DETAILED ACTION
Notices to Applicant
This communication is a Non-Final Office Action on the merits. Claims 1, 5-17, and 21-33 as filed 012/18/2025, are currently pending and have been considered below.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/18/2025 has been entered.
Priority
This application claims the benefit of U.S. Provisional Application No. 63/048,375, and filed 07/06/2020, and U.S. Provisional Application No. 63/198,657, filed 11/02/2020.
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, 5-17, and 21-33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Claims 1 and 5-16 are drawn to a method for managing clinical studies, which is within the four statutory categories (i.e. method).
Independent Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1 recites:
A method comprising: defining, by processing circuitry, a data model comprising metadata that specifies a data standard representative of requirements for regulatory-compliant exchange of data between entities,
wherein the data model includes one or more client objects, each client object specifying a sequence of a plurality of gates for a process of a clinical research study protocol,
wherein each gate of the plurality of gates defines one or more conditions for completion of the gate and at least one of the one or more conditions is shared by two or more of the plurality of gates;
expressing, by the processing circuitry, the data model to define the clinical research study protocol;
outputting, by the processing circuitry, an indication that the process of the clinical research study protocol is at a first gate of the sequence of the plurality of gates;
determining, by the processing circuitry, that one or more conditions of the first gate are satisfied,
wherein determining that one or more conditions of the first gate are satisfied comprises:
receiving, via a user interface application executed by the processing circuitry and from one or more first users, data associated with the first gate;
displaying, via the user interface application and to one or more second users, the data associated with the first gate;
receiving, via the user interface application and from the one or more second users, an indication that the one or more conditions of the first gate are satisfied, including the at least one of the one or more conditions that are shared by the two or more of the plurality of gates;
transmitting, by the user interface application and to a microservice executed by the processing circuitry, the indication that the one or more conditions of the first gate are satisfied, wherein transmitting, by the user interface application and to the microservice, the indication that the one or more conditions of the first gate are satisfied comprises transmitting, by the user interface application and according to a guaranteed messaging protocol, the indication that the one or more conditions of the gate are satisfied;
processing, by the microservice, the indication that the one or more conditions of the first gate are satisfied, to identify one of the two or more gates that share the at least one of the one or more conditions;
transmitting, by the microservice and to the user interface application, an indication that the at least one of the one or more conditions of the one of the two or more gates is satisfied;
determining, by the processing circuitry and in response to determining that each of the one or more conditions of the first gate are satisfied, that the first gate is completed,
wherein determining, in response to determining that each of the one or more conditions of the first gate are satisfied, that the first gate is completed comprises:
determining, by the microservice and in response to the indication from the user interface application that the one or more conditions of the first gate are satisfied, that the first gate is completed wherein the microservice manages a state machine for the first gate comprising an in-progress state, a ready-for-review state, and an approved state, and automatically transitions the first gate from the in-progress state to the ready-for-review state only upon receiving the indication that the one or more conditions are satisfied; and
only after determining that the first gate is completed, outputting an indication that the clinical research study protocol is at a second gate of the sequence of the plurality of gates subsequent to the first gate.
