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
Response to Amendment
The present Office Action is in response to the Request for Continued Examination dated 06/03/2026.
In the amendment dated 06/03/2026, the following occurred: Claims 1, 8, 9, 20 and 21 were amended. Claim 22 was canceled.
Claims 1-21 are currently pending.
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/03/2026 has been entered.
Claim Objections
Claim 2 is objected to for the following informality: “…presenting a graphical user interface representing…” should read “…presenting the graphical user interface representing…”
Appropriate action 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.
Claims 1-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1, 20 and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claims recite a method, system and one or more non-transitory computer-readable media (CRM) for generating content, which are within a statutory category.
Step 2A1
Regarding claims 1, 20 and 21, the limitation of (claim 1 being representative) reading […] first data representing a plurality of first clinical trial protocols; reading […] second data representing a plurality of content generation tools available for use with the one or more […] models; receiving […] a user input instructing […] to generate a second clinical trial protocol using the one or more […] models, wherein the user input comprises an indication of a subject of the second clinical trial protocol; determining […] a plurality of actions to generate the second clinical trial protocol; determining […] one or more content generation tools associated with each of the actions; causing the one or more […] models to perform each of the actions using the one or more content generation tools associated with that action and based on the first data, wherein performance of each of the actions causes the one or more […] models to generate an output using […]; as each action is performed, causing rendering of a […],comprising one or more visualizations of a status of execution of the action performed by the […] using the one or more content generation tools associated with that action; generating […] the second clinical trial protocol based on the output of the one or more […] models; and storing […] a data structure representing the second clinical trial protocol as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for the recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, for reading first data; reading second data; receiving a user input; determining a plurality of actions; determining one or more content generation tools; causing to perform each of the actions using the one or more content generation tools to generate an output; causing rendering comprising one or more visualizations of a status of execution of the action performed; generating the second clinical trial protocol; and storing a data structure representing the second clinical trial protocol in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “reading…reading…receiving…determining…determining…causing…causing…generating and storing a data structure representing the second clinical trial protocol” as indicated supra.
Other than reciting generic computer components (discussed infra), i.e., a computer system, one or more hardware storage devices and a system bus (in claim 1), a system, at least one processing device, a memory, one or more hardware storage devices, a system bus and a computer system (in claim 20) and one or more CRM’s, at least one processor, one or more hardware storage devices, a system bus and a computer system (claim 21), the claimed invention amounts to managing personal behavior or interaction between people. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity – Managing Personal Behavior Relationships, Interactions Between People (e.g. social activities, teaching, following rules or instructions)” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Note that the broadest reasonable interpretation of “one or more computerized large language models (LLMs)” and “generative transformer model” and in light of the disclosure, represent the creation of mathematical interrelationships between data. See Spec. Para. [0043] describing LLMs to include models having or more generative pre-trained transformers (GPTs), such as those implemented using or more artificial neural networks and Para. [00135]-[00164] that describe the generative transform as a mathematical concept. Thus given the broadest reasonable interpretation, the Examiner interprets the one or more computerized large language models (LLMs) and generative transformer model to be implemented using existing, known mathematical techniques. As such, the one or more computerized large language models (LLMs) and the generative transformer model are interpreted to be part of the identified abstract idea, supra. The types of identified abstract ideas are considered together as a single abstract idea for analysis purposes.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, claim 1 recites the additional elements of a computer system, one or more hardware storage devices and a system bus. Claim 20 recites the additional elements of a system, at least one processing device, a memory, one or more hardware storage devices, a system bus and a computer system. Claim 21 recites the additional elements of one or more CRM’s, at least one processor, one or more hardware storage devices, a system bus and a computer system. These additional elements are not exclusively defined by the applicant and are recited at a high-level of generality (i.e., a generic computers or components thereof) such that they amounts to no more than mere instructions to apply the exception using a generic computer component. As set forth in MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Claims 1, 20 and 21 further recite the additional elements of one or more computerized large language models (LLMs), and a generative transformer model having at least one of an encoder or a decoder. The additional elements of one or more computerized large language models (LLMs) and a generative transformer model having at least one of an encoder or a decoder represent a mathematical concept as described in the Specification at Para. [0043] and [00135]-[00164]. This mathematical concept is applied to (“apply it’) the abstract idea. MPEP 2106.04(d)(I) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Claims 1, 20 and 21 also recite the additional elements of an input/output (I/O) device and a graphical user interface on a display. These additional elements merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a computer system, at least one processing device, memory, one or more hardware storage devices, a system bus, one or more CRM’s and at least one processor to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). Moreover, using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention”). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
As discussed with respect to integration of the abstract idea into a practical application, the additional elements of one or more computerized large language models (LLMs) and a generative transformer model having at least one of an encoder or a decoder were determined to be the application of mathematical concept to the identified abstract idea. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP2106.05(1)(A) indicates that merely saying “apply it’ or equivalent to the abstract idea cannot provide an inventive concept (“significantly more’). As such the claim is not patent eligible.
