DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Final office action is in response to the amended claims filed on February 13, 2026.
Claims 1 and 20 have been amended.
Claims 12-19 were previously withdrawn.
Claim 3 was previously canceled.
Claims 1-2, 4-11, and 20-22 are pending and have been examined.
Claims 1-2, 4-11, and 20-22 included subject matter free of prior art as indicated in the final office action dated March 26, 2025. Applicant has amended the claims to be narrower, as such, the claims remain free of prior art.
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 1-2, 4-11, and 20-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Eligibility Step 1 (does the subject matter fall within a statutory category?):
Claims 1-2, 4-11, 21 and 22 are drawn to a method and claim 20 is drawn to a system, all of which are within the four statutory categories.
Eligibility Step 2A-1 (does the claim recite an abstract idea, law of nature, or natural phenomenon?):
Claims 1-2, 4-11, 20-22 are further directed to an abstract idea on the grounds set out in detail below:
The Examiner has identified independent method claim 1 as the claim that represents the claimed invention for analysis and is similar to independent system claim 20.
Claims 1 and 20 recite a series of step for predicting a clinical study outcome based on the associated clinical study protocol, identifying problematic sections in the protocol, and recommending improvements to the protocol document, which, under the broadest reasonable interpretation, is an abstract idea that falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas such as managing behavior or relationships or interactions between people (i.e., following a set of rules or instructions to read and analyze the text of the different sections in the protocol and predict the likelihood of success for the clinical trial based on the provided protocol contents and provide recommendations to improve the clinical study protocol).
Claim 1 recites the following limitations which set forth the abstract idea:
receiving a protocol document for a clinical study for a medical condition;
identifying text from sections of the protocol document;
processing, […], the text from the sections, wherein each section of the sections is processed differently; and
providing […] a section output for each section of the sections of the protocol document that provides a prediction of success for implementing each section of the protocol document, wherein the prediction for each section is based on requirements for each section;
calculating a predicted clinical study outcome for the clinical study by aggregating the section output for each section;
providing, […], a list of problematic sections in the protocol document, wherein a section is added to the list of problematic sections in response to […] determining a predicted outcome for the section is below a threshold level;
accessing, […], a datastore with a plurality of historical protocol documents;
identifying, […], similar historical protocol documents to the protocol document in the datastore;
providing, using requirements of the similar historical clinical trial protocol documents, a recommendation to improve the list of problematic sections, wherein the recommendation is based on trends identified by analyzing the similar historical clinical trial protocol documents resulting in successful clinical trials;
providing an output with the predicted clinical study outcome for the clinical study using the protocol document and the list of problematic section and the recommendation;
automatically updating, […], the protocol document generating an updated protocol document by modifying text in at least one problematic section based on the recommendation, wherein the updated protocol document provides detailed information for conducting the clinical study for a new drug treating the medical condition; and
presenting, […], the updated protocol document with updates visually distinguishing modified text from original text in the protocol document.
Eligibility Step 2A-2 (does the claim recite additional elements that integrate the judicial exception into a practical application?):
This judicial exception is not integrated into a practical application.
Limitations that are not indicative of integration into a practical application include: (1) Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (MPEP 2106.05.f), (2) Adding insignificant extra- solution activity to the judicial exception (MPEP 2106.05.g), (3) Generally linking the use of the judicial exception to a particular technological environment or field of use (MPEP 2106.05.h).
Claims 1 and 20 recite the following additional elements:
plurality of transformer network machine learning models trained using historical clinical trial protocol documents to estimate a successful execution of the protocol document
processing by a different transformer network machine learning model of the plurality of machine learning models
analyzing the predicted clinical study outcome, using a self-attention mechanism executed by the plurality of transformer machine learning models that splits the sections into layers and generating predicted outcome for the sections by analyzing each section in each layer;
using the self-attention mechanism
a memory to store data and instructions (claim 20)
a datastore
at least one processor operable to communicate with the memory (claim 20)
a processor
a graphical user interface
The memory, processor, datastore, GUI, and self-attention mechanism are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function for [e.g., receiving a document, identifying text, processing text, and generating output]) such that it amounts to no more than mere instructions to implement an abstract idea by adding the words ‘apply it’ (or an equivalent) with the judicial exception. The use of a plurality of transformer network machine learning models is merely applying transformer network machine learning models to the abstract idea using a computer (“apply it”). Analyzing the predicted clinical study outcome by splitting the sections into layers using the self-attention mechanism executed by transformer machine learning models is merely applying the machine learning models to the abstract idea. Training the plurality of transformer network machine learning models is a mathematical concept, which is an abstract idea and is subsumed within the identified abstract idea for further analysis. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea (see MPEP 2106.04 (d)(I) which states that merely having the words “apply it” and/or “generally linking” the claimed invention to a particular technological environment or field of use is insufficient to provide a practical application or significantly more). Therefore, claims 1 & 20 are directed to an abstract idea without a practical application.
The use of additional elements noted above as tools to implement/automate the abstract idea does not render claims 1 and 20 to be patent eligible because it does not provide meaningful limitations and requires no more than a computer performing functions that correspond to acts required to carry out the abstract idea.
