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 .
DETAILED ACTION
Response to Amendment
In the amendment dated 11/24/2025, the following occurred: Claims 1, 4, 6-8, 11, 13-15, 18 and 20 have been amended. Claims 2, 3, 5, 9, 10, 12, 16, 17 and 19 were canceled. Claims 21-29 are new.
Claims 1, 4, 6-8, 11, 13-15, 18 and 20-29 are currently pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4, 6-8, 11, 13-15, 18 and 20-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1, 8 and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites a method, a system and a non-transitory computer readable media for clinical trial matching.
Regarding claims 1, 8 and 15, the limitation of (claim 1 being representative) displaying, information indicating: pre-screening criteria associated with corresponding clinical trials, and compensation data indicating pre-screening compensation amounts associated with performance of pre-screening activities by providers, based on the pre- screening criteria, in association with the corresponding clinical trials; receiving user input indicating that a provider has completed the pre-screening activities for a particular clinical trial in association with patients of the provider, wherein; the user input indicates a number of the patients of the provider that the provider has determined are eligible for the particular clinical trial based on the pre-screening activities; causing a transfer of a pre-screening compensation amount based on the compensation data associated with the particular clinical trial wherein; the transfer is from an operator to the provider based on completion of the pre-screening activities by the provider; receiving patient data associated with a patient of the provider, wherein; the provider referred the patient for the participation in the particular clinical trial in response to the pre-screening activities performed by the provider; verifying, and based on the patient data, that the patient is eligible for the particular clinical trial; and providing the patient data to a trial sponsor of the particular clinical trial based on verifying that the patient is eligible for the particular clinical trial as drafted, is a process that, under the broadest reasonable interpretation, covers a certain method organizing human activity but for the recitation of generic computer components. That is other than reciting a clinical trial matching platform, one or more processors and a computing system (in claim 1), a computing system, at least one processor, memory and a clinical trial matching platform (in claim 8) and one or more non-transitory computer-readable media, a clinical trial matching platform and at least one processor (in claim 15), the claimed invention amounts to managing personal behavior or interaction between people (i.e., rules or instructions). For example, but for the clinical trial matching platform, one or more processors, computing system, at least one processor, memory and one or more non-transitory computer-readable media, the claims encompass displaying information, receiving user input, causing a transfer of a pre-screening compensation amount, receiving patient data, verifying that the patient is eligible for the particular clinical trial and providing the patient data to a trial sponsor in the manner described in the identified abstract idea, supra. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, claim 1 recites the additional elements of a clinical trial matching platform, one or more processors and a computing system. Claim 8 recites the additional elements of a computing system, at least one processor, memory and a clinical trial matching platform. Claim 15 recites the additional elements of one or more non-transitory computer-readable media, a clinical trial matching platform and at least one processor. These additional elements are not exclusively defined by the applicant and are recited at a high-level of generality (i.e., a generic computer components for enabling access to medical information or for performing generic computer functions. See Specification at para. [0081]-[0084] and [0089] which teach that the additional elements are generic computer components) such that they amounts to no more than mere instructions to apply the exception using a generic computer component. As set forth in MPEP 2106.04(d) “merely including 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. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Claims 1, 8 and 15 further recite the additional element of a user interface. The user interface merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application.
The claims 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 the clinical trial matching platform, one or more processors, computing system, at least one processor, memory and one or more non-transitory computer-readable media to perform the noted steps amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). Moreover, using generic computer components to perform abstract ideas does not provide a necessary 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”). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Also as discussed above with respect to integration of the abstract idea into a practical application, the additional element of the user interface was determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. Accordingly, even in combination, this additional element does not provide significantly more. As such the claim is not patent eligible.
The examiner notes that: A well-known, general-purpose computer has been determined by the courts to be a well-understood, routine and conventional element (see, e.g., Alice Corp. v. CLS Bank; see also MPEP 2106.05(d)); Receiving and/or transmitting data over a network (“a communications network”) has also been recognized by the courts as a well - understood, routine and conventional function (see, e.g., buySAFE v. Google; MPEP 2016(d)(II)); and Performing repetitive calculations is/are also well-understood, routine and conventional computer functions when they are claimed in a merely generic manner (see, e.g., Parker v. Flook; MPEP 2016.05(d)).
