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
The present office action represents the first action on the merits.
Claims 1-20 are pending.
Priority
This application claims priority to Patent Application No. 18/986,048 dated 26 December 2023.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
(Claim 1, 20) first and second portals configured to:
create and manage profiles specifying at least one of first entity specialties, research interests, and collaboration goals;
filter and select clinical trials of the first entity and the second entity based on therapeutic area and clinical trial phase; and
initiate secure communications with the second entity;
(Claim 1) a data management module (or first data management modules) configured to: store and organize first and second entities' profiles, message logs, and interaction histories; and maintain audit trails for regulatory compliance;
(Claim 1, 20) a content update provider enabling the second entity to deliver real-time updates on therapeutic products, first entity clinical trials, and collaboration opportunities; and
(Claim 1, 20) a privacy and security module configured to: encrypt data during transmission and storage; provide entity-controlled permissions for content access; and automate log deletion for non-disclosure agreement-protected discussions after a predefined period.
(Claim 5, 20) a second data management module employing machine learning to: analyze interactions of the first and second entities to generate personalized recommendations for first entity clinical trials, collaborations, and connections; identify potential synergies using external datasets; and predict emerging trends in the first entity and the second entity collaborations.
(Claim 13, 20) a first entity survey module integrated into the platform to gather and analyze clinician feedback on clinical trials and collaborations.
(Claim 7, 20) an artificial intelligence controller configured to: integrate external data sources, including at least one of first entity surveys, content management system data, National Comprehensive Cancer Network guidelines, and medical journal publications; and dynamically update communication workflows and recommendations.
(Claim 1, 20) a communication subsystem configured to: facilitate real-time messaging between the first and second entities; transmit pre-configured non-disclosure agreements upon initiating sensitive discussions to ensure privacy; and log communication events, timestamps, and non-disclosure agreement metadata;
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The Examiner has reviewed the as-filed disclosure and determined the following:
(Claim 1, 20) first and second portals configured to: create, filter, initiate, upload, classify, interact.
Components responsible to allow for user interaction.
Tied to a server at Spec. Para. 00110.
(Claim 1) a data management module configured to: store and organize first and second entities' profiles, message logs, and interaction histories; and maintain audit trails for regulatory compliance;
A component responsible for organizing, storing, and retrieving user profiles, interaction histories, and communication logs. This term broadly refers to systems performing similar functions, including database management systems and integrated data repositories.
Virtual platform including… a data management module
Virtual platform hosted on servers
(Claim 1, 20) a content update provider enabling the second entity to deliver real-time updates on therapeutic products, first entity clinical trials, and collaboration opportunities; and
A feature enabling real-time dissemination of updates, such as trial information, research developments, or collaborative opportunities. The term includes any tool or mechanism that delivers similar updates within or outside the platform context.
(Claim 1) a privacy and security module configured to: encrypt data during transmission and storage; provide entity-controlled permissions for content access; and automate log deletion for non-disclosure agreement-protected discussions after a predefined period.
A system component implementing encryption, access control, and data compliance measures. The term broadly includes any system or module designed to protect user data and maintain privacy, irrespective of specific encryption methods or protocols.
(Claim 5, 20) a second data management module employing machine learning to: analyze interactions of the first and second entities to generate personalized recommendations for first entity clinical trials, collaborations, and connections; identify potential synergies using external datasets; and predict emerging trends in the first entity and the second entity collaborations.
A software engine utilizing algorithms… to analyze large datasets and provide actionable insights.
Virtual platform including… a second data management module
Virtual platform hosted on servers
(Claim 7, 20) an artificial intelligence (AI) controller configured to: integrate external data sources, including at least one of first entity surveys, content management system data, National Comprehensive Cancer Network guidelines, and medical journal publications; and dynamically update communication workflows and recommendations.
A module… The term applies broadly to any artificial intelligence system that supports real-time decision-making or process optimization
Virtual platform including… an AI controller
Virtual platform hosted on servers
Defined as a module at Spec. Para. 0042. Modules are tied to a computer at Spec. Para. 00110.
(Claim 13, 20) a first entity survey module integrated into the platform to gather and analyze clinician feedback on clinical trials and collaborations
A tool integrated into the platform to gather and analyze feedback from users. This term includes any system capable of collecting structured or unstructured user inputs and generating insights for system improvement or operational enhancement.
