DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Claim Objection
Applicant's arguments filed 03/27/2026 have been fully considered. Applicant argues that the amendments to the claim make the objection moot and therefore the objection should be withdrawn. In response to Applicant’s argument, the arguments are persuasive, however, due to the current amendments there are new claim objections that have arisen. See the current claim objection below for further clarification.
Rejection Under 101
Applicant's arguments filed 03/27/2026 have been fully considered.
Applicant argues that the amended claims, in view of Ex Parte Desjardins, are not directed to organizing human activity or performing mental processes, but rather recite a specific computer-implemented technique for representing and transforming a workflow state using structured data models that define nodes, edges, and anchoring relationships. The claimed operations perform transformations of the structured representations based on the stored context information and branching conditions.
In response to Applicant’s argument, since the claims are directed at managing a workflow state and schedule patients in clinical trials for their visits and determine when to change their protocols, this falls under organizing human activity. The claims were not classified as a mental process. Additionally, the claims are unlike Desjardins since the claims in Desjardins represent an improvement to machine learning and as discussed, Applicant’s claims are directed at managing workflows and clinical trial protocols and thus do not provide such an improvement similar to Desjardins. Any improvements would be to the abstract idea, which is not a technical problem.
Applicant argues that the amended claims cannot be performed by the human mind.
In response to Applicant’s argument, the claim was classified as falling under organizing human activity, not a mental process.
Claim Objections
Claim 1 is objected to because of the following informalities: the amended claims recite “defined by the first projected visit path and/or adding one or more previously unscheduled visit that were not defined for the first projected visit path.” Applicant is reminded that 37 CFR 1.71(a) requires the use of "full, clear, concise and exact terms". This requirement would be better met by amending "and/or" to "or" because the claim scope would not change, but the claim language would be more concise and exact. Appropriate correction or clarification is required.
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 1-21 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.
Step 1 of the Alice/Mayo Test
Claims 1-21 are drawn to a method, which is within the four statutory categories (i.e. process).
Step 2A of the Alice/Mayo Test - Prong One
The independent claims recite an abstract idea. For example, claim 1 (and substantially similar with independent claim 8, 15, 21) recites:
A method of managing a workflow of scheduled nodes that is performed by an application executing on a computer system, the method comprising:
Instantiating, in memory, a first structured representation of a first plurality of nodes, each of which is representative of a possible visit as defined in accordance with a first protocol, that are interconnected with edges, each of which is representative of a possible path from one possible visit to another visit,
wherein the first structured representation manages a subject in a clinical trial on a first projected visit path that is representative of a first sequence of the first plurality of nodes, defines time-based anchors that establish rules for computing time relationships between the first plurality of nodes defines sequence-based anchors that establish rules for computing sequence relationships between the first plurality of nodes, defines activities to be performed when completing the first plurality of nodes, and defines a first plurality of computational branches and a first plurality of associated branching conditions;
for each workflow object of a plurality of workflow objects, determining a workflow schedule that comprises at least a subset of the first plurality of nodes to be performed in completing the workflow, wherein the application determines the workflow schedule based on
(i) a baseline time of that workflow object,
(ii) the time-based anchors between nodes in the subset defined by the first structured representation, and
(iii) the sequence-based anchors between nodes in the subset defined by the first structured representation, and
wherein each node in the subset is associated with a different one of a plurality of data structures;
presenting a list of activities to be performed when performing a node in the subset associated with a workflow path of the workflow object based on the first structured representation;
storing context information about completion of the activities performed when performing the node in a corresponding data structure of the plurality of data structures;
determining that a branching condition of the first plurality of associated branching conditions has occurred based on an analysis of the context information about completion of activities performed during visits on the first projected visit path;
in response to determining that the branching condition has occurred, placing the subject on a new visit path for the clinical trial that is different than the first projected visit path, by removing one or more previously scheduled visits that were defined by the first projected visit path and/or adding one or more previously unscheduled visit that were not defined for the first projected visit path;
in response to placing the subject on the new visit path and based on parsing the first structured representation, determining a second projected visit path for the subject using time-based anchors and sequence-based anchors of any nodes that are defined for the new visit path, wherein the second visit path is representative of a second sequence of at least some of the first plurality of nodes;
receiving input that indicates the clinical trial is being transitioned to a second protocol different than the first protocol; and
in response to receiving the input,
assigning a synchronization identity to each of the visits on the second projected visit path;
