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
In the reply filed on 09 February 2026, the following changes have been made: amendments to claims 1 and 2.
Claims 1-8 are currently pending and have been examined.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/240,744 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. For claim 3, the prior-filed application does not provide support for wherein the channel is selected based, at least in part, on one or more permissions associated with providing communications to the member via one or more channels. While [0035] of the specification states permissions, that is with respect to respect to accessing and receiving data, it does not deal with channel selection as in claim 3. For claim 4, the prior-filed application does not provide support for wherein the channel is selected based, at least in part, on a capacity of the channel in association with providing communications to the member or the provider. Examiner cannot find disclosure for this claimed feature in the prior filed application. For claim 6, the prior-filed application does not provide support for wherein the channel is selected based, at least in part, on a set of rules associated with providing communications to the member and the provider. Examiner cannot find disclosure for this claimed feature in the prior filed application.
Accordingly, claims 3-4 and 6 are not entitled to the benefit of the prior application.
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 1-8 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.
Step 1
The claim(s) recite(s) subject matter within a statutory category as a process (claims 1-8).
INDEPENDENT CLAIMS
Step 2A Prong 1
Claim 1 recites steps of
determining, by one or more processors, a current gap-in-care for the member, wherein the current gap-in-care for the member is defined as a difference between a current health-related behavior of the member and a guideline behavior for the member;
receiving a response to a database query, the response including a number of feature vectors associated with a plurality of members;
filtering, by the one or more processors, the feature vectors of the response to reduce the number of feature vector;
processing, by the one or more processors, the filtered feature vectors using a trained machine learning model to generate, for each channel of a plurality of channels, a probability of at least partially closing the current gap-in-care within a clinically-defined period of time for the member;
determining, by the one or more processors, for each channel, a clinical impact associated with at least partially closing the current gap-in-care for the member, by estimating an effect of the clinical impact on the member using the probability of at least partially closing the current-gap-in-care;
determining, by the one or more processors, a gap-in-care closure rate for the member;
selecting, by the one or more processors, the channel from the plurality of channels based, at least in part, on a combination of the probability of at least partially closing the current-gap-in-care, the determined clinical impact associated with at least partially closing the current gap-in-care for the member; and the gap-in-care closure rate for the member;
and
using the selected channel to transmit an electronic message to at least one of the member and a provider, wherein the electronic message comprises data associated with one or more actions for the member to take in connection with at least partially closing the current gap-in-care for the member and an impact associated with taking the one or more actions.
These steps for determining channel selection to address gap in care for the member, as drafted, under the broadest reasonable interpretation, includes methods of organizing human activity. That is nothing in the claim element precludes the italicized portions from managing personal behavior or relationships or interactions between people through managing the interactions between the member and provider to address the gap in care for the member. This could be analogized to considering historical usage information while inputting data. The italicized portions containing the recitation of filtering feature vectors, processing feature vectors, and generating a probability have been treated as part of the abstract idea, specifically as mathematical calculations which falls within the abstract idea of mathematical concepts, in light of the 2024 USPTO AI Guidance. If a claim limitation, under its broadest reasonable interpretation, covers performance as organizing human activity and mathematical calculations but for the recitation of generic computer components, then it falls within the “Methods of Organizing Human Activity” and “Mathematical Concepts” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A Prong 2
This judicial exception is not integrated into a practical application. In particular, the additional elements, non-italicized portions identified above for claim 1 do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception (such as by one or more processors; using a machine learning model; and, using the selected channel to transmit an electronic message amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of receiving a response to a database query amounts to mere data output since it does not add meaningful limitations to the receiving performed, see MPEP 2106.05(g))
Each of the above additional element(s) therefore only amounts to mere instructions to implement functions within the abstract idea using generic computer components or other machines within their ordinary capacity, and add insignificant extra-solution activity to the abstract idea. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. These elements are therefore not sufficient to integrate the abstract idea into a practical application. Therefore, the above claims, as a whole, are directed to an abstract idea.
