DETAILED ACTION
This action is made in response to the amendments/remarks filed on June 5, 2026. This action is made final.
Claims 1-10 are pending. Claims 1-7 have been amended. Claims 8-10 are newly added. Claim 1 is the sole independent claim.
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 Arguments
Applicant’s arguments with respect to the prior art rejection are moot in light of the new grounds of rejection.
Applicant’s arguments with respect to the previous 101 rejection have been fully considered but are not persuasive.
Applicant argues the claims are directed to improvements in computer-implemented clinical-trial recruitment systems by reducing mismatches, reducing inefficient qualification failures, and facilitating rapid and accurate enrollment of qualified clinical-trial participants. However, the examiner respectfully disagrees.
MPEP 2106.04(d)(1) states “the word ‘improvements’ in the context of this consideration is limited to improvements to the functioning of a computer or any other technology/technical field, whether in Step 2A Prong Two or in Step 2B.” Here, there is no improvement to the computer nor is there an improvement to another technology. The reduction of mismatches between trial requirements, reducing inefficient qualification failures, and facilitating rapid and accurate enrollment of qualified clinical-trial participants, at best, provides an improvement to the abstract idea of clinical-trial recruitment, but is neither an improvement to the computer or another technology, but rather merely uses a computer as a tool. Accordingly, the previous 101 rejection is maintained.
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 1-10 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 1-10 recite a system of matching patients to clinical trials, which is within the statutory category of a machine.
Claims are eligible for patent protection under § 101 if they are in one of the four statutory categories and not directed to a judicial exception to patentability. Alice Corp. v. CLS Bank Int'l, 573 U.S. ___ (2014). Claims 1-10, each considered as a whole and as an ordered combination, are directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
MPEP 2106 Step 2A – Prong 1:
The limitations of:
Claim 1
A system for recruiting clinical trial targets on the basis of big data, the system comprising: a user terminal configured to upload medical data and receive a list of clinical trials matching the medical data; at least one research institution terminal configured to register clinical trial requirements and request recruitment of clinical trial targets; and a management service provision server configured to: receive a request for recruitment of a clinical trial from the at least one research institution terminal, determine whether the medical data uploaded by the user terminal matches the clinical trial requirements registered by the at least one research institution terminal, transmit a list of clinical trials matching the medical data to the user terminal; receive an application for participation in at least one clinical trial from the list of clinical trials from the user terminal; provide an electronic signature link to the user terminal to obtain written consent to apply for participation when the application for participation in the at least one clinical trial is received; collect medical history data of the user terminal from at least one information provision server after the consent is obtained; and provide an online questionnaire to the user terminal to determine whether a user satisfies the clinical trial requirements after the consent is obtained.
as presently drafted, under the broadest reasonable interpretation, covers a method of organizing human activity (i.e., managing personal behavior including following rules or instructions). For example, but for the noted computer elements, the claim encompasses a person following rules or instructions to send and process data in the manner described in the abstract idea. For instance, the claims describe the process a person would take to identify clinical trials a patient is eligible for based on the patient’s information and clinical trial information. The examiner further notes that “methods of organizing human activity” includes a person’s interaction with a computer (see October 2019 Update: Subject Matter Eligibility at Pg. 5). If the claim limitation, under its broadest reasonable interpretation, covers managing persona behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
MPEP 2106 Step 2A – Prong 2:
This judicial exception is not integrated into a practical application because there are no meaningful limitations that transform the exception into a patent eligible application. The additional elements merely amount to instructions to apply the exception using generic computer components (“system”, "terminal”, “server”, “online”, and “electronic”—all recited at a high level of generality). Although they have and execute instructions to perform the abstract idea itself, this also does not serve to integrate the abstract idea into a practical application as it merely amounts to instructions to "apply it." (See MPEP 2106.04(d)(I) indicating mere instructions to apply an abstract idea does not amount to integrating the abstract idea into a practical application). Accordingly, the additional elements do not integrate the abstract idea into a practical application because they do not impose meaningful limits on practicing the abstract idea. Therefore, the claims are directed to an abstract idea.
Additionally, the questionnaire being provide “online” and the signature being “electronic link” are recited at a high level of generality and additionally amount to generally linking the abstract idea to a particular technological environment. (See MPEP 2106.04(d)(I) indicating generally linking an abstract idea to a particular technological environment does not amount to integrating the abstract idea into a practical application).
The claims only manipulate abstract data elements as part of performing the abstract idea. They do not set forth improvements to another technological field or the functioning of the computer itself and instead use computer elements as tools in a conventional way to improve the functioning of the abstract idea identified above. 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. None of the additional elements recited "offers a meaningful limitation beyond generally linking 'the use of the [method] to a particular technological environment,' that is, implementation via computers." Alice Corp., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)).