The above limitations, as drafted, is a method that, under its broadest reasonable interpretation, covers performance of the limitations through managing personal behavior or interactions between people through following rules or instructions but for the recitation of generic computer components. That is, other than reciting the above bolded elements (such as “by processing circuitry,” “a user interface application,” “a microservice,” and “a state machine,”) nothing in the claim elements precludes the steps from managing personal behavior or interactions between people through following rules or instructions. For example, but for the above bolded language, defining a data model through metadata specifying a data standard representative for data exchange and client objects specifying a sequence of a plurality of gates each with specified conditions for completion for a process of a clinical research study protocol, expressing the data model to define the clinical research study protocol, outputting an indication that the process of the clinical study protocol is at a first gate of the sequence of the plurality of gates, determining that one or more conditions of the first gate are satisfied by receiving data associated with the first gate and an indication that the one or more conditions of the first gate are satisfied including the at least one or the one or more conditions that are shared by the two or more of the plurality of gates, analyzing the indications that the one or more conditions of the first gate are satisfied to identify one of the two or more gates that share the at least one of the one or more conditions, determining that the first gate is completed by analyzing in response to determining that each of the one or more conditions of the first ate are satisfied based on an indication that the one or more conditions of the first gate are satisfied, and outputting an indication that the clinical research study protocol is at a second gate of the sequence of the plurality gates subsequent to the first gate after determining that the first gate is completed and automatically transitioning the first gate from the in-progress state to the ready-for-review state in the context of this claim encompasses the management of clinical research study protocol. If a claim limitation, under its broadest reasonable interpretation, covers performance managing personal behavior or interactions between people through following rules or instructions but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Further, but for the above bolded limitations, the claim recites limitations that cover performance of the limitation in the mind but for the recitation of generic computer components, such then it falls within the “Mental Processes” grouping of abstract ideas (e.g. “determine that the one or more conditions of the first gate are satisfied,” processing … the indication that the one or more conditions of the first gate are satisfied, to identify one of the two or more gates that share the at least one of the one or more conditions; determine … in response to the indication … that the one or more conditions of the first gate are satisfied, that the first gate is completed,”). Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites the above bolded additional elements such as using “by processing circuitry,” “a user interface application,” “a microservice,” and “a state machine,”) to perform the above claim limitations. The elements in each of these steps are recited at a high-level of generality (i.e., processing circuitry such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, a user interface application such as a graphical user interface application, and microservice user interface applications as they relate to a general purpose computers (Application Specification [0049], [0092], [0203])). As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea. See MPEP 2106.05(f). Further, the steps of “transmitting, by the user interface application and to a microservice executed by the processing circuity” and vice versa, including the “transmitting according to a guaranteed messaging protocol” amount to extra-solution activity as mere data gathering using generic computer components. See MPEP 2106.05(f),(g). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does 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 above bolded additional elements, such as “by processing circuitry,” “a user interface application,” “a microservice,” and “a state machine,”) recited to perform the claim limitations amount to no more than mere instructions to apply the exception using a generic computer component. (i.e., processing circuitry such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, a user interface application such as a graphical user interface application, and microservice user interface applications as they relate to a general purpose computers (Application Specification [0049], [0092], [0203])). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See MPEP 2106.05(f). Further, the steps of “transmitting, by the user interface application and to a microservice executed by the processing circuity” and vice versa, including the “transmitting according to a guaranteed messaging protocol” amount to well-understood, routine, and conventional activity using generic computer components to send and receive data over a network. See MPEP 2106.05(f),(d). Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network). The claim is not patent eligible.
Dependent claims 5-16 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the clinical research study data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond the observation, evaluations, judgment, and/or opinion of clinical research study data. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore the dependent claims are rejected under 35 U.S.C. § 101.
Claims 17 and 21-32 are drawn to a computing device for managing clinical studies, which is within the four statutory categories (i.e. machine).
