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 .
Status of Claims
The following is a non-final office action.
Claims [1-20] are currently pending and have been examined based on their merits.
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 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception that is an abstract idea without a practical application or significantly more.
Step 1: Claims 1-19 recite a system and claim 20 recites a method (i.e. a process such as an act or series of steps), and therefore each claim falls within one of the four statutory categories.
Step 2A prong 1 (Is a judicial exception recited?):
The representative claim 1 recites: store a set of regulatory approval submission data and associated metadata for a medical product of a supplier; and filter, based on the associated metadata and users’ roles, the set of regulatory approval submission data and the associated metadata to provide user specific submission data and metadata to users of the supplier and users of a regulatory agency.
Claims 13 and 20: receive, from a supplier of a medical product, a set of regulatory approval submission data associated with the medical product for approval by a regulatory agency; store the set of regulatory approval submission data; receive, from users of the supplier and users of the regulatory agency, metadata associated with corresponding elements of the set of regulatory approval submission data, wherein metadata associated with an element of the set of regulatory approval submission data includes an attribute indicating accessibility of the element or the metadata associated with the element; store the metadata with the corresponding elements of the set of regulatory approval submission data; and filter, based on users’ roles and the metadata associated with the corresponding elements, the set of regulatory approval submission data and the metadata associated with the corresponding elements stored in the repository to provide user specific submission data and metadata to the users of the supplier and the users of the regulatory agency.
The claims recite a certain method of organizing human activity. The claims recite a certain method of organizing human activity as the disclosure recites commercial or legal interaction. The claims simply recite a series of steps to receive, store, and manage data pertaining to regulatory submissions from a supplier to a regulatory agency. The processes of receiving a submission for regulatory approval for a device or product from a user or supplier to a regulatory agency and managing the information in the submission is a common practice such as a medical device developer submitting information to the FDA for approval. Merely receiving, storing, and filtering the submitted data to help the process of reviewing a submission for regulatory approval are fundamental steps in the review process of regulatory agencies and therefore the claims recite a commercial or legal interaction between a supplier and a regulatory agency.
Alternatively, the claims recite a mental process. The claims merely recite the process of receiving a set of regulatory submission data, storing the set of regulatory submission data, and filtering the receiving metadata based on a user’s role to provide specific data to a supplier user and a regulatory agency user. The claims are found to merely recite a series of steps that can be performed in the human mind or with the use of a simple tool such as pen and paper. As a person such as a member of a regulatory agency would be capable of mentally, or with basic tools, receive regulatory submission data and corresponding metadata and filtering or identifying portions of the metadata to be presented to various users based on their role. For example, a person would be mentally capable of identifying and presenting only the portions of the regulatory submission metadata to a member of the regulatory agency that are pertinent in the review process. Additionally, the claimed invention of receiving, storing, and filtering metadata based on a user’s role is found to be similar to concepts the courts have defined as a mental process including observations, evaluations, judgements, and opinions.
Therefore, the claims are found to recite an abstract idea.
Step 2A Prong 2 (Is the exception integrated into a practical application?): The claims additionally recite additional elements, including;
Claim 1: A regulatory approval submission and review system comprising: a repository configured to store; a portal communicatively coupled to the repository.
Claim 13: A system comprising: one or more processors; and one or more processor-readable media storing instructions which, when executed by the one or more processors, and a repository.
Claim 20: A processor-implemented method comprising: and a repository.
The additional elements of a system comprising generic computer elements to receive and store information are directed to merely reciting instructions to apply a generic computer and technology to execute the method in the recited claim limitations.
The claim limitations recite mere instructions to implement the abstract idea of receiving and filtering metadata.
Therefore, the limitations merely amount to adding the words “apply it” (or an equivalent) to 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, as discussed in MPEP 2106.05(f). Furthermore, a method for transmitting, receiving, and processing information does not amount to improvements to the functioning of a computer, or to any other technology or technical field, as discussed in MPEP 2106.05(a), applying the judicial exception with, or by use of, a particular machine, as discussed in MPEP 2106.05(b), effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP 2106.05(c), or applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP 2106.05(e).
Accordingly, the 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. As the additional elements are not significant improvements to the functionality of a generic computer and are directed to merely “apply it” or applying the abstract idea on a computer.
Step 2B (Does the claim recite additional elements that amount to significantly more than the judicial exception?):
As discussed above, the additional imitations amount to adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, and merely uses a computer as a tool to perform an abstract idea of receiving, storing, and filtering metadata of a regulatory approval submission based on a user’s role, as discussed in MPEP 2106.05(f). The additional elements of generic computer elements to perform the abstract idea are not directed to an improvement in a technology or technical field. Therefore, the additional elements do not amount to significantly more than the judicial exception.
The dependent claims 2-12 and 14-19 further narrow the abstract idea of receiving, storing, and providing regulatory approval submission data and associated metadata to a user based on a user’s role as recited in the independent claims 1, 13, and 20.
The dependent claims recite the following additional elements:
Claims 8 and 18: a dashboard of a user interface.
Claims 10 and 19: a user interface.
However, the additional elements are directed to merely “apply it” or applying generic computer elements to perform the abstract idea.
Therefore, claims 1-20 are rejected under 35 U.S.C. 101.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arazy (US 2013/0198094) in view of Levine (US 2020/0357000).
