DETAILED ACTION
Introduction
This Final Office Action is in response to amendments and remarks submitted on November 10, 2025, for the application with serial number 18/606,913.
Claims 1 and 16 are amended.
Claim 11 is canceled.
Claim 21 is new.
Claims 1-10 and 12-21 are pending.
Information Disclosure Statement
The information disclosure statement filed on November 10, 2025, has been considered.
Interview
The Examiner acknowledges the interview conducted on October 8, 2025, in which proposed amendments were discussed.
Response to Remarks/Amendments
35 USC §101 Rejections
The Applicant traverses the rejection of the claims as being directed to an ineligible abstract idea, contending that the identified abstract idea of storing and displaying regulator submission data is not the same as any of the examples from case law or the MPEP. See Remarks pp. 8-10. In response, the Examiner points out that the examples are just that – examples. As examples, they are non-limiting. The present claims attempt to manage personal behavior because the claims recite steps for processing and displaying regulatory submission data. The steps could be implemented mentally or on paper by a human being, but generic computer hardware is recited for implementation. Contrary to the Applicant’s assertions, the steps of the claims could be followed by a human. A human being could provide feedback on submitted regulatory information and display views of products as recited in independent claim 1. The recited user interface is generic computer hardware that does not provide a practical application or significantly more than the recited abstract idea. The newly recited limitation of building a knowledgebase is part of the abstract idea of storing and displaying regulatory submission data because a “knowledgebase” could be a collection of information, such as a paper file or document. The recited portal has no particular structure. Therefore, it is part of a generic computer system. Lack of conventionality does not imply subject matter eligibility. The claims have been properly analyzed in the rejection, below, and found to be ineligible. Additional elements outside the scope of the abstract idea have been considered, but they have been found to amount to generic computer hardware.
The rejection for lack of subject matter eligibility is updated and maintained.
35 USC §103 Rejections
Amendments to independent claims 1 and 16 changed the scope of the claims, necessitating further search and consideration of the prior art. Claims 1 and 16 now stand rejected as being obvious over Arazy in view of Wong. Claim 20 is presented as originally filed, and it remains anticipated by Arazy.
The Applicant traverses the rejection of independent claims 1 and 16 as being obvious over Arazy in view of Wong, contending that the Wong reference is deficient. Specifically, the Applicant submits that Wong pertains to evaluating 3D displays. See Remarks p. 12. While it is true that Wong covers subject matter for evaluating 3D displays, Wong also teaches changing displays and using the displays to compare prototypes in the cited passages. In particular, cited ¶[0176] of Wong discusses a 3D object that is mapped to a display shown in Fig. 28. As indicated in Wong, the 2D image of the 3D object is adjustable, so it “changes;” meeting the recitation of exemplary independent claim 1. Due to the breadth of the claim language in independent claim 16: “the first user interface or the second user interface enables a user to compare at least two versions of a medical product . . . “; Wong also reads on this limitation. Cited ¶[129] teaches comparing reported metrics of prototypes of products. This teaching reads on the claim language: “enables a user to compare at least two versions of a [ ] product.” Comparing metrics is taught by Wong, which meets the broad recitation.
The rejection of the dependent claims stands or falls with the rejection of the independent claims.
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.
The Manual of Patent Examining Procedure (MPEP) provides detailed rules for determining subject matter eligibility for claims in §2106. Those rules provide a basis for the analysis and finding of ineligibility that follows.
Claims 1-10 and 12-21 are rejected under 35 U.S.C. 101. The claimed invention is directed to non-statutory subject matter because the claimed invention recites a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Although claims(s) 1-10 and 12-21 are all directed to one of the four statutory categories of invention, the claims are directed to storing and displaying regulatory submission data (as evidenced by exemplary independent claim 1; “store the common set of regulatory approval submission data to the repository;” and “provide, via a second computing device of a regulatory agency, a second user interface for reviewing and providing feedback on the common set of regulatory approval submission”), an abstract idea. Certain methods of organizing human activity are ineligible abstract ideas, including managing personal behavior or relationships or interactions between people. See MPEP §2106.04(a). The limitations of exemplary claim 1 include: “provide . . . a first user interface for submitting and updating a common set of regulatory approval submission data;” “store the common set of regulatory approval submission data;” “provide . . . a second user interface for reviewing and providing feedback on the common set of regulatory approval submission data;” “control access to respective subsets of the common set of regulatory approval submission data;” and “build a searchable knowledgebase based on the feedback.” The steps are all steps for managing personal behavior related to the abstract idea of storing and displaying regulatory submission data that, when considered alone and in combination, are part of the abstract idea of storing and displaying regulatory submission data. The dependent claims further recite steps for managing personal behavior that are part of the abstract idea of storing and displaying regulatory submission data. These claim elements, when considered alone and in combination, are considered to be abstract ideas because they are directed to a method of organizing human activity which includes providing a database for medical device regulatory submission, review, and approval.