Step 2B
The claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than add insignificant extra-solution activity. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to mere instructions to apply an exception in particular fields such as using a machine learning mode, e.g., requiring the use of software to tailor information and provide it to the user on a generic computer, Intellectual Ventures I LLC v. Capital One Bank., MPEP 2106.05(f); by one or more processors; and, using the selected channel to transmit an electronic message, e.g., a commonplace business method or mathematical algorithm being applied on a general-purpose computer, Alice Corp. v. CLS Bank, MPEP 2106.05(f).
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields such as recitation of receiving a response to a database query, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i).
Looking at the limitations as an ordered combination 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 or improves any other technology. Their collective functions merely provide generic computer implementation.
DEPENDENT CLAIMS
Step 2A Prong 1
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2-8 particular aspects for determining channel selection to address gap in care for the member such as
[Claim 2 wherein determining the gap-in-care closure rate for the member comprises one or more of the following:
measuring an average closure rate through a randomized control trial experimentation;
predicting an average closure rate, regressed post-hoc using a causal inferential approach; and
deriving the closure rate for the member from the machine learning model;
[Claim 3] wherein the channel is selected based, at least in part, on one or more permissions associated with providing communications to the member via one or more channels;
[Claim 4] wherein the channel is selected based, at least in part, on a capacity of the channel in association with providing communications to the member or the provider;
[Claim 5] wherein the channel is selected based, at least in part, on a cost associated with providing the electronic message using the channel;
[Claim 6] wherein the channel is selected based, at least in part, on a set of rules associated with providing electronic messages to the member and the provider;
[Claim 7] wherein the one or more actions comprise at least one of the following:
instructing the member to talk to a care provider;
instructing the care provider to talk to the member;
instructing the member to talk to a pharmacist;
instructing the member to self-monitor a health indicator;
instructing the member on lifestyle management;
instructing the member to obtain a medical screening;
instructing the member for medical adherence;
querying the member to achieve a medication optimization; and
a digital outreach;
[Claim 8] wherein the selected channel comprises at least one of:
a selected pharmacist;
a health hub;
a clinic;
a direct communication;
a digital application;
a trained team outreach;
an in-home assessment; and
a provider outreach;
these italicized portions covers performance as organizing human activity since they merely describe types of data and determinations performed by humans). The italicized portion containing the recitation of deriving from the machine learning model has been treated as part of the abstract idea, specifically as mathematical calculations which falls within the abstract idea of mathematical concepts, in light of the 2024 USPTO AI Guidance.
Step 2A Prong 2
Dependent claims 7-8 recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (the additional limitations in claim 7 (a digital outreach); and, claim 8 (a digital application) amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f))). Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B
Dependent claims 7-8 recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea, e.g., a commonplace business method or mathematical algorithm being applied on a general-purpose computer, Alice Corp. v. CLS Bank, MPEP 2106.05(f). Also, see [0052] which provides an example of an off-the-shelf system buses, [0054] which provides examples of off-the-shelf processors, [0065] which provides examples of off-the-shelf memory devices, and [0033] which provides examples of off-the-shelf personal computing devices. There is no indication that these additional elements improve the functioning of a computer or improves any other technology. Their collective functions merely provide generic computer implementation.
Response to Arguments
The arguments filed on 09 February 2026 have been considered, but are not fully persuasive.
Regarding the double patenting rejection, applicant has filed a Terminal Disclaimer which has been approved by the USPTO. Therefore, the double patenting rejection has been withdrawn.