Virtual platform hosted on servers
(Claim 1, 20) a communication subsystem configured to: facilitate…; transmit…; and log.
Defined as a module at Spec. Para. 0039. Modules are tied to a computer at Spec. Para. 00110.
If applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation recite(s) sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
The Examiner notes that because the various items discussed above are tied to sufficient structure, a rejection under 112(a) and 112(b) is not required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
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.
Claims 1-13 are 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 pre-AIA the applicant regards as the invention.
Claim 1 is rejected because it is unclear and thus indefinite. Claim 1 previously recited “a smartphone application” in the first limitation. It is unclear whether the “a smartphone application” cited in the fifth limitation is the same smartphone application or a different smartphone application. For examination purposes, the fifth limitation will be read as “the smartphone application.”
By virtue of their dependence from Claim 1, this basis of rejection also applies to dependent claims 2-13.
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 (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1, 15, and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claims recite systems and a method for facilitating collaboration between a first entity and a second entity, and therefore meet step 1.
Step 2A1
The limitations of (Claim 15 being representative) …the first entity creates a profile specifying research interests, therapeutic expertise, and collaboration goals, and wherein the first entity filters clinical trials of the first entity and the second entity by criteria including therapeutic area or trial phase; …the second entity uploads and classifies content, including therapeutic pipelines and first entity trial updates…; facilitating communication through a communication subsystem, by enabling real-time messaging between the first entity and the second entity, transmitting pre-configured non-disclosure agreements upon initiating sensitive discussions, and recording interaction logs and associated metadata for traceability; analyzing interactions of the first and second entities… to generate personalized recommendations for first entity clinical trials, collaborations, and partnerships; predict potential synergies between first and second entities; and identify trends in the engagement of the first and second entities;…integrate external data from first entity surveys, content management system datasets, National Comprehensive Cancer Network guidelines, and medical journals; and generate recommendations and workflows based on evolving first and second entities behavior; enabling the second entity to deliver trial updates and therapeutic content through a content update provider; gathering feedback… for analysis and reporting; and securing interactions…, manage permissions, and automate log deletion for non-disclosure agreement-protected discussions, as drafted, is a process that, under the broadest reasonable interpretation, falls in the grouping of certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions).
Per the 112(f) interpretation, supra, the first entity portal, second entity portal, artificial intelligence controller, data management module, second data management module, first entity survey module, and privacy and security module, etc., are part of a computing device. That is, other than reciting various networked computers or computer components (one or more general-purpose computing devices), the claimed invention amounts to managing personal behavior or interaction between people. The Examiner notes that claim 15 is not confined to any particular technological environment and also amounts to managing personal behavior or interaction between people. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. The Examiner notes that the Applicant has not described what the particular training of the machine learning model entails and thus it is interpreted to be simple enough for a human to accomplish (i.e., linear or logistic regression) and has been included in the abstract idea. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, Claim 1, 20 recites various networked computers or computer components (see 112(f) interpretation) that implement the identified abstract idea while Claim 15 recites does not recite any particular technological environment. The computer of Claims 1 and 20 implements the identified abstract idea. The various networked computers or computer components are not exclusively described by the applicant and are recited at a high-level of generality (i.e., general purpose processor) such that it amounts to no more than mere instructions to apply the exception using a generic computer or components thereof. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The claims recite the additional element of a smartphone application or web login. The smartphone application or web login merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a general-purpose computer to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component cannot provide an inventive concept (“significantly more”).
As discussed above with respect to integration of the abstract idea into a practical application, the additional element of a smartphone application or web login was considered to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more.
Claims 2-13 and 16-19 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claim 2 merely describes the communication subsystem, which further defines the abstract idea.
Claim 3 merely describes the virtual platform, which further defines the abstract idea. Claim 4 merely describes the network server, which further defines the abstract idea.
Claim 3 further recites the additional elements of a support server and a support cloud server, which are considered to “generally link” under both the practical application and significantly more analysis.
Claims 3 and 4 further recite the additional element of a network server, which is considered to “generally link” under both the practical application and significantly more analysis.
Claims 5 and 6 merely describe the second data management module, which further defines the abstract idea.
Claim 6 further recites the additional element of natural language processing, which is considered to “generally link” under both the practical application and significantly more analysis.
Claims 7-9 merely describe the artificial intelligence controller, which further defines the abstract idea.
Claim 10 merely describes the content update provider, which further defines the abstract idea.