Claims 4, 6, 7, 11, 13, 14, 18 and 20-29 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Claim(s) 4, 11 and 18 further merely describe(s) what the information displayed is based on. Claim(s) 6, 13 and 20 further merely describe(s) the patient data and navigation services. Claim(s) 7 and 14 further merely describe(s) receiving a notification and providing information. Claim 21 further merely describe(s) receiving a notification and providing information in response to the notification. Claim 22 further merely describe(s) the communication session. Claim 22 further recites the additional element of “a communication tool” that is interpreted as to generally link the abstract idea to a particular technological environment or field of use and does not provide practical application or significantly more. Claim 23 further merely describe(s) the provider platform and the navigation platform. Claim 23 further recites the additional element of “a provider platform” and “a navigation platform” that are interpreted the same as the clinical trial matching platform and do not provide practical application or significantly more. Claim 23 also recites the additional element of “the user interface” and “one or more communication tools comprising at least one of a messaging tool, a chat tool, a voice call tool or a videoconferencing tool” that are all interpreted as to generally link the abstract idea to a particular technological environment or field of use and do not provide practical application or significantly more. Claim 24 further merely describe(s) the one or more communication tools. Claim 24 further recites the additional element of “an automated translation tool” that is interpreted as to generally link the abstract idea to a particular technological environment or field of use and does not provide practical application or significantly more. Claim 25 further merely describe(s) the partner. Claim 26 further merely describe(s) storing clinical trial information and compensation data and displaying information. Claim 26 further recites the additional element of “a database” that is interpreted as extra solution activity and does not provide practical application or significantly more. Claim 27 further merely describe(s) the pre-screening compensation amount transferred. Claim 28 further merely describe(s) displaying a provider dashboard. Claim 29 further merely describe(s) determining that the patient data omitted a data element, providing a notification and receiving additional patient data.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4, 7, 8, 11, 14, 15, 18 and 21, 25-29 are rejected under 35 U.S.C. 103 as being unpatentable over Graiver (US 2018/0046780) and in further view of Wager (US 2016/0188811).
REGARDING CLAIM 1
Graiver discloses a computer-implemented method, comprising: displaying, by a clinical trial matching platform executed by one or more processors of a computing system, and via a user interface, information indicating: pre-screening criteria associated with corresponding clinical trials, and compensation data ([0013] teaches clinical trial matching system (interpreted by examiner as the clinical trial matching platform) Fig. 20-26 and Fig. 28 teaches a UI (interpreted by examiner as the user interface) for display of information. [0008] teaches a patient completing a pre-screener form for a particular trial (interpreted by examiner as the pre-screening criteria associated with corresponding clinical trials) [0144] teaches the trial sponsor may select information related to financial compensation and FIG. 13 shows a study page with additional details such as financial compensation (interpreted by examiner as displaying compensation data of Wager below)); receiving, by the clinical trial matching platform, and via the user interface, user input indicating that a provider has completed the pre-screening activities for a particular clinical trial in association with patients of the provider, wherein ([0449] teaches numbers, age and gender of people who complete the pre-screener and [0450] teaches numbers, age and gender of eligible candidates and approved referrals (as described in Section 6.1) while [0451] teaches percentages of ineligible candidates failing on each question of pre-screener (if an advanced study-specific pre-screener is selected). [0505] teaches the physician may also has the ability to launch immediately into prescreening questions to book the patient in for a screening visit if they match the initial criteria and [0516] teaches the medically qualified agents prescreen patients on the basis of the entire protocol, thereby sending only very highly qualified patients to sites (interpreted by examiner as means to receive a user input indicating that a provider has completed the pre-screening activities for a particular clinical trial in association with patients of the provider)); the user input indicates a number of the patients of the provider that the provider has determined are eligible for the particular clinical trial based on pre-screening activities ([0450] teaches numbers (interpreted by examiner as the number of the patients of the provider that the provider has determined are eligible for the particular clinical trial based on pre-screening activities), age and gender of eligible candidates and approved referrals (as described in Section 6.1)); receiving, by the clinical trial matching platform, patient data associated with a patient of the provider, wherein the provider referred the patient for participation in the particular clinical trial in response to the pre-screening activities performed by the provider ([0015] teaches the clinical trial matching system outputs a list of multiple different, matching trials in response to a patient answering the questions and [0347] teaches information about the patient may be obtained by either (i) asking a series of questions via a web UI or (ii) from the patient's EHR (interpreted by