At the levels of abstraction described above, the claims do not readily lend themselves to a finding that they are directed to a nonabstract idea. Therefore, the analysis proceeds to step 2B. See BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1349 (Fed. Cir. 2016) ("The Enfish claims, understood in light of their specific limitations, were unambiguously directed to an improvement in computer capabilities. Here, in contrast, the claims and their specific limitations do not readily lend themselves to a step-one finding that they are directed to a nonabstract idea. We therefore defer our consideration of the specific claim limitations’ narrowing effect for step two.") (citations omitted).
MPEP 2106 Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the same reasons as presented in Step 2A Prong 2. Moreover, the additional elements recited are known and conventional generic computing elements (“system”, "terminal”, “server”, “online”, and “electronic” —see Specification Fig. 2, Pages 10, 25, describing the various components as general purpose, common, standard, known to one of ordinary skill, and at a high level of generality, and in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy the statutory disclosure requirements). Therefore, these additional elements 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 that amounts to significantly more. See MPEP 2106.05(f).
Furthermore, as discussed above, the additional element of the questionnaire being “online” and the signature as an “electronic link” is additionally is recited at high levels of generality and were determined to generally link the abstract idea into a particular technological environment or field of use. This additional element have been re-evaluated under step 2B and have also been found insufficient to provide significantly more. (See MPEP 2106.05(A) indicating generally linking an abstract idea to a particular technological environment does not amount to significantly more).
The Federal Circuit has recognized that "an invocation of already-available computers that are not themselves plausibly asserted to be an advance, for use in carrying out improved mathematical calculations, amounts to a recitation of what is 'well-understood, routine, [and] conventional.'" SAP Am., Inc. v. InvestPic, LLC, 890 F.3d 1016, 1023 (Fed. Cir. 2018) (alteration in original) (citing Mayo v. Prometheus, 566 U.S. 66, 73 (2012)). Apart from the instructions to implement the abstract idea, they only serve to perform well-understood functions (e.g., receiving, translating, and displaying data—see Specification above as well as Alice Corp.; Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307 (Fed. Cir. 2016); and Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334 (Fed. Cir. 2015) covering the well-known nature of these computer functions).
Dependent Claims
The limitations of dependent but for those addressed below merely set forth further refinements of the abstract idea without changing the analysis already presented. Claims 3 and 8 merely recites further collecting and transmitting medical history and questionnaire information, claim 4 merely recites providing a questionnaire, claim 5 merely recites providing payment to the patient upon trial completion, and claim 6 merely recites predicting a health state to increase targets and categorizing a patient for the trial when they meet the health state, which covers a method of organizing human activity (i.e., managing personal behavior including following rules or instructions).
Claim 4 further refines the abstract idea described in the independent claim and further recites utilizing generative artificial intelligence. Claim 5 further refines the abstract idea described in the independent claim and further recites retrieving information from a wearable device. These additional elements are considered to “generally link” under both the practical application and significantly more analysis, as detailed in the analysis above.
Claims 7 and 10 further refines the abstract idea described in the independent claim and further recites using a previously prepared model. When given the broadest reasonable interpretation in light of the nonexistent description of model training in the disclosure, training of an AI model with the noted data amounts to a mathematical concept that creates data associations. The use of the model provides nothing more than mere instructions to implement an abstract idea on a generic computer (“apply it”) for both the practical application and significantly more analysis. See MPEP 2106.05(f), MPEP 2106.05(A); July 2024 Subject Matter Eligibility Examples, Example 47, Claim 2, discussion of items (d) and (e) at Pgs. 8-9.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1-3 and 6-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graiver et al. (USPPN: 2018/0046780; hereinafter Graiver) in further view of Gardner et al. (USPPN: 2018/0316509; hereinafter Gardner) and Marks (USPN: 7,483,838; hereinafter Marks).
