10/DETAILED ACTION
Notice to Applicant
The present application is being examined under the pre-AIA first to invent provisions.
This communication is in response to the amendment filed 11/10/25. Claims 1-23 are pending.
Claim Objections
Claim 23 is objected to because of the following informalities: the term “said generate steps” should be “said generated steps.” Appropriate correction is required.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-6, and 12-17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Michelson et al (US 20080133270 A1) in view of Pierce et al (US 20080256128 A1), and in further view of Thangaraj et al (US 20030208378 A1)
Claim 1 Michelson teaches a method for implementing multiple 2portals in a common, constructed centralized clinical trials communications website system, the method comprising the steps of:
executing code by one or more processor of the website system to perform operations (par. 81-82) comprising:
4 6implementing a clinical document exchange portal of the centralized, clinical 7trials communications system with a content management web farm to 8process collaborative clinical trials software to provide central 9administration of clinical trials (par. 9; par. 81- 82, 84- promotes exchange of information among clinical study sponsors, clinical study investigators, and clinical study subjects; par. 111-document exchange); and
10configuring the centralized, clinical trials communications website system with 11multiple servers to store and execute collaborative trial system software, 12collaboration portal software, workflow software, and extranet access 13control software (par. 9: An extranet is coupled to the investigator database and the subject database. The extranet permits the secure exchange between sponsors and investigators of documents required prior to the start of a clinical study. The forum also optionally includes one or more web pages that provide information describing clinical studies to potential clinical study subjects and permit potential clinical study subjects to register for inclusion in the subject database; par. 81- 82: Computer systems 101 and 102, and other computers that interface with network 103, may also be such workstations or servers, or may comprise any type of commercially available personal computers capable of communicating over a computer network.; par. 89-important part of system 100 is its incorporation of an extranet to facilitate secure collaborations between a clinical study sponsor (or its designees) and its investigator(s) during the process leading up to the start of a clinical study); and
14generating in the constructed centralized, clinical communications website system (Fig. 1B, par. 82: a block diagram of an integrated online system 100 that promotes exchange of information among clinical study sponsors, clinical study investigators, and clinical study subjects):
clinical trial websites for each clinical trial providing authorized access to perform second communication functions to exchange clinical trial documents with an administrator portal and each clinical trial web site having separate files for storing data supporting the associated clinical trial (par. 9- The forum also optionally includes one or more web pages that provide information describing clinical studies to potential clinical study subjects and permit potential clinical study subjects to register for inclusion in the subject database; par.95-Search clinical studies web page 600 allows the user to search for clinical studies relating to the therapeutic area identified in search area 501; See also the subject site, par. 93-94-subject submits information to register for eligible studies and which allows the sponsors to obtain info. on possible clinical trial participants)
15the administrator portal, communicatively coupled to the clinical
trial websites, and configured to provide management functions to manage at least one clinical trial website and first communication functions to exchange clinical trial documents with said clinical trial website utilizing the content management
software (par. 64-clinical sponsor is interpreted as the administrator; par. 89- extranet allows for the exchange of information…several documents … will in most instances be exchanged between the sponsor and the investigator. The present invention provides a secure environment for these communications, as well as functionality that manages and tracks the documents needed to start the clinical study... this functionality is achieved by allocating individual workspaces to sponsors and investigators within the professional site; par. 108-sponsor access to investigator, subject data and clinical trial study documents)20; and ,
28an investigator portal communicatively coupled to the clinical trial
websites, configured to upload documents, (par. 82-The clinical study sponsors, investigators and subjects may access system 100 using computers such as computers 101, 102; par. 85- the investigator database includes data about the clinical study investigators who wish to inform clinical study sponsors of their clinical study experience and/or training, submitted by the investigators themselves. This self-reported data is typically entered into the investigator database…when a given investigator logs onto the professional site, and registers with the system as described further with reference to FIGS. 7A through 7C; par. 89- exchange of documents: several documents (e.g., an investigator questionnaire, answers to the investigator questionnaire, a confidentiality agreement, a contract, a budget, an FDA form 1572, IRB documents, the study protocol, etc.) will in most instances be exchanged between the sponsor and the investigator); said - 2 of 14-A/N: 13/081,818documents related to a clinical trial and said documents being stored in the separate 32files of the associated clinical trial website, (par. 15- A data record is stored for each investigator …includes information corresponding to the history of laboratory procedure requests made by the investigator. The database also optionally stores information that associates each of the laboratory procedure requests with one or more disease conditions; par. 86-documentation of investigator prescription writing history and lab requests, par. 89), wherein the 34investigator portal includes functionality to monitor through said 35investigator portal activities and communications related to the clinical 36trial; (par. 89-A given sponsor or investigator is then able to receive, send, and track documents from within his or her workspace)
Claim 1 further recites:
in a clinical collaboration portal, representing each of the clinical trial websites, the administrator portal, and the investigator portal as an entity in a data model, wherein: the logical data model organizes the entities and relationships between entities; each entity has properties in the data model that at least describe or identify the entity; each instance of an entity is uniquely identified with a primary key;
the data model includes links between a primary key of each entity and a foreign key linked to at least one other entity.
