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
This action is in reply to the RCE filed on 06/16/26 and supplemental amendment filed on 08/04/2026.
Claims 98-111, 120 have been amended and are hereby entered.
Claims 121-129 have been added.
Claims 1-97, 112-119 have been canceled.
Claims 98-111, 120-129 are currently pending and have been examined.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/16/26 and 08/04/26 has been entered.
Continuity/Priority Date
Status of this application as a continuation of application 15/360,799, which claims priority to provisional application 62/365,317, filed 07/21/2016, is acknowledged. Accordingly, a priority date of 07/21/16 has been given to this 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 98-111, 120-129 are rejected under 35 U.S.C.101 because the claimed invention is directed to a judicial exception (an abstract idea) without significantly more.
Step 1
Claims 1-18 are drawn to a method, and Claim 19 is drawn to a computing system, both of which are within the four statutory categories. Claims 98-111, 120-129 are further directed to an abstract idea on the grounds set out in detail below.
Step 2A Prong 1
Claim 98 recites implementing the steps of:
(a) receiving, for a patient, baseline data acquired before an initial administration of a specialty drug for treatment of a disease or disorder and comprising disease-activity data and drug- or disease-specific diagnostic or theragnostic data;
(b) generating and providing a patient-specific administration instruction, and receiving patient-linked administration information documenting that the initial administration occurred;
(c) for each of one or more post-administration time points specified by a treatment protocol:
(i) receiving, for the patient, corresponding follow-up data acquired at the post- administration time point and comprising therapeutic-outcome data and drug- or disease-specific diagnostic or theragnostic data; and
(ii) determining a corresponding patient-specific therapeutic-effectiveness metric by comparing the baseline data with the corresponding follow-up data according to one or more disease-specific clinical or theragnostic criteria;
(d) developing and maintaining a therapeutic-effectiveness dataset representing one selected scope from among:
(i) the patient; (ii) a stratified subset of treated patients that includes the patient and is identified by applying one or more drug- or disease-specific clinical or theragnostic stratification criteria to respective clinical or theragnostic data of the treated patients; or (iii) a disease-specific treated population that includes the patient; wherein, for each post-administration time point, the therapeutic-effectiveness dataset comprises the corresponding patient-specific therapeutic-effectiveness metric and, under (ii) or (iii), patient-specific therapeutic-effectiveness metrics determined for one or more other treated patients in the selected scope at their respective post-administration time points; and updating the therapeutic-effectiveness dataset at each post-administration time point to associate the corresponding patient-specific therapeutic-effectiveness metric with the patient and the post-administration time point; and
(e) at each post-administration time point:
(i) accessing, from the updated therapeutic-effectiveness dataset, the patient- specific therapeutic-effectiveness metric or metrics represented for the selected scope, and applying a disease-specific therapeutic-effectiveness criterion to the accessed metric or metrics to determine a criterion result indicating whether the criterion is satisfied or maintained;
(ii) based on the criterion result and the accessed metric or metrics, determining, for the same selected scope; (A) a therapeutic-efficacy-assurance outcome; (B) a financial-assurance outcome; or (C) an outcome-based payment determination affecting an amount paid or payable for treatment with the specialty drug;
(iii) using the determined outcome or payment determination to generate a therapeutic-effectiveness output record that identifies the selected scope and the corresponding post-administration time point, specifies the criterion result, and:
(A) specifies an assurance status corresponding to, or authorizes implementation of, the therapeutic-efficacy-assurance outcome or the financial-assurance outcome; or
(B) specifies a payment status or payment amount corresponding to, or authorizes a payment transaction implementing, the outcome-based payment determination; and
(iv) updating the therapeutic-effectiveness dataset to associate the criterion result, the determined outcome or payment determination, and the output record with the selected scope, the accessed metric or metrics, and the corresponding post-administration time point
These steps amount to managing personal behavior or relationships or interactions
between people and therefore recite certain methods of organizing human activity. Receiving patient pre-treatment data, generating and providing an administration instruction and receiving documentation that the treatment was administered, receiving follow up data at various time points comprising therapeutic outcome data, diagnostic or theragnostic data, determining a corresponding therapeutic effectiveness metric, developing and maintaining a therapeutic-effectiveness dataset representing the patient, a stratified subset of treated patients, or disease-specific treated population, accessing patient specific therapeutic effectiveness metrics at each post-administration time point and applying disease-specific criterion to the metrics to determine a result for whether the criterion is satisfied or maintained, based on the result and metrics, determining an efficacy assurance outcome, a financial assurance outcome, or an outcome-based payment determination; using the determined outcome or payment determination to generate a therapeutic effectiveness output record that specifies an assurance status corresponding to the efficacy assurance or financial assurance outcome, or specifies a payment status; and updating the therapeutic effectiveness dataset to associate the criterion result, determined outcome or payment and output record with a selected scope, accessed metrics, and corresponding time point are personal behaviors that may be performed by healthcare providers or insurance providers.
Claim 105 recites implementing the steps of:
(i) receive, for a patient, baseline data acquired before an initial administration of a specialty drug for treatment of a disease or disorder and comprising disease-activity data and drug- or disease-specific diagnostic or theragnostic data;
(ii) generate and provide a patient-specific administration instruction, and receive patient-linked administration information documenting that the initial administration occurred;
(iii) for each of one or more post-administration time points specified by a treatment protocol:
(A) receive, for the patient, corresponding follow-up data acquired at the post- administration time point and comprising therapeutic-outcome data and drug- or disease-specific diagnostic or theragnostic data; and
(B) determine a corresponding patient-specific therapeutic-effectiveness metric by comparing the baseline data with the corresponding follow-up data according to one or more disease-specific clinical or theragnostic criteria;
(iv) develop and maintain a therapeutic-effectiveness dataset representing one selected scope from among: (A) the patient; (B) a stratified subset of treated patients that includes the patient and is identified applying one or more drug- or disease-specific clinical or theragnostic stratification criteria to respective clinical or theragnostic data of the treated patients; or (C) a disease-specific treated population that includes the patient; wherein, for each post-administration time point, the therapeutic-effectiveness dataset comprises the corresponding patient-specific therapeutic-effectiveness metric and, under (B) or (C), patient-specific therapeutic-effectiveness metrics determined for one or more other treated patients in the selected scope at their respective post-administration time points; and update the therapeutic-effectiveness dataset at each post- administration time point to associate the corresponding patient-specific therapeutic- effectiveness metric with the patient and the post-administration time point;
(v) at each post-administration time point, access, from the updated therapeutic- effectiveness dataset, the patient-specific therapeutic-effectiveness metric or metrics represented for the selected scope, and apply a disease-specific therapeutic- effectiveness criterion to the accessed metric or metrics to determine a criterion result indicating whether the criterion is satisfied or maintained;
(vi) based on the criterion result and the accessed metric or metrics, determine, for the same selected scope: (A) a therapeutic-efficacy-assurance outcome; (B) a financial-assurance outcome; or (C) an outcome-based payment determination affecting an amount paid or payable for treatment with the specialty drug;
(vii) use the determined outcome or payment determination to generate a therapeutic-effectiveness output record that identifies the selected scope and the corresponding post-administration time point, specifies the criterion result, and: (A) specifies an assurance status corresponding to, or authorizes implementation of, the therapeutic-efficacy-assurance outcome or the financial-assurance outcome; or (B) specifies a payment status or payment amount corresponding to, or authorizes a payment transaction implementing, the outcome-based payment determination; and
(viii) update the therapeutic-effectiveness dataset to associate the criterion result, the determined outcome or payment determination, and the output record with the selected scope, the accessed metric or metrics, and the corresponding post-administration time point.
These steps amount to managing personal behavior or relationships or interactions
between people and therefore recite certain methods of organizing human activity. Receiving patient pre-treatment data, generating and providing an administration instruction and receiving documentation that the treatment was administered, receiving follow up data at various time points comprising therapeutic outcome data, diagnostic or theragnostic data, determining a corresponding therapeutic effectiveness metric, developing and maintaining a therapeutic-effectiveness dataset representing the patient, a stratified subset of treated patients, or disease-specific treated population, accessing patient specific therapeutic effectiveness metrics at each post-administration time point and applying disease-specific criterion to the metrics to determine a result for whether the criterion is satisfied or maintained, based on the result and metrics, determining an efficacy assurance outcome, a financial assurance outcome, or an outcome-based payment determination; using the determined outcome or payment determination to generate a therapeutic effectiveness output record that specifies an assurance status corresponding to the efficacy assurance or financial assurance outcome, or specifies a payment status; and updating the therapeutic effectiveness dataset to associate the criterion result, determined outcome or payment and output record with a selected scope, accessed metrics, and corresponding time point are personal behaviors that may be performed by healthcare providers or insurance providers.
