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 .
Response to Amendment
In the amendment filed on August 17, 2026, the following has occurred: claim(s) 169, 174, 185, 191-194, 199 have been amended. Now, claim(s) 169, 172, 174-176, 185, 188-189, 191-202 are pending.
Claim Objections
Claim 169 objected to because of the following informalities: “the computer-readable administration communication,” in p. 3, ll. 23-24, “the manner or timing of” in p. 6, ll. 7. These appear to be typographical errors. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portions as “the subject-specific computer-readable administration communication” and “a manner or timing of”.
Claim 185 objected to because of the following informalities: “the computer-readable administration communication,” in p. 11, ll. 5-6. This appears to be a typographical error. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “the subject-specific computer-readable administration communication”.
Claim 199 objected to because of the following informalities: “the computer-readable administration communication,” in p. 24, ll. 3-4. This appears to be a typographical error. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “the subject-specific computer-readable administration communication”.
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.
Claim(s) 169, 172, 174-176, 185, 188-189, 191-202 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 169, 172, 174-176, 191-196: Step 2A Prong One
Claim 169 recite(s):
a) for each of one or more subjects enrolled in the clinical trial:
(i) generating and transmitting or making available through the one or more electronic interfaces a subject-specific computer-readable administration communication that identifies the subject and the drug, directs administration of the drug to the subject under the clinical-trial protocol for treatment of the disease or condition, and specifies a drug dose, a dosing schedule, or both;
ii) administering, under the direction or control of the third-party clinical-trial sponsor and in accordance with the subject-specific computer-readable administration communication, the drug to the subject for treatment of the disease or condition in accordance with the drug dose, the dosing schedule, or both specified by the subject- specific computer-readable administration communication; and
(iii) receiving, after the administration under step (a)(ii), an electronic administration- confirmation record that identifies the subject-specific computer-readable administration communication and confirms that the drug was administered to the subject in accordance with the subject- specific computer-readable administration communication;
(b) receiving, for each subject:
(i) baseline clinical data comprising a disease-status or disease-severity measure specified by the clinical-trial protocol, and baseline diagnostic or theragnostic data comprising a measure specific to the drug, the disease or condition, or both, the baseline clinical data and baseline diagnostic or theragnostic data having been acquired before initiation of administration of the drug; and
(ii) follow-up clinical data and follow-up diagnostic or theragnostic data acquired during or after the administration confirmed under step (a)(ii) at one or more follow-up time points specified by the clinical-trial protocol;
(c) determining, for each subject and a corresponding follow-up time point, a therapeutic-effectiveness metric by comparing the baseline clinical data and the baseline diagnostic or theragnostic data with the follow-up clinical data, the follow-up diagnostic or theragnostic data, according to one or more clinical or theragnostic criteria specified by the clinical-trial protocol;
(d) developing and storing, within one or more computer-readable data structures in the computer-readable memory, for each of one or more selected dataset scopes, both of the following datasets:
(i) a first therapeutic-effectiveness dataset developed from one or more therapeutic- effectiveness metrics determined under step (c) and comprising stored associations among the one or more therapeutic-effectiveness metrics, data identifying the subject or subjects in the selected dataset scope to which the one or more therapeutic- effectiveness metrics apply, and the corresponding follow-up time point; and
(ii) a second clinical-trial dataset developed from the one or more therapeutic-effectiveness metrics and comprising, for the subject or subjects in the selected dataset scope, the one or more therapeutic-effectiveness metrics, the baseline clinical data, the baseline diagnostic or theragnostic data, the follow-up clinical data, the follow-up diagnostic or theragnostic data, the subject-specific computer-readable administration communication, and the electronic administration-confirmation record, stored in association with the clinical-trial protocol and the corresponding follow-up time point;
wherein the computer-readable memory stores clinical or theragnostic stratification criteria based on one or more of mechanism of action of the drug, a disease subtype, a disease stage, a disease severity, genotype, an immunological feature, or a treatment-response feature;
wherein each selected dataset scope is one of:
(A) a single subject characterized by the electronic clinical- trial system applying the clinical or theragnostic stratification criteria to clinical, diagnostic, or theragnostic data of the single subject;
(B) a stratified subset comprising a plurality of subjects assigned to a common category by the electronic clinical-trial system applying the clinical or theragnostic stratification criteria to clinical, diagnostic, or theragnostic data of the plurality of subjects; or
(C) an entire clinical-trial population;
