ultrasound examination by applying trained models to ultrasound images;
determine by applying the trained models relative completeness of scans for the scanning view;”
The rejection to claim 1 applies to claim 12 and claim 20 for substantially identical claim limitations recited in the claim.
An algorithm is defined, for example, as "a finite sequence of steps for solving a logical or mathematical problem or performing a task." Microsoft Computer Dictionary (5th ed., 2002). Applicant may "express that algorithm in any understandable terms including as a mathematical formula, in prose, or as a flow chart, or in any other manner that provides sufficient structure." Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340 (Fed. Cir. 2008) (internal citation omitted). This can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015), see MPEP § 2161(I).
The claim is rejected under 35 USC § 112(a) for a lack of written description. Proper written description cannot be identified in the specification, claims, and drawings directed to the computer implemented steps for how the identifying of a scanning view during the ultrasound examination and determining a relative completeness of scans for the scanning view can be achieved by machine learning techniques using i.e., the trained model. Specifically, the specification does not provide and lacks detailed a step-by-step description, any algorithmic or flowchart-based disclosure, specific functions, and/or weights for the machine learning techniques or convolutional networks used for segmentation.
These limitations are computer/processor-implemented functional claim limitation as it is directed to a processor-controlled algorithm configured to determine a location. Yet the specification does not disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed functions, i.e., “identify a scanning view captured during the ultrasound examination by applying trained models to ultrasound images; determine by applying the trained models relative completeness of scans for the scanning view;”, in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. It is not enough to disclose that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015). As the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention, these claims are rejected for lack of written description. For more information regarding the written description requirement, see MPEP §§ 2161, 2162-2163.07(b).
Indeed, the specification paragraph ¶0036, ¶0037-0039, ¶0055, ¶0059, are directed to a mere example of generalized machine learning models tantamount to a black box, rather than showing procession of a particular implementation. Without the level of detail regarding the weights used, parameters used, and operations for how the identifying of a scanning view during the ultrasound examination and determining a relative completeness of scans for the scanning view can be achieved by machine learning techniques using i.e., the trained model, the written description requirement is not satisfied. The mere use of stating these steps are achieved by machine learning techniques is not sufficient. One of ordinary skill in the art would not be able to implement the described process without disclosure of said weights, parameters, and/or operations of the segmentation achieved by machine learning techniques in a step-by-step manner. In addition, an assertion that could be derived using simulations or test (i.e., prophetic examples) does not demonstrate that the inventors actual did so or had possession of the specific functional relationships and constraints to obviate the lack of written description requirement.
Consequently, one of ordinary skill in the art would not deem the instant specification having sufficient detail so that they could understand how the inventor intended to achieve the aforementioned step. Since the instant specification fails to provide a finite sequence of steps for performing step, the aforementioned claim fails to meet the written description requirement under 35 U.S.C. 112(a).
The above rejection to claim 1 apply to claim 12 and claim 20 for substantially identical claim limitations recited in the claim.
Dependent claims are rejected by virtue of their dependency to abovementioned claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 5-13, 15-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1-3, 5-11 are drawn to a “system” which describes one of the four statutory categories, i.e., a machine.
Claim 12-13, 15-17 is directed to a “method” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Claim 18-20 is directed to an “apparatus” which describes one of the four statutory categories of patentable subject matter, i.e., a machine.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One:
Claims 1 recite (“sets forth” or “describes”) the abstract idea of “a mental process” (MPEP 2106.04(a)(2).III.), & the abstract idea of “mathematical concepts” (MPEP 2106.04(a)(2).I.), substantially as follows:
“identify anatomical features captured in the ultrasound imagery during the ultrasound examination;
identify a scanning view captured during the ultrasound examination by applying trained models to ultrasound images;
determine by applying the trained models relative completeness of scans for the scanning view; and ”
Claims 12 recite (“sets forth” or “describes”) the abstract idea of “a mental process” (MPEP 2106.04(a)(2).III.), & the abstract idea of “mathematical concepts” (MPEP 2106.04(a)(2).I.), substantially as follows:
“identifying, by a controller with a processor executing instructions from a memory, anatomical features captured in the ultrasound imagery during the ultrasound examination;
identifying, by the controller, a scanning view captured during the ultrasound examination by applying trained models to ultrasound images;
determining by applying the trained models relative completeness of scans for the scanning view;”
Claims 18 recite (“sets forth” or “describes”) the abstract idea of “a mental process” (MPEP 2106.04(a)(2).III.), & the abstract idea of “mathematical concepts” (MPEP 2106.04(a)(2).I.), substantially as follows:
“identify anatomical features captured in the ultrasound imagery during the ultrasound examination;
identify a scanning view captured during the ultrasound examination by applying trained models to ultrasound images;
determine by applying the trained models relative completeness of scans for the scanning view;”
In claims (1, 12, 18), the identified limitations recite abstract ideas because they set forth both the abstract idea of “a mental process” (MPEP 2106.04(a)(2).III.), & the abstract idea of “mathematical concepts” (MPEP 2106.04(a)(2).I.), substantially as follows: Specifically, the limitations directed to identifying anatomical features in ultrasound imagery and identifying a scanning view by applying trained models describe activities that fundamentally involve evaluation, judgment, and recognition of patterns in visual information. A medical professional can mentally review ultrasound images, compare observed shapes and structures to known anatomical knowledge, and determine what organs or features are present, as well as recognize the scanning view based on experience. These acts constitute a mental process that can be practically performed in the human mind without aid of a computer. In addition, the recitation directed to applying trained models to identify features or views describe mathematical relationships and calculations such as classification, comparison, or pattern matching that are abstract mathematical concepts. Similarly, the same applies to the generic determination by applying the trained models relative completeness of scans for the scanning view. The claimed limitations identified above broadly cover conceptual steps of analyzing image data and labeling results. Accordingly, these limitations set fourth abstract ideas of mental processes and mathematical concepts. There is nothing recited in the claim to suggest an undue level of complexity in how the identification is done.
Prong Two: Claims (1, 12, 18) do not include additional elements that integrate the mental process into a practical application.
This judicial exception is not integrated into a practical application.
In particular, the claims recites (1) additional steps of “a memory that stores instructions; a processor that executes the instructions; and a display, wherein in response to being executed by the processor, the instructions cause the ultrasound system to: control an ultrasound probe to capture ultrasound imagery during an ultrasound examination by emitting ultrasound imaging beams and receiving and detecting feedback from the ultrasound imaging beams” – (claim 1), “A method for supplementing ultrasound images, the method comprising: controlling an ultrasound probe to capture ultrasound imagery during an ultrasound examination by emitting ultrasound imaging beams and receiving and detecting feedback from the ultrasound imaging beams, [...]; [...], by the controller, [...]; and”-(claim 12), “a memory that stores instructions; and a processor that executes the instructions, wherein in response to being executed by the processor, the instructions cause the controller to: control an ultrasound probe to capture ultrasound imagery during an ultrasound examination by emitting ultrasound imaging beams and receiving and detecting feedback from the ultrasound imaging beams;;”-(claim 18); and (2) further an addition step of generat[ing] from the ultrasound images during the ultrasound examination, supplemental ultrasound images supplemented with a list of one or more anatomical features captured in the ultrasound imagery during the ultrasound examination, and some completion information indicating the relative completeness of scans for the scanning view, and identification information of the scanning view. (claims 1, 12, 18).