Claim 122 recites implementing the steps of:
(a) accessing an assurance record comprising one or more pre-agreed assurance terms that:
(i) identify a specialty drug and an assurance counterparty;
(ii) identify one selected scope from among: (A) an individual patient; (B) a stratified subset of patients identified by applying one or more drug- or disease-specific clinical or theragnostic stratification criteria to respective clinical or theragnostic data of the patients; or (C) a disease-specific patient population; and
(iii) condition a financial responsibility of an assurance-participating entity or the assurance counterparty for at least a portion of a cost of treatment with the specialty drug on a criterion result indicating whether a disease-specific therapeutic-effectiveness criterion is satisfied or maintained for the selected scope;
(b) before an initial administration of the specialty drug to a patient included in the selected scope:
(i) receive, for the patient, baseline data comprising disease-activity data and drug- or disease-specific diagnostic or theragnostic data;
(ii) apply one or more drug- or disease-specific clinical or theragnostic criteria to the baseline data to determine that the specialty drug is therapeutically appropriate for the patient individually or as a member of a stratified subset of patients and to select, for the patient, a patient-specific dose or dosing schedule for treatment with the specialty drug, thereby producing a therapeutic-appropriateness determination;
(iii) based on the therapeutic-appropriateness determination, generate and provide a patient-specific administration instruction specifying the selected patient-specific dose or dosing schedule
(iv) receive patient-linked administration information documenting that the initial administration occurred; and
(v) update the assurance record to associate the baseline data, the therapeutic-appropriateness determination, the administration instruction, and the administration information with the patient, the selected scope, and an initial-administration time point;
(c) after the initial administration, receiving a therapeutic-effectiveness output record that identifies the selected scope and a post-administration time point and specifies the criterion result, wherein:
(i) the criterion result was determined by applying the disease-specific therapeutic- effectiveness criterion to one or more patient-specific therapeutic-effectiveness metrics represented for the selected scope in a stored therapeutic-effectiveness dataset, the one or more metrics including a patient-specific therapeutic-effectiveness metric for the patient and, when the selected scope is the stratified subset or the disease-specific patient population, patient-specific therapeutic-effectiveness metrics for multiple treated patients; and
(ii) each patient-specific therapeutic-effectiveness metric was determined, for a respective treated patient, by comparing baseline data acquired before an initial administration of the specialty drug and comprising disease-activity data and drug- or disease-specific diagnostic or theragnostic data with corresponding follow-up data acquired at a respective post-administration time point and comprising therapeutic-outcome data and drug- or disease-specific diagnostic or theragnostic data, according to one or more disease-specific clinical or theragnostic criteria, wherein the comparison uses theragnostic data, a theragnostic criterion, or both, and the patient-specific therapeutic-effectiveness metric for the patient was determined using the baseline data received under step (b)(i);
(d) applying the pre-agreed assurance terms to the criterion result to determine, for the same selected scope, a financial-assurance outcome specifying a financial adjustment that changes an amount paid or payable by or to the assurance- participating entity or the assurance counterparty for at least a portion of the cost of treatment with the specialty drug;
(e) using the financial-assurance outcome to generate a payment instruction specifying the financial adjustment, executing a financial transaction applying the financial adjustment, and receiving transaction information documenting that the financial transaction was executed; and
(f) in response to receiving the transaction information, updating the assurance record to associate the therapeutic-effectiveness output record, the criterion result, the financial-assurance outcome, the payment instruction, and the transaction information with the selected scope and the post-administration time point; wherein the assurance-participating entity is a party to the pre-agreed assurance terms or administers the financial adjustment determined under step (d), and the assurance- participating entity.
These steps amount to managing personal behavior or relationships or interactions
between people and therefore recite certain methods of organizing human activity. Accessing an assurance record comprising pre-agreed terms; prior to an initial administration of a specialty drug to a patient, receiving baseline data, applying drug or disease specific clinical or theragnostic criteria to the baseline data to make a determination of therapeutic appropriateness, based on the determination of therapeutic appropriateness, generating and providing an administration instruction for the patient, receiving documentation that the administration occurred, updating the assurance record; after the initial administration, receiving a therapeutic effectiveness record that identifies a selected scope and criterion result; applying pre-agreed assurance terms to the criterion result to determine a financial assurance outcome; using the financial assurance outcome to generate a payment instruction specifying a financial adjustment, executing a financial transaction applying the financial adjustment and receiving documentation that the transaction was executed; and updating the assurance record, are personal behaviors that may be performed by healthcare providers or insurance providers.
Claim 126 recites implementing the steps of:
(i) access the assurance record, wherein the record:
(A) identifies a specialty drug and an assurance counterparty;
(B) identifies one selected scope from among:
(1) an individual patient treated with the specialty drug;
(2) a stratified subset of patients treated with the specialty drug and identified by applying one or more drug- or disease-specific clinical or theragnostic stratification criteria to respective clinical or theragnostic data of the treated patients; or
(3) a disease-specific population of patients treated with the specialty drug; and
(C) comprises one or more pre-agreed assurance terms that condition a financial responsibility of an assurance-participating entity or the assurance counterparty for at least a portion of a cost of treatment with the specialty drug on a criterion result indicating whether a disease-specific therapeutic-effectiveness criterion is satisfied or maintained for the selected scope;
(ii) receive a therapeutic-effectiveness output record that identifies the selected scope and a post- administration time point and specifies the criterion result, wherein:
(A) the criterion result was determined by applying the disease-specific therapeutic- effectiveness criterion to one or more patient-specific therapeutic-effectiveness metrics represented for the selected scope in a stored therapeutic-effectiveness dataset, including patient-specific therapeutic-effectiveness metrics for multiple treated patients when the selected scope is the stratified subset or the disease-specific population; and
(B) each patient-specific therapeutic-effectiveness metric was determined, for a respective treated patient, by comparing baseline data acquired before an initial administration of the specialty drug and comprising disease-activity data and drug- or disease-specific diagnostic or theragnostic data with corresponding follow-up data acquired at a respective post-administration time point and comprising therapeutic-outcome data and drug- or disease-specific diagnostic or theragnostic data, according to one or more disease-specific clinical or theragnostic criteria, wherein the comparison uses theragnostic data, a theragnostic criterion, or both;
(iii) apply the one or more pre-agreed assurance terms to the criterion result to determine, for the same selected scope, a financial determination comprising a financial-assurance outcome or an outcome-based payment determination and specifying a financial adjustment that changes an amount paid or payable by or to the assurance-participating entity or the assurance counterparty for at least a portion of the cost of treatment with the specialty drug;
(iv) use the financial determination to generate a payment instruction specifying the financial adjustment, executing a financial transaction applying the financial adjustment, and receiving transaction information documenting that the financial transaction was executed;
(v) in response to receiving the transaction information, update the assurance record to associate the therapeutic-effectiveness output record, the criterion result, the financial determination, the payment instruction, and the transaction information with the selected scope and the post- administration time point; and
(vi) transmit the updated assurance record to, or make the record accessible to, the assurance-participating entity, the assurance counterparty, or both; wherein the assurance-participating entity is a party to the pre-agreed assurance terms or administers the financial adjustment determined under operation (iii).
These steps amount to managing personal behavior or relationships or interactions
between people and therefore recite certain methods of organizing human activity. Accessing an assurance record comprising pre-agreed terms; receiving a therapeutic-effectiveness output record that identifies a scope and post-administration time point and specifies a criterion result, applying the pre-agreed terms to the criterion result to determine a financial determination comprising a financial assurance outcome or outcome based payment determination and specifying a financial adjustment, using the financial determination to generate a payment instruction to apply the financial transaction, and receiving documentation that the financial transaction was executed; and updating and transmitting the assurance record are personal behaviors that may be performed by healthcare providers or insurance providers.
The above claims are therefore directed to an abstract idea.
