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 .
Status of the Application
Claims 1-20 are currently pending in this case and have been examined and addressed below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/26/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 16 is objected to because of the following informalities:
Claim 16 is objected due to the typographical error in line 4. The claim limitation recites “providing at last one of the ultrasound machine log file or clinical parameters of the exam”. The limitation should recite “providing at least one of the ultrasound machine log file or clinical parameters of the exam”.
Appropriate correction is required.
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.
Independent claims 1 and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Step 1: Independent claim 1 is drawn to a machine. Independent claim 16 is drawn to a process. As such, independent claims 1 and 16 are drawn to one of the statutory categories of invention (Step 1: YES).
Step 2A - Prong One: In prong one of step 2A, the claim(s) is/are analyzed to evaluate whether it/they recite(s) a judicial exception.
Independent Claim 1: A ultrasound user performance evaluation system comprising:
a display;
and one or more processors in communication with the display and at least one memory which comprises computer-readable instructions which when executed cause the processor to:
generate one or more ultrasound user performance scores associated with a ultrasound user, the one or more ultrasound user performance scores based, at least in part, on information recorded in an ultrasound machine log file resulting from an ultrasound exam performed by the ultrasound user with an ultrasound scanner;
and display a ultrasound user performance dashboard configured to graphically represent the one or more ultrasound user performance scores.
Independent Claim 16: A method of providing performance evaluation of a ultrasound user, the method comprising:
receiving, by a processor in communication with a display, an ultrasound machine log file generated responsive to an exam performed by the ultrasound user with an ultrasound scanner;
providing at last one of the ultrasound machine log file or clinical context parameters of the exam to a predictive model;
using an output from the predictive model, determining one or more ultrasound user performance scores;
and graphically representing the one or more ultrasound user performance scores in a first graphical user interface (GUI) screen of a ultrasound user performance dashboard, the ultrasound user performance dashboard further comprising GUI widget for controlling information provided by the ultrasound user performance dashboard.
(Examiner notes: The above claim terms underlined are additional elements that fall under Step 2A - Prong Two analysis section detailed below)
These steps amount to methods of organizing human activity which includes functions relating to interpersonal and intrapersonal activities, such as managing relationships or transactions between people, social activities, and human behavior; satisfying or avoiding a legal obligation; advertising, marketing, and sales activities or behaviors; and managing human mental activity (MPEP § 2106.04(a)(2)(II)(C) citing the abstract idea grouping for methods of organizing human activity for managing personal behavior or relationships or interactions between people). Therefore, generate ultrasound user performance scores associated with a ultrasound user resulting from an ultrasound exam performed by the ultrasound user, graphically represent the ultrasound user performance scores, receiving an ultrasound machine log file generated responsive to an exam performed by the ultrasound user, providing the ultrasound machine log file or clinical context parameters of the exam, and determining ultrasound user performance scores are directed to managing personal interactions or personal behavior.
Step 2A - Prong Two: In prong two of step 2A, an evaluation is made whether a claim recites any additional element, or combination of additional elements, that integrate the exception into a practical application of that exception. An “additional element” is an element that is recited in the claim in addition to (beyond) the judicial exception (i.e., an element/limitation that sets forth an abstract idea is not an additional element). The phrase “integration into a practical application” is defined as requiring an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
Claim 1 recites the use of an ultrasound user performance evaluation system, display, one or more processors in communication with the display, one or more processors in communication with the display, at least one memory comprises computer-readable instructions when executed cause the processor, in this case to generate one or more ultrasound user performance scores associated with a ultrasound user, the one or more ultrasound user performance scores based, at least in part, on information recorded in an ultrasound machine log file resulting from an ultrasound exam performed by the ultrasound user. The claim further recites the use of a display a ultrasound user performance dashboard, in this case to graphically represent the one or more ultrasound user performance scores. The ultrasound user performance evaluation system, display, one or more processors in communication with the display, one or more processors in communication with the display, at least one memory comprises computer-readable instructions when executed cause the processor, and display a ultrasound user performance dashboard are only recited as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)).
Claims 1 and 16 recite the use of a ultrasound scanner, only as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)).
Claim 16 recite the use of a processor in communication with a display, in this case to receiving an ultrasound machine log file generated responsive to an exam performed by the ultrasound user, providing at last one of the ultrasound machine log file or clinical context parameters of the exam, using an output, determining one or more ultrasound user performance scores, and graphically representing the one or more ultrasound user performance scores. The claim further recites the use of a first graphical user interface (GUI) screen of a ultrasound user performance dashboard, the ultrasound user performance dashboard further comprising GUI widget for controlling information provided by the ultrasound user performance dashboard. The processor in communication with a display and the first graphical user interface (GUI) screen of a ultrasound user performance dashboard, the ultrasound user performance dashboard further comprising GUI widget for controlling information provided by the ultrasound user performance dashboard are only recited as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)). Additionally, the claim recites the use of a predictive model, in this case to determining one or more ultrasound user performance scores, only recites the predictive model as a tool to apply data to an algorithm and report the results (MPEP § 2106.05(f)(2)) amounting to instruction to implement the abstract idea using a general purpose computer.
Step 2B: In step 2B, the claims are analyzed to determine whether any additional element, or combination of additional elements, is/are sufficient to ensure that the claims amount to significantly more than the judicial exception.