Claim 11 merely describes the privacy and security module, which further defines the abstract idea.
Claim 12 merely describes the first entity portal, which further defines the abstract idea.
Claim 12 further recites the additional element of a dashboard, which is considered part of the computer, and therefore part of the abstract idea.
Claims 13 and 14 merely describe the first entity survey module, which further defines the abstract idea.
Claims 16 and 18 merely describe enabling clinicians, which further defines the abstract idea.
Claim 17 merely describes integrating external electronic health records, which further defines the abstract idea.
Claim 19 merely describes enabling the second entity, which further defines the abstract idea.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-11 and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Steenstra et al. (U.S. 2024/0145074) in view of Shanks et al. (U.S. 2022/0006623) and Baez et al. (U.S. 2023/0090799), referred to hereinafter as Steenstra, Shanks, and Baez, respectively.
The Examiner notes that because the functionality of the claimed invention is taught by the prior art, the various modules, etc. are necessarily also taught (otherwise a 112(a) rejection of Applicant’s claim would be required). This interpretation applies to the entirety of the rejection.
REGARDING CLAIM 1
Steenstra teaches a system for facilitating collaboration between a first entity and a second entity, comprising:
a first entity portal accessible via at least one of a smartphone application or web login, the first entity portal configured to allow the first entity to: [Para. 0038 teaches a smartphone. Para. 0060 teaches a user-level application.]
create and manage profiles specifying at least one of first entity specialties, research interests, and collaboration goals; [Para. 0258 teaches receiving onboarding information through an entity generating a user profile. Para. 0274 teaches onboarding information includes identifications of at least one of abilities or desires of the first entity. Para. 0050 teaches the entity is associated with a goal. Para. 0194 teaches collaboration involves entities working together towards a common goal. Para. 0141 teaches expertise is determined based on stored profile information.]
filter and select clinical trials of the first entity and the second entity based on therapeutic area and clinical trial phase; and [Para. 0245 teaches criteria including phases of a clinical trial.]
initiate secure communications with the second entity; [Para. 0251 teaches opening a communication forum such as a messaging platform.]
a second entity portal accessible via at least one of a smartphone application or web login, the second entity portal configured to allow the second entity to: [Para. 0279 teaches updating how the unmet technological needs are organized based on new or relevant information included in the second onboarding information.]
upload and manage therapeutic pipelines, first entity trial updates, and research opportunities; [Para. 0275 teaches any of the entities uploading documents.]
classify content by clinical trial phase, therapeutic area, and geographic region; and [Para. 0078 teaches a user (second entity) selecting from a list of known beneficiaries or unmet technological needs (goals) to classify content.]
interact with the first entity based on shared research goals; [Para. 0230 teaches matching (aligning) the entity with the need and the entity with the skill, interest, or ability to fulfill that need.]
a communication subsystem configured to: [Para. 0251 teaches opening a communication forum such as a messaging platform.]
facilitate real-time messaging between the first and second entities;
transmit pre-configured non-disclosure agreements upon initiating sensitive discussions to ensure privacy; and [Para. 0185 teaches executing an electronic nondisclosure agreement.]
log communication events, timestamps, and non-disclosure agreement metadata; [Para. 0181 teaches storing log data.]
a data management module configured to:
store and organize first and second entities' profiles, message logs, and interaction histories; and [Para. 0181 teaches storing log data.]
a content update provider enabling the second entity to deliver real-time updates on therapeutic products, first entity clinical trials, and collaboration opportunities; and [Para. 0279 teaches updating how the unmet technological needs are organized based on new or relevant information included in the second onboarding information.]
Steenstra may not explicitly teach
maintain audit trails for regulatory compliance;
a privacy and security module configured to:
encrypt data during transmission and storage;
provide entity-controlled permissions for content access; and
However, Shanks teaches the following:
maintain audit trails for regulatory compliance; [Para. 0030 teaches generating an audit log.]
a privacy and security module configured to:
encrypt data during transmission and storage; [Para. 0004 teaches generating an encrypted log.]
provide entity-controlled permissions for content access; and [Para. 0024 teaches users of high-level authority maintain access to logs generated upon access by the users of low-level authority.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the system of Steenstra to maintain audit logs as taught by Shanks, with the motivation of improving security (see Shanks at Para. 0054).