examiner as the patient data associated with a patient of the provider) [0508] and Fig. 36 teach a referral management patient flow for a HER provider collaboration and [0515] teaches referral through provider collaboration); verifying, by the clinical trial matching platform, and based on the patient data, that the patient is eligible for the particular clinical trial ([0024] teaches the clinical trial matching system outputs a list of multiple different, matching trials in response to a patient answering the questions and [0347] teaches a machine interpretable representation of the eligibility criteria for a corpus of clinical trials and some information about a patient's medical history, it would be desirable to determine automatically whether the patient is eligible for any of the trials (interpreted by examiner as verifying, by the clinical trial matching platform, and based on the patient data, that the patient is eligible for the particular clinical trial)); and providing, by the clinical trial matching platform, the patient data to a trial sponsor of the particular clinical trial based on verifying that the patient is eligible for the particular clinical trial ([0154] teaches the sponsor enrolling participants. [0447] teaches a TrialManager, a dashboard through which sponsors can view key metrics relating to a particular Study, as shown in FIGS. 34 and 35: [0448] Numbers and geographical location of visitors to the Study Page; [0449] Numbers, age and gender of people who complete the pre-screener; [0450] Numbers, age and gender of eligible candidates and approved referrals (as described in Section 6.1); [0451] Percentages of ineligible candidates failing on each question of pre-screener (if an advanced study-specific pre-screener is selected); [0452] Progress of referrals across the trial by stage from new referral to randomized as provided by the sites via the Site Portal (interpreted by examiner as providing, by the clinical trial matching platform, the patient data to a trial sponsor of the particular clinical trial based on verifying that the patient is eligible for the particular clinical trial)).
Graiver does not explicitly disclose, however Wager discloses:
compensation data indicating pre-screening compensation amounts associated with performance of pre-screening activities by providers, based on the pre- screening criteria, in association with the corresponding clinical trials; causing, by the clinical trial matching platform, a transfer of a pre-screening compensation amount based on the compensation data associated with the particular clinical trial, wherein; the transfer is from an operator of the clinical trial matching platform to the provider based on completion of the pre-screening activities by the provider (Wager at [0006] teaches requiring a fee (interpreted by examiner as the pre-screening compensation amount) to be paid to the one or more healthcare providers (interpreted by the provider), and upon payment of the fee from the one or more clinical trial sponsors (interpreted by examiner as the operator of the clinical trial matching platform), notifying the one or more clinical trial sponsors of the one or more patients that fulfill the clinical trial eligibility requirements of the one or more clinical trials. [0033] teaches incentive payments to eligible professionals, thus, in one embodiment, a first hospital refers patients that qualify for a clinical trial to a second hospital, where those patients will join patients from the second hospital that qualify for the same clinical trial. Those individuals that referred the clinical trial patients could be compensated (interpreted by examiner as compensation data indicating pre-screening compensation amounts associated with performance of pre-screening activities by providers, based on the pre- screening criteria, in association with the corresponding clinical trials) and [0034] teaches healthcare provider is compensated by the clinical trial sponsor upon notification of the one or more patients qualifying for the clinical trial participation (interpreted by examiner as causing, by the clinical trial matching platform, a transfer of a pre-screening compensation amount based on the compensation data associated with the particular clinical trial, wherein; the transfer is from an operator of the clinical trial matching platform to the provider based on completion of the pre-screening activities by the provider));
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of determining clinical trial suitability of Graiver to incorporate the clinical trial management as taught by Wager, with the motivation of reducing cost and time consumption (Wager at [0001]).
REGARDING CLAIM 4
Graiver and Wager disclose the limitation of claim 1.
Wager does not explicitly disclose, however Graiver further discloses:
The computer-implemented method of claim 1, wherein the information displayed via the user interface is associated with clinical trials identified by the clinical trial matching platform based on at least one of: a location of the provider, population demographics of areas served by the provider, target locations for the clinical trials, target demographics for participants of the clinical trials, preferences entered by the provider, or search criteria entered by the provider (Graiver at [0045] teaches key metrics of the demographic makeup of the patients using MATCH may be displayed and analyzed dynamically such as the total number of patients, the breakdown patients versus age range, and the percentage of female or male, as seen in FIG. 29. FIG. 30 shows location demographics with a map displaying the location of the users within the USA of MATCH (interpreted by examiner as wherein the information displayed via the user interface is associated with clinical trials identified by the clinical trial matching platform based on at least one of target demographics for participants of the clinical trials)).