Under step 2A of the subject matter eligibility analysis, a claim that recites a judicial exception must be evaluated to determine whether the claim provides a practical application of the judicial exception. Additional elements of the independent claims amount to generic computer hardware that does not provide a practical application (computing devices and user interfaces in independent claim 1; a system with processors, media storing instructions, and computing devices in independent claim 15; and a processor with a computing device in independent claim 19). See MPEP §2106.04(d)[I]. The claims do not recite an improvement to another technology or technical field, nor do they recite an improvement to the functioning of the computer itself. See MPEP §2106.05(a). The claims require no more than a generic computer (computing devices and user interfaces in independent claim 1; a system with processors, media storing instructions, and computing devices in independent claim 15; and a processor with a computing device in independent claim 19) to implement the abstract idea, which does not amount to significantly more than an abstract idea. See MPEP §2106.05(f). Because the claims only recite use of a generic computer, they do not apply the judicial exception with a particular machine. See MPEP §2106.05(b). For these reasons, the claims do not provide a practical application of the abstract idea, nor do they amount to significantly more than an abstract idea under step 2B of the subject matter eligibility analysis. Using a generic computer to implement an abstract idea does not provide an inventive concept. Therefore, the claims recite ineligible subject matter under 35 USC §101.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20130198094 A1 to Arazy (hereinafter ‘ARAZY’).
Claim 20 (Original)
ARAZY discloses a processor-implemented method (see abstract; expert system running on a server with a user submitting documents. See also claims 1 and 11; a computer screen) comprising:
providing, via a first computing device of a submitter (see again abstract; expert system running on a server with a user submitting documents. See also claims 1 and 11; a computer screen), a first user interface (see again ¶[0152]-[0161]; a user interface) for submitting (see again abstract; submit documents) for submitting and updating a common set of regulatory approval submission data for a medical product (see ¶[0076]-[0082]; the major properties of the system comprise: [0077] a. an updated database of the complete device compliance requirements for each country, including risk class and device type. [0078] b. an updated database of compete regulatory application requirements (compliance route) for each country including risk class and device type. [0079] c. an updated database for the complete country specific related requirements. [0080] d. an updated database of the generic master regulatory file for each type of medical device for each country. [0081] e. a platform for upload, review, and download of documents and exchange of information between user, experts and auditors. (This may include an implementation of "Document Control") [0082] f. an updated database of a master regulatory file for any single client product);
storing the common set of regulatory approval submission data in a repository (see ¶[0011]; a server adapted to store said databases and provide communications between said databases, said users, said experts, said expert system, and said agencies);
providing, via a second computing device of a regulatory agency, a second user interface for reviewing (see again abstract; domain experts review and edit compliance documents) and
providing feedback on the common set of regulatory approval submission data (see ¶[0065]; receive approval/failure); and
controlling access to respective subsets of the common set of regulatory approval submission data by the submitter and the regulatory agency (see ¶[0137]; the process is hermetic and compartmentalized, which also eliminates certain risks concerning information security as will be clear to one skilled in the art. See again abstract; regulatory agencies may be given access. Compliance documents are provided by given users).
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 4, 5, 10, 12, 13, 15, 16, 19, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20130198094 A1 to Arazy (hereinafter ‘ARAZY’) in view of US 20240022698 A1 to Wong et al. (hereinafter ‘WONG’).