The steps in (1) represent merely data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with conventionally used tools (see below Step IIB for further details). Data gathering and mere instructions to implement an abstract idea on a computer do not integrate a judicial exception into a practical application (MPEP 2106.05 (f and g)). Regarding the limitations of claim 12, directed to the controller with a processor executing instructions from a memory (i.e., “identifying, by a controller with a processor executing instructions from a memory, anatomical features captured in the ultrasound imagery during the ultrasound examination; and [...] identifying, by the controller, a scanning view captured during the ultrasound examination by applying trained models to the ultrasound images; and”) is treated as a generic computer implementation, which falls under mere instructions to apply the abstract idea on a computer and therefore does not place the abstract idea into a practical application that solves a technological solution in a meaningful way or improve the functionality of the technology or generic computer “itself”. Simply, it’s a generic computer implementation of a mental process rather than a meaningful limitation. Regarding the processor language written at such a high level of generality of structural limitations, the processor language amounts to a generic computer component with mere instructions to implement the abstract idea on a computer.
The step in (2) represents merely amounts to insignificant post-solution activity and is recited at a high level of generality. It amounts to insignificant post-solution activity because it amounts to no more than presenting desired results of the abstract mental process, rather than integrating the abstract idea into a practical application that solves a technological solution in a meaningful way.
As a whole, the additional elements merely serve to gather and feed information to the abstract idea and to output a notification based on the abstract idea, while generically implementing it on conventionally used tools. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the information is not outputted in any way such that a practical benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Further, there is no evidence of record that would support the assertion that this step is an improvement to a computer or technological solution to a technological problem. Ultimately, the Applicant’s describe improvement in the process of using displaying anatomical features of interest, but this is not an improvement in the function of a computer or other technology (See MPEP 2106.05(a)(ii); “the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology”; See MPEP 2106.04(d)(1); 2106.05(a); and 2106.05(f)). The claims are directed to the abstract idea. Also, there does not appear to be any particular structure or machine, treatment or prophylaxis, transformation, or any other meaningful application that would render the claim eligible at step 2A, prong 2.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims (1, 12, 18) do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claims recite additional steps of instructions to control an ultrasound probe for capturing ultrasound imagery during an examination. These steps represents mere data gathering, data outputting or pre/post/extra-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality. Furthermore, as discussed above, limitations with respect to the processor languages/terms, respectively, amount to mere instructions to implement the abstract idea on a computer. As discussed with respect to Step 2A Prong Two, the additional elements in the claims amount to no more than insignificant extra solution activity and mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B and does not provide an inventive concept. The data gathering steps that were considered insignificant extra-solution activity in Step 2A Prong Two, have been re-evaluated in Step 2B and determined to be well-understood, routine, conventional activity in the field.
As an evidence, Popovic et al (US 2019/0290247 A1) discloses:
¶0044, ‘endoscope controller 30 is structurally configured as well known in the art of the present disclosure for controlling an operation of an endoscope in generating an endoscopic image, LUS probe controller 40 is structurally configured as well known in the art for controlling an operation of a LUS probe in generating ultrasound image(s), and display controller 60 is structurally configured as well known in the art for controlling an operation of a display/monitor.’
For these reasons, there is no inventive concept. The claim is not patent eligible. Even when viewed as a whole, nothing in the claim adds significantly more to the abstract idea.
Dependent Claims
The following dependent claims merely further define the abstract idea and are, therefore, recite an abstract idea for similar reasons:
Defining identifying anatomical organs captured during the ultrasound examination; and– (claim 5 & 15 & 20) directed to the aforementioned mental concepts therefore directed to the abstract idea. Whereas the step of supplementing the ultrasound images with the anatomical organs among the list of one or more anatomical features captured in the ultrasound imagery during the ultrasound examination is directed to data gathering steps and post-solution activity/insignificant post solution activity which is recited conventionally and recited at high level of generality. As such, the abstract idea is not applied, relied on, or used in a meaningful way. No improved to the technology is evident, and the determined visualization of context is not outputted in any way such that the practical benefit is realized.
Defining updating the list of one or more anatomical features captured in the ultrasound imagery in response to the captured ultrasound imagery changing during the ultrasound examination thereby capturing at least one previously uncaptured anatomical feature. (claim 8 & 16) directed to the abstract idea of mental observation and mentally updating the list to keep track of the anatomical features. The claims do not preclude this interpretation of the abstract idea.
Defining populating a template with the list of one or more anatomical features. (claim 11)
The following dependent claims merely further describe the extra-solution activities and therefore, do not amount to significantly more than the judicial exception or integrate the abstract idea into a practical application for similar reasons:
Describing the instructions cause the ultrasound system further to: receive information from an external processor; wherein the ultrasound images are supplemented with the information received from the external processor, (claim 2)
Describing display the ultrasound images supplemented with the information received from the processor and the list of one or more anatomical features captured in the ultrasound imagery during the ultrasound examination (claim 3 & 13, 19), where as the transmitting and receiving ultrasound beams is pre-solution data gathering.
describing connecting to an external record system during the ultrasound examination to retrieve data, and supplement the ultrasound images with the data retrieved from the external record system. – (claim 6).
Describing connecting to an external record system during the ultrasound examination to retrieve data, and upload data to the external record system during the ultrasound examination. – (claim 7)
Describing the merge of the ultrasound images in an output file with subject-specific information. (claim 9).
Describing displaying information indicating completion of one or more scans for one or more scanning view captured during the ultrasound examination. – (claim 10 & 17). The Examiner agrees displaying information on a monitor cannot performed in the human mind; hence, it is not part of the abstract idea. However, it is not a practical application either. It is merely an insignificant post-solution activity. In addition, the abstract idea is not applied, relied on, or used in a meaningful way. No improved to the technology is evident, and the determined visualization of context is not outputted in any way such that the practical benefit is realized.
In claims (2-3, 6-7, 9-10, 13, 17, 19), The data gathering steps and pre/post-solution activity and/or insignificant extra-solution activity which is recited conventionally and recited at high level of generality. As such, the abstract idea is not applied, relied on, or used in a meaningful way. No improved to the technology is evident, and the determined visualization of context is not outputted in any way such that the practical benefit is realized.
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5, 8, 11-12, 15-16, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mienkina (US 2022/0071595 A1).