As to claim 1, Graiver teaches A system for recruiting clinical trial targets on the basis of big data (e.g., see Fig. 1, abstract), the system comprising:
a user terminal configured to upload medical data and receive a list of clinical trials matching the medical data (e.g., see Fig. 26, [0347], [0436], [0439], [0489]-[0498], [0501] teaching a user interface in which a patient can register their medical information to identify suitable clinical trials);
at least one research institution terminal configured to register clinical trial requirements and request recruitment of clinical trial targets (e.g., see [0140], [0142]-[0144], [0151], [0154], [0178] wherein a clinical trial sponsor can input information, including inclusion and exclusion criteria, for a particular trial the sponsor is enrolling participants); and
a management service provision server (e.g., see [0126], [0338], [0343] teaching a web-based computer system having a server) configured to:
receive a request for recruitment of clinical trial targets from the at least one research institution terminal (e.g., see Figs. 1, 2, [0137], [0140]-[0155], [0453]- [0461] wherein a trial designer provide details for candidate recruitment to a trial),
determine whether the medical data uploaded by the user terminal matches the clinical trial requirements registered by the at least one research institution terminal (e.g., see Figs. 1, 2, [0346], [0347], [0395], [0421] wherein various trials for which a patient is eligible are determined based on the received trial information and patient information),
transmit a list of clinical trials matching the medical data to the user terminal (e.g., see Fig. 24, [0426] wherein a patient is provided a list of suitable or relevant trials);
receive an application for participation in at least one clinical trial from the list of clinical trials from the user terminal (e.g., see [0439], [0515] wherein a patient can register their information to be enrolled in trials and/or opt-in for next steps for a trial);
collect medical history data of the user terminal from at least one information provision server after the consent is obtained (e.g., see [0502]-[0503], [0516] wherein some patient medical data may be retrieved after opt-in/selection for participation in a trial (i.e., after consent)); and
provide an online questionnaire to the user terminal to determine whether a user satisfies the clinical trial requirements after the consent is obtained (e.g., see [0402], [0509], [0510], [0515] wherein a patient can be further validated after confirming their interest in participating through additional questions that may be provided electronically).
While Graiver teaches a user selecting to participate in at least one clinical trial from the list of clinical trials and registering/opting-in for participation in the trial (e.g., see [0517], [0518] wherein a patient may participate for the selected trial), Graiver fails to teach provide an electronic signature link to the user terminal to obtain written consent to apply for participation when the application for participation in the at least one clinical trial is received.
However, in the same field of endeavor authenticating users, Gardner teaches provide an electronic signature link to the user terminal to obtain written consent to apply for participation when the application for participation in the at least one clinical trial is received (e.g., see [0027], [0032] providing an interface for receiving a user signature is provided to a user at their device and the user’s signature is authenticated to their user device).
Accordingly, it would have been obvious to modify Graiver in view of Gardner before the effective date with a reasonable expectation of success. One would have been motivated to make the modification in order to provide enhanced security in the electronically signing of electronic documents (e.g., see Abstract of Gardner).
While Graiver-Gardner teach collecting health information and provide an online questionnaire after consent is obtained, wherein Graiver teaches collecting health information and providing an online questionnaire after patient registration/opt-in and Garder teaches consent via electronic signature, should the recited features not provide sufficient support, additionally cited Marks is further relied upon for curing any such deficiency.
In the same filed of endeavor of patient recruitment for clinical trials, Marks teaches collect medical history data of the user terminal from at least one information provision server after the consent is obtained and provide an online questionnaire to the user terminal to determine whether a user satisfies the clinical trial requirements after the consent is obtained (e.g., see 4:11-37 wherein after user consent for a trial, patient health data is collected and a questionnaire is provided to the user). Accordingly, it would have been obvious to modify Graiver-Gardner in view of Marks with a reasonable expectation of success. One would have been motivated to make the modification to prevent the unwanted dissemination of personal and/or medial information (e.g., see 1:35-55 of Marks).
As to claim 2, the rejection of claim 1 is incorporated. While Graiver teaches a user selecting to participate in at least one clinical trial from the list of clinical trials (e.g., see [0517], [0518] wherein a patient may participate for the selected trial), Graiver fails to teach map an electronic signature of the user terminal to the user terminal and store the electronic signature when the electronic signature is completed on the user terminal.
However, in the same field of endeavor authenticating users, Gardner teaches map an electronic signature of the user terminal to the user terminal and store the electronic signature when the electronic signature is completed on the user terminal (e.g., see [0027], [0032] providing an interface for receiving a user signature is provided to a user at their device and the user’s signature is authenticated to their user device, wherein the document can be saved locally by the user).
Accordingly, it would have been obvious to modify Graiver in view of Gardner before the effective date with a reasonable expectation of success. One would have been motivated to make the modification in order to provide enhanced security in the electronically signing of electronic documents (e.g., see Abstract of Gardner).
As to claim 3, the rejection of claim 1 is incorporated. Graiver-Marks further teaches submit the collected medical history data to the research institution terminal on the basis of electronic consent after collecting the medical history data of the user terminal from the at least one information provision server (e.g., see [0445] of Graiver wherein the collected medical history data is provided to the system to determine a match. See also Fig. 2 and 4:11-37 of Marks wherein medical history is collected after user consent for a trial and transmitted to the research study).
