DETAILED ACTION
This action is in reference to the communication filed on 2 OCT 2023.
Claims 1-13 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 1-13 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) 1-13 the independent claim(s) 1, 12, 13 recite(s) a method, a computer readable recording medium, and an information processing device each of 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) 1-13, the independent claim(s) (claims 1, 12, 13) is/are directed, in part, to:
A flow control method
extracting, from a plurality of subjects, one or more first subjects each satisfying a first condition, the one or more first subjects being extracted based on a result of assignment of the plurality of subjects to a node based on a workflow that includes the node connected to a conditional branch by a directed edge;
determining an insertion point of a new conditional branch in the workflow, based on distribution of the one or more extracted first subjects in the workflow;
inserting a second condition, as the new conditional branch, at the insertion point, the second condition separating, at a lower node that is lower than the determined insertion point, the one or more first subjects from a subject not satisfying the first condition among the plurality of subjects; and
inserting a new node at a branch destination of the new conditional branch.
These claim elements are considered to be abstract ideas because they are directed to a mental process, in that the claims ensconce concepts performed in the human mind including observation, evaluation, judgment, and opinion functions. Controlling a workflow method using a system of branches and nodes, based on extracted information, If a claim limitation, under its broadest reasonable interpretation, covers a concept performed in the human mind, then it/they falls/ fall into the “mental processes” category. In the interest of compact prosecution, Examiner also notes that the graph construction and node/branch relationships are arguably evidence of a mathematical concepts – i.e. mathematical relationships in the graphing process.
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 independent claim(s) recite(s) additional element(s): claim 1 recites a “computer,” claim 12 recites “a computer readable recording medium storing…a program that causes a computer to execute a process,” and claim 13 recites an information processing device comprising a memory and a processor coupled to the memory, with the processor configured,” all to execute the claimed limitations as identified above. The computer, computer readable recording medium storing a program causing a computer to execute a process, and the information processing device comprising a memory and a processor coupled to the memory, with the processor in claims 1, 12, 13 is 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 2106.05h). Examiner finds no improvement to the functioning of the computer or any other technology or technical field in the above identified elements 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). Examiner further notes that sending and receiving of data via a computer is usually found to be analogous to adding insignificant extra solution activity to the judicial exception(s) identified (see MPEP 2106.05g).
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 such as: claim 1 recites a “computer,” claim 12 recites “a computer readable recording medium storing…a program that causes a computer to execute a process,” and claim 13 recites an information processing device comprising a memory and a processor coupled to the memory, with the processor configured,” all to execute the claimed limitations. When considered individually, the above 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:
[0062] The client device 202 is a computer used by a user. The user, for example, is the planner of a measure. The client device 202, for example, is a personal computer (PC), a tablet terminal, etc.
0068] The communications I/F 305 is connected to the network 210 through a communications line and is connected to an external computer (for example, the client device 202 depicted in FIG. 2) through the network 210. Further, the communications I/F 305 administers an internal interface between the flow controller device 201 and the network 210 and controls the input and output of data from the external computer. The communications I/F 305, for example, may be a modem, a LAN adapter, etc.
[0069] The removable recording medium I/F 306, under the control of the CPU 301, controls the reading and writing of data with respect to the removable recording medium 307. The removable recording medium 307 stores data written thereto under the control of the removable recording medium I/F 306. The removable recording medium 307, for example, is a compact disc (CD)-ROM, a Digital Versatile Disk (DVD), a universal serial bus (USB) memory, etc.
[0070] The flow controller device 201, in addition to the components described above, for example, may further have an input device, a display, etc. Further, of the components described above, the flow controller device 201, for example, may omit the removable recording medium I/F 306 and the removable recording medium 307. Further, the client device 202 depicted in FIG. 2 may also be implemented by a hardware configuration similar to that of the flow controller device 201. However, in addition to the components described above, the client device 202, for example, has the input device, the display, etc.