Claim 1: Arazy discloses a regulatory approval submission and review system comprising: a repository configured to store a set of regulatory approval submission data and associated metadata for a medical product of a supplier (Paragraph [0006-0012]; Fig. 1, the system and method to disclose a regulatory compliance tool for users seeking to achieve licenses for devices to be licensed by regulatory agencies comprising: a database of regulations concerning a plurality of devices; a database of experts having expertise in matters of regulatory compliance; a database of regulatory compliance documents; an expert system adapted to guide users along a regulatory compliance route; whereby users can upload and peruse said regulatory compliance documents, experts may review and revise said compliance documents, and regulatory agencies may evaluate said compliance documents);
Arazy discloses a portal for providing regulatory approval submission information, however, Arazy does not specifically disclose the following claim limitations: and a portal communicatively coupled to the repository and configured to filter, based on the associated metadata and users’ roles, the set of regulatory approval submission data and the associated metadata in the repository to provide user specific submission data and metadata to users of the supplier and users of a regulatory agency.
In the same field of endeavor of providing an online service to help perform regulatory reviews Levine teaches and a portal communicatively coupled to the repository and configured to filter, based on the associated metadata and users’ roles, the set of regulatory approval submission data and the associated metadata in the repository to provide user specific submission data and metadata to users of the supplier and users of a regulatory agency (Paragraph [0030-0031]; [0038]; [0046-0048]; Fig. 6, each of the computing devices includes respective memory storing instructions and relevant data for performing operations applicable to the respective device. The requestor’s and regulator’s computing devices may each include or be associated with a user interface device for displaying information to users and receiving inputs from users. Using the user interface device, a human reviewer can review a request and its accompanying proposal, which have been received by the agency from the regulatory compliance system. The proposal may be presented to the human reviewer via a graphical user interface. Each submitting organization may be expected to provide confidential data to the system, i.e. data that is not intended to be shared with other organizations. To maintain the privacy of the respective organizations, the system does not share each organization’s confidential data and requests with other submitting organizations. In one embodiment, the RCS interface receives the requestor’s data and places it in appropriate format for the agency receiving the new request. The one embodiment, the RCS interface collates the data and submits to each target regulatory agency only the data required by that agency. The RCS interface may determine what types of request are needed for the requestor to be able to use a new composition/process and may generate two or more individualized requests for submitting to different regulatory agencies, based on the same set of requestor data. The database generation component extracts information from the submitted requests and stores the information in the RCS database. (The examiner notes that the broadest reasonable interpretation of a portal configured to filter a set of regulatory approval submission data and associated metadata based on a user’s role to provide data to users of the supplier and regulatory agency would include a system for receiving data pertaining to requests for regulatory approval, formatting the data in the request by extracting and collating only relevant data, and presenting, via a user interface, the relevant data to a user such as an organization or regulatory agency based on their access and permission to view information as is taught in the prior art)).
Before the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the system of providing tools for guiding users through the regulatory approval process by allowing users to submit regulatory approval requests and corresponding agents to review the information as disclosed by Arazy with the system of and a portal communicatively coupled to the repository and configured to filter, based on the associated metadata and users’ roles, the set of regulatory approval submission data and the associated metadata in the repository to provide user specific submission data and metadata to users of the supplier and users of a regulatory agency as taught by Levine (Levine [0031]). With the motivation of helping to identify, organize, and present information to help during the review of regulatory compliance (Levine [0003]).
Claim 2: Modified Arazy discloses the regulatory approval submission and review system as per claim 1. However, Arazy does not disclose wherein the associated metadata includes: a subset of public metadata that is accessible by the users of the regulatory agency and the users of the supplier; and one or more subsets of supplier metadata that are accessible by the users of the supplier but are not accessible by the users of the regulatory agency, one or more subsets of agency metadata that are accessible by the users of the regulatory agency but are not accessible by the users of the supplier, or a combination thereof.
In the same field of endeavor of providing an online service to help perform regulatory reviews Levine teaches wherein the associated metadata includes: a subset of public metadata that is accessible by the users of the regulatory agency and the users of the supplier; and one or more subsets of supplier metadata that are accessible by the users of the supplier but are not accessible by the users of the regulatory agency, one or more subsets of agency metadata that are accessible by the users of the regulatory agency but are not accessible by the users of the supplier, or a combination thereof (Paragraph [0030-0031]; [0038]; [0046-0048]; Fig. 6, each of the computing devices includes respective memory storing instructions and relevant data for performing operations applicable to the respective device. The requestor’s and regulator’s computing devices may each include or be associated with a user interface device for displaying information to users and receiving inputs from users. Using the user interface device, a human reviewer can review a request and its accompanying proposal, which have been received by the agency from the regulatory compliance system. The proposal may be presented to the human reviewer via a graphical user interface. Each submitting organization may be expected to provide confidential data to the system, i.e. data that is not intended to be shared with other organizations. To maintain the privacy of the respective organizations, the system does not share each organization’s confidential data and requests with other submitting organizations. In one embodiment, the RCS interface receives the requestor’s data and places it in appropriate format for the agency receiving the new request. The one embodiment, the RCS interface collates the data and submits to each target regulatory agency only the data required by that agency. The RCS interface may determine what types of request are needed for the requestor to be able to use a new composition/process and may generate two or more individualized requests for submitting to different regulatory agencies, based on the same set of requestor data. The database generation component extracts information from the submitted requests and stores the information in the RCS database).