Claim 1 (Currently Amended)
ARAZY discloses a regulatory approval submission and review system (see abstract and ¶[0004]; databases include lists of domain experts, who may be called upon to review and edit these compliance documents) comprising: a repository (see again abstract; databases); and a portal communicatively coupled to the repository (see ¶[0152]-[0161]; a user interface portal) and configured to:
provide, via a first computing device of a submitter (see abstract; expert system running on a server with a user submitting documents. See also claims 1 and 11; a computer screen), a first user interface (see again ¶[0152]-[0161]; a user interface) for submitting (see again abstract; submit documents) and updating a common set of regulatory approval submission data for medical product (see ¶[0076]-[0082]; the major properties of the system comprise: [0077] a. an updated database of the complete device compliance requirements for each country, including risk class and device type. [0078] b. an updated database of compete regulatory application requirements (compliance route) for each country including risk class and device type. [0079] c. an updated database for the complete country specific related requirements. [0080] d. an updated database of the generic master regulatory file for each type of medical device for each country. [0081] e. a platform for upload, review, and download of documents and exchange of information between user, experts and auditors. (This may include an implementation of "Document Control") [0082] f. an updated database of a master regulatory file for any single client product);
store the common set of regulatory approval submission data to the repository (see ¶[0011]; a server adapted to store said databases and provide communications between said databases, said users, said experts, said expert system, and said agencies);
provide, via a second computing device of a regulatory agency, a second user interface for reviewing (see again abstract; domain experts review and edit compliance documents) and providing feedback on the common set of regulatory approval submission data (see ¶[0065]; receive approval/failure).
ARAZY does not specifically disclose, but WONG discloses, wherein the first user interface or the second user interface enables a user to change views of the medical product, a subassembly of the medical product, or a component of the subassembly of the medical product (see ¶[0129]; a 3D display so different prototypes and products can be compared for benchmarking and quality assurance. See also ¶[0168] and [0176]; pivot around the eyeball's center of rotation to observe the different views. A 3D model on a 2D display that can be rotated using viewing software).
ARAZY further discloses control access to respective subsets of the common set of regulatory approval submission data by the submitter and the regulatory agency (see ¶[0137]; the process is hermetic and compartmentalized, which also eliminates certain risks concerning information security as will be clear to one skilled in the art. See again abstract; regulatory agencies may be given access. Compliance documents are provided by given users); and
build a searchable knowledgebase based on the feedback on the common set of regulatory approval submission data (see ¶[0203]; one may query the system in a form that cannot be addressed attempted without it. For example, a given manufacturer may formulate the following question: "based on my current level of compliance, what are the additional markets my product can get access to over the next 4 months for a budget equal or less than $10,000?". Due to the various databases of the system described above, the system will be able to correlate, index, and cross-reference between knowledge and requirements in order to answer such queries quickly and correctly).
ARAZY discloses a system and method for regulatory compliance that uses a database for submission and approval. WONG discloses benchmarking and quality assurance using a 3D display of prototypes and products. It would have been obvious for one of ordinary skill in the art at the time of invention to include the 3D display as taught by WONG in the system executing the method of ARAZY with the motivation to assure regulatory compliance and quality assurance.
Claim 4 (Original)
The combination of ARAZY and WONG discloses the regulatory approval submission and review system as set forth in claim 1.
ARAZY further discloses wherein the common set of regulatory approval submission data includes one or more documents (see abstract; compliance documents), one or more design files (see ¶[0076]; regulatory files), video content, audio content, multimedia content, or a combination thereof.
Claim 5 (Original)
The combination of ARAZY and WONG discloses the regulatory approval submission and review system as set forth in claim 1.
ARAZY further discloses wherein elements of the common set of regulatory approval submission data are configured to be individually added or modified by the submitter or the regulatory agency (see abstract; submit documents. Edit compliance documents).
Claim 10 (Original)
The combination of ARAZY and WONG discloses the regulatory approval submission and review system as set forth in claim 1.
ARAZY further discloses wherein the portal is further configured to provide, to the first user interface or the second user interface, a status of review of an element of the common set of regulatory approval submission data (see ¶[0065]; ¶[0065]; receive approval/failure).
Claim 12 (Original)
The combination of ARAZY and WONG discloses the regulatory approval submission and review system as set forth in claim 1.
ARAZY does not specifically disclose, but WONG discloses, wherein the first user interface or the second user interface enables a user to compare at least two versions of a medical product, a subassembly of the medical product, or a component of the subassembly of the medical product (see ¶[0129]; a 3D display so different prototypes and products can be compared for benchmarking and quality assurance).