Michelson does not disclose, but Pierce teaches
in a clinical collaboration portal, representing each of the clinical trial websites, the administrator portal, and the investigator portal as an entity in a data model, (par. 37- data models; par. 50-52 study configuration ODM; par. 93-94) wherein:
the data model organizes the entities and relationships between entities (par. 50-52: study/ protocol configuration: this tool may support importing Operational Data Modeling (ODM) v1.2.1 schemas which define the study model; par. 93-94);
each entity has properties in the data model that at least describe or identify the entity (par. 50-52: study/ protocol configuration: this tool may support importing Operational Data Modeling (ODM) v1.2.1 schemas which define the study model; par. 93-94);
each instance of an entity is uniquely identified with a primary key (fig. 2a-d; par. 36-37; par. 50-52);
the data model includes links between a primary key of each entity and a foreign key linked to at least one other entity (Figs 2a-d; par. 36-37; par. 50-52).
At the time of filing, it would have been obvious to one of ordinary skill in the art to modify the system Michaelson with the teachings of Pierce to establish/implement a clinical study data model with the motivation of supporting industry standards (par. 50) and facilitating secured document management in clinical trials. (Pierce: par. 3, and 6-7)
Claim 1 has been amended to recite: wherein the clinical trial websites, the administrator portal, the investigator portal, and the clinical collaboration portal all comprise separate websites.
Michaelson and Pierce in combination disclose a clinical trial system for clinical trial management for the input and exchange of information regarding clinical trial management, including clinical trial websites, the administrator portal, and the investigator portal. It is unclear from the Michaelson and Pierce references that the clinical trial websites, the administrator portal, the investigator portal, and the clinical collaboration portal all comprise separate websites.
Thangaraj discloses a system/method an internet-based clinical trial management system, including a clinical trial portal (par. 69-70: Clinical trial portal 45 provides such an environment in which users use a common interface to perform their tasks) and including multiple individualized interfaces based on a user’s role (teaches wherein the clinical trial websites, the administrator portal, the investigator portal, and the clinical collaboration portal all comprise separate websites. The Examiner is interpreting the individualized internet user interfaces as websites--par. 70-73: par. 70- Depending on the user and his or her access, the system reconfigures the internet interfaces to suite the use and the job at hand. The user is also given the freedom to manipulate and customize the system interfaces to make the experience personalized… par. 72- FIG. 2, clinical trial portal 45 presents each user with an initial portal screen 50 having areas that correspond to the functions (F) that the user is permitted to access, based on that user's defined role in the clinical trial (e.g., patient, site manager, etc.). For example, if there are six functions (F1-F6), and a user is only permitted access to functions 1-5, that user's initial portal screen 50 might look like that shown in FIG. 2.)
