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 .
Respond to applicant arguments
35 U.S.C. § 112(b)
Applicant’s arguments presented in the remarks filed on 05/28/2026 at page 7 have been fully considered. For the reasons set forth below, the arguments are found persuasive with respect to the rejections under 35 U.S.C. § 112(b).
Applicant argues the § 112 rejection is moot because claim 19 now recites “common interest, a regulator collaborator, a regulatory decision” with proper antecedent basis.
The Examiner agreed that the amendment removes the prior antecedent-basis issue, so the § 112(b) rejection is withdrawn.
35 U.S.C. § 101
Applicant’s arguments presented in the remarks filed on 05/28/2026 at pages 7-12 have been fully considered. For the reasons set forth below, the arguments are found not persuasive with respect to the rejections under 35 U.S.C. § 101 Subject Matter Eligibility.
Applicant argues amended claim 1 is not abstract because it uses a “specific, domain-specific data architecture” in a digital environment.
Examiner respectfully disagrees because, under BRI, claim 1 still recites “regulatory acceptance,” “plurality of collaborators,” “regulatory determination,” and “documenting the regulatory determination,” which organize legal/regulatory interactions under MPEP 2106.
Applicant argues the amended claim cannot be a mental process because no human can maintain the layered central data structure and digital workflow.
Examiner respectfully disagrees because, the rejection does not rely on treating the “digital environment” or “central data structure” as a mental process. The rejection is maintained because the claim still recites a regulatory collaboration workflow, i.e., certain methods of organizing human activity refer to prong one below for further details.
Applicant argues Enfish applies because the layered data architecture is a computer-implemented improvement.
Examiner respectfully disagrees because, Claim 1 does not recite an improved database table, index, query rule, storage mechanism, or computer operation; the specification states the central data structure “may include one or more databases” at [00100] that is not an improvement.
Applicant argues Prong Two is satisfied because the claim creates a tangible structured output: a standardized digital measurement solution with documented regulatory acceptance.
Examiner respectfully disagrees because, the output is regulatory information recorded in the “central data structure,” and the specification describes the digital environment as a “virtual network” providing access to files at [00115]; this improves the regulatory workflow, not computer or measurement-device technology.
Applicant argues the ordered combination is not WURC because the digital environment and layered central data structure are functionally interdependent.
Examiner respectfully disagrees because, the alleged interdependence is that the environment provides collaborator access and the data structure stores layered evidence; the specification implements this with “any suitable processing platform, computing platform, computing device” at [00207]. The ordered combination therefore uses generic computer tools to perform the abstract workflow.
Applicant argues specification paragraphs [0001], [0038], [0046], and [0079] prove the invention solved nonconventional gaps in standardization and pre-submission regulatory engagement.
Examiner respectfully disagrees because, those passages identify “lack of standardization” and regulatory-pathway concerns, but they do not show an unconventional computer component, database operation, network mechanism, or measurement-device improvement. The argument may address usefulness, but not significantly more under Step 2B.
Applicant argues claim 1 is analogous to USPTO Example 36, claims 2 and 3.
Examiner respectfully disagrees because, example 36 relied on a “high-resolution video camera array” and reconstruction of “3-D coordinates” to solve a computer-vision tracking problem, while claim 1 recites a “digital environment” and “central data structure” for regulatory evidence management. The analogy is not persuasive, so the § 101 rejection is maintained.
Response to Arguments - Prior Art Rejections
Applicant’s arguments, see Remarks at pages 12-16, filed 05/28/26, with respect to claims 1-20 under 35 U.S.C. 102(a)(1) over Arazy have been fully considered but are moot because the claim amendments necessitated the new ground of rejection under 35 U.S.C. 103 over US20130198094A1- Arazy in view of WO2015143309A1- Booker set forth in this Office action, and the arguments do not address that combination.
Applicant argues that Arazy is wholly unrelated to digital measurement standardization, that Arazy is a regulatory document management and filing system while the present disclosure is a collaborative platform for the standardization of digital clinical measurement solutions, and that this categorical distinction alone defeats anticipation.
Examiner respectfully disagrees, and maintains Arazy that remains relevant because it teaches the claimed regulatory-acceptance workflow, including the collaborative digital environment, regulatory file management, agency evaluation, and approval documentation, while Booker supplies the disease-characterizing digital measurement content absent from Arazy. Therefore, the argument does not overcome the rejection based on the combined teachings of Arazy and Booker.
Applicant argues that Arazy’s thirteen basic blocks are administrative data objects that do not perform clinical measurement functions, and that grouping them into three categories does not mean Arazy discloses a validation layer, an instrumentation layer, and a definition layer in the sense claimed, citing MPEP 2131 and Verdegaal.
