DETAILED ACTION
Status of the Claims
The following is a non-final Office Action in response to claims filed 18 August 2025.
Claims 1-20 are pending.
Claims 1-20 have been examined.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 25 November 2025 are 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 therefor, subject to the conditions and requirements of this title.
Claims 1-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims are directed to a process (an act, or series of acts or steps), a machine (a concrete thing, consisting of parts, or of certain devices and combination of devices), and a manufacture (an article produced from raw or prepared materials by giving these materials new forms, qualities, properties, or combinations, whether by hand labor or by machinery). Thus, each of the claims falls within one of the four statutory categories (Step 1). The claims recite a method (process), system with apparatuses, and apparatus, however, the claim(s) recite(s) processes for validating assets or processes which is an abstract idea of organizing human activities.
The limitations of “receiving, a request to initiate a validation study for a selected asset or process; retrieving, from a validation protocol database, a pre-approved validation protocol corresponding to a type of the selected asset or process; displaying, one or more verification tests of the validation protocol, each verification test having associated instructions, acceptance criteria, and/or required data entry fields; receiving, from an authenticated user, input data for at least one of the verification tests; receiving an electronic signature from the authenticated user, the electronic signature being applied using multi-factor authentication; automatically recording the user input data, electronic signature, and corresponding timestamps in an audit trail database; and generating, responsive to completion of the validation protocol, an electronic validation report in a compliance-ready format,” as drafted, is a process that, under its broadest reasonable interpretation, covers organizing human activities--fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) but for the recitation of generic computer components (Step 2A Prong 1). That is, other than reciting “A computer-implemented method for...,” (or “A system for performing a regulatory validation process, the system comprising: a processor; and a memory that stores instructions that, when executed by the processor, cause the system to...:” in claim 16 or “A non-transitory computer-readable medium storing instructions that, when executed by a processor, cause a computing system to:” in claim 19) nothing in the claim element precludes the step from the methods of organizing human interactions grouping. For example, but for the “A computer-implemented method for...,” (or “A system for performing a regulatory validation process, the system comprising: a processor; and a memory that stores instructions that, when executed by the processor, cause the system to...:” in claim 16 or “A non-transitory computer-readable medium storing instructions that, when executed by a processor, cause a computing system to:” in claim 19) language, “receiving...” “retrieving...” “displaying...” “receiving...” “receiving....” “automatically...” and “generating...” in the context of this claim encompasses the user manually organizing protocols for assets or processes for validation and recording/generating results which is business relation/fundamental economic practice/commercial or legal interaction/managing personal behavior of following validation instructions. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, while some of the limitations may be based on mathematical concepts, but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim(s) recite(s) an abstract idea (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application (Step 2A Prong Two). The “via a web-based application” and “validation protocol database” in the steps are simply elements performing insignificant data gathering activities. The “via a user interface” in the steps is simply an insignificant post solution output. Next, the claims only recites one additional element – using a computer or processor to perform both the ranking and determining steps. The computer or processor steps is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of electronic data query, storage and retrieval) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Specifically the claims amount to nothing more than an instruction to apply the abstract idea using a generic computer or invoking computers as tools by 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 - see MPEP 2106.04(d)(I) discussing MPEP 2106.05(f). The claims recitation of the “via a web-based application” “validation protocol database” and “via a user interface” are only generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.04(d)(I) discussing MPEP 2106.05(h). Accordingly, the combination of these additional elements does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea, even when considered as a whole (Step 2A Prong Two: NO).
The claim does not include a combination of additional elements that are sufficient to amount to significantly more than the judicial exception (Step 2B). As discussed above with respect to integration of the abstract idea into a practical application (Step 2A Prong 2), the combination of additional elements of using a computer or processor to perform the 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. Reevaluating here in step 2B, the via a web-based application” “validation protocol database” and “via a user interface” in the step(s) which are insignificant extrasolution activities are also determined to be well-understood, routine and conventional activity in the field. The Symantec, TLI, and OIP Techs court decisions in MPEP 2106.05(d)(II) indicate that the mere receipt or transmission of data over a network is well-understood, routine, and conventional function when it is claimed in a merely generic manner (as is here). Therefore, when considering the additional elements alone, and in combination, there is no inventive concept in the claim. As such, the claim(s) is/are not patent eligible, even when considered as a whole (Step 2B: NO).