Before the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the system of providing tools for guiding users through the regulatory approval process by allowing users to submit regulatory approval requests and corresponding agents to review the information as disclosed by Arazy with the system of and a portal communicatively coupled to the repository and configured to filter, based on the associated metadata and users’ roles, the set of regulatory approval submission data and the associated metadata in the repository to provide user specific submission data and metadata to users of the supplier and users of a regulatory agency as taught by Levine (Levine [0031]). With the motivation of helping to identify, organize, and present information to help during the review of regulatory compliance (Levine [0003]).
Claim 3: Modified Arazy discloses the regulatory approval submission and review system as per claim 2. However, Arazy does not disclose wherein: the set of regulatory approval submission data includes a plurality of elements; and metadata associated with an element of the plurality of elements of the set of regulatory approval submission data includes an attribute indicating whether the metadata belongs to the subset of public metadata, a subset of supplier metadata of the one or more subsets of supplier metadata, or a subset of agency metadata of the one or more subsets of agency metadata.
In the same field of endeavor of providing an online service to help perform regulatory reviews Levine teaches wherein: the set of regulatory approval submission data includes a plurality of elements; and metadata associated with an element of the plurality of elements of the set of regulatory approval submission data includes an attribute indicating whether the metadata belongs to the subset of public metadata, a subset of supplier metadata of the one or more subsets of supplier metadata, or a subset of agency metadata of the one or more subsets of agency metadata (Paragraph [0030-0031]; [0038]; [0046-0048]; Fig. 6, each of the computing devices includes respective memory storing instructions and relevant data for performing operations applicable to the respective device. The requestor’s and regulator’s computing devices may each include or be associated with a user interface device for displaying information to users and receiving inputs from users. Using the user interface device, a human reviewer can review a request and its accompanying proposal, which have been received by the agency from the regulatory compliance system. The proposal may be presented to the human reviewer via a graphical user interface. Each submitting organization may be expected to provide confidential data to the system, i.e. data that is not intended to be shared with other organizations. To maintain the privacy of the respective organizations, the system does not share each organization’s confidential data and requests with other submitting organizations. In one embodiment, the RCS interface receives the requestor’s data and places it in appropriate format for the agency receiving the new request. The one embodiment, the RCS interface collates the data and submits to each target regulatory agency only the data required by that agency. The RCS interface may determine what types of request are needed for the requestor to be able to use a new composition/process and may generate two or more individualized requests for submitting to different regulatory agencies, based on the same set of requestor data. The database generation component extracts information from the submitted requests and stores the information in the RCS database).
Before the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the system of providing tools for guiding users through the regulatory approval process by allowing users to submit regulatory approval requests and corresponding agents to review the information as disclosed by Arazy with the system of and a portal communicatively coupled to the repository and configured to filter, based on the associated metadata and users’ roles, the set of regulatory approval submission data and the associated metadata in the repository to provide user specific submission data and metadata to users of the supplier and users of a regulatory agency as taught by Levine (Levine [0031]). With the motivation of helping to identify, organize, and present information to help during the review of regulatory compliance (Levine [0003]).
Claim 4: Modified Arazy discloses the regulatory approval submission and review system as per claim 3. However, Arazy does not disclose wherein metadata associated with the plurality of elements of the set of regulatory approval submission data is categorized or is searchable.
In the same field of endeavor of providing an online service to help perform regulatory reviews Levine teaches wherein metadata associated with the plurality of elements of the set of regulatory approval submission data is categorized or is searchable (Paragraph [0041]; [0089]; [0097]; [0105]; Fig. 6, the instructions include an RCS interface, a database generation component, a proposal generator, a submission component, a response reception component, a prediction model generation component, and a querying component. The submission component outputs the proposal for the current request. The proposal enables an authorized human reviewer to search or query the decision tree to understand why the system made a decision. In the case of the prediction component, the keywords to be searched and corresponding regulated parameters, may be identified manually or semi-manually from the relevant regulations. In one embodiment, the reviewer may use the system to perform queries of the database. The querying component of the system receives the query and outputs a response).
Before the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the system of providing tools for guiding users through the regulatory approval process by allowing users to submit regulatory approval requests and corresponding agents to review the information as disclosed by Arazy with the system of and a portal communicatively coupled to the repository and configured to filter, based on the associated metadata and users’ roles, the set of regulatory approval submission data and the associated metadata in the repository to provide user specific submission data and metadata to users of the supplier and users of a regulatory agency as taught by Levine (Levine [0031]). With the motivation of helping to identify, organize, and present information to help during the review of regulatory compliance (Levine [0003]).
Claim 5: Modified Arazy discloses the regulatory approval submission and review system as per claim 1. However, Arazy does not disclose wherein the associated metadata includes comments, modifications, revision history, status, or other attributes associated with individual elements of the set of regulatory approval submission data.
In the same field of endeavor of providing an online service to help perform regulatory reviews Levine teaches wherein the associated metadata includes comments, modifications, revision history, status, or other attributes associated with individual elements of the set of regulatory approval submission data (Paragraph [0048-0049]; [0086-0087] the database generation component extracts information from the submitted requests and stores the information in the database. The extracted information may include information for learning/ updating a prediction model. The proposal generator generates a proposal concerning whether the new request should be approved or not. The proposal generator may employ the prediction model which is informed by historical data stored in the database. The evaluation makes use of historical data sets already acquired such as the history of the current request).
