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 .
DETAILED ACTION
Status of Claims
The present Office Action is pursuant to Applicant’s communication on 08-01-2025; current application filed on 08-01-2025; Continuation of application No. 18/143,260, filed on May 4, 2023, now Pat. No. 12,417,822.
Examiner’s Note
The rejections below group claims that may not be identical, but whose language and scope are so substantively similar as to lend themselves to grouping, in the interests of clarity and conciseness.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 08-01-2025, have been acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
I. Analysis of Independent Claims (Claims 1 & 11)
Step 1: Statutory CategoryClaims 1 and 11 are directed to a method and a system, respectively, which fall within the statutory categories of "process" and "machine."Claim 1 recites "A method of managing access to data corresponding with trials for digital therapeutics on participants..." and Claim 11 recites "A system for managing access to data corresponding with trials for digital therapeutics on participants, comprising: one or more processors coupled with memory..."
Step 2A Prong One: Judicial Exception (Abstract Idea)The claims recite an abstract idea. The core limitations involve collecting, organizing, and displaying data related to clinical trial phases, participants, and endpoints. This falls under the "organizing human activity" (managing clinical trial administration and data access) and "mental processes" (collecting, analyzing, and correlating information) groupings of abstract ideas.Specification discloses a centralized repository for managing trial data across multiple phases, receiving user requests, selecting datasets based on constraints, and providing access.
[0014]: "One or more processors can maintain a data lake for a plurality of phases associated with a trial for a digital therapeutic on a plurality of participants... The one or more processors can receive from a user device, a request corresponding with at least one of a participant or group of participants, an endpoint, and a phase... The one or more processors can select a corresponding portion of the plurality of datasets based on the request... provide the user device access to the corresponding portion."
Step 2A Prong Two: Practical ApplicationThe additional elements (e.g., "one or more processors," "user device," "data lake") do not integrate the abstract idea into a practical application. They are recited at a high level of generality and merely serve as generic tools to implement the abstract idea on a computer. The specification describes these components in a conventional manner without improving the functioning of the computer itself or any other technology.Specification discloses generic computing hardware used for standard data management tasks.
[0032]: "the data management service 105 may... be any computing device comprising one or more processors coupled with memory and software." And
[0044]: "The data lake 185 may be a repository to store and maintain the data in both structured and unstructured formats." These are conventional computer components performing routine data storage and retrieval functions.
Step 2B: Significantly MoreThe additional elements do not amount to significantly more than the judicial exception. Maintaining a database, receiving requests, selecting data based on constraints, and providing access are well-understood, routine, and conventional activities in the field of data management.Specification discloses these as standard database querying and access control operations.
[0065]: "Upon receipt, the access handler 160 may parse the access request 305 to extract or identify the one or more constraints identified therein for finding a corresponding portion of dataset... Based on the constraint, the access handler 160 may identify or select a corresponding portion of the datasets." And [0069]: "With the selection, the access handler 160 may provide the user device 130 access to the portion of the datasets." These steps describe conventional database querying and permission-checking mechanisms that do not transform the abstract idea into patent-eligible subject matter.
II. Analysis of Dependent Claims (Claims 2-10 & 12-20)
The dependent claims further limit the independent claims by adding features such as identifying trials for different conditions, linking data storages, defining access privileges, adding questionnaires, de-duplicating datasets, correlating participant data, using EDC/identity verification/informed consent, concurrent pharmaceutical administration, and linkage requests. These limitations merely add more details to the abstract idea of managing clinical trial data and access control. They do not transform the claims into patent-eligible subject matter because they still rely on generic computer components performing conventional data management tasks.
Step 2A Prong One & Two (Dependent Claims)The additional limitations in the dependent claims are directed to routine administrative and data organization tasks. For example, setting user permissions, de-duplicating records, and linking databases are standard database administration functions that do not integrate the abstract idea into a practical application.Specification discloses these features as routine data management operations.
[0059]: "the data manager 155 may de-duplicate the datasets 180 across the phases 230 on the data storage 175... remove the duplicated information from at least one of the identified datasets." And [0067]: "The access privileges may be defined for the user of the device 130 in the trial setup request 205 used to establish the data storage 175, and may specify which types of operations the user is permitted (e.g., read, write, view, or create)."
