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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/02/2026 has been entered.
Status of Claims
This action is in response to the RCE filed 9/02/2026.
Claim 1 was amended 8/10/2026.
Claims 1 and 3-11 are currently pending 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, 3-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1, 3-11 are drawn to a method which is a statutory category of invention (Step 1: YES).
Independent claim 1 recites: generating a clinical pathway, comprising: creating a new data object for representing the clinical pathway; displaying to a user; receiving, an identification of a first node to add to the clinical pathway; updating to include a graphical representation of the first node; receiving, an identification of a patient status in association with the first node; updating the data object to include data representing the first node and the identification of the patient status; receiving, an identification of at least one decision node to add to the clinical pathway; receiving, a first characteristic in association with the decision node, wherein the first characteristic defines criteria for determining applicability of the decision node to a patient wherein comprises rule-based logic for the decision node based on one or more of data model parameters, ontologies, and value sets; and updating the data object to include data representing the decision node and the first characteristic; and storing the data object in association with an identification of a disease for future retrieval; wherein the clinical pathway is navigated toward a terminating node by retrieving accessed patient information from a patient electronic medical record (EMR) and checking the access patient information against conditional values built into each decision node.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity between a user and a patient, as reflected in the specification, which states that “the user may set whether a previous treatment performed as planned and whether a new treatment plan is curative or palliative via radio icons in detailed report tile 832. Once the user has input appropriate information in detailed report tile 832, a commit button 834 may be pressed to approve the information and enter it (e.g., via API call, etc.) into a respective electronic medical record (EMR) for the patient.” (see: specification paragraph 150). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The present claims cover certain methods of organizing human activity because they address “improving patient outcomes and staff experience and containing healthcare costs. Decision support tools have been unable to facilitate bringing relevant up-to-date clinical evidence into the hands of clinicians while they have extracted and/or discretized patient data for interpretation and creation of clinical treatment plans.” (see: specification paragraph 46). Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).”
Further, the recited limitations, as drafted, under the broadest reasonable interpretation, cover mathematical relationships by calculating user-defined rule-based logic for the decision node based on one or more of data model parameters, ontologies, and value sets. If a claim limitation, under its broadest reasonable interpretation, covers mathematical relationships or mathematical calculations, then it falls within the “Mathematical Concepts” grouping of abstract ideas. Accordingly, the claims recite an abstract idea (Step 2A Prong One: YES).
The judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including “computer”, “graphical tool”, and “database”, are recited at a high level of generality (e.g., that the updating and displaying is performed using generic computer components with instructions are executed to perform the claimed limitations). Such that they amount to no more than mere instructions to apply the exception using generic computer components. See: MPEP 2106.05(f).
Hence, the 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. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
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 integration of the abstract idea into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic component cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion at Figure 1, Figure 20 and
Paragraph 205, where “The computer system 2000 includes one or more computing components in communication via a bus 2002. In one implementation, the computing system 2000 includes one or more processors 2014. The processor 2014 can include one or more internal levels of cache 2016 and a bus controller or bus interface unit to direct interaction with the bus 2002. The processor 2014 may specifically implement the various methods discussed herein. Main memory 2008 may include one or more memory cards and a control circuit (not depicted), or other forms of removable memory, and may store various software applications including computer executable instructions, that when run on the processor 2014, implement the methods and systems set out herein. Other forms of memory, such as a storage device 2010 and a mass storage device 2012, may also be included and accessible, by the processor (or processors) 2014 via the bus 2002. The storage device 2010 and mass storage device 2012 can each contain any or all of the methods and systems discussed herein.”
Paragraph 142, where “At operation 710, the updated graph is stored for later revision, updating, and/or review. The graph, and respective mapping information to data in a knowledgebase and/or BPMN network, may be stored in a local database, cloud storage, remote store or repository, etc.”
Paragraph 62, where "New pathways can be created using a graphical tool provided through the GUI. For example, new decision nodes can be added to a new decision tree corresponding to the new pathway. Moreover, terminal nodes may be created and added to the decision tree, which link treatment plans and/or clinical trials to the decision tree or pathway”
Paragraph 110, where “In some examples, workflow engine 102 receives inputs from users through a graphical user interface (GUI) (discussed below in reference to FIGURES 2-6B and 8-15), and includes, or interfaces with, system controller and/or dispatcher components (not depicted).|
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with route, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claims 3-11 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are directed to an abstract idea without significantly more. Claim 3-9 and 11 recite transmitting, receiving, and updating ontological values from treatment and clinical trial data on the generically recited computing device as shown in the parent claims above.