Before the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the system of providing tools for guiding users through the regulatory approval process by allowing users to submit regulatory approval requests and corresponding agents to review the information as disclosed by Arazy with the system of and a portal communicatively coupled to the repository and configured to filter, based on the associated metadata and users’ roles, the set of regulatory approval submission data and the associated metadata in the repository to provide user specific submission data and metadata to users of the supplier and users of a regulatory agency as taught by Levine (Levine [0031]). With the motivation of helping to identify, organize, and present information to help during the review of regulatory compliance (Levine [0003]).
Claim 6: Modified Arazy discloses the regulatory approval submission and review system as per claim 1. Arazy further discloses wherein: the set of regulatory approval submission data is stored in the repository according to a multi-level hierarchical structure; and the associated metadata is stored with corresponding elements of the set of regulatory approval submission data in the multi-level hierarchical structure (Paragraph [0069]; [0106-0109]; [0244-0246]; Fig. 8, the system prepares the regulatory application. Information is stored in appropriately identified fields in a database. A document can be examined on a superficial level to make sure it is the type of document required and it contains the right sections of information. In order to make accessing application documents easier the system may comprise a custom visual interface that summarizes all the information and client documents on one screen. The information required in attaining compliance is divided into several categories according to the type of manufacturer, the safety attributes of the device, the clinical efficacy of its use, the domestic import, license rights, and legal issues).
Claim 7: Modified Arazy discloses the regulatory approval submission and review system as per claim 6. Arazy further discloses wherein the multi-level hierarchical structure includes a project level, a section level below the project level, an assembly level below the section level, and a component level below the assembly level (Paragraph [0069]; [0106-0109]; [0244-0246]; Fig. 8, the system prepares the regulatory application. Information is stored in appropriately identified fields in a database. A document can be examined on a superficial level to make sure it is the type of document required and it contains the right sections of information. In order to make accessing application documents easier the system may comprise a custom visual interface that summarizes all the information and client documents on one screen. The information required in attaining compliance is divided into several categories according to the type of manufacturer, the safety attributes of the device, the clinical efficacy of its use, the domestic import, license rights, and legal issues).
Claim 8: Modified Arazy discloses the regulatory approval submission and review system as per claim 1. However, Arazy does not disclose wherein the portal is configured to provide, based on the associated metadata and a user’s role, user specific metrics data to a dashboard of a user interface.
In the same field of endeavor of providing an online service to help perform regulatory reviews Levine teaches wherein the portal is configured to provide, based on the associated metadata and a user’s role, user specific metrics data to a dashboard of a user interface (Paragraph [0030-0031]; [0038]; [0046-0048]; Fig. 6, each of the computing devices includes respective memory storing instructions and relevant data for performing operations applicable to the respective device. The requestor’s and regulator’s computing devices may each include or be associated with a user interface device for displaying information to users and receiving inputs from users. Using the user interface device, a human reviewer can review a request and its accompanying proposal, which have been received by the agency from the regulatory compliance system. The proposal may be presented to the human reviewer via a graphical user interface. Each submitting organization may be expected to provide confidential data to the system, i.e. data that is not intended to be shared with other organizations. To maintain the privacy of the respective organizations, the system does not share each organization’s confidential data and requests with other submitting organizations. In one embodiment, the RCS interface receives the requestor’s data and places it in appropriate format for the agency receiving the new request. The one embodiment, the RCS interface collates the data and submits to each target regulatory agency only the data required by that agency. The RCS interface may determine what types of request are needed for the requestor to be able to use a new composition/process and may generate two or more individualized requests for submitting to different regulatory agencies, based on the same set of requestor data. The database generation component extracts information from the submitted requests and stores the information in the RCS database).
Before the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the system of providing tools for guiding users through the regulatory approval process by allowing users to submit regulatory approval requests and corresponding agents to review the information as disclosed by Arazy with the system of and a portal communicatively coupled to the repository and configured to filter, based on the associated metadata and users’ roles, the set of regulatory approval submission data and the associated metadata in the repository to provide user specific submission data and metadata to users of the supplier and users of a regulatory agency as taught by Levine (Levine [0031]). With the motivation of helping to identify, organize, and present information to help during the review of regulatory compliance (Levine [0003]).
Claim 9: Arazy discloses the regulatory approval submission and review system as per claim 8. However, Arazy does not disclose wherein the user specific metrics data includes user specific statistical data generated based on the associated metadata and the user’s role.
In the same field of endeavor of providing an online service to help perform regulatory reviews Levine teaches wherein the user specific metrics data includes user specific statistical data generated based on the associated metadata and the user’s role (Paragraph [0030-0031]; [0038]; [0046-0048]; Fig. 6, each of the computing devices includes respective memory storing instructions and relevant data for performing operations applicable to the respective device. The requestor’s and regulator’s computing devices may each include or be associated with a user interface device for displaying information to users and receiving inputs from users. Using the user interface device, a human reviewer can review a request and its accompanying proposal, which have been received by the agency from the regulatory compliance system. The proposal may be presented to the human reviewer via a graphical user interface. Each submitting organization may be expected to provide confidential data to the system, i.e. data that is not intended to be shared with other organizations. To maintain the privacy of the respective organizations, the system does not share each organization’s confidential data and requests with other submitting organizations. In one embodiment, the RCS interface receives the requestor’s data and places it in appropriate format for the agency receiving the new request. The one embodiment, the RCS interface collates the data and submits to each target regulatory agency only the data required by that agency. The RCS interface may determine what types of request are needed for the requestor to be able to use a new composition/process and may generate two or more individualized requests for submitting to different regulatory agencies, based on the same set of requestor data. The database generation component extracts information from the submitted requests and stores the information in the RCS database).