REGARDING CLAIM 7
Graiver and Wager disclose the limitation of claim 1.
Graiver does not explicitly disclose, however Wager further discloses:
The computer-implemented method of claim 1,further comprising: receiving, by the clinical trial matching platform, a notification from a partner indicating that an evaluation of records of the partner, associated with the patient, indicates that the patient is likely to meet the pre-screening criteria for the particular clinical trial; and providing, by the clinical trial matching platform, the provider with the information associated with the particular clinical trial in response to the notification indicating that the patient is likely to meet the pre-screening criteria for the clinical trial, wherein the partner is different from the provider, the trial sponsor and the operator of the clinical trial matching platform (Wager at [0005] teaches notifying a healthcare provider that one or more patients from the healthcare provider qualify for clinical trial participation. Screening the EMR information of the one or more patients from the first healthcare provider for matching clinical trial participation qualifications; determining that one or more patients of the first healthcare provider qualifies for clinical trial participation of the clinical trial sponsor, wherein the qualification for clinical trial participation is based on the matching of the EMR information of the one or more patients and the clinical trial participation qualifications and notifying to the first healthcare provider that the one or more patients from the first healthcare provider qualifies for clinical trial participation (interpreted by examiner as a notification from a partner indicating that an evaluation of records of the partner, associated with the patient, indicates that the patient is likely to meet the pre-screening criteria for the clinical trial and providing, by the clinical trial matching platform, the provider with the information associated with the clinical trial in response to the notification indicating that the patient is likely to meet the pre-screening criteria for the clinical trial) [0034] teaches a first healthcare provider, a second healthcare provider and a trial sponsor (interpreted by examiner as wherein the partner is different from the provider, the trial sponsor and the operator of the clinical trial matching platform)).
REGARDING CLAIMS 8, 11, 14, 15, 18, 21 and 28
Claims 8, 11, 14, 15, 18, 21 and 28 are analogous to Claims 1, 4 and 7 thus Claims 8, 11, 14, 15, 18 and 21 are similarly analyzed and rejected in a manner consistent with the rejection of Claims 1, 4 and 7.
REGARDING CLAIM 25
Graiver and Wager disclose the limitation of claim 1.
Graiver does not explicitly disclose, however Wager further discloses:
The computer-implemented method of claim 7, wherein the partner comprises at least one of a pharmacy, a genomic research entity, a benefit plan operator, or an insurance provider (Wager at [0025] teaches partner such as pharmaceutical company).
REGARDING CLAIM 26
Graiver and Wager disclose the limitation of claim 1.
Wager does not explicitly disclose, however Graiver further discloses:
The computer-implemented method of claim 1, wherein: the clinical trial matching platform comprises a database storing clinical trial information comprising the pre-screening criteria and the compensation data associated with the corresponding clinical trials, and the user interface displays the information based on the clinical trial information stored in the database (Graiver at [0055] teaches a computer implemented system for matching a patient to clinical trial(s) comprising a database storing computer parseable representation of clinical trials. [0141] teaches a clinical trial protocol description as directly obtained from clinical trial databases, [0454] teaches a dynamic system is developed such that when a clinical trial criterion is entered, the population the trial may be able to target is predicted and displayed via a heat map for example. This is done through accessing in real time the database of harvested data (interpreted by examiner as database storing clinical trial information comprising the pre-screening criteria and the compensation data associated with the corresponding clinical trials, and the user interface displays the information based on the clinical trial information stored in the database)).
REGARDING CLAIM 27
Graiver and Wager disclose the limitation of claim 1.
Wager does not explicitly disclose, however Graiver further discloses:
The computer-implemented method of claim 1, wherein the pre-screening compensation amount transferred from the operator of the clinical trial matching platform to the provider is different from a referral amount transferred from the trial sponsor to the operator of the clinical trial matching platform based on a referral of the patient for participation in the particular clinical trial (Graiver at [0144] teaches information related to financial compensation (the examiner interprets this pre-screening compensation amount to be inherently different from any other compensation amount including a referral amount. The Examiner notes that the claim does not require a referral amount to be transferred)).
REGARDING CLAIM 29
Graiver and Wager disclose the limitation of claim 1.