Claim 10 further recites “a computer assisted design (CAD) interface)” which is recited at a high level of generality (e.g., that the displaying of graphics are performed using generic computer components with instructions are executed to perform the claimed limitations) as shown in the specification paragraphs 123-124, 140 and Figure 4. Such that they amount to no more than mere instructions to apply the exception using generic computer components. See: MPEP 2106.05(f).
These claims fail to remedy the deficiencies of their parent claims above, and therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Response to Arguments
The arguments filed 8/10/2026 have been fully considered.
The arguments pertaining to the Claim Objections are persuasive. The claims have been sufficiently amended and the Claim Objections have been withdrawn.
The arguments pertaining to the 112 rejections are persuasive. The claims have been sufficiently amended to overcome the rejections and the 112 rejections have been withdrawn.
The arguments pertaining to the 101 rejection are not persuasive. Applicant argues that the claimed invention is not directed to “Certain Methods of Organizing Human Activity” as the claims as a whole are not directed to an abstract idea. Examiner respectfully disagrees as the claimed invention as a whole is directed towards Certain Methods of Organizing Human Activity as the claimed invention is directed towards the interactions between a user and a patient. The specification recites that the claimed invention is directed towards a user creating treatment plans using the clinical pathways for treatment data for a patient (specification paragraphs 150, 46). The claimed invention, as a whole as evidenced in the specification, is directed towards a user interacting with a patient and falls under the category of “Certain Methods of Organizing Human Activity” as shown in the rejection above. Applicant cites In re Marco, In re Brown, and Bilski v. Kappos, however the claimed invention is not similar to these but is instead directed towards interactions between people (i.e., a user and a patient).
Applicant further argues that the claims are not directed towards the abstract idea of mental processes, however the claimed invention has been directed towards Certain Methods of Organizing Human Activity, not Mental Processes.
Applicant further argues that the claimed invention creates a practical application of generating and storing a data object, where the data object comprises at least: (i) a first node with a patient status in association with the first node; and (ii) a decision node with a first characteristic in association with the decision node; and where the data object is configured to permit automated navigation of the clinical pathway to a terminating node based on application of accessed patient information to each decision node. Examiner respectfully disagrees, as the claim limitation “and where the data object is configured to permit automated navigation of the clinical pathway to a terminating node based on application of accessed patient information to each decision node” no longer exists in the current claimed invention. Further, the applications of routing data through decision nodes in a clinical pathway does not create a specific improved computational architecture as it is merely using user-defined calculations on a generic computing device to input/output data.
Regarding MPEP 2106.04(d)(1), this is the section in its entirety:
A claim reciting a judicial exception is not directed to the judicial exception if it also recites additional elements demonstrating that the claim as a whole integrates the exception into a practical application. One way to demonstrate such integration is when the claimed invention improves the functioning of a computer or improves another technology or technical field. The application or use of the judicial exception in this manner meaningfully limits the claim by going beyond generally linking the use of the judicial exception to a particular technological environment, and thus transforms a claim into patent-eligible subject matter. Such claims are eligible at Step 2A because they are not "directed to" the recited judicial exception.
The courts have not provided an explicit test for this consideration, but have instead illustrated how it is evaluated in numerous decisions. These decisions, and a detailed explanation of how examiners should evaluate this consideration are provided in MPEP § 2106.05(a). In short, first the specification should be evaluated to determine if the disclosure provides sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Conversely, if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology. Second, if the specification sets forth an improvement in technology, the claim must be evaluated to ensure that the claim itself reflects the disclosed improvement. That is, the claim includes the components or steps of the invention that provide the improvement described in the specification. The claim itself does not need to explicitly recite the improvement described in the specification (e.g., "thereby increasing the bandwidth of the channel").[AltContent: rect]
While the courts usually evaluate "improvements" as part of the "directed to" inquiry in part one of the Alice/Mayo test (equivalent to Step 2A), they have also performed this evaluation in part two of the Alice/Mayo test (equivalent to Step 2B). See, e.g., BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1349-50, 119 USPQ2d 1236, 1241-42 (Fed. Cir. 2016). However, the improvement analysis at Step 2A Prong Two differs in some respects from the improvements analysis at Step 2B. Specifically, the "improvements" analysis in Step 2A determines whether the claim pertains to an improvement to the functioning of a computer or to another technology without reference to what is well-understood, routine, conventional activity. That is, the claimed invention may integrate the judicial exception into a practical application by demonstrating that it improves the relevant existing technology although it may not be an improvement over well-understood, routine, conventional activity. It should be noted that while this consideration is often referred to in an abbreviated manner as the "improvements consideration," the word "improvements" in the context of this consideration is limited to improvements to the functioning of a computer or any other technology/technical field, whether in Step 2A Prong Two or in Step 2B.