ARAZY discloses a system and method for regulatory compliance that uses a database for submission and approval. WONG discloses benchmarking and quality assurance using a 3D display of prototypes and products. It would have been obvious for one of ordinary skill in the art at the time of invention to include the 3D display as taught by WONG in the system executing the method of ARAZY with the motivation to assure regulatory compliance and quality assurance.
Claim 13 (Original)
The combination of ARAZY and WONG discloses the regulatory approval submission and review system as set forth in claim 1.
ARAZY further discloses wherein the portal is further configured to provide, to the first user interface or the second user interface, a risk analysis graph that includes at least one link to details of a risk associated with the medical product for approval by the regulatory agency (see ¶[0076], [0177]. and [0211] & Fig. 5; an updated database of the complete device compliance requirements for each country, including risk class and device type. [Categories of risk] are linked with respect to their functions and/or data as represented by a block diagram. Download links of related documents).
Claim 15 (Original)
The combination of ARAZY and WONG discloses the regulatory approval submission and review system as set forth in claim 1.
ARAZY further discloses wherein the portal is further configured to: send notification to the regulatory agency after receiving a submission or update from the submitter; send notification to the submitter after receiving the feedback from the regulatory agency; or a combination thereof (see ¶[0095] and [0229]; client is notified when license is achieved).
Claim 16 (Currently Amended)
ARAZY discloses a system comprising: one or more processors (see abstract and ¶[0074]; provide computerized information, lookup, tracking, and guidelines for many of the activities, and maintains up-to-date information integrity. An expert system running on a server with a user submitting documents); and one or more processor-readable media storing instructions which, when executed by the one or more processors, cause the one or more processors (see abstract and ¶[0177]; software on a server) to:
provide, via a first computing device of a submitter (see abstract; expert system running on a server with a user submitting documents. See also claims 1 and 11; a computer screen), a first user interface (see again ¶[0152]-[0161]; a user interface) for submitting (see again abstract; submit documents) for submitting and updating a common set of regulatory approval submission data for a medical product (see ¶[0076]-[0082]; the major properties of the system comprise: [0077] a. an updated database of the complete device compliance requirements for each country, including risk class and device type. [0078] b. an updated database of compete regulatory application requirements (compliance route) for each country including risk class and device type. [0079] c. an updated database for the complete country specific related requirements. [0080] d. an updated database of the generic master regulatory file for each type of medical device for each country. [0081] e. a platform for upload, review, and download of documents and exchange of information between user, experts and auditors. (This may include an implementation of "Document Control") [0082] f. an updated database of a master regulatory file for any single client product);
store the common set of regulatory approval submission data in a repository (see ¶[0011]; a server adapted to store said databases and provide communications between said databases, said users, said experts, said expert system, and said agencies);
provide, via a second computing device of a regulatory agency, a second user interface for reviewing (see again abstract; domain experts review and edit compliance documents); and
providing feedback on the common set of regulatory approval submission data (see ¶[0065]; receive approval/failure).
ARAZY does not specifically disclose, but WONG discloses, wherein the first user interface or the second user interface enables a user to compare at least two versions of a medical product, a subassembly of the medical product, or a component of the subassembly of the medical product see ¶[0129]; a 3D display so different prototypes and products can be compared for benchmarking and quality assurance. See also ¶[0168] and [0176]; pivot around the eyeball's center of rotation to observe the different views. A 3D model on a 2D display that can be rotated using viewing software).
ARAZY further discloses control access to respective subsets of the common set of regulatory approval submission data by the submitter and the regulatory agency (see ¶[0137]; the process is hermetic and compartmentalized, which also eliminates certain risks concerning information security as will be clear to one skilled in the art. See again abstract; regulatory agencies may be given access. Compliance documents are provided by given users); and
build a searchable knowledgebase based on the feedback on the common set of regulatory approval submission data (see ¶[0203]; one may query the system in a form that cannot be addressed attempted without it. For example, a given manufacturer may formulate the following question: "based on my current level of compliance, what are the additional markets my product can get access to over the next 4 months for a budget equal or less than $10,000?". Due to the various databases of the system described above, the system will be able to correlate, index, and cross-reference between knowledge and requirements in order to answer such queries quickly and correctly).
ARAZY discloses a system and method for regulatory compliance that uses a database for submission and approval. WONG discloses benchmarking and quality assurance using a 3D display of prototypes and products. It would have been obvious for one of ordinary skill in the art at the time of invention to include the 3D display as taught by WONG in the system executing the method of ARAZY with the motivation to assure regulatory compliance and quality assurance.