Claims 2 recite(s) the additional limitation(s) further the selected asset or process which is still directed towards the abstract idea previously identified and is not an inventive concept that meaningfully limits the abstract idea. Again, as discussed with respect to claims 1, 16, and 19, the claims are simply limitations which are no more than mere instructions to apply the exception using a computer or with computing components. Accordingly, the additional element(s) does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Even when considered as a whole, the claims do not integrate the judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Claims 3-4 recite(s) the additional limitation(s) further limiting the technical environment (cloud, quality management system) which is not an inventive concept that meaningfully limits the abstract idea. Again, as discussed with respect to claims 1, 16, and 19, the claims are simply limitations which are no more than mere instructions to apply the exception using a computer or with computing components. Accordingly, the additional element(s) does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Even when considered as a whole, the claims do not integrate the judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Claims 5, 17, and 20 recite(s) the additional limitation(s) further including deviation requests for users which is still directed towards the abstract idea previously identified and is not an inventive concept that meaningfully limits the abstract idea. Again, as discussed with respect to claims 1, 16, and 19, the claims are simply limitations which are no more than mere instructions to apply the exception using a computer or with computing components. Accordingly, the additional element(s) does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Even when considered as a whole, the claims do not integrate the judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Claims 6-8 recite(s) the additional limitation(s) further limiting access and document format which is not an inventive concept that meaningfully limits the abstract idea. Again, as discussed with respect to claims 1, 16, and 19, the claims are simply limitations which are no more than mere instructions to apply the exception using a computer or with computing components. Accordingly, the additional element(s) does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Even when considered as a whole, the claims do not integrate the judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Claims 9-15 and 18 recite(s) the additional limitation(s) further limiting the technical environment via the use of machine learning, AI or natural language processing which is not an inventive concept that meaningfully limits the abstract idea. Again, as discussed with respect to claims 1, 16, and 19, the claims are simply limitations which are no more than mere instructions to apply the exception using a computer or with computing components. Accordingly, the additional element(s) does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Even when considered as a whole, the claims do not integrate the judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Claims 1-20 are therefore not eligible subject matter, even when considered as a whole.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4, 7-8, 16, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Perkins et al. (US PG Pub. 2010/0058114) further in view of Blackburn et al. (US PG Pub. 2022/0084665).
As per claims 1, 16, and 19, Perkins discloses a computer-implemented method for performing a regulatory validation process, a system for performing a regulatory validation process, the system comprising: a processor; and a memory that stores instructions that, when executed by the processor, cause the system to: and a non-transitory computer-readable medium storing instructions that, when executed by a processor, cause a computing system to: the method comprising (automated certification and accreditation system, Perkins ¶50; memory, database, ¶51; client/server, processor, ¶55):
receiving, via a web-based application, a request to initiate a validation study for a selected asset or process;
retrieving, from a validation protocol database, a pre-approved validation protocol corresponding to a type of the selected asset or process (In one embodiment a method, system or computer readable medium having instructions for automated management of compliance of a target asset to a predetermined requirement including receiving a predetermined requirement, such as from a source document, for compliance testing of one of a plurality of assets. Each asset can have a profile including a category and classification for the asset. The method also includes comparing the received predetermined requirement to one or more stored compliance requirements to identify whether one or more stored compliance requirements corresponds to the received predetermined requirement, Perkins ¶30; based on profile of target asset, ¶38);
displaying, via a user interface, one or more verification tests of the validation protocol, each verification test having associated instructions, acceptance criteria, and/or required data entry fields (predetermined requirements for compliance testing, Perkins ¶35; The tester users 202 can be remote systems or can be persons or their computer or other support system. The tester users 202 perform compliance test cases 222 on the target assets TAN and return the test results 220 back to the AC&A System 100. Additionally, automatic test links can be utilized wherein the AC&A System 100 can directly communicate with and/or access the target assets for performing one or more test cases 222 and receiving back the test results, ¶51);
receiving, from an authenticated user, input data for at least one of the verification tests (add IA control, add source documents, Perkins ¶217-¶218; identified deficiencies of stored compliance requirements, ¶37; modification ¶31; based upon user roles, A role 204 defines the access a user 202 has to different parts, functions and capabilities of the AC&A System 100. This is usually created by the User Manager as a system administrator function and provided with a unique name. The SA DBA and Test Plan Editor are Administrative roles. The Program Manager, Tester, and Reviewer are AC&A System roles, ¶120; select test plans, requirement sets., ¶221-¶222) (Examiner interprets user roles as having authenticated users access and use the system);