Steenstra in view of Shanks may not explicitly teach
automate log deletion for non-disclosure agreement-protected discussions after a predefined period.
However, Baez teaches the following:
automate log deletion for non-disclosure agreement-protected discussions after a predefined period. [Para. 0090 teaches a communication platform automatically deleting objects associated with the new deleted data retention rule after a set date. Para. 0092 teaches a user selecting particular conversations to apply to the new deleted data retention rule.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the computer-implemented method of Steenstra in view of Shanks to automate log deletion of protected discussions as taught by Baez, with the motivation of improving the electronic discovery of information associated with an organization and/or a user (see Baez at Para. 0022).
REGARDING CLAIM 2
Steenstra in view of Shanks and Baez teaches the system of claim 1.
Steenstra further teaches
the communication subsystem categorizes messages by therapeutic area, trial phase, or sender department. [Para. 0245 teaches criteria including phases of a clinical trial.]
REGARDING CLAIM 3
Steenstra in view of Shanks and Baez teaches the system of claim 1.
Steenstra further teaches
a virtual platform hosted on: a support server and a support cloud server for managing data storage, communication processing, and entities interaction logs; and a network server configured for secure, real-time data exchange between the first entity portal and the second entity portal. [Para. 0038 teaches a cloud computing platform. Para. 0248 teaches a cloud server. Para. 0249 teaches a processing device associated with a network server.]
REGARDING CLAIM 4
Steenstra in view of Shanks and Baez teaches the system of claim 3.
Steenstra further teaches
the network server employs distributed ledger technology for data integrity and traceability. [Para. 0048 teaches data is stored in a distributed manner.]
REGARDING CLAIM 5
Steenstra in view of Shanks and Baez teaches the system of claim 1.
Steenstra further teaches
a second data management module employing machine learning to: analyze interactions of the first and second entities to generate personalized recommendations for first entity clinical trials, collaborations, and connections; identify potential synergies using external datasets; and predict emerging trends in the first entity and the second entity collaborations. [Para. 0279 teaches using machine learning to analyze log files with user activity records. Para. 0227 teaches providing recommendations based on stages of progress. Para. 0229 teaches collaboration includes any form of partnership between two or more entities. Para. 0256 teaches mapping unmet technological needs to identify potential relationships. Unmet technological needs are represented as nodes. Entities are associated with the nodes.]
REGARDING CLAIM 6
Steenstra in view of Shanks and Baez teaches the system of claim 4.
Steenstra further teaches
the second data management module utilizes natural language processing to analyze message content and refine collaboration suggestions. [Para. 0068 teaches natural language processing.]
REGARDING CLAIM 7
Steenstra in view of Shanks and Baez teaches the system of claim 1.
Steenstra further teaches
an artificial intelligence controller configured to: integrate external data sources, including at least one of first entity surveys, content management system data, National Comprehensive Cancer Network guidelines, and medical journal publications; and dynamically update communication workflows and recommendations. [Para. 0232 teaches an artificial intelligence crawler extracts data from the internet. Para. 0052 teaches accessing information from a journal database. Para. 0256 teaches an evolutionary system. Para. 0260 teaches collecting external data. Para. 0227 teaches providing recommendations based on stages of progress.]
REGARDING CLAIM 8
Steenstra in view of Shanks and Baez teaches the system of claim 6.
Steenstra further teaches
the artificial intelligence controller predicts emerging research trends and suggests partnerships accordingly. [Para. 0232 teaches an artificial intelligence crawler extracts data from the internet. Para. 0227 teaches providing recommendations based on stages of progress. Para. 0229 teaches collaboration includes any form of partnership between two or more entities. Para. 0256 teaches mapping unmet technological needs to identify potential relationships. Unmet technological needs are represented as nodes. Entities are associated with the nodes.]
REGARDING CLAIM 9
Steenstra in view of Shanks and Baez teaches the system of claim 6.
Steenstra further teaches
the artificial intelligence controller dynamically adjusts recommendations based on real-time interactions of the first entity and the second entity. [Para. 0232 teaches an artificial intelligence crawler extracts data from the internet. Para. 0158 teaches recommendations are informed by information scraped from a wide variety of sources. In particular, information is scraped from a wide variety of current sources, such as social media platforms.]
REGARDING CLAIM 10
Steenstra in view of Shanks and Baez teaches the system of claim 1.