Claim 1: Mienkina discloses, An ultrasound system (ultrasound system 100), comprising (¶Abstract – real-time anatomical structure recognition in acquired ultrasound image views is provided.)
a memory that stores instructions; (Archive 138 includes databases and sets of information and instructions for detecting anatomical and/or image featured in the acquired ultrasound image views-¶0056)
a processor (signal processor 132 (i.e., controller) includes processor 140, 150, and 160) that executes the instructions; and (¶0036, ‘The signal processor 132, including the view detection processor 140, the anatomical structure detection processor 150, and the user interface element processor 160, may be capable of executing any of the method(s) and/or set(s) of instructions discussed herein in accordance with the various embodiments, for example.’, see also - ¶0056, ¶0070)
a display (display system 134), wherein in response to being executed by the processor, the instructions cause the ultrasound system to: (¶0027, ¶0054-0055, ¶0070, Claim 8 – regarding the display system is configured to present the ultrasound image view and user interface elements)
control an ultrasound probe to capture ultrasound imagery during an ultrasound examination by emitting ultrasound imaging beams and receiving and detecting feedback from the ultrasound imaging beams; (Claims 1, 7-8, & 15, ¶0029, ¶0035, ¶0067-0068, ¶0070, The system 100 comprises an ultrasound probe 104 configured to acquire an ultrasound image view, which is during a scanning session. The system and method also includes the step of acquiring an ultrasound image view. The ultrasound system includes a transmit beamformer 114 that controls a transmitter 102 to drive the transmit transducer elements 106 to emit ultrasound transmit signals into a region of interest. The system utilizes “back-scattered from structures in the object of interest [...] to produce echoes”. The echoes are received by the receive elements 108. This continuous process of transmission signals and processing the received echo feedback allows the system to acquire the ultrasound imagery during the scanning session)
identify anatomical features captured in the ultrasound imagery during the ultrasound examination; (Claims 8, 15, ¶0039-0040, ¶0061, ¶0070, -The processor is configured to automatically determine one or more a presence or absence of a plurality of anatomical features associated with a detected target view in the acquired ultrasound image view. Specifically, the anatomical structure detection processor 150 performs image analysis techniques such as artificial intelligence or deep neural network image analysis to determine the features present and absent)
identify a scanning view captured during the ultrasound examination by applying trained models to ultrasound images; and (Claim 1, Claim 15, Claim 7-8, ¶0036, ¶0038-0040, ¶0060-0061, ¶0067-0068, ¶0070, ¶0072, Mienkina discloses a view detection processor that automatically detects a target view corresponding to the acquired ultrasound image view. To identify this scanning view, the processor utilizes trained models, (i.e., artificial intelligence image analysis algorithms, machine learning processing functionality, and one or more deep neural networks) such as a U-NET. Mienkina teaches how neurons in the layers of these deep learning networks learn to recognize edges, shapes, and the relative positions of those shapes to successfully identify the target view provided by the ultrasound image with a high degree of probability.)
determine by applying the trained models relative completeness of scans for the scanning view; and (¶0038-0041, ¶0044, FIG. 2, ¶0061, ¶0067-0068, ¶0070, Mienkina teaches evaluating how complete a scan is relative to a specific protocol by using the trained models to detect which required features are present, and which are missing/absent.)
generate, from the ultrasound images during the ultrasound examination, supplemented ultrasound images supplemented with a list of one or more of the anatomical features captured in the ultrasound imagery during the ultrasound examination, completion information indicating the relative completeness of scans for the scanning view, and identification information of the scanning view. (¶0042, ¶0070, Claims 4-6, 8, 12-14, 17-19, - The processor specifically the user interface elements processor 160 is configured to generate at least one user interface element (220-270) indicating the presence or absence of each of the anatomical features. One type of user interface element is a list (230). This list 230 contains the anatomical and/or image features present 232 and/or missing 234 in the acquired ultrasound image view 210 corresponding to a target view. The display system 134 presents the ultrasound image view 210 along with the user interface elements, including the list. The system of Mienkina operates in real-time during a scanning session, detecting the presence of absence of these features as the echo signals are received, ¶0035, ¶0039, ¶0061. As previously discussed, Mienkina system includes the “view detection processor 140” which automatically detects a target view (i.e., the scanning view) corresponding to the acquired image. The system then supplements the image with identification information regarding this view such as a 3D anatomical model having representation 262 of a location of the acquired ultrasound image view, ¶0038, ¶0042, ¶0053, ¶0060, ¶0065.)
Specifically, under the broadest reasonable interpretation, Mienkina teaches providing supplemented ultrasound images, the user interface elements processor coordinates with the system display to present this generated list concurrently with the live ultrasound imagery, ¶0043-0055, ¶0070, see Claim 8, “a display system configured to present the at least one user interface element and the ultrasound image view”.
Specifically, Mienkina teaches that the determining of the completeness of the scan by evaluating its protocol adherence, ¶0020. See ¶0039, ¶0044, based on the detected target view, the anatomical detection processor 150 automatically determines whether the specific required anatomical features defined by the examination protocol are present or absent, as established above. During the second trimester examination, if the target view is a head plane view, the system evaluates the image of the presence of a cerebrum, [...] and brain symmetry. The supplemented list and other visual markers provided direct feedback on this completeness by explicitly indicating which of the required anatomical features are present and which are missing in the captured imagery.
Specifically, as established above, Mienkina system utilizes a view detection processor that automatically detects which specific target view corresponds to the acquired ultrasound image view, ¶0038. To identify this scanning view for the user, the system can supplement the image with identification information, such as a 3D model featuring a representation of the spatial location or plane of the acquired view relative to the overall anatomy, ¶0042, ¶0053. The system also identifies the view by displaying pictograms or structural markers corresponding to the detected target view, ¶0041, ¶0051.
Claim 5: Mienkina discloses all the elements above in claim 1, Mienkina discloses: wherein in response to being executed by the processor, the instructions cause the ultrasound system(¶Abstract, ¶0036, ¶0039, ¶0058, ¶0061, ¶0072, Claim 1, Claim 8-9, Claim 15: - Mienkina discloses acquiring by the ultrasound system an ultrasound image view. The system then automatically detects a target view corresponding to the acquired image. After the target view is identified, the system automatically determines one or both of a presence or absence of a plurality of anatomical features associated with the target view in the ultrasound image view. This determination is performed by the anatomical detection processor 150. The anatomical features are components of organs or specific structures for protocol adherence during an examination. In the head trans cerebellar plane view of a second trimester obstetric fetal examination, the features include anatomical features, such as a cerebellum, cavum septum pellucidum, cisterna magna, midline falx, and brain symmetry, and image features, such as a particular magnification of the acquired ultrasound image view.)
supplement the ultrasound images with the anatomical organs among the list of the one or more anatomical features captured in the ultrasound imagery during the ultrasound examination. (¶0042, ¶0044, ¶0062, ¶0069, ¶0071, Claim 4-5, 12-14, 18-19: -Mienkina discloses supplementation is providing a list 230 that indicates the presence or absence of the anatomical and/or image features captured or expected to be captured in the view. This list provides the feedback regarding whether the image is protocol adherent by identifying the features that are present and/or missing during the ultrasound examination.)