Eligibility Step 2B (Does the claim amount to significantly more?):
Claims 1 and 20 do not include additional elements that are sufficient to amount to significantly more than the abstract idea. As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements noted above to perform the generic computer functions amount to no more than mere instructions to apply the abstract idea using a generic computer component or generally link the claimed invention to a particular technological environment or field of use (see MPEP 2106.05 (I)(A)). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Claims 1 and 20 are, therefore, not patent eligible.
The dependent claims 2, 4-11, and 21-22 further define the abstract idea that is present in their respective independent claims and hence are abstract for at least the reasons presented above.
Dependent claims 2, 4-10, and 21-22 do not recite any additional elements not already listed in their respective independent claims.
Dependent claim 11 recites the following additional element:
A display
The display is recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea by adding the words ‘apply it’ (or an equivalent) with the judicial exception. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea (see MPEP 2106.04 (d)(I) which states that merely having the words “apply it” and/or “generally linking” the claimed invention to a particular technological environment or field of use is insufficient to provide a practical application or significantly more). Therefore, claim 11 is directed to an abstract idea without a practical application.
The dependent claim do not include any additional elements that integrate the abstract idea into a practical application or are sufficient to amount to significantly more than the judicial exception when considered both individually and as an ordered combination. Therefore, the dependent claims are directed to an abstract idea. Claims 2, 4-11, 21 and 22 are, therefore, not patent eligible.
Response to Arguments
35 U.S.C. § 101 REJECTION of claims 1-2, 4-11 and 20-22
Regarding the rejection of claims 1-2, 4-11 and 20-22,
Applicant argues that the amended independent claims do not recite a judicial exception. Amended independent claim 1 recites, among other eligible recitations, "analyzing the predicted clinical study outcome using a self-attention mechanism executed by the plurality of transformer machine learning models that splits the sections into layers and provides predicted outcome for the sections by analyzing each section in each layer; [and] providing by the self- attention mechanism, a list of problematic sections in the protocol document, wherein a section is added to the list of problematic sections in response to the self-attention mechanism determining a predicted outcome for the section is below a threshold level."
Applicant respectfully submits that the amended independent claims require the self- attention mechanism executed by the plurality of transformer machine learning models to perform the recited features. Applicant further submits that the plurality of transformer machine learning models are part of "a self-learning system that identifies trends and/or criteria in the protocol documents used as the training input that resulted in successful and/or unsuccessful clinical studies 12 and uses the identified trends and/or criteria in determining the predicted clinical study outcome." See, Specification, paragraph [0022]. As such, Applicant respectfully submits that the allegations in the Office Action that the features recited in the amended independent claims can be performed by a clinical trial expert are improper since the claims require the self-attention mechanism of transformer machine learning models to perform the recited features.
The Examiner respectfully disagrees. As characterized in the 101 rejection above, the self-attention mechanism of the transformer machine learning models is an additional element that is merely implementing the abstract idea by adding the words ‘apply it’. MPEP 2106.04 (d)(I) states that merely having the words “apply it” and/or “generally linking” the claimed invention to a particular technological environment or field of use is insufficient to provide a practical application or significantly more.
Applicant argues that the 101 rejection should be withdrawn in the light of the amendments. The Applicant submits the amended independent claims are directed to improving the graphical user interface by displaying information so that “a user can easily identify the changes made to the protocol document.” See, Specification, paragraph [0040]. The Applicant further submits that the amended independent claims incorporate features that have a practical application of improving "the development of the protocol documents used with clinical trials" and "reducing the failures of the clinical trials." See, paragraph [0016] of the Specification. The Applicant also submits that the amended independent claims incorporate features that have a practical application of using the protocol document to provide "detailed information for conducting the clinical study" for a new drug treating the medical condition. See, paragraphs [0020] and [0057].
The Examiner respectfully disagrees. The Examiner has considered the amended claims and does not find that the amendments are sufficient to overcome the 101 rejection. The claims are directed to an abstract idea that falls under “Certain Methods of Organizing Human Activity specifically following a set of rules or instructions to analyze a protocol document, identify sections of the document that could affect the success of the clinical trial, and providing recommendations for improving the protocol. Although the claims recite additional elements, as explained in the 101 rejection above, the additional elements do not integrate the abstract idea into a practical application. Additionally, MPEP 2106.04(d)(1) states “the word ‘improvements’ in the context of this consideration is limited to improvements to the functioning of a computer or any other technology/technical field, whether in Step 2A Prong Two or in Step 2B.” Here, there is no improvement to the computer nor is there an improvement to another technology. Because neither type of improvement is present in the claims, an improvement to technology is not present and there is no practical application.
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure and is listed in the attached form PTO-892 (Notice of References Cited). Unless expressly noted otherwise by the Examiner, all documents listed on form PTO-892 are cited in their entirety.
Abraham-Fuchs et al. (US 20130253945 A1) teaches: Method and System for Measuring Quality of Performance and/or Compliance with Protocol of a Clinical Study.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALAK M NASSER whose telephone number is (703)756-4610. The examiner can normally be reached M-F 8:00 AM-5:00 PM.
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/MALAK M NASSER/Examiner, Art Unit 3687
/MAMON OBEID/Supervisory Patent Examiner, Art Unit 3687