Claim 19 (Original)
The combination of ARAZY and WONG discloses the system as set forth in claim 16,
ARAZY further discloses wherein the common set of regulatory approval submission data includes one or more documents (see abstract; compliance documents), one or more design files (see ¶[0076]; regulatory files), one or more images, video content, audio content, multimedia content, or a combination thereof.
Claim 21 (New)
The combination of ARAZY and WONG discloses the regulatory approval submission and review system as set forth in claim 16.
ARAZY does not specifically disclose, but WONG discloses, wherein the first user interface or the second user interface enables a user to change views of the medical product, a subassembly of the medical product, or a component of the subassembly of the medical product (see ¶[0129]; a 3D display so different prototypes and products can be compared for benchmarking and quality assurance. See also ¶[0168] and [0176]; pivot around the eyeball's center of rotation to observe the different views. A 3D model on a 2D display that can be rotated using viewing software).
Claim(s) 2, 3, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20130198094 A1 to ARAZY in view of US 20240022698 A1 to WONG et al. as applied to claim 1 above, and further in view of US 20180053128 A1 to Costas (hereinafter ‘COSTAS’).
Claim 2 (Original)
The combination of ARAZY and WONG discloses the regulatory approval submission and review system as set forth in claim 1.
The combination of ARAZY and WONG does not specifically disclose, but COSTAS discloses, wherein the repository is configured to store the common set of regulatory approval submission data in a multi-level hierarchical structure to enable a user to navigate to specific elements of the common set of regulatory approval submission data according to the multi-level hierarchical structure (see ¶[0027] & [0035]-[0036] and Fig. 1; the system processes regulations, expert opinion, regulatory actions, standards, and other reference text. It also shows the result of the process, which is a hierarchical classification model and a hierarchical topic model. FIG. 1 provides high-level steps of the internal process of the system, implemented using databases, computer code, and computing processing devices).
ARAZY discloses a system and method for regulatory compliance that uses a database for submission and approval. COSTAS discloses ranking regulatory compliance risks in a database with a hierarchical classification and topic model. It would have been obvious to include the hierarchical classification and topic model as taught by COSTAS in the system executing the method of ARAZY with the motivation to provide a database for regulatory compliance and approval.
Claim 3 (Original)
The combination of ARAZY, WONG, and COSTAS discloses the regulatory approval submission and review system of claim 2..
ARAZY does not specifically disclose, but COSTAS 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 (see ¶[0027] & [0035]-[0036] and Fig. 1; the system processes regulations, expert opinion, regulatory actions, standards, and other reference text. It also shows the result of the process, which is a hierarchical classification model and a hierarchical topic model. FIG. 1 provides high-level steps of the internal process of the system, implemented using databases, computer code, and computing processing devices. Examiner Note: names of categories and sub-categories are non-functional, and they are not given patentable weight. For example, a claim to a memory stick containing tables of batting averages, or tracks of recorded music, utilizes the intended computer system merely as a support for the information. Such claims are directed toward conveying meaning to the human reader rather than towards establishing a functional relationship between recorded data and the computer. See MPEP §2111.05).
ARAZY discloses a system and method for regulatory compliance that uses a database for submission and approval. COSTAS discloses ranking regulatory compliance risks in a database with a hierarchical classification and topic model. It would have been obvious to include the hierarchical classification and topic model as taught by COSTAS in the system executing the method of ARAZY with the motivation to provide a database for regulatory compliance and approval.
Claim 17 (Original)
The combination of ARAZY and WONG discloses the system as set forth in claim 16,
The combination of ARAZY and WONG does not specifically disclose, but COSTAS discloses, wherein: the common set of regulatory approval submission data is stored in a multi-level hierarchical structure in the repository to enable a user to navigate to specific elements of the common set of regulatory approval submission data according to the multi-level hierarchical structure (see ¶[0027] & [0035]-[0036] and Fig. 1; the system processes regulations, expert opinion, regulatory actions, standards, and other reference text. It also shows the result of the process, which is a hierarchical classification model and a hierarchical topic model. FIG. 1 provides high-level steps of the internal process of the system, implemented using databases, computer code, and computing processing devices).