Examiner respectfully disagrees because, applicant’s argument is moot to the extent it attacks the withdrawn anticipation mapping of Arazy’s thirteen basic blocks, because the present rejection is under 35 U.S.C. § 103 over Arazy in view of Booker, not single-reference anticipation under MPEP 2131 and Verdegaal. The argument is otherwise not persuasive because claim 1 recites that each component is included in one or more of a validation layer, instrumentation layer, or definition layer, so the claim does not require Arazy alone to disclose all three clinical layer categories as separate structures. Arazy supplies the central regulatory evidence record and validation-type content, including Verification and Validation, while Booker supplies the missing disease-measurement content through diagnostic instruments, assay-generated data sets, QC/calibration results, and patient/test data; therefore, the rejection of claims 1-20 under 35 U.S.C. § 103 over Arazy in view of Booker is maintained.
Applicant argues that Arazy’s autofill populates administrative form fields and is categorically different from assembling a new standardized digital measurement solution by applying previously approved clinical measurement components, so the operations are not the same operation under any reasonable interpretation of the claims.
Examiner respectfully disagrees, because claim 1 step (d) requires assembling a new solution by applying previously stored components, not specifically creating new scientific or clinical content. Arazy teaches this assembly function by assessing required elements for licensing and reusing stored content through automatically filling application forms. Booker supplies the disease-characterizing measurement components in the combination. Therefore, the rejection relies on the combined teachings of Arazy and Booker, and the § 103 rejection is maintained. Refer to Arazy, pars. 0019, 0092 and Booker, pars. 0074, 0075, 0078.
Applicant argues that in Arazy the regulatory agency is the external recipient of a completed regulatory filing application, not a collaborator operating within the platform, that the direction of the interaction is opposite to the claimed invention, and that the claimed invention provides pre-submission collaborative regulatory feedback visible to all collaborators.
Examiner respectfully disagrees, because claim 1 step (g) does not require pre-submission feedback or visibility to all collaborators. Arazy teaches agency participation within the digital environment because regulatory agencies may evaluate said compliance documents and the database may be read, written to, and modified by said users, said experts, and said agencies according to a set of permissions. Arazy further teaches the resulting regulatory determination by changing the device status from pending to approved. Arazy, pars. 0012, 0018, 0095. Booker supplies the measurement components being evaluated; therefore, the § 103 rejection is maintained.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5-7 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 5-7 are rejected under 35 U.S.C. § 112(b) as indefinite. Claim 1, as amended, recites assembling the new standardized digital measurement solution in step d, while claims 5 and 7 recite generating the new standardized digital measurement solution. It is unclear whether generating corresponds to the assembling step of claim 1 or a separate operation. Accordingly, the scope of claims 5 and 7 is unclear. Claim 6 depends on claim 5 and is rejected for the same reason.
For purposes of compact prosecution, generating in claims 5-7 is interpreted as the assembling recited in claim 1, step d.
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.
Subject Matter eligibility Rejection 35 U.S.C 101
Claims 1-20 are rejected under 35 U.S.C. § 101 because the claimed subject matter is directed to a judicial exception (an abstract idea) without reciting elements that integrate the exception into a practical application or provide an inventive concept amounting to significantly more than the exception itself.
Step 1: Statutory Categories
The claims are directed to statutory subject matter, encompassing the following statutory categories:
Process (Claims 1-20): The independent claim recites a " A computer-implemented method” limitations describe a series of steps to be performed, which aligns with the definition of a Process in MPEP § 2106.03.
Having confirmed the claims are directed to statutory subject matter, the analysis proceeds to Step 2A Prong one.
Step 2A, Prong One: Judicial Exception Analysis
Step 2A, Prong One verifies whether a claim recites a specific judicial exception.
Independent Claim 1 Recites the Following Non-bold abstract idea and bold additional elements:
Claim 1.
A computer-implemented method of facilitating regulatory acceptance of at least one component of a new standardized digital measurement solution for obtaining a measurement relevant for characterizing a disease in a patient, the method comprising:
(a) creating a digital environment comprising a plurality of components of previously approved standardized digital measurement solutions, wherein the digital environment is accessible by a plurality of collaborators;
(b) obtaining a central data structure from the digital environment, wherein the central data structure comprises compiled evidence of the plurality of components of one or more previously-approved standardized digital measurement solutions for characterizing the disease, wherein each of the plurality of components are respectively included in one or more of (i) a validation layer, (ii) an instrumentation layer, or (iii) a definition layer;
(c) receiving a request for the new standardized digital measurement solution for characterizing the disease;
(d) assembling, the new standardized digital measurement solution by leveraging applying one or more components of the plurality of components of the one or more previously-approved standardized digital measurement solutions in the central data structure;
(e) receiving additional data for the new standardized digital measurement solution from a collaborator of the plurality of collaborators;
(f) modifying, the central data structure to incorporate the additional data;
(g) receiving, via the digital environment, feedback a regulatory determination from a regulatory collaborator, wherein the regulatory determination comprises regulatory acceptance of the at least one component of the new standardized digital measurement solution; and
(h) documenting the regulatory determination from the regulatory collaborator in the central data structure, facilitating the regulatory acceptance of the at least one component of the new standardized solution.