Independent Claim 17 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 17 recites:
A computing device comprising: one or more processors configured to:
define, by processing circuitry, a data model comprising metadata that specifies a data standard representative of requirements for regulatory-compliant exchange of data between entities,
wherein the data model includes one or more client objects, each client object specifying a sequence of a plurality of gates for a process of a clinical research study protocol,
wherein each gate of the plurality of gates defines one or more conditions for completion of the gate and at least one of the one or more conditions is shared by two or more of the plurality of gates;
express the data model to define the clinical research study protocol;
output an indication that the process of the clinical research study protocol is at a first gate of the sequence of the plurality of gates;
determine that the one or more conditions of the first gate are satisfied
wherein the one or more processors are configured, when determining that one or more conditions of the first gate are satisfied, to:
receive, via a user interface application and from one or more first users, data associated with the first gate;
display, via the user interface application and to one or more second users, the data associated with the first gate;
receive, via the user interface application and from the one or more second users, an indication that the one or more conditions of the first gate are satisfied, including the at least one of the one or more conditions that are shared by the two or more of the plurality of gates; and
transmit, by the user interface application and to a microservice executed by the processing circuitry, the indication that the one or more conditions of the first gate are satisfied, wherein the one or more processors are configured, when transmitting, by the user interface application and to the microservice, the indication that the one or more conditions of the first gate are satisfied, to transmit, by the user interface application and according to a guaranteed messaging protocol, the indication that the one or more conditions of the gate are satisfied; and
processing, by the microservice, the indication that the one or more conditions of the first gate are satisfied, to identify one of the two or more gates that share the at least one of the one or more conditions;
transmitting, by the microservice and to the user interface application, an indication that the at least one of the one or more conditions of the one of the two or more gates is satisfied;
only after determining that the first gate is completed, output an indication that the clinical research study protocol is at a second gate of the sequence of the plurality of gates subsequent to the first gate; and
determining, in response to determining that each of the one or more conditions of the first gate are satisfied, that the first gate is completed,
wherein the processing circuitry is, when determining that the first gate is completed, configured to:
determine, by the microservice and in response to the indication from the user interface application that the one or more conditions of the first gate are satisfied, that the first gate is completed wherein the microservice manages a state machine for the first gate comprising an in-progress state, a ready-for-review state, and an approved state, and automatically transitions the first gate from the in-progress state to the ready-for-review state only upon receiving the indication that the one or more conditions are satisfied; and
a memory configured to store the data model.
The above limitations, as drafted, is a machine that, under its broadest reasonable interpretation, covers performance of the limitations through managing personal behavior or interactions between people through following rules or instructions but for the recitation of generic computer components. That is, other than reciting the above bolded elements (such as “a computing device,” “one or more processors,” “processing circuitry,” “a user interface application,” “a microservice,” “a state machine,” and “a memory,”) nothing in the claim elements precludes the steps from managing personal behavior or interactions between people through following rules or instructions. For example, but for the “a computing device,” “one or more processors,” “processing circuitry,” “a user interface application,” “a microservice,” “a state machine,” and “a memory,” language, defining a data model through metadata specifying a data standard representative for data exchange and client objects specifying a sequence of a plurality of gates each with specified conditions for completion for a process of a clinical research study protocol, expressing the data model to define the clinical research study protocol, outputting an indication that the process of the clinical study protocol is at a first gate of the sequence of the plurality of gates, determining that one or more conditions of the first gate are satisfied by receiving data associated with the first gate and an indication that the one or more conditions of the first gate are satisfied including the at least one or the one or more conditions that are shared by the two or more of the plurality of gates, analyzing the indications that the one or more conditions of the first gate are satisfied to identify one of the two or more gates that share the at least one of the one or more conditions, and determining that the first gate is completed by analyzing in response to determining that each of the one or more conditions of the first ate are satisfied based on an indication that the one or more conditions of the first gate are satisfied and automatically transitioning the first gate from the in-progress state to the ready-for-review state in the context of this claim encompasses the management of clinical research study protocol. If a claim limitation, under its broadest reasonable interpretation, covers performance managing personal behavior or interactions between people through following rules or instructions but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Further, but for the above bolded limitations, the claim recites limitations that cover performance of the limitation in the mind but for the recitation of generic computer components, such then it falls within the “Mental Processes” grouping of abstract ideas (e.g. “determine that the one or more conditions of the first gate are satisfied,” processing … the indication that the one or more conditions of the first gate are satisfied, to identify one of the two or more gates that share the at least one of the one or more conditions; determine … in response to the indication … that the one or more conditions of the first gate are satisfied, that the first gate is completed,”). Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites the above bolded additional elements, such as “a computing device,” “one or more processors,” “processing circuitry,” “a user interface application,” “a microservice,” “a state machine,” and “a memory,” to perform the claim limitations. The elements in each of these steps are recited at a high-level of generality (i.e., computing device, one or more processors such as microprocessors, processing circuitry such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, and memory such as RAM, ROM, etc. a user interface application such as a graphical user interface application, and microservice user interface applications as they relate to a general purpose computer components (Application Specification [0049], [0089], [0092], [0203], [0348])). As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea. See MPEP 2106.05(f). Further, the steps of “transmitting, by the user interface application and to a microservice executed by the processing circuity” and vice versa, including the “transmitting according to a guaranteed messaging protocol” amount to extra-solution activity as mere data gathering using generic computer components. See MPEP 2106.05(f),(g). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does 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 above bolded additional elements, such as using ““a computing device,” “one or more processors,” “processing circuitry,” “a user interface application,” “a microservice,” “a state machine,” and “a memory,” to perform the claim limitations amounts to no more than mere instructions to apply the exception using a generic computer component(i.e., computing device, one or more processors such as microprocessors, processing circuitry such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, and memory such as RAM, ROM, etc. a user interface application such as a graphical user interface application, and microservice user interface applications as they relate to a general purpose computers as they relate to a general purpose computers (Application Specification [0049], [0089], [0092], [0203], [0348])). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See MPEP 2106.05(f). Further, the steps of “transmitting, by the user interface application and to a microservice executed by the processing circuity” and vice versa, including the “transmitting according to a guaranteed messaging protocol” amount to well-understood, routine, and conventional activity using generic computer components to send and receive data over a network. See MPEP 2106.05(f),(d). Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network). The claim is not patent eligible.
Dependent claims 17 and 21-32 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the clinical research study data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond the observation, evaluations, judgment, and/or opinion of clinical research study data. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore the dependent claims are rejected under 35 U.S.C. § 101.
Claim 33 is drawn to a non-transitory computer-readable medium for managing clinical studies, which is within the four statutory categories (i.e. manufacture).
Independent Claim 33 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 33 recites:
A non-transitory, computer-readable medium comprising instructions that, when executed, are configured to cause processing circuitry to:
define a data model comprising metadata that specifies a data standard representative of requirements for regulatory-compliant exchange of data between entities,
wherein the data model includes one or more client objects, each client object specifying a sequence of a plurality of gates for a process of a clinical research study protocol,
wherein each gate of the plurality of gates defines one or more conditions for completion of the gate and at least one of the one or more conditions is shared by two or more of the plurality of gates;
express the data model to define the clinical research study protocol
output an indication that the process of the clinical research study protocol is at a first gate of the sequence of the plurality of gates;
determine that one or more conditions of the first gate are satisfied;
wherein the instruction that, when executed are configured to cause the one or more processors, when determining that one or more conditions of the first gate are satisfied, to:
receive, via a user interface application and from one or more first users, data associated with the first gate;
display, via the user interface application and to one or more second users, the data associated with the first gate;
receive, via the user interface application and from the one or more second users, an indication that the one or more conditions of the first gate are satisfied, including the at least one of the one or more conditions that are shared by the two or more of the plurality of gates; and
transmit, by the user interface application and to a microservice executed by the processing circuitry, the indication that the one or more conditions of the first gate are satisfied,
wherein the instruction that, when executed are configured to cause the one or more processors, when transmitting, by the user interface application and to the microservice, the indication that the one or more conditions of the first gate are satisfied, to transmit, by the user interface application and according to a guaranteed messaging protocol, the indication that the one or more conditions of the gate are satisfied;
processing, by the microservice, the indication that the one or more conditions of the first gate are satisfied, to identify one of the two or more gates that share the at least one of the one or more conditions;
transmitting, by the microservice and to the user interface application, an indication that the at least one of the one or more conditions of the one of the two or more gates is satisfied; and
only after determining that the first gate is completed, output an indication that the clinical research study protocol is at a second gate of the sequence of the plurality of gates subsequent to the first gate; and
determining, in response to determining that each of the one or more conditions of the first gate are satisfied, that the first gate is completed,
wherein the instruction that, when executed are configured to cause the one or more processors, when determining that the first gate is completed, to:
determine, by the microservice and in response to the indication from the user interface application that the one or more conditions of the first gate are satisfied, that the first gate is completed, wherein the microservice manages a state machine for the first gate comprising an in-progress state, a ready-for-review state, and an approved state, and automatically transitions the first gate from the in-progress state to the ready-for-review state only upon receiving the indication that the one or more conditions are satisfied;.