ARAZY discloses a system and method for regulatory compliance that uses a database for submission and approval. COSTAS discloses ranking regulatory compliance risks in a database with a hierarchical classification and topic model. It would have been obvious to include the hierarchical classification and topic model as taught by COSTAS in the system executing the method of ARAZY with the motivation to provide a database for regulatory compliance and approval.
ARAZY further discloses and elements of the common set of regulatory approval submission data are configured to be individually added or modified by the submitter or the regulatory agency (see abstract; submit documents. Edit compliance documents).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20130198094 A1 to ARAZY in view of US 20240022698 A1 to WONG et al. as applied to claim 1 above, and further in view of US 20180253669 A1 to Thunoli et al. (hereinafter ‘THUNOLI’).
Claim 6 (Original)
The combination of ARAZY and WONG discloses the regulatory approval submission and review system as set forth in claim 5.
The combination of ARAZY and WONG does not specifically disclose, but THUNOLI discloses, wherein modifying the elements of the common set of regulatory approval submission data individually includes adding or modifying metadata associated with individual elements of the common set of regulatory approval submission data (see abstract and ¶[0055]; a dynamic canonical ontology (or an enterprise wide metadata) is first created and updated based on machine learning techniques applied on regulatory data collected from heterogeneous data sources).
ARAZY discloses a system and method for regulatory compliance that uses a database for submission and approval. THUNOLI discloses analyzing regulatory data from multiple sources, where an enterprise wide metadata is updated and applied to source data. It would have been obvious for one of ordinary skill in the art at the time of invention to include the metadata as taught by THUNOLI in the system executing the method of ARAZY with the motivation to analyze regulatory data.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20130198094 A1 to ARAZY in view of US 20240022698 A1 to WONG et al. as applied to claims 1 and 5 above, and further in view of US 20050222778 A1 to Levinson et al. (hereinafter ‘LEVINSON’).
Claim 7 (Original)
The combination of ARAZY and WONG discloses the regulatory approval submission and review system as set forth in claim 5.
The combination of ARAZY and WONG does not specifically disclose, but LEVINSON discloses, wherein modified elements of the common set of regulatory approval submission data are highlighted in the first user interface or the second user interface (see abstract and ¶[0041] and [0050]; The audit records of the audit application include the transaction information for the record in question and highlight the field(s) that was modified during a data record update).
ARAZY discloses a system and method for regulatory compliance that uses a database for submission and approval. LEVINSON discloses compliance reporting where modified fields are updated. It would have been obvious to include highlighting of modified fields as taught by LEVINSON in the system executing the method of ARAZY with the motivation to identify modified records in a database.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable US 20130198094 A1 to ARAZY in view of US 20240022698 A1 to WONG et al. as applied to claim 1 above, and further in view of US 20130066670 A1 to Krishnan (hereinafter ‘KRISHNAN’).
Claim 8 (Original)
The combination of ARAZY and WONG discloses the regulatory approval submission and review system as set forth in claim 1.
The combination of ARAZY and WONG does not specifically disclose, but KRISHNAN discloses, wherein the portal is further configured to provide, to the first user interface or the second user interface, a dashboard displaying user specific metrics data (see ¶[0068]; The management dashboard module 139 monitors the performance of the business at the process level to identify a transaction metrics, at the entity level to identify a customer metrics, a product metrics and a partner metrics and at the policy level to identify a pricing plan and a product launch with respect to a customer segment. The plurality of strategic exercises include identification of customer segmentation and usage patterns for designing promotional campaigns, designing and redesigning of product and service packaging, designing and redesigning of a pricing structure, a partner settlement framework and partner reviews, a customer relationship management and retention plans, a revenue estimation and budgeting process and a regulatory compliance and reporting process.).
ARAZY discloses a system and method for regulatory compliance that uses a database for submission and approval. KRISHNAN discloses management with a dashboard of metrics for regulatory compliance and reporting. It would have been obvious to include the dashboard as taught by KRISHNAN in the system executing the method of ARAZY with the motivation to view compliance submissions and determine regulatory compliance of a submission.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20130198094 A1 to ARAZY in view of US 20240022698 A1 to WONG et al. as applied to claim 1 above, and further in view of US 20230013012 A1 to Bond (hereinafter ‘BOND’).