At the time of filing, it would have been obvious to one of ordinary skill in the art to modify the system/method of Michaelson and Pierce in combination with the teaching of Thangaraj to provide multiple websites for various roles in the clinical trial management process. One would have been motivated to include this feature to provide a base of users that participate in the clinical trial with a comprehensive clinical trial solution that enables each user to enter, retrieve, and manage data, as well as obtain the products of data processing according to that user's role in the clinical trial and to provide the user base with access to ancillary services useful in conducting the clinical trial because it is Internet-based. (Thangaraj: par. 16)
Claim 2 Michelson teaches method as in claim 1, the administrator portal further listing a plurality of clinical investigators and enabling communication of an invitation to the clinical investigator portal to participate in a clinical trial. (par. 89-sponsor can contact/engage with selected investigator and exchange documents needed to start a clinical trial; par. 110-web page that shows the results of an investigator search in accordance with the present invention is shown in FIG. 11. As shown in that figure, for each investigator identified in the search, the sponsor is shown the name of the investigator, the investigator's specialty, the city/state in which the investigator is located)
Claim 3. Michelson teaches a method as in claim 1, the administrator portal further enabling creation of a clinical trial master file, based on a template, for an associated clinical trial website for customization. (par. 111-This extranet preferably includes document templates that allow sponsors (and/or investigators) to quickly generate documents relevant to the launch of a clinical study….These documents are preferably created using standard templates found in the workspace on the professional site associated with each sponsor or investigator)
Claim 4. Michelson teaches a method as in claim 1, the investigator portal further listing a plurality of clinical trials and enabling communication of interest in participating in a particular clinical trial to said administrator. (par. 100- investigators can register with system to make sponsors aware of their interest in a clinical trial; Figs. 21 and par. 126-system identifies investigators available for a clinical study using the database information of registered investigators)
Claim 5 Michelson teaches a method as in claim 1, the investigator portal
further enabling defining a personal profile for access by said administrator. (par. 100-investigator registers with system and creates a profile for matching with clinical trials; par. 108-the sponsor determines whether the sponsor desires to use the investigator database to perform investigator recruitment for the study; par. 111-In step 822, the sponsor selects one or more investigators for the clinical study, and in step 823 begins the process of engaging the investigator(s) for the study)
claim 6 Michelson teaches a method as in claim 1, the investigator portal
further enabling defining a site profile for access by said administrator. (par. 100-investigator registers with system and creates a profile for matching with clinical trials; par. 108-the sponsor determines whether the sponsor desires to use the investigator database to perform investigator recruitment for the study; par. 111-In step 822, the sponsor selects one or more investigators for the clinical study, and in step 823 begins the process of engaging the investigator(s) for the study)
Claim 12. Michelson teaches a system for constructing and implementing multiple portals in a common, clinical trials communications website system for administering clinical trials, the system comprising:
at least one processor and at least one memory storing instructions (par. that when executed by said at least one processor (par. 81-82: Computer system 100..may be any of a number of commercially available computer systems, including a conventional server or workstation. Such systems may include… one or more microprocessors, computer memory…Computer systems 101 and 102, and other computers that interface with network 103, may also be such workstations or servers, or may comprise any type of commercially available personal computers capable of communicating over a computer network) cause said at least one processor to:
implement a clinical document exchange portal of the centralized, clinical trials communications website system with a content management web farm to process collaborative clinical trials software to provide central administration of clinical trials (par. 9; par. 81- 82, 84- promotes exchange of information among clinical study sponsors, clinical study investigators, and clinical study subjects; par. 111-document exchange);
configure the centralized, clinical trials communications website system with multiple servers to store and execute collaborative trial system software, collaboration portal software, workflow software, and extranet access control software (par. 9,: An extranet is coupled to the investigator database and the subject database. The extranet permits the secure exchange between sponsors and investigators of documents required prior to the start of a clinical study. The forum also optionally includes one or more web pages that provide information describing clinical studies to potential clinical study subjects and permit potential clinical study subjects to register for inclusion in the subject database; par. 81- 82: Computer systems 101 and 102, and other computers that interface with network 103, may also be such workstations or servers, or may comprise any type of commercially available personal computers capable of communicating over a computer network.; par. 89-important part of system 100 is its incorporation of an extranet to facilitate secure collaborations between a clinical study sponsor (or its designees) and its investigator(s) during the process leading up to the start of a clinical study);
generate in a constructed centralized, clinical communications website system (fig. 1 A-B; par. 81-82: website system including a network of clinical trial parties):