wherein the first therapeutic-effectiveness dataset and the second clinical-trial dataset for each selected dataset scope are electronically associated through stored data identifying the subject or subjects in the selected dataset scope and the corresponding follow-up time point; and
(e) for a subject or a stratified subset of subjects represented in the electronically associated first therapeutic-effectiveness dataset and second clinical-trial dataset developed under step (d), and at a corresponding follow-up time point specified by the clinical-trial protocol, performing a feedback operation comprising:
(i) electronically retrieving from the first therapeutic-effectiveness dataset and using the stored data identifying the subject or the subjects in the stratified subset and the corresponding follow-up time point, one or more therapeutic-effectiveness metrics recorded for the subject or the subjects at the corresponding follow-up time point, and evaluating, using the retrieved one or more therapeutic-effectiveness metrics, whether a therapeutic-effectiveness criterion specified by the clinical-trial protocol is met or maintained;
(ii) based on a result of the evaluation and according to the clinical-trial protocol, selecting at least one treatment action and generating a computer-readable clinical- trial treatment output identifying the at least one selected treatment action, wherein:
(A) when the therapeutic-effectiveness criterion is met or maintained, the at least one selected treatment action comprises continuation or modification of treatment with the drug, or completion of a course of treatment with the drug; and
(B) when the therapeutic-effectiveness criterion is not met or is not maintained, the at least one selected treatment action comprises one or both of: (1) modification or discontinuation of treatment with the drug; and (2) initiation of an alternative therapy identified in the computer-readable clinical-trial treatment output;
(iii) generating or updating one or more stored clinical-trial treatment records that identify the subject or the subjects in the stratified subset, the at least one selected treatment action, and one or more of a drug dose, a dosing schedule, a clinical-trial-arm
assignment, a treatment regimen, or an alternative therapy identified in the computer- readable clinical-trial treatment output, and transmitting or making available through the one or more electronic interfaces a computer-readable clinical-trial treatment communication that identifies the subject or the subjects, directs implementation of the at least one selected treatment action under the clinical-trial protocol, and identifies the at least one selected treatment action under the clinical-trial protocol, and identifies the at least one selected treatment action;
(iv) implementing, under the direction or control of the third-party clinical-trial sponsor and in accordance with the computer-readable clinical-trial treatment communication, the at least one selected treatment action for the subject or the subjects in the stratified subset, wherein the implementing comprises, as applicable to the at least one selected treatment action, continuing administration of the drug, administering the drug according to a modified drug dose, dosing schedule, clinical-trial-arm assignment, or treatment regimen, administering the drug to complete a course of treatment, discontinuing administration of the drug, or initiating the alternative therapy identified in the computer-readable clinical-trial treatment output;
(v) receiving, after the implementation under step (e)(iv), an electronic implementation-confirmation record that identifies the computer-readable clinical-trial treatment communication, confirms that the at least one selected treatment action was implemented for the subject or the subjects in accordance with the computer-readable clinical-trial treatment communication, and comprises at least one of administration information, order-fulfillment information, treatment-status information, telehealth remote-monitoring information, or device telemetry; and
(vi) in response to receiving the electronic implementation-confirmation record under step(e)(v), updating the electronically associated second clinical-trial dataset to record, in association with the subject or the stratified subset and the corresponding follow-up time point, the one or more therapeutic-effectiveness metrics used in the evaluation, the result of the stored evaluation, the computer-readable clinical-trial treatment output, the one or more stored clinical-trial treatment records, the computer-readable clinical-trial treatment communication, and the electronic implementation-confirmation record, while maintaining the electronic association between the updated second clinical-trial dataset and the first therapeutic-effectiveness dataset;
wherein the electronic clinical-trial system performs the generating, transmitting or making available, receiving, determining, developing, storing, retrieving, evaluating, selecting, and updating operations recited in steps (a)-(e); and
wherein the third-party clinical-trial sponsor exercises direction or control over performance of steps (a)-(e) by conditioning clinical-trial participation or funding on performance of the recited steps operations and actions and by establishing a manner or timing of the administering under step (a)(ii) and the implementing under step (e)(iv) through the clinical- trial protocol, the subject-specific computer-readable administration communication, and the computer-readable clinical-trial treatment communication, the recited operations and actions being performed by one or more entities acting individually or collectively.