Step 2A Prong 2
This judicial exception is not integrated into a practical application because the additional
elements within the claims only amount to:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
The independent claims additionally recite:
computer-implemented method performed by one or more processors as implementing the steps of the abstract idea (Claim 98)
“electronically” implementing various steps
“electronic” as descriptive of various items (e.g., electronic administration information, transaction information, payment system)
“computer-readable” items (e.g., administration instruction, output record)
patient-side application or a healthcare-provider-associated electronic system, patient-linked electronic administration
an “electronically” stored therapeutic-effectiveness dataset
An electronic computer system comprising: (a) one or more processors; (b) one or more electronic storage devices storing program instructions and an electronic repository comprising one or more databases; and (c) one or more electronic interfaces; wherein the program instructions, when executed by the one or more processors, cause the electronic computer system to implement the steps of the abstract idea (Claim 105 and 126)
one or more processors as implementing the steps of the abstract idea (Claim 122)
an electronic interface as implementing the step of receiving a therapeutic-effectiveness output record
an electronic repository as the entity from which an electronic assurance record comprising one or more pre-agreed assurance terms is accessed:
an electronic payment system as implementing the step of executing a financial transaction applying the financial adjustment, and receiving transaction information documenting that the financial transaction was executed;
The broad recitation of the aforementioned general purpose computing elements and performing steps “electronically” at a high level of generality only amounts to mere instructions to implement the abstract idea using computing components as tools.
Regarding computer-implemented method/one or more processors and an electronic computer system comprising: (a) one or more processors; (b) one or more electronic storage devices storing program instructions and an electronic repository comprising one or more databases; and (c) one or more electronic interfaces; wherein the program instructions, the specification does not appear to disclose any particulars (e.g., structure) of these elements. Per originally filed claims (3/16/21) this is understood to be a computer system with a processor, storage devices, and interfaces operating in its ordinary capacity to implement the steps of the abstract idea.
Regarding (various) computer-readable instructions, the specification does not appear to disclose any particulars of computer-readable instructions. Per originally filed claims (3/16/21) this is understood to be a computer system with a processor operating in its ordinary capacity to execute computer-readable instructions to implement the steps of the abstract idea.
Regarding the patient-side application, the specification only discloses that the system may be made available via a “mobile device app’’ (para. [0123]). No particulars of the app are provided. As such, it is given its broadest reasonable interpretation as a general purpose computing element and amounts to mere instructions to apply the abstract idea on a general purpose computing device.
Regarding a healthcare provider-associated electronic system, no particulars of the provider system are disclosed. Per originally filed claims (3/16/21) this is understood to be a computer system with a processor operating in its ordinary capacity.
Regarding an interface, no particulars of the interface are provided. This is interpreted as being the interface of a mobile device per [0123]; as no particulars of the mobile device or any other computing devices are provided, this element is given its broadest reasonable interpretation as the electronic interface of a general purpose computing device functioning in its ordinary capacity.
Regarding the various instances of “electronic” and “electronically”, e.g., electronic approval, electronic payment instruction, electronically writing a time-stamped event, an electronic ledger: this only amounts to mere instructions to apply the abstract idea on a computer. Per originally filed claims (3/16/21) this is understood to be a computer system with a processor operating in its ordinary capacity.
Regarding the electronic payment system and electronic repository, no particulars are provided. These are given their broadest reasonable interpretation as general purpose computers used to apply the abstract idea (e.g., using an electronic computer system to perform a financial transaction
B. Insignificant Extra-Solution Activity. MPEP 2106.05(g)
Claim 98 and 105 additionally recite limitations pertaining to causing the initial administration [of a specialty drug] to the patient and Claim 122 additionally recites limitations pertaining to causing the initial administration of the specialty drug to the patient, which constitute insignificant extra-solution activity.
As stated in MPEP 2106.05(g), "[t]he term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim." In the present claims, the function causing initial administration of a specialty drug to a patient is only nominally or tangentially related to the process of using treatment outcome data to determine efficacy or financial assurance, and accordingly constitutes insignificant extra-solution activity. The step of causing administration of a specialty drug in order to gather data for the subsequent steps, and is a necessary precursor for all uses of the recited exception.
The above additional elements are therefore not sufficient to integrate the abstract idea into a practical application. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
Claims 98, 105, 122, 126, as a whole, are therefore directed to an abstract idea.
Step 2B
The present claims do not include additional elements that are sufficient to amount to
more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
As explained above, claims 98, 105, 122, 126 only recite the aforementioned computing elements as tools for performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f).
B. Insignificant Extra-Solution Activity. MPEP 2106.05(g)
Likewise, as explained above, the step of causing the initial administration of the specialty drug to the patient only amounts to insignificant extra-solution activity.
C. Well-Understood, Routine and Conventional Activities. MPEP 2106.05(d)
In addition to amounting to insignificant extra-solution activity the elements in Section B above constitute well-understood, routine and conventional activity. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of causing the initial administration of the specialty drug to the patient were considered extra-solution activity. This has been re-evaluated under the “significantly more” analysis and determined to be well-understood, routine, conventional activity in the field. As evidenced by the prior art of record, administering an initial dose of a drug to a patient is a well understood, routine and conventional element in the field of computerized healthcare. See the following references:
US 20020004725 A1, para. [0055] administering a treatment plan to a patients so that actual outcomes can be compared to expected outcomes to evaluate effectiveness of the treatment plan
US Publication 20120220640 A1, para. [0034], administering a therapy, taking measurements following administration to analyze outcome of therapy
US 20140274764 A1, para. [0008], administering or delivering an effective amount of a treatment or alternative treatment to a patient based on a determination of patient’s likely responsiveness to the therapy
Well-understood, routine, conventional activity cannot provide an inventive concept (“significantly more”). As such the claim is not patent eligible.
Thus, taken alone, the additional elements do not amount to significantly more than the
above-identified judicial exception. Looking at the limitations as an ordered combination adds
nothing that is not already present when looking at the elements taken individually. Their
collective functions merely provide conventional computer implementation.
Depending Claims
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims.
Claim 99 recites wherein the determined outcome or payment determination comprises the financial-assurance outcome or the outcome-based payment determination and specifies a full or partial financial adjustment affecting one or more of: (a) a patient copayment, coinsurance, or other cost-sharing amount; (b) an amount paid or payable by a payer for treatment with the specialty drug; or (c) an amount retained, refunded, or reimbursed by a pharmaceutical company for treatment with the specialty drug; wherein the one or more processors include the financial adjustment in the output record, generate a computer-readable financial-assurance instruction specifying the financial adjustment, cause an electronic payment system to execute an electronic financial transaction corresponding to the financial adjustment, and update the therapeutic-effectiveness dataset with the financial adjustment, the financial-assurance instruction, and electronic payment information reflecting the transaction, which further narrows the scope of the abstract idea of the respective parent claim, and also includes certain methods of organizing human activity, e.g., managing personal behaviors. Recitation of computing components only amounts to mere instructions to implement the abstract idea using computing components. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 100 recites wherein the financial-assurance instruction and electronic financial transaction recited in claim 99 comprise, respectively, a second computer-readable payment instruction and a subsequent electronic financial transaction applying the adjustment, and wherein the one or more processors:(a) before determining the financial-assurance outcome or the outcome-based payment determination, generate a first computer-readable payment instruction, cause the electronic payment system to execute an initial electronic payment for treatment with the specialty drug, and store the first payment instruction and electronic payment information reflecting the initial electronic payment in a patient-linked electronic payment record;(b) after determining the financial-assurance outcome or the outcome-based payment determination, access the electronic payment record, generate the second payment instruction, and cause the electronic payment system to execute the subsequent electronic financial transaction that makes an additional payment, reduces an amount otherwise payable, refunds all or part of the initial electronic payment, or otherwise adjusts an amount paid or payable for treatment with the specialty drug according to the financial adjustment; and(c) update the electronic payment record with the second payment instruction and electronic payment information reflecting the subsequent electronic financial transaction, and update the therapeutic-effectiveness dataset to associate the electronic payment record with the selected scope and the determined outcome or payment determination, which further narrows the scope of the abstract idea of the respective parent claim, and also includes certain methods of organizing human activity, e.g., managing personal behaviors. Recitation of computing components only amounts to mere instructions to implement the abstract idea using computing components. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 101 recites wherein the post-administration time points comprise a first post- administration time point and a later second post-administration time point; and wherein, at the later second post-administration time point, the one or more processors access, from the therapeutic-effectiveness dataset updated under step (d), the patient-specific therapeutic-effectiveness metrics associated with both time points and any patient- specific therapeutic-effectiveness metrics determined for other treated patients in the selected scope, apply the disease-specific therapeutic-effectiveness criterion to the accessed metrics to determine the criterion result for the later second post-administration time point, and use that criterion result in performing steps (e)(ii)-(iv) of claim 98, which further narrows the scope of the abstract idea of the respective parent claim, and also includes certain methods of organizing human activity, e.g., managing personal behaviors. Recitation of computing components only amounts to mere instructions to implement the abstract idea using computing components. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 102 recites wherein the determining under step (e)(ii) comprises determining, for the same selected scope, both: (a) the therapeutic-efficacy-assurance outcome based on the criterion result; and (b) the financial-assurance outcome by applying one or more pre-agreed terms to the accessed metric or metrics, the financial-assurance outcome specifying a full, partial, or no financial adjustment; wherein the one or more processors generate a computer-readable financial-assurance instruction corresponding to the financial-assurance outcome; when the financial- assurance outcome specifies a full or partial financial adjustment, cause an electronic payment system to execute a transaction changing an amount paid or payable for treatment with the specialty drug; and update the therapeutic-effectiveness dataset with both outcomes, the financial-assurance instruction, and, when executed, electronic payment information reflecting the transaction, which further narrows the scope of the abstract idea of the respective parent claim, and also includes certain methods of organizing human activity, e.g., managing personal behaviors. Recitation of computing components only amounts to mere instructions to implement the abstract idea using computing components. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 103 recites wherein the selected scope is the patient or the stratified subset,
and wherein the one or more processors: (a) receive, at one or more specified post-administration time points, patient-linked adherence data for one or more treated patients in the selected scope and update a corresponding electronic adherence record for each treated patient; (b) determine, from the updated adherence record or records, a patient therapeutic adherence rate, a therapy-guidelines adherence rate, or both, wherein the patient therapeutic adherence rate is based on confirmed administration events relative to prescribed administration events, and the therapy-guidelines adherence rate is based on recorded treatment events relative to an applicable therapy guideline and any documented clinical reason for deviation; (c) determine efficacy-assurance eligibility for the selected scope based on a comparison of the determined rate or rates with one or more corresponding predefined thresholds; (d) generate an electronic efficacy-assurance-eligibility record identifying the selected scope and specifying whether eligibility is satisfied; and (e) update the therapeutic-effectiveness dataset with the adherence record or records, each determined rate, and the efficacy-assurance-eligibility record, which further narrows the scope of the abstract idea of the respective parent claim, and also includes certain methods of organizing human activity, e.g., managing personal behaviors. Recitation of computing components only amounts to mere instructions to implement the abstract idea using computing components. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 104 recites wherein the efficacy-assurance-eligibility record specifies that eligibility is satisfied, the determined outcome or payment determination under step (e)(ii) of claim 98 comprises the financial-assurance outcome or the outcome-based payment determination and specifies a full or partial financial adjustment, and the one or more processors: (a) use the efficacy-assurance-eligibility record to generate a computer-readable financial-assurance or payment instruction specifying the financial adjustment; (b) cause an electronic payment system to execute a transaction applying the financial adjustment; and(c) update the therapeutic-effectiveness dataset with the efficacy-assurance-eligibility record, the financial-assurance or payment instruction, and electronic payment information reflecting the transaction, which further narrows the scope of the abstract idea of the respective parent claim, and also includes certain methods of organizing human activity, e.g., managing personal behaviors. Recitation of computing components only amounts to mere instructions to implement the abstract idea using computing components. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 106 recites wherein the program instructions further cause the electronic computer system, based on the criterion result determined under operation (v), to: (a) cause one of the following by generating and electronically providing a patient- specific computer-readable administration instruction: (i) a subsequent administration of the specialty drug to the patient according to a current or modified patient-specific dose or dosing schedule; or (ii) initiation of treatment of the patient with a specific alternative drug or therapy identified in the administration instruction; (b) receive, from a patient-side application or a healthcare-provider-associated electronic system, patient-linked electronic administration information documenting that the specified subsequent administration or initiation occurred; and (c) update the therapeutic-effectiveness dataset with the administration instruction, the administration information, and a corresponding treatment-implementation time point; wherein operations (vi)-(viii) of claim 105 and operations (a)-(c) of this claim are based on the same criterion result, which also includes certain methods of organizing human activity and amounts to mere instructions to implement the abstract idea using computing components. Recitation of (a) causing a subsequent administration only amounts to insignificant extra solution activity, as it is a precursor that must be performed in order for the following steps of the abstract idea to be performed. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 107 recites wherein the post-administration time points comprise a first post-administration time point and a later second post-administration time point; and wherein, at the later second post-administration time point, the program instructions further cause the electronic computer system to access, from the therapeutic-effectiveness dataset updated under operation (iv), the patient-specific therapeutic-effectiveness metrics associated with both time points and any patient- specific therapeutic-effectiveness metrics determined for other treated patients in the selected scope, apply the disease-specific therapeutic-effectiveness criterion to the accessed metrics to determine the criterion result for the later second post- administration time point, and use that criterion result in performing operations (vi)-(viii) of claim 105, which further narrows the scope of the abstract idea of the respective parent claim, and also includes certain methods of organizing human activity, e.g., managing personal behaviors. Recitation of computing components only amounts to mere instructions to implement the abstract idea using computing components. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 108 recites wherein the determined outcome under step (e) (ii) comprises the therapeutic-efficacy-assurance outcome or the financial-assurance outcome, further comprising assurance-based prior-authorization processing in which the one or more processors:
(a) based on the criterion result, the accessed metric or metrics, and the determined outcome for the selected scope at the corresponding post-administration time point, determine that the specialty drug remains therapeutically appropriate for the patient or select a specific alternative drug or therapy as therapeutically appropriate for the patient, thereby identifying the specialty drug or specific alternative drug or therapy, respectively, as a selected drug or therapy;
(b) generate and electronically provide, to a healthcare-payer system, a computer- readable prior-authorization outcome record identifying the selected drug or therapy and specifying authorization of the selected drug or therapy for administration; (c) based on the prior-authorization outcome record, cause the selected drug or therapy to be dispensed for administration to the patient by generating and electronically providing, to a specialty-pharmacy or manufacturer-distribution system, a computer- readable fulfillment instruction; (d) cause administration of the selected drug or therapy to the patient by generating and electronically providing, to a patient-side application or healthcare-provider- associated electronic system, a patient-specific computer-readable administration instruction, (e) receive electronic dispensing evidence and patient-linked electronic administration evidence confirming that the selected drug or therapy was dispensed and administered responsive to the fulfillment instruction and administration instruction, respectively; and (f) update the therapeutic-effectiveness dataset with the determination that the specialty drug remains therapeutically appropriate or the selection of the alternative drug or therapy, the prior-authorization outcome record, the fulfillment instruction, the administration instruction, the dispensing evidence, and the administration evidence, which further narrows the scope of the abstract idea of the respective parent claim, and also includes certain methods of organizing human activity, e.g., managing personal behaviors. Recitation of computing components only amounts to mere instructions to implement the abstract idea using computing components. Recitation of (d) causing administration of the selected drug or therapy only amounts to insignificant extra solution activity, as it is a precursor that must be performed in order for the following steps of the abstract idea to be performed. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 109 recites limitations pertaining to wherein the determined outcome comprises the financial- assurance outcome, and wherein the one or more processors: (a) determine, from patient-linked electronic administration evidence received at one or more specified post-administration time points, a patient therapeutic adherence rate that satisfies a predefined threshold of at least 70 percent, and, based on the satisfied threshold, determine that efficacy-assurance eligibility is satisfied; (b) generate a computer-readable financial-assurance or payment instruction, corresponding to the determined outcome under step (e)(ii) of claim 98, that specifies a full or partial financial adjustment, and cause an electronic payment system to execute a transaction applying the adjustment; and (c) update the therapeutic-effectiveness dataset with the adherence rate, the efficacy- assurance-eligibility determination, the financial-assurance or payment instruction, and electronic payment information reflecting the transaction, which further narrows the scope of the abstract idea of the respective parent claim, and also includes certain methods of organizing human activity, e.g., managing personal behaviors. Recitation of computing components only amounts to mere instructions to implement the abstract idea using computing components. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 110 recites wherein the determined outcome or payment determination comprises the outcome-based payment determination specifying an increase or decrease in an amount paid or payable for treatment with the specialty drug, and the one or more processors: (a) generate a computer-readable payment-adjustment instruction specifying the change;