Wager does not explicitly disclose, however Graiver further discloses:
The computer-implemented method of claim 1, further comprising: determining, by the clinical trial matching platform, that the patient data omitted a data element; providing, by the clinical trial matching platform, a notification to the provider indicating the patient data omitted a data element; and receiving, by the clinical trial matching platform, and from the provider in response to the notification, additional patient data that is associated with the patient and that includes the data element, wherein the clinical trial matching platform verifies that the patient is eligible for the particular clinical trial based on the patient data and the additional patient data (Graiver at [0360] teaches when the patient decides to click either on a ‘skip’ or ‘I don't know’ button instead of providing an answer to a particular question (interpreted by examiner as determining, by the clinical trial matching platform, that the patient data omitted a data element) [0455] teaches capabilities to inform and [0505] teaches alerting physicians in real time (interpreted by examiner as means to provide a notification to the provider indicating the patient data omitted a data element) [0482] teaches statistical models may be used to model the conditional probability distribution over an unknown patient attribute given some other patient attributes and [0483] teaches statistical models may be obtained using data provided by real patients, for example during question-based patient trial matching or whilst obtaining additional patient-provided information to supplement that already present in EHRs (interpreted by examiner as receiving, by the clinical trial matching platform, and from the provider in response to the notification, additional patient data that is associated with the patient and that includes the data element, wherein the clinical trial matching platform verifies that the patient is eligible for the particular clinical trial based on the patient data and the additional patient data)).
Claims 6, 13 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Graiver (US 2018/0046780), in view of Wager (US 2016/0188811) and in further view of Wamberg (US 2023/0005071).
REGARDING CLAIM 6
Graiver and Wager disclose the limitation of claim 1.
Graiver and Wager do not explicitly disclose, however Wamberg further discloses:
The computer-implemented method of claim 1, wherein: the patient data indicates a request for navigation services, the method further comprises initiating, by the clinical trial matching platform, a communication session between the patient and a navigator associated with the clinical trial matching platform, and the navigator provides the navigation services during or after the communication session to assist the patient in participating in the particular clinical trial (Wamberg at [0018] and [0055] teaches a component for providing navigational support with a range of support services delivered by a precision navigator. [0102] teaches a nurse navigator—we send with a member to their first appointment to help explain medical jargon. [0105] teaches members may significantly increase access to important and potentially lifesaving clinical trial via Clinical Trial Navigator. Moreover, [table 1] teaches navigator/patient communication process that features navigator available for ad hoc Q&A with patient via scheduling software within patient portal, progress updates and support provided via patient preferred communication throughout each phase of the deliverable (interpreted by examiner as the patient data indicates a request for navigation services, the method further comprises initiating, by the clinical trial matching platform, a communication session between the patient and a navigator associated with the clinical trial matching platform, and the navigator provides the navigation services during or after the communication session to assist the patient in participating in the clinical trial)).
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of determining clinical trial suitability of Graiver and the clinical trial management system of Wager to incorporate the navigating services as taught by Wamberg, with the motivation of providing the ability to build vertical ecosystems within a specific therapeutic area and then integrate them through efficient process design and technology creating end-to-end experiences that dramatically reduce the friction of health navigation. (Wamberg at [0059]).
REGARDING CLAIMS 13 and 20
Claims 13 and 20 are analogous to Claim 6 thus Claims 13 and 20 are similarly analyzed and rejected in a manner consistent with the rejection of Claim 6.
Claims 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Graiver (US 2018/0046780), in view of Wager (US 2016/0188811), in view of Wamberg (US 2023/0005071) and in further view of Joao (US 2021/0319895) .
REGARDING CLAIM 22
Graiver, Wager and Wamberg disclose the limitation of claim 6.
Graiver, Wager and Wamberg do not explicitly disclose, however Joao further discloses:
The computer-implemented method of claim 6, wherein the communication session comprises a videoconference implemented via a communication tool of the clinical trial matching platform (Joao at [0258] teaches identifying or selecting individuals for clinical trials and [0012] teaches the apparatus and method of the present invention can also be utilized to facilitate remote or virtual conferences, discussions, and/or consultations, via and/or through the use of video calls, video chat sessions, and/or videoconferences, with and between an individual, a patient, and/or a caregiver for the individual or the patient, a healthcare provider, a healthcare insurer or a healthcare payer, and/or an intermediary (interpreted by examiner as the communication session comprises a videoconference implemented via a communication tool of the clinical trial matching platform of Graiver)).