Before the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the system of providing tools for guiding users through the regulatory approval process by allowing users to submit regulatory approval requests and corresponding agents to review the information as disclosed by Arazy with the system of and a portal communicatively coupled to the repository and configured to filter, based on the associated metadata and users’ roles, the set of regulatory approval submission data and the associated metadata in the repository to provide user specific submission data and metadata to users of the supplier and users of a regulatory agency as taught by Levine (Levine [0031]). With the motivation of helping to identify, organize, and present information to help during the review of regulatory compliance (Levine [0003]).
Claim 10: Arazy discloses the regulatory approval submission and review system as per claim 1. Arazy further discloses wherein the portal is further configured to provide, based on the associated metadata, a submission knowledgebase to a user of the supplier through a user interface, the submission knowledgebase including knowledge regarding a regulatory approval submission and review process learned from pending projects and complete projects (Paragraph [0030-0031]; [0038]; [0046-0048]; Fig. 6, each of the computing devices includes respective memory storing instructions and relevant data for performing operations applicable to the respective device. The requestor’s and regulator’s computing devices may each include or be associated with a user interface device for displaying information to users and receiving inputs from users. Using the user interface device, a human reviewer can review a request and its accompanying proposal, which have been received by the agency from the regulatory compliance system. The proposal may be presented to the human reviewer via a graphical user interface. Each submitting organization may be expected to provide confidential data to the system, i.e. data that is not intended to be shared with other organizations. To maintain the privacy of the respective organizations, the system does not share each organization’s confidential data and requests with other submitting organizations. In one embodiment, the RCS interface receives the requestor’s data and places it in appropriate format for the agency receiving the new request. The one embodiment, the RCS interface collates the data and submits to each target regulatory agency only the data required by that agency. The RCS interface may determine what types of request are needed for the requestor to be able to use a new composition/process and may generate two or more individualized requests for submitting to different regulatory agencies, based on the same set of requestor data. The database generation component extracts information from the submitted requests and stores the information in the RCS database).
Claim 11: Arazy discloses the regulatory approval submission and review system as per claim 1. Arazy further discloses wherein the set of regulatory approval submission data includes one or more documents, one or more design files, one or more images, video content, audio content, multimedia content, or a combination thereof (Paragraph [0030-0031]; [0038]; [0046-0048]; Fig. 6, each of the computing devices includes respective memory storing instructions and relevant data for performing operations applicable to the respective device. The requestor’s and regulator’s computing devices may each include or be associated with a user interface device for displaying information to users and receiving inputs from users. Using the user interface device, a human reviewer can review a request and its accompanying proposal, which have been received by the agency from the regulatory compliance system. The proposal may be presented to the human reviewer via a graphical user interface. Each submitting organization may be expected to provide confidential data to the system, i.e. data that is not intended to be shared with other organizations. To maintain the privacy of the respective organizations, the system does not share each organization’s confidential data and requests with other submitting organizations. In one embodiment, the RCS interface receives the requestor’s data and places it in appropriate format for the agency receiving the new request. The one embodiment, the RCS interface collates the data and submits to each target regulatory agency only the data required by that agency. The RCS interface may determine what types of request are needed for the requestor to be able to use a new composition/process and may generate two or more individualized requests for submitting to different regulatory agencies, based on the same set of requestor data. The database generation component extracts information from the submitted requests and stores the information in the RCS database).
Claim 12: Arazy discloses the regulatory approval submission and review system as per claim 1. However, Arazy does not disclose wherein the portal is configured to provide different data and metadata to two users of the supplier having different roles
In the same field of endeavor of providing an online service to help perform regulatory reviews Levine teaches wherein the portal is configured to provide different data and metadata to two users of the supplier having different roles (Paragraph [0030-0031]; [0038]; [0046-0048]; Fig. 6, each of the computing devices includes respective memory storing instructions and relevant data for performing operations applicable to the respective device. The requestor’s and regulator’s computing devices may each include or be associated with a user interface device for displaying information to users and receiving inputs from users. Using the user interface device, a human reviewer can review a request and its accompanying proposal, which have been received by the agency from the regulatory compliance system. The proposal may be presented to the human reviewer via a graphical user interface. Each submitting organization may be expected to provide confidential data to the system, i.e. data that is not intended to be shared with other organizations. To maintain the privacy of the respective organizations, the system does not share each organization’s confidential data and requests with other submitting organizations. In one embodiment, the RCS interface receives the requestor’s data and places it in appropriate format for the agency receiving the new request. The one embodiment, the RCS interface collates the data and submits to each target regulatory agency only the data required by that agency. The RCS interface may determine what types of request are needed for the requestor to be able to use a new composition/process and may generate two or more individualized requests for submitting to different regulatory agencies, based on the same set of requestor data. The database generation component extracts information from the submitted requests and stores the information in the RCS database).
Before the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the system of providing tools for guiding users through the regulatory approval process by allowing users to submit regulatory approval requests and corresponding agents to review the information as disclosed by Arazy with the system of and a portal communicatively coupled to the repository and configured to filter, based on the associated metadata and users’ roles, the set of regulatory approval submission data and the associated metadata in the repository to provide user specific submission data and metadata to users of the supplier and users of a regulatory agency as taught by Levine (Levine [0031]). With the motivation of helping to identify, organize, and present information to help during the review of regulatory compliance (Levine [0003]).