Claim Abstract Classification Rationale
Claim 1 recites a certain method of organizing human activity because, under BRI, limitations non-bold language (a)-(h) describe coordinating people and regulatory evidence to obtain acceptance of a component of a new standardized digital measurement solution. The abstract idea is: collecting prior approval evidence, receiving a new request, reusing approved components, receiving collaborator input, obtaining a regulatory determination, and documenting that determination for regulatory acceptance.
This falls within the USPTO grouping for “certain methods of organizing human activity” because MPEP § 2106.04(a)(2) includes “commercial or legal interactions,” including “legal obligations,” and “managing personal behavior or relationships or interactions between people,” including “following rules or instructions.” The claim language tracks that grouping: “plurality of collaborators,” “request,” “additional data,” “regulatory collaborator,” “regulatory determination,” and “regulatory acceptance” define an interaction among collaborators and a regulator governed by regulatory rules.
The recited “digital environment” and “central data structure” do not change what is abstract at Prong One; they are the setting and storage vehicle for the regulatory workflow. The following human analogue strength the abstract recitation rational because a project manager maintaining an approved-evidence repository, assembling a new submission package from prior approved materials, collecting collaborator updates, recording the regulator’s acceptance, and using that record to facilitate future acceptance is read in the judicial exception of claim 1.
Dependent Claims Analysis
Dependent claims 2-20 also recite an abstract idea under Step 2A, Prong One.
Claims 2-9, 15-16, and 18 add data-content or evaluative details, including “measurement data,” “different patient populations,” “validation layer,” “acceptability categorization,” “medical condition,” “diagnostic specific algorithm,” “measurement definition,” “dataset,” and “clinical information.” Under BRI, these limitations specify what information is collected, classified, or used in the regulatory workflow; they therefore further define the same certain methods of organizing human activity identified for claim 1, because they describe the content of the interactions among collaborators and the regulator rather than any additional element.
Claim 17 characterizes the digital environment as a collaborative platform using a measurement stack model, which standardizes how solutions are described. Under BRI, this model is merely an organizational framework for structuring regulatory evidence and interactions, so the claim remains directed to organizing human activity rather than a technical implementation.
Claims 10-14 and 19 add collaborator-governance rules, including “standardized roles,” “primary” and “secondary” rights, stakeholder roles, “agreement,” “terms and conditions,” templates, “mission rules,” and collaborator editing of terms. These limitations fall within certain methods of organizing human activity because MPEP § 2106.04(a)(2) identifies “commercial or legal interactions” and “managing personal behavior or relationships or interactions between people” as abstract-idea groupings.
Claim 20 adds “generating a dossier for facilitating regulatory acceptance,” which is administrative compilation of regulatory documentation and therefore remains part of the same organizing-human-activity exception.
Because the dependent claims do not remove the inherited abstract regulatory approval workflow, Prong One is satisfied and the analysis proceeds to Prong Two. Source
Step 2A, Prong Two: Integration Into A Practical Application
Under Step 2A, Prong Two, the analysis determines whether the claim as a whole integrates the recited abstract idea into a practical application, rather than merely using generic computer components as tools to perform the abstract idea.
Claim 1 recites additional computer elements, including a “computer-implemented method,” “digital environment,” “central data structure,”.
These elements do not integrate the abstract idea because they use a computer as a tool for the regulatory evidence workflow identified in Prong One. The specification confirms the implementation is generic: apparatus 300 “may include a processor 304 and a memory,” the central data structure “may include one or more databases,” requests may arrive through a “mobile application, web browser, web portal,” and the digital environment may be a “virtual network” providing access to digital files. Spec. [0099], [00100], [00106], [00115]. Thus, the claim improves the regulatory recordkeeping process, not computer functionality, database operation, network operation, or measurement-device operation. Under MPEP § 2106.05(a), (f), and (h), the additional elements therefore amount to computer implementation, data storage, communication, and field-of-use linkage, not a practical application.
Claims 2-20 do not add any additional element that changes the Prong Two result. The dependent claims merely further define the same abstract workflow identified in Prong One by specifying evidence content, patient-population categories, validation layers, roles, agreements, templates, a measurement stack model, and a dossier. These limitations refine what information is organized and how collaborators interact, but they do not recite a new sensor structure, data-transmission mechanism, database architecture, signal-processing rule, or particular treatment. Viewed as a whole, claims 1-20 do not integrate the abstract idea into a practical application, so the analysis proceeds to Step 2B.
Step 2B: Inventive Concept Analysis
Under Step 2B, the additional elements, individually and as an ordered combination, do not amount to significantly more than the judicial exception.