As discussed above in “Step 2A – Prong 2”, the identified additional elements, such as the ultrasound user performance evaluation system, display, one or more processors in communication with the display, at least one memory comprises computer-readable instructions when executed cause the processor, ultrasound scanner, display a ultrasound user performance dashboard, processor in communication with a display, predictive model, and first graphical user interface (GUI) screen of a ultrasound user performance dashboard, the ultrasound user performance dashboard further comprising GUI widget for controlling information provided by the ultrasound user performance dashboard in independent claims 1 and 16 are equivalent to adding the words “apply it” on a generic computer. Each of these elements is only recited as a tool for performing steps of the abstract idea, such as the use of the computer and data processing devices to apply the algorithm. These additional elements therefore only amount to mere instructions to perform the abstract idea using a computer and are not sufficient to amount to significantly more than the abstract idea (MPEP 2016.05(f) see for additional guidance on the “mere instructions to apply an exception”). Each additional element under Step 2A, Prong 2 is analyzed in light of the specification’s explanation of the additional element’s structure. The claimed invention’s additional elements are directed to generic computer component and functions being used to perform the abstract idea.
This conclusion is based on a factual determination. Applicant’s own disclosure on paragraph [0031] acknowledges that the “processor 340 may be implemented by one or more general purpose processors and/or microprocessors configured to perform the tasks described herein, application specific circuits (ASICs), graphical processing units (GPUs), programmable gate arrays (FPGAs) or any suitable combinations thereof”. Paragraph [0033] discloses “local memory 330, which may be implemented by one or more memory devices arranged in any suitable combination. The memory 330 is configured to stores information 333 used or generated by the system 300. For example, the memory 330 may store executable instructions that configure the processor 340 to execute one or more of the functions associated therewith”. Additionally, paragraph [0030] discloses “the processor, display and memory of workstation 210 are part of the ultrasound scanner”. Paragraphs [0032], [0052], and [0055] acknowledge that the “user interface 350 includes a control panel 354, which may include any suitable combination of mechanical or hard controls (e.g., buttons, switches, dials, sliders, encoders, a trackball, etc.) and/or soft controls, such as a touch pad and various graphical user interface (GUI) elements that may include any suitable combination of menus, selectable icons, text-input fields, and various other controls or widgets, provided on a touch-sensitive display (or touch screen). The user interface 350 may include other well-known input and output devices. For example, the user interface 350 may optionally include audio feedback device(s) (e.g., alarms or buzzers), voice command receivers, which can receive and recognize a variety of auditory inputs, and tactile input and/or output devices (e.g., a vibrator arranged on a handheld probe for tactile feedback to the user)…and…The information presented via the GUI or dashboard 600 may be provided on one or more GUI screens or windows, such as the GUI screen 610 in FIG. 6, and optionally in additional screens 710and/or 810…and…The dashboard 600 may include one or more user controls or widgets (e.g., drill-down widget 620,evaluation period widget 626, etc.)”. Furthermore, the disclosure acknowledges in paragraphs [0004] and [0049] “the predictive model (e.g., a neural network)…and… the predictive model 430 may be implemented by one or more analytical models (e.g., regression analysis model), by one or more neural networks of any suitable architecture (e.g., an artificial, convolutional, or recurrent neural network)”. Paragraph [0024] discloses the “evaluation workstation 210 includes a processor 212, a display 214, and memory 216, which may be implemented by any suitable number and/or combination of non-volatile memory devices”. Additionally, paragraph [0037] discloses “the memory 330, which may be implemented by any suitable non-transitory computer readable medium (e.g., flash drive, disk drive)”.
The Examiner has therefore determined that no additional element, or combination of additional claims elements is/are sufficient to ensure the claim(s) amount to significantly more than the abstract idea identified above (Step 2B: NO).
Therefore, independent claims 1 and 16 are not eligible subject matter under 35 USC 101.
Similarly to independent claims 1 and 16, their dependent claims 2-15 and 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Step 1: As for the dependent claims, claims 2-15 are drawn to a machine and claims 17-20 are drawn to a process, as their respective independent claims. Therefore, similarly to the independent claims, the dependent claims are drawn to one of the statutory categories of invention (Step 1: YES).
Step 2A - Prong One:
The dependent claim 2 is directed to the ultrasound user performance scores comprises a numerical score and display a graphic representing the numerical score in addition to or instead of displaying the numerical score.
The dependent claim 3 is directed to display any ultrasound user performance scores associated with exam efficiency, display any ultrasound user performance scores associated with anatomical information efficiency, and display any ultrasound user performance scores associated with image quality.
The dependent claim 4 is directed to display ultrasound user feedback customized based on the one or more ultrasound user performance scores.
The dependent claim 5 is directed to provide the ultrasound machine log file as input and obtain the one or more ultrasound user performance scores as output.
The dependent claim 6 is directed to determine actual ultrasound user performance metrics associated with the ultrasound user from the ultrasound machine log file, obtain predicted ultrasound user performance metrics, and compare the actual performance ultrasound user metrics with the predicted ultrasound user performance metrics to generate the one or more ultrasound user performance scores.
