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 .
DETAILED ACTION
Status of the Application
Claims 1-20 are currently pending in this case and have been examined and addressed below. This communication is a Final Rejection in response to the Amendment to the Claims and Remarks filed on 06/23/2026.
Claims 1, 9, and 17 are currently amended.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/14/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 therefore, subject to the conditions and requirements of this title.
Claims 1-20 are rejected because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1-8 fall within the statutory category of a process. Claims 9-16 fall within the statutory category of an apparatus or system. Claims 17-20 fall within the statutory category of an apparatus or system.
Step 2A, Prong One
As per Claims 1, 9, and 17, the limitations of generating a standardized training dataset by applying one or more data transformations to each clinical trial participant record in a corpus of data gathered about clinical trial participants of one or more historical clinical trials; determining one or more key features of the clinical trial participants, wherein one or more key features correspond to individual characteristics of the clinical trial participants; training a machine learning computer model using the standardized training dataset and the one or more key features of the clinical trial participants to generate a patient burden score, a site burden score, and a cost burden quantifying a patient’s burden and experience participant in at least one clinical trial which comprises determining a structure of the data and at least one protocol-specific dimension associated with patient burden or convenience factors based on clinical study data and patient data in the standardized training dataset, determining associations between the patient burden score and protocol performance outcomes including at least one of cycle times, number of amendments, enrollment rate, patient retention, and screen failure rates, based on historical operational parameters and the one or more key features, and updating the machine learning computer model based on testing and validating the association using de-identified protocols and previous studies assessing protocol design practices until one or more accuracy thresholds are satisfied; mapping the set of operational parameters and the set of endpoints to one or more procedures of the clinical trial; and calculating a patient burden score, a site burden score, and cost burden quantifying a patient’s burden and experience participating in the clinical trial based on the set of operational parameters, the set of endpoints, and the one or more key features, under its broadest reasonable interpretation, covers performance of the limitation in the mind. Generating a standardized training dataset by applying one or more data transformations to each clinical trial participant record does not recite a particular mathematical calculation used for the data transformations and therefore can be performed in any manner. Therefore, this can be performed using human mental observation, evaluation, judgement and opinion. Determining key features of the clinical trial participants can also be performed using human mental observation, evaluation, judgement and opinion. The type of training utilized by the claimed invention is only described as determining a structure of the data and a protocol-specific dimension associated with patient burden or convenience factors, determining associations between the patient burden score and protocol performance outcomes, and updating the machine learning model based on testing and validating the associations using de-identified protocols and previous studies until accuracy thresholds are reached. Because this does not recite or describe a particular mathematical calculation to perform the training, Examiner then analyzes the training based on the steps recited in the claims which can be performed using human mental evaluation, observation, judgment, and opinion. The updating of the model additionally is not described beyond testing and validating using de-identified protocols and determining accuracy thresholds are satisfied, which are activities that can be performed using human mental observation, evaluation, judgement and opinion. Therefore, the training a machine learning computing model is considered to be part of the abstract idea because the steps of training fall under data manipulations that humans perform and are thus a part of the mental process. Mapping the operational parameters and the endpoints to procedures of the clinical trial and calculating burden scores quantifying a patient’s burden and experience are concepts performed including observation, evaluation, judgement and opinion in the human mind. If a claim limitation, under its broadest reasonable interpretation, covers the performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Step 2A, Prong Two
The judicial exception is not integrated into a practical application because the additional elements and combination of additional elements do not impose meaningful limits on the judicial exception. In particular, the claims recite the additional element – a server comprising a processor and non-transitory computer-readable medium. The server in these steps is recited at a high-level of generality, such that it amounts to no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims recite the additional elements of using a strength of feature analysis and executing the machine learning computer model to carry out the abstract idea. This amounts to mere instructions to apply the exception, as per MPEP 2106.05(f)(2) because the use of a mathematical algorithm (a strength of feature analysis, and the machine learning computer model) applied on a general purpose computer amounts to mere instructions to apply the exception. The claim elements do not include any details of how the training is performed or how the learning a strength of relationship between the parameters of historical trials and key features is performed. Based on the claim language, any method of determining a strength of relationship could be used to learn a strength of relationship which is used to train the model. This is merely claiming the result or solution and not the details of how the solution is accomplished, which amounts to mere instructions to apply the exception, as per MPEP 2106.05(f)(1). Mere instructions to apply the exception does not integrate the abstract idea into a practical application or provide significantly more than the abstract idea. The claims also recite the additional elements of receiving a set of operational parameters associated with a clinical trial, a set of endpoints associated with the clinical trial, and at least one attribute associated with the clinical trial which amounts to insignificant extra-solution activity, as in MPEP 2106.05(g), because the step of receiving operational parameter attributes are mere data gathering in conjunction with the abstract idea where the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering). The claims also recite the additional element of populating a set of visual elements within a graphical user interface, which indicate the scores and burden classification for each procedure of the clinical