Step 2B (Dependent Claims)The additional elements do not amount to significantly more than the judicial exception. They are merely instructions to apply the abstract idea using generic computer functions.Claim 4 recites "identifying... an access privilege for a user... providing the user device access... responsive to the access privilege defining that the user is permitted to access the portion," which is a conventional database permission check.
Claim 6 recites "removing, from the data lake, a first dataset in one portion... corresponding to a second dataset in another portion," which is routine data de-duplication.
Claim 10 recites "the request comprises a linkage request to link data across the plurality of datasets within the data lake," which describes standard database joining/linking operations. These limitations are well-understood, routine, and conventional activities that do not provide an inventive concept beyond the abstract idea itself.
Conclusion: Claims 1-20 are directed to an abstract idea (managing and organizing clinical trial data/access) implemented using generic computer components performing conventional functions. They fail to integrate the exception into a practical application or amount to significantly more and are therefore rejected under 35 U.S.C. § 101.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claim(s) 1-20 is/are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Double Patenting
The non-statutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A non-statutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on non-statutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 of continuation application 19/288,455 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-18 of parent patent US 12,417,822 B2. Although the claims are not identical, they are not patentably distinct from each other. The continuation and parent applications share the same inventors, derive from a common lineage, and claim substantially overlapping subject matter directed to managing and coordinating data access for digital therapeutics trials via a centralized data lake.
I. Analysis of Independent Claims
Continuation Claim 1 vs. Parent Claim 1Continuation Application Claim 1:
"A method of managing access to data corresponding with trials for digital therapeutics on participants, comprising: maintaining, by one or more processors, a data lake for a plurality of phases corresponding with a trial for a digital therapeutic provided by at least one digital therapeutic application to a plurality of participants, the data lake comprising a plurality of datasets corresponding to at least one of the plurality of phases; receiving, by the one or more processors from a user device, a request corresponding with at least one of a participant or group of participants, an endpoint, and a phase of the plurality of phases corresponding with accessing the plurality of datasets; selecting, by the one or more processors, a corresponding portion of the plurality of datasets based on the request, wherein the corresponding portion is selected by identifying linked data, wherein the linked data is linked by an association between a plurality of trials; and providing, by the one or more processors, to the user device, the corresponding portion of the plurality of datasets in the data lake." [19/288,455]
Parent Patent Claim 1:
"A method of managing access to data associated with trials for digital therapeutics on participants, comprising: receiving, by a server, from a user device, a request to define a plurality of parameters for at least one trial... establishing, by the server, a data lake comprising a data storage to store a plurality of datasets... maintaining, by the server, for multiple digital therapeutics, the data lake for a plurality of phases associated with a trial... receiving, by the server, from the user device, an additional request associated with a participant or group of participants, an endpoint, and a phase of the plurality of phases for which the plurality of datasets is to be accessed; selecting, by the server, a corresponding portion of the plurality of datasets based on the additional request, wherein the corresponding portion is selected by identifying linked data linked by an association between a plurality of trials; and providing, by the server, to the user device, the corresponding portion of the plurality of datasets in the data lake." [18/143,260]
Analysis: Parent Claim 1 encompasses the initial setup steps ("receiving a request to define parameters," "establishing a data lake") before transitioning into the ongoing maintenance and access control phase. Continuation Claim 1 omits the explicit setup steps but retains the core functional limitations: maintaining a centralized data lake across trial phases, receiving participant/endpoint/phase requests, selecting data portions by identifying linked data across multiple trials, and providing controlled access. The omission of preliminary configuration steps does not render the continuation claim patentably distinct, as both claims protect the same fundamental method of managing cross-trial data access via a unified data lake architecture.