instantiating, in memory, a second structured representation of a second plurality of nodes, each of which is representative of a possible visit as defined in accordance with the second protocol, that are interconnected with edges, each of which is representative of a possible path from one possible visit to another possible visit; and
transferring the subject from the first protocol to the second protocol by adapting the second projected visit path that is determined based on the first structured representation to a third projected visit path that is determined based on the second structured representation,
wherein the third projected visit path is representative of a sequence of the second plurality of nodes, defines time- based anchors that establish rules for computing time relationships between the second plurality of nodes, defines sequence-based anchors that establish rules for computing sequence relationships between the second plurality of nodes, defines activities to be performed when completing the second plurality of nodes, and defines a second plurality of computational branches and a second plurality of associated branching conditions, and
wherein to adapt the second projected visit path to the third projected visit path,
(i) synchronization identities, if any, that are associated with visits along the third projected visit path and that are identical to visits along the second projected visit path are retained,
(ii) synchronization identities, if any, that are associated with visits along the third projected visit path and that correspond to visits along the second projected visit path but have at least modified parameter are modified,
(iii) synchronization identities, if any, that are associated with visits along the third projected visit path but that do not correspond to any visits along the second projected visit path are created, and/or
(iv) synchronization identifies, if any, that are associated with visits along the second projected visit path but that do not correspond to any visits along the third projected visit path are deleted, such that correspondence is maintained between the first and second structured representation to enable transformation of workflow state across the transition from the first protocol to the second protocol.
These underlined elements recite an abstract idea that can be categorized, under its broadest reasonable interpretation, to cover the management of personal behavior or interactions (i.e., following rules), but for the recitation of generic computer components. For example, but for an application executing on a computer system, memory, the limitations in the context of this claim encompass an automation of organizing information and following rules in order to manage a schedule workflow and schedule patients in clinical trials for their visits and determine when to change their protocols. If a claim limitation, under its broadest reasonable interpretation, covers management of personal behavior or interactions but for the recitation of generic computer components, then the limitations fall within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See MPEP § 2106.04(a).
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2-7, 9-14, and 16-20 reciting particular aspects of the abstract idea).
Step 2A of the Alice/Mayo Test - Prong Two
For example, claim 1 (and substantially similar with independent claim 8, 15, 21) recites:
A method of managing a workflow of scheduled nodes that is performed by an application executing on a computer system, (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) the method comprising:
Instantiating, in memory (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)), a first structured representation of a first plurality of nodes, each of which is representative of a possible visit as defined in accordance with a first protocol, that are interconnected with edges, each of which is representative of a possible path from one possible visit to another visit,
wherein the first structured representation manages a subject in a clinical trial on a first projected visit path that is representative of a first sequence of the first plurality of nodes, defines time-based anchors that establish rules for computing time relationships between the first plurality of nodes defines sequence-based anchors that establish rules for computing sequence relationships between the first plurality of nodes, defines activities to be performed when completing the first plurality of nodes, and defines a first plurality of computational branches and a first plurality of associated branching conditions;
for each workflow object of a plurality of workflow objects, determining a workflow schedule that comprises at least a subset of the first plurality of nodes to be performed in completing the workflow, wherein the application determines the workflow schedule based on
(i) a baseline time of that workflow object,
(ii) the time-based anchors between nodes in the subset defined by the first structured representation, and
(iii) the sequence-based anchors between nodes in the subset defined by the first structured representation, and
wherein each node in the subset is associated with a different one of a plurality of data structures;
presenting a list of activities to be performed when performing a node in the subset associated with a workflow path of the workflow object based on the first structured representation;
storing context information about completion of the activities performed when performing the node in a corresponding data structure of the plurality of data structures; (merely insignificant extrasolution activity steps as noted below, see MPEP 2106.05(g))
determining that a branching condition of the first plurality of associated branching conditions has occurred based on an analysis of the context information about completion of activities performed during visits on the first projected visit path;
in response to determining that the branching condition has occurred, placing the subject on a new visit path for the clinical trial that is different than the first projected visit path, by removing one or more previously scheduled visits that were defined by the first projected visit path and/or adding one or more previously unscheduled visit that were not defined for the first projected visit path;
in response to placing the subject on the new visit path and based on parsing the first structured representation, determining a second projected visit path for the subject using time-based anchors and sequence-based anchors of any nodes that are defined for the new visit path, wherein the second visit path is representative of a second sequence of at least some of the first plurality of nodes;