clinical trial websites for each of multiple clinical trials to be administered, the clinical trial websites configured to provide authorized access to perform second communication functions to exchange clinical trial documents with an administrator portal and each clinical trial web site having separate files for storing data supporting the associated clinical trial (par. 9- The forum also optionally includes one or more web pages that provide information describing clinical studies to potential clinical study subjects and permit potential clinical study subjects to register for inclusion in the subject database; par.95-Search clinical studies web page 600 allows the user to search for clinical studies relating to the therapeutic area identified in search area 501; See also the subject site, par. 93-94-subject submits information to register for eligible studies and which allows the sponsors to obtain info. on possible clinical trial participants)
15the administrator portal, communicatively coupled to the 25clinical trial websites, to provide management 26functions to manage at least one clinical trial website and 27first communication functions to exchange clinical trial 28documents with said clinical trial website (par. 64-clinical sponsor is interpreted as the administrator; par. 89- extranet allows for the exchange of information…several documents … will in most instances be exchanged between the sponsor and the investigator. The present invention provides a secure environment for these communications, as well as functionality that manages and tracks the documents needed to start the clinical study… this functionality is achieved by allocating individual workspaces to sponsors and investigators within the professional site; par. 108-sponsor access to investigator, subject data and clinical trial study documents); 20 and ,
28 an investigator portal, communicatively coupled to the clinical trial websites, and configured to upload documents, (par. 82-The clinical study sponsors, investigators and subjects may access system 100 using computers such as computers 101, 102; par. 85- the investigator database includes data about the clinical study investigators who wish to inform clinical study sponsors of their clinical study experience and/or training, submitted by the investigators themselves. This self-reported data is typically entered into the investigator database…when a given investigator logs onto the professional site, and registers with the system as described further with reference to FIGS. 7A through 7C; par. 89- exchange of documents: several documents (e.g., an investigator questionnaire, answers to the investigator questionnaire, a confidentiality agreement, a contract, a budget, an FDA form 1572, IRB documents, the study protocol, etc.) will in most instances be exchanged between the sponsor and the investigator); said - 2 of 14-A/N: 13/081,818 documents related to a clinical trial and said documents being stored in the separate 32files of the associated clinical trial websites, (par. 15- A data record is stored for each investigator …includes information corresponding to the history of laboratory procedure requests made by the investigator. The database also optionally stores information that associates each of the laboratory procedure requests with one or more disease conditions; par. 86-documentation of investigator prescription writing history and lab requests, par. 89), wherein the 34investigator portal includes functionality to monitor through said 35investigator portal activities and communications related to the clinical 36trial; (par. 89-A given sponsor or investigator is then able to receive, send, and track documents from within his or her workspace)
Claim 12 has been further amended to recite:
a clinical collaboration portal, representing each of the clinical trial websites, the administrator portal, and the investigator portal as an entity in a data model, wherein: the logical data model organizes the entities and relationships between entities; each entity has properties in the data model that at least describe or identify the entity; each instance of an entity is uniquely identified with a primary key;
the data model includes links between a primary key of each entity and a foreign key linked to at least one other entity.
Michelson does not disclose, but Pierce teaches
in a clinical collaboration portal, representing each of the clinical trial websites, the administrator portal, and the investigator portal as an entity in a data model, (par. 37- data models; par. 50-52 study configuration ODM; par. 93-94)) wherein:
the logical data model organizes the entities and relationships between entities (par. 50-52: study/ protocol configuration: this tool may support importing Operational Data Modeling (ODM) v1.2.1 schemas which define the study model; par. 93-94);
each entity has properties in the data model that at least describe or identify the entity (par. 50-52: study/ protocol configuration: this tool may support importing Operational Data Modeling (ODM) v1.2.1 schemas which define the study model; par. 93-94);
each instance of an entity is uniquely identified with a primary key (fig. 2a-d; par. 36-37; par. 50-52);
the data model includes links between a primary key of each entity and a foreign key linked to at least one other entity (Figs 2a-d; par. 36-37; par. 50-52).
At the time of filing, it would have been obvious to one of ordinary skill in the art to modify the system of Pierce to establish/implement a clinical study data model with the motivation of supporting industry standards (par. 50) and facilitating secured document management in clinical trials. (Pierce: par. 3, and 6-7)
Claim 12 has been amended to recite: wherein the clinical trial websites, the administrator portal, the investigator portal, and the clinical collaboration portal all comprise separate websites.
Michaelson and Pierce in combination disclose a clinical trial system for clinical trial management for the input and exchange of information regarding clinical trial management, including clinical trial websites, the administrator portal, and the investigator portal. It is unclear from the Michaelson and Pierce references that the clinical trial websites, the administrator portal, the investigator portal, and the clinical collaboration portal all comprise separate websites.
