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 .
Status of Claims
This action is in response to the reply received 1/26/2026.
The specification paragraphs 110-111 were amended 1/26/2026.
Claims 12-18 were previously withdrawn.
Claim 2 was canceled 1/26/2026.
Claims 1, 3, and 5 were amended 1/26/2026.
Claims 1, 3-11 are currently pending and have been examined.
Claim Objections
Claim 1 objected to because of the following informalities: “to a terminating node based on application of accessed patient information to each decision node” is not grammatically correct. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 and therefore its dependent claims are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claim limitation of “wherein the data object is configured to permit automated navigating of the clinical pathway to a terminating node based on application of accessed patient information to each decision node” is not in the specification. The specification it is the workflow engine that initiates automated navigation through decision trees (paragraphs 88, 68). The automated navigation in the specification appears to be accomplished through pathways corresponding to the respective decision tree, and is not based on the configuration of a data object. Further, the specification recites that the automatic navigation identifies the data object and not that the data object is configured to permit automated navigating (paragraph 153). However, the specification does not recite that a data object permits automatic navigation.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 and therefore its dependent claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The claim limitation of “wherein the data object is configured to permit automated navigating of the clinical pathway to a terminating node based on application of accessed patient information to each decision node”, however in the specification it is the workflow engine that initiates automated navigation through decision trees (paragraphs 88, 68). The automated navigation in the specification appears to be accomplished through pathways corresponding to the respective decision tree, and is not based on the configuration of a data object. Further, the specification recites that the automatic navigation identifies the data object and not that the data object is configured to permit automated navigating (paragraph 153). Further clarification on how the automated navigation is being implemented is needed.
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; 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 data object is configured to permit automated navigating of the clinical pathway to a terminating node based on application of accessed patient information to 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).”
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.
Allowable Subject Matter
Claims 1, 3-11 are allowable over the prior art. Independent claim 1’s limitation of “wherein the data object is configured to permit automated navigating of the clinical pathway to a terminating node based on application of accessed patient information to each decision node” and in combination with the other claim limitations is not taught by the previous prior art of Ellis (US 20140350954 A1), Lucas (US 20200176098 A1), Cerello (US 20140222444 A1) and Dries (WO 2014037922 A2). A new prior art search was conducted and found the prior art of Beardall (WO 2014130392 A1) that teaches using workflow nodes for patient treatment however it did not teach automated navigation of data points based on accessed patient information for each node.
Response to Arguments
The arguments filed 1/26/2026 have been fully considered.
The amendments to the specification overcome the drawing objection and the drawing objection has been withdrawn.
The arguments pertaining to the 103 rejection are persuasive. Independent claim 1 has been amended to overcome the prior art of record. A new prior art search was conducted and found the prior art of Beardall (WO 2014130392 A1) that teaches using workflow nodes for patient treatment however it did not teach automated navigation of data points based on accessed patient information for each node. The 103 rejection has 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 additional elements cannot be considered as well-understood, routine, or conventional as the MPEP 2106. 04(d)(1) recites “Step 2A excludes consideration of whether the additional elements represent well-understood, routine, conventional activity”. No such recitation exists in MPEP 2106.04(d)(1). However, 2106.04(d)(1) does recite: “the ‘improvements’ analysis in Step 2A determines whether the claim pertains to an improvement to the function 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 in to 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”. 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). Improved data 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.
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 and the 101 rejection is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Beardall (WO 2014130392 A1) teaches using workflow nodes for patient treatment however it did not teach automated navigation of data points based on accessed patient information for each node.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.A.S./Examiner, Art Unit 3686
/JASON B DUNHAM/Supervisory Patent Examiner, Art Unit 3686
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