Steenstra further teaches
the content update provider includes tools for automating the delivery of real-time updates on first entity clinical trials to matched clinicians. [Para. 0163 teaches users receiving updates. Para. 0204 teaches understanding incomplete data in a clinical trial activity, in real-time.]
REGARDING CLAIM 11
Steenstra in view of Shanks and Baez teaches the system of claim 1.
Shanks further teaches
the privacy and security module incorporates multi- factor authentication for verification of at least one of the first entity and the second entity. [Para. 0037 teaches employing certificate-based authentication, passcode-based authentication, and biometric-based authentication, or a combination thereof.]
REGARDING CLAIM 13
Steenstra in view of Shanks and Baez teaches the system of claim 1.
Steenstra further teaches
a first entity survey module integrated into the platform to gather and analyze clinician feedback on clinical trials and collaborations. [Para. 0244 teaches the activity of the first entity and the second entity may be monitored in various other ways, such as reporting from the first entity and second entity, receiving feedback or information from a third party, tracking progress indicated in a database or data structure, tracking data recorded in blocks in a blockchain, or any other methods for tracking progress electronically. An example may include analyzing peer review and discussing the conclusion of a specific result.]
REGARDING CLAIM 14
Steenstra in view of Shanks and Baez teaches the system of claim 13.
Steenstra further teaches
the first entity survey module anonymizes feedback data for the second entity analysis while preserving clinician confidentiality. [Para. 0235 teaches maintaining the anonymity of the at least two entities.]
REGARDING CLAIM 15
Steenstra teaches a method for enabling collaboration between a first entity and a second entity using a virtual platform, comprising: [Para. 0038 teaches a cloud computing platform.]
providing a first entity portal for the first entity to access via at least one of a smartphone application and a web login, wherein the first entity creates a profile specifying research interests, therapeutic expertise, and collaboration goals, and wherein the first entity filters clinical trials of the first entity and the second entity by criteria including therapeutic area or trial phase; [Para. 0038 teaches a smartphone. Para. 0060 teaches a user-level application. Para. 0258 teaches receiving onboarding information through an entity generating a user profile. Para. 0274 teaches onboarding information includes identifications of at least one of abilities or desires of the first entity. Para. 0050 teaches the entity is associated with a goal. Para. 0194 teaches collaboration involves entities working together towards a common goal. Para. 0141 teaches expertise is determined based on stored profile information. Para. 0245 teaches criteria including phases of a clinical trial.]
providing a second entity portal for the second entity to access via at least one of a smartphone application and a web login, wherein the second entity uploads and classifies content, including therapeutic pipelines and first entity trial updates, and wherein the second entity portal targets the first entity based on research alignment; [Para. 0275 teaches any of the entities uploading documents. Para. 0078 teaches a user (second entity) selecting from a list of known beneficiaries or unmet technological needs (goals) to classify content. Para. 0279 teaches updating how the unmet technological needs are organized based on new or relevant information included in the second onboarding information. Para. 0230 teaches matching (aligning) the entity with the need and the entity with the skill, interest, or ability to fulfill that need.]
facilitating communication through a communication subsystem, by enabling real- time messaging between the first entity and the second entity, transmitting pre-configured non-disclosure agreements upon initiating sensitive discussions, and recording interaction logs and associated metadata for traceability; [Para. 0251 teaches opening a communication forum such as a messaging platform. Para. 0185 teaches executing an electronic nondisclosure agreement. Para. 0181 teaches storing log data.]
analyzing interactions of the first and second entities using a second data management module employing machine learning to generate personalized recommendations for first entity clinical trials, collaborations, and partnerships; predict potential synergies between first and second entities; and identify trends in the engagement of the first and second entities; [Para. 0279 teaches using machine learning to analyze log files with user activity records. Para. 0227 teaches providing recommendations based on stages of progress. Para. 0229 teaches collaboration includes any form of partnership between two or more entities. Para. 0256 teaches mapping unmet technological needs to identify potential relationships. Unmet technological needs are represented as nodes. Entities are associated with the nodes.]
utilizing an artificial intelligence controller to integrate external data from first entity surveys, content management system datasets, National Comprehensive Cancer Network guidelines, and medical journals; and generate recommendations and workflows based on evolving first and second entities behavior; [Para. 0232 teaches an artificial intelligence crawler extracts data from the internet. Para. 0052 teaches accessing information from a journal database. Para. 0256 teaches an evolutionary system. Para. 0260 teaches collecting external data. Para. 0227 teaches providing recommendations based on stages of progress.]
enabling the second entity to deliver trial updates and therapeutic content through a content update provider; [Para. 0279 teaches updating how the unmet technological needs are organized based on new or relevant information included in the second onboarding information.]
gathering feedback via a first entity survey module for analysis and reporting; and [Para. 0244 teaches monitoring the activity of the first entity and the second entity through reporting from the first entity and second entity or receiving feedback.]