Claim 8: Mienkina discloses all the elements above in claim 1, Mienkina discloses: wherein in response to being executed by the processor, the instructions cause the ultrasound system
-The entire method and system of Mienkina is designed for adapting the user interface elements based on real-time anatomical structure recognition in acquired ultrasound image views, ¶Abstract, ¶0005, ¶0019, ¶0035-0036, ¶0067-0068. The user interface elements include the list 230 that indicates the presence 232 and/or absence 234 of anatomical features, generated based on the current determination of structure present in the image view, ¶0041-0042, ¶0044, ¶0069. The system automatically determines the presence and/or absence of a plurality of anatomical features in the ultrasound image view, ¶Abstract, ¶0068, Claim 1. The system provides user feedback for manipulating an ultrasound probe to acquire a protocol adherent ultrasound iamge view. This feedback includes instructions 270 based on what features are currently present and/or missing, ¶0042, ¶0065-0066. The operator follows the instructions 270 for manipulating the probe position or orientation, and the acquired ultrasound image view changes, ¶0067-0068. When the image view changes due to manipulation the process is designed to return to step 1304 to acquire a different ultrasound image view 210. Steps 1306 and 1308 then re-analyze the new image view to detect the view and determine the presence and/or absence of the anatomical features, ¶0060-0061, ¶0067-0068. Subsequently, the system presents identification 220-234 which includes the list 230, of the anatomical structures present and/or absent, ¶0062.
Claim 11: Mienkina discloses all the elements above in claim 1, Mienkina discloses: wherein supplementing the ultrasound images comprises populating a template with the list of the one or more anatomical features. (¶Abstract, ¶0041, ¶0070: -supplementing the ultrasound iamge 210 involves presenting user interface elements 220-270. One of these elements is the list of anatomical and/or image features. The examination protocol defines a number of specific target views and criteria for adherence based on the present of certain anatomical features, ¶0038, ¶0058, ¶0060. This defined set of required features is a structural template for the displayed list. See also ¶0041, ‘the user interface element processor 160 may be configured to register a pictogram template 240 or structural overlay template 250 with the acquired ultrasound image view 210 and present the pictogram template 240 or structural overlay template 250 overlaid on the acquired ultrasound image view 210 with markers 224, 226 or other identifiers indicating the presence 224 and/or absence 226 of anatomical and/or image features in the acquired ultrasound image view 210.’)
Claim 12: Mienkina discloses, A method for supplementing ultrasound images, the method comprising: (¶Abstract – real-time anatomical structure recognition in acquired ultrasound image views is provided, where supplemental 3D models, ¶0065, pictograms, ¶0041 and list, ¶0042, are provided.)
controlling an ultrasound probe to capture ultrasound imagery during an ultrasound examination by emitting ultrasound imaging beams and receiving and detecting feedback from the ultrasound imaging beams; (Claims 1, 7-8, & 15, ¶0029, ¶0035, ¶0067-0068, ¶0070, The system 100 comprises an ultrasound probe 104 configured to acquire an ultrasound image view, which is during a scanning session. The system and method also includes the step of acquiring an ultrasound image view. The ultrasound system includes a transmit beamformer 114 that controls a transmitter 102 to drive the transmit transducer elements 106 to emit ultrasound transmit signals into a region of interest. The system utilizes “back-scattered from structures in the object of interest [...] to produce echoes”. The echoes are received by the receive elements 108. This continuous process of transmission signals and processing the received echo feedback allows the system to acquire the ultrasound imagery during the scanning session)
identifying, by a controller ((signal processor 132 (i.e., controller) includes processor 140, 150, and 160) with a processor (processor 140, 150, 160 - (¶0036, ‘The signal processor 132, including the view detection processor 140, the anatomical structure detection processor 150, and the user interface element processor 160, may be capable of executing any of the method(s) and/or set(s) of instructions discussed herein in accordance with the various embodiments, for example.’, see also - ¶0056, ¶0070)) executing instructions from a memory, (Archive 138 includes databases and sets of information and instructions for detecting anatomical and/or image featured in the acquired ultrasound image views-¶0056) anatomical features captured in the ultrasound imagery during the ultrasound examination; and (Claims 8, 15, ¶0039-0040, ¶0061, ¶0070, -The processor is configured to automatically determine one or more a presence or absence of a plurality of anatomical features associated with a detected target view in the acquired ultrasound image view. Specifically, the anatomical structure detection processor 150 performs image analysis techniques such as artificial intelligence or deep neural network image analysis to determine the features present and absent)
identifying, by the controller, a scanning view captured during the ultrasound examination by applying trained models to ultrasound images; and (Claim 1, Claim 15, Claim 7-8, ¶0036, ¶0038-0040, ¶0060-0061, ¶0067-0068, ¶0070, ¶0072, Mienkina discloses a view detection processor that automatically detects a target view corresponding to the acquired ultrasound image view. To identify this scanning view, the processor utilizes trained models, (i.e., artificial intelligence image analysis algorithms, machine learning processing functionality, and one or more deep neural networks) such as a U-NET. Mienkina teaches how neurons in the layers of these deep learning networks learn to recognize edges, shapes, and the relative positions of those shapes to successfully identify the target view provided by the ultrasound image with a high degree of probability.)
determining by applying the trained models relative completeness of scans for the scanning view; and (¶0038-0041, ¶0044, FIG. 2, ¶0061, ¶0067-0068, ¶0070, Mienkina teaches evaluating how complete a scan is relative to a specific protocol by using the trained models to detect which required features are present, and which are missing/absent.)
generating, from the ultrasound images during the ultrasound examination, supplemented ultrasound images supplemented with a list of one or more of the anatomical features captured in the ultrasound imagery during the ultrasound examination, completion information indicating the relative completeness of scans for the scanning view, and identification information of the scanning view. (¶0042, ¶0070, Claims 4-6, 8, 12-14, 17-19, - The processor specifically the user interface elements processor 160 is configured to generate at least one user interface element (220-270) indicating the presence or absence of each of the anatomical features. One type of user interface element is a list (230). This list 230 contains the anatomical and/or image features present 232 and/or missing 234 in the acquired ultrasound image view 210 corresponding to a target view. The display system 134 presents the ultrasound image view 210 along with the user interface elements, including the list. The system of Mienkina operates in real-time during a scanning session, detecting the presence of absence of these features as the echo signals are received, ¶0035, ¶0039, ¶0061. As previously discussed, Mienkina system includes the “view detection processor 140” which automatically detects a target view (i.e., the scanning view) corresponding to the acquired image. The system then supplements the image with identification information regarding this view such as a 3D anatomical model having representation 262 of a location of the acquired ultrasound image view, ¶0038, ¶0042, ¶0053, ¶0060, ¶0065.)