These limitations, as drafted given the broadest reasonable interpretation, but for the recitation of generic computer components, encompass managing interactions between people, including following rules or instructions, which is a subgrouping of Certain Methods of Organizing Human Activity. That is other than reciting, “the one or more electronic interfaces”, “the subject-specific computer-readable administration communication”, “one or more computer-readable data structures in the computer-readable memory”, “the electronic administration-confirmation record”, “the electronic clinical-trial system”, “a computer-readable clinical- trial treatment output”, “an electronic implementation-confirmation record”, “the computer-readable clinical-trial treatment communication”, the claim recites a Certain Method of Organizing Human Activity. For example, the claim encompasses a person following instructions to develop guidelines for a clinical trial, use the guidelines to conduct a clinical trial, update the data from the clinical trial, selecting certain data and linking the data to another set of data, determining, using metrics, if a criterion is met or maintained, and repeating the operations. These steps could be accomplished by a user following rules or instructions to conduct a clinical trial, such as scientific researchers or medical professionals.
Claims 172, 174-176, 191-196 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea. For example, claim 172 incorporates the abstract idea and describes determining an efficacy assurance and financial assurance and providing said assurances to a healthcare payer or a subject. Similarly, claim 174 incorporates the abstract idea and further describes the dataset scope and payment statuses. Similarly, claims 175-176 incorporate the abstract idea and further describe the clinical trial. Similarly, claim 191 incorporates the abstract idea and describes an electronic regulatory submission. Similarly, claim 192 incorporates the abstract idea and further describe rules or instructions when utilizing the generic computer components to perform the method steps. Similarly, claim 193 incorporates the abstract idea and describes linking the subject who meets a criteria to a stratified subset that includes the subject. Similarly, claim 194 incorporates the abstract idea and further describes the feedback operation of step (e). Similarly, claim 195 incorporates the abstract idea and further describes the entity that participates in the clinical trial funding. Finally, claim 196 incorporates the abstract idea and describes generating an output record. Such steps encompass Certain Methods of Organizing Human Activity.
Claims 169, 172, 174-176, 191-196: Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining element amounts to no more than general purpose computer components programmed to perform the abstract idea, generally linking the abstract idea to a technical environment, and insignificant extra-solution activity.
Claims 169, 172, 174-176, 191-196, directly or indirectly, recite the following generic computer components, “the one or more electronic interfaces”, “the subject-specific computer-readable administration communication”, “one or more computer-readable data structures in the computer-readable memory”, “the electronic administration-confirmation record”, “the electronic clinical-trial system”, “a computer-readable clinical- trial treatment output”, “an electronic implementation-confirmation record”, “the computer-readable clinical-trial treatment communication”. As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 “merely include[ing] instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application.
Additionally, the claims recite “electronically associated through stored data”, “the electronically associated first therapeutic-effectiveness dataset and second clinical-trial dataset”, “the electronically associated second clinical-trial dataset”, “the electronic association between the updated second clinical-trial dataset and the first therapeutic-effectiveness dataset” at a high degree of generality, amount no more than generally linking the abstract idea to a particular technical environment. The recitation is also similar to adding the words “apply it” to the abstract idea. As set forth in MPEP 2106.05(f), merely reciting the words “apply it” or an equivalent, is an example of when an abstract idea has not been integrated into a practical application.