Also as discussed with respect to integration of the abstract idea into a practical application, the additional elements of an input/output (I/O) device and a graphical user interface on a display were determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. As such the claim is not patent eligible.
The examiner notes that: A well-known, general-purpose computer has been determined by the courts to be a well-understood, routine and conventional element (see, e.g., Alice Corp. v. CLS Bank; see also MPEP 2106.05(d)); Receiving and/or transmitting data over a network (“a communications network”) has also been recognized by the courts as a well - understood, routine and conventional function (see, e.g., buySAFE v. Google; MPEP 2016(d)(II)); and Performing repetitive calculations is/are also well-understood, routine and conventional computer functions when they are claimed in a merely generic manner (see, e.g., Parker v. Flook; MPEP 2016.05(d)).
Claims 2-19 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Claim(s) 2 further merely describe(s) representing the generation of the second clinical trial. Claim(s) 3 further merely describe(s) continuously updating contents of the graphical user interface. Claim(s) 4 further merely describe(s) the graphical user interface comprises a plurality of first graphical display elements, each representing a different respective one of the actions. Claim(s) 5 further merely describe(s) the graphical user interface comprises a plurality of second graphical display elements, each representing a summary of content generated. Claim(s) 6 further merely describe(s) the subject of the second clinical trial protocol is one of a drug or a medical procedure. Claim(s) 7 further merely describe(s) the first data representing at least one of a plurality of drugs or a plurality of medical treatments. Claim(s) 8 further merely describe(s) the first data comprises structured data, and wherein reading the first data comprises at least one of querying the structured data, normalizing the structured data, augmenting the structured data, adding metadata to the structured data, or ingesting the structured data into a vector database. Claim(s) 9 merely describe(s) the first data comprises one or more documents, and wherein reading the first data comprises at least one of parsing the one or more documents, augmenting the one or more documents, segmenting the one or more documents, adding metadata to the one or more documents, or ingesting the documents. Claim(s) 8 and 9 include the additional element of “a vector database” which is as a form of extra-solution activity and does not provide practical application or significantly more. Claim(s) 10 further merely describe(s) the actions comprise at least one of searching the first data for content relevant to second clinical trial protocol, generating a preview of the second clinical trial protocol, or generating the second clinical trial protocol. Claim(s) 11-15 further merely describe(s) the content generation tools. Claim(s) 11 includes the additional element of “one or more external databases” which is interpreted as a form of extra-solution activity and does not provide practical application or significantly more. Claim(s) 16 further merely describe(s) the at least one of the encoder or the decoder. Claim(s) 17 further merely describe(s) receiving a second user input, determining a plurality of second actions to generate the one or more clinical trial documents, determining one or more second content generation tool, perform each of the second actions to generate a second output, generating the one or more clinical trial documents and storing a second data structure. Claim(s) 18 and 19 further merely describe(s) the one or more clinical trial documents. Claims 2-19 further define the abstract idea and are rejected for the same reason presented above with respect to claims 1, 20 and 21.
