CDETAILED 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/11/2026 has been entered.
Response to Amendment
This action is in response to the amendments filed on 02/11/2026. Claims 1, 5, 6, 9, and 10 have been amended, claims 2 and 4 have been previously canceled, and new claims 11-14 have been added. Claims 1, 3, and 5-14 are currently pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, and 5-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Representative claim 1 recites (additional limitations crossed out):
A method of
receiving information on an agreement between the first member company and the second company for a product;
establishing a connection for data sharing between the first
controlling, based on the rule, sharing of data between the first
based on the rule, controlling the first DB and the second DB to perform the plurality of tasks according to the workflow
controlling the first
generating, by the at least one of the first
wherein the information on the agreement comprises information of the product, information related to a scope of safety information to be reported, a reporting deadline, and information related to a pharmacovigilance procedure,
wherein the rule for the data sharing comprises information related to a scope of shared data between the first
wherein the sharing timing includes a time limit for notifying the detection of an adverse event related to the product, and the time limit is earlier than the reporting deadline,
wherein the controlling sharing of the data comprises:
receiving, by the second
detecting, by the second
wherein the controlling, based on the rule, automatic sharing of the result comprises:
performing, by the other
wherein
The above limitations, as drafted, are processes that, under their broadest reasonable interpretation, covers the management of personal behaviors. That is, other than reciting the utilization of a “server”, “databases”, and “API authentication keys” to perform the steps, nothing precludes the steps from being described as the management of personal behavior. For example, but for the computer components, the claims describe the performing of tasks and sharing results of said tasks between two entities based upon a rule, and controlling access to data while the tasks are being performed, which describes the management of personal behavior. If a claim limitation, under its broadest reasonable interpretation, covers the management of personal behavior, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
The judicial exception is not integrated into a practical application. In particular, the claims only recite the additional elements of a “server”, “databases”, and “API authentication keys” to perform the steps. These additional elements are recited at a high level of generality (see at least paras. [0034], [0040], [0074], and [0086]) such that they amount to no more than mere instructions to apply the exception using generic computing components. The claims also feature the language “…using an artificial intelligence model…”, however the use of the “artificial intelligence model” is considered to be generic computer function and/or field-of-use/”general link” implementations and does not meaningfully limit the claim (See Accenture, 728 F.3d 1336, 108 U.S.P.Q.2d 1173 (Fed. Cir. 2013), citing Cf. Diamond v. Diehr, 450 U.S. 175, 191-192 (1981) ("[I]nsignificant post-solution activity will not transform an unpatentable principle in to a patentable process.”). Moreover, the functionality intended to be performed by the artificial intelligence model appears to be based on very rudimentary constraints (e.g., determined plurality of tasks). Without some prohibition in the claims regarding scalability, computation load, etc., this artificial intelligence model could reasonably be considered an additional abstract idea in the “mental process” category, but for which is simply automated (i.e., “apply it”). The claims also state that several features are performed “automatically”. However, this is mere automation of a manual process which is not sufficient to show an improvement in computer-functionality (See MPEP 2106.05(a).I). Accordingly, 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 claims are therefore still directed to an abstract idea.
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 using a “server”, “databases”, and “API authentication keys” to perform the steps, amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Further, as stated above, the performance of some of the functions “using an artificial intelligence model” and “automatically” is not sufficient to show an improvement in computer-functionality. Therefore, the claims are not found to be patent eligible.
Claims 10 features limitations similar to those of claim 1, and is therefore also found to be directed to an abstract idea without sign
Claims 2, 5-9, and 13-14 are dependent on claim 1, and include all the limitations of claim 1. Claims 11-12 are dependent on claim 10, and include all the limitations of claim 10. Therefore, they are also found to be directed to an abstract idea. The remaining dependent claims merely serve to further narrow the abstract idea. Therefore, the dependent claims are found to be directed to an abstract idea without significantly more. Therefore, the claims are not found to be patent eligible.
Examiner Notes
No prior art could be found at this time for the limitation “automatically determining a workflow for a plurality of tasks involved in a pharmacovigilance procedure based on the information on the agreement, when the data is shared between the first DB and the second DB”. While prior art was found regarding the determination of a pharmacovigilance workflow, no prior art could be found explicitly reciting the determination of a pharmacovigilance workflow performed automatically by a server after receiving notification of an adverse effect.
Response to Arguments
Applicant's arguments regarding claims rejected under 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant argues with substance:
Applicant argues that the claims improve the functioning of the pharmacovigilance (PV) platform by i) ensuring timely detection and reporting of an adverse event; ii) using an AI model to automate complex data validation and coding task in a manner that reduces human error and increases efficiency; and iii) managing user access and workflow scheduling to prevent unauthorized access and ensure procedural compliance. This is not persuasive. First the Examiner notes that items i and iii are not technological improvements. If anything, they merely present an improvement to business methods. Further, as stated above, the use of AI, merely provides the automation of an abstract idea (“apply it”).
Applicant’s arguments that the claims provide “a technical improvement in database synchronization and system-wide task coordination” are not persuasive. Applicant’s assertion of this alleged benefit is made after the fact, and there is no mention within the specification of this alleged benefit whatsoever.
Applicant’s arguments that the claims “improve computer system security and data integrity by strictly controlling access to sensitive information based on defined workflows and authority information” is not persuasive. The mere restriction of data to particular users does not equate to improved computer system security as the functioning capabilities of the computer system remains unchanged.
Applicant’s arguments regarding claims 5, 9, and 11-14 are not persuasive. The limitations of the claims do not feature additional elements beyond the judicial exception as they are abstract in themselves and merely further narrow the abstract idea introduced in the independent claims.
Based on at least the above, the 101 rejection is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Pharmacovigilance Workflow, available May 9, 2021 states that pharmacovigilance is a business process, and discusses the automatic assigning of tasks.
“Five Steps for Automating the Pharmacovigilance Process”1 by Venu Mallarapu, available January 31, 2022 discusses the use of AI in the pharmacovigilance process.
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/KYLE G ROBINSON/Examiner, Art Unit 3685
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
1 Available at https://www.pharmexec.com/view/five-steps-for-automating-the-pharmacovigilance-process