Thangaraj discloses a system/method an internet-based clinical trial management system, including a clinical trial portal (par. 69-70: Clinical trial portal 45 provides such an environment in which users use a common interface to perform their tasks) and including multiple individualized interfaces based on a user’s role (teaches wherein the clinical trial websites, the administrator portal, the investigator portal, and the clinical collaboration portal all comprise separate websites. The Examiner is interpreting the individualized internet user interfaces as websites--par. 70-73: par. 70- Depending on the user and his or her access, the system reconfigures the internet interfaces to suite the use and the job at hand. The user is also given the freedom to manipulate and customize the system interfaces to make the experience personalized… par. 72- FIG. 2, clinical trial portal 45 presents each user with an initial portal screen 50 having areas that correspond to the functions (F) that the user is permitted to access, based on that user's defined role in the clinical trial (e.g., patient, site manager, etc.). For example, if there are six functions (F1-F6), and a user is only permitted access to functions 1-5, that user's initial portal screen 50 might look like that shown in FIG. 2.)
At the time of filing, it would have been obvious to one of ordinary skill in the art to modify the system/method of Michaelson and Pierce in combination with the teaching of Thangaraj to provide multiple websites for various roles in the clinical trial management process. One would have been motivated to include this feature to provide a base of users that participate in the clinical trial with a comprehensive clinical trial solution that enables each user to enter, retrieve, and manage data, as well as obtain the products of data processing according to that user's role in the clinical trial and to provide the user base with access to ancillary services useful in conducting the clinical trial because it is Internet-based. (Thangaraj: par. 16)
claim 13 Michelson teaches system as in claim 12, wherein the administrator portal lists a plurality of clinical investigators and enables communication of an invitation to the clinical investigator portal to participate in a clinical trial portal enables the clinical investigator to define a personal profile for access by said administrator. (par. 89-sponsor can contact/engage with selected investigator and exchange documents needed to start a clinical trial; par. 110-web page that shows the results of an investigator search in accordance with the present invention is shown in FIG. 11. As shown in that figure, for each investigator identified in the search, the sponsor is shown the name of the investigator, the investigator's specialty, the city/state in which the investigator is located)
claim 14. Michelson teaches a system as in claim 12, wherein the administrator portal enables creation of a clinical trial master file, based on a template, for an associated clinical trial website for customization. (par. 111-This extranet preferably includes document templates that allow sponsors (and/or investigators) to quickly generate documents relevant to the launch of a clinical study….These documents are preferably created using standard templates found in the workspace on the professional site associated with each sponsor or investigator)
Claim 15. Michelson teaches a system as in claim 12, wherein the investigator portal lists a plurality of clinical trials and enabling communication of interest in participating in a particular clinical trial to said administrator. (par. 100- investigators can register with system to make sponsors aware of their interest in a clinical trial; Figs. 21 and par. 126-system identifies investigators available for a clinical study using the database information of registered investigators)
Claim 16. Michelson teaches a system as in claim 12, wherein the investigator portal enables defining a personal profile for access by said administrator portal (par. 100-investigator registers with system and creates a profile for matching with clinical trials; par. 108-the sponsor determines whether the sponsor desires to use the investigator database to perform investigator recruitment for the study; par. 111-In step 822, the sponsor selects one or more investigators for the clinical study, and in step 823 begins the process of engaging the investigator(s) for the study)
Claim 17 Michelson teaches a system as in claim 12, wherein the investigator portal enables defining a site profile for access by said administrator portal. (par. 100-investigator registers with system and creates a profile for matching with clinical trials; par. 108-the sponsor determines whether the sponsor desires to use the investigator database to perform investigator recruitment for the study; par. 111-In step 822, the sponsor selects one or more investigators for the clinical study, and in step 823 begins the process of engaging the investigator(s) for the study)
Claims 7, 11, 18, and 22 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Michelson et al (US 20080133270 A1), Pierce et al (US 20080256128 A1), and in further view of Thangaraj et al (US 20030208378 A1) as applied to claims 1 and 12, and in further view of Finken et al (US 20160125171 A1)
claims 7 and 18 Michelson, Pierce, and Thangaraj in combination teach the method and system as in claims 1 and 12 respectively as explained in the rejections of claims 1 and 12, but do not expressly disclose enabling access product files relating to characteristics of the product being tested in the clinical trial.