(b) cause an electronic payment system to execute a transaction applying the change; and (c) update the therapeutic-effectiveness dataset with the payment-adjustment instruction and electronic payment information reflecting the transaction, in association with the outcome-based payment determination, the selected scope, the accessed metric or metrics on which the determination was based, and the post-administration time point for which the determination was made; wherein at least one entity selected from the group consisting of a pharmaceutical company that manufactures or commercializes the specialty drug, a payer, an entity administering a prescription-drug plan, a pharmacy benefit manager, and an efficacy- assurance company causes the one or more processors to perform each of steps (a)-(e) of claim 98 and each of paragraphs (a)-(c) of this claim, which further narrows the scope of the abstract idea of the respective parent claim, and also includes certain methods of organizing human activity, e.g., managing personal behaviors. Recitation of computing components only amounts to mere instructions to implement the abstract idea using computing components. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 111 recites wherein the one or more processors: (a) before the initial administration, apply one or more drug- or disease-specific theragnostic criteria to the baseline data to select the specialty drug from a plurality of candidate drugs and determine that the selected drug is therapeutically appropriate for the patient individually or for a stratified subset that includes the patient, thereby producing a therapeutic-appropriateness determination;
(b) before the initial administration, electronically write the selected drug and the therapeutic-appropriateness determination into a patient-linked treatment record and, based on the determination, generate and electronically provide the administration instruction recited in step (b) of claim 98; and (c) after receiving the administration information recited in step (b) of claim 98, update the treatment record with the administration information documenting that the initial administration of the selected drug occurred, which further narrows the scope of the abstract idea of the respective parent claim, and also includes certain methods of organizing human activity, e.g., managing personal behaviors. Recitation of computing components only amounts to mere instructions to implement the abstract idea using computing components. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 120 recites wherein, based on the criterion result determined under step (e)(i),the one or more processors: (a) cause one of the following by generating and electronically providing a patient- specific computer-readable administration instruction: (i) a subsequent administration of the specialty drug to the patient according to a current or modified patient-specific dose or dosing schedule; or (ii) initiation of treatment of the patient with a specific alternative drug or therapy identified in the administration instruction; (b) receive, from a patient-side application or a healthcare-provider-associated electronic system, patient-linked electronic administration information documenting that the specified subsequent administration or initiation occurred; and (c) update the therapeutic-effectiveness dataset with the administration instruction, the administration information, and a corresponding treatment-implementation time point; wherein steps (e)(ii)-(iv) of claim 98 and steps (a)-(c) of this claim are based on the same criterion result, which further narrows the scope of the abstract idea of the respective parent claim, and also includes certain methods of organizing human activity, e.g., managing personal behaviors. Recitation of computing components only amounts to mere instructions to implement the abstract idea using computing components. Recitation of (a) causing a subsequent administration of the specialty drug or alternative drug/therapy only amounts to insignificant extra solution activity, as it is a precursor that must be performed in order for the following steps of the abstract idea to be performed. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 121 recites wherein execution of the program instructions further causes the electronic computer system to:(a) receive, through the one or more electronic interfaces, an electronic request, submitted by a requesting entity selected from the group consisting of a payer, an entity administering a prescription-drug plan, a pharmacy benefit manager, a pharmaceutical company that manufactures or commercializes the specialty drug, and an efficacy-assurance company, for an outcome or payment determination under operation (vi) for the selected scope; (b) in response to the electronic request, perform operations (v)-(viii) using the therapeutic-effectiveness dataset developed and maintained under operation (iv);and (c) through the one or more electronic interfaces, transmit the computer-readable therapeutic-effectiveness output record generated under operation (vii) to the requesting entity or make the computer-readable therapeutic-effectiveness output record electronically accessible to the requesting entity, which further includes certain methods of organizing human activity, e.g., managing personal behaviors. Recitation of computing components only amounts to mere instructions to implement the abstract idea using computing components. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 123 recites wherein one of the following applies:(a) the assurance-participating entity is a pharmaceutical company that manufactures or commercializes the specialty drug, the assurance counterparty is a payer or patient, and, when the criterion result indicates that the disease-specific therapeutic- effectiveness criterion is not satisfied or maintained, the electronic financial transaction causes a full or partial return, from the pharmaceutical company to the payer or patient, of an amount previously paid for treatment with the specialty drug; or (b) the assurance-participating entity is a payer, an entity administering a prescription- drug plan, or a pharmacy benefit manager, the assurance counterparty is a pharmaceutical company that manufactures or commercializes the specialty drug or a patient, and:(i) when the criterion result indicates that the disease-specific therapeutic- effectiveness criterion is not satisfied or maintained, the electronic financial transaction reduces or refunds an amount paid or payable by the assurance- participating entity or the assurance counterparty for treatment with the specialty drug, including a patient copayment, coinsurance, or other cost-sharing amount; or (ii) the assurance counterparty is the pharmaceutical company and, when the criterion result indicates that the disease-specific therapeutic-effectiveness criterion is satisfied or maintained, the electronic financial transaction increases an amount paid or payable by the assurance-participating entity to the pharmaceutical company, which further narrows the scope of the abstract idea of the respective parent claim, and also includes certain methods of organizing human activity, e.g., managing personal behaviors. Recitation of computing components only amounts to mere instructions to implement the abstract idea using computing components. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 124 recites wherein the electronic financial transaction under step (e) is a subsequent transaction, the method further comprising, before receiving the computer-readable therapeutic-effectiveness output record: (a) causing the electronic payment system to execute an initial electronic payment for at least a portion of the cost of treatment with the specialty drug; and (b) electronically updating the electronic assurance record with initial payment information reflecting the initial electronic payment; wherein, according to the one or more pre-agreed assurance terms, the subsequent transaction makes an additional payment, reduces an amount otherwise payable, refunds all or part of the initial electronic payment, or otherwise adjusts the financial responsibility, which further narrows the scope of the abstract idea of the respective parent claim, and also includes certain methods of organizing human activity, e.g., managing personal behaviors. Recitation of computing components only amounts to mere instructions to implement the abstract idea using computing components. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more, which further narrows the scope of the abstract idea of the respective parent claim, and also includes certain methods of organizing human activity, e.g., managing personal behaviors. Recitation of computing components only amounts to mere instructions to implement the abstract idea using computing components. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 125 recites wherein the selected scope is the individual patient or the stratified subset, and wherein, based on the same criterion result used to determine the financial adjustment, the one or more processors:(a) determine, for the same selected scope, a therapeutic-efficacy-assurance outcome;(b) for a treated patient represented in the selected scope, cause:(i) a subsequent administration of the specialty drug to the treated patient according to a current or modified patient-specific dose or dosing schedule; or (ii) initiation of treatment of the treated patient with a specific alternative drug or therapy; by generating and electronically providing, to a patient-side application or healthcare-provider-associated electronic system, a patient-specific computer- readable administration instruction specifying the subsequent administration or the specific alternative drug or therapy;(c) receive, from the patient-side application or healthcare-provider-associated electronic system, patient-linked electronic administration information documenting that the specified subsequent administration or initiation of treatment of the treated patient occurred; and (d) update the electronic assurance record to associate the therapeutic-efficacy- assurance outcome, the administration instruction, the administration information, and a corresponding treatment-implementation time point with the criterion result and the electronic financial transaction, which further narrows the scope of the abstract idea of the respective parent claim, and also includes certain methods of organizing human activity, e.g., managing personal behaviors. Recitation of computing components only amounts to mere instructions to implement the abstract idea using computing components. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 127 recites wherein one of the following applies:(a) the assurance-participating entity is a pharmaceutical company that manufactures or commercializes the specialty drug, the assurance counterparty is a payer or patient, and, when the criterion result indicates that the disease-specific therapeutic- effectiveness criterion is not satisfied or maintained, the electronic financial transaction causes a full or partial return, from the pharmaceutical company to the payer or patient, of an amount previously paid for treatment with the specialty drug; or (b) the assurance-participating entity is a payer, an entity administering a prescription- drug plan, or a pharmacy benefit manager, the assurance counterparty is a pharmaceutical company that manufactures or commercializes the specialty drug or a patient, and:(i) when the criterion result indicates that the disease-specific therapeutic- effectiveness criterion is not satisfied or maintained, the electronic financial transaction reduces or refunds an amount paid or payable by the assurance- participating entity or the assurance counterparty for treatment with the specialty drug, including a patient copayment, coinsurance, or other cost-sharing amount; or (ii) the assurance counterparty is the pharmaceutical company and, when the criterion result indicates that the disease-specific therapeutic-effectiveness criterion is satisfied or maintained, the electronic financial transaction increases an amount paid or payable by the assurance-participating entity to the pharmaceutical company. which further narrows the scope of the abstract idea of the respective parent claim, and also includes certain methods of organizing human activity, e.g., managing personal behaviors. Recitation of computing components only amounts to mere instructions to implement the abstract idea using computing components. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 128 recites wherein the selected scope is the individual patient or the stratified subset, the one or more pre-agreed assurance terms further condition application of the financial adjustment on satisfaction of a predefined patient-therapeutic-adherence threshold, and the program instructions further cause the electronic computer system to:(a) receive, at one or more specified post-administration time points, patient-linked electronic administration information for one or more treated patients represented in the selected scope and update a corresponding electronic adherence record for each treated patient;(b) determine, from the electronic adherence record or records, one or more patient therapeutic adherence rates based on confirmed administration events relative to prescribed administration events;(c) compare the one or more patient therapeutic adherence rates with the predefined patient-therapeutic-adherence threshold to determine efficacy-assurance eligibility for the selected scope and generate an electronic efficacy-assurance-eligibility record specifying that eligibility is satisfied; and(d) use the electronic efficacy-assurance-eligibility record together with the criterion result in performing operations (iii)-(vi) of claim 126, wherein the electronic financial transaction under operation (iv) is caused only after the electronic efficacy- assurance-eligibility record specifies that eligibility is satisfied; and(e) update the electronic assurance record to associate the one or more patient therapeutic adherence rates and the electronic efficacy-assurance-eligibility record with the selected scope, the criterion result, and the electronic financial transaction, which further narrows the scope of the abstract idea of the respective parent claim, and also includes certain methods of organizing human activity, e.g., managing personal behaviors. Recitation of computing components only amounts to mere instructions to implement the abstract idea using computing components. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 129 recites wherein the selected scope is the individual patient or the stratified subset, and wherein, based on the same criterion result used to determine the financial adjustment, the program instructions further cause the electronic computer system to:(a) determine, for the same selected scope, a therapeutic-efficacy-assurance outcome;(b) for a treated patient represented in the selected scope, cause:(i) a subsequent administration of the specialty drug to the treated patient according to a current or modified patient-specific dose or dosing schedule; or (ii) initiation of treatment of the treated patient with a specific alternative drug or therapy; by generating and electronically providing, to a patient-side application or healthcare-provider-associated electronic system, a patient-specific computer- readable administration instruction specifying the subsequent administration or the specific alternative drug or therapy;(c) receive, from the patient-side application or healthcare-provider-associated electronic system, patient-linked electronic administration information documenting that the specified subsequent administration or initiation of treatment of the treated patient occurred; and (d) update the electronic assurance record to associate the therapeutic-efficacy- assurance outcome, the administration instruction, the administration information, and a corresponding treatment-implementation time point with the criterion result and the electronic financial transaction, which further narrows the scope of the abstract idea of the respective parent claim, and also includes certain methods of organizing human activity, e.g., managing personal behaviors. Recitation of computing components only amounts to mere instructions to implement the abstract idea using computing components. Recitation of (b)(i) causing a subsequent administration of the specialty drug or (ii) treatment with a specific alternative drug or therapy only amounts to insignificant extra solution activity, as it is a precursor that must be performed in order for the following steps of the abstract idea to be performed. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Dependent claims 98-104, 106-111, 120, 123-125, 127-129 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. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. 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 conventional computer implementation.
The dependent claims have been given the full two-part analysis including analyzing the additional limitations both individually and in combination. The dependent claims, when analyzed individually, and in combination, are also held to be patent ineligible under 35 U.S.C. 101 as they include all of the limitations of claims 98, 105, 122, 126 respectively. The additional recited limitations of the dependent claims fail to establish that the claims do not recite an abstract idea because the additional recited limitations of the dependent claims merely further narrow the abstract idea. Beyond the limitations which recite the abstract idea, the claims recite additional elements consistent with those identified above with respect to the independent claims which encompass 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). 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.
Dependent claims 98-104, 106-111, 120, 123-125, 127-129 recite additional subject matter which amounts to additional elements consistent with those identified in the analysis of the independent claims above. As discussed above with respect to Claims 98, 105, 122, 126 and integration of the abstract idea into a practical application, recitation of these additional elements only amounts to invoking computers as a tool to perform the abstract idea. 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 conventional computer implementation.
Dependent claims 98-104, 106-111, 120, 123-125, 127-129 when analyzed as a whole, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
For the reasons stated, Claims 98-111, 120-129 fail the Subject Matter Eligibility Test and are consequently rejected under 35 U.S.C. 101.
Response to Applicant’s Remarks/Arguments
Please note: When referencing page numbers of Applicant’s response, references are to page numbers as printed.
Regarding remarks filed 06/15/26:
Interpretations under USC 112(f) and corresponding 112(a)/112(b) Rejections
The 112(f) interpretations and corresponding 112(a) and 112(b) rejections are withdrawn in view of Applicant’s amendments to the claims to remove the language warranting the 112(f) interpretations and corresponding rejections under 35 USC 112.
Rejections under 35 USC 112(a)
Applicant’s remarks have been fully considered. The rejections are withdrawn in view of Applicant’s amendments to the claims.
Rejections under 35 USC 101
Applicant’s remarks have been fully considered. Examiner notes that Applicant’s amendments filed 08/04/26 have significantly overhauled the claim language filed with the remarks submitted 06/15/26, and as such, the arguments submitted 06/15/26 do not align with the amended claim limitations filed 08/04/26. Examiner will address the specific arguments made with respect to the most recently filed claims in the section titled “Regarding remarks file d 08/04/26” below. However, Examiner notes the following recurring argument(s) in the remarks dated 06/15/26 and make the following responses:
Regarding Applicant’s remarks that certain claims (e.g., Claim 98, argued at page 28) are not “a mental process”. Examiner submits that the claim limitations have not been characterized as being directed to mental processes. All arguments pertaining to the claims not being a mental process are moot. For argument’s sake, simply because the steps are “not a mental process” does not preclude the claims from being directed to certain methods of organizing human activity. This argument is not persuasive.
Regarding Applicant’s remarks that the steps are performed by electronics (e.g., at page 28, “the method steps are performed by the integrated treatment payment platform itself; page 34 with respect to Claim 115, “directed to a statutory machine (a computer system with processors and memory storing programs”), Examiner submits that any electronic/computer components recited by the claims are understood to be general purpose computing devices/components functioning in their ordinary capacity to implement the abstract idea and do not render the claims subject-matter eligible. MPEP 2106.05(f).
Regarding remarks to “practical application”, (see at least pages 28-35), Examiner submits that any purported improvements may improvements to the abstract idea itself, e.g., an improvement to specialty drug commercialization operations. However, any purported improvements appear to come from the steps of the abstract idea itself. Regarding patentability requirements under 35 USC 101, please reference MPEP 2106.04(d)(II) which states, “The analysis under Step 2A Prong Two is the same for all claims reciting a judicial exception, whether the exception is an abstract idea, a law of nature, or a natural phenomenon (including products of nature). Examiners evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application, using one or more of the considerations introduced in subsection I supra, and discussed in more detail in MPEP §§ 2106.04(d)(1), 2106.04(d)(2), 2106.05(a) through (c) and 2106.05(e) through (h)”; please see also MPEP 2106.05(a) which states, “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements.” Applicant has not demonstrated, nor can Examiner find, evidence in the originally filed disclosure that describes how the additional elements provide an improvement over prior art systems. This argument is not persuasive.
The rejections of all pending claims under 35 USC 101 are maintained.
Regarding supplementary remarks filed 08/04/26:
35 USC 112(f) interpretations, 35 USC 112(a) and 35 USC 112(b) Rejections have been withdrawn as noted above with respect to the remarks filed 06/15/26.
35 USC 101 Rejections:
Applicant’s remarks have been fully considered but are not persuasive.
Regarding (A) at page 38: Regarding remarks at page 38 pertaining to evaluating claims as a whole, Examiner respectfully submits that the claims have been evaluated as a whole. Please reference remarks at page 40 of Final Action dated 12/16/25 and MPEP 2106.05(d) pertaining to the “ordered combination” analysis and additional elements. The identified additional elements only amount to using general purpose computing components in their ordinary capacities to apply the abstract idea. Applicant has not provided evidence of, nor can Examiner find evidence, an ordered combination of additional elements that renders the claimed invention eligible. The claims have been analyzed independently as shown above in 101 analysis section. These arguments in (A) are not persuasive.