The “computer-implemented method” does not provide an inventive concept because the specification describes implementation using “any suitable processing platform, computing platform, computing device” and “any suitable combination of hardware and/or software.” Spec. [00207]. Thus, the computer performs the abstract regulatory-evidence workflow with generic processing equipment.
The “digital environment” does not provide an inventive concept because the specification describes it as a “virtual network” that provides access to “digital files.” Spec. [00115]. Providing collaborators access to files is ordinary computer communication and does not recite an unconventional platform architecture, security mechanism, or network improvement.
The “central data structure” does not provide an inventive concept because the specification states that it “may include one or more databases.” Spec. [00100]. Storing compiled evidence in a database is ordinary electronic recordkeeping and does not recite an improved database schema, indexing rule, or storage technique.
As an ordered combination, these elements use a generic computer environment to access, store, update, receive, and document regulatory evidence. The combination may centralize the regulatory workflow, but that is an administrative improvement, not a technical improvement. Therefore, the additional elements do not add significantly more than the abstract idea.
Claims 2-20 likewise do not add an inventive concept. The dependent limitations narrow the regulatory evidence workflow to particular data types, collaborator rules, organizational layers, agreement terms, and dossier output, but they rely on the same generic digital environment and central data structure recited in claim 1. Because these limitations remain part of the abstract organization of regulatory evidence and do not add a non-generic technical arrangement or unconventional computer function, claims 1-20 do not amount to significantly more than the judicial exception.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being obvious by Arazy US20130198094A1 in view of WO2015143309A1- Booker
Claim 1.
Arazy teaches, Claim 1.
A computer-implemented method of facilitating regulatory acceptance of at least one component of a new (Arazy, par. 0006 a regulatory compliance tool for users seeking to achieve licenses for devices to be licensed by regulatory agencies, par. 0059 solutions for the medical and Invitro diagnostic (IVD) device industry)
A POSITA reads Arazy's regulatory compliance tool as a computer-implemented method for obtaining regulatory acceptance of evidence for medical and IVD products.
(a) creating a digital environment comprising a plurality of components of previously approved (Arazy, par. 0011 a server adapted to store said databases and provide communications between said databases, said users, said experts, said expert system, and said agencies, par. 0081 a platform for upload, review, and download of documents and exchange of information between user, experts and auditors, par. 0095 changing a status field associated with the relevant device, from pending to approved)
Arazy's workspace is the claimed digital environment, and it holds previously approved content because the status field records items that moved from pending to approved.
(b) obtaining a central data structure from the digital environment, wherein the central data structure comprises compiled evidence of the plurality of components of one or more previously-approved (Arazy, par. 0007 a database of regulations concerning a plurality of devices and countries, par. 0009 a database of regulatory compliance documents, par. 0080 an updated database of the generic master regulatory file for each type of medical device for each country, par. 0082 an updated database of a master regulatory file for any single client product, par. 0070 Verification and Validation, wherein the device quality and performance will be tested)
Arazy's master regulatory file databases as one central record that compiles, for each product, the evidence required for approval, which is the same role the specification gives a central data structure that may include one or more databases (Spec. par. 00100). Under BRI, compiled evidence reads on Arazy's stored device information and supporting documents, and Arazy even holds validation-type evidence because compliance requires testing device quality and performance.
(c) receiving a request for the new (Arazy, par. 0087 Client chooses the Type of medical device, par. 0088 Client chooses the Country(ies) for registration, par. 0243 View or create new application)
Arazy's intake steps as receiving a request that opens a new work item for a chosen product and market.
(d) assembling, the new (Arazy, par. 0019 assess necessary elements required for said devices to be licensed and guide said users through the process of generating said necessary elements, par. 0092 preparing applications by automatically filling the appropriate locations of various forms)
Arazy's expert system and autofill functions as assembling the new deliverable from components already stored in the central file, because recurring fields, forms, and documents from earlier approved filings are reused to build the new application.
(e) receiving additional data for the new (Arazy, par. 0083 a pharmaceutical manager in Jerusalem can upload laboratory results that a licensing manager in Hyderabad can use in his licensing route, par. 0012 users can upload and peruse said regulatory compliance documents, experts may review and revise said compliance documents)
Arazy's permissioned global access as collaborators contributing additional evidence, expressly including laboratory results, to pending regulatory work.
(f) modifying, the central data structure to incorporate the additional data; (Arazy, par. 0018 read, written to, and modified by said users, said experts, and said agencies according to a set of permissions determined by said users, par. 0091 The system validates document and information integrity, and suggests modifications)
Arazy's document database as the central record incorporate newly added material, with integrity checking applied to what was added.