automatically recording the user input data, electronic signature, and corresponding timestamps in an audit trail database (An Event Reports application can provide a summary of the findings by the test event. In some embodiments, this can be made visible only where the AC&A System 100 classification is either secret or test. The Event Reports can include, but is not limited to, various user 202 functions. Some of those functions can include a test event 216 function, a duplicate machine entries function, an application counts function, a category counts function, a findings report function, a testers addendum function, a findings not imported function, and a VMS XML import function. The test event 216 function can enable a user 202 to select the desired test event 216 in this list to view the summary of findings 336. The duplicate machine entries function can indicate whether the XML file had the same machine name listed multiple times for a given test case. In some embodiments, this is generally cleared before a findings 336 report is generated. A user 202 of the AC&A System 100 can review each test case 222 listed and can remove duplicate findings where required or desired. The application counts function can list the number of findings for each test plan, broken down by category level. The category counts function can list the number of findings for each category level, as well as the total number of findings, ¶156; reports in database, ¶194) (Examiner interprets the reports stored in the database as the equivalent to the audit trail database); and
generating, responsive to completion of the validation protocol, an electronic validation report in a compliance-ready format (An external reporting sub-system provides the necessary compiled reports, data and compliance information to external Reporting Entities that can include persons, communication links, or systems, Perkins ¶51; see also OSHA mandated format, ¶211).
Perkins does not expressly disclose receiving an electronic signature from the authenticated user, the electronic signature being applied using multi-factor authentication.
However, Blackburn teaches receiving an electronic signature from the authenticated user, the electronic signature being applied using multi-factor authentication (individuals may be verified and paired with a virtual representation using two-factor authentication. The individual can be provided with user information and specifications or other design requirements that can be represented by a task record. The task record can be stored on the persistent storage. Once installed the system can verify that the article was used (which can be individually inspected) according to the task record, create a task verification record and store the task verification record on the persistent storage. The task verification record represents that a task associated with the article was performed and can signify that the task was completed. The task record can represent that the task was performed by proper individual and in compliance with any requirements as well as if the article passes one or more inspections. Prior to, during and after a task is completed, an inspection can be performed that can include a pre-task inspection, task inspection, post task inspection and any combination. A pre-task inspection, task inspection, and post task inspection record can be created so that the three records can be stored on the persistent storage. The task record can include information that the inspection resulted in passing, passing with deficiencies, and failing. If the inspection fails, the official, team, participants or players or other entities can be given the opportunity to remedy the failure and the inspection process can be performed again. The process can also determine if, while the task passed the inspection, the deficiencies should be remedied, Blackburn ¶151-¶153).
Both the Perkins and Blackburn references are analogous in that both are directed towards/concerned with testing and compliance. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to use Blackburn’s ability to record proper individuals performing the tests in Perkins’ system to improve the system and method with reasonable expectation that this would result in a compliance management system that is able to link and verify data.
The motivation being that there is a need to verify digital data in order to automatically detect, determine and record compliance (Blackburn ¶3).
As per claim 2, Perkins and Blackburn disclose as shown above with respect to claim 1. Perkins further discloses wherein the selected asset or process comprises at least one of: laboratory equipment, manufacturing equipment, a production process, a shipping method, controlled temperature units (CTUs) a computerized system, or a utility system (The method can also include identifying a new asset, creating a new profile for the new asset including a classification and a category associated with the new asset, identifying one or more stored compliance requirements associated with the classification and category within the created profile of the new asset and automatically adding the identified one or more stored compliance requirements to the new profile for the new asset. It should be noted that each asset can be a system having a plurality of machines and the compliance requirement is a system level compliance requirement, and wherein transmitting the new compliance requirement includes transmitting associated with each of the machines of the target asset and receiving results is for each of the machines, Perkins ¶32-¶33).
The Examiner asserts that the selected asset or process is simply a label for the components and adds little, if anything, to the claimed acts or steps and thus does not serve to distinguish over the prior art. Any differences related merely to the meaning and information conveyed through labels (i.e., comprises at least one of: laboratory equipment, manufacturing equipment, a production process, a shipping method, controlled temperature units (CTUs) a computerized system, or a utility system) which does not explicitly alter or impact the steps of the method does not patentably distinguish the claimed invention from the prior art in terms of patentability (see MPEP 2144.04).