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 2-11:
Dependent claims 2, 5-10 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 description of the workflow process, node insertion, and additional conditions and considerations. 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.
Dependent claims 3, 4, do not recite any additional elements than those identified above, but they do at least nominally recite a “storage unit.” In the interest of compact prosecution, Examiner considers this as an additional element. Examiner does not find anything beyond an application of the storage unit to implement the abstract idea, nor any improvement to the functioning of said storage unit. Examiner further notes that storage of information is generally found to be insignificant extra solution activity. As such Examiner does not find evidence of a practical application nor significantly more than the abstract idea identified above.
Claim 12 further rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The United States Patent and Trademark Office (USPTO) is obliged to give claims their broadest reasonable interpretation consistent with the specification during proceedings before the USPTO. See In re Zletz, 893 F.2d 319 (Fed. Cir. 1989) (during patent examination the pending claims must be interpreted as broadly as their terms reasonably allow). The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called machine readable medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent. See MPEP 2111.01. When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. § 101 as covering non-statutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter) and Interim Examination Instructions for Evaluating Subject Matter Eligibility Under 35 U.S.C. §101, Aug. 24, 2009; p. 2.
The USPTO recognizes that applicants may have claims directed to computer readable media that cover signals per se, which the USPTO must reject under 35 U.S.C. § 101 as covering both non-statutory subject matter and statutory subject matter. In an effort to assist the patent community in overcoming a rejection or potential rejection under 35 U.S.C. § 101 in this situation, the USPTO suggests the following approach. A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. § 101 by adding the limitation “non-transitory” to the claim. Cf. Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (suggesting that applicants add the limitation “non-human” to a claim covering a multi-cellular organism to avoid a rejection under 35 U.S.C. § 101). Such an amendment would typically not raise the issue of new matter, even when the specification is silent because the broadest reasonable interpretation relies on the ordinary and customary meaning that includes signals per se. The limited situations in which such an amendment could raise issues of new matter occur, for example, when the specification does not support a non-transitory embodiment because a signal per se is the only viable embodiment such that the amended claim is impermissibly broadened beyond the supporting disclosure. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998). Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: storage unit in claims 3, 4.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 2 , 4, 5, 12, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cox et al (US 20210134401 A1, hereinafter Cox), in view of John et al (US 20060067252 A1, hereinafter John).
In reference to claim 1, 12, 13:
A flow control method executed by a computer, the flow control method comprising (at least [fig 12 and related text]:
A computer readable recording medium storing therein, a flow control program that causes a computer to execute a process comprising (at least [0106, 0112-113, and fig 12 and related text], :
An information processing device, comprising a memory, a processor, coupled to the memory, the processor (at least [fig 12 and related text] configured to:
extracting, from a plurality of subjects, one or more first subjects each satisfying a first condition (at least [054-056] “The data store 108 may comprise or store a computer instantiated mathematical model 110, a plurality of subject visit schedules 112, and a plurality of context information objects 114…The visit schedules 112 may be associated with different subjects participating in a clinical trial associated with the mathematical model 110.. Each of the context information objects 114 may be associated with one of the subjects participating in the clinical trial associated with the mathematical model 110. Alternatively, the context information objects 114 may be associated with a workday or a milestone in an extended work or project to be completed. It will be appreciated that the system 100 is capable of managing a plurality of independent clinical trials concurrently, each clinical trial associated with its own mathematical model 110, its own plurality of subject visit schedules 112, and its own plurality of context information objects 114.”), the one or more first subjects being extracted based on a result of assignment of the plurality of subjects to a node based on a workflow that includes the node connected to a conditional branch by a directed edge (at least [069-9] “ In an embodiment, the mathematical model 110 is an electronic file that articulates all visits defined by a protocol as nodes and all possible anchors between visits as edges. Hence, in this embodiment, the protocol is transcoded as an abstract mathematical graph… A time-based anchor associated with nodes in a visit schedule 112 of a subject may be represented as a time-based anchor edge, and a sequence-based anchor associated with nodes in a visit schedule 112 of the subject may be represented as a sequence-based anchor edge.”)