Examples of claims that improve technology and are not directed to a judicial exception include: Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1339, 118 USPQ2d 1684, 1691-92 (Fed. Cir. 2016) (claims to a self-referential table for a computer database were directed to an improvement in computer capabilities and not directed to an abstract idea); McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102-03 (Fed. Cir. 2016) (claims to automatic lip synchronization and facial expression animation were directed to an improvement in computer-related technology and not directed to an abstract idea); Visual Memory LLC v. NVIDIA Corp., 867 F.3d 1253,1259-60, 123 USPQ2d 1712, 1717 (Fed. Cir. 2017) (claims to an enhanced computer memory system were directed to an improvement in computer capabilities and not an abstract idea); Finjan Inc. v. Blue Coat Systems, Inc., 879 F.3d 1299, 125 USPQ2d 1282 (Fed. Cir. 2018) (claims to virus scanning were found to be an improvement in computer technology and not directed to an abstract idea); SRI Int’l, Inc. v. Cisco Systems, Inc., 930 F.3d 1295, 1303 (Fed. Cir. 2019) (claims to detecting suspicious activity by using network monitors and analyzing network packets were found to be an improvement in computer network technology and not directed to an abstract idea). Additional examples are provided in MPEP § 2106.05(a).
Examiner assumes Applicant is referring to the recitation in 2106.04(d) not 2106.04(d)(1). 2106.04(d) is at the previous step of Step 2A where the claimed invention is evaluated as it pertains to an abstract idea. It is in Step 2A Prong Two where the additional elements are analyzed and it is in Prong Two wherein the additional elements were determined to be no more than well-understood, routine and conventional computer components. Applicant is confusing Step 2A (MPEP 2106.04(d)) with Step 2A Prong Two (MPEP 2106.04(d)(1)) and is reciting quotations form Step 2A and applying them erroneously to Step 2A Prong Two. The claimed invention has been analyzed accordingly to the steps properly and follows USPTO guidelines.
Applicant further argues that the improvement to the technical field of clinical pathways to solve a technological problem. However, the cited paragraphs (45-51) support that the claimed invention is directed towards “Certain Methods of Organizing Human Activity”. Improving data transfers in clinical pathways to improve patient care through decision making (by a clinician for their patient) by improving the interactions between a clinician and a patient as evidenced in the specification show that the claims are directed to organizing human activity. The improvement is between a clinician (the user) and the patient, which is part of the abstract idea. The “medical field” is not necessarily a “technical field”, nor is a treatment effected. Classen is an example of adding a meaningful limitation to the claims that create a practical application, however Classen integrated the results of the analysis into a specific and tangible method that resulted in the method “moving from abstract scientific principle to specific application” (Classen Immunotherapies Inc. v. Biogen IDEC). The current claimed limitations fail to provide this practical application as they focus on data transmission using generic computing components.
Applicant further argues that the claims integrate the abstract idea into a practical application by addressing specific pathway data object and node-level rule architecture. Examiner respectfully disagrees. The claimed invention does not provide an improvement of relevant existing technology and merely uses generic computing elements uses specialized data to display data (clinical pathways). The argued node-level architecture is not a specific improvement and the specification recites that the systems architecture can be realized by “a variety of architectural approaches” (paragraph 109, Figure 1) and does not recite a specific architecture that provides a specific technological improvement. Transmitting data through user-defined calculations on generic nodal pathways on a generic computing device does not provide a practical application. The functions argued are representative of the abstract idea. The claims here are not directed to a specific improvement to computer functionality that amount to a practical application. Rather, they are directed to the use of conventional or generic technology in a well-known environment, without any claim that the invention reflects an inventive solution to a technical problem presented by combining the two. In the present case, the claims fail to recite any elements that individually or as an ordered combination transform the identified abstract idea(s) in the rejection into a patent-eligible application of that idea.
Further, not every claim that recites concrete, tangible components escapes the reach of the abstract-idea inquiry. (See, e.g., Alice, 134). It is well-settled that mere recitation of concrete, tangible components that are generic is insufficient to confer patent eligibility to an otherwise abstract idea. In order to amount to an inventive concept, the components must involve more than performance of “’well-understood, routine, conventional activities’ previously known to the industry.” (Alice, 134 S. Ct. at 2359 (quoting Mayo, 132 S.Ct. at 1294)). The originally filed specification was investigated and found to support this conclusion.
The dependent claims rely on the arguments of the independent claims and are rejected for the reasons stated above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Altman (US 20120310667 A1) teaches dynamic clinical pathways, however does not explicitly teach using a graphical tool with user-defined rule-based logic.
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/KIMBERLY A. SASS/ Examiner, Art Unit 3686
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