As per claim 3, Perkins and Blackburn disclose as shown above with respect to claim 1. Blackburn further teaches storing the electronic validation report in a cloud-based data storage service with geo-redundant backup (cloud computing environment, Blackburn ¶79) (Examiner interprets the use of cloud based storage as including a geo-redundant backup).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to use Blackburn’s ability to utilize a cloud storge system in Perkins’ system to improve the system and method with reasonable expectation that this would result in a compliance management system that is able to link and verify data.
The motivation being that there is a need to verify digital data in order to automatically detect, determine and record compliance (Blackburn ¶3).
As per claim 4, Perkins and Blackburn disclose as shown above with respect to claim 1. Perkins further discloses wherein the validation protocol is pre-configured based on quality management system (QMS) requirements related to a specific organization (as dictated by customer requirements, Perkins ¶210) (Examiner notes the customer requirements as being based upon the customer’s quality management system requirements specific to their particular organization and regulations).
As per claim 7, Perkins and Blackburn disclose as shown above with respect to claim 1. Perkins further discloses assigning role-based access permissions to the authenticated user prior to initiating the validation study (based upon user roles, A role 204 defines the access a user 202 has to different parts, functions and capabilities of the AC&A System 100. This is usually created by the User Manager as a system administrator function and provided with a unique name. The SA DBA and Test Plan Editor are Administrative roles. The Program Manager, Tester, and Reviewer are AC&A System roles, Perkins ¶120; select test plans, requirement sets., ¶221-¶222).
As per claim 8, Perkins and Blackburn disclose as shown above with respect to claim 1. Perkins further discloses wherein the compliance-ready format is a portable document format (PDF) file generated automatically by the application (PDF formatted file, Perkins ¶235).
Claim(s) 5, 9-15, 17-18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Perkins et al. (US PG Pub. 2010/0058114) and Blackburn et al. (US PG Pub. 2022/0084665) further in view of Maggiore et al. (US PG Pub. 2025/0131375).
As per claims 5, 17, and 20, Perkins and Blackburn disclose as shown above with respect to claims 1, 16, and 19. The combination of Perkins and Blackburn do not expressly disclose receiving a deviation request when test results fall outside predetermined acceptable criteria; routing the deviation request to designated personnel for review and approval; and storing deviation approval data in the audit trail database.
However, Maggiore teaches receiving a deviation request when test results fall outside predetermined acceptable criteria; routing the deviation request to designated personnel for review and approval; and storing deviation approval data in the audit trail database (reporting deviation, pharmaceutical drug, emergency notification, which supervisor signed off for audit trail, Maggiore ¶115-¶116; for quality group to review, ¶117; operating or testing pharmaceutical production equipment, ¶18).
The Perkins, Blackburn, and Maggiore references are analogous in that both are directed towards/concerned with testing and compliance. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to use Maggiore’s automated deviation reporting in Blackburn and Perkins’ system to improve the system and method with reasonable expectation that this would result in a compliance management system that is able to more efficiently handle process risks or deviations while maintaining regulatory compliance.
The motivation being that there is a need to improve the audit trail and improve the processes overall (Maggiore ¶27-¶28).
As per claim 9, Perkins and Blackburn disclose as shown above with respect to claim 1. The combination of Perkins and Blackburn do not expressly disclose analyzing historical validation data using a machine learning model to recommend a validation protocol for the selected asset or process.
However, Maggiore teaches analyzing historical validation data using a machine learning model to recommend a validation protocol for the selected asset or process (As shown in FIG. 2, a method S100 is provided for an agentic platform in which an Artificial Intelligent software system (AI) that generates multiple instances, with each instance assuming a specific role and acting as an AI agent on behalf of that role, document, and/or viewpoint to form an ensemble of experts within an AI forum to discuss and develop consensus solutions to complex manufacturing and regulatory requirements utilizing multiple viewpoints for more accurate and complete steps, reporting, and/or answers. The purpose of this platform is to automate the creation of digital procedures within a facility, provide logic-based pathways for the sequencing of responding within the procedure steps, detect deviations automatically, provide clear guidance for addressing these deviations, and answer complex manufacturing and regulatory questions that may require input from multiple sources, Maggiore ¶15; The database for the agent roles may be trained and curated to contain the optimized knowledge for the role and approved responses for how the agent responded previously based on scoring, alignment, and evaluation which are stored in the audit trail logs, ¶25; The agentic platform retrieves information from a database to determine the priorities and knowledge base associated with each instance acting as an agent for a particular role. It provides an AI forum where the instances and roles can engage in discussions, optimized for formulating a consensus and prioritizing responses based on the assigned priorities. The platform formulates clear and concise responses to requests, such as answering questions, providing regulatory guidance, suggesting deviation responses, or proposing changes to existing procedures or new procedure steps to address issues during execution, ¶17).