Steenstra may not explicitly teach
securing interactions with a privacy and security module configured to encrypt data, manage permissions, and…
However, Shanks teaches the following:
securing interactions with a privacy and security module configured to encrypt data, manage permissions, and… [Para. 0004 teaches generating an encrypted log. Para. 0024 teaches users of high-level authority maintain access to logs generated upon access by the users of low-level authority.]
Motivation to combine the teaching of Shanks with the teachings of Steenstra is the same as that used with respect to claim 1 and is therefore reiterated here.
Steenstra in view of Shanks may not explicitly teach
…automate log deletion for non-disclosure agreement-protected discussions.
However, Baez teaches the following:
…automate log deletion for non-disclosure agreement-protected discussions. [Para. 0090 teaches a communication platform automatically deleting objects associated with the new deleted data retention rule after a set date. Para. 0092 teaches a user selecting particular conversations to apply to the new deleted data retention rule.]
Motivation to combine the teaching of Baez with the teachings of Steenstra and Shanks is the same as that used with respect to claim 1 and is therefore reiterated here.
REGARDING CLAIM 16
Steenstra in view of Shanks and Baez teaches the method of claim 15.
Steenstra further teaches
enabling clinicians to sort potential collaborations by geographic location of the trial sites or sponsors. [Para. 0117 teaches a requirement may be that the solution be performed in a particular geographic location.]
REGARDING CLAIM 17
Steenstra in view of Shanks and Baez teaches the method of claim 15.
Steenstra further teaches
integrating external electronic health records into the virtual platform for data sharing. [Para. 0079 teaches extracting data from medical records.]
REGARDING CLAIM 18
Steenstra in view of Shanks and Baez teaches the method of claim 15.
Steenstra further teaches
enabling clinicians to receive real-time alerts for updates matching their first entity interests. [Para. 0067 teaches alerts. Para. 0163 teaches users receiving updates.]
REGARDING CLAIM 19
Steenstra in view of Shanks and Baez teaches the method of claim 15.
Steenstra further teaches
enabling the second entity to access engagement metrics, including response rates and message open rates, for optimizing communication strategies. [Para. 0068 teaches behavior classification indicating a behavioral response by a user. For example, the behavioral classification may indicate that the text was exposed to the user for a specified duration and was ignored by the user, or similar behavioral classifications that may indicate a behavioral response by the user.]
REGARDING CLAIM 20
Claim 20 is analogous to claim 15 and is therefore rejected in a manner consistent with that of the rejection for claim 15.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Steenstra in view of Shanks, Baez, and Moore (U.S. 2007/0106753).
REGARDING CLAIM 12
Steenstra in view of Shanks and Baez teaches the system of claim 1.
Steenstra in view of Shanks and Baez may not explicitly teach
the first entity portal provides a dashboard displaying trial recommendations, recent communications, and upcoming collaboration opportunities.
However, Moore teaches the following:
the first entity portal provides a dashboard displaying trial recommendations, recent communications, and upcoming collaboration opportunities. [Moore teaches a dashboard for viewing health care data pools. Para. 0190 teaches a security service provides for secure communications among users. An authentication service receiving user credentials. Para. 0335 teaches an institution engaged in a high-volume cardiology practice is able to subscribe to syndicated data feeds for particular research journals, organizations, and the like, and receive regular updates on new clinical findings and recommendations.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the computer-implemented method of Steenstra in view of Shanks and Baez to provide a dashboard as taught by Moore, with the motivation of enabling more efficient and effective communications about research endeavors (see Moore at Para. 0629).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Verstraete et al. (U.S. 2023/0124321) which discloses a system for training a machine learning model to predict performance of a clinical trial facilitator.
DeMeyer et al. (U.S. 2020/0357088) which discloses a system and method of compartmentalizing some or all aspects of clinical trial data acquisition and management.
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/CAMRYN B LEWIS/
Examiner, Art Unit 3683
/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683
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