determining an insertion point of a new conditional branch in the workflow, based on distribution of the one or more extracted first subjects in the workflow (at least [071] “The workflow management application 104 processes the mathematical model 110 and information about a subject to generate an end-to-end visit path or visit schedule 112 for the subject. The workflow management application 104 constructs the end-to-end visit schedule 112 such that the schedules of visits satisfy both the sequence constraints and the timing constraints defined by the mathematical model 110. Said in another way, the workflow management application 104 constructs the end-to-end visit schedule 112 to maintain the sequence-based anchors and the time-based anchors defined for visits by the mathematical model 110. The workflow management application 104 constructs the end-to-end visit schedule 112, in part, by expanding cycles defined in the mathematical model 110 into the sequence of visits the cycle defines. For example, if the cycle defines 10 iterations, and each iteration comprises 3 visits, complete expansion of the cycle may comprise inserting 30 visits into the end-to-end visit schedule 112 associated with the cycle.” At [0092] “At block 304, the method 300 comprises receiving inputs by the mathematical model building tool defining a cycle of nodes to be iteratively scheduled by the workflow application, wherein the inputs define a number of iterations of the cycle, nodes that the cycle comprises, sequence-based anchors among the nodes of the cycle, time-based anchors among the nodes of the cycle, and time-based anchors between iterations of the cycle of nodes. At block 306, the method 300 comprises inserting the cycle of nodes by the mathematical modeling tool into the mathematical model.”);
inserting a second condition, as the new conditional branch, at the insertion point, the second condition separating, at a lower node that is lower than the determined insertion point, the one or more first subjects from a subject not satisfying the first condition among the plurality of subjects (at least [0073] “For example, the visit schedule 112 may be changed by the workflow management application 104 in response to a cycle exit condition evaluating true, in which case the completion of remaining iterations of the cycle may be omitted and the schedule may be revised to show the next visit is the first visit scheduled after completion of the cycle. In an embodiment, the workflow management UI 122 may support a research coordinator altering an exit condition of a cycle, whereupon the workflow management application 104 may subsequently change the visit schedule 112 based on the revised exit condition evaluating true.”). Cox as cited teaches a workflow nodes system and claimed, however does not specifically disclose inserting a new node at a destination of a conditional branch. John however does teach: inserting a new node at a branch destination of the new conditional branch (at least [fig 2 and related text] “If it is determined during step 238 that no expert responds to the invitation within a configured time limit, the boss needs to be alerted that no expert is available during step 242. “ i.e. conditional node 238, and box 246/248 are “inserted” based on the answer collected). John and Cox are analogous as both references disclose a sequencing/node means of organizing schedules and information as pertaining to a group of people. One of ordinary skill in the art would have found the inclusion of the conditional branch/responses as taught by John to be an obvious improvement to the workflow/node processing of Cox in order to account for the variability that naturally arises when scheduling a large group of people in a given time.