Finken teaches enabling the clinical investigator to access product files relating to characteristics of the product being tested in the clinical trial (par. 62- system generates an alert and notifies participates, including investigators, of safety issues with a product being tested e.g., data that indicates an emergency symptom or action was reported. An alert may also be generated where there is a strong correlation in similar category historical studies between one or more reported data fields and a dangerous result. ) At the time of the applicant’s invention, it would have been obvious to one ordinary skill in the art to modify the system/method of Michelson, Pierce, and Thangaraj in combination with the teaching of Finken to have the investigator portal enable the clinical investigator to access product files relating to characteristics of the product being tested in the clinical trial. As suggested by Finken, one would have been motivated to include this feature to in order to analyze, assess quality control, spot inconsistency and safety issues, and make real-time adjustments as needed. (par.28)
Claims 11 and 22. Michelson, Pierce, and Thangaraj in combination teach a method and method as in claim 1 and claim 12, but do not teach communicating safety reports related to the products under investigation to said administrator.
Finken teaches communicating safety reports related to the products under investigation to said administrator portal (par. 62- system generates an alert and notifies participates, including investigators, of safety issues with a product being tested e.g., data that indicates an emergency symptom or action was reported. An alert may also be generated where there is a strong correlation in similar category historical studies between one or more reported data fields and a dangerous result.) At the time of the applicant’s invention, it would have been obvious to one ordinary skill in the art to modify the system/method Michelson, Pierce, and Thangaraj in combination with the teaching of Finken to have the investigator portal communicating safety reports related to the products under investigation between said administrator and said clinical investigator. As suggested by Finken, one would have been motivated to include this feature to in order to analyze, assess quality control, spot inconsistency and safety issues, and make real-time adjustments as needed. (par.28)
Claims 8 and 19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Michelson et al (US 20080133270 A1), Pierce et al (US 20080256128 A1), and in further view of Thangaraj et al (US 20030208378 A1) as applied to claims 1 and 12, in view of Schmidt (US 9378205 B1)
Claims 8 and 19 Michelson, Pierce, and Thangaraj in combination teach the method and system of claims 1 and 12 as explained in the rejection of claim 12, but does not teach the investigator portal further enabling the clinical investigator to index uploaded documents with identifying metadata.
Schmidt teaches a system and method for handling clinical trial documents further enabling indexing uploaded documents with identifying metadata. (col. 12, lines 21-33; See also col. 16, lines 11-24-metadata is extracted and a database index is created). At the time of applicant’s invention, it would have been obvious to one of ordinary skill in the art to modify the system and method of Michelson, Pierce, and Thangaraj in combination with the teaching of Schmidt to have the investigator portal further enable the clinical investigator to index uploaded documents with identifying metadata. As suggested by Schmidt, one would have been motivated to include this feature to provide a better system and method for managing and sharing clinical trial regulatory documents. (col. 1, lines 46-48)
Claims 9 and 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Michelson et al (US 20080133270 A1), Pierce et al (US 20080256128 A1), and in further view of Thangaraj et al (US 20030208378 A1) as applied to claims 1 and 12, in view of Miller (US 20090276463 A1)
Claims 9 and 20 Michelson, Pierce, and Thangaraj in combination disclose the method and system of claim 1 and claim 12, but do not expressly disclose the investigator portal further enabling real-time access to current versions of essential clinical trial documents.
Miller discloses a system and method in which current versions of clinical trial essential documents are accessible in real-time. (par. 19; par. 39- principals interact with one another in real-time as they view the identical original, data, at the same time, even as soon as immediately after the data are entered, and even from different locations… the investigator and the sponsor are able to view the same original data concurrently) At the time of the applicant’s invention, it would have been obvious to one of ordinary skill in the art to modify the system and method of Michelson, Pierce, and Thangaraj in combination with the teaching of Miller to have an investigator portal enable the clinical investigator to access current versions of essential documents that govern the conduct of the clinical trial in real-time. As suggested by Miller, one would have been motivated to include this feature to allow regulatory compliance, protocol compliance, or safety issues can be identified and corrected in a timely manner. (par. 39)
Claims 10, 21, and 23 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Michelson et al (US 20080133270 A1) , Pierce et al (US 20080256128 A1), and in further view of Thangaraj et al (US 20030208378 A1) as applied to claims 1 and 12, in view of Broverman et al (US 20040249664 A1)
Claims 10 and 21 Michelson, Pierce, and Thangaraj in combination teach the method and system of claims 1 and 12, but do not expressly disclose the investigator portal communicating a to-do list of required work items between said administrator portal and said investigator portal.