Specifically, under the broadest reasonable interpretation, Mienkina teaches providing supplemented ultrasound images, the user interface elements processor coordinates with the system display to present this generated list concurrently with the live ultrasound imagery, ¶0043-0055, ¶0070, see Claim 8, “a display system configured to present the at least one user interface element and the ultrasound image view”.
Specifically, Mienkina teaches that the determining of the completeness of the scan by evaluating its protocol adherence, ¶0020. See ¶0039, ¶0044, based on the detected target view, the anatomical detection processor 150 automatically determines whether the specific required anatomical features defined by the examination protocol are present or absent, as established above. During the second trimester examination, if the target view is a head plane view, the system evaluates the image of the presence of a cerebrum, [...] and brain symmetry. The supplemented list and other visual markers provided direct feedback on this completeness by explicitly indicating which of the required anatomical features are present and which are missing in the captured imagery.
Specifically, as established above, Mienkina system utilizes a view detection processor that automatically detects which specific target view corresponds to the acquired ultrasound image view, ¶0038. To identify this scanning view for the user, the system can supplement the image with identification information, such as a 3D model featuring a representation of the spatial location or plane of the acquired view relative to the overall anatomy, ¶0042, ¶0053. The system also identifies the view by displaying pictograms or structural markers corresponding to the detected target view, ¶0041, ¶0051.
Claim 15: Mienkina discloses all the elements above in claim 12, Mienkina discloses: further comprising: identifying anatomical organs captured during the ultrasound examination; and
(¶Abstract, ¶0036, ¶0039, ¶0058, ¶0061, ¶0072, Claim 1, Claim 8-9, Claim 15: - Mienkina discloses acquiring by the ultrasound system an ultrasound image view. The system then automatically detects a target view corresponding to the acquired image. After the target view is identified, the system automatically determines one or both of a presence or absence of a plurality of anatomical features associated with the target view in the ultrasound image view. This determination is performed by the anatomical detection processor 150. The anatomical features are components of organs or specific structures for protocol adherence during an examination. In the head transcerebellar plane view of a second trimester obstetric fetal examination, the features include include anatomical features, such as a cerebellum, cavum septum pellucidum, cisterna magna, midline falx, and brain symmetry, and image features, such as a particular magnification of the acquired ultrasound image view.)
supplementing the ultrasound images with the anatomical organs among the list of the one or more anatomical features captured in the ultrasound imagery during the ultrasound examination. (¶0042, ¶0044, ¶0062, ¶0069, ¶0071, Claim 4-5, 12-14, 18-19: -Mienkina discloses supplementation is providing a list 230 that indicates the presence or absence of the anatomical and/or image features captured or expected to be captured in the view. This list provides the feedback regarding whether the image is protocol adherent by identifying the features that are present and/or missing during the ultrasound examination.)
Claim 16: Mienkina discloses all the elements above in claim 12, Mienkina discloses: further comprising: updating the list of the one or more anatomical features captured in the ultrasound imagery in response to the captured ultrasound imagery changing during the ultrasound examination thereby capturing at least one previously uncaptured anatomical
feature.
-The entire method and system of Mienkina is designed for adapting the user interface elements based on real-time anatomical structure recognition in acquired ultrasound image views, ¶Abstract, ¶0005, ¶0019, ¶0035-0036, ¶0067-0068. The user interface elements include the list 230 that indicates the presence 232 and/or absence 234 of anatomical features, generated based on the current determination of structure present in the image view, ¶0041-0042, ¶0044, ¶0069. The system automatically determines the presence and/or absence of a plurality of anatomical features in the ultrasound image view, ¶Abstract, ¶0068, Claim 1. The system provides user feedback for manipulating an ultrasound probe to acquire a protocol adherent ultrasound iamge view. This feedback includes instructions 270 based on what features are currently present and/or missing, ¶0042, ¶0065-0066. The operator follows the instructions 270 for manipulating the probe position or orientation, and the acquired ultrasound image view changes, ¶0067-0068. When the image view changes due to manipulation the process is designed to return to step 1304 to acquire a different ultrasound image view 210. Steps 1306 and 1308 then re-analyze the new image view to detect the view and determine the presence and/or absence of the anatomical features, ¶0060-0061, ¶0067-0068. Subsequently, the system presents identification 220-234 which includes the list 230, of the anatomical structures present and/or absent, ¶0062.
Claim 18: Mienkina disclose, A controller (signal processor 132 (i.e., controller) includes processor 140, 150, and 160) for an ultrasound system (ultrasound system 100), comprising: a memory that stores instructions; and (¶Abstract – real-time anatomical structure recognition in acquired ultrasound image views is provided, where supplemental 3D models, ¶0065, pictograms, ¶0041 and list, ¶0042, are provided.)(Archive 138 includes databases and sets of information and instructions for detecting anatomical and/or image featured in the acquired ultrasound image views-¶0056)
a processor that executes the instructions, wherein in response to being executed by the processor, the instructions cause the controller to: (¶0036, ‘The signal processor 132, including the view detection processor 140, the anatomical structure detection processor 150, and the user interface element processor 160, may be capable of executing any of the method(s) and/or set(s) of instructions discussed herein in accordance with the various embodiments, for example.’, see also - ¶0056, ¶0070)
control an ultrasound probe to capture ultrasound imagery during an ultrasound examination by emitting ultrasound imaging beams and receiving and detecting feedback from the ultrasound imaging beams; (Claims 1, 7-8, & 15, ¶0035, ¶0067-0068, ¶0070, - The system 100 comprises an ultrasound probe 104 configured to acquire an ultrasound image view, which is during a scanning session. The system and method also includes the step of acquiring an ultrasound image view.)
-The entire method and system of Mienkina is designed for adapting the user interface elements based on real-time anatomical structure recognition in acquired ultrasound image views, ¶Abstract, ¶0005, ¶0019, ¶0035-0036, ¶0067-0068. The user interface elements include the list 230 that indicates the presence 232 and/or absence 234 of anatomical features, generated based on the current determination of structure present in the image view, ¶0041-0042, ¶0044, ¶0069. The system automatically determines the presence and/or absence of a plurality of anatomical features in the ultrasound image view, ¶Abstract, ¶0068, Claim 1. The system provides user feedback for manipulating an ultrasound probe to acquire a protocol adherent ultrasound image view. This feedback includes instructions 270 based on what features are currently present and/or missing, ¶0042, ¶0065-0066. The operator follows the instructions 270 for manipulating the probe position or orientation, and the acquired ultrasound image view changes, ¶0067-0068. When the image view changes due to manipulation the process is designed to return to step 1304 to acquire a different ultrasound image view 210. Steps 1306 and 1308 then re-analyze the new image view to detect the view and determine the presence and/or absence of the anatomical features, ¶0060-0061, ¶0067-0068. Subsequently, the system presents identification 220-234 which includes the list 230, of the anatomical structures present and/or absent, ¶0062.