(g) receiving, via the digital environment, a regulatory determination from a regulatory collaborator, wherein the regulatory determination comprises regulatory acceptance of the at least one component of the new (Arazy, par. 0012 regulatory agencies may evaluate said compliance documents, par. 0095 changing a status field associated with the relevant device, from pending to approved, par. 0219 available through the system to the authorities, who must all agree as to the integrity of the product information)
Arazy's agencies as the claimed regulatory collaborator: the agency evaluates inside the system, and its approval is received and recognized automatically because the system reacts to the approval notice by changing the device status. Under BRI, a regulatory determination comprising regulatory acceptance is reasonably read as that approval event;
(h) documenting the regulatory determination from the regulatory collaborator in the central data structure, facilitating the regulatory acceptance of the at least one component of the new (Arazy, par. 0095 changing a status field associated with the relevant device, from pending to approved, par. 0096 The system maintains license validity and updated regulatory status, par. 0217 The Regulatory file application content, and all dependent documents in the version at the time approval was granted, may be hashed)
Arazy's post-approval recording as documenting the determination in the same central record: the status field changes, the regulatory status is kept current, and the approved version of the file content is fixed by hashing.
35 U.S.C 103 Rational:
Arazy teaches the regulatory-acceptance workflow for medical and IVD devices, including a server storing regulatory databases, compliance documents, expert review, agency evaluation, automatic application preparation, and approval/status documentation. However, Arazy does not clearly teach that the content being compiled and accepted is a disease-characterizing digital measurement solution.
Booker supplies that missing measurement content. Booker teaches diagnostic instruments that perform clinical diagnostic assays on patient samples, convert assay results into digital data sets, store those data sets in server databases, permit restricted remote access, and support QC/calibration, diagnostic-instrument information, patient information, assay information, test results, LOINC codes, and SNOMED codes. Thus, Booker provides the validation, instrumentation, and definition-type measurement evidence that Arazy’s regulatory file lacks.
A POSITA would have combined Arazy with Booker by using Booker’s diagnostic-instrument data sets as the clinical measurement evidence compiled, updated, and routed through Arazy’s medical/IVD regulatory file and application generator, because Arazy expressly seeks medical/IVD compliance evidence and Booker supplies server-stored diagnostic assay evidence from medical diagnostic instruments. The combination would have predictably produced a permissioned regulatory platform that facilitates acceptance of components of a disease-characterizing digital measurement solution, with Arazy performing regulatory compilation and approval workflow and Booker supplying the measurement-solution content. Arazy, pars. 0006, 0011, 0012, 0059, 0070, 0092, 0095; Booker, pars. 0008, 0047-0052, 0066, 0077-0079, 0091.
Claim 2.
Arazy in combination with Booker teaches, The method of claim 1, The method of claim 1, wherein the one or more components of the plurality of components of previously-approved standardized digital measurement solutions include measurement data collected via a medical device.(Arazy, 0006, 0013, 0070, 0087)
Arazy teaches a permissioned regulatory platform that receives uploaded laboratory results for a licensing route, but does not teach measurement data collected via a medical device. Booker teaches that missing feature because a diagnostic instrument performs a diagnostic test on a subject sample, analyzes the result, and converts the result into computer-processable data. A POSITA would have combined Booker’s device-generated diagnostic data with Arazy’s medical/IVD regulatory workflow because Arazy expressly accepts laboratory evidence for device licensing, predictably producing a regulatory file containing measurement data collected via a medical device. Arazy, pars. 0059, 0083; Booker, pars. 0047-0048.
Claim 3.
Arazy in combination with Booker teaches, further comprising generating a plurality of new standardized digital measurement solutions for different patient populations.(Arazy, par. 0071, 0073, 0191, 0097, 0192, 0203)
Under the Broadest Reasonable Interpretation (MPEP 2111), the ability to "repeat steps" to generate applications for "additional markets" encompasses the creation of solutions for different "patient populations."
Claim 4.
Arazy in combination with Booker teaches, The method of claim 1, wherein
(i) the validation layer relates to a technical, analytical, or clinical validation,
ii the instrumentation layer relates to a device used to capture a measurement of interest, or
(iii) the definition layer relates to definition of at least one concept relevant to the disease or an aspect of health meaningfully related to the disease. (Arazy, par.0177-0178, 0191, 0199 )
The prior art describes a data architecture composed of "thirteen basic blocks" (Para [0177]) used to manage the "Master Regulatory File." Under MPEP 2111, the term "layer" is interpreted broadly to include functional groupings of data objects. Arazy’s device and risk blocks categorize the identity of the solution (Definition Layer), its biocompatibility and safety modules categorize the technical performance (Instrumentation Layer), and its compliance forms categorize the evidence for approval (Validation Layer).
Claim 5.