Claims 13 and 20: Arazy discloses (Claim 13) A system comprising: one or more processors; and one or more processor-readable media storing instructions which, when executed by the one or more processors, cause the one or more processors to: (Claim 20) A processor-implemented method comprising: receive, from a supplier of a medical product, a set of regulatory approval submission data associated with the medical product for approval by a regulatory agency; store the set of regulatory approval submission data in a repository (Paragraph [0030-0031]; [0038]; [0046-0048]; Fig. 6, each of the computing devices includes respective memory storing instructions and relevant data for performing operations applicable to the respective device. The requestor’s and regulator’s computing devices may each include or be associated with a user interface device for displaying information to users and receiving inputs from users. Using the user interface device, a human reviewer can review a request and its accompanying proposal, which have been received by the agency from the regulatory compliance system. The proposal may be presented to the human reviewer via a graphical user interface. Each submitting organization may be expected to provide confidential data to the system, i.e. data that is not intended to be shared with other organizations. To maintain the privacy of the respective organizations, the system does not share each organization’s confidential data and requests with other submitting organizations. In one embodiment, the RCS interface receives the requestor’s data and places it in appropriate format for the agency receiving the new request. The one embodiment, the RCS interface collates the data and submits to each target regulatory agency only the data required by that agency. The RCS interface may determine what types of request are needed for the requestor to be able to use a new composition/process and may generate two or more individualized requests for submitting to different regulatory agencies, based on the same set of requestor data. The database generation component extracts information from the submitted requests and stores the information in the RCS database);
receive, from users of the supplier and users of the regulatory agency, metadata associated with corresponding elements of the set of regulatory approval submission data, wherein metadata associated with an element of the set of regulatory approval submission data includes an attribute indicating accessibility of the element or the metadata associated with the element; store the metadata with the corresponding elements of the set of regulatory approval submission data in the repository (Paragraph [0030-0031]; [0038]; [0046-0048]; Fig. 6, each of the computing devices includes respective memory storing instructions and relevant data for performing operations applicable to the respective device. The requestor’s and regulator’s computing devices may each include or be associated with a user interface device for displaying information to users and receiving inputs from users. Using the user interface device, a human reviewer can review a request and its accompanying proposal, which have been received by the agency from the regulatory compliance system. The proposal may be presented to the human reviewer via a graphical user interface. Each submitting organization may be expected to provide confidential data to the system, i.e. data that is not intended to be shared with other organizations. To maintain the privacy of the respective organizations, the system does not share each organization’s confidential data and requests with other submitting organizations. In one embodiment, the RCS interface receives the requestor’s data and places it in appropriate format for the agency receiving the new request. The one embodiment, the RCS interface collates the data and submits to each target regulatory agency only the data required by that agency. The RCS interface may determine what types of request are needed for the requestor to be able to use a new composition/process and may generate two or more individualized requests for submitting to different regulatory agencies, based on the same set of requestor data. The database generation component extracts information from the submitted requests and stores the information in the RCS database).
Arazy discloses a portal for providing regulatory approval submission information, however, Arazy does not specifically disclose the following claim limitations: and filter, based on users’ roles and the metadata associated with the corresponding elements, the set of regulatory approval submission data and the metadata associated with the corresponding elements stored in the repository to provide user specific submission data and metadata to the users of the supplier and the users of the regulatory agency.
In the same field of endeavor of providing an online service to help perform regulatory reviews Levine teaches and filter, based on users’ roles and the metadata associated with the corresponding elements, the set of regulatory approval submission data and the metadata associated with the corresponding elements stored in the repository to provide user specific submission data and metadata to the users of the supplier and the users of the regulatory agency (Paragraph [0030-0031]; [0038]; [0046-0048]; Fig. 6, each of the computing devices includes respective memory storing instructions and relevant data for performing operations applicable to the respective device. The requestor’s and regulator’s computing devices may each include or be associated with a user interface device for displaying information to users and receiving inputs from users. Using the user interface device, a human reviewer can review a request and its accompanying proposal, which have been received by the agency from the regulatory compliance system. The proposal may be presented to the human reviewer via a graphical user interface. Each submitting organization may be expected to provide confidential data to the system, i.e. data that is not intended to be shared with other organizations. To maintain the privacy of the respective organizations, the system does not share each organization’s confidential data and requests with other submitting organizations. In one embodiment, the RCS interface receives the requestor’s data and places it in appropriate format for the agency receiving the new request. The one embodiment, the RCS interface collates the data and submits to each target regulatory agency only the data required by that agency. The RCS interface may determine what types of request are needed for the requestor to be able to use a new composition/process and may generate two or more individualized requests for submitting to different regulatory agencies, based on the same set of requestor data. The database generation component extracts information from the submitted requests and stores the information in the RCS database).
Before the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the system of providing tools for guiding users through the regulatory approval process by allowing users to submit regulatory approval requests and corresponding agents to review the information as disclosed by Arazy with the system of and filter, based on users’ roles and the metadata associated with the corresponding elements, the set of regulatory approval submission data and the metadata associated with the corresponding elements stored in the repository to provide user specific submission data and metadata to the users of the supplier and the users of the regulatory agency as taught by Levine (Levine [0031]). With the motivation of helping to identify, organize, and present information to help during the review of regulatory compliance (Levine [0003]).