receiving input that indicates the clinical trial is being transitioned to a second protocol different than the first protocol; and
in response to receiving the input,
assigning a synchronization identity to each of the visits on the second projected visit path;
instantiating, in memory (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)), a second structured representation of a second plurality of nodes, each of which is representative of a possible visit as defined in accordance with the second protocol, that are interconnected with edges, each of which is representative of a possible path from one possible visit to another possible visit; and
transferring the subject from the first protocol to the second protocol by adapting the second projected visit path that is determined based on the first structured representation to a third projected visit path that is determined based on the second structured representation,
wherein the third projected visit path is representative of a sequence of the second plurality of nodes, defines time- based anchors that establish rules for computing time relationships between the second plurality of nodes, defines sequence-based anchors that establish rules for computing sequence relationships between the second plurality of nodes, defines activities to be performed when completing the second plurality of nodes, and defines a second plurality of computational branches and a second plurality of associated branching conditions, and
wherein to adapt the second projected visit path to the third projected visit path,
(i) synchronization identities, if any, that are associated with visits along the third projected visit path and that are identical to visits along the second projected visit path are retained,
(ii) synchronization identities, if any, that are associated with visits along the third projected visit path and that correspond to visits along the second projected visit path but have at least modified parameter are modified,
(iii) synchronization identities, if any, that are associated with visits along the third projected visit path but that do not correspond to any visits along the second projected visit path are created, and/or
(iv) synchronization identifies, if any, that are associated with visits along the second projected visit path but that do not correspond to any visits along the third projected visit path are deleted, such that correspondence is maintained between the first and second structured representation to enable transformation of workflow state across the transition from the first protocol to the second protocol.
The judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations, which:
amount to mere instructions to apply an exception (such as recitations of an application executing on a computer system, memory, thereby invoking computers as a tool to perform the abstract idea, see applicant’s specification [0075]-[0077], [00121]-[00122], see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of storing context information about completion of the activities performed amounts to insignificant extrasolution activity, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2-7, 9-14, and 16-20 recite additional limitations which amount to invoking computers as a tool to perform the abstract idea, and claims 2-7, 9-14, and 16-20 additional limitations which generally link the abstract idea to a particular technological environment or field of use). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B of the Alice/Mayo Test for Claims
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 discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional elements, other than the abstract idea per se, amount to no more than elements which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as using an application executing on a computer system, memory, e.g., Applicant’s spec describes the computer system with it being well-understood, routine, and conventional because it describes in a manner that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such elements to satisfy 112a. (See Applicant’s Spec. [0075]-[0077], [00121]-[00122]); storing context information about completion of the activities performed, e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv); using computer system with an application, memory, e.g., merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions, Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2358-59, 110 USPQ2d 1976, 1983-84 (2014).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea, adding insignificant extra solution activity, and are generally linking the abstract idea to a particular field of environment. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. Therefore, the claims are not patent eligible, and are rejected under 35 U.S.C. § 101.
Subject Matter Free of Prior Art
Claims 1-21 are free of prior art over Ponce de Leon (US 8400467) in view of Kleeman et al. (US2014/0316822) and Stephenson (US 2007/0250344). The prior art references, or reasonable combination thereof, could not be found to disclose, or suggest all of the limitations found in the independent claims. The closest prior art is Ponce de Leon (US 8400467), which teaches a graphical planning and scheduling system. Kleeman et al. (US2014/0316822) teaches generating clinical study reports by analyzing submitted clinical study data. Stephenson (US 2007/0250344) teaches systems and methods for scheduling and sequencing sessions or appointments using a follow-up system. The references taken solely, or in combination, fail to provide the required limitations, and modification of any complementary combination of the references of record would be impermissible hindsight and not provide any advantages over their present application. The dependent claims are also free of prior art due to their corresponding dependency of the independent claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA R COVINGTON whose telephone number is (303)297-4604. The examiner can normally be reached Monday - Friday, 10 - 5 MT.
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/AMANDA R. COVINGTON/Examiner, Art Unit 3686
/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
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