Continuation Claim 11 vs. Parent Claim 10Continuation Application Claim 11:
"A system for managing access to data corresponding with trials for digital therapeutics on participants, comprising: one or more processors coupled with memory, configured to: maintain a data lake for a plurality of phases corresponding with a trial... receive, from a user device, a request corresponding with at least one of a participant or group of participants, an endpoint, and a phase... select a corresponding portion of the plurality of datasets based on the request, wherein the corresponding portion is selected by identifying linked data, wherein the linked data is linked by an association between a plurality of trials; and provide, to the user device, the corresponding portion of the plurality of datasets in the data lake." [19/288,455]
Parent Patent Claim 10:
"A system for managing access to data associated with trials for digital therapeutics on participants, comprising: at least one server having one or more processors coupled with memory, configured to: receive, from a user device, a request to define a plurality of parameters... establish a data lake comprising a data storage... maintain, for multiple digital therapeutics, the data lake for a plurality of phases... receive, from the user device, an additional request associated with a participant or group of participants, an endpoint, and a phase... select a corresponding portion of the plurality of datasets based on the additional request, wherein the corresponding portion is selected by identifying linked data linked by an association between a plurality of trials; and provide, to the user device, the corresponding portion of the plurality of datasets in the data lake." [18/143,260]
Analysis: The system claims mirror the method claims. Both define a processor-based architecture configured to maintain a centralized data lake, process access requests tied to participants/endpoints/phases, select data portions via cross-trial linkage, and grant controlled access. The structural and functional limitations are substantially identical, rendering them not patentably distinct.
II. Analysis of Dependent Claims
The dependent claims in the continuation application add limitations that are either explicitly recited or inherently encompassed by the corresponding dependent claims in the parent patent. A claim-by-claim comparison demonstrates substantial overlap:
Analysis: The dependent claims in the continuation application do not introduce patentably distinct subject matter. Each limitation is either explicitly recited in the corresponding parent claim or is inherently disclosed in the parent specification as part of the same integrated data management framework. For example, both applications describe how "the linked data is linked by an association between a plurality of trials" [19/288,455] and how the system handles "electronic data capture (EDC), identity verification, and informed consent" [18/143,260]. The overlapping scope confirms that the continuation claims are not patentably distinct from the parent claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-20 are rejected under 35 U.S.C. § 103 as being unpatentable over Jain (US 11,605,038 A1) in view of Jain (US 12,007,870).
I. Introduction
Both references are directed to managing, collecting, and sharing data in the context of clinical trials involving digital therapeutics/digital health technology. US 11,605,038 is titled "SELECTING DIGITAL HEALTH TECHNOLOGY TO ACHIEVE DATA COLLECTION COMPLIANCE IN CLINICAL TRIALS”, and US 12,007,870 discloses a computer system 110 for sharing research data across clinical trials with permission-based access.
II. Independent Claims 1 and 11
Claim 1 (Method) – Complete Limitation Listing
A method of managing access to data corresponding with trials for digital therapeutics on participants, comprising:
(A) maintaining, by one or more processors, a data lake for a plurality of phases corresponding with a trial for a digital therapeutic provided by at least one digital therapeutic application to a plurality of participants, the data lake comprising a plurality of datasets corresponding to at least one of the plurality of phases;
(B) receiving, by the one or more processors from a user device, a request corresponding with at least one of a participant or group of participants, an endpoint, and a phase of the plurality of phases corresponding with accessing the plurality of datasets;
(C) selecting, by the one or more processors, a corresponding portion of the plurality of datasets based on the request, wherein the corresponding portion is selected by identifying linked data, wherein the linked data is linked by an association between a plurality of trials; and
(D) providing, by the one or more processors, to the user device, the corresponding portion of the plurality of datasets in the data lake.
Claim 11 (System) – Complete Limitation Listing
A system for managing access to data corresponding with trials for digital therapeutics on participants, comprising:
one or more processors coupled with memory, configured to:
(A) maintain a data lake for a plurality of phases corresponding with a trial for a digital therapeutic provided by at least one digital therapeutic application to a plurality of participants, the data lake comprising a plurality of datasets corresponding to at least one of the plurality of phases;
(B) receive, from a user device, a request corresponding with at least one of a participant or group of participants, an endpoint, and a phase of the plurality of phases corresponding with accessing the plurality of datasets;
(C) select a corresponding portion of the plurality of datasets based on the request, wherein the corresponding portion is selected by identifying linked data, wherein the linked data is linked by an association between a plurality of trials; and
(D) provide, to the user device, the corresponding portion of the plurality of datasets in the data lake.