In reference to claim 2:
Cox/John teaches all the limitations above. Cox further teaches: wherein determining the insertion point includes determining the insertion point to be a lowest point that encompasses the node to which the one or more first subjects are assigned in the workflow (at least [figs. 2a/b and related text including [071-077] “The workflow management application 104 processes the mathematical model 110 and information about a subject to generate an end-to-end visit path or visit schedule 112 for the subject. The workflow management application 104 constructs the end-to-end visit schedule 112 such that the schedules of visits satisfy both the sequence constraints and the timing constraints defined by the mathematical model 110. Said in another way, the workflow management application 104 constructs the end-to-end visit schedule 112 to maintain the sequence-based anchors and the time-based anchors defined for visits by the mathematical model 110. The workflow management application 104 constructs the end-to-end visit schedule 112, in part, by expanding cycles defined in the mathematical model 110 into the sequence of visits the cycle defines. For example, if the cycle defines 10 iterations, and each iteration comprises 3 visits, complete expansion of the cycle may comprise inserting 30 visits into the end-to-end visit schedule 112 associated with the cycle…“The infinite iterations cycle definition is described further below with reference to FIG. 2B. The technician defines a time-based anchor (e.g., a cycle anchor) that applies for each subsequent iteration of the cycle (e.g., the second iteration of the cycle has a time-based link to the end of the first cycle, the third iteration of the cycle has a time-based link to the end of the second cycle, the fourth iteration of the cycle has a time-based link to the end of the third cycle, etc., where each of these time-based links between cycles have the same minimum and/or maximum time durations).” At [0092] “At block 304, the method 300 comprises receiving inputs by the mathematical model building tool defining a cycle of nodes to be iteratively scheduled by the workflow application, wherein the inputs define a number of iterations of the cycle, nodes that the cycle comprises, sequence-based anchors among the nodes of the cycle, time-based anchors among the nodes of the cycle, and time-based anchors between iterations of the cycle of nodes. At block 306, the method 300 comprises inserting the cycle of nodes by the mathematical modeling tool into the mathematical model.”)
In reference to claim 4:
Cox/John teaches all the limitations above. Cox further teaches: referring to a storage unit storing therein various types of characteristics amounts for each of the plurality of subjects and based on the various types of characteristics amounts of the one or more first subjects, determining the new node from among a plurality of types of nodes so that the one or more first subjects satisfy a third condition (at least [fig 4 and related text] “.A protocol may define a plurality of protocol arms such as a first protocol arm 164, a second protocol arm 166, and a third protocol arm 168. A subject who completes a screening visit 162 and is accepted into the clinical trial may be assigned to any of the three protocol arms 164, 166, 168. In an embodiment, the subject is randomly assigned to a protocol arm 164, 166, 168 by an activity referred to as randomization. In different protocol arms 164, 166, 168 different activities and possibly different visits are completed with subjects assigned to each protocol arm. For example, subjects on the first protocol arm 164 may receive placebos rather than active medication, subjects on the second protocol arm 166 may receive active medication at a half-dosage level, and subjects on the third protocol arm 168 may receive active medication at a full-dosage level.”, see also figs 5/6 and related text “when the workflow management application 104 parses the branching point or computational branch defined by the mathematical model 110, it evaluates a condition defined for the computational branch by the mathematical model 110. The condition may identify an event. The condition may identify a threshold value of a metric or vitals indication associated with a subject, for example blood pressure above a first threshold value, O2 level less than a second threshold value, INR below a third threshold value. If the condition is not satisfied, the visit schedule of the subject may follow the first branch 184 defined by the mathematical model 110, and if the condition is satisfied, the visit schedule of the subject may follow the second branch 186 defined by the mathematical model 110. “). Cox does not teach specifically the insertion at the branch destination. John however doe teach: wherein inserting the new node includes inserting the determined new node at the branch destination (at least [fig 2 and related text] “If it is determined during step 238 that no expert responds to the invitation within a configured time limit, the boss needs to be alerted that no expert is available during step 242. “ i.e. conditional node 238, and box 246/248 are “inserted” based on the answer collected). John and Cox are analogous as both references disclose a sequencing/node means of organizing schedules and information as pertaining to a group of people. One of ordinary skill in the art would have found the inclusion of the conditional branch/responses as taught by John to be an obvious improvement to the workflow/node processing of Cox in order to account for the variability that naturally arises when scheduling a large group of people in a given time.
