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 .
DETAILED ACTION
This action is in reference to the communication filed on 18 NOV 2025.
Amendments to claims 1, 7, 13, entered and considered, as is the prior cancellation of claims 2,6, 8, 12, 14, 18.
Claims 1, 3-5, 7, 9-11, 13, 15-17 are still 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, 3-5, 7, 9-11, 13, 15-17 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 claims 1, 3-5, 7, 9-11, 13, 15-17, the independent claims 1, 7, 13, each recite 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 claims 1, 3-5, 7, 9-11, 13, 15-17, the independent claims (claims 1, 7, 13) are directed, in part, “a method for enabling a data driven clinical decision support system….comprising: receiving data associated with one or more users for a condition and one or more biomarkers, wherein the data is collected from each of the one or more users; generating an interactive visualization of one or more progression trajectories…wherein the visualization integrates Gaussian process models for user guided exploration of disease progression patterns from longitudinal observational data in real time; determining by the probabilistic modeling each of the one or more progression trajectories based on one or more differences…using Hidden Markov Models…wherein the HMM incorporates constraints…; mapping a plurality of endotypes…from each of the one or more progression trajectories…and wherein the interactive visualization allows user to explore and filter the progression trajectories…; identifying a presymptomatic stage from the one or more progression trajectories…; predicting a particular user is in the presymptomatic stage of the condition, based on identifying one or more particular biomarkers…; generating a risk assessment for development of the condition…based on receiving new user data associated with the particular user; identifying a risk level for the particular user developing the condition, wherein the risk level is calculated using a support vector machines derived from data for the presymptomatic endotype; comparing the risk level to a threshold; and based on the risk level exceeding the threshold, recommending one or more personalized interventions….comprising continued monitoring… information regarding lifestyle changes…or matching the one or more users to a clinical trial for a new treatment…”.
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. Receiving information, determining, identifying, and generating information are all concepts performed in the human mind. Receiving the information, and using the information to make identifications, predictions, a risk assessment, identifying a risk level, comparing a risk level, and making a personalized intervention to a user all involve the concepts as identified above. Examiner notes that the filtering limitation as added is similarly found to identify concepts such as evaluation, judgement, and observation(s).
Examiner further finds that the use of a hidden Markov modeling and the related limitations, the use of a gaussian process model, and the limitations pertaining to the mapping of the progression trajectories and application to a given user’s biomarkers, are also a mathematical concept – i.e. a mathematical relationship, formula/equation, or calculation. Modeling and applying the model falls amidst a mathematical equation/calculation/relationship.
If a claim limitation, under its broadest reasonable interpretation, covers a concept performed in the human mind, and/or a mathematical concepts, then it/they falls/ fall into the “mental processes” or “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 recites additional element – claim 1 includes a “computer” as well as a processor, claim 7 recites a system comprising a memory and a processor, with claim 13 reciting a computer program product comprising a computer readable storage medium having program instructions embodied therewith, the program instructions executable by a processor to cause the processor to perform operations, each to execute the claimed limitations. In the interest of compact prosecution, Examiner notes the independent claims each also recite a “visual analytics system.” The computer, processor, memory, and computer program product in each of the claims is recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception to implement an abstract idea on a computer, or merely using a computer as a tool to perform the abstract idea(s) identified (See MPEPE 2106.05f), or, generally linking the use of the judicial exception to a particular technological field (i.e. computing technology) (see MPEP 2106.05h). Similarly, Examiner finds the visual analytics system is also at best analogous to adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f). Examiner further notes that while no display itself is claimed in the newly amended limitations, displaying information is often found to be insignificant extra solution activity (see MPEP 2106.05g). Accordingly, this additional element does 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 claims are additionally directed to claim elements such as: claim 1 includes a “computer” as well as a processor, claim 7 recites a system comprising a memory and a processor, with claim 13 reciting a computer program product comprising a computer readable storage medium having program instructions embodied therewith, the program instructions executable by a processor to cause the processor to perform operations, each to execute the claimed limitations. In the interest of compact prosecution, Examiner notes the independent claims each also recite a “visual analytics system.” When considered individually, the “computer, processor, memory, and computer program product” 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 (See MPEP 2106.05a).