(Claims 1, 7-8, & 15, ¶0029, ¶0035, ¶0067-0068, ¶0070, The system 100 comprises an ultrasound probe 104 configured to acquire an ultrasound image view, which is during a scanning session. The system and method also includes the step of acquiring an ultrasound image view. The ultrasound system includes a transmit beamformer 114 that controls a transmitter 102 to drive the transmit transducer elements 106 to emit ultrasound transmit signals into a region of interest. The system utilizes “back-scattered from structures in the object of interest [...] to produce echoes”. The echoes are received by the receive elements 108. This continuous process of transmission signals and processing the received echo feedback allows the system to acquire the ultrasound imagery during the scanning session)
identify anatomical features captured in the ultrasound imagery during the ultrasound examination; (Claims 8, 15, ¶0039-0040, ¶0061, ¶0070, -The processor is configured to automatically determine one or more a presence or absence of a plurality of anatomical features associated with a detected target view in the acquired ultrasound image view. Specifically, the anatomical structure detection processor 150 performs image analysis techniques such as artificial intelligence or deep neural network image analysis to determine the features present and absent)
identify a scanning view captured during the ultrasound examination by applying trained models to ultrasound images; and (Claim 1, Claim 15, Claim 7-8, ¶0036, ¶0038-0040, ¶0060-0061, ¶0067-0068, ¶0070, ¶0072, Mienkina discloses a view detection processor that automatically detects a target view corresponding to the acquired ultrasound image view. To identify this scanning view, the processor utilizes trained models, (i.e., artificial intelligence image analysis algorithms, machine learning processing functionality, and one or more deep neural networks) such as a U-NET. Mienkina teaches how neurons in the layers of these deep learning networks learn to recognize edges, shapes, and the relative positions of those shapes to successfully identify the target view provided by the ultrasound image with a high degree of probability.)
determine by applying the trained models relative completeness of scans for the scanning view; and (¶0038-0041, ¶0044, FIG. 2, ¶0061, ¶0067-0068, ¶0070, Mienkina teaches evaluating how complete a scan is relative to a specific protocol by using the trained models to detect which required features are present, and which are missing/absent.)
generate, from the ultrasound images during the ultrasound examination, supplemented ultrasound images supplemented with a list of one or more of the anatomical features captured in the ultrasound imagery during the ultrasound examination, completion information indicating the relative completeness of scans for the scanning view, and identification information of the scanning view. (¶0042, ¶0070, Claims 4-6, 8, 12-14, 17-19, - The processor specifically the user interface elements processor 160 is configured to generate at least one user interface element (220-270) indicating the presence or absence of each of the anatomical features. One type of user interface element is a list (230). This list 230 contains the anatomical and/or image features present 232 and/or missing 234 in the acquired ultrasound image view 210 corresponding to a target view. The display system 134 presents the ultrasound image view 210 along with the user interface elements, including the list. The system of Mienkina operates in real-time during a scanning session, detecting the presence of absence of these features as the echo signals are received, ¶0035, ¶0039, ¶0061. As previously discussed, Mienkina system includes the “view detection processor 140” which automatically detects a target view (i.e., the scanning view) corresponding to the acquired image. The system then supplements the image with identification information regarding this view such as a 3D anatomical model having representation 262 of a location of the acquired ultrasound image view, ¶0038, ¶0042, ¶0053, ¶0060, ¶0065.)
Specifically, under the broadest reasonable interpretation, Mienkina teaches providing supplemented ultrasound images, the user interface elements processor coordinates with the system display to present this generated list concurrently with the live ultrasound imagery, ¶0043-0055, ¶0070, see Claim 8, “a display system configured to presentthe at least one user interface element and the ultrasound image view”.
Specifically, Mienkina teaches that the determining of the completeness of the scan by evaluating its protocol adherence, ¶0020. See ¶0039, ¶0044, based on the detected target view, the anatomical detection processor 150 automatically determines whether the specific required anatomical features defined by the examination protocol are present or absent, as established above. During the second trimester examination, if the target view is a head plane view, the system evaluates the image of the presence of a cerebrum, [...] and brain symmetry. The supplemented list and other visual markers provided direct feedback on this completeness by explicitly indicating which of the required anatomical features are present and which are missing in the captured imagery.
Specifically, as established above, Mienkina system utilizes a view detection processor that automatically detects which specific target view corresponds to the acquired ultrasound image view, ¶0038. To identify this scanning view for the user, the system can supplement the image with identification information, such as a 3D model featuring a representation of the spatial location or plane of the acquired view relative to the overall anatomy, ¶0042, ¶0053. The system also identifies the view by displaying pictograms or structural markers corresponding to the detected target view, ¶0041, ¶0051.
Claim 19: Mienkina discloses all the elements above in claim 17, Mienkina discloses:
wherein in response to being executed by the processor, the instructions cause the controller further to: transmit, by the ultrasound probe, ultrasound imaging beams; receive and detect, by the ultrasound probe, feedback from the ultrasound imaging beams to capture the ultrasound imagery during the ultrasound examination.
-Mienkina teaches a beamformer 110 that controls a transmitter drive to a group of transmit transducer elements 106 within the ultrasound probe, ¶0028-0029. The transmitted signals are back-scattered from the structures in the object of interest to produce echoes. These echoes (i.e., feedback) are received by the receive transducer elements 108 in the ultrasound probe, ¶0029-0030.
Claim 20: Mienkina discloses all the elements above in claim 18, Mienkina discloses: wherein in response to being executed by the processor, the instructions cause the ultrasound system(¶Abstract, ¶0036, ¶0039, ¶0058, ¶0061, ¶0072, Claim 1, Claim 8-9, Claim 15: - Mienkina discloses acquiring by the ultrasound system an ultrasound image view. The system then automatically detects a target view corresponding to the acquired image. After the target view is identified, the system automatically determines one or both of a presence or absence of a plurality of anatomical features associated with the target view in the ultrasound image view. This determination is performed by the anatomical detection processor 150. The anatomical features are components of organs or specific structures for protocol adherence during an examination. In the head transcerebellar plane view of a second trimester obstetric fetal examination, the features include include anatomical features, such as a cerebellum, cavum septum pellucidum, cisterna magna, midline falx, and brain symmetry, and image features, such as a particular magnification of the acquired ultrasound image view.)
supplement the ultrasound images with the anatomical organs among the list of the one or more anatomical features captured in the ultrasound imagery during the ultrasound examination. (¶0042, ¶0044, ¶0062, ¶0069, ¶0071, Claim 4-5, 12-14, 18-19: -Mienkina discloses supplementation is providing a list 230 that indicates the presence or absence of the anatomical and/or image features captured or expected to be captured in the view. This list provides the feedback regarding whether the image is protocol adherent by identifying the features that are present and/or missing during the ultrasound examination.)