Limitation (A) – Maintaining a data lake for a plurality of phases of a trial for a digital therapeutic, comprising a plurality of datasets:
Jain (US 11,605,038) is directed to "SELECTING DIGITAL HEALTH TECHNOLOGY TO ACHIEVE DATA COLLECTION COMPLIANCE IN CLINICAL TRIALS" , establishing the context of a trial for a digital therapeutic (digital health technology) with data collection across phases. Jain (US 12,007,870) discloses a computer system 110 that maintains data storage for clinical trial monitoring data:
"The system can maintain a separate data storage area or partition for the shared data in the collection, so that alterations to the data and new derived data can be collected and maintained for the parties without affecting the source data sets from which the shared data was derived."
"The researcher 1002a shares a subset 1012a of monitoring data 176a for Study 1, and the researcher 1002b shares a subset 1012b of monitoring data 176b for Study 2."
This discloses maintaining a data storage (data lake) comprising datasets (monitoring data 176a, 176b) corresponding to phases of a trial for a digital therapeutic.
Limitation (B) – Receiving a request from a user device corresponding with a participant/group, endpoint, or phase for accessing datasets:
Jain (US 11,605,038) does not explicitly disclose as disclosed by Jain (US 12,007,870) discloses:
"The computer system 110 can enable both among researchers affiliated with a clinical trial and with others who are not affiliated with the clinical trial. For example, the platform can be used to share to the broader research community (beyond researcher counterparts) to provide research data, analyses, and findings, which enables recipient to utilize this data for validation, to inform new studies based on the findings, and identify populations of participants or patients to engage in future studies."
"By combining the shared data and permissions set by each of multiple parties, the system can create a shared collection, with a shared portal customized to permit the actions and data analysis processes permitted by the parties."
This discloses receiving a request (from a user/researcher via the platform) corresponding with participants and phases for accessing datasets.
Limitation (C) – Selecting a corresponding portion by identifying linked data linked by an association between a plurality of trials:
Jain (US 11,605,038) does not explicitly disclose as disclosed by Jain (US 12,007,870)
Jain (US 12,007,870) discloses:
"The example of FIG. 10 shows how two researchers 1002a, 1002b that are affiliated with different research studies and different organizations each provide data to a collaboration account 1010 or shared project."
"these two instances of data sharing each have a separate data sharing record 1020a, 1020b that defines the corresponding subset 1012a, 1012b and specifies how the respective shared data can be used in the collaboration account."
"the computer system 110 can use the collected health data and compliance information from a first clinical trial to identify candidates that the computer system 110 determined to have high relevance and/or high likelihood of successful participation (e.g., retention and high compliance) in a second clinical trial."
This discloses selecting a portion of datasets by identifying linked data (monitoring data 176a from Study 1 linked with monitoring data 176b from Study 2) linked by an association between a plurality of trials (Study 1 and Study 2).
Limitation (D) – Providing the corresponding portion to the user device:
Jain (US 11,605,038) does not explicitly disclose as disclosed by Jain (US 12,007,870)
Jain (US 12,007,870) discloses:
"This can function as a virtual data sharing room, where the customized portal to access the shared data is provided to all parties involved and each party can interact with and manipulate the data according to the permissions granted by the respective data owners."
"The information about these prospects or candidates can be shared securely to researchers of the second clinical trial, without revealing the identities of the candidates until authorized by the participants."
This discloses providing the corresponding portion of datasets to the user device (researcher) via the shared portal.
It would have been obvious to one of ordinary skill in the art before the effective filing date to combine the digital health technology data collection compliance framework of Jain (US 11,605,038) with the cross-trial data sharing and collaboration system of Jain (US 12,007,870) , because both references are directed to managing clinical trial data for digital therapeutics, and combining them would provide a unified system for maintaining, linking, and providing access to trial data across multiple phases and trials. The motivation is to "increase value and reduce cost of scientific research by sharing to broader community.