Regarding (B) at page 38: The Examiner respectfully disagrees with Applicant’s position. While “Healthcare” may not be an enumerated Abstract idea grouping, Certain Methods of Organizing Human Activity, including managing personal behaviors or interactions between people, is an abstract idea grouping. Examiner has never characterized the abstract idea grouping as “healthcare”. The abstract idea has been categorized as Certain methods of organizing human activity in this office action and all prior actions. This argument is not persuasive.
Regarding remarks to “the claims recite materially different additional elements and ordered interactions that must be analyzed under Prong Two and Step 2B”, the additional elements are understood to be general purpose computing components functioning in their ordinary capacity and as such, do not integrate the judicial exception into a practical application or amount to significantly more. This argument is not persuasive.
These arguments in (B) are not persuasive.
Regarding (C) at page 39, Applicant remarks “Claims 98 and 105 do not merely request the result of "evaluating treatment effectiveness." They recite how the evidence is constructed, scoped, applied, output, and retained. One operative scope is established from three claim-defined alternative scope types. The stratified-subset branch is generated through drug- or disease-specific clinical or theragnostic stratification criteria. In every branch, the same selected scope is preserved through the longitudinal evidence and downstream operations”. Examiner submits that all steps cited by Applicant fall within the scope of the abstract idea. While it may be a very detailed abstract idea, e.g., more detailed than “evaluating treatment effectiveness”, it is nonetheless abstract. Regarding the chart at page 39-40, Examiner submits that all of the steps identified fall within the scope of the abstract idea, e.g., a doctor could develop and maintain a dataset and access metrics and apply disease-specific therapeutic criterion to a set of metric data. This argument is not persuasive.
Regarding remarks to McRo (page 40), the Examiner submits that the instant claims are not analogous to McRo. In McRo, the claimed invention recited a very specific set of rules that allowed a computer to perform animation in a manner that was previously only performable by human animators. The very fact that the animation could not be previously performed by computers and that the rules applied by the claimed invention solved this problem was the reason the claimed invention in McRo was found to be not directed to an abstract idea. Here, there is no evidence on record that establishes that the claimed invention was only previously performable by humans in the manner of McRo.
Regarding remarks directed to CardioNet at page 40, Examiner respectfully disagrees that the instant claims are analogous to those found to be subject matter eligible in CardioNet. CardioNet claimed a particular cardiac monitoring device that detected atrial fibrillation and atrial flutter from heart rhythms in a particular manner thus resulting in an improved device; no abstract idea was present. The instant claims do not recite any of the particulars of how physiological monitoring is performed in a manner akin to the claims in CardioNet. CardioNet Claim 1 recites:
A device, comprising:
a beat detector to identify a beat-to-beat timing of cardiac activity;
a ventricular beat detector to identify ventricular beats in the cardiac activity;
variability determination logic to determine a variability in the beat-to-beat timing of a collection of beats;
relevance determination logic to identify a relevance of the variability in the beat-to-beat timing to at least one of atrial fibrillation and atrial flutter; and
an event generator to generate an event when the variability in the beat-to-beat timing is identified as relevant to the at least one of atrial fibrillation
The written description of CardioNet explains that, by identifying “variability in the beat-to-beat timing . . . as relevant to the at least one of atrial fibrillation and atrial flutter in light of the variability in the beat-to-beat timing caused by ventricular beats identified by the ventricular beat detector,” the claimed invention achieves multiple technological improvements. Applicant has not cited to, nor can Examiner find, evidence in the instant written description that the instant invention is directed to a particular cardiac monitoring device improvement or anything remotely analogous. This argument is not persuasive.
Examiner submits that the “claimed architecture” only amounts to mere instructions to apply the abstract idea. As previously discussed, these are general purpose computing devices functioning in their ordinary capacities to implement the steps of the abstract idea. This is not persuasive.
Regarding remarks at page 40 to “initial administration instruction”, providing an administration instruction “causes/causing the initial administration” of the specialty drug to the patients in the independent claims, in the instant claims, only amounts to insignificant extra-solution activity to the patient”. This administration step is performed in order to gather data for subsequent steps of the abstract idea, and is a necessary precursor for all uses of the recited exception. Therefore, it is extra-solution activity and does not integrate the judicial exception into a practical application. See MPEP 2106.04(d)(2)(c), Whether the Limitations are Merely Extra-Solution Activity or a Field of Use and the example pertaining to steps (a) and (b) of the vaccination schedule example. This argument with respect to “administration” is not persuasive. Regarding “confirmation”, receiving a confirmation of an event falls within the scope of the abstract idea. These arguments are not persuasive.
These arguments in (C) are not persuasive.
Regarding (D) and “practical application” (page 41), the Examiner respectfully disagrees with Applicant’s position. MPEP 2106.04(a)(2)(II) states that a claimed invention is directed to certain methods of organizing human activity if the identified claim elements contain limitations that encompass fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The Examiner submits that the identified claim elements represent a series of personal behaviors that a person or persons, with or without the aid of a computer, would follow to use patient data pertaining to a treatment and follow up data to determining a therapeutic effectiveness metric and determine an efficacy/financial assurance outcome. As such, the claimed invention is directed to an abstract idea. Regarding remarks at top of page 29 pertaining to remarks “These limitations integrate any data processing into a practical application that controls real-world treatment delivery and platform-executed follow-up actions, rather than reciting a result that could be performed in the human mind.” As an initial matter, Examiner submits that whether or not the claimed steps can be performed in the human mind is irrelevant as the claims have been categorized as certain methods of organizing human activity. Regarding practical application, MPEP 2106.04(d)(1) states that a practical application may be present where the claimed invention improves the functioning of a computer. See also MPEP 2106.05(a)(I). The technological environment of Applicant’s claim is a general-purpose computer (see original claim 42). Applicant has not identified nor can the Examiner locate any physical improvement to the functioning of the computer that results from the implementation of Applicant’s claim. There is no indication that the computer is made to run faster, more efficiently, or utilize less power. In fact, the computer may be caused to operate slower and less efficiently through the implementation of Applicant’s claimed invention; we do not know. Because there is no improvement to the function of the computer, a practical application is not present. MPEP 2106.04(d)(1) also states that a practical application may be present where the claimed invention improves another technology. See also MPEP 2106.05(a)(II). Applicant’s claim is confined to a general-purpose computer as discussed above and does not recite “another technology.” Because no other technology is recited in the claim, the claim cannot improve another technology (see, e.g., MPEP 2106.05(I)(A)(i) describing an example of an improvement to another technology where the abstract idea implemented on a computer improved the claimed additional element of a rubber molding machine). As such, recitation of these additional elements does not provide an improvement through implementation of the abstract idea and a practical application is not present. Examiner notes that the limitations to which Applicant cites at pages 28-29 are limitations that fall within the scope of the abstract idea but for recitation of computing elements, e.g., a human operator could provide an administration instruction for a drug and receive an administration confirmation, receive baseline and follow up data at different time points, determine a therapeutic effectiveness metric, and perform a feedback controlled theragnostic evaluation. These remarks are not persuasive.
In view of the above, Examiner submits that using post-administration, scope-specific therapeutic effectiveness evidence to implement the financial assurance is not a practical application, it falls within the scope of the abstract idea. The steps of Claim 22 as cited by Applicant are all within the scope of the abstract idea (e.g., receiving data, applying criteria to make a determination, using criteria to select a dose). Regarding “causing actual initial administration according to the dosing schedule”, in the instant claims, this only amounts to insignificant extra-solution activity to the patient”. As discussed above, this administration step is performed in order to gather data for subsequent steps of the abstract idea, and is a necessary precursor for all uses of the recited exception. Therefore, it is extra-solution activity and does not integrate the judicial exception into a practical application. See MPEP 2106.04(d)(2)(c), Whether the Limitations are Merely Extra-Solution Activity or a Field of Use and the example pertaining to steps (a) and (b) of the vaccination schedule example. These arguments are not persuasive.
Regarding remarks to Vanda (page 41), Examiner directs Applicant to Claim 1 of the ‘610 patent which has been recopied below:
A method for treating a patient with iloperidone, wherein the patient is suffering from schizophrenia, the method comprising the steps of: determining whether the patient is a CYP2D6 poor metabolizer by: obtaining or having obtained a biological sample from the patient; and performing or having performed a genotyping assay on the biological sample to determine if the patient has a CYP2D6 poor metabolizer genotype; and if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less, and if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day, wherein a risk of QTc prolongation for a patient having a CYP2D6 poor metabolizer genotype is lower following the internal administration of 12 mg/day or less than it would be if the iloperidone were administered in an amount of greater than 12 mg/day, up to 24 mg/day.
