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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/13/2026 has been entered.
Response to Arguments
Applicant’s arguments and amendments regarding the 112 rejection, see pages 8-10, filed 4/13/2026, with respect to claims 1-20 have been fully considered and are persuasive. The 112 rejection of claims 1-20 has been withdrawn.
Regarding the Applicant’s arguments to the 101 rejection, the Examiner respectfully disagrees. The Applicant argued that the determination of a compliance rate for parameters of the active protocol is more than mere mental steps. A concordance rate is defined as the rate at which patient data is consistent with the compliance rules. A trained physician can learn compliance and eligibility rules beforehand, observe vitals data that has been collected, compare them to a past time, and calculate how long the patient's vitals have been above a threshold for a period of time to determine the next course of action. The visual display of results amounts to the insignificant extrasolution activity of mere data outputting (see MPEP 2106.05(g)). The Examiner recommends adding in claim language for a specific treatment step or improving a model. 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, Claims 1-8 and 15-20 recite an apparatus, claims 9-14 recite a method.
Step 2A Prong 1: Is there an abstract idea involved? YES, the claim language recites determining a patient to be eligible for a protocol (determination), determining a dynamic concordance rate for the active protocol as a function of the received patient a data and the compliance rules relating to the active protocol (mental process/mathematical calculations) and providing a recommendation for modifying the active protocol (determination) which are grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG.
Step 2a Prong 2: Do the claims recite additional elements that integrate the exception into a practical application? NO, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. The claims recite the additional elements of a computer and one or more sensors/medical devices. These limitations are generically recited computer elements in independent Claims 1, 9, and 15 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, alert module is recited in a broad manner to amount to necessary data gathering and outputting, which are insignificant extra-solution activities (see MPEP 2106.05(g)). For at least these reasons, the abstract idea identified above in independent Claims 1, 9, and 15 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B: Do the additional elements amount to “Significantly More” than the judicial exception? NO, 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)).
Further, dependent Claims 2-8, 10-14, and 16-20 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
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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