trial based on a comparison between the scores and a range of scores from a set of historical clinical studies, which comprises: a first visual indicator representing a range of burden values for the set of historical clinical studies displayed as a bounded graphical region; a second visual indicator representing the burden score for the clinical trial positioned within the bounded graphical region relative to the range of burden values, wherein the second visual indicator is dynamically updated in response to a revision to one or more attributes of the clinical trial, such that the at least one second visual indicator is repositioned within the bounded graphical region based on a recalculated burden score; and one or more benchmark visual indicators representing burden scores of one or more benchmark clinical trials positioned within the bounded graphical region, wherein the set of visual elements allows a user to visually compare the patient burden score of the clinical trial against both the range of historical values and the benchmark clinical trials without navigating through multiple screens or raw protocol documents, which amounts to insignificant extra-solution activity, as in MPEP 2106.05(g), because the steps of populating a set of elements in a graphical user interface are mere data outputting in conjunction with the abstract idea where the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering). The key features are described as corresponding to individual characteristics of the clinical trial participants. The visual elements are described as representing a range of burden values for the set of historical studies displayed as a bounded graphical region, a burden score for the clinical trial positioned within the bounded graphical region, and a benchmark visual indicator representing burden scores of benchmark trials positioned within the bounded graphical region. This is merely a description of the data type and not a functional limitation, therefore, this does not integrate the abstract idea into a practical application. The claims also include updating the second visual indicator in response to a revision to attributes of the clinical trial. This describes mere data outputting as a result of the abstract idea. Any revision of the attributes of the clinical trial results in an update to the data analysis performed as part of the abstract idea and the update to the visual indicator is merely outputting the updated results of the data analysis, which is insignificant extra-solution activity as mere data outputting. The claims also recite the visual elements allow a user to visually compare the patient burden score of the clinical trial against both the range of historical values and the benchmark clinical trials without navigating through multiple screens or raw protocol documents. This is the intended use of the display of visual elements, which is not positively recited and therefore is not given patentable weight in the analysis. Because the additional elements do not impose meaningful limitations on the judicial exception, the claim is directed to an abstract idea.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. As discussed above with the respect to integration of the abstract idea into a practical application, the additional element of a server comprising a processor and non-transitory computer-readable medium to perform the method of the invention amounts to no more than mere instructions to apply the exception using a generic computing component. The server including the processor and non-transitory computer-readable medium are recited at a high level of generality and are recited as generic computer components by reciting any of various processors including circuitry that performs a function or operation embodied as a microprocessor, microcontroller, etc. (Specification, [0003-0004]), and a RAM, ROM, or other optical disk storage (Specification [00148]), which do not add meaningful limitations to the abstract idea beyond mere instructions to apply an exception. The claims also include the use of mathematical algorithms applied on the general purpose computer to carry out the abstract idea, including a strength of feature analysis and machine learning computer model. These amount to mere instructions to apply the exception, as per MPEP 2106.05(f)(2). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claims also include the additional elements of receiving a set of operational parameter attributes associated of a clinical trial and populating a set of visual elements within a graphical user interface, which indicated the scores and burden classification based on a comparison between the scores and a range of scores from a set of historical clinical studies, which comprises: a first visual indicator representing a range of burden values for the set of historical clinical studies displayed as a bounded graphical region; a second visual indicator representing the burden score for the clinical trial positioned within the bounded graphical region relative to the range of burden values, wherein the second visual indicator is dynamically updated in response to a revision to one or more attributes of the clinical trial, such that the at least one second visual indicator is repositioned within the bounded graphical region based on a recalculated burden score; and one or more benchmark visual indicators representing burden scores of one or more benchmark clinical trials positioned within the bounded graphical region, wherein the set of visual elements allows a user to visually compare the patient burden score of the clinical trial against both the range of historical values and the benchmark clinical trials without navigating through multiple screens or raw protocol documents, which are elements that are well-understood, routine and conventional computer functions in the field of data management because they are claimed at a high level of generality and include receiving or transmitting data as well as presenting data, which have been found to be well-understood, routine and conventional computer functions by the Court (MPEP 2106.05(d)(II)(i) Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added) and (iv) Presenting offers and gathering statistics, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93). Updating the second visual indicator in response to a revision to attributes of the clinical trial is described in the specification ([0007]) as performed by the interactive electronic platform displaying patient burden scores using various visual aids displayed on different GUIs and easy-to-understand graphs, which dynamically revise the GUIs accordingly. The electronic platform is not described in any detail beyond as an electronic platform having a series of GUIs using various computer models to project and display data on electronic data sources, computing device, or user devices ([0051]), or as a website accessible to end users which presents content ([0052]). The use of general purpose computing components such as GUIs, computing devices, user devices, and websites to display data is well-understood, routine, and conventional in the field of computing. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of the computer or improves another technology. The claims do not amount to significantly more than the underlying abstract idea.
