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 .
Notice to Applicant
Claims 1, 2, 4-11, 13-20 have been amended. Claims 3 and 12 have been canceled. Claims 21 and 22 are new. Now, claims 1, 2, 4-11, 13-22 are pending.
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 12, 4-11, and 13-22 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, 2, 4-9, 21, and 22 are drawn to a method, claims 10, 11, and 13-18 are drawn to a system, and claims 19-20 are drawn to a non-transitory computer-readable storage media which are one of the statutory categories of invention.
Independent claims 1, 10, and 19 recites a method, a system, and/or a non-transitory computer-readable storage media comprising the following:
Receiving a plurality of system data sets;
Receiving a plurality of user data sets associated with a plurality of respective users;
Determining by applying one or more filters to the plurality of system data sets;
Determining from among the plurality of users, one or more target users associated with each of the one or more target systems;
Determining from among the plurality of user data sets, one or more target user data sets associated with each of the one or more target users;
Transforming the plurality of target user data sets by (i) removing irrelevant or redundant data types from the plurality of data types, and (ii) converting the plurality of data formats into a standard format;
applying to the transformed plurality of target user data sets to generate a plurality of user-level scores for the plurality of target users indicative of a likelihood of protocol change from the first protocol to a second protocol different from the first protocol;
generating based on at least a subset of the plurality of user-level scores the plurality of target users, a system-level score for the target system; and
initiating performance of one or more actions in association with the target system based on the system-level score.
These steps amount to resource allocation which are functions performable in the mind or with pen and paper and are only concepts relating to organizing or analyzing information in a way that can be performed mentally or is analogous to human mental work (MPEP § 2106.04(a)(2)(III)(B) citing the abstract idea grouping for mental processes with or without physical aid).
Claim 1 does recite additional elements:
by one or more processors;
a plurality of systems;
a target system;
a plurality of data sources;
a machine-learning model.
These additional elements merely amount to the general application of the abstract idea to a technological environment (“by one or more processors”; “a plurality of systems”; “a target system”; “a plurality of data sources”; “a machine-learning model”) and insignificant pre-and-post solution activity (receiving, determining, transforming, applying, generating, initiating). The specification makes clear the general-purpose nature of the technological environment. Paragraphs 33, 122, and 131 indicate that while exemplary general purpose systems may be specific for descriptive purposes, any elements or combinations of elements capable of implementing the claimed invention are acceptable. That is, the technology used to implement the invention is not specific or integral to the claim.
Therefore, considered both individually and as an ordered combination, the additional elements do no more than generally link the use of the abstract idea to a particular technological environment or field of use. That is, given the generality with which the additional limitations are recited, the limitations do not implement the abstract idea with, or use the abstract idea in conjunction with, a particular machine or manufacture that is integral to the claim. Additionally, the claims do not reflect an improvement in the functioning of a computer, or an improvement to other technology or technical field, do not apply or use the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition, do not effect a transformation or reduction of a particular article to a different state or thing; and do not apply or use the abstract idea in some other meaningful way beyond generally linking the use of the abstract idea to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the abstract idea. Accordingly, the Examiner concludes that the claim fails to integrate the abstract idea into a practical application, and is therefore “directed to” the abstract idea.
Under step 2B of the Alice/Mayo framework, it must finally be considered whether the claim includes any additional element or combination of elements that provide an inventive concept (i.e., whether the additional element or elements are sufficient to amount to significantly more than the abstract idea). As indicated above, considered both individually and as an ordered combination, the additional elements do not implement the abstract idea with, or use the abstract idea in conjunction with, a particular machine or manufacture that is integral to the claim, do not reflect an improvement in the functioning of a computer, or an improvement to other technology or technical field, do not apply or use the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition, do not effect a transformation or reduction of a particular article to a different state or thing, and do not apply or use the abstract idea in some other meaningful way beyond generally linking the use of the abstract idea to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the abstract idea
Further, the additional elements (recited above) simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. Communicating information (i.e., receiving or transmitting data over a network) has been repeatedly considered well-understood, routine, and conventional activity by the Courts (See MPEP 2106.05(d)). Accordingly, the Examiner asserts that the additional elements, considered both individually, and as an ordered combination, do not provide an inventive concept, and the claim is ineligible for patent.