Claim 14 (Original)
The combination of ARAZY and WONG discloses the regulatory approval submission and review system as set forth in claim 1.
The combination of ARAZY and WONG does not specifically disclose, but BOND discloses, wherein the common set of regulatory approval submission data includes: a subset of public data that is accessible by the submitter and the regulatory agency; and one or more subsets of private data that are accessible by the submitter but are not accessible by the regulatory agency, one or more subsets of private data that are accessible by the regulatory agency but are not accessible by the submitter, or both (see ¶[0033] and [0048]; store product data retrieved from public and/or private databases).
ARAZY discloses a system and method for regulatory compliance that uses a database for submission and approval. BOND discloses a regulatory compliance analysis platform that includes information from both public and private databases. It would have been obvious to include private and public databases as taught by BOND in the system executing the method of ARAZY with the motivation to provide a compartmentalized database for regulatory submissions (see ARAZY ¶[0137]).
Claim(s) 9 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20130198094 A1 to ARAZY in view of US 20240022698 A1 to WONG et al. and US 20130066670 A1 to KRISHNAN as applied to claims 1 and 8 above, and further in view of US 20120078648 A1 to Reiner (hereinafter ‘REINER’).
Claim 9 (Original)
The combination of ARAZAY, WONG, and KRISHNAN discloses the regulatory approval submission and review system of claim 8.
The combination of ARAZAY, WONG, and KRISHNAN does not specifically disclose, but REINER discloses, wherein the user specific metrics data includes statistical data generated based on a user’s role (see ¶[0017]; the only reliable way to counter-act the above fraudulent activities is to track, record, and analyze data throughout the supply chain and hold each individual party accountable to their respective role/s in ensuring quality and clinical effectiveness. Further, the ability to perform trending analysis and large sample size statistics (through meta-analysis), provides better understanding as to inherent deficiencies, contributing factors, and responsible parties).
ARAZY discloses a system and method for regulatory compliance that uses a database for submission and approval. REINER discloses analyzing data on medical agents and devices that includes collecting statistics relating to roles to ensure regulatory compliance. It would have been obvious to include the collection of statistics based on roles as taught by REINER in the system executing the method of ARAZY with the motivation to ensure regulatory compliance.
Claim 18 (Original)
The combination of ARAZY and WONG discloses the system as set forth in claim 16,
The combination of ARAZY and WONG does not specifically disclose, but KRISHNAN discloses, wherein the instructions, when executed by the one or more processors, further cause the one or more processors to provide, to the first user interface or the second user interface, a dashboard displaying user specific metrics data (see ¶[0068]; The management dashboard module 139 monitors the performance of the business at the process level to identify a transaction metrics, at the entity level to identify a customer metrics, a product metrics and a partner metrics and at the policy level to identify a pricing plan and a product launch with respect to a customer segment. The plurality of strategic exercises include identification of customer segmentation and usage patterns for designing promotional campaigns, designing and redesigning of product and service packaging, designing and redesigning of a pricing structure, a partner settlement framework and partner reviews, a customer relationship management and retention plans, a revenue estimation and budgeting process and a regulatory compliance and reporting process.).
ARAZY discloses a system and method for regulatory compliance that uses a database for submission and approval. KRISHNAN discloses management with a dashboard of metrics for regulatory compliance and reporting. It would have been obvious to include the dashboard as taught by KRISHNAN in the system executing the method of ARAZY with the motivation to view compliance submissions and determine regulatory compliance of a submission.
The combination of ARAZAY, WONG, and KRISHNAN does not specifically disclose, but REINER discloses, generated based on a user’s role (see ¶[0017]; the only reliable way to counter-act the above fraudulent activities is to track, record, and analyze data throughout the supply chain and hold each individual party accountable to their respective role/s in ensuring quality and clinical effectiveness. Further, the ability to perform trending analysis and large sample size statistics (through meta-analysis), provides better understanding as to inherent deficiencies, contributing factors, and responsible parties).
ARAZY discloses a system and method for regulatory compliance that uses a database for submission and approval. REINER discloses analyzing data on medical agents and devices that includes collecting statistics relating to roles to ensure regulatory compliance. It would have been obvious to include the collection of statistics based on roles as taught by REINER in the system executing the method of ARAZY with the motivation to ensure regulatory compliance.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/RICHARD N SCHEUNEMANN/ Primary Examiner, Art Unit 3624