Broverman teaches a system and method of identifying and providing a list of tasks (i.e. to-do list) for a given clinical trial protocol (par. 121-122) At the time of the applicant’s invention, it would have been obvious to one of ordinary skill in the art to modify the system and method of Michelson, Pierce, and Thangaraj in combination, with the teaching of Broverman to identify and provide a list of tasks (i.e. to-do list) for a given clinical trial protocol to the investigator portal between said administrator and said clinical investigator. As suggested by Broverman, one would have been motivated to include this feature to assist in the operational management required to initiate, execute, and complete a clinical trial successfully within budget and time frame. (par. 7)
Claim 23 Michelson, Pierce, and Thangaraj in combination teach the system as in claim 12 as explained in the rejection of claim, but do not teach the processor further executes instructions of workflow management software that causes said generated steps to be implemented according to an order and sequence of a predetermined workflow driven by templates. Broverman teaches a system wherein the processor executes instructions of workflow management software that causes said generated steps to be implemented according to an order and sequence of a predetermined workflow driven by templates. (par. 18-The protocol design tool also can suggest specific tasks that the designer might want to include in the protocol, based on a historical database of tasks that were associated with previous clinical trial protocols; par. 104- dynamic template is a pre-programmed procedure that automatically generates complex content from iCP elements, such as a list of all tasks to be performed at any time during the study, and instantiates the content into the document instance. At the time of the applicant’s invention, it would have been obvious to one of ordinary skill in the art to modify the system/method of Michelson, Pierce, and Thangaraj in combination to execute instructions of workflow management software that causes said generated steps to be implemented according to an order and sequence of a predetermined workflow driven by templates, with the motivation of assisting in the design of clinical trial protocols in a cost-effective manner, taking advantage of knowledge built into previous protocols. (par. 18)
Response to Arguments
The Applicant's arguments filed 11/10/25 have been fully considered but they are not persuasive.
(A) Applicant argues that the Thangaraj reference does not disclose or support statement interpreting the individualized internet user interfaces as websites, and that the combination of Michaelson, Pierce and Thangaraj does not disclose generating clinical trial websites, an administrator portal, an investigator portal, and a clinical collaboration portal as required by claim 1.
In response, the Examiner respectfully disagrees. It is further noted that, the language applicant’s disclosure does not match the system as claimed, comprising: “clinical trial websites, an administrator portal, an investigator portal, and a clinical collaboration portal” as currently recited in the claim language. In particular, the Applicant’s specification explains that the generated clinical trial website is the collaboration portal (abstract, par. 5: The invention programmatically creates a secure account the clinical investigator can use to access the clinical trial website (called a collaboration portal)); the recited clinical document exchange portal is the administrator portal (Fig. 3; Fig. 1(101); par. 68: a website 101 called the Clinical Document Exchange (CDE) or administrator portal is accessed to provide access to clinical trial websites 102, 103, and 104 ).
Similarly, while Applicant argues and the claim language recites “wherein the clinical trial websites, the administrator portal, the investigator portal, and the clinical collaboration portal all comprise separate websites…,” it is unclear where this is expressly disclosed in Applicant’s originally filed disclosure. The abstract explains: “[o]nce the clinical investigator logs into the collaboration portal, he/she is able to appoint sub-investigators and additional administrative accounts for the portal. The clinical investigator also uploads essential trial documentation via the collaboration portal into the document repository that the trial sponsor set up for the clinical trial. The investigator portal also gives the principal investigator a central place to access clinical trial alerts, notifications and a to-do list.” (abstract, emphasis added) The term “portal” only means that there are “gateways” or different entry points or versions for the various users. However, these gateways may lead to the same website, not necessarily distinct websites as argued by Applicant.
In response to applicant's argument that Thangaraj does not disclose distinct websites, only different interfaces, the test for obviousness is not that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Contrary to applicant’s assertion, it is not necessary to establish inherency, as the rejection is based on obviousness.