Arazy in combination with Booker teaches, The method of claim 1, wherein generating the new standardized digital measurement solution comprises:
(i) analyzing evidence data of the plurality of components of previously- approved digital measurement solutions; and
(ii) generating the new standardized digital measurement solution based on at least an acceptability categorization of the evidence data. (Arazy, par. 0091, 0070, 0098, 0138, 0203)
Under MPEP 2111, an "acceptability categorization" is broadly interpreted to include "quality ratings" or "integrity validations" used to filter data. Arazy's system assesses these ratings to determine the "maturity of the client's product information" and automatically generates the appropriate next steps for a new filing. (Arazy, Para [0121]). By utilizing these "document quality ratings" to guide the creation of new applications, Arazy performs the exact functional step recited in the claim.
Claim 6.
Arazy in combination with Booker teaches, The method of claim 5, wherein the acceptability categorization is determined according to one or more of:
a freshness of the evidence data,
a quantity of the evidence data,
a patient population of the evidence data,
regulatory acceptance of the evidence data,
clinical validation of the evidence data, technical verification of the evidence data,
a content validity of the evidence data,
a construct validity of the evidence data,
a sensitivity to change of the evidence data, or any combination thereof.. (Arazy, Para 0015, 0070, 0138).
Arazy utilizes an intelligent system to assign quality ratings to documents after they have undergone Verification and Validation to ensure they meet the requirements of each FDA. Furthermore, the system ensures continuously updated information (freshness) is used to maintain the master file. By rating the data based on its update status and its performance results, Arazy performs the exact functional determination required by the claim.
Claim 7.
Arazy in combination with Booker teaches, The method of claim 1, wherein generating the new standardized digital measurement solution is based on a medical condition or a diagnosis method. (Arazy, Para 0059,0069, 0087)
Arazy’s system triggers the Application Preparation Process based on the user's selection of a medical device or an IVD (diagnostic) device. Because the resulting digital record is tailored to the specific module (e.g., angioplasty) or risk class associated with that medical condition, Arazy performs the exact functional generation recited in the claim.
Claim 8.
Arazy in combination with Booker teaches, The method of claim 1, wherein the new standardized digital measurement solution includes a diagnostic specific algorithm. (Arazy, Para 0092, 0069, 0180, 0199).
Under the Broadest Reasonable Interpretation (MPEP 2111), "including an algorithm" encompasses the storage of Software validation data within the product’s digital record. Arazy’s system manages these software modules for IVD (diagnostic) and laser (therapeutic) devices, ensuring the logic used to perform the medical function is part of the central data structure. Since the diagnostic utility of an IVD device is driven by its internal calculations, Arazy’s documentation of the software validation for these devices describe the inclusion of a diagnostic specific algorithm.
Claim 9.
Arazy in combination with Booker teaches, The method of claim 1, wherein the at least one component of the new standardized digital measurement solution comprises any one of:
a measurable concept of interest component;
a measurement method component;
a raw data component;
an algorithm component;
a dataset component;
a technical validation component;
an analytical validation component;
a clinical validation component; or a regulatory component..
(Arazy, par. 0009, 0070, 0080, 0177, 0181, 0199)
Arazy’s system is structured around Thirteen basic blocks and multiple Modules that specifically include Software validation (algorithm component), clinical evidence (clinical validation), and regulatory compliance documents (regulatory component). Arazy also utilizes Verification and Validation testing to generate the test reports that function as the technical validation and datasets for the device.
Claim 10.
Arazy in combination with Booker teaches, The method of claim 1, further comprising
prior to receiving the request, generating a mission within the digital environment by establishing standardized roles for two or more collaborators of the plurality of collaborators, wherein each of the two or more collaborators is a discrete stakeholder in the mission. (Arazy, par. 0081, 0086, 0125, 0160, 0176, 0234; Figure 1)
Arazy describes a system where the "mission" (the regulatory process) is a pre-existing structural framework into which stakeholders are "integrated." In Arazy, the act of "generating the mission" environment is accomplished by the initial setup of standardized roles (Administrators, Experts, Clients) and the creation of an assignment matrix. Because the expert assignment matrix must exist as a functional prerequisite before a client can ever initiate a request for an application the temporal requirement of "prior to receiving the request" is satisfied. Arazy’s architecture ensures that the roles for the discrete stakeholders (manufacturer, expert, agency) are defined at the foundational level, thus anticipating the claim.
Claim 11.
Arazy in combination with Booker teaches, The method of claim 10, wherein establishing the standardized roles for the two or more collaborators comprises assigning a primary role to a first of the two or more collaborators and assigning a secondary role to a second of the two or more collaborators, and wherein the primary role possesses additional rights in comparison to the secondary role, wherein the additional rights comprise rights to access, view, and/or use results developed from the mission. (Arazy, par. 0125, 0234, 0244)
Under the Broadest Reasonable Interpretation (MPEP 2111), primary and secondary roles are met by the hierarchical relationship between a legal owner and a subject user. Arazy identifies the Client/Manufacturer as the legal owner who holds the ultimate authority to set permission levels for every document, folder, and product. In this mission environment, the primary role (the Client) possesses additional rights because it controls the access and viewing capabilities of the secondary roles (the Experts). By distinguishing between the actor who determines the permissions and the actor who is subject to them, Arazy in combination with Booker teaches the exact role-based hierarchy and rights distribution required by the claim.