III. Dependent Claims 2 and 12
Claim 2 / Claim 12 – Complete Limitation Listing
The method of claim 1, further comprising:
identifying, by the one or more processors, the plurality of trials associated with a corresponding plurality of conditions of the plurality of participants provided with the digital therapeutic; and
establishing, by the one or more processors, a plurality of data storages for the corresponding plurality of trials.
The system of claim 11, wherein the one or more processors are further configured to:
identify the plurality of trials associated with a corresponding plurality of conditions of the plurality of participants provided with the digital therapeutic; and
establish a plurality of data storages for the corresponding plurality of trials.
Jain (US 12,007,870) discloses:
"The example of FIG. 10 shows how two researchers 1002a, 1002b that are affiliated with different research studies and different organizations each provide data to a collaboration account 1010 or shared project. The researcher 1002a shares a subset 1012a of monitoring data 176a for Study 1, and the researcher 1002b shares a subset 1012b of monitoring data 176b for Study 2."
"The system can maintain a separate data storage area or partition for the shared data in the collection, so that alterations to the data and new derived data can be collected and maintained for the parties without affecting the source data sets from which the shared data was derived."
This discloses identifying a plurality of trials (Study 1, Study 2) associated with conditions of participants, and establishing a plurality of data storages (separate data storage area or partition) for the corresponding plurality of trials.
IV. Dependent Claims 3 and 13
Claim 3 / Claim 13 – Complete Limitation Listing
The method of claim 1, wherein the data lake comprises a data storage, the method further comprising:
receiving, by the one or more processors, from the user device, a second request to associate the data storage with a second data storage, the second data storage comprising a second plurality of datasets from a second trial separate from the trial associated with the data storage; and
linking, by the one or more processors, responsive to the second request, the second data storage with the data storage to provide the user device access to the data storage and the second data storage.
The system of claim 11, wherein the data lake comprises a data storage, wherein the one or more processors are further configured to:
receive, from the user device, a second request to associate the data storage with a second data storage, the second data storage comprising a second plurality of datasets from a second trial separate from the trial associated with the data storage; and
link, responsive to the second request, the second data storage with the data storage to provide the user device access to the data storage and the second data storage.
Jain (US 12,007,870) discloses:
"The example of FIG. 10 shows how two researchers 1002a, 1002b that are affiliated with different research studies and different organizations each provide data to a collaboration account 1010 or shared project. The researcher 1002a shares a subset 1012a of monitoring data 176a for Study 1, and the researcher 1002b shares a subset 1012b of monitoring data 176b for Study 2."
"By combining the shared data and permissions set by each of multiple parties, the system can create a shared collection, with a shared portal customized to permit the actions and data analysis processes permitted by the parties. This can function as a virtual data sharing room, where the customized portal to access the shared data is provided to all parties involved and each party can interact with and manipulate the data according to the permissions granted by the respective data owners."
This discloses receiving a second request (researcher 1002b providing data to the collaboration account) to associate a data storage (Study 1 data) with a second data storage (Study 2 data, a second trial separate from the first), and linking the second data storage with the data storage (creating a shared collection/collaboration account) to provide access to both.
V. Dependent Claims 4 and 14
Claim 4 / Claim 14 – Complete Limitation Listing
The method of claim 1, further comprising:
identifying, by the one or more processors, from a plurality of access privileges, an access privilege for a user associated with the user device;
wherein providing the corresponding portion further comprises providing the user device access to the portion of the plurality of datasets, responsive to the access privilege defining that the user is permitted to access the portion.
The system of claim 11, wherein the one or more processors are further configured to:
identify, from a plurality of access privileges, an access privilege for a user associated with the user device;
wherein providing the corresponding portion further comprises providing the user device access to the portion of the plurality of datasets, responsive to the access privilege defining that the user is permitted to access the portion.
Jain (US 12,007,870) discloses:
"By combining the shared data and permissions set by each of multiple parties, the system can create a shared collection, with a shared portal customized to permit the actions and data analysis processes permitted by the parties."
"each party can interact with and manipulate the data according to the permissions granted by the respective data owners."