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 2, 3, 13 are rejected under 35 U.S.C. 103 as being unpatentable over Mienkina (US 2022/0071595 A1), as applied to claim 1 & 12 respectively, in further view of Lundberg et al (US 2019/0269384 A1).
Claim 2: Mienkina discloses all the elements above in claim 1, Mienkina discloses, further comprising: the ultrasound probe, wherein in response to being executed by the processor, the instructions cause the ultrasound system further to: receive information from an external processor; wherein the ultrasound images are supplemented with the information received from the external processor,
¶0038, ¶0040 – In determining the presence and absence of anatomical and/or image features additionally and/or alternatively a remote processor is communicatively coupled to the ultrasound system 100. This received information (whether local or remotely) is then used by the user interface element processor 160 to generate and present the user interface elements identifying the anatomical structure present and/or absent from the acquired ultrasound image view, ¶0041, ¶0062. These user interface elements supplement the ultrasound images include the list 230 and pictogram 240 and 3D anatomical model 260.
Mienkina fails to explicitly disclose: an external monitor
However Lundberg in the context of annotating ultrasound examination discloses: an external monitor (¶0016, ¶0018, ¶0024-0025, ¶003-0033 – pictographs are presented to the operator and associated with the ultrasound image are retrieved from a memory of a remote source over a wired or wireless communication. The processor of the ultrasound imaging system can request transmission of pictographs stored on a remote computing device. The pictographs are blended into or stored in associated with the ultrasound image in a patient record.)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the external processor of Mienkina to be configured as a external monitor as taught by Lundberg. The motivation to do this yields predictable results such as providing an increase in additional computing power for the imaging system as suggested by Lundberg, ¶0016.
Claim 3: Modified Mienkina discloses all the elements above in claim 2, Mienkina discloses, wherein in response to being executed by the processor, the instructions cause the ultrasound system further to: display the ultrasound images supplemented with the information received from the processor and the list of the one or more anatomical features captured in the ultrasound imagery during the ultrasound examination. (¶0042, ¶0070, Claims 4-6, 8, 12-14, 17-19, - The processor specifically the user interface elements processor 160 is configured to generate at least one user interface element (220-270) indicating the presence or absence of each of the anatomical features. One type of user interface element is a list (230). This list 230 contains the anatomical and/or image features present 232 and/or missing 234 in the acquired ultrasound image view 210 corresponding to a target view. The display system 134 presents the ultrasound image view 210 along with the user interface elements, including the list.)
Mienkina fails to explicitly disclose: display the ultrasound images supplemented with the information received from the external monitor.
However, Lundberg is relied upon above discloses, display the ultrasound images supplemented with the information received from the external monitor. (-The ultrasound image is stored with metadata that indicates which pictograph is to be displayed with the image and where the pictograph is to appear as an overlay on the image, ¶0016, ¶0025)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the display of modified Mienkina to include displaying the ultrasound images supplemented with the information received from the external monitor as taught by Lundberg. The motivation to do this yields predictable results such as providing an increase in additional computing power for the imaging system as suggested by Lundberg, ¶0016.
Claim 13: Mienkina discloses all the elements above in claim 12, Mienkina discloses, further comprising: transmitting, by the ultrasound probe, ultrasound imaging beams; receiving and detecting, by the ultrasound probe, feedback from the ultrasound imaging beams to capture the ultrasound imagery during the ultrasound examination.
-Mienkina teaches a beamformer 110 that controls a transmitter drive to a group of transmit transducer elements 106 within the ultrasound probe, ¶0028-0029. The transmitted signals are back-scattered from the structures in the object of interest to produce echoes. These echoes (i.e., feedback) are received by the receive transducer elements 108 in the ultrasound probe, ¶0029-0030.
receiving information from an external monitor; and displaying the ultrasound images supplemented with the information received from the processor and the list of the one or more anatomical features captured in the ultrasound imagery during the ultrasound examination, (¶0042, ¶0070, Claims 4-6, 8, 12-14, 17-19, - The processor specifically the user interface elements processor 160 is configured to generate at least one user interface element (220-270) indicating the presence or absence of each of the anatomical features. One type of user interface element is a list (230). This list 230 contains the anatomical and/or image features present 232 and/or missing 234 in the acquired ultrasound image view 210 corresponding to a target view. The display system 134 presents the ultrasound image view 210 along with the user interface elements, including the list.)
Mienkina fails to explicitly disclose: an external monitor & displaying the ultrasound images supplemented with the information received from the external monitor
However Lundberg in the context of annotating ultrasound examination discloses: an external monitor (¶0016, ¶0018, ¶0024-0025, ¶003-0033 – pictographs are presented to the operator and associated with the ultrasound image are retrieved from a memory of a remote source over a wired or wireless communication. The processor of the ultrasound imaging system can request transmission of pictographs stored on a remote computing device. The pictographs are blended into or stored in associated with the ultrasound image in a patient record.) & displaying the ultrasound images supplemented with the information received from the external monitor (-The ultrasound image is stored with metadata that indicates which pictograph is to be displayed with the image and where the pictograph is to appear as an overlay on the image, ¶0016, ¶0025)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the external processor of modified Mienkina to be configured as a external monitor as taught by Lundberg. The motivation to do this yields predictable results such as providing an increase in additional computing power for the imaging system as suggested by Lundberg, ¶0016.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the display of modified Mienkina to include displaying the ultrasound images supplemented with the information received from the external monitor as taught by Lundberg. The motivation to do this yields predictable results such as providing an increase in additional computing power for the imaging system as suggested by Lundberg, ¶0016.
Claims 6-7, 9 are rejected under 35 U.S.C. 103 as being unpatentable over Mienkina (US 2022/0071595 A1), as applied to claim 1, in further view of Tanabe (US 2020/0265930 A1).
Claim 6: Mienkina discloses all the elements above in claim 1, Mienkina fails to disclose: wherein in response to being executed by the processor, the instructions cause the ultrasound system further to: connect to an external record system during the ultrasound examination to retrieve data, and supplement the ultrasound images with the data retrieved from the external record system.