Regarding the USC 101 rejection, applicant argues on pages 9 to 11 for Step 2A Prong 1 that the claim 1 does not recite a judicial exception and does not include limitations directed to mathematical calculations, mental process, or methods of organizing human activity. Applicant points to the feature of receiving a response from a database query and asserts that it does not involve mathematical relationships or formulas and cannot be interpreted as such. Applicant then asserts that the feature of filtering the feature vectors begins to incorporate the features of the claim into a practical application. Applicant also asserts that the feature of generating probabilities does not involve mathematical relationships or formulas and instead are outputs of a trained machine learning model processing a feature vector; that they are used in a concrete selection process and directly result in a transmitted electronic message. Applicant asserts that the amended claims describe a specific, computer-implemented method of processing structured healthcare data to select a communication channel using machine learning; that the claims apply to data-driven technology to determine how best to deliver individualized communications to support medical adherence and gap closure. Applicant states that the features of claim 1 requires machine-based computation where the use of a trained machine learning model alone is sufficient to remove the claim from a mental process category. Applicant states that the USC 101 should be withdrawn.
Examiner disagrees with the applicant’s arguments. Examiner first points out that
improvements to computer functionality or practical application is not a consideration under Step 2A Prong 1, but rather under Step 2A Prong 2. The feature of receiving a response from a database query has been treated as data gathering and further examined under Step 2A Prong 2. As indicated in the rejection, the argued filtering of feature vector limitation and probability limitation were treated under the mathematical concepts abstract idea in light of the 2024 USPTO AI Guidance. Examiner again asserts that tacking on generic language of machine learning (which the applicant did not contend they invented), feature vectors, and probability without delineating the algorithmic steps explaining the “how” that is unique to the machine learning does not automatically save the claims from USC 101. Examiner has considered the recitation of using the machine learning as an additional element under Step 2A Prong 2. MPEP 2106 is clear in that claims can recite an abstract idea even if they are claimed as being performed on a computer. If the applicant’s claims truly weren’t directed to methods of organizing human activity, then the claims wouldn’t be directed towards determining how best to deliver individualized communications to support medical adherence and gap closure (but that is not the case presently). The computer components recited in the present application are still recited at a high level of generality. The computers in the claims are not used in a specific, inventive way. Again, the claims are very outcome-focused and do not detail how each of the outcomes are exactly reached. The present machine learning claimed is a black box model with no clarity on the actual computer processing or how the computer is programmed to achieve the results in a non-abstract way different from how humans analyze/process data. Merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions does not automatically overcome an eligibility rejection. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 224, 110 USPQ2d 1976, 1984 (2014). See also OIP Techs. v. Amazon.com, 788 F.3d 1359, 1364, 115 USPQ2d 1090, 1093-94 (Fed. Cir. 2015) ("Just as Diehr could not save the claims in Alice, which were directed to ‘implement[ing] the abstract idea of intermediated settlement on a generic computer’, it cannot save OIP's claims directed to implementing the abstract idea of price optimization on a generic computer.") (citations omitted). Even if the claims nominally recites computer components that are rooted in technology, there is no recitation of how the computer components are specifically programmed to distinguish from generic computer processes. Thus, the present claim(s) are still not eligible under Step 2A Prong 1.
On pages 11 to 12 the applicant argues that for Step 2A Prong 2 the claims integrate any such abstract idea into a practical application. Specifically, that the method includes significant data processing steps that go beyond trivial
or conventional activities. Applicant asserts that claim 1 is a technical solution to a concrete problem in healthcare gap management. Applicant also asserts that the processing step is not a generic recitation of "apply a model," but a clearly
defined application of machine learning to derive probabilities used in downstream decisions. Citing [0020]-[0024] with respect to channel efficacy or patient-specific clinical considerations, the applicant states that the claim 1 provides a specific technological solution that addresses a known problem in healthcare systems: poor or non-optimized communication for closing care gaps.
Applicant states that the method yields a concrete and useful result: the transmission of an electronic message over a selected channel to a recipient. Applicant requests withdrawal of the USC 101 rejection.