Claim 14: Modified Arazy discloses the system as per claim 13. However, Arazy does not disclose wherein the metadata associated with the corresponding elements of the set of regulatory approval submission data includes comments, modifications, questions, review decisions, revision history, status, or other attributes associated with the corresponding elements.
In the same field of endeavor of providing an online service to help perform regulatory reviews Levine teaches wherein the metadata associated with the corresponding elements of the set of regulatory approval submission data includes comments, modifications, questions, review decisions, revision history, status, or other attributes associated with the corresponding elements (Paragraph [0048-0049]; [0086-0087] the database generation component extracts information from the submitted requests and stores the information in the database. The extracted information may include information for learning/ updating a prediction model. The proposal generator generates a proposal concerning whether the new request should be approved or not. The proposal generator may employ the prediction model which is informed by historical data stored in the database. The evaluation makes use of historical data sets already acquired such as the history of the current request).
Before the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the system of providing tools for guiding users through the regulatory approval process by allowing users to submit regulatory approval requests and corresponding agents to review the information as disclosed by Arazy with the system of and a portal communicatively coupled to the repository and configured to filter, based on the associated metadata and users’ roles, the set of regulatory approval submission data and the associated metadata in the repository to provide user specific submission data and metadata to users of the supplier and users of a regulatory agency as taught by Levine (Levine [0031]). With the motivation of helping to identify, organize, and present information to help during the review of regulatory compliance (Levine [0003]).
Claim 15: Modified Arazy discloses the system as per claim 13. However, Arazy does not disclose wherein the attribute indicates whether the metadata associated with the element belongs to a subset of public metadata that is accessible by the users of the regulatory agency and the users of the supplier, a subset of supplier metadata that is accessible by the users of the supplier but is not accessible by the users of the regulatory agency, or a subset of agency metadata that is accessible by the users of the regulatory agency but is not accessible by the users of the supplier.
In the same field of endeavor of providing an online service to help perform regulatory reviews Levine teaches wherein the attribute indicates whether the metadata associated with the element belongs to a subset of public metadata that is accessible by the users of the regulatory agency and the users of the supplier, a subset of supplier metadata that is accessible by the users of the supplier but is not accessible by the users of the regulatory agency, or a subset of agency metadata that is accessible by the users of the regulatory agency but is not accessible by the users of the supplier (Paragraph [0030-0031]; [0038]; [0046-0048]; Fig. 6, each of the computing devices includes respective memory storing instructions and relevant data for performing operations applicable to the respective device. The requestor’s and regulator’s computing devices may each include or be associated with a user interface device for displaying information to users and receiving inputs from users. Using the user interface device, a human reviewer can review a request and its accompanying proposal, which have been received by the agency from the regulatory compliance system. The proposal may be presented to the human reviewer via a graphical user interface. Each submitting organization may be expected to provide confidential data to the system, i.e. data that is not intended to be shared with other organizations. To maintain the privacy of the respective organizations, the system does not share each organization’s confidential data and requests with other submitting organizations. In one embodiment, the RCS interface receives the requestor’s data and places it in appropriate format for the agency receiving the new request. The one embodiment, the RCS interface collates the data and submits to each target regulatory agency only the data required by that agency. The RCS interface may determine what types of request are needed for the requestor to be able to use a new composition/process and may generate two or more individualized requests for submitting to different regulatory agencies, based on the same set of requestor data. The database generation component extracts information from the submitted requests and stores the information in the RCS database).
Before the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the system of providing tools for guiding users through the regulatory approval process by allowing users to submit regulatory approval requests and corresponding agents to review the information as disclosed by Arazy with the system of and filter, based on users’ roles and the metadata associated with the corresponding elements, the set of regulatory approval submission data and the metadata associated with the corresponding elements stored in the repository to provide user specific submission data and metadata to the users of the supplier and the users of the regulatory agency as taught by Levine (Levine [0031]). With the motivation of helping to identify, organize, and present information to help during the review of regulatory compliance (Levine [0003]).
Claim 16: Modified Arazy discloses the system as per claim 13. Arazy further discloses wherein the set of regulatory approval submission data includes one or more documents, one or more design files, one or more images, video content, audio content, multimedia content, or a combination thereof (Paragraph [0030-0031]; [0038]; [0046-0048]; Fig. 6, each of the computing devices includes respective memory storing instructions and relevant data for performing operations applicable to the respective device. The requestor’s and regulator’s computing devices may each include or be associated with a user interface device for displaying information to users and receiving inputs from users. Using the user interface device, a human reviewer can review a request and its accompanying proposal, which have been received by the agency from the regulatory compliance system. The proposal may be presented to the human reviewer via a graphical user interface. Each submitting organization may be expected to provide confidential data to the system, i.e. data that is not intended to be shared with other organizations. To maintain the privacy of the respective organizations, the system does not share each organization’s confidential data and requests with other submitting organizations. In one embodiment, the RCS interface receives the requestor’s data and places it in appropriate format for the agency receiving the new request. The one embodiment, the RCS interface collates the data and submits to each target regulatory agency only the data required by that agency. The RCS interface may determine what types of request are needed for the requestor to be able to use a new composition/process and may generate two or more individualized requests for submitting to different regulatory agencies, based on the same set of requestor data. The database generation component extracts information from the submitted requests and stores the information in the RCS database).
