DETAILED ACTION
This action is in reference to the communication filed on 27 FEB 2026.
Amendments to claims 1-5 are entered and considered.
Claims 1-5 are present and have been examined.
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 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. As explained below, the claim(s) are directed to an abstract idea without significantly more.
Step One: Is the Claim directed to a process, machine, manufacture or composition of matter? YES
With respect to claim(s) 1-5 the independent claim(s) 1 recite(s) a system, i.e. a process, which is a statutory category of invention.
Step 2A – Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? YES
With respect to claim(s) 1-5 the independent claim(s) (claims 1) is/are directed, in part, to:
A system for visualizing and managing a clinical study visit schedule, the system comprising:
selected from the group consisting of a visit node, a cycle node, a jump node, a track selector node, an exist node, a participant verification node, and an information node; and, a visit schedule
wherein each of the plurality of nodes comprises a node position and node attributes;
wherein the node position comprises a node track identifying the track, and a node step;
wherein the track comprises a step sequence of the plurality of nodes sequentially ordered according to the node step of each node;
wherein the track is selected from a study track, an exit track, and an unscheduled visits track;
wherein the visit schedule
wherein the visit schedule
wherein the visit schedule
wherein the track graphic comprises a plurality of
wherein each of the
wherein each of the
wherein the visit schedule in sequence with a last node;
wherein the last node may be a selected node or a track last node and wherein the last node comprises last node attributes including a last visit timing;
wherein the visit schedule
wherein, responsive to adding the new node as the cycle node comprising a cycle start step, a cycle end step, and cycle node attributes having a cycle timing and a number of repetitions, the visit schedule
wherein, responsive to adding the new node as the track selector node having track selector node attributes comprising a number of destination tracks, the visit schedule interface is configured to:
cause
wherein the visit schedule
wherein the visit schedule
wherein the visit schedule selected nodes of the plurality of nodes a selection position of the one or more selected nodes to a move to position;
wherein the selection position comprises a selection node track;
wherein the visit schedule
wherein to update the track graphic by repositioning the selectable node graphics, the visit schedule interface is configured to:
receive the move to position
wherein the move from track is the selection node track;
wherein the visit schedule and,
wherein the visit schedule
These claim elements are considered to be abstract ideas because they are directed to a method of organizing human activity which include managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). Creating, editing, and executing a visit schedule are all examples of personal behaviors. The claims are further directed to amental process, i.e. concepts performed in the human mind including observation, evaluation, judgement, and opinion. Managing the data as it pertains to the scheduling process is essentially managing data, which is performable in the human mind. Examiner also notes that the amended limitations regarding calculating/recalculating are directed to a mathematical concept- i.e. the calculations themselves. If a claim limitation, under its broadest reasonable interpretation, covers commercial and legal interactions, then it falls within the “method of organizing human activity” grouping of abstract ideas. If a claim limitation, under its broadest reasonable interpretation, covers concepts performed in the human mind, then it falls within the “mental process” grouping of abstract ideas. If a claim limitation, under its broadest reasonable interpretation, covers mathematical calculations, then it falls into the mathematical concepts category. Accordingly, the claim recites an abstract idea.
Step 2A – Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? NO.
This judicial exception is not integrated into a practical application. In particular, the claim(s) recite(s) additional element: claim 1 recites a “processor,” “input device,” and a database, as well as a “schedule control” which may interact with the database and the display of selectable graphics, to perform the claim steps. The “processor,” “input device,” and a database, as well as a “schedule control” which may interact with the database and the display of selectable graphics in the form of an interface, in claim 1, are all recited at a high level of generality and as such amount to no more than adding the words “apply it” to the judicial exception, or mere instructions to implement the abstract idea on a computer, or merely uses the computer as a tool to perform the abstract idea (see MPEP 2106.05f), or generally links the use of the judicial exception to a particular technological field of use/computing environment (see MPEP 2106. adding insignificant extra solution activity to the judicial exception(s) identified (see MPEP 2106.05g).05h). Examiner further notes that a database storing data, and a display displaying data, are found to be adding insignificant extra solution activity to the judicial exception(s) identified (see MPEP 2106.05g). Examiner finds no improvement to the functioning of the computer or any other technology or technical field in the processor, input device, database, and/or display/controls therein, as claimed (see MPEP 2106.05a), nor any other application or use of the judicial exception in some meaningful way beyond a general like between the use of the judicial exception to a particular technological environment (see MPEP 2106.05e).
Accordingly, this/these additional element(s) do(es) not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? NO.
The independent claim(s) is/are additionally directed to claim elements: claim 1 recites a “processor,” “input device,” and a database, as well as a “schedule control” which may interact with the database and the “display of selectable graphics” in the form of an interface. When considered individually, these identified claim elements only contribute generic recitations of technical elements to the claims. It is readily apparent, for example, that the claim is not directed to any specific improvements of these elements. Examiner looks to Applicant’s specification in:
[0051] Database 2 may be a SQL, Non-SQL, relational, or non-relational database (e.g., MySQL, Oracle, Mongo, Cassandra, ElasticSearch, Neo4J, and others) or any other datastore or repository for persistently storing and managing collections of data according to the invention. Database 2 may comprise a database server comprising a processor. Preferably, database 2 is secured within the private cloud 6, and may be further secured by isolating it in a private subnet within the private cloud 6, effectively preventing anyone outside the private cloud from gaining access to database 2. All data stored in database 2 preferably are encrypted while at rest (e.g., when stored in database 2) using encryption tools 11…. Other methods of using unique identifier 12 and other methods of protecting data in relational and non-relational databases are well known. Servers 3 may be web servers 4, application servers 5, or both, and may use dedicated or shared computing resources (e.g., processors, hardware, etc.). Servers 3 preferably are secured within private cloud 6.
