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 .
Notice to Applicant
This communication is in response to amendment and remarks dated 3/30/26. Claims 1, 8, 17, 18, 24, 26 and 33 have been amended. Claims 1-33 are 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 1-33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1-16 are drawn to an apparatus for automated improved matching of patients with clinical trials, which is within the four statutory categories (i.e. machine). Claims 17-32 and 33 are drawn to a method for automated improved matching of patients with clinical trials, which is within the four statutory categories (i.e. process).
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
1. Apparatus for automated improved matching of patients with clinical trials, the apparatus comprising:
a. a controller comprising a processor and a digital storage;
b. a communications device in logical communication with the controller and capable of transceiving digital data ;
c. executable software stored on the digital storage and executable upon command to cause the controller to perform the following steps:
i. receive in digital data comprising physiological metrics objectively quantifying one or more physical attributes of a first patient;
ii. receive in digital data comprising a subjective health assessment of the first patient;
iii. receive in digital data comprising potential physiological effects of a health treatment to a participant included in a clinical trial;
iv. receive in digital data comprising a length of time that the participant included in the clinical trial will need to receive treatment; and
v. generate an assessment of whether the first patient will benefit from inclusion as the participant in the clinical trial, wherein generating the assessment comprises: (A) associating a respective weight with each of multiple aspects drawn from one or both of the physiological metrics and the subjective health assessment; (B) providing an aggregated inclusion score computed from the respective weight of each of the multiple aspects; and (C) referencing the aggregated inclusion score to determine that the first patient will benefit from inclusion as the participant in the clinical trial.
These recited underlined limitations fall within the "Mental Processes" grouping of abstract ideas as it relates to mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III). The Examiner submits that the foregoing underlined limitations constitute “a mental process” because generating an assessment to determine if a patient will benefit from inclusion in a clinical trial are observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind or by pen and paper. Associating a respective weight with multiple aspects, computing an aggregated inclusion score, and referencing the aggregated inclusion score are part of the abstract analysis/evaluation itself. A mental process that could practically be performed in the human mind or by pen and paper falls into one category of abstract idea. (see 2019 Revised Patent Subject Matter Eligibility Guidance issued January 7, 2019). That is other than reciting “by a processor” and “digital data” language, nothing precludes the steps from practically being performed mentally in one’s head or by pen and paper. For instance, an administrator could review and determine the received data to determine if a patient would benefit from inclusion in a clinical trial. Accordingly, the claim describes at least one abstract idea.
In the present case, the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
1. Apparatus for automated improved matching of patients with clinical trials, the apparatus comprising:
a. a controller comprising a processor and a digital storage;
b. a communications device in logical communication with the controller and capable of transceiving digital data ;
c. executable software stored on the digital storage and executable upon command to cause the controller to perform the following steps:
i. receive in digital data comprising physiological metrics objectively quantifying one or more physical attributes of a first patient;
ii. receive in digital data comprising a subjective health assessment of the first patient;
iii. receive in digital data comprising potential physiological effects of a health treatment to a participant included in a clinical trial;
iv. receive in digital data comprising a length of time that the participant included in the clinical trial will need to receive treatment; and
v. generate an assessment of whether the first patient will benefit from inclusion as the participant in the clinical trial, wherein generating the assessment comprises: (A) associating a respective weight with each of multiple aspects drawn from one or both of the physiological metrics and the subjective health assessment; (B) providing an aggregated inclusion score computed from the respective weight of each of the multiple aspects; and (C) referencing the aggregated inclusion score to determine that the first patient will benefit from inclusion as the participant in the clinical trial.
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
The additional elements (i.e. the limitations not identified as part of the abstract idea) amount to no more than limitations which:
add insignificant extrasolution activity to the abstract idea, see MPEP 2106.05(g).
Receiving the various digital data amounts to mere data gathering
amount to mere instructions to apply an exception, see MPEP 2106.05(f).
the recitations performing the functions by the at least one processor, communications device and executable software amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see paragraphs [0149] – [0151] of the present Specification.
generally link the abstract idea to a particular technological environment or field of use, see MPEP 2106.05(h)– for example, the recitation of performing the functions by the processor, communications device and executable software merely limits the abstract idea the environment of a computer,
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Independent claim 1 does not include additional elements that are sufficient to amount to “significantly more” than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception and generally linking the abstract idea to a particular technological environment or field of use and the same analysis applies with regards to whether they amount to “significantly more.” Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
Specifically, for the collecting step that was considered extra-solution activity in Step 2A, this has been re-evaluated in Step 2B and determined to be well-understood, routine, conventional activity in the field.
The background does not provide any indication that the network appliance is anything other than a generic, off-the-shelf computer component and there is no indication that the combination of steps collect the data in an unconventional way to provide an inventive concept.
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature: paragraphs [0149] – [0151] of the Specification discloses that the current invention embodiments may include a plurality of different types of general purpose computing systems, none of which, even when programmed to perform the limitations of the current invention, may properly be deemed a “particular machine” for the purposes of subject matter eligibility and performing generic computer functions that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. receiving and generating a data analysis) and conventional activities previously known to the pertinent industry (i.e. healthcare).
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP § 2106.05(g) and MPEP 2106.05(d)(II),:
Receiving or transmitting data over a network, e.g., using the Internet to gather data, see Intellectual Ventures v. Symantec – similarly, the current invention receives the document and link data, and transmits the data to a user terminal over a network, for example the Internet;
Therefore, the additional elements do not add significantly more to the at least one abstract idea.
As per claims 17 and 33, the claim teaches limitations similar to claim 1 and the same abstract idea (“mental process”) for the same reasons as stated above. Claims 17 and 33 teach the same functionality as claim 1 but in method form. Independent claims 17 and 33 are directed to an abstract idea.
Furthermore, for similar reasons as representative independent claim 1, analogous independent claims 17 and 33 do not recite additional elements that integrate the judicial exception into a practical application nor add significantly more.
The following dependent claims further the define the abstract idea or are also directed to an abstract idea itself:
Dependent claims 2, 4, 7, 13, 18, 20, 23, and 29 further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract).
In relation to claims 3, 6, 8, 10-12, 15-16, 19, 22, 24, 26-28, 31-32, these claims specify generating recommendations, assessments, costs, and savings, which are mental processes as they are evaluations that can, at the currently claimed high level of generality, be practically performed in the human mind.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
Claims 5 and 21: These claims specify automating an assessment which thus does no more than generally link use of the abstract idea to a particular technological environment or field of use without altering or affecting how the at least one abstract idea is performed (see MPEP § 2106.05(e)).
Claims 9, 14, 25, and 30: These claims recite receiving data which therefore merely represent insignificant extra-solution (data gathering) activity (see MPEP § 2106.05(g)).
The dependent claims further do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
Therefore, claims 1-33 are ineligible under 35 USC §101.
Response to