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of determining clinical trial suitability of Graiver, the clinical trial management system of Wager and the communication session of Wamberg to incorporate videoconferencing as taught by Joao, with the motivation of facilitating communications and data and/or information exchange with and/or between an individual or a patient and a healthcare provider or a healthcare professional. (Joao at [0002]).
REGARDING CLAIM 23
Graiver, Wager and Wamberg disclose the limitation of claim 6.
Wager and Wamberg do not explicitly disclose, however Graiver further discloses:
The computer-implemented method of claim 6, wherein: the clinical trial matching platform comprises a provider platform and a navigation platform, the provider platform comprises the user interface that displays the information and receives the user input in association with the provider (Graiver at [0013] teaches clinical trial matching system (interpreted by examiner as the clinical trial matching platform) and Fig. 20-26 and Fig. 28 teaches a UI for display of information and [0055] teaches another aspect of the system for matching is an input search query (interpreted by examiner as the provider platform)),
Graiver, Wager and Wamberg do not explicitly disclose, however Joao further discloses:
and the navigation platform provides one or more communication tools, associated with the communication session between the navigator and the patient, comprising at least one of a messaging tool, a chat tool, a voice call tool, or a videoconference tool (Joao at [0258] teaches identifying or selecting individuals for clinical trials and [0012] teaches the apparatus and method of the present invention can also be utilized to facilitate remote or virtual conferences, discussions, and/or consultations, via and/or through the use of video calls, video chat sessions, and/or videoconferences, with and between an individual, a patient, and/or a caregiver for the individual or the patient, a healthcare provider, a healthcare insurer or a healthcare payer, and/or an intermediary (interpreted by examiner as the navigation platform)).
REGARDING CLAIM 24
Graiver, Wager and Wamberg disclose the limitation of claim 23.
Graiver, Wager and Wamberg do not explicitly disclose, however Joao further discloses:
The computer-implemented method of claim 23, wherein the one or more communication tools further comprise an automated translation tool configured to automatically translate communications between the navigator and the patient during the communication session (Joao at [0704] teaches the user or patient communication device and/or the personal health record utilized in connection with same, can be equipped with hardware and/or software for translating any data and/or information from one language into any other language, for translating audio information into text information for storing in the user or patient communication device, for storing audio information, for translating text information into audio information, for providing reminders to schedule appointments with providers, for providing reminders for scheduled appointments with providers, and/or for providing any other functions which are described herein as being performed in connection with the user or patient communication device (interpreted by examiner as an automated translation tool configured to automatically translate communications between the navigator and the patient during the communication session)).
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of determining clinical trial suitability of Graiver, the clinical trial management system of Wager and the communication session of Wamberg to incorporate an automated translation tool as taught by Joao, with the motivation of facilitating communications and data and/or information exchange with and/or between an individual or a patient and a healthcare provider or a healthcare professional. (Joao at [0002]).
Response to Arguments
Rejection under 35 U.S.C. § 101
Regarding the rejection of claims 1, 4, 6-8, 11, 13-15, 18 and 20-29, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
Here, Applicant respectfully submits that the claims, as currently amended, recite additional elements that demonstrate that the claims, as a whole, are not directed to the alleged abstract idea. For example, amended claim 1 recites elements such as a "user interface" that presents "pre-screening criteria associated with corresponding clinical trials" and "pre-screening compensation amounts associated with performance of pre-screening activities by providers, based on the pre-screening criteria, in association with the corresponding clinical trials," "user input" that is provided via the "user interface" to indicate that "a provider has completed the pre-screening activities for a particular clinical trial," receipt of "patient data" associated with a patient of the provider that has been referred "for participation in the particular clinical trial in response to the pre-screening activities performed by the provider," and "verifying, ... based on the patient data, that the patient is eligible for the particular clinical trial" before the patient data is provided to trial sponsor of the particular clinical trial. Applicant respectfully submits that such elements are additional elements, beyond "managing personal behavior or interaction between people," that are to be considered at Prong Two of Step 2A and at Step 2B of the subject matter eligibility analysis. Applicant also respectfully submits that these additional elements integrate the alleged abstract idea into a practical application such that the claims are, as a whole, not directed to an abstract idea and are patent-eligible.