In comparison to the claim in Vanda, which specifies a particular treatment (iloperidone) which is administered for a particular condition (schizophrenia) in a particular dosage depending on a genotype, the instant claims lack the specificity required for a claim to be deemed eligible at Step 2A Prong 2 as a particular treatment/prophylaxis. Reciting a “specialty drug” is analogous to the example cited in MPEP which is determined not to be indicative of a particular treatment (see MPEP 2106.04(d)(2), “The treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). For example, consider a claim that recites mentally analyzing information to identify if a patient has a genotype associated with poor metabolism of beta blocker medications. This falls within the mental process grouping of abstract ideas enumerated in MPEP § 2106.04(a). The claim also recites "administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype." This administration step is particular, and it integrates the mental analysis step into a practical application. Conversely, consider a claim that recites the same abstract idea and "administering a suitable medication to a patient." This administration step is not particular, and is instead merely instructions to "apply" the exception in a generic way. Thus, the administration step does not integrate the mental analysis step into a practical application”. Further, as discussed above, the initial administration only servers as a data gathering step, e.g., to determine a treatment efficacy outcome and whether or not to provide financial assurance for the treatment. This is not analogous to Vanda.
Regarding remarks to Mayo: Examiner respectfully disagrees with Applicant’s position that “Claim 122 is materially unlike Mayo”. In Mayo, the claims described an administration step that administered a drug to a patient; however, the drug was not a treatment/prophylaxis, it was a drug utilized to gather information about the patient and was thus merely a nominal data gathering step. The claims in Mayo were found to be ineligible. In contrast, the treatment in Vanda was provided to the patient in order to more safely treat the patient in order to limit a particular side-effect, which provided a practical application to the claimed invention. Examiner submits that the step of causing an initial administration of a specialty drug to a patient in the instant claims is analogous to Mayo; it serves as a data gathering step to determine how the patient responds to the treatment and subsequently make a determination of financial assurance/payment. Examiner submits that the steps of dose/schedule selection before administration and confirmation of the treatment fall within the scope of the abstract idea as shown in the 101 analysis section above. See also above remarks regarding “financial assurance” and Practical Application. This argument is not persuasive.
These arguments in (D) are not persuasive.
Regarding (E), Examiner submits that the points Applicant is arguing (“the specific arrangement and the maintained relationship among the clinically defined source scope, time-pointed therapeutic evidence, criterion result, financial implementation, execution confirmation, and updated record”) all fall within the scope of the abstract idea.
Regarding remarks to Finjan, the claims in Finjan were determined to provide a physical improvement to the computer by implementing behavior-based virus scanning according to a security profile that is specific to a user, which allowed a computer system to do things it previously could not do, as discussed in specification; hence, the court identified an improvement in computer functionality and verified that the claims recited additional elements that reflected the improvement. Applicant has not cited to, nor can Examiner find, evidence of anything in the instant specification that is analogous to Finjan.
Regarding McRO, this has already been addressed.
Regarding Example 42, Examiner notes that this claim was found eligible at the Step 2A Prong 2 analysis because the Applicant described particular problems caused by the environment to which the claim is confined (computers); see Background which discloses physically separate medical providers recording patient notes in their own local patient records and storing these records in a non-standard format selected by whichever hardware/software platform is in use in the medical provider’s office, which causes problems if healthcare providers need to share updated information about a patient’s condition. Applicant then presents a solution to the existing system which “collects, converts and consolidates patient information” into a “standardized format” and generates messages to notify HCP’s or patients when that information is updated. As such, the claims were found to recite a combination of additional elements that recite a specific improvement over prior art systems. Applicant’s specification does not appear to disclose analogous problems created by the EHR/computing systems to which the claims provide a specific improvement. As such, this argument is not persuasive.
Regarding remarks to BASCOM at bottom of page 43, the claims in BASCOM were found to be eligible because they presented a technology-based improvement to methods in which web filtering was performed which overcame disadvantages with prior art systems disclosed in the specification by using a non-conventional arrangement of web filters (e.g., additional elements). Unlike BASCOM, Applicant has not provided evidence in the specification as originally filed to demonstrate how the claimed invention provides a non-conventional arrangement of additional elements.
Examiner submits that the table of steps presented at pages 43-44 are limitations that fall within the scope of the abstract idea.
These arguments in (E) are not persuasive.
Regarding (F), Examiner submits that as shown above, the limitations of the dependent claims only serve to further narrow the scope of the abstract idea or amount to mere instructions to apply the abstract idea (MPEP 2106.05(f)).
Examiner notes the following with respect to claims 106, 120, and 108: While the claims may recite using post-administration results to cause administration under a current/modified dose schedule or initiation of a specific alternative drug therapy, these do not meet the criteria of a “particular treatment” as no dosing schedule or specific drug is recited. Reciting a “specialty drug” or “a specific alternative drug or therapy” is analogous to the example cited in MPEP which is determined not to be indicative of a particular treatment (see MPEP 2106.04(d)(2), “The treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). For example, consider a claim that recites mentally analyzing information to identify if a patient has a genotype associated with poor metabolism of beta blocker medications. This falls within the mental process grouping of abstract ideas enumerated in MPEP § 2106.04(a). The claim also recites "administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype." This administration step is particular, and it integrates the mental analysis step into a practical application. Conversely, consider a claim that recites the same abstract idea and "administering a suitable medication to a patient." This administration step is not particular, and is instead merely instructions to "apply" the exception in a generic way. Thus, the administration step does not integrate the mental analysis step into a practical application”. Examiner submits that recitation of “specialty drug” or “specific alternative” are analogous to the MPEP example of “a suitable medication”. We do not know what the “specialty drug” or “specific alternative” actually is. Similarly, “a current or modified dosing schedule” is not particular as it does not actually define a specific dosing schedule; we do not know what the current or modified dosing schedule is. This is not analogous to Vanda which recites the specific drug name and dosing schedule based on the patient’s genotype.
Regarding Claim 111, pertaining to causing administration, see above remarks in preceding paragraph pertaining to the administration step not being particular as it only recites “specialty drug”.
These arguments in (F) are not persuasive.
Regarding (G) and “ordered combinations”, this has already been addressed above. Regarding BASCOM, this has also been addressed above. Regarding specific steps listed by Applicant at pages 44-45, Examiner submits that these fall within the scope of the abstract idea and are not additional elements. This has previously been discussed above. Applicant has not cited to specific combinations of additional elements (e.g., those identified in the 101 analysis section above) and provided evidence that the ordered combination provides an improvement, nor can Examiner find evidence of an ordered combination disclosed in the Specification.
Regarding remarks pertaining to Berkheimer (page 45), Examiner respectfully submits that the Berkheimer analysis is only required when something is determined to be well-understood, routine and conventional. Examiner never considered the use of the additional elements (e.g., computer system, processor) to be well-understood, routine and conventional. Therefore, Berkheimer evidence is not required.
Regarding remarks to the claims being free of the prior art ag page 45, please see MPEP 2106.05(I) which states, “Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting "the Government’s invitation to substitute §§ 102, 103, and 112 inquiries for the better established inquiry under § 101"). As made clear by the courts, the "novelty” of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter."
These arguments in (G) are not persuasive.
For all of the above reasons, Applicant’s remarks are not persuasive and the rejections of all pending claims under 35 USC 101 are maintained.
Examiner has thoroughly reviewed the original disclosure and does not have any recommendations for material to incorporate into the claims to lead to subject matter eligibility under current USPTO 101 guidelines.
Conclusion
In the interest of expediting prosecution, Examiner respectfully requests that Applicant provides citations to relevant paragraphs of specification for support for amendments in future correspondence.
The following relevant prior art not cited is made of record:
US Publication 20080262866A1, teaching on methods for improving clinical outcome of patient care while reducing healthcare costs using evidence-based medicine and a pay-for-performance agreement
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNE-MARIE K ALDERSON whose telephone number is (571)272-3370. The examiner can normally be reached on Mon-Fri 9:00am-5:00pm EST and generally schedules interviews in the timeframe of 2:00-5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long, can be reached on 571-270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANNE-MARIE K ALDERSON/Primary Examiner, Art Unit 3682
Prosecution Insights