Independent Claims 10 and 19 are parallel in scope to claim 1 and ineligible for similar reasons.
Dependent claims
Dependent Claims 1, 2, 4-9, 11, 13-18, and 20-22 add further limitations which are also directed to an abstract idea.
For example, Claims 7 and 25 sets forth:
Claims 7 and 16 set forth:
wherein each user data set of the plurality of user data sets includes a time-series data set, the time-series data set comprising a chronological sequence of entries, each entry corresponding to one or more protocols associated with the user and arranged according to an order in which the one or more protocols were employed or recorded.
Such a recitation merely embellishes the abstract idea of allocating resources, which are functions performable in the mind or with pen and paper and are only concepts relating to organizing or analyzing information in a way that can be performed mentally or is analogous to human mental work. As such, it does not integrate the abstract idea into a practical application, and does not provide an inventive concept. Accordingly, the claims do not confer eligibility on the claimed invention and are ineligible for similar reasons to claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The 35 U.S.C. 102(a)(1) rejections of claims 1-20 as being anticipated by United States Patent Application Publication Number 2021/0202103, Bostic, et al., hereinafter Bostic are hereby withdrawn to the amendments filed on December 23, 2025.
Response to Arguments
Applicant's arguments filed December 23, 2025 have been fully considered but they are not persuasive.
Applicant argues that the independent claims do not fall within the “Mental Process” grouping or any other subject matter groupings under Prong One of Step 2A and are therefore, patent eligible subject matter.
In response, Examiner respectfully disagrees. The claims as written are directed towards resource allocation, specifically identifying and prioritizing healthcare providers who are most likely to prescribe a specific drug/protocol. These steps amount to functions performable in the mind or with pen and paper and are only concepts relating to organizing or analyzing information in a way that can be performed mentally or is analogous to human mental work (MPEP § 2106.04(a)(2)(III)(B) citing the abstract idea grouping for mental processes with or without physical aid).
The additional elements merely amount to the general application of the abstract idea to a technological environment. Accordingly, the claims do not recite additional limitations that integrate the exception into a Practical Application, and the application of the abstract idea is therefore not eligible.
Applicant argues that at least the transforming element is an additional element that, when evaluated together and in further combination with remaining elements of the independent claims, reflects an improvement to technology, including an improvement to the model, and thus integrates the alleged abstract into a practical application.
In response, Examiner respectfully disagrees. The claims do not integrate the abstract idea into a practical application, and do not include additional elements that provide an inventive concept (are sufficient to amount to significantly more than the abstract idea). (Digitech Image Tech., LLC v. Electronics for Imaging, Inc. (Fed. Cir. 2014)). This judicial exception is not integrated into a practical application. In particular, the claim only recites additional elements of “by one or more processors”; “a plurality of systems”; “a target system”; “a plurality of data sources”; “a machine-learning model”. The elements in each of these independent claims are recited at a high-level of generality (i.e., “by one or more processors”; “a plurality of systems”; “a target system”; “a plurality of data sources”; “a machine-learning model”), such that the claims are directed to utilizing general purpose computer components (Application Specification [0032], [0121], and [0132])). As such, the limitations amount to no more than 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).
The present claims in the instant application are not analogous to Ex Parte Desjardins. The present claims are drawn to determining resource allocation and not to improving system performance. Examiner would also like to note that the decision in Ex Parte Desjardins does not nullify the decision rendered in Alice.
As a result, there are no meaningful limitations in the claim that transform the exception into a patent eligible application such that the claim amounts to significantly more than the exception itself, and the claims are properly rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter. Thus, the claims do not recite additional limitations that integrate the exception into a Practical Application.
Conclusion
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Adaptive data collection in clinical trials to increase the likelihood of on-time completion of a trial (US 11789837 B1) teaches managing and adapting monitoring programs. In some implementations, a system communicates with a set of remote devices involved in a monitoring program that involves collection of data from the remote devices over a communication network.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amber Misiaszek whose telephone number is 571-270-1362. The examiner can normally be reached M-F 8:00-5:30, First Friday Off.
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/AMBER A MISIASZEK/Primary Examiner, Art Unit 3682