The dependent claim 7 is directed to provide the ultrasound machine log file, one or more clinical context parameters, one or more clinical context parameters (404) associated with the ultrasound exam, or a combination thereof to obtain the predicted ultrasound user performance metrics.
The dependent claim 8 is directed to the one or more clinical context parameters are selected from patient age, patient body mass index (BM), patient type, nature or purpose of the ultrasound exam, and model of the ultrasound scanner.
The dependent claim 9 is directed to generate a respective set of predicted ultrasound user performance metrics for each of a plurality of different ultrasound user experience levels responsive to user input specifying a desired ultrasound user experience level.
The dependent claim 11 is directed to the actual ultrasound user performance metrics and the predicted ultrasound user performance metrics each comprise a plurality of actual and expected metrics, respectively, the metrics selected from total idle time, total dead time, total exam time, total patient preparation time, total number of button clicks, total number of button clicks of a given button type, and total number of acquisition settings changes.
The dependent claim 12 is directed to upon selection, to display one or more of the actual ultrasound user performance metrics concurrently with corresponding ones of the predicted ultrasound user performance metrics.
The dependent claim 13 is directed to enable a user to select a ultrasound user experience level against which the actual ultrasound user performance metrics are compared.
The dependent claim 14 is directed to receive respective ultrasound machine log files.
The dependent claim 17 is directed to providing the clinical context parameters to obtaining predicted performance metrics, determining actual performance metrics of the ultrasound user from information recorded in the ultrasound machine log file, comparing the actual performance metrics to corresponding ones of the predicted performance metrics to generate the one or more ultrasound user performance scores.
The dependent claim 18 is directed to determining the actual performance metrics comprises at least two of: determining a total idle time during the exam, determining a total dead time during the exam, determining a total duration of the exam, determining total imaging time of the exam, determining a total number of button clicks during the exam, and determining a total number of button clicks of a given type.
The dependent claim 19 is directed to comprising at least one of: displaying, responsive to a user request, the actual performance metrics concurrently with the predicted performance metrics; and specifying, by user input, a desired ultrasound user experience level to be compared against and updating the predicted performance metrics on the display based on the user input.
The dependent claim 20 is directed to access one or more ultrasound machine log files.
Each of these steps of the preceding dependent claims 2-15 and 17-20 only serve to further limit or specify the features of independent claims 1 and 16 accordingly, and hence are nonetheless directed towards fundamentally the same abstract idea as the independent claim and utilize the additional elements analyzed below in the expected manner.
As such, the Examiner concludes that the preceding claims recite an abstract idea (Step 2A – Prong One: YES).
Step 2A - Prong Two:
Dependent claim 2 recites the use of a ultrasound user performance dashboard, in this case to display a graphic representing the numerical score in addition to or instead of displaying the numerical score, only recites the ultrasound user performance dashboard as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)).
Dependent claim 3 recites the use of a graphical user interface (GUI) screen divided into a plurality of display areas selected from a first display area, in this case to display any ultrasound user performance scores associated with exam efficiency. The claim further recites the use of a second display area, in this case to display any ultrasound user performance scores associated with anatomical information efficiency. The graphical user interface (GUI) screen divided into a plurality of display areas selected from a first display area and the second display area are only recited as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)).
Dependent claims 3-4 recite the use of a third display area, in this case to display any ultrasound user performance scores associated with image quality, display ultrasound user feedback customized based on the one or more ultrasound user performance scores, only recites the third display area as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)).
Dependent claims 5-7 and 17 recite the use of a processor, in this case to provide the ultrasound machine log file as input, obtain the one or more ultrasound user performance scores as output, determine actual ultrasound user performance metrics associated with the ultrasound user from the ultrasound machine log file, obtain predicted ultrasound user performance metrics, compare the actual performance ultrasound user metrics with the predicted ultrasound user performance metrics to generate the one or more ultrasound user performance scores, provide the ultrasound machine log file, one or more clinical context parameters associated with the ultrasound exam to obtain the predicted ultrasound user performance metrics, only recites the processor as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)).
Dependent claims 5 and 17 recite the use of a trained neural network, only as a tool to apply data to an algorithm and report the results (MPEP § 2106.05(f)(2)) amounting to instruction to implement the abstract idea using a general purpose computer.
Dependent claims 6-7 and 9 recite the use of a predictive model, in this case to generate a respective set of predicted ultrasound user performance metrics for each of a plurality of different ultrasound user experience levels responsive to user input specifying a desired ultrasound user experience level, only recites the predictive model as a tool to apply data to an algorithm and report the results (MPEP § 2106.05(f)(2)) amounting to instruction to implement the abstract idea using a general purpose computer.
Dependent claim 10 recites the use of a predictive model comprises a trained neural network, only as a tool to apply data to an algorithm and report the results (MPEP § 2106.05(f)(2)) amounting to instruction to implement the abstract idea using a general purpose computer.
Dependent claims 12-13 recite the use of a the ultrasound user performance dashboard comprises a user control, in this case to display one or more of the actual ultrasound user performance metrics concurrently with corresponding ones of the predicted ultrasound user performance metrics, enable a user to select a ultrasound user experience level against which the actual ultrasound user performance metrics are compared, only recites the ultrasound user performance dashboard comprises a user control as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)).