Additionally, the claims recite “transmitting or making available”, “(iii) receiving, after the administration under step (a)(ii), an electronic administration- confirmation record that identifies the subject-specific computer-readable administration communication and confirms that the drug was administered to the subject in accordance with the subject- specific computer-readable administration communication;”, “(b) receiving, for each subject: (i) baseline clinical data comprising a disease-status or disease-severity measure specified by the clinical-trial protocol, and baseline diagnostic or theragnostic data comprising a measure specific to the drug, the disease or condition, or both, the baseline clinical data and baseline diagnostic or theragnostic data having been acquired before initiation of administration of the drug; and (ii) follow-up clinical data and follow-up diagnostic or theragnostic data acquired during or after the administration confirmed under step (a)(ii) at one or more follow-up time points specified by the clinical-trial protocol;”, “(i) electronically retrieving from the first therapeutic-effectiveness dataset and using the stored data identifying the subject or the subjects in the stratified subset and the corresponding follow-up time point, one or more therapeutic-effectiveness metrics recorded for the subject or the subjects at the corresponding follow-up time point, and evaluating, using the retrieved one or more therapeutic-effectiveness metrics, whether a therapeutic-effectiveness criterion specified by the clinical-trial protocol is met or maintained”, “(v) receiving, after the implementation under step (e)(iv), an electronic implementation-confirmation record that identifies the computer-readable clinical-trial treatment communication, confirms that the at least one selected treatment action was implemented for the subject or the subjects in accordance with the computer-readable clinical-trial treatment communication, and comprises at least one of administration information, order-fulfillment information, treatment-status information, telehealth remote-monitoring information, or device telemetry” at a high degree of generality, amount no more than receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information). As set forth in MPEP 2106.05(d)(II), computer functions as well-understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity, is an example of when an abstract idea has not been integrated into a practical application.
Claims 169, 172, 174-176, 191-196: Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to
significantly more than the judicial exception. As discussed above with respect to integration of
the abstract idea into a practical application, the additional elements of using a computer configured to perform above identified functions amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See Alice 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea
into a patent-eligible invention.”)
Additionally, generally linking the abstract idea to a particular technological environment does not amount to significantly more than the abstract idea (See MPEP 2106.05(h) and Affinity Labs of Texas v. DirectTV, LLC, 838 F.3d 1253, 120 USP12d 1201 (Fed. Cir. 2016)).
Insignificant, extra solution, data gathering activity has been found to not amount to
significantly more than an abstract idea (See MPEP 2106.05(g)). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Dependent claims recite additional subject matter which amount to limitations consisted
with the additional elements in independent claim 169 (such as claim 172 recite additional
limitations that amount to generic computer components).
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 and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Claim 185, 197-198 are similar to claims 169, 191, 196 but in system form, and are similarly rejected. The additional elements of “(a) computer-readable memory on one or more electronic storage devices storing clinical-trial data in one or more databases, a data warehouse, or both; (b) one or more processors operatively coupled to the computer-readable memory; and (c) one or more electronic interfaces operatively coupled to the one or more processors and configured to transmit and receive clinical-trial data and computer-readable communications;
wherein the one or more processors are configured to:” are recited at a high level of generality that amounts to no more than general purpose computer components programmed to perform the abstract idea. Claims 188-189 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea. For example, claim 188 incorporates the abstract idea and further describes following instructions to associate information from one datasource with information from another datasource. Finally, claim 189 incorporates the abstract idea and further describes following instructions to store or update datasource based on information received at a follow up timepoint. Such steps encompass Certain Methods of Organizing Human Activity. Dependent claims recite additional subject matter which amount to limitations consisted
with the additional elements in independent claim 185 (such as claims 188-189 recite additional
limitations that amount to generic computer components).
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 and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The claims are not patent eligible.
Claim 199-201 are similar to claims 169, 185, 189, 191, 196 but in non-transitory computer-readable storage form, and are similarly rejected.
Independent claim 185 lacks the step of “updating operations recited in steps (a)-(e)”, but are similarly rejected as independent claim 169 has been. The claims are not patent eligible.