The Thangaraj reference discloses an internet-based system that generates individual web interfaces for users based upon their different roles and the functions they are authorized to perform: “Depending on the user and his or her access, the system reconfigures the internet interfaces to suite the use and the job at hand. “ (par. 70) Thangaraj further discloses: “clinical trial portal 45 presents each user with an initial portal screen 50 having areas that correspond to the functions (F) that the user is permitted to access, based on that user's defined role in the clinical trial (e.g., patient, site manager, etc.). For example, if there are six functions (F1-F6), and a user is only permitted access to functions 1-5, that user's initial portal screen 50 might look like that shown in FIG. 2. (par. 72)… RBAC 47 (stored in data repository 49) enables the system to alter the functionality presented to the user based on, e.g., the role of the user (such as patient 14, FDA 26 etc.). For example, person 1 shown in FIG. 2 may have access only to functions F1-F4, while person 2 may utilize only functions F1, F3, F5, and F6. (par. 74)
At the time of filing, it would have been obvious to one of ordinary skill in the art to modify the system/method of Michaelson and Pierce in combination with the teaching of Thangaraj to provide multiple websites for various roles in the clinical trial management process. One would have been motivated to include this feature to provide a base of users that participate in the clinical trial with a comprehensive clinical trial solution that enables each user to enter, retrieve, and manage data, as well as obtain the products of data processing according to that user's role in the clinical trial and to provide the user base with access to ancillary services useful in conducting the clinical trial because it is Internet-based. (Thangaraj: par. 16)
(C) Applicant argues that the Thangaraj reference discloses only a ”single website ‘clinical trial portal 45’ provides all of the attributes identified in paragraphs 70-73 including the attributes identified by the Examiner. Referring to Fig. 1, it is through the clinical trial portal 45 ‘through which user base 12 interacts with clinical trial solution 42, professional services module 44, and learning center 46.’ Thus, the clinical trial portal 45 is one website.”
In response, the Examiner disagrees. Again, the term “portal” only means that there are “gateways” or different entry points or versions for the various users. However, these gateways may lead to the same website, not necessarily distinct websites as argued by Applicant.
Moreover, it is noted that applicant’s own disclosure states that “[t]he investigator accesses the clinical trial website through an investigator portal for each clinical investigator, the investigator portal enabling the clinical investigator to upload documents related to a clinical trial to the separate files of the associated clinical trial website to which the investigator is authorized to participate” (par. 6 of PG-Pub), suggesting that the investigator portal itself is not a separate website, but merely a gateway, access point, or interface for the investigator to access the clinical trial website for the functions and data relevant to their role.
(D) Applicant’s arguments regarding the additional claims are based upon the arguments for Claims 1 and 12. As such, these arguments are addressed by the response to arguments in paragraphs A-C, which are incorporated herein.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Grady et al (US 20090083703 A1)- discloses an electronic clinical system that receives protocol information from a clinical study or trial designer and automatically generates source code modules and a data model for a website used in conducting the study or trial.
Wallach et al ( US 20070250779 A1)- discloses a software and infrastructure for supporting an Internet web portal, whereby the web portal enables clinical site personnel to enter subject enrollment data that is stored in the database as it is entered (i.e., in real-time). A set of computer forms corresponding to an application enable administrative personnel to define a plurality of clinical trial parameters, including trial protocols, clinical sites, and optional regions.
Webber et al (US 20090319535 A1) discloses method and system allow sharing and integrating clinical trial operational data for easy accessibility of operational data. An administrator 150, 250 configures the shared database system 200, 300 by accessing the linked server 210 that launches the configuration user interface 960 (as shown in FIG. 14) allowing the administrator 150, 250 to select and apply configuration parameters. A user can then view operational data populated in the tables, and the linked server 210 can communicate with the shared server 110 for requesting, receiving or updating data. Any user can view and input operational data from the user interface 310 of the portal applications 320, business applications 330 through the linked server 210 or the clinical applications 350, enterprise applications 360, customized application 370, to communicate with the shared server 110 via the data connections (SEE par. 66)
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachel L Porter whose telephone number is (571)272-6775. The examiner can normally be reached M-F, 10-6:30.
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/Rachel L. Porter/Primary Examiner, Art Unit 3684