The above limitations, as drafted, is a manufacture that, under its broadest reasonable interpretation, covers performance of the limitations through managing personal behavior or interactions between people through following rules or instructions but for the recitation of generic computer components. That is, other than reciting the above bolded elements (such as “a non-transitory, computer-readable medium,” “processing circuitry,” “a user interface application,” and “a microservice,”) nothing in the claim elements precludes the steps from managing personal behavior or interactions between people through following rules or instructions. For example, but for the “a non-transitory, computer-readable medium,” “processing circuitry,” “a user interface application,” “a microservice,” and “a state machine,” language, defining a data model through metadata specifying a data standard representative for data exchange and client objects specifying a sequence of a plurality of gates each with specified conditions for completion for a process of a clinical research study protocol, expressing the data model to define the clinical research study protocol, outputting an indication that the process of the clinical study protocol is at a first gate of the sequence of the plurality of gates, determining that one or more conditions of the first gate are satisfied by receiving data associated with the first gate and an indication that the one or more conditions of the first gate are satisfied including the at least one or the one or more conditions that are shared by the two or more of the plurality of gates, analyzing the indications that the one or more conditions of the first gate are satisfied to identify one of the two or more gates that share the at least one of the one or more conditions, and determining that the first gate is completed by analyzing in response to determining that each of the one or more conditions of the first ate are satisfied based on an indication that the one or more conditions of the first gate are satisfied and automatically transitioning the first gate from the in-progress state to the ready-for-review state in the context of this claim encompasses the management of clinical research study protocol. If a claim limitation, under its broadest reasonable interpretation, covers performance managing personal behavior or interactions between people through following rules or instructions but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Further, but for the above bolded limitations, the claim recites limitations that cover performance of the limitation in the mind but for the recitation of generic computer components, such then it falls within the “Mental Processes” grouping of abstract ideas (e.g. “determine that the one or more conditions of the first gate are satisfied,” processing … the indication that the one or more conditions of the first gate are satisfied, to identify one of the two or more gates that share the at least one of the one or more conditions; determine … in response to the indication … that the one or more conditions of the first gate are satisfied, that the first gate is completed,”). Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites the above bolded additional elements such as using “a non-transitory, computer-readable medium,” “processing circuitry,” “a microservice,” and “a state machine,” to perform the claim limitations. The elements in each of these steps are recited at a high-level of generality (i.e., non-transitory computer readable medium comprising processing circuitry such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, a user interface application such as a graphical user interface application, and microservice user interface applications as they relate to a general purpose computers as they relate to a general purpose computers (Application Specification [0049], [0089], [0092], [0203], [0331])). As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea. See MPEP 2106.05(f). Further, the steps of “transmitting, by the user interface application and to a microservice executed by the processing circuity” and vice versa, including the “transmitting according to a guaranteed messaging protocol” amount to extra-solution activity as mere data gathering using generic computer components. See MPEP 2106.05(f),(g). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does 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 above bolded additional elements such as using “a non-transitory, computer-readable medium,” “processing circuitry,” “a user interface application,” “a microservice,” and “a state machine,” to perform the collecting, analyzing, and displaying limitations amounts to no more than mere instructions to apply the exception using a generic computer component. (i.e., non-transitory computer readable medium comprising processing circuitry such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, a user interface application such as a graphical user interface application, and microservice user interface applications as they relate to a general purpose computers as they relate to a general purpose computers (Application Specification [0049], [0089], [0092], [0203], [0331])). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See MPEP 2106.05(f). Further, the steps of “transmitting, by the user interface application and to a microservice executed by the processing circuity” and vice versa, including the “transmitting according to a guaranteed messaging protocol” amount to well-understood, routine, and conventional activity using generic computer components to send and receive data over a network. See MPEP 2106.05(f),(d). Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network). The claim is not patent eligible.
Response to Arguments
Applicant's arguments filed 12/18/2025 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed herein below in the order in which they appear in the response filed on 12/18/2025.