Distinguishing Subject Matter
The following is a statement of reasons for the indication of distinguishing subject
matter: Claims 169, 172, 174-176, 185, 188-189, 191-202 distinguish over the prior art. The closest prior art (Elton et al. (U.S. Patent Pre-Grant Publication No. 2012/0231959), Bockelman et al. (U.S. Patent Pre-Grant Publication No. 2014/0330572), Lake et al. (U.S. Patent Pre-Grant Publication No.2019/0019573), Keeling et al. (U.S. Patent Pre-Grant Publication No. 2008/0065411)), describes systems and methods for the assignment of oncology patients to specific clinical episodes of care for purposes of treatment reimbursement, combined with modeling a clinical trial study, which may implement a cross-over design, combined with a patient care system comprising a medical device for administering a medical treatment to a patient and a server system configured to receive and transmit data via a communications network to, respectively from users including patients and health care professionals, and combined with a method of developing a personalised medicine business plan. However, the prior does not describe the specific order of the steps of independent claims 169, 185, and 199 as the Applicant’s claims recite “receive”, for each subject, “baseline clinical data” and “follow-up clinical data” to then follow to the “determination” step that identifies a “therapeutic-effectiveness metric”, and following the step to “develop and store” associations between a “first therapeutic-effectiveness dataset” and “stored associations among the one or more therapeutic-effectiveness metric”, and “determine or update” to “one or more stored clinical-trial treatment records” based on the previous steps.
Response to Arguments
In the Remarks filed on August 17, 2026, the Applicant argues that the newly amended and/or added claims overcome the Claim Objection(s) and 35 U.S.C. 101 rejection(s). The Examiner acknowledges that the newly added and/or amended claims overcome the previous Claim Objection(s). However, the Examiner does not acknowledge that the newly added and/or amended claims overcome the newly added Claim Objection(s) and the 35 U.S.C. 101 rejection(s).
The Applicant argues that:
(1) Step 2A Prong One: the Office’s “clinical trial” abstraction does not identify an enumerated abstract idea recited by the claims;
(2) claim 169 affirmatively effects treatment and applies the evaluation result to a later treatment action;
(3) steps (d)-(e) define a scope-preserving treatment-and-evidence architecture-not a collage of clinical-trial data;
(4) the communications and confirmations are operative control points, not generic network activity;
(5) under Step 2A, Prong Two, any alleged exception is not integrated into a practical application;
(6) the dependent claims require separate claim-as-a-whole consideration and add concrete downstream applications;
(7) alternatively, the record does not establish that the ordered combination was well-understood, routine, and conventional under Step 2B.
In response to argument (1), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner The newly amended claims recite limitations, as drafted given the broadest reasonable interpretation, but for the recitation of generic computer components, encompass managing interactions between people, including following rules or instructions, which is a subgrouping of Certain Methods of Organizing Human Activity. The Applicant’s claims recite generic computer components that are no more than general purpose computer components programmed to perform the abstract idea of developing a clinical trial and carrying out a clinical trial. The Examiner maintains that the Applicant’s newly amended claims recite a Certain Method of Organizing Human Activity as the Applicant’s claims are similar to “iii. a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982)” (See MPEP 2106.04(a)(2)(C)). Each newly amended step of the Applicant’s claims either details guidelines on how to accomplish each step or which computer components to use to accomplish the guidelines. The Examiner has reproduced the Applicant’s newly amended independent claim 169 and has bolded the additional elements within the reproduced newly amended independent claim 169 to highlight the placement of the additional elements within the abstract idea. For example, but for the “the one or more electronic interfaces a subject-specific computer-readable administration communication”, “transmitting or making available” language, the “generating” function in the context of this claim encompasses a person following instructions to identify the subject and the drug, and communicates that a drug should be administered to the identified subject. Similarly, but for the “the subject-specific computer-readable administration communication” language, the “administering” function in the context of this claim encompasses a person following instructions to administer a drug under the direct supervision of another person. Similarly, the “determining” function in the context of this claim encompasses a person following instructions to determine a therapeutic-effectiveness metric based on received data. Similarly, but for the “one or more computer-readable data structures in the computer-readable memory”, “the subject-specific computer-readable administration communication” , “the computer-readable memory”, “the electronic clinical-trial system”, “electronically associated through stored data” language, the “developing and storing” function in the context of this claim encompasses a person following instructions to record and collect a first therapeutic-effectiveness dataset and a second clinical-trial dataset. Finally, but for the “the electronically associated first therapeutic-effectiveness dataset and second clinical-trial dataset”, “a computer-readable clinical- trial treatment output”, “transmitting or making available through the one or more electronic interface”, “the electronically associated second clinical-trial dataset”, “the computer-readable clinical-trial treatment output”, “the computer-readable clinical-trial treatment communication”, “the electronic implementation-confirmation record”, “the electronic association between the updated second clinical-trial dataset and the first therapeutic-effectiveness dataset”, “the electronic clinical-trial system” language, the “performing” function in the context of this claim encompasses a person following instructions to make a determination by comparing the therapeutic-effectiveness metric to a therapeutic-effectiveness criterion to identify if the clinical-trial protocol is met or maintained, and implementing, under the direction or control of the third-party clinical-trial sponsor the at least one selected treatment action for the subject or the subjects, and generating, transmitting or making available, receiving, determining, developing, storing, retrieving, evaluating, selecting, and updating operations recited in steps (a)-(e). The Examiner maintains that the Applicant’s newly amended claimed limitations recite a Certain Method of Organizing Human Activity as the Applicant’s claims are similar to “iii. a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982)” (See MPEP 2106.04(a)(2)(C) (Other examples of managing personal behavior recited in a claim)).
