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 .
Response to Amendment
This action is in response to the amendments filed on 06/09/2026. Claims 1, 3, 5, 6, and 8-14 have been amended, claims 2 and 4 have been previously canceled, and new claims 15-16 have been added. Claims 1, 3, and 5-16 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
extracting, from an electronic document, information on an agreement between the first member company and the second company for a product;
establishing a connection for sharing data between the first
controlling, based on the data sharing control rule, sharing of data between the first
controlling the first
generating, at the first
transmitting the first data from the first
monitoring, at the first
automatically transmitting a message for confirming progress to the second
performing a reconciliation task by comparing a data transmission history from the first
controlling the first
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”, and “databases” 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 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 “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 13-16 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 do not feature any additional elements that have been found to integrate the judicial exception into a practical application, or provide significantly more than the abstract idea, and instead merely further narrow the abstract idea. Therefore, the dependent claims are found to be directed to an abstract idea without significantly more. and 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 processing data associated with the adverse event between the first DB and the second DB based on the information on the agreement, when the data is shared between the first DB and the second DB, wherein the workflow includes processing allocation information specifying processing operations assigned to the first DB and the second DB for processing the data associated with the adverse event”. 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 appear to argue that the claims provide an improvement to technology. Applicant argues that the claims “prove elements and processes that are significantly more to resolve issues of data synchronization delays, inter-database processing errors, and inefficient data allocation in a distributed environment”. Applicant’s assertion of this alleged improvement is made after the fact, and there is no mention within the specification of this alleged improvement whatsoever.
Applicant argues that the features of “automatically determining a workflow” and “processing allocation information specifying processing operations” are not merely an automation of a business practice. The Examiner respectfully disagrees. The determination of a workflow is abstract in itself (i.e., organization of human activity, and mental process). The fact that the workflow automatically determined through use of a generic computing device does not make it any less abstract; even if the workflow includes processing allocation information specifying assignment of operations.
Applicant argues that the “reconciliation task” cannot be practically performed mentally or manually. The Examiner respectfully disagrees. The comparing of transmission history information and reception history information recorded in different databases most certainly describes a mental process as it is merely the comparison of data.
Applicant’s arguments concerning the features of claims 8 and 9 are not persuasive as the claims merely further narrow the abstract idea.
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.
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 KYLE G ROBINSON whose telephone number is (571)272-9261. The examiner can normally be reached Monday - Thursday, 7:00 - 4:30 EST; Friday 7:00-11:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached on 571-272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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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
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