Examiner disagrees with the applicant’s arguments. Further analyzing the additional elements under Step 2A Prong 2, examiner asserts that the specification provides a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art. The MPEP provides that improvements to the functioning of a computer or to any other technology or technical field can signal eligibility, see MPEP 2106.05(a), and provides examples of improvements to computer functionality, MPEP 2106.05(a)(I), and improvements to any other technology of technical field, MPEP 2106.05(a)(I). “In computer-related technologies, the examiner should determine whether the claim purports to improve computer capabilities or, instead, invokes computers merely as a tool”. Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1336, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016). In Enfish, the court evaluated the patent eligibility of claims related to a self-referential database. Id. The court concluded the claims were not directed to an abstract idea, but rather an improvement to computer functionality. Id. It was the specification' s discussion of the prior art and how the invention improved the way the computer stores and retrieves data in memory in combination with the specific data structure recited in the claims that demonstrated eligibility. 822 F.3d at 1339, 118 USPQ2d at 1691. The claim was not simply the addition of general-purpose computers added post-hoc to an abstract idea, but a specific implementation of a solution to a problem in the software arts. 822 F.3d at 1339, 118 USPQ2d at 1691. Unlike Enfish, the instant claimed invention appears to improve upon a judicial exception rather than a problem in the software arts. Rather than improving a computer's algorithm (i.e., solving a technically based problem), the claimed invention purports to solve the non-technological problem of gap-in-care ([0003] of the specification) through determining how best to deliver individualized communications to support medical adherence and gap closure. The applicant’s main/glaring issue is that specification does not show or describe a deficiency in computer technology; applicant is certainly not inventing a new communications system to address care gaps. Additionally, the applicant’s assertion in the present arguments of the problems of optimal channel efficacy or patient-specific clinical considerations are not problems associated with computer technology, but rather with the care process. Applicant is simply using computers as a tool to improve upon the judicial exception.
The examiner asserts the following facts:
1) the invention does NOT involve a novel algorithm or data structure that significantly improves the computer's functionality,
2) the invention does NOT involve a new hardware component or configuration that works with the computer to achieve a specific technical benefit, and
3) the computer is NOT used in a completely new way demonstrating a significant technical advancement. Improvement to the abstract idea is not an improvement to computer technology. Thus, examiner does not see how the present claims improve the functioning of a computer or provide improvements to any other technology or technical field. As hinted by the applicant in their arguments on pg. 12 (regarding data processing steps), all the applicant is indeed doing is applying existing/generic machine learning model(s)/techniques to a new data environment and calling it an improvement. Applicant’s amended claim does not show any improvement to the additional element(s), rather applicant is clearly applying/using machine learning for its intended and well-known benefits. It also does not seem the applicant is doing any algorithmic modification in the claims other than applying off-the-shelf machine learning. Examiner is not persuaded by the applicant’s assertion of a concrete and useful result; nowhere in the MPEP are these listed as considerations that help demonstrate practical application. The claimed invention appears similar to the example of improvements that are insufficient to show an improvement in computer-functionality such as arranging transactional information on a graphical user interface in a manner that assists traders in processing information more quickly, Trading Technologies v. IBG LLC, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019). See MPEP 2106.05(a)(I)(viii). The asserted benefits from the applicant’s invention seem to come as a result of the use of general-purpose computers. The broad claims are lacking concrete limitations to integrate the abstract idea into a practical application. Examiner points out that the claimed limitations have no indication in the specification that the operations recited invoke any inventive programming, require any specialized computer hardware or other inventive computer components, i.e., a particular machine, or that the claimed invention is implemented using other than generic computer components to perform generic computer functions. See DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1256 (fed Cir. 2014) (“[A]fter Alice, there can remain no doubt: recitation of generic computer limitations does not make an otherwise ineligible claim patent-eligible.”). Most