Examiner looks to Applicant’s specification in [fig 4 and related text] FIG. 4, illustrated is a high-level block diagram of an example computer system 401 that may be used in implementing one or more of the methods, tools, and modules, and any related functions, described herein (e.g., using one or more processor circuits or computer processors of the computer), in accordance with embodiments of the present disclosure. In some embodiments, the major components of the computer system 401 may comprise one or more CPUs 402, a memory subsystem 404, a terminal interface 412, a storage interface 416, an I/O (Input/Output) device interface 414, and a network interface 418, all of which may be communicatively coupled, directly or indirectly, for inter-component communication via a memory bus 403, an I/O bus 408, and an I/O bus interface unit 410… The computer system 401 may contain one or more general-purpose programmable central processing units (CPUs) 402A, 402B, 402C, and 402D, herein generically referred to as the CPU 402. In some embodiments, the computer system 401 may contain multiple processors typical of a relatively large system; however, in other embodiments the computer system 401 may alternatively be a single CPU system. Each CPU 402 may execute instructions stored in the memory subsystem 404 and may include one or more levels of on-board cache.”
At [021] “In some embodiments, the one or more progression trajectories may be assessed using visual analytics methods. In some embodiments, the processor may utilize visual analytics methods to explore and discover patterns from longitudinal data in clinical studies. In some embodiments, the processor may utilize visual analytic methods to represent temporal event sequences. In some embodiments, visual analytic methods may allow users (e.g., clinicians) to steer the algorithm by user interactions, so that users can find meaningful summaries of event sequences.”
These passages, as well as others, makes it clear that the invention is not directed to a technical improvement. The claims and the specification do not recite anything beyond mere application of the computing environment, including any applicability to the visual analytics. (See MPEP 2106.05f), nor is the computing technology any recitation of a particular machine or transformation. 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 (see MPEP 2106.05h, 2106d). 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. Examiner again notes that displaying information is insignificant extra solution activity (see MPEP 2106.05g). The fact that the generic computing devices are facilitating the abstract concept is not enough to confer statutory subject matter eligibility.
Dependent claims 3,4, 9, 10, 15, 16, directed to additional mental processes including identifying, analyzing, indicating, and visualizing different types of data and or conclusions. These processes are similar to the abstract idea noted in the independent claims because they further the limitations of the independent claim which are directed to a method of organizing human activity which include mental processes. These claims provide helpful context in that they identify the types of risks and calculations executed, however they are insufficient to amount beyond mere description. Accordingly, these claim elements do not serve to confer subject matter eligibility to the claims since they are directed to abstract ideas.
Dependent claims 5, 11, 17 are not directed any additional abstract ideas, however they do nominally recite the use of a Markov model. However, the addition is insufficient to amount to a practical application as it is found to be a mere application rather than an improvement or transformation. Further, it is insufficient to amount to significantly more than the abstract idea, in that again, it is recited as a mere application thereof instead of meaningful limitation. The claims recite an abstract idea without significantly more.
Response to Arguments
Applicant’s remarks as filed on 18 NOV 2025 have been fully considered.
Applicant’s remarks regarding the 101 rejection begin on page 9, with various elements of USPTO Guidance regarding subject matter eligibility through page 10 of the remarks.
Applicant includes a reproduction of exemplary claim 1 on page 11, Examiner notes Applicant’s amendments have been incorporated into the rejection above.
Applicant argues that the abstract idea(s) identified do not fall within the subject matter groupings. Examiner respectfully disagrees, and notes that these concepts were identified above with respect to the mental processes category/grouping. Examiner also notes that the elements that were identified as mathematical concepts were similarly identified above.
Applicant then turns to a discussion of the practical application step of the analysis on page 12. Examiner does not find an improvement therein, contrary to the remarks on page 12 – use of a specifically named model is not itself sufficient to support a finding of a practical application. The use of a Gaussian process/HMM improving “medical accuracy” is not, as stated by Applicant – “in the functioning of a computer or an improvement to other technology or technical field.” Contrary to Applicants portions of the specification on page 13, calculating risk is not itself a technical field or endeavor. These purported improvements are worthy goals, and are implemented with technology, but the claims themselves do not specifically improve the technology itself.
Examiner respectfully disagrees with Applicant’s conclusion on page 13, and further respectfully disagrees with the remarks regarding the dependent claims, at least in view of the rejection above. Examiner notes Applicant does not provide discussion regarding a finding of significantly more.
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 Monday - Friday.
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/KATHERINE . KOLOSOWSKI-GAGER/
Primary Examiner
Art Unit 3687
/KATHERINE KOLOSOWSKI-GAGER/Primary Examiner, Art Unit 3687
Prosecution Insights