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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/8/2026 has been entered.
Response to Arguments
Applicant's arguments and amendments filed 5/8/2026 have been fully considered but they are not persuasive. The Applicant amended the claims to use a probabilistic with hidden or partially observed physiological variables to overcome the 101 rejection. The Examiner respectfully disagrees. A real-time automatic determination does not provide strict time limitations; it essentially means processing/analyzing the data as it is received. Probabilistic models with hidden layers/variables are considered well-known and conventional in the art in view of Barbour (US 2018/0110458 A1) eg. Para. 274 and Batchinsky (US 2015/0150517 A1) eg. Para. 39 such as using derived physiological parameters in probabilistic models in determining patient statuses. To reiterate the previous action, the claims recite collecting, aggregating, and storing patient data (extrasolution activity of mere data gathering) and monitoring and determining the patient data for compliance and eligibility (data analysis and determination, use of probabilistic models is mathematical calculations), and outputting a result on a screen (extrasolution activity of data outputting). The analysis of data and making determinations about them as claimed does not recite limitations that would preclude a person from performing these steps mentally. The Examiner interprets the abstract ideas as a trained physician analyzing a collection of data over a period of time and making decisions about whether a person has been above a threshold for a certain amount of time and using mathematical models (mathematical calculations) to make those determinations. The claims do not contain language that would amount to significantly more than the abstract ideas highlighted in the rejection. Looking at the computer limitations, the claims don't recite any limitations that would amount to more than what are generic computer functions nor would improve the functioning of a computer. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
The Examiner recommends adding in claim language that improves the machine learning model and/or improvements to a computer component of system performance based on adjustments to parameters of a machine learning model associated with tasks or workstreams (see Ex Parte Desjardins), or an active treatment step. The 101 rejection is maintained below.
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 1-20 are rejected under 35 U.S.C. 101 because of the following analysis:
Step 1: Do the claims recite one of the statutory categories of matter (i.e. method, apparatus, etc.)? YES, 1-9 and 19-20 recite an apparatus and claims 10-17 recite a method.
Step 2A Prong 1: Is there an abstract idea involved? YES, the claim language recites determining patient eligibility and compliance with a medical protocol, receive patient data from sensors, and determine a dynamic concordance rate. These limitations, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in mind or by a person using a pen and paper.
Step 2a Prong 2: Do the claims recite additional elements that integrate the exception into a practical application? NO, the claims recite a sensor, medical library, and medical device interface, which are well-known, routine and conventional structure in monitoring patients. The medical library and medical device interface are recited at a high level of generality and is recited as performing generic computer functions. i.e., data processing and display. The elements amount to 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 2106.04(d) and 2106.05(f)). Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea.
Step 2B: Do the additional elements amount to “Significantly More” than the judicial exception?
The emphasized elements cited above do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’I, 110 USPQ2d 1976 (2014)).
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1, 10, and 19 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1-20 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1-20 amounts to significantly more than the abstract idea itself.
Accordingly, Claims 1-20 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 PM.
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/MICHAEL J LAU/Examiner, Art Unit 3796
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