Dependent Claims 2-8, 10-16, and 18-20 add further limitations which are also directed to an abstract idea. For example, Claims 2-4, 10-12, and 18-20 recite the historical clinical studies share a common operational parameter attribute with the clinical trial, the operational parameter is one of timing, medications, lab tests, blood tests, etc., and the patient burden score corresponds to one of demographics, participating logistics, lifestyle factors, etc. which further specify or limit the elements of the independent claims, and hence are nonetheless directed towards fundamentally the same abstract idea as independent Claims 1, 9, and 17. Claims 5 and 13 include extracting an attribute from an electronic document which is an additional element which amounts to insignificant extra-solution activity as data gathering that, similar to the independent claims, is well-understood, routine and conventional in the field of data management because it involves electronically scanning or extracting data from a document, as per MPEP 2106.05(d)(II). Claims 6-7 and 14-15 include a description of the visual elements which further specify or limit the elements of the independent claims, and hence are nonetheless directed towards fundamentally the same abstract idea as independent Claims 1 and 9. Claims 8 and 16 include a description of the operational parameter attributes which further specify or limit the elements of the independent claims, and hence are nonetheless directed towards fundamentally the same abstract idea as independent Claims 1 and 9. Because the additional elements do not impose meaningful limitations on the judicial exception and the additional elements are well-understood, routine and conventional functionalities in the art, the claims are directed to an abstract idea and are not patent eligible.
Response to Arguments
Applicant’s arguments, see Pages 10-16, “Rejections Under 35 U.S.C. §101”, filed 06/23/2026 with respect to claims 1-20 have been fully considered but they are not persuasive.
Applicant argues that the claims integrate the abstract idea into a practical application by reciting specific graphical user interface mechanisms that improve computer functionality because the claimed GUI provides a specific improvement to the way computer display and present clinical trial burden information. Applicant further argues that this improvement is analogous to Trading Technologies and Core Wireless. Examiner respectfully disagrees.
With regard to Trading Technologies, the claims were found eligible provided a specific functionality of the graphic user interface which enables pertinent order data (e.g., bid price, ask price, bid quantity, ask quantity, last price, last quantity) to be presented in a specifically structured display; therefore, the data can be more quickly assimilated by a trader in an environment where fractions of seconds are important for the success of a trade. The instant application does not embody a similarly structured display, and although the instant application describes the data which is to be displayed, it does not describe any specifically structured display. Furthermore, unlike the Trading Technologies case, the disclosure and claims in the instant application do not embody the invention of hardware or software specifically designed to improve an interface to overcome a specific data comprehension problem by implementing a specifically structured GUI having a prescribed functionality. In the instant application, the generic visual elements with a graphical user interface are merely used as part of a generic computing system to display data, and the structure of the display itself is not identified as an integral part of the inventive solution. The instant application is more similar to the non-statutory Electric Power v Alstom case whereby the mere display of data in a non-specific format does not amount to significantly more. In that precedential case, the court states, “Nothing in the claims, understood in light of the specification, requires anything other than off-the-shelf, conventional computer, network, and display technology for gathering, sending, and presenting the desired information. The information which is to be displayed is described, but it is merely described as being displayed on a graphical user interface. There is no improvement to the functionality of the interface or a description of how the interface improves a technical problem.
With regard to Core Wireless, the claims were found eligible because the claims provide a specific manner in which information is displayed. Examiner respectfully disagrees that the current claims provide an improvement similar to that which was found eligible in Core Wireless. The claims at issue in Core Wireless were found to be eligible because they were directed to an improved user interface for computer devices. The improvement included a particular manner of summarizing and presenting information in electronic devices by enabling a device to access a summary window which is presented while the applications are in an un-launched state, which allows the user to access data or functions without actually opening the application up. The claims of Core Wireless are directed to the particular manner in which the functions and data are accessed and not to the particular information which is being displayed on the user interface. The present claims are directed to the populating visual elements within a graphical user interface and detail the set of visual elements and what information is populated in those elements of the user interface. The graphical user interface is used as a tool to present and receive information to/from the user. The claims do not provide an improvement in the particular manner of accessing functions and data in an un-launched state such that the user does not actually have to open the application similar to that of Core Wireless.
Applicant argues that the instant claims address the problem of forecasting patient burden being slow, expensive, inefficient, and inaccurate. The improvement in speed and accuracy which is realized by the instant application is a result of the abstract idea and by applying the abstract idea to a computer. This does not integrate the abstract idea into a practical application or provide significantly more than the abstract idea. Applicant also argues that the instant application presents the patient burden scores in a manner that can be easily understood by users which overcomes the problem in conventional methods of failing to provide an interactive electronic platform where the patient burden is displayed using visual elements to provide a holistic snapshot for clinical trials. Examiner respectfully disagrees that this is a technical solution to a technical problem. The interfaces of the instant claims do not provide any functionality beyond what is well-understood, routine, and conventional, as the interface merely displays the selected data. The improvement is to what information is being displayed and not to any functionality of the interface itself. Therefore, this does not integrate the abstract idea into a practical application or provide significantly more than the abstract idea. Therefore, the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evangeline Barr whose telephone number is (571)272-0369. The examiner can normally be reached Monday to Friday 8:00 am to 4:00 pm.
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/EVANGELINE BARR/Primary Examiner, Art Unit 3682
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