In the remarks, Applicant argues in substance that:
Regarding the 101 rejection of claims 1, 5-17, and 21-33, Applicant argues the claims recite an improvement to technology such that the claim recites an integration into a practical application and recite significantly more than the abstract idea.
In response to Applicant’s argument that (a) regarding the 101 rejection of claims 1, 5-17, and 21-33, Examiner respectfully disagrees.
Applicant argues that the claims recite an improvement to technology such that the claim recites an integration into a practical application. In particular, Applicant argues that implementing a microservice-managed state machine is a specific computing structure, not a mental process such that is a technical improvement. Examiner respectfully disagrees. That is, the present application specification does not provide any particular hardware/computer structure for “a state machine,” and, under broadest reasonable interpretation, a “state machine” is a software model based for representing the state of a system based on inputs. In this case, the instant claims recite “the microservice manages a state machine for the first gate comprising an in-progress state, a ready-for-review state, and an approved state, and automatically transitions the first gate from the in-progress state to the ready-for-review state only upon receiving the indication that the one or more conditions are satisfied” such that the step applies generic computer components of the microservice managing a software model for representing the state of the first gate of the clinical study protocol based on conditions being met. This is an instruction steps are performed by application of generic computer components to performing the claimed analysis. See MPEP 2106.05(f).
Applicant further argues that the claims are directed to significantly more than the abstract idea through the additional elements of a user interface application that captures data, a guaranteed messaging protocol, and a microservice managing a state machine. Examiner respectfully disagrees. The additional elements of this claim, e.g. the user interface a microservice to manage a state machine, under broadest reasonable interpretation as a software model for representing the state of a system based on conditions, are recited using a generic computer components applied as a tool to perform the steps of the abstract idea. See MPEP 2106.05(f). Further, the steps of “transmitting, by the user interface application and to a microservice executed by the processing circuity” and vice versa, including the “transmitting according to a guaranteed messaging protocol” amount to extra-solution activity as mere data gathering using generic computer components. See MPEP 2106.05(f),(g). The claims do not recite the guaranteed messaging protocol in any particular manner, type, or improvement thereof outside of a high-level application to “transmit” data. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network). The claim is not patent eligible. Accordingly, the additional elements of the claim do not integrate the abstract idea identified in the claims into a practical application as they do not recite an improvement to technology itself, but are directed to an alleged improvement to the abstract idea of clinical study design protocols.
Accordingly, Examiner respectfully maintains the 101 rejection of claims 1, 5-17, and 21-33 as applied in the above Office Action in light of the amendments to the claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
W.O. 2011/135456 A2 teaches a clinical trial module may be designed or built to perform one or more of the following: (i) design a clinical study, (ii) recruit patients for the study, (iii) execute the study, and (iv) refine or modify the study based on results from the study; The clinical trial module may include any module, script, program, agent, state machine, component or set of executable instructions executing on one or more machines or servers (Pg. 34);
U.S. Patent Application Pub. No. 2017/035778 A1 teaches a clinical trial data management system (Abstract);
U.S. Patent Application Pub. No. 2012/0035954 A1 teaches selecting cohorts for a clinical trial (Abstract);
U.S. Patent Application Pub. No. 2009/0313048 A1 (hereinafter “Kahn et al.”) teaches clinical trial protocol design (Abstract);
U.S. Patent Application Pub. No. 2005/0256380 A1 teaches receiving patient information for a patient is a candidate for a study (Abstract);
U.S. Patent Application Pub. No. 2014/0222444 A1 teaches a system that can receive a user input selecting a particular workflow for which the user has been authorized i.e. dynamically configured properties such as a section locking element ([0053]);
U.S. Patent Application Pub. No. 2012/0101838 A1 teaches systems and processes for managing and supporting clinical trials and clinical trial operations (Abstract); and
U.S. Patent Application Pub. No. 2014/0039921 A1 teaches tools for assisting in the design of clinical trial protocols ([0019]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.M.B./Examiner, Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682