Claim 12.
Arazy in combination with Booker teaches, The method of claim 10, wherein a collaborator of the two or more collaborators is assigned to any one of following roles: a funder, observer, technology provider, or data partner.. (Arazy, par. Abstract, 0081, 0083, 0101, 0176, 0192)
Arazy explicitly identifies the Device Manufacturer (Technology Provider) and the Regulatory Agency (Observer) as key participants in the digital environment. Furthermore, the Client who pays the license fees serves the functional role of a Funder, and the stakeholders who upload laboratory results are the Data Partners
Claim 13.
Arazy in combination with Booker teaches, The method of claim 10, further comprising
prior to receiving input from one or both of the two or more collaborators to define the at least one component of the new standardized digital measurement solution, receiving agreement from each of the two or more collaborators on one or more criteria of the mission, wherein the one or more criteria of the mission comprise terms and conditions of an agreement. (Arazy, par. 0099-0114, 0127, 0129, 0168, 0170, 0216)
Under the Broadest Reasonable Interpretation (MPEP 2111), receiving agreement is functionally met by the combination of a client selecting a service profile and an expert accepting a job offer under pre-set income sharing terms. Arazy describes a system where the rules of the mission specifically the Review level and Number of people to review are chosen by the client before the work commences.
These selections, paired with the standardized Income sharing rates, constitute the terms and conditions of an agreement. Because Arazy’s CRM platform manages these stakeholder relationships and requires the service scope to be defined before an expert can provide the professional review (technical input), the reference teaches the temporal and functional requirements of the claim.
Claim 14.
Arazy in combination with Booker teaches, The method of claim 13, further comprising
prior to receiving agreement from the each of the two or more collaborators, generating a pre-defined template identifying the one or more criteria of the mission; (Arazy, par. 0093, 0120, 0193, 0213, 0215)
Arazy discloses pre-defined templates sample forms, boilerplate text, and blank documents that define the mission by selecting forms based on client risk and country. Clients choose these templates, experts review them, and this selection occurs before the agreement is finalized.
and providing the pre-defined template to the each of the two or more collaborators. (Arazy, 0081, 0161, 0244)
Arazy satisfies the “providing” requirement by digitally making the same predefined application document accessible to both collaborators within a shared mission environment.
Claim 15.
Arazy in combination with Booker teaches, The method of claim 1, wherein the new standardized digital measurement solution comprises:
i a measurement definition defining one or more concepts of interest relevant to the disease; (Arazy, par. 0177, 0181, 0184, 0199)
Arazy discloses that each regulatory file includes a measurement definition via the GMDN block and clinical evidence module, which specify the device’s medical purpose and measurable unit such as analytes measured by a centrifuge thereby satisfying the measurement definition requirement.
ii an instrumentation asset configured to transform a measurement of interest captured according to the measurement definition to a dataset that is informative for characterizing the disease, wherein the instrumentation asset of the new standardized digital measurement solution is specific for a device used to capture the measurement of interest. (Arazy, par. 0082, 0185, 0191, 0199)
Arazy discloses an instrumentation asset through device-specific Software Validation and Technical modules stored in a master regulatory file for a single product. These modules, organized by device name, validate how the device converts test measurements into FDA-required performance reports, thereby satisfying the claimed limitation.
Claim 16.
Arazy in combination with Booker teaches, The method of claim 1, wherein the new standardized digital measurement solution is a target solution profile representing a common class of digital measurement solutions; (Arazy, par. 0075, 0178, 0247)
Arazy teaches a target solution profile representing a common class through its disclosure of modules representing a class of device. Arazy's system utilizes these modules to create a unique category for similar devices, allowing the system to infer the regulatory and technical requirements for any product within that common class. This functional "category" acts as the template for all subsequent devices of that type, matching the claimed TSP.
and wherein the target solution profile comprises:
(i) a measurement definition defining one or more concepts of interest relevant to disease; (Arazy, par. 0177,0181,0184)
Arazy teaches a measurement definition through the use of the GMDN block, which serves as a universal classification system. In Arazy's system, the GMDN block defines what the device is and its clinical utility, such as measuring analytes in patient samples. By identifying the clinical metric (analytes) relevant to the health condition, Arazy's system provides the measurement definition defining a concept of interest within the device class profile.
and
(ii) an instrumentation asset configured to transform data captured according to the measurement definition to a dataset, wherein the instrumentation asset is device technology agnostic and is thereby interchangeable across different target solution profiles; (Arazy, par. 0177, 0181, 0184, 0080, 0178, 0199, 0247)
Arazy teaches an instrumentation asset through its generic master regulatory files and technical Modules (e.g., electrical safety, sterility, software validation). These assets are device technology agnostic because they are defined at the module level representing a class of device rather than a single specific hardware model. Arazy explicitly describes how these requirements are inferred and applied to later similar devices within a category. Because Arazy allows these modular technical requirements to be interchanged and applied across any new device entering that unique category, it fulfills the requirement of an interchangeable, technology-agnostic instrumentation asset.