Regarding 1, The Examiner respectfully disagrees. The claims recite the abstract idea of displaying information…, receiving user input…, causing a transfer of a pre-screening compensation amount…, receiving patient data…, verifying that the patient is eligible for the particular clinical trial… and providing the patient data to a trial sponsor… Under the broadest reasonable interpretation, this covers a certain method organizing human activity but for the recitation of generic computer components as a person can follow a set of rules or instructions to perform said abstract idea. The additional elements of the clinical trial matching platform, one or more processors, computing system, at least one processor, memory and one or more non-transitory computer-readable media are not exclusively defined by the applicant and are recited at a high-level of generality (i.e., a generic computer components for enabling access to medical information or for performing generic computer functions. See Specification at para. [0081]-[0084] and [0089] which teach that the additional elements are generic computer components) such that they amounts to no more than mere instructions to apply the exception using a generic computer component. As set forth in MPEP 2106.04(d) “merely including 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. Furthermore, the additional element of a user interface merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Here, Applicant respectfully submits that the additional elements recited in the claims lead to technical improvements over conventional processes for identifying eligible participants for clinical trials, and that Applicant's specification describes those technical improvements. For example, Applicant's specification notes that it "can be difficult for trial sponsors to find participants for clinical trials," and that even if a candidate participant is found, the trial sponsor of the clinical trial may have to expend time and resources to verify that the patient is eligible to participate in the clinical trial, communicate with the patient to confirm that the patient can participate in the clinical trial, and perform other tasks."… The specification also notes that "conventionally a trial sponsor 112 may use time, processing resources, bandwidth resources, other computing resources, and/or other resources to contact a potential participant of a clinical trial, and/or to obtain and verify information associated with the potential participant," but "may ultimately determine that the potential participant does not actually qualify to be a participant of the clinical trial" such that resources that were used by the trial sponsor in association with that potential participant "may be wasted."… Applicant's specification notes that the claimed system provides "benefits over conventional systems associated with clinical trials," because "the clinical trial matching platform 102 may provide a trial sponsor 112 with information about patient 116 who have already been pre-screened and vetted…such that the claimed system may "reduce the burden on the trial sponsors" and "reduce the time and amounts of processing resources, bandwidth resources, other computing resources, and/or other resources used by the trial sponsors 112."… Applicant respectfully submits that the additional elements recited in the claims reflect the technical improvements, including reduced usage of computing resources by trial sponsors, discussed in the specification…Additionally, Applicant respectfully submits that the claims cover "a particular solution to a problem or a particular way to achieve a desired outcome, as opposed to merely claiming the idea of a solution or outcome," which the August 2025 USPTO Memorandum indicates is an "important consideration in determining whether a claim improves technology or a technical field." See August 2025 USPTO Memorandum, page 4 (emphasis added).
Regarding 2, The Examiner respectfully disagrees. Applicants invention does not provide improvements to the functioning of a computer nor does not provide improvements to a technical field. The improvements the specification and Applicant refer to are all non-technical improvements. Waisted resources used to determine eligible participants does not render a technical improvements. The improvements Applicant refers to are all administrative/healthcare improvements. Providing a trial sponsor with information about patient who have already been pre-screened and vetted is an abstract idea and does not qualify for technical improvement. Moreover, the problem of reducing the time and amounts of processing resources, bandwidth resources, other computing resources, and/or other resources used by the trial sponsors was not caused by the computer. The claim is ineligible.
… Applicant respectfully submits that there is no indication that the combination of elements recited in Applicant's claims is "well-understood, routine, conventional activity in the field." Id. Applicant also respectfully submits that the specification provides support indicating that the combination of elements recited in the claims is not conventional. For example, as discussed above, Applicant's specification notes that the described system operates differently than, and provides benefits over, "conventional systems" in which "a trial sponsor 112 may use time, processing resources, bandwidth resources, other computing resources, and/or other resources to contact a potential participant of a clinical trial, and/or to obtain and verify information associated with the potential participant," but "may ultimately determine that the potential participant does not actually qualify to be a participant of the clinical trial."… Accordingly, Applicant respectfully submits that there is no indication that it is "well- understood, routine, conventional activity in the field" to use a combination of elements that includes: 1) a provider accessing, via a user interface, information about "pre-screening criteria associated with corresponding clinical trials;" 2) the provider providing user input via the user interface to indicate that the provider has "completed the pre-screening activities for a particular clinical trial in association with patients of the provider;" 3) the provider receiving a corresponding "pre-screening compensation amount" from an operator of a clinical trial matching platform (different from a trial sponsor of the particular clinical trial) based on completion of the pre- screening activities by the provider;" and 4) the clinical trial matching platform using patient data (associated with a patient referred based on the provider-performed pre-screening activities) to verify "that a patient is eligible for the particular clinical trial" before that patient data is provided to the trial sponsor of the particular clinical trial, as amended claim 1 recites. Because Applicant respectfully submits that the combination of elements recited in the claims is not "well-understood, routine, conventional activity in the field," Applicant respectfully submits that the claims amount to "significantly more" than the alleged abstract idea and are therefore patent-eligible. See MPEP § 2106.05.