importantly, in DDR Holdings & unlike the present claims, the claims at issue specified how interactions with the Internet were manipulated to yield a desired result—a result that overrode the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink. 773 F.3d at 1258; 113 USPQ2d at 1106. The examiner also points out that there is no indication in the specification that the claimed invention affects a transformation or reduction of a particular article to a different state or thing. Examiner points to the recitation of machine learning in the claim(s) as generic. "[T]he mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention." Alice Corp. v. CLS Banklnt'l, 573 U.S. 208 223 (2014). Applicant does not and cannot contend they invented the concept of machine learning, nor does the specification disclose any new machine learning technique. In fact, the specification [0055] recognizes known machine learning models in the art. The alleged improvement of using the machine learning model lies in the abstract idea itself, not to any technological improvement nor to any improvement to the functioning of a computer. See BSG Tech LLC v. Buyseasons, Inc., 899 F.3d 1281, 1287-88 (Fed. Cir. 2018). The present claims do not delineate steps through which the machine learning technology achieves an improvement. To show an involvement of a computer assists in improving technology, the claims must recite details regarding how a computer aids the method, the extent to which the computer aids the method, or the significance of a computer to the performance of the method. Merely adding generic computer components to perform the method is not sufficient. Thus, the claim must include more than mere instructions to perform the method on a generic component or machinery to qualify as an improvement to an existing technology (MPEP 2106.05(a)(II)). In Finjan, Inc. v. Blue Coat Systems the courts found that the claims were “directed to a non-abstract improvement in computer functionality…” (MPEP 2106.04(d)). The present invention does not meet the condition set forth by the courts and thus does not integrate the judicial exception into a practical application. The claims are clearly not eligible under Step 2A Prong 2.
On pages 12 to 13 the applicant argues that for Step 2B the claims do not simply "use a computer," but require a machine learning model to make sophisticated channel selection decisions. Applicant states that the method involves a
trained machine learning model operating on a feature vector to generate channel-specific probabilities that goes beyond what is well-understood, routine, and conventional in the field. Applicant states that the channel selection and communication step demonstrates real-world utility and integration of the results into a healthcare workflow. Applicant requests withdrawal of the USC 101 rejection.
Examiner disagrees with the applicant’s arguments. Examiner points out that the “apply it” and “well-understood, routine, and conventional” analysis was performed under Step 2B which didn’t result in the claim being eligible under USC 101. In comparison to Bascom, examiner points out that Bascom is not similar to the present application because Bascom claimed a technical improvement in the art i.e., a technology-based solution to filter content on the internet while the present application is not presenting an improvement (as indicated above). The use of a computer or other machinery in its ordinary capacity for economic or other tasks or simply adding a general-purpose computer or computer components after the fact to an abstract idea does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Examiner is not persuaded by the applicant’s assertion of real-world utility; nowhere in the MPEP is this listed as a consideration. The invention is presently not patent-eligible under USC 101. Therefore, the USC 101 rejection is strongly maintained.
Regarding the USC 103 rejection, the references of record are understood to be the closest prior art. For claim 1, while the combination of Anand et al. (US20200117860A1) in view of Holub et al. (US20210313063A1) and further in view of Luellen (US20180308569A1) teaches most of the limitations of the claim, the scope of the claims clarifies determining a gap-in-care closure rate for the member. This goes beyond any teachings or suggestions in the art. Therefore, the USC 103 rejection has been withdrawn.
Prior Art Cited but Not Relied Upon
The following document was found relevant to the disclosure but not applied:
Samal, L., Dykes, P. C., Greenberg, J. O., Hasan, O., Venkatesh, A. K., Volk, L. A., & Bates, D. W. (2016). Care coordination gaps due to lack of interoperability in the United States: a qualitative study and literature review. BMC health services research, 16, 1-8.
This reference is relevant since it discloses determination of gap in care from a clinician’s perspective as well as from a patient’s perspective.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WINSTON FURTADO whose telephone number is (571)272-5349. The examiner can normally be reached Monday-Friday 8:00 AM to 4:00 PM EST.
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/WINSTON R FURTADO/Examiner, Art Unit 3687