[0052]… Workstation 40 may be any computing device comprising a processor such as a personal computer, laptop, tablet, mobile device, thin client, or any other device capable of displaying the GUI and connecting to a network (e.g., the internet, internal networks, other public or private networks). Input device 41 may be a mouse, keyboard, microphone, voice, optical input, camera, tape, and other known devices or methods for inputting data.
[0053] Display 42 may be any display or monitor (e.g., screen, projector, e ink, holographic, etc.) and a display controller (e.g., display hardware and software controlling the display), as well as any other hardware or software instrumentality, or interface used or known to properly operate display 42. Display 42 may display GUI 43 using client software or program capable of visualizing information received over a network and/or input device 41, and of securely transmitting the information over a network, for example a browser capable of utilizing network protocols (e.g., HTTP, HTTPS, AS2, AS3, AS4, RTP, UDP, etc.) to send and receive data over networks and of displaying data using markup (e.g., HTML, XML, SGML, etc.) or other visualization techniques.
These passages, as well as others, makes it clear that the invention is not directed to a technical improvement. When the claims are considered individually and as a whole, the additional elements noted above, appear to merely apply the abstract concept to a technical environment in a very general sense – i.e. a generic computer receives information from another generic computer, processes the information and then sends information back. The most significant elements of the claims, that is the elements that really outline the inventive elements of the claims, are set forth in the elements identified as an abstract idea. The fact that the generic computing devices are facilitating the abstract concept is not enough to confer statutory subject matter eligibility.
As per dependent claims 2-5:
Dependent claims 2-5 are not directed any additional abstract ideas and are also not directed to any additional non-abstract claim elements. Rather, these claims offer further descriptive limitations of elements found in the independent claims and addressed above – such as the types of visit tracking, the means through which the display/visits are controlled or changed, the use of a travel policy, and a start/end point of the cycle/scheduling. While these descriptive elements may provide further helpful context for the claimed invention these elements do not serve to confer subject matter eligibility to the invention since their individual and combined significance is still not heavier than the abstract concepts at the core of the claimed invention.
Response to Arguments
Applicant’s remarks as filed on 27 FEB 2026 are fully considered.
Applicant begins with a summary of the Office Action and the amended claims on page 9.
Examiner notes and appreciates the chart indicating support for the amendments on pages 9/10.
Applicant’s remarks regarding the 101 rejection begin on page 11, with a summary of USPTO policy regarding subject matter eligibility and reference to the amendments of claim 1. Examiner respectfully disagrees with Applicant’s conclusion that the claims do not fall into the categories of abstract ideas identified above. Examiner notes that the database elements are more suitably addressed in the additional elements sections of the rejection. No improvement to the GUI is present by applying the technology to implement the abstract idea(s).
Applicant turns to a discussion of Step 2A prong 2 on page 13. Examiner respectfully disagrees with Applicant’s remarks, including analogy to BASCOM. Applicant does not identify what element(s) and/or order is/are believed to be non-generic. Similarly, Examiner respectfully disagrees with Applicant’s discussion of a purported improvement to a GUI on page 13 – Examiner does not find that the GUI itself is being improved in functioning, or synchronizing. Instead the GUI is merely being “used.”
Applicant’s remarks regarding Enfish on page 14 are also found unpersuasive. The referenced amendments to claim 1 are not found to be analogous to the self-referential table as was found eligible in Enfish. Similarly, Examiner does not find the analogy to the filtering in BASCOM to be persuasive, in that Applicant appears to be arguing the database elements in reference to a display argument at the bottom of page 14.
Applicant continues with a discussion of improvements to the GUI/Database on page 15 – again, Examiner respectfully disagrees that the “improvements” identified are related to the technical elements themselves rather than the tracking of the visits.
Applicant turns to a discussion of significantly more on page 15, again referencing an improvement. Examiner respectfully disagrees and reiterates that Applicant’s claims do not appear to provide a technical improvement as required to support a finding of eligibility. Applicant references BASCOM on page 16, however, Examiner does not find that a “filtering” of visits occurs, nor does Examiner find that a filtering of types of visit is analogous to the filtering in BASCOM. Examiner also does not find that the customizable components improve the functioning of the GUI itself in a technical manner. That the GUI can be controlled or manipulated is helpful, but not an improvement per se, nor does the communication between the GUI and the database solve a technical problem as alleged on page 17. The rejection is maintained.
Conclusion
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 KATHERINE KOLOSOWSKI-GAGER whose telephone number is (571)270-5920. The examiner can normally be reached on Monday - Friday.
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/KATHERINE KOLOSOWSKI-GAGER/Primary Examiner, Art Unit 3687
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