However, Tanabe in the context of medical examination apparatus and medical examination systems, discloses: connect to an external record system during the ultrasound examination to retrieve data, and supplement the ultrasound images with the data retrieved from the external record system. (¶0040, ‘The number of electronic medical record terminals 10A, 10B, and 10C and ultrasound diagnostic apparatuses 20X, 20Y, and 20Z is not particularly limited. The medical examination system 100 is installed in a hospital. Each apparatus configuring the medical examination system 100 conforms to the digital image and communications in medicine (DICOM) standard, and communication between apparatuses is performed according to the DICOM.’; ¶0043, ‘The ultrasound diagnostic apparatus 20 generates supplementary information on the generated ultrasound image data based on the order information. The ultrasound diagnostic apparatus 20 generates an image file in accordance with the DICOM standard by adding the supplementary information to the ultrasound image data, and transmits the generated image file to PACS 30. DICOM is an abbreviation for Digital Imaging and Communication in Medicine.’) – This supplementary information is then added to the ultrasound image data to generate an image file configured to include DICOM image data (i.e., the standard use for medical communication). Therefore, the data received from the external record system is explicitly used to supplement the ultrasound images.)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the processor of Mienkina to be further configured to connect to an external record system during the ultrasound examination to retrieve data, and supplement the ultrasound images with the data retrieved from the external record system as taught by Tanabe. The motivation to do this yields predictable results such as improving security for example leakage of personal information can be prevented, as suggested by Tanabe, ¶0091.
Claim 7: Mienkina discloses all the elements above in claim 1, Mienkina fails to disclose:: wherein in response to being executed by the processor the instructions cause the ultrasound system
However, Tanabe in the context of medical examination apparatus and medical examination systems, discloses: connect to an external record system during the ultrasound examination to retrieve data, and upload data to the external record system during the ultrasound examination. (¶0040, ‘The number of electronic medical record terminals 10A, 10B, and 10C and ultrasound diagnostic apparatuses 20X, 20Y, and 20Z is not particularly limited. The medical examination system 100 is installed in a hospital. Each apparatus configuring the medical examination system 100 conforms to the digital image and communications in medicine (DICOM) standard, and communication between apparatuses is performed according to the DICOM.’; ¶0043, ‘The ultrasound diagnostic apparatus 20 generates supplementary information on the generated ultrasound image data based on the order information. The ultrasound diagnostic apparatus 20 generates an image file in accordance with the DICOM standard by adding the supplementary information to the ultrasound image data, and transmits the generated image file to PACS 30. DICOM is an abbreviation for Digital Imaging and Communication in Medicine.’) – This supplementary information is then added to the ultrasound image data to generate an image file configured to include DICOM image data (i.e., the standard use for medical communication). Therefore, the data received from the external record system is explicitly used to supplement the ultrasound images.)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the processor of Mienkina to be further configured to connect to an external record system during the ultrasound examination to retrieve data, and upload data to the external record system during the ultrasound examination as taught by Tanabe. The motivation to do this yields predictable results such as improving security for example leakage of personal information can be prevented, as suggested by Tanabe, ¶0091.
Claim 9: Mienkina discloses all the elements above in claim 1, Mienkina fails to disclose: wherein in response to being executed by the processor, the instructions cause the ultrasound system
However, Tanabe in the context of medical examination apparatus and medical examination systems, discloses: merge the ultrasound images in an output file with subject-specific information. (¶0040, ‘The number of electronic medical record terminals 10A, 10B, and 10C and ultrasound diagnostic apparatuses 20X, 20Y, and 20Z is not particularly limited. The medical examination system 100 is installed in a hospital. Each apparatus configuring the medical examination system 100 conforms to the digital image and communications in medicine (DICOM) standard, and communication between apparatuses is performed according to the DICOM.’; ¶0043, ‘The ultrasound diagnostic apparatus 20 generates supplementary information on the generated ultrasound image data based on the order information. The ultrasound diagnostic apparatus 20 generates an image file in accordance with the DICOM standard by adding the supplementary information to the ultrasound image data, and transmits the generated image file to PACS 30. DICOM is an abbreviation for Digital Imaging and Communication in Medicine.’, see also ¶0040-0044) – The apparat adds the supplementary information to the ultrasound image data to generate an image filed configured to include DICOM image data conforming to the DICOM standard.)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the processor of Mienkina to be further configured to merge the ultrasound images in an output file with subject-specific information as taught by Tanabe. The motivation to do this yields predictable results such as improving security for example leakage of personal information can be prevented, as suggested by Tanabe, ¶0091.
Claims 10 & 17 are rejected under 35 U.S.C. 103 as being unpatentable over Mienkina (US 2022/0071595 A1), as applied to claim 1, in further view of Choi et al (US 2018/0161010 A1).
Claim 10: Mienkina discloses all the elements above in claim 1, Mienkina fails to disclose: wherein in response to being executed by the processor, the instructions cause the ultrasound system
display information indicating completion of one or more scans for one or more scanning view captured during the ultrasound examination.
However, Choi in the context of ultrasound image processing discloses: display information indicating completion of one or more scans for one or more scanning view captured during the ultrasound examination. (¶0036, ‘Throughout the specification, “imaging status information” refers to imaging status information regarding target regions included in an imaging list, which includes pieces of information such as a target region of which imaging is completed, a target region of which imaging has been mistakenly omitted, a quality value for an acquired ultrasound image, progression of imaging being performed on the entire imaging list, etc.’; ¶0136, ‘When the target region E is currently being imaged, since imaging of the two (2) target regions A and B among a total of five (5) target regions is completed, the ultrasound image processing apparatus 300 may display the third imaging status information as the progress bar 820a or pie chart 820b indicating that about 40% of the ultrasound imaging has been completed.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the display of Mienkina such that it is configured to display information indicating completion of one or more scans for one or more scanning view captured during the ultrasound examination as taught by Choi. The motivation to do this yields predictable results such as preventing omission of imaging due to human errors that may occur during an ultrasound scan for acquiring a larger number of images of targer regions or standard vis, thereby improving the accuracy of the ultrasound scan, as suggested by Choi, ¶0129.
Claim 17: Mienkina discloses all the elements above in claim 12, Mienkina fails to disclose: further comprising: displaying information indicating completion of one or more scans for one or more scanning views captured during the ultrasound examination.
However, Choi in the context of ultrasound image processing discloses: displaying information indicating completion of one or more scans for one or more scanning views captured during the ultrasound examination. (¶0036, ‘Throughout the specification, “imaging status information” refers to imaging status information regarding target regions included in an imaging list, which includes pieces of information such as a target region of which imaging is completed, a target region of which imaging has been mistakenly omitted, a quality value for an acquired ultrasound image, progression of imaging being performed on the entire imaging list, etc.’; ¶0136, ‘When the target region E is currently being imaged, since imaging of the two (2) target regions A and B among a total of five (5) target regions is completed, the ultrasound image processing apparatus 300 may display the third imaging status information as the progress bar 820a or pie chart 820b indicating that about 40% of the ultrasound imaging has been completed.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the display of Mienkina such that it is configured for displaying information indicating completion of one or more scans for one or more scanning views captured during the ultrasound examination as taught by Choi. The motivation to do this yields predictable results such as preventing omission of imaging due to human errors that may occur during an ultrasound scan for acquiring a larger number of images of targer regions or standard vis, thereby improving the accuracy of the ultrasound scan, as suggested by Choi, ¶0129.
Conclusion
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/N.A.R./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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