Dependent claim 14 recites the use of a processor, the display, and the memory are integrated into a workstation of a medical institution, the workstation be communicatively coupled, via a network, to a plurality of ultrasound scanners of the medical institution, only as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)).
Dependent claim 15 recites the use of a processor, the display, and the memory are part of the ultrasound scanner, only as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)).
Dependent claim 20 recites the use of a non-transitory computer readable medium comprising computer- readable instructions, which when executed by one or more processors , in this case to access one or more ultrasound machine log files, only recites the A non-transitory computer readable medium comprising computer- readable instructions, which when executed by one or more processors as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)).
The Examiner has therefore determined that the additional elements, or combination of additional elements, do not integrate the abstract idea into a practical application. Accordingly, the claim(s) is/are directed to an abstract idea (Step 2A – Prong two: NO).
Step 2B:
As discussed above in “Step 2A – Prong 2”, the identified additional elements, such as the ultrasound user performance dashboard, graphical user interface (GUI) screen divided into a plurality of display areas selected from a first display area, second display area, third display area, processor, trained neural network, predictive model, predictive model comprises a trained neural network, the ultrasound user performance dashboard comprises a user control, the processor, the display, and the memory are part of the ultrasound scanner, and a non-transitory computer readable medium comprising computer- readable instructions, which when executed by one or more processors in dependent claims 2-15 and 17-20 are equivalent to adding the words “apply it” on a generic computer. Each of these elements is only recited as a tool for performing steps of the abstract idea, such as the use of the computer and data processing devices to apply the algorithm. These additional elements therefore only amount to mere instructions to perform the abstract idea using a computer and are not sufficient to amount to significantly more than the abstract idea (MPEP 2016.05(f) see for additional guidance on the “mere instructions to apply an exception”). Each additional element under Step 2A, Prong 2 is analyzed in light of the specification’s explanation of the additional element’s structure. The claimed invention’s additional elements are directed to generic computer component and functions being used to perform the abstract idea.
The Examiner has therefore determined that no additional element, or combination of additional claims elements is/are sufficient to ensure the claim(s) amount to significantly more than the abstract idea identified above (Step 2B: NO).
Therefore, dependent claims 2-15 and 17-20 are not eligible subject matter under 35 USC 101.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cyr (US-20100203487-A1)[hereinafter Cyr].
As per Claim 1, Cyr discloses a ultrasound user performance evaluation system in paragraphs [0013] and [0018] and [0020] (ultrasound imaging simulation system that assesses the candidate's competency in performing an examination) comprising: a display in paragraph [0020] (a console); and one or more processors in communication with the display in paragraph [0020] (central processing unit interfacing with the console) and at least one memory which comprises computer-readable instructions which when executed cause the processor in paragraphs [0020] and [0022] (a memory that includes computer-readable instructions executed by the central processing unit to perform the necessary certification examination functions) to: generate one or more ultrasound user performance scores associated with a ultrasound user, the one or more ultrasound user performance scores based, at least in part, on information recorded in an ultrasound machine log file resulting from an ultrasound exam performed by the ultrasound user with an ultrasound scanner in paragraphs [0003] and [0020-0021] and [0023-0025] (determine a performance score (synonymous to one or more ultrasound user performance scores) associated with the candidate (synonymous to a ultrasound user), the performance score based on final settings of the knobs (synonymous to an ultrasound machine log file) resulting from an ultrasound exam performed by the candidate with a medical ultrasound imaging instrument (synonymous to an ultrasound scanner)); and display a ultrasound user performance dashboard configured to graphically represent the one or more ultrasound user performance scores in paragraph [0021] (provide the assessment score, wherein the assessment score includes the performance score).
Claims 16 and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by ABDOLELL et al. (US-20230071400-A1)[hereinafter Abdolell].
As per Claim 16, Abdolell discloses a method of providing performance evaluation of a ultrasound user in paragraphs [0065] and [0125] and [0134] (a method of allowing for visual assessment of medical images taken by a medical radiation therapist (synonymous to a ultrasound user), wherein a medical radiation therapist may be evaluated on ultrasound images), the method comprising: receiving, by a processor in communication with a display, an ultrasound machine log file generated responsive to an exam performed by the ultrasound user with an ultrasound scanner in paragraphs [0022] and [0029] and [0121-0122] and [0125] and [0139] and [0225-0231] (receiving, by a processor in communication with a display device, image metadata (synonymous to an ultrasound machine log file) generated responsive to an exam performed by the medical radiation therapist with a medical imaging system (synonymous to an ultrasound scanner)); providing at last one of the ultrasound machine log file or clinical context parameters of the exam to a predictive model in paragraph [0005] and Figure 2 (providing the plurality of image quality parameter features (synonymous to clinical context parameters)to predictive models); using an output from the predictive model, determining one or more ultrasound user performance scores in paragraphs [0005-0006] and [0142] and Figures 3 and 4 (using an output from the predictive model to determine an overall predicted image quality score (synonymous to one or more ultrasound user performance scores)); and graphically representing the one or more ultrasound user performance scores in a first graphical user interface (GUI) screen of a ultrasound user performance dashboard, the ultrasound user performance dashboard further comprising GUI widget for controlling information provided by the ultrasound user performance dashboard in paragraphs [0005] and [0011] and [0015] and [0142] and [0153] (display the overall predicted image quality score in a graphical user interface (GUI) of a user report card interface (synonymous to a ultrasound user performance dashboard), the user report card interface includes a user configurable operating point (synonymous to a GUI widget) for controlling information provided by the user report card interface).