"separate collaboration account settings 1040 can be used to further define how the data in the account is used."
This discloses identifying access privileges (permissions set by each of multiple parties, collaboration account settings 1040) for a user, and providing access responsive to the access privilege (each party can interact with data "according to the permissions granted by the respective data owners").
VI. Dependent Claims 5 and 15
Claim 5 / Claim 15 – Complete Limitation Listing
The method of claim 1, wherein receiving the request further comprises:
receiving the request identifying a questionnaire to add to the phase of the plurality of phases; and
generating, by the one or more processors, at least one dataset identifying the questionnaire to add to at least one corresponding portion of the plurality of datasets.
The system of claim 11, wherein receiving the request further comprises:
receiving the request identifying a questionnaire to add to the phase of the plurality of phases; and
generating at least one dataset identifying the questionnaire to add to at least one corresponding portion of the plurality of datasets.
Jain (US 11,605,038) is directed to "SELECTING DIGITAL HEALTH TECHNOLOGY TO ACHIEVE DATA COLLECTION COMPLIANCE IN CLINICAL TRIALS" , which inherently involves data collection instruments (questionnaires) added to trial phases. Jain (US 12,007,870) discloses:
"the platform can be used to share to the broader research community (beyond researcher counterparts) to provide research data, analyses, and findings, which enables recipient to utilize this data for validation, to inform new studies based on the findings, and identify populations of participants or patients to engage in future studies."
"When a user shares data, the user can specify whether combination of shared data is permitted, and how the results from a combined data set (e.g., shared data plus other data) can be used."
This discloses receiving a request to add data (questionnaire) to a phase and generating a dataset (combined data set) identifying the questionnaire to add to a corresponding portion.
VII. Dependent Claims 6 and 16
Claim 6 / Claim 16 – Complete Limitation Listing
The method of claim 1, wherein maintaining the data lake further comprises removing, from the data lake, a first dataset in one portion of the plurality of datasets corresponding to a second dataset in another portion of the plurality of datasets.
The system of claim 11, wherein maintaining the data lake further comprises removing, from the data lake, a first dataset in one portion of the plurality of datasets corresponding to a second dataset in another portion of the plurality of datasets.
Jain (US 12,007,870) discloses:
"The system can maintain a separate data storage area or partition for the shared data in the collection, so that alterations to the data and new derived data can be collected and maintained for the parties without affecting the source data sets from which the shared data was derived."
"these two instances of data sharing each have a separate data sharing record 1020a, 1020b that defines the corresponding subset 1012a, 1012b and specifies how the respective shared data can be used in the collaboration account."
This discloses maintaining the data lake by managing (including removing/deduplicating) a first dataset in one portion (subset 1012a) corresponding to a second dataset in another portion (subset 1012b), as the system maintains separate records and partitions to avoid duplication.
VIII. Dependent Claims 7 and 17
Claim 7 / Claim 17 – Complete Limitation Listing
The method of claim 1, wherein receiving the request further comprises receiving the request identifying a participant of the plurality of participants for which the plurality of datasets is to be accessed;
wherein providing the access further comprises correlating, within the plurality of datasets on the data lake, one or more datasets associated with the participant identified in the request.
The system of claim 11, wherein receiving the request further comprises receiving the request identifying a participant of the plurality of participants for which the plurality of datasets is to be accessed;
wherein providing the access further comprises correlating, within the plurality of datasets on the data lake, one or more datasets associated with the participant identified in the request.
Jain (US 12,007,870) discloses:
"the computer system 110 can use the collected health data and compliance information from a first clinical trial to identify candidates that the computer system 110 determined to have high relevance and/or high likelihood of successful participation (e.g., retention and high compliance) in a second clinical trial."
"The information about these prospects or candidates can be shared securely to researchers of the second clinical trial, without revealing the identities of the candidates until authorized by the participants."
"identify populations of participants or patients to engage in future studies"
This discloses receiving a request identifying a participant (candidates identified from health data and compliance information) and correlating datasets associated with the participant (using collected health data and compliance information to identify and correlate participant data across trials).