The 35 U.S.C. 101 rejection(s) stand.
In response to argument (2), the Examiner does not find the Applicant’s argument(s) persuasive. The Applicant’s claims recite in claim 169(a)(ii) “actual administration of the protocol-identified drug to the subject for treatment of the disease or condition at the dose and/or schedule specified in the subject-specific administration communication” and claim 169(e)(iv) “actual implementation of the metric-selected treatment action, including, as applicable, continuing, modifying, completing, or discontinuing treatment with the drug, or initiating the identified alternative therapy”, the Examiner maintains that these recitations require the managing of personal behavior or relationships or interactions between people as the Applicant’s newly amended claim requires the management of interactions between people to accomplish both of these steps as a person’s interaction between another person is dictated by the guidelines or protocols. “Examiners should keep in mind that in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of "administering amazonic acid to a patient" or a step of "administering a course of plasmapheresis to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used.” (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.” (See MPEP 2106.04(d)(2)(a)). The Examiner maintains that the Applicant’s claimed limitation of “administering” is general, and not “particular” as the Applicant’s claims recite administering at a general level that encompasses all applications of the judicial exception. The 35 U.S.C. 101 rejection(s) stand.
In response to argument (3), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that the Applicant’s claimed limitations of claim 169 steps (d)-(e) of “electronically associated through stored data”, “the electronically associated first therapeutic-effectiveness dataset and second clinical-trial dataset”, “the electronically associated second clinical-trial dataset”, “the electronic association between the updated second clinical-trial dataset and the first therapeutic-effectiveness dataset” are recited at a high-level of generality that amounts to no more than generally linking the abstract idea to a particular technical environment. The recitation is also similar to adding the words “apply it” to the abstract idea. As set forth in MPEP 2106.05(f), merely reciting the words “apply it” or an equivalent, is an example of when an abstract idea has not been integrated into a practical application. The Applicant’s claimed limitations invokes computers or other machinery merely as a tool to perform an existing process (See MPEP 2106.05(f)(2)), and are similar to “v. Requiring the use of software to tailor information and provide it to the user on a generic computer, Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1370-71, 115 USPQ2d 1636, 1642 (Fed. Cir. 2015)”. The 35 U.S.C. 101 rejection(s) stand.