As per Claim 20, Abdolell discloses the method of claim 16, Abdolell also discloses a non-transitory computer readable medium comprising computer- readable instructions, which when executed by one or more processors configured to access one or more ultrasound machine log files, cause the one or more processors to perform the method of claim 16 in paragraphs [0022] and [0029] and [0121-0125] and [0139] and [0225-0231] (a non-transitory computer-readable storage medium comprising computer programs, when executed by one or more processors to access the image metadata (synonymous to an ultrasound machine log file)).
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.
Claim 2 are rejected under 35 U.S.C. 103 as being unpatentable over Cyr (US-20100203487-A1)[hereinafter Cyr], in view of Dandan (US-20220318716-A1)[hereinafter Dandan].
As per Claim 2, Cyr discloses the system of claim 1, Cyr also discloses wherein each of the one or more ultrasound user performance scores comprises a numerical score in paragraph [0032] (the performance score is a numerical score).
Cyr does not disclose the following limitations. However, Dandan discloses and wherein the ultrasound user performance dashboard is configured to display a graphic representing the numerical score in addition to or instead of displaying the numerical score in paragraphs [0024] and [0048] (the user interface may display an indication of performance scores (synonymous to a graphic representing the numerical score), wherein the indication may include a letter grade scale or a color scale).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a ultrasound user performance evaluation system, as disclosed by Cyr, to be combined with the performance scores including a numerical score and the performance dashboard displaying a graphic representing the numerical score, as disclosed by Dandan, for the purpose of improving the presentation of a performance evaluation for an employee [0001].
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Cyr (US-20100203487-A1)[hereinafter Cyr], in view of Dandan (US-20220318716-A1)[hereinafter Dandan], in view of Tolsgaard, M.G. (“Reliable and valid assessment of ultrasound operator competence in obstetrics and gynecology”)[hereinafter Tolsgaard].
As per Claim 3, Cyr and Dandan disclose the system of claim 2.
Cyr does not disclose the following limitations. However, Dandan discloses wherein the ultrasound user performance dashboard comprises a graphical user interface (GUI) screen divided into a plurality of display areas selected from a first display area configured to display any ultrasound user performance scores in paragraphs [0015] and [0022] and [0046] (the user interface includes a plurality of display areas to display performance scores).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a ultrasound user performance evaluation system, as disclosed by Cyr, to be combined with displaying the performance scores, as disclosed by Dandan, for the purpose of improving the presentation of a performance evaluation for an employee [0001].
Cyr and Dandan do not disclose the following limitations. However, Tolsgaard discloses display any ultrasound user performance scores associated with exam efficiency in Table 1 on page 439 and Figure 3 on page 440 (display a performance score associated with exam efficiency (Examiner notes that the operator of the ultrasound being evaluated on the familiarity with operating the equipment during the exam indicates exam efficiency)), display any ultrasound user performance scores associated with anatomical information efficiency in Table 1 on page 439 and Figure 3 on page 440 (display a performance score associated with interpretation of images (synonymous to anatomical information efficiency)), and display any ultrasound user performance scores associated with image quality in Table 1 on page 439 and Figure 3 on page 440 (display a performance score associated with image optimization).
Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself- that is in the substitution of the performance scores associated with exam efficiency, anatomical information efficiency, and image quality, as discloses in Tolsgaard, for the performance score, as disclosed in Dandan.
As per Claim 4, Cyr, Dandan, Tolsgaard disclose the system of claim 3.
Cyr does not disclose the following limitations. However, Dandan discloses wherein the GUI screen further comprises a third display area configured to display ultrasound user feedback customized based on the one or more ultrasound user performance scores in paragraphs [0054] (the user interface includes a display area to display feedback customized based on the performance score).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a ultrasound user performance evaluation system, as disclosed by Cyr, to be combined with displaying user feedback customized based on the performance scores, as disclosed by Dandan, for the purpose of improving the presentation of a performance evaluation for an employee [0001].
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Cyr (US-20100203487-A1)[hereinafter Cyr], in view of Park et al. (US-20220237540-A1)[hereinafter Park).
As per Claim 5, Cyr discloses the system of claim 1.
Cyr does not disclose the following limitations. However, Park discloses wherein the processor is configured to provide the ultrasound machine log file as input to a trained neural network and obtain the one or more ultrasound user performance scores as output from the trained neural network in paragraphs [0020] and [0025-0026] (provide the sequence of actions for a particular task (synonymous to the ultrasound machine log file) as input to the model (synonymous to a trained neural network), wherein the model may be a recurrent neural network, and obtain one or more performance ratings of the user (synonymous to one or more ultrasound user performance scores) as output from the model (Examiner notes that the tasks may be identified from logs)).
It would have been obvious to one of ordinary still in the art to include in the ultrasound user performance evaluation system of Cyr with providing the machine log file as input to a trained neural network and obtain user performance scores as the output as taught by Park since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately. One of ordinary skill in the art would have recognized that the results of the combination were predictably an ultrasound user performance evaluation system that obtains user performance scores.