IX. Dependent Claims 8 and 18
Claim 8 / Claim 18 – Complete Limitation Listing
The method of claim 1, wherein at least one of the plurality of datasets are generated using at least one of electronic data capture (EDC), identity verification, and informed consent.
The system of claim 11, wherein at least one of the plurality of datasets are generated using at least one of electronic data capture (EDC), identity verification, and informed consent.
Jain (US 11,605,038) is titled "SELECTING DIGITAL HEALTH TECHNOLOGY TO ACHIEVE DATA COLLECTION COMPLIANCE IN CLINICAL TRIALS" , which inherently involves electronic data capture (EDC) and compliance (including informed consent and identity verification) in clinical trials. Jain (US 12,007,870) discloses:
"In compliance with best practices for secure data sharing, personal health information (PHI) and personal identifying information (PII) can be maintained confidential in most cases by the computer system 110 even as substantive data is shared."
"without revealing the identities of the candidates until authorized by the participants"
This discloses datasets generated using identity verification (PII maintained confidential, identities not revealed until authorized) and informed consent (authorized by the participants).
X. Dependent Claims 9 and 19
Claim 9 / Claim 19 – Complete Limitation Listing
The method of claim 1, wherein at least one of the plurality of participants is administered with a pharmaceutical to address a condition, at least partially concurrently with use of the digital therapeutic.
The system of claim 11, wherein at least one of the plurality of participants is administered with a pharmaceutical to address a condition, at least partially concurrently with use of the digital therapeutic.
Jain (US 11,605,038) is directed to "SELECTING DIGITAL HEALTH TECHNOLOGY TO ACHIEVE DATA COLLECTION COMPLIANCE IN CLINICAL TRIALS" , where clinical trials for digital therapeutics commonly involve concurrent pharmaceutical administration. Jain (US 12,007,870) discloses:
"the computer system 110 can use the collected health data and compliance information from a first clinical trial to identify candidates that the computer system 110 determined to have high relevance and/or high likelihood of successful participation (e.g., retention and high compliance) in a second clinical trial."
"identify populations of participants or patients to engage in future studies"
The context of clinical trials for digital therapeutics inherently contemplates participants being administered with a pharmaceutical to address a condition concurrently with the digital therapeutic, as this is standard in clinical trial design for digital therapeutics.
XI. Dependent Claims 10 and 20
Claim 10 / Claim 20 – Complete Limitation Listing
The method of claim 1, wherein the request comprises a linkage request to link data across the plurality of datasets within the data lake.
The system of claim 11, wherein the request comprises a linkage request to link data across the plurality of datasets within the data lake.
Jain (US 12,007,870) discloses:
"By combining the shared data and permissions set by each of multiple parties, the system can create a shared collection, with a shared portal customized to permit the actions and data analysis processes permitted by the parties."
"The example of FIG. 10 shows how two researchers 1002a, 1002b that are affiliated with different research studies and different organizations each provide data to a collaboration account 1010 or shared project."
"When a user shares data, the user can specify whether combination of shared data is permitted, and how the results from a combined data set (e.g., shared data plus other data) can be used."
This discloses a linkage request (user specifying combination of shared data) to link data across the plurality of datasets (monitoring data 176a and 176b from different studies) within the data lake (collaboration account 1010 / shared collection).
Conclusion
The prior art made of record1 and NOT relied upon is considered pertinent to applicant's disclosure:
Hudson (US 7,711,580): A system and method for matching patients with clinical trials and particular trial sites, prequalifying patients for clinical trials and trial sites, and providing information to patients to allow them to inform themselves about available clinical trials and trial sites. The method comprises receiving patient profile information for a patient at a server connected to a computer network, the patient profile information submitted by a user at a terminal connected to the network, comparing the patient profile information with acceptance criteria for clinical trials stored in a database, the comparison performed by the server, determining whether the patient prequalifies for any of the clinical trials, and notifying the user and the trial site whether the patient has prequalified for any clinical trials.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL EZEWOKO whose telephone number is 571 272 7850. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached on 571 270 5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-7850.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL I EZEWOKO/Primary Examiner, Art Unit 3682
1Please see Form 892 for complete listing
Prosecution Insights