Claim 17: Modified Arazy discloses the system as per claim 13. Arazy further discloses wherein: the set of regulatory approval submission data is stored in the repository according to a multi-level hierarchical structure; and the metadata associated with the corresponding elements of the set of regulatory approval submission data is stored with the corresponding elements in the multi-level hierarchical structure (Paragraph [0069]; [0106-0109]; [0244-0246]; Fig. 8, the system prepares the regulatory application. Information is stored in appropriately identified fields in a database. A document can be examined on a superficial level to make sure it is the type of document required and it contains the right sections of information. In order to make accessing application documents easier the system may comprise a custom visual interface that summarizes all the information and client documents on one screen. The information required in attaining compliance is divided into several categories according to the type of manufacturer, the safety attributes of the device, the clinical efficacy of its use, the domestic import, license rights, and legal issues).
Claim 18: Modified Arazy discloses the system as per claim 13. However, Arazy does not disclose wherein the instructions, when executed by the one or more processors, further cause the one or more processors to provide, based on the metadata associated with the corresponding elements and a user’s role, user specific metrics data to a dashboard of a user interface.
In the same field of endeavor of providing an online service to help perform regulatory reviews Levine teaches wherein the instructions, when executed by the one or more processors, further cause the one or more processors to provide, based on the metadata associated with the corresponding elements and a user’s role, user specific metrics data to a dashboard of a user interface (Paragraph [0030-0031]; [0038]; [0046-0048]; Fig. 6, each of the computing devices includes respective memory storing instructions and relevant data for performing operations applicable to the respective device. The requestor’s and regulator’s computing devices may each include or be associated with a user interface device for displaying information to users and receiving inputs from users. Using the user interface device, a human reviewer can review a request and its accompanying proposal, which have been received by the agency from the regulatory compliance system. The proposal may be presented to the human reviewer via a graphical user interface. Each submitting organization may be expected to provide confidential data to the system, i.e. data that is not intended to be shared with other organizations. To maintain the privacy of the respective organizations, the system does not share each organization’s confidential data and requests with other submitting organizations. In one embodiment, the RCS interface receives the requestor’s data and places it in appropriate format for the agency receiving the new request. The one embodiment, the RCS interface collates the data and submits to each target regulatory agency only the data required by that agency. The RCS interface may determine what types of request are needed for the requestor to be able to use a new composition/process and may generate two or more individualized requests for submitting to different regulatory agencies, based on the same set of requestor data. The database generation component extracts information from the submitted requests and stores the information in the RCS database).
Before the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the system of providing tools for guiding users through the regulatory approval process by allowing users to submit regulatory approval requests and corresponding agents to review the information as disclosed by Arazy with the system of and filter, based on users’ roles and the metadata associated with the corresponding elements, the set of regulatory approval submission data and the metadata associated with the corresponding elements stored in the repository to provide user specific submission data and metadata to the users of the supplier and the users of the regulatory agency as taught by Levine (Levine [0031]). With the motivation of helping to identify, organize, and present information to help during the review of regulatory compliance (Levine [0003]).
Claim 19: Modified Arazy discloses the system as per claim 13. Arazy further discloses wherein the instructions, when executed by the one or more processors, further cause the one or more processors to provide, based on the metadata associated with the corresponding elements, a submission knowledgebase to a user of the supplier through a user interface, the submission knowledgebase including knowledge regarding a regulatory approval submission and review process learned from pending projects and complete projects (Paragraph [0030-0031]; [0038]; [0046-0048]; Fig. 6, each of the computing devices includes respective memory storing instructions and relevant data for performing operations applicable to the respective device. The requestor’s and regulator’s computing devices may each include or be associated with a user interface device for displaying information to users and receiving inputs from users. Using the user interface device, a human reviewer can review a request and its accompanying proposal, which have been received by the agency from the regulatory compliance system. The proposal may be presented to the human reviewer via a graphical user interface. Each submitting organization may be expected to provide confidential data to the system, i.e. data that is not intended to be shared with other organizations. To maintain the privacy of the respective organizations, the system does not share each organization’s confidential data and requests with other submitting organizations. In one embodiment, the RCS interface receives the requestor’s data and places it in appropriate format for the agency receiving the new request. The one embodiment, the RCS interface collates the data and submits to each target regulatory agency only the data required by that agency. The RCS interface may determine what types of request are needed for the requestor to be able to use a new composition/process and may generate two or more individualized requests for submitting to different regulatory agencies, based on the same set of requestor data. The database generation component extracts information from the submitted requests and stores the information in the RCS database).
Therefore, claim 1-20 are rejected under U.S.C. 103.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Fagan (US 2009/0132278) Integrated biomedical information portal system and methods.
Miller (US 2022/0253871) Multi-dimensional product information analysis, management, and application system and methods.
Goodlett (US 2004/0193634) Managing regulatory information.
Schwenk (US 2014/0052653) System and method for completing, validating, and submitting regulatory forms.
Hoang (US 2023/0237399) Identifying regulatory data corresponding to executable rules.
Pondicherry Murugappan (US 2020/0111023) Artificial intelligence (AI)-based regulatory data processing system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COREY RUSS whose telephone number is (571)270-5902. The examiner can normally be reached on M-F 7:30-4:30.
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) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lynda Jasmin can be reached on 5712726782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service. Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/COREY RUSS/Examiner, Art Unit 3629