Claims 6-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Cyr (US-20100203487-A1)[hereinafter Cyr], in view of Fox et al. (US-20120070811-A1)[hereinafter Fox], in view of AMTHOR (US-20190027243-A1)[hereinafter Amthor].
As per Claim 6, Cyr discloses the system of claim 1.
Cyr does not disclose the following limitations. However, Fox discloses wherein the processor is configured to: determine actual ultrasound user performance metrics associated with the ultrasound user from the ultrasound machine log file in paragraphs [0021] (determine the known radiologist's performance metrics (synonymous to actual ultrasound user performance metrics) associated with the radiologist (synonymous to the ultrasound user) from the work list (synonymous to the ultrasound machine log file)); and compare the actual performance ultrasound user metrics with the predicted ultrasound user performance metrics to generate the one or more ultrasound user performance scores in paragraphs [0009] and [0021-0022] and [0036-0037] (compare the known radiologist's performance metrics with the estimated radiologist's performance metrics (synonymous to predicted ultrasound user performance metrics) to generate a performance score).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention a ultrasound user performance evaluation system, as disclosed by Cyr, to be combined with determine actual user performance metrics from the machine log file, as disclosed by Fox, for the purpose of improving the radiologist's efficiency and satisfaction and improving the radiologist department quality and profitability [0004-0007].
The combination of Cyr and Fox disclose obtaining the predicted user performance metrics, but do not disclose obtaining the predicted user performance metrics from a predictive model. However, Amthor discloses obtain predicted ultrasound user performance metrics from a predictive model in paragraphs [0076] and [0078] and [0081] (obtain predictive diagnostic values of clinical workflows (synonymous to ultrasound user performance metrics) from a predictive model (Examiner notes that the diagnostic value of clinical workflow are based on the radiologist's clinical workflow or performance that results in the acquisition of the medical images, indicating the diagnostic value being an ultrasound user performance metric)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention a ultrasound user performance evaluation system, as disclosed by Cyr and Fox, to be combined with obtaining predicted user performance metrics from a predictive model, as disclosed by Amthor, for the purpose of improving the cost and quality of care [0002-0003].
As per Claim 7, Cyr, Fox, and Amthor disclose the system of claim 6.
Cyr and Fox do not disclose the following limitations. However, Amthor discloses wherein the processor is configured to provide the ultrasound machine log file, one or more clinical context parameters associated with the ultrasound exam, or a combination thereof to the predictive model to obtain the predicted ultrasound user performance metrics in paragraphs [0016] and [0076] and [0081] and [0085-0086] (provide the imaging apparatus system log (synonymous to an ultrasound machine log file), clinical workflow parameters associated with the clinical workflow that results in acquisition of medical images during a patient exam (synonymous to the clinical context parameters associated with the ultrasound exam) to the predictive model to obtain the predicted diagnostic value).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention a ultrasound user performance evaluation system, as disclosed by Cyr and Fox, to be combined with providing the machine log file and clinical context parameters to the predictive model to obtain the predicted user performance metrics, as disclosed by Amthor, for the purpose of improving the cost and quality of care [0002-0003].
As per Claim 8, Cyr, Fox, and Amthor disclose the system of claim 7.
Cyr and Fox do not disclose the following limitations. However, Amthor discloses wherein the one or more clinical context parameters are selected from patient age, patient body mass index (BM), patient type, nature or purpose of the ultrasound exam, and model of the ultrasound scanner in paragraphs [0086-0088] (the clinical workflow parameters are selected from patient information, wherein patient information includes whether the patient moves a lot during the exam (Examiner notes that whether the patient moves a lot during the exam indicates a patient type. Additionally, the patient type being a clinical workflow parameter meets the limitation of the patient type being selected from the list of clinical context parameters)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention a ultrasound user performance evaluation system, as disclosed by Cyr and Fox, to be combined with the patient type being selected as the clinical context parameter, as disclosed by Amthor, for the purpose of improving the cost and quality of care [0002-0003].
As per Claim 10, Cyr Fox, and Amthor disclose the system of claim 6.
Cyr and Fox do not disclose the following limitations. However, Amthor discloses wherein the predictive model comprises a trained neural network in paragraphs [0080] and [0085-0086] (the predictive model includes a trained neural network).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention a ultrasound user performance evaluation system, as disclosed by Cyr and Fox, to be combined with the predictive model including a trained neural network, as disclosed by Amthor, for the purpose of improving the cost and quality of care [0002-0003].
Claims 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Cyr (US-20100203487-A1)[hereinafter Cyr], in view of Fox et al. (US-20120070811-A1)[hereinafter Fox], in view of AMTHOR (US-20190027243-A1)[hereinafter Amthor], in view of Lindkvist (US-20190340956-A1)[hereinafter Lindkvist].
As per Claim 9, Cyr, Fox, and Amthor disclose the system of claim 6.