The Perkins, Blackburn, and Maggiore references are analogous in that both are directed towards/concerned with testing and compliance. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to use Maggiore’s recommendations and predictions in Blackburn and Perkins’ system to improve the system and method with reasonable expectation that this would result in a compliance management system that is able to more efficiently handle process risks or deviations while maintaining regulatory compliance.
The motivation being that there is a need to improve the audit trail and improve the processes overall (Maggiore ¶27-¶28).
As per claim 10, Perkins and Blackburn disclose as shown above with respect to claim 1. The combination of Perkins and Blackburn do not expressly disclose wherein the one or more verification tests include dynamically generated acceptance criteria predicted by a trained machine learning algorithm based on asset-specific operating history.
However, Maggiore teaches wherein the one or more verification tests include dynamically generated acceptance criteria predicted by a trained machine learning algorithm based on asset-specific operating history (The agentic platform retrieves information from a database to determine the priorities and knowledge base associated with each instance acting as an agent for a particular role. It provides an AI forum where the instances and roles can engage in discussions, optimized for formulating a consensus and prioritizing responses based on the assigned priorities. The platform formulates clear and concise responses to requests, such as answering questions, providing regulatory guidance, suggesting deviation responses, or proposing changes to existing procedures or new procedure steps to address issues during execution, Maggiore ¶17).
The Perkins, Blackburn, and Maggiore references are analogous in that both are directed towards/concerned with testing and compliance. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to use Maggiore’s recommendations and predictions in Blackburn and Perkins’ system to improve the system and method with reasonable expectation that this would result in a compliance management system that is able to more efficiently handle process risks or deviations while maintaining regulatory compliance.
The motivation being that there is a need to improve the audit trail and improve the processes overall (Maggiore ¶27-¶28).
As per claim 11, Perkins and Blackburn disclose as shown above with respect to claim 10. Maggiore further teaches wherein the trained machine learning algorithm is trained using a plurality of prior validation studies across multiple organizations to predict optimal test sequences that minimize total validation time while maintaining compliance (The database for the agent roles may be trained and curated to contain the optimized knowledge for the role and approved responses for how the agent responded previously based on scoring, alignment, and evaluation which are stored in the audit trail logs, Maggiore ¶25; The agentic platform retrieves information from a database to determine the priorities and knowledge base associated with each instance acting as an agent for a particular role. It provides an AI forum where the instances and roles can engage in discussions, optimized for formulating a consensus and prioritizing responses based on the assigned priorities. The platform formulates clear and concise responses to requests, such as answering questions, providing regulatory guidance, suggesting deviation responses, or proposing changes to existing procedures or new procedure steps to address issues during execution, ¶17).
As per claim 12, Perkins and Blackburn disclose as shown above with respect to claim 10. Maggiore further teaches retraining the machine learning model with results of completed validation studies to improve accuracy of future protocol recommendations (The database for the agent roles may be trained and curated to contain the optimized knowledge for the role and approved responses for how the agent responded previously based on scoring, alignment, and evaluation which are stored in the audit trail logs, Maggiore ¶25; The agentic platform retrieves information from a database to determine the priorities and knowledge base associated with each instance acting as an agent for a particular role. It provides an AI forum where the instances and roles can engage in discussions, optimized for formulating a consensus and prioritizing responses based on the assigned priorities. The platform formulates clear and concise responses to requests, such as answering questions, providing regulatory guidance, suggesting deviation responses, or proposing changes to existing procedures or new procedure steps to address issues during execution, ¶17).
As per claims 13 and 18, Perkins and Blackburn disclose as shown above with respect to claims 1 and 16. The combination of Perkins and Blackburn do not expressly disclose automatically detecting anomalies in received input data using an artificial intelligence (Al) anomaly detection model; and generating a deviation request responsive to detection of the anomalies.