Claim 17.
Arazy in combination with Booker teaches, The method of claim 1, wherein the digital environment is a collaborative platform built upon a measurement stack model. (Arazy, par. 0081, 0177, 0199)
Under the Broadest Reasonable Interpretation (MPEP 2111), the measurement stack model is functionally identical to Arazy’s Thirteen basic blocks and Modules that are logically connected to form a product record. Arazy’s system is a collaborative platform because it provides a centralized environment for users, experts, and auditors to interact with these data blocks. Because Arazy’s architecture relies on this tiered organization of technical and clinical "Modules" to facilitate collaborative regulatory work, it fulfills the structural requirements of the claim.
Claim 18.
Arazy in combination with Booker teaches, The method of claim 1, wherein the additional data received from the collaborator comprises one or more of following types of information:
technical feasibility information, patient perspective information, and/or clinical information. (Arazy, Paras 0070, 0145, 0151, 0199).
Under the Broadest Reasonable Interpretation (MPEP 2111), "receiving input" includes the "upload" or "exchange" of any document required for regulatory compliance. Arazy explicitly lists clinical evidence (Clinical Information) as a primary module of the regulatory file. Furthermore, the Verification and Validation data (Technical Feasibility) and post-marketing feedback (Patient Perspective) are integral parts of the dossier managed by the Arazy system. Since Arazy is designed to ingest and validate all these specific categories of medical and technical data to meet FDA requirements, it fulfills every element of the claim.
Claim 19.
Arazy in combination with Booker teaches, The method of claim 10, wherein the method further comprises:
i generating an agreement based on one or more of:
common interest, a regulator collaborator, a regulatory decision, and established roles of the two or more collaborators, wherein the agreement comprises terms comprising one or more of mission rules and collaborator rights; (Arazy, 0129, 0168, 0216, 0234)
Arazy in combination with Booker teaches the generation of an agreement through its CRM (Customer Relationship Management) platform, which manages the relationship and service profile between the client and the expert. This agreement is based on the established roles because the system generates specific actions and income sharing terms derived from whether the collaborator is an Expert or a Client. Because the CRM system creates these professional associations to facilitate a specific regulatory application.
ii) providing, via the digital environment, the each of the two or more collaborators with the agreement; (Arazy, par. 0106, 0125, 0129)
Arazy’s agreement contains collaborator rights through the disclosure of permission levels and legal ownership rights determined by the manufacturer. It also contains mission rules by defining the Review level (e.g., integrity vs. professional review) and the income sharing terms that govern the expert's participation.
and
(iii providing, via the digital environment, a framework for one or more collaborators of the plurality of collaborators to edit the terms. (Arazy, Para 0135, 0161).
Arazy in combination with Booker teaches providing the agreement and a framework to edit the terms through the Client Portal and the version and document control system. The portal allows the expert and client to communicate and comment upon the mission requirements (the terms), while the version control provides the structural framework to track and incorporate those edits. Because this collaborative interface is used to finalize the "final version" of the document/agreement before it enters the master file, Arazy describe the provision of an editing framework.
Claim 20.
Arazy in combination with Booker teaches, The method of claim 1, further comprising: generating a dossier for facilitating regulatory acceptance, the dossier being related to the at least one component of the new standardized digital measurement solution. (Arazy, 0082, 0092, 0094, 0199, 0217)
Under the Broadest Reasonable Interpretation (MPEP 2111), the dossier is functionally met by Arazy’s master regulatory file and regulatory application. Arazy’s system is configured to prepare these files by aggregating all product/client/country information required for a license application. This dossier incorporates the various technical and clinical Modules (components) that describe the device’s performance and safety.
Relevant Prior Arts:
US 20110224933
A method for providing a service to assist in obtaining regulatory approval of a product. (abstract)
The method further includes receiving at the web site the experimental data for the product to provide a second data set, generating comparative data by making comparisons between the first data set and the second data set data indicative of substantial equivalence for the product, and compiling a document comprising data for submission to a regulatory body using the comparative data. (par.0018)
US 20040128220
a method for allowing a mutual access of regulatory approving data required for obtaining an approval of a government and/or regulations among a plurality of parties resident in a variety of jurisdictions. (par. 0030, fig.4)
US20120101838
templates, regulatory team leader review, sending, collecting and reviewing site specific documents, and development and approval of informed consent documents as well as translation of relevant documents to be used in clinical trial. Par. 0044, fig. 1
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JOSHUA DAMIAN RUIZ/Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684
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