Cyr, Fox, and Amthor do not disclose the following limitations. However, Lindkvist discloses wherein the predictive model is configured to generate a respective set of predicted ultrasound user performance metrics for each of a plurality of different ultrasound user experience levels responsive to user input specifying a desired ultrasound user experience level in paragraphs [0022] and [0030] and [0071-0072] and [0090] (generate the expected performance metrics for each of a variety of different experience levels (synonymous to a plurality of different ultrasound user experience levels) responsive to a specified proficiency or experience level).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a ultrasound user performance evaluation system, as disclosed by Cyr, Fox, and Amthor, to be combined with the predictive model to generate predicted user performance metrics for each of a plurality of different experience levels responsive to user input specifying a desired user experience level, as disclosed by Lindkvist, for the purpose of clearly, objectively, and unambiguously assessing a medical practitioner's performance of a medical procedure [0006].
As per Claim 11, Cyr, Fox, and Amthor disclose the system of claim 6.
Cyr, Fox, and Amthor do not disclose the following limitations. However, Lindkvist discloses wherein the actual ultrasound user performance metrics and the predicted ultrasound user performance metrics each comprise a plurality of actual and expected metrics, respectively, the metrics selected from total idle time, total dead time, total exam time, total patient preparation time, total number of button clicks, total number of button clicks of a given button type, and total number of acquisition settings changes in paragraphs [0028] and [0030] and [0032] and [0036-0040] (the performance metrics include actual and expected metrics selected from total procedure time (synonymous to total exam time) (Examiner notes that total procedure time being a performance metric meets the limitation of the total exam time being selected from the list of performance metrics)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a ultrasound user performance evaluation system, as disclosed by Cyr, Fox, and Amthor, to be combined with total exam time being selected as performance metrics, as disclosed by Lindkvist, for the purpose of clearly, objectively, and unambiguously assessing a medical practitioner's performance of a medical procedure [0006].
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Cyr (US-20100203487-A1)[hereinafter Cyr], in view of Fox et al. (US-20120070811-A1)[hereinafter Fox], in view of AMTHOR (US-20190027243-A1)[hereinafter Amthor], in view of Mullinjer (US-20220253784-A1)[hereinafter Mullinjer].
As per Claim 12, Cyr, Fox, and Amthor disclose the system of claim 6.
Cyr, Fox, and Amthor do not disclose the following limitations. However, Mullinjer discloses wherein the ultrasound user performance dashboard comprises a user control configured, upon selection, to display one or more of the actual ultrasound user performance metrics concurrently with corresponding ones of the predicted ultrasound user performance metrics in paragraphs [0027] and [0042] and [0116] and [0140-0142] (the graphical user interface (synonymous to the ultrasound user performance dashboard) includes an interactive tool (synonymous to user control), upon selection, to display actual performance metrics (synonymous to actual ultrasound user performance metrics) with corresponding predicted performance metrics (synonymous to predicted ultrasound user performance metrics)).
It would have been obvious to one of ordinary still in the art to include in the ultrasound user performance evaluation system of the combination Cyr, Fox, Amthor with the graphical user interface including an interactive tool to display the actual and predicted user performance metrics as taught by Mullinjer since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately. One of ordinary skill in the art would have recognized that the results of the combination were predictably an ultrasound user performance evaluation system including an ultrasound user performance dashboard including user control to display the actual and predicted user performance metrics.
As per Claim 13, Cyr, Fox, and Amthor disclose the system of claim 6.
Cyr, Fox, and Amthor do not disclose the following limitations. However, Mullinjer discloses wherein the ultrasound user performance dashboard comprises a user control configured to enable a user to select a ultrasound user experience level against which the actual ultrasound user performance metrics are compared in paragraphs [0042] and [0110] and [0118] and [0122] (the graphical user interface includes an interactive tool to enable a user to select a performance level to understand the relationship between to the actual performance metrics and the user's performance).
It would have been obvious to one of ordinary still in the art to include in the ultrasound user performance evaluation system of the combination Cyr, Fox, Amthor with the graphical user interface including an interactive tool to enable the user to select a performance level to compare against the actual user performance metrics as taught by Mullinjer since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately. One of ordinary skill in the art would have recognized that the results of the combination were predictably an ultrasound user performance evaluation system including an ultrasound user performance dashboard including user control to enable a user to select a ultrasound user experience level against the actual ultrasound user performance metrics are compared.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Cyr (US-20100203487-A1)[hereinafter Cyr], in view of AMTHOR (US-20190027243-A1)[hereinafter Amthor].
As per Claim 14, Cyr discloses the system of claim 1.
Cyr does not disclose the following limitations. However, Amthor discloses wherein the processor, the display and the memory are integrated into a workstation of a medical institution, the workstation being communicatively coupled, via a network, to a plurality of ultrasound scanners of the medical institution to receive respective ultrasound machine log files from any one of the plurality of ultrasound scanners in paragraphs [0077-0078] and [0083-0085] and [0104] and Figure 1 (the processor, display, and the memory are integrated into a system, referred to as a workstation of a hospital (synonymous to medical institution), the system couples to a network, to a plurality of imaging apparatuses of the hospital to receive system logs from the imaging apparatuses).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention a ultrasound user performance evaluation system, as disclosed by Cyr, to be combined with the processor, the display, and memory integrated into a workstation of a medical institution to receive machine log files from ultrasound scanners, as disclosed by Amthor, for the purpose of improving the cost and quality of care [0002-0003].
As per Claim 15, Cyr discloses the system of claim 1.