As to claim 6, the rejection of claim 1 is incorporated. Graiver further teaches compare bio-information data measured from a wearable device with the clinical trial requirements to determine whether the bio-information data satisfies the clinical trial requirements when the wearable device is used at the user terminal and the user terminal consents to collect and use bio-information data collected by the wearable device (e.g., see [0439], [0498] wherein a patient can opt-in to register their information to the system, wherein their information can be retrieved through a wearable device).
As to claim 7, the rejection of claim 1 is incorporated. Graiver further teaches predict a current health state by inputting the medical data into a previously prepared prediction model to increase a number of targets when the number of targets matching the clinical trial requirements is lower than a preset number, and categorize a user into a possibility group and then transmit clinical trial information of the clinical trial to the possibility group when the health state matches the clinical trial requirements (e.g., see [0454]-[0457], [0507] wherein the system can further predict a targeted population for the trial and further predict what amount the targeted population will increase/decrease based on a particular criterion and transmit clinical trials to suitable patients).
As to claim 8, the rejection of claim 1 is incorporated. Graiver-Marks further teaches wherein the management service provision server is further configured to transmit, to the at least one research institution terminal, response data to the online questionnaire together with medical history data collected from the at least one information provision server after consent is obtained (e.g., see [0445] of Graiver wherein the collected medical history data and questionnaire data is provided to the system to determine a match. See also Fig. 2 and 4:11-37 of Marks wherein medical history and questionnaire data is collected after user consent for a trial and transmitted to the research study).
As to claim 9, the rejection of claim 1 is incorporated. Graiver further teaches obtain a subject list including users satisfying the clinical trial requirements after collecting the medical history data and response data to the online questionnaire (e.g., see Figs. 34, 35, [0447]-[0452], [0485] wherein those that satisfy the trial, among other conditions, are provided).
As to claim 10, the rejection of claim 8 is incorporated. Graiver further teaches predict a current health state of the user using a prediction model, categorize the user into a possibility group, and transmit information regarding a clinical trial when the health state matches the clinical trial requirements (e.g., see [0454]-[0457], [0507] wherein the system can further predict a targeted population for the trial and further predict what amount the targeted population will increase/decrease based on a particular criterion and transmit clinical trials to suitable patients).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graiver, Gardner, and Marks, as applied above, and in further view of Mitjans et al. (USPPN: 2023/0395204; hereinafter Mitjans)
As to claim 4, the rejection of claim 1 is incorporated. While Graiver and Marks teaches an online questionnaire, Graiver-Gardner-Marks fail to teach the online questionnaire is provided using generative artificial intelligence in a format in which a human asks a question and the generative artificial intelligence gives an answer
However, in the same field of online questionnaires, Mitjans teaches the online questionnaire is provided using generative artificial intelligence in a format in which a human asks a question and the generative artificial intelligence gives an answer (e.g., see [0033]-[0034] teaching generative machine-learning model for generating questions and answers in response to user input).
Accordingly, it would have been obvious to modify Graiver-Gardner-Marks in view of Mitjans before the effective date with a reasonable expectation of success. One would have been motivated to make the modification in order to automatically generate surveys in real-time using computer-implemented rules (e.g., see [0031] of Mitjans).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graiver and Weber, as applied above, and in further view of Borno et al. (USPPN: 2024/0257924; hereinafter Borno).
As to claim 5, the rejection of claim 1 is incorporated. While Graiver teaches the trial providing a compensation to the patient for participating as well as following up with the trial to ensure patient engagement (e.g., see Fig. 13, [0144], [0518]), Graiver fails to explicitly teach check preset reward payment conditions and then make a payment to a user of the user terminal when the research institute terminal finally selects the user of the user terminal as a clinical target subject and the clinical trial has been conducted and completed.
However, in the same field of endeavor of matching patients to clinical trials, Borno teaches check preset reward payment conditions and then make a payment to a user of the user terminal when the research institute terminal finally selects the user of the user terminal as a clinical target subject and the clinical trial has been conducted and completed (e.g., see [0063], [0064] wherein upon verification that the activities for the clinical trial have been completed, the user is provided payment. While Borno teaches payment being provided to the medical provider upon verification of successful completion of clinical trial activities, it would have at least been obvious the payment can be provided to the participant in view of Graiver).
Accordingly, it would have been obvious to modify Graiver-Weber in view of Borno before the effective filing data with a reasonable expectation of success. One would have been motivated to make the modification to increase patient participation.
It is noted that any citation to specific pages, columns, lines, or figures in the prior art references and any interpretation of the references should not be considered to be limiting in any way. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). Further, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STELLA HIGGS whose telephone number is (571)270-5891. The examiner can normally be reached Monday-Friday: 9-5PM.
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/STELLA HIGGS/Primary Examiner, Art Unit 3681
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