In response to argument (4), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that the Applicant’s claimed limitations of “transmitting or making available”, “(iii) receiving, after the administration under step (a)(ii), an electronic administration- confirmation record that identifies the subject-specific computer-readable administration communication and confirms that the drug was administered to the subject in accordance with the subject- specific computer-readable administration communication;”, “(b) receiving, for each subject: (i) baseline clinical data comprising a disease-status or disease-severity measure specified by the clinical-trial protocol, and baseline diagnostic or theragnostic data comprising a measure specific to the drug, the disease or condition, or both, the baseline clinical data and baseline diagnostic or theragnostic data having been acquired before initiation of administration of the drug; and (ii) follow-up clinical data and follow-up diagnostic or theragnostic data acquired during or after the administration confirmed under step (a)(ii) at one or more follow-up time points specified by the clinical-trial protocol;”, “(i) electronically retrieving from the first therapeutic-effectiveness dataset and using the stored data identifying the subject or the subjects in the stratified subset and the corresponding follow-up time point, one or more therapeutic-effectiveness metrics recorded for the subject or the subjects at the corresponding follow-up time point, and evaluating, using the retrieved one or more therapeutic-effectiveness metrics, whether a therapeutic-effectiveness criterion specified by the clinical-trial protocol is met or maintained”, “(v) receiving, after the implementation under step (e)(iv), an electronic implementation-confirmation record that identifies the computer-readable clinical-trial treatment communication, confirms that the at least one selected treatment action was implemented for the subject or the subjects in accordance with the computer-readable clinical-trial treatment communication, and comprises at least one of administration information, order-fulfillment information, treatment-status information, telehealth remote-monitoring information, or device telemetry” amounts to insignificant, extra solution, data gathering activity. The Applicant’s claimed limitations are similar to the mere data gathering steps outlined in MPEP 2106.05(g), specifically the examples of activities that the courts have found to be insignificant extra-solution activity of “i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989)”, “v. Consulting and updating an activity log, Ultramercial, 772 F.3d at 715, 112 USPQ2d at 1754;”, and “vi. Determining the level of a biomarker in blood, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968. See also PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012) (assessing or measuring data derived from an ultrasound scan, to be used in a diagnosis)”. The 35 U.S.C. 101 rejection(s) stand.
In response to argument (5), the Examiner does not find the Applicant’s argument(s) persuasive. The claim(s) does/do not include additional elements that are sufficient to amount to
significantly more than the judicial exception. As discussed above with respect to integration of
the abstract idea into a practical application, the additional elements of using a computer configured to perform above identified functions amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See Alice 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea
into a patent-eligible invention.”) Additionally, generally linking the abstract idea to a particular technological environment does not amount to significantly more than the abstract idea (See MPEP 2106.05(h) and Affinity Labs of Texas v. DirectTV, LLC, 838 F.3d 1253, 120 USP12d 1201 (Fed. Cir. 2016)). Insignificant, extra solution, data gathering activity has been found to not amount to significantly more than an abstract idea (See MPEP 2106.05(g)). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea. The 35 U.S.C. 101 rejection(s) stand.
In response to argument (6), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that the claims 172, 174-176, 191-196 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea. The Examiner maintains that the dependent claims recite steps encompass Certain Methods of Organizing Human Activity, and do not recite additional elements that integrate the abstract idea into a practical application and does not recite significantly more. 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 and do not impose a meaningful limit to integrate the abstract idea into a practical application. The 35 U.S.C. 101 rejection(s) stand.
In response to argument (7), the Examiner does not find the Applicant’s argument(s) persuasive. The courts have recognized the following computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity, the Applicant’s claimed additional elements are similar to “i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink."”, “i. Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims.")”, “iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93” (See MPEP 2106.05(d)(II)). Further, the courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity, and the Applicant’s claimed additional elements are similar to “i. Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017)” (See MPEP 2106.05(d)(II)). The 35 U.S.C. 101 rejection(s) stand.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Moeller et al. (U.S. Patent Pre-Grant Publication No. 2011/0076685), describes a multiplex assay as a tool for in vitro detection and/or early detection and/or differentiation and/or progress monitoring and/or evaluation of pathophysiological conditions of a patient.
De Bruin et al. (U.S. Patent Pre-Grant Publication No. 2011/0119212), describes a system utilizes data fusion, advanced signal/information processing and machine learning/inference methodologies and technologies to integrate and explore diverse sets of attributes, parameters and information that are available to select the optimal treatment choice for an individual or for a subset of individuals suffering from any illness or disease including psychiatric, mental or neurological disorders and illnesses.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bennett S Erickson whose telephone number is (571)270-3690. The examiner can normally be reached Monday - Friday: 9:00am - 5:00pm.
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, Robert Morgan can be reached at (571) 272-6773. 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.
/Bennett Stephen Erickson/Primary Examiner, Art Unit 3683
Prosecution Insights