Regarding 3, The Examiner respectfully disagrees. The additional elements recited in the claim are sufficient to amount to significantly more than the judicial exception. The additional elements of the clinical trial matching platform, one or more processors, computing system, at least one processor, memory and one or more non-transitory computer-readable media to perform the abstract idea identified in bold amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). Moreover, using generic computer components to perform abstract ideas does not provide a necessary 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”).
Also as discussed above with respect to integration of the abstract idea into a practical application, the additional element of the user interface was determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Rejection under 35 U.S.C. § 103
Regarding the rejection of claims 1, 4, 6-8, 11, 13-15, 18 and 20-29, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
For example, the Office argues that, in the proposed combination, Graiver describes a user interface that displays "compensation data" associated with a clinical trial. See Office Action, page 8. However, Applicant respectfully submits that, at best, Graiver discusses potential financial compensation to participants of clinical trials. As an example, FIG. 6 of Graiver indicates that a trial sponsor may provide information indicating whether there is "financial compensation for participation, beyond reasonable travel expenses, food vouchers, etc." See Graiver, paragraph [0144] and FIG. 6 (emphasis added). As another example, FIG. 13 of Graiver shows a "study page" that presents "[f]inancial compensation" information indicating that "[p]articipants will not be compensated beyond reasonable considerations of time, trouble, and expense." See Graiver, paragraph [0154] and FIG. 13 (emphasis added). Accordingly, although Graiver mentions potential compensation from a trial sponsor to patients who participate in that trial sponsor's clinical trial, Applicant respectfully submits that Graiver does not teach or suggest a "pre-screening compensation amount" that is transferred to a "provider" based on the "provider" completing performance of "pre-screening activities," as amended claim 1 recites… Wager does indicate that a trial sponsor of a clinical trial may compensate a provider in some situations. See Wager, paragraph [0034]. However, Applicant respectfully notes that the compensation described by Wager would be directly from the clinical trial sponsor to the provider, and not "from an operator of the clinical trial matching platform to the provider," as amended claim 1 recites (emphasis added). Id.
Regarding 1, The Examiner respectfully disagrees. Graiver in view of Wager discloses “
compensation data indicating pre-screening compensation amounts associated with performance of pre-screening activities by providers” Wager at [0006] teaches requiring a fee (interpreted by examiner as the pre-screening compensation amount) to be paid to the one or more healthcare providers (interpreted by the provider), and upon payment of the fee from the one or more clinical trial sponsors (interpreted by examiner as the operator of the clinical trial matching platform), notifying the one or more clinical trial sponsors of the one or more patients that fulfill the clinical trial eligibility requirements of the one or more clinical trials. [0033] teaches incentive payments to eligible professionals, thus, in one embodiment, a first hospital refers patients that qualify for a clinical trial to a second hospital, where those patients will join patients from the second hospital that qualify for the same clinical trial. Those individuals that referred the clinical trial patients could be compensated and [0034] teaches healthcare provider is compensated by the clinical trial sponsor upon notification of the one or more patients qualifying for the clinical trial participation. This is interpreted by examiner as compensation data indicating pre-screening compensation amounts associated with performance of pre-screening activities by providers, based on the pre- screening criteria, in association with the corresponding clinical trials. Given the broadest reasonable interpretation, the cited references in combination teach the claimed features.
Conclusion
Applicant’s amendment necessitated the new grounds of rejection presented in this Office action. THIS ACTION IS MADE FINAL. See MPEP §706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
The prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Naley (US 2015/0228041) teaches clinical trial recruitment platform driven by molecular profile.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIZA TONY KANAAN whose telephone number is (571)272-4664. The examiner can normally be reached on Mon-Thu 9:00am-6:00pm ET.
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/L.T.K./Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683