Cyr does not disclose the following limitations. However, Amthor discloses wherein the processor, the display and the memory are part of the ultrasound scanner in paragraphs [0026] and [0077-0078] and [0083-0085] and Figure 1 (the processor, display, and memory are part of the imaging apparatus (Examiner notes that the system may be embodied as a workstation or an imaging apparatus, wherein the imaging apparatus may be an ultrasound)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention a ultrasound user performance evaluation system, as disclosed by Cyr, to be combined with the processor, the display, and memory part of the ultrasound scanner, as disclosed by Amthor, for the purpose of improving the cost and quality of care [0002-0003].
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over ABDOLELL et al. (US-20230071400-A1)[hereinafter Abdolell], in view of Fox et al. (US-20120070811-A1)[hereinafter Fox].
As per Claim 17, Abdolell discloses the method of claim 16 further comprising: Abdolell also discloses providing the clinical context parameters to a trained neural network to obtaining predicted performance metrics in paragraphs [0005] and [0019-0020] and [0135] (providing the plurality of image quality parameter features (synonymous to clinical context parameters)to a trained neural network to obtain image quality parameter scores (synonymous to predicted performance metrics)).
Abdolell does not disclose the following limitations. However, Fox discloses determining, by the processor, actual performance metrics of the ultrasound user from information recorded in the ultrasound machine log file in paragraphs [0021] and [0052] (determine, by the processor, the known radiologist's performance metrics (synonymous to actual ultrasound user performance metrics)of the radiologist (synonymous to the ultrasound user) from the work list (synonymous to the information recorded in the ultrasound machine log file)); and comparing the actual performance metrics to corresponding ones of the predicted performance metrics to generate the one or more ultrasound user performance scores in paragraphs [0009] and [0021-0022] and [0036-0037] (compare the known radiologist's performance metrics with the estimated radiologist's performance metrics (synonymous to predicted ultrasound user performance metrics) to generate a performance score).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention a method of providing performance evaluation of a ultrasound user, as disclosed by Abdolell, to be combined with determine actual user performance metrics from the machine log file and generating user performance scores by comparing the actual and predicted performance metrics, as disclosed by Fox, for the purpose of improving the radiologist's efficiency and satisfaction and improving the radiologist department quality and profitability [0004-0007].
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over ABDOLELL et al. (US-20230071400-A1)[hereinafter Abdolell], in view of Fox et al. (US-20120070811-A1)[hereinafter Fox], in view of Lindkvist (US-20190340956-A1)[hereinafter Lindkvist].
As per Claim 18, Abdolell and Fox disclose the method of claim 17.
Abdolell and Fox do not disclose the following limitations. However, Lindkvist discloses wherein said determining the actual performance metrics comprises at least two of: determining a total idle time during the exam, determining a total dead time during the exam, determining a total duration of the exam, determining total imaging time of the exam, determining a total number of button clicks during the exam, and determining a total number of button clicks of a given type in paragraphs [0028] and [0030] and [0032] and [0036-0040] (determining the performance metrics include a from total procedure time (synonymous to total exam time) and total imaging time of the exam (Examiner notes that total procedure time and the total imaging time meet the at least two of limitation)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a method of providing performance evaluation of a ultrasound user, as disclosed by Abdolell and Fox, to be combined with total exam time being selected as performance metrics, as disclosed by Lindkvist, for the purpose of clearly, objectively, and unambiguously assessing a medical practitioner's performance of a medical procedure [0006].
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over ABDOLELL et al. (US-20230071400-A1)[hereinafter Abdolell], in view of Fox et al. (US-20120070811-A1)[hereinafter Fox], in view of Mullinjer (US-20220253784-A1)[hereinafter Mullinjer].
As per Claim 19, Abdolell and Fox disclose the method of claim 17.
Abdolell and Fox do not disclose the following limitations. However, Mullinjer discloses further comprising at least one of: displaying, responsive to a user request, the actual performance metrics concurrently with the predicted performance metrics in paragraphs [0027] and [0042] and [0116] and [0140-0142] (displaying, responsive to user selection, actual performance metrics (synonymous to actual ultrasound user performance metrics) with corresponding predicted performance metrics (synonymous to predicted ultrasound user performance metrics)); and specifying, by user input, a desired ultrasound user experience level to be compared against and updating the predicted performance metrics on the display based on the user input in paragraphs [0029] and [0042] and [0110] and [0118] and [0122] (selecting, by user input, a performance level (synonymous to a desired ultrasound user experience level) to understand the relationship between to the actual performance metrics and the user's performance and updating the predictive performance metrics on the user interface based on the user input).
It would have been obvious to one of ordinary still in the art to include in a method of providing performance evaluation of a ultrasound user of the combination Abdolell and Fox with the graphical user interface including an interactive tool to display the actual and predicted user performance metrics and enable the user to select a performance level to compare against the actual user performance metrics as taught by Mullinjer since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately. One of ordinary skill in the art would have recognized that the results of the combination were predictably a method for providing a ultrasound user performance evaluation displaying the predicted performance metrics and enabling a user to select a ultrasound user experience level against the actual ultrasound user performance metrics are compared.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Oglat AA, Dheyab MA. Performance Evaluation of Ultrasonic Imaging System (Part I). J Med Ultrasound. (2021) teaches on evaluating the performance of an ultrasound imaging system.
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/K.N.W./Examiner, Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682