However, Maggiore teaches automatically detecting anomalies in received input data using an artificial intelligence (Al) anomaly detection model; and generating a deviation request responsive to detection of the anomalies (reporting deviation, pharmaceutical drug, emergency notification, which supervisor signed off for audit trail, Maggiore ¶115-¶116; for quality group to review, ¶117; operating or testing pharmaceutical production equipment, ¶18).
The Perkins, Blackburn, and Maggiore references are analogous in that both are directed towards/concerned with testing and compliance. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to use Maggiore’s automated deviation reporting in Blackburn and Perkins’ system to improve the system and method with reasonable expectation that this would result in a compliance management system that is able to more efficiently handle process risks or deviations while maintaining regulatory compliance.
The motivation being that there is a need to improve the audit trail and improve the processes overall (Maggiore ¶27-¶28).
As per claim 14, Perkins and Blackburn disclose as shown above with respect to claim 13. Maggiore further teaches wherein the Al detection model provides real-time guidance to the authenticated user during execution of the validation protocol based on context- aware analysis of current test results (The database for the agent roles may be trained and curated to contain the optimized knowledge for the role and approved responses for how the agent responded previously based on scoring, alignment, and evaluation which are stored in the audit trail logs, Maggiore ¶25; The agentic platform retrieves information from a database to determine the priorities and knowledge base associated with each instance acting as an agent for a particular role. It provides an AI forum where the instances and roles can engage in discussions, optimized for formulating a consensus and prioritizing responses based on the assigned priorities. The platform formulates clear and concise responses to requests, such as answering questions, providing regulatory guidance, suggesting deviation responses, or proposing changes to existing procedures or new procedure steps to address issues during execution, ¶17).
As per claim 15, Perkins and Blackburn disclose as shown above with respect to claim 1. The combination of Perkins and Blackburn do not expressly disclose using a natural language processing model to parse unstructured regulatory guidance documents and extract protocol requirements for storage in the validation protocol database.
However, Maggiore teaches using a natural language processing model to parse unstructured regulatory guidance documents and extract protocol requirements for storage in the validation protocol database (natural language processing of text regarding equipment or specific processes, Maggiore ¶34; in order to set guidance or instructions based on regulated environment, ¶52).
The Perkins, Blackburn, and Maggiore references are analogous in that both are directed towards/concerned with testing and compliance. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to use Maggiore’s automated deviation reporting in Blackburn and Perkins’ system to improve the system and method with reasonable expectation that this would result in a compliance management system that is able to more efficiently handle process risks or deviations while maintaining regulatory compliance.
The motivation being that there is a need to improve the audit trail and improve the processes overall (Maggiore ¶27-¶28).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Perkins et al. (US PG Pub. 2010/0058114) and Blackburn et al. (US PG Pub. 2022/0084665) further in view of Hendrix et al. (US PG Pub. 2013/0036057).
As per claim 6, Perkins and Blackburn disclose as shown above with respect to claim 1. The combination of Perkins and Blackburn do not expressly disclose wherein the multi-factor authentication comprises sending a one-time password (OTP) to a registered communication address of the authenticated user.
However, Hendrix teaches wherein the multi-factor authentication comprises sending a one-time password (OTP) to a registered communication address of the authenticated user (one-time-password, Hendrix ¶134; for validating their identity and authority, ¶137).
The Perkins, Blackburn, and Hendrix references are analogous in that both are directed towards/concerned with compliance. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to use Hendrix’s ability to identify and verifity user authority with one-time-passwords in Blackburn and Perkins’ system to improve the system and method with reasonable expectation that this would result in a compliance management system that is able to more securely handle pharmaceuticals, drugs, or controlled substances while maintaining regulatory compliance.
The motivation being that there is a need to increase security and compliance (Hendrix ¶10-¶12).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure (additional art can be located on the PTO-892):
Wiig et al. (US PG Pub. 2018/0114169) System And Method Of A Requirement, Compliance And Resource Management
Douglas (US PG Pub. 2022/0318700) FDA compliant quality system to risk-mitigate, develop, and maintain software-based medical systems
Tewari et al. (US PG Pub. 2015/0347390) Compliance Standards Metadata Generation
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ANDREW B WHITAKER whose telephone number is (571)270-7563. The examiner can normally be reached on M-F, 8am-5pm, EST.
If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Lynda Jasmin can be reached on (571) 272-6782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-
automated- interview-request-air-form
/ANDREW B WHITAKER/Primary Examiner, Art Unit 3629
Prosecution Insights