Response to Arguments
Rejection under 35 U.S.C. § 101
Regarding the rejection of claims 1-21, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
… As amended, Claim 1 involves features that can only be performed by execution in a computer system and these features are intimately involved in a practical application of these features on the computer system. Each feature of Claim 1 can only be performed on the computer system and/or by an I/O interface. For example, Claim 1 requires the feature of "as each action is performed, causing rendering, by one or more I/O interfaces, of a graphical user interface on a display of an I/O device, with the graphical user interface comprising one or more visualizations of a status of execution of the action performed by the one or more LLMs using the one or more content generation tools associated with that action." This feature requires causing of rendering of a graphical user interface by one or more I/O interfaces. A human mind cannot perform this feature. Therefore, under the 2019 Guidance, the claimed subject matter does not involve a so- called patent ineligible abstract idea and thus does not invoke the abstract exception under Alice, at least because the subject matter does not involve any of the above mentioned groupings. Therefore, this rejection is improper and should be withdrawn.
Regarding 1, The Examiner respectfully disagrees. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, for reading first data… reading second data… receiving a user input… determining a plurality of actions… determining one or more content generation tools… causing to perform each of the actions using the one or more content generation tools to generate an output… causing rendering comprising one or more visualizations of a status of execution of the action performed… generating the second clinical trial protocol… and storing a data structure representing the second clinical trial protocol in the manner described in the bolded identified abstract idea under 101 analysis. This is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for the recitation of generic computer components. Moreover, the Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). See Applicant disclosure at para. 0052, 0072, 00202-00204 that describe a user interacting with the system. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity – Managing Personal Behavior Relationships, Interactions Between People (e.g. social activities, teaching, following rules or instructions)” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
The features of amended claim 1 include a combination of elements that integrate the exception into a practical application, as discussed with the Examiner during the telephonic interview. Amended claim 1 recites "reading, by the computer system using a system bus from the one or more hardware storage devices, second data representing a plurality of content generation tools available for use with the one or more LLMs ... as each action is performed, causing rendering, by one or more I/O interfaces, of a graphical user interface on a display of an I/O device, with the graphical user interface comprising one or more visualizations of a status of execution of the action performed by the one or more LLMs using the one or more content generation tools associated with that action." This combination of elements integrate the abstract idea into a practical application because they impose meaningful limits on practicing the abstract idea. The combination of elements enables "an improved graphical user interface that provides a user with information regarding the generation of documents using an LLM, in [a] manner that is particularly intuitive for the user to understand. Accordingly, the operation of the computer system is improved (e.g., by increasing the ease by which a user can interact with the computer system)."8 For at least this reason, the features of amended claim 1 integrate a judicial exception into a practical application and claim 1 recites patentable subject matter.
Regarding 2, The Examiner respectfully disagrees. The combination of additional elements does not provide a practical application. The additional elements of a computer system, at least one processing device, memory, one or more hardware storage devices, a system bus, one or more CRM’s and at least one processor are not exclusively defined by the applicant and are recited at a high-level of generality (i.e., a generic computers or components to perform generic computer functions) such that they amounts to no more than mere instructions to apply the exception using a generic computer component. As set forth in MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Furthermore, in regards to Applicant argument that “the combination of elements enables "an improved graphical user interface that provides a user with information regarding the generation of documents using an LLM, in [a] manner that is particularly intuitive for the user to understand. Accordingly, the operation of the computer system is improved (e.g., by increasing the ease by which a user can interact with the computer system)."”The Examiner notes that it is unclear what the improvement to the graphical user interface is as GUI’s are already know to provide information. The technology of GUI’s is not being improved upon, yet utilized to provide data. The Specification at para. [009] states improvements in design and performance of clinical trials, allowing researchers to better assess the effectiveness of medical interventions, improving the safety and/or efficacy of the treatment of patients, automatically generate robust and comprehensive clinical trials protocols to accurately assess the safety and/or efficacy of a particular medial intervention, improve medical intervention safety and/or efficacy, none of these are technical improvement but are improvement in the field of clinical trials and healthcare improvements. As such the claim is ineligible.
Conclusion
The prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Rosenblatt (US 2010/0082821) discloses device to device workflows.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIZA TONY KANAAN whose telephone number is (571)272-4664. The examiner can normally be reached on Mon-Thu 9:00am-6:00pm ET.
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/LIZA TONY KANAAN/Examiner, Art Unit 3683
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