In reference to claim 5:
Cox/John teaches all the limitations above. Cox further teaches: wherein the workflow represents a measure for achieving an objective, and the node represents an intervention for achieving the objective (at least [024-029] “The cycle may be interrupted, for example, if a cycle exit condition is determined to be present, such as a subject is cured of a physical malady. The cycle may continue until it has been iterated a predefined number of times and then exit the cycle. The cycle may continue indefinitely until the subject leaves the clinical trial for any reason. In embodiments, a cycle may comprise at least one visit which repeats (e.g., a cycle may comprise one or more visits which repeat). In embodiments, a cycle may comprise two or more nodes which repeat. The cycle of nodes may be repeated until a cycle exit condition evaluates true. Alternatively, the cycle of nodes may be repeated indefinitely until the workflow is terminated for another reason, for example because the subject is too ill to continue treatment. The nodes may be visits of a subject in a clinical trial. The nodes may be milestones to be completed in a project workflow. The nodes may be jobs to be completed by a worker or delivery person.”)
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cox in view of John, further in view of Bonnard et al (US 20140324759 A1, hereinafter Bonnard).
In reference to claim 9:
Cox/John teaches all the limitations above. Cox as cited teaches a first condition, and an intervention represented by an assigned node (at least fig 5 and related text). However, Cox does not specifically disclose a predicted probability for a current condition nor a threshold. Bonnard however does teach: wherein the first condition is a predicted probability not being received is at least equal to a threshold (at least [ fig 5 and related text] “Referring to FIG. 5, an example of expediting a resource constrained process using the EPE of an embodiment is shown. In the example depicted in FIG. 5, the process designer has created a process diagram 500 and process data model 510 for a "Missed Visit Followup" process. A process instance of this process diagram 500 will be started each time a patient in a monitored pregnancy cohort misses a pre-natal visit without having made prior arrangements to reschedule…At some point during execution of process instances, a nurse shortage may cause the predicted wait time for the Evaluate Risk activity 530 to exceed the threshold set by the rule, requiring the policy engine 260 to inquire of the probabilistic engine 240 (e.g., the Bayesian engine) if the probability condition applied to this process instance is true. The probability condition may fail because the conditional probability tables required are not yet complete, because the computed probability does not exceed the threshold, or because the confidence of the computed probability is not sufficient. If the probability condition passes, than this particular process instance will bypass the Evaluate Risk activity 530 and go directly to the Personal Followup activity 550.” Bonnard and Cox are analogous references as both disclose workflow sequencing of patients based on detected or inferred condition. One of ordinary skill would have found it obvious to include probability predictions above a threshold, as this would improve the potential outcome of the intervention when incorporated in the patient treatment flow common to both references.
In reference to claim 10:
Cox/John teaches all the limitations above. Cox further teaches: wherein the workflow represents a measure for achieving an objective, the node represents an intervention for achieving the objective (at least [024-029] “The cycle may be interrupted, for example, if a cycle exit condition is determined to be present, such as a subject is cured of a physical malady. The cycle may continue until it has been iterated a predefined number of times and then exit the cycle. The cycle may continue indefinitely until the subject leaves the clinical trial for any reason. In embodiments, a cycle may comprise at least one visit which repeats (e.g., a cycle may comprise one or more visits which repeat). In embodiments, a cycle may comprise two or more nodes which repeat. The cycle of nodes may be repeated until a cycle exit condition evaluates true. Alternatively, the cycle of nodes may be repeated indefinitely until the workflow is terminated for another reason, for example because the subject is too ill to continue treatment. The nodes may be visits of a subject in a clinical trial. The nodes may be milestones to be completed in a project workflow. The nodes may be jobs to be completed by a worker or delivery person.”), a third condition, and an intervention represented by an assigned node (at least fig 5 and related text)
However, Cox does not specifically disclose a predicted probability for a current condition nor a threshold. Bonnard however does teach: wherein the [ ]condition is a predicted probability not being received is at least equal to a threshold (at least [ fig 5 and related text] “Referring to FIG. 5, an example of expediting a resource constrained process using the EPE of an embodiment is shown. In the example depicted in FIG. 5, the process designer has created a process diagram 500 and process data model 510 for a "Missed Visit Followup" process. A process instance of this process diagram 500 will be started each time a patient in a monitored pregnancy cohort misses a pre-natal visit without having made prior arrangements to reschedule…At some point during execution of process instances, a nurse shortage may cause the predicted wait time for the Evaluate Risk activity 530 to exceed the threshold set by the rule, requiring the policy engine 260 to inquire of the probabilistic engine 240 (e.g., the Bayesian engine) if the probability condition applied to this process instance is true. The probability condition may fail because the conditional probability tables required are not yet complete, because the computed probability does not exceed the threshold, or because the confidence of the computed probability is not sufficient. If the probability condition passes, than this particular process instance will bypass the Evaluate Risk activity 530 and go directly to the Personal Followup activity 550.” Bonnard and Cox are analogous references as both disclose workflow sequencing of patients based on detected or inferred condition. One of ordinary skill would have found it obvious to include probability predictions above a threshold, as this would improve the potential outcome of the intervention when incorporated in the patient treatment flow common to both references.
In reference to claim 11:
Cox further teaches: outputting the workflow into which the new node is inserted (at least [071] “The workflow management application 104 constructs the end-to-end visit schedule 112 such that the schedules of visits satisfy both the sequence constraints and the timing constraints defined by the mathematical model 110. Said in another way, the workflow management application 104 constructs the end-to-end visit schedule 112 to maintain the sequence-based anchors and the time-based anchors defined for visits by the mathematical model 110. The workflow management application 104 constructs the end-to-end visit schedule 112, in part, by expanding cycles defined in the mathematical model 110 into the sequence of visits the cycle defines. For example, if the cycle defines 10 iterations, and each iteration comprises 3 visits, complete expansion of the cycle may comprise inserting 30 visits into the end-to-end visit schedule 112 associated with the cycle.”).
Claims 3, 7, and by extension claims 6, 8, are believed to be free of the prior art.
In reference to claim 3, Cox teaches a second condition associated generally with characteristics such as symptoms and/or treatments, as well as using nodes, and John teaches insertion of the new conditional branch. However, the combination of references does not fairly teach the claimed idea of characteristics as assigned to node position to determine the condition specifically, nor the subsequent insertion based on that determination.
In reference to claim 6, Claim 6 further narrows the scope of claim 3 and is therefore by extension believed to be free of the prior art. Also, the prior art of record does not fairly teach the requirement of a percentage satisfying the first condition exceeding a threshold.
In reference to claim 7, The combination of Cox/Johns teaches an insertion point as the conditional branch, as well as one or more conditions, and an arrangement of nodes and branches. However, the cited references do not fairly teach the claimed combination of stages as combined with the first stage and node placement in the workflow with the first stage node of a first stage from a highest point in order to determine the insertion point based on the distribution of the subjects, nor the subsequent positioning of the second condition as pertaining to the nodes.
In reference to claim 8, Claim 8 further narrows the scope of claim 7 and is therefore by extension believed to be free of the prior art. Also, the prior art of record does not fairly teach the requirement of a an insertion point based on a node placement in relation to each stage on a basis of each range, nor inserting the new node based on the fourth condition as claimed.
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
11789837, to Jain, teaches managing and modifying the workflow of a clinical trial in order to make changes to the schedule as the trial progresses.
US 20240136055, to Gray, teaches managing a workflow at a clinical trial site.
US 20090313048, to Kahn, teaches using a workflow graph to manage the clinical trial visits, and accounts for additions/deletions in the schedule based on the trial progression.
Conclusion
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 Monday - Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached at 571-270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE . KOLOSOWSKI-GAGER/
Primary Examiner
Art Unit 3687
/KATHERINE KOLOSOWSKI-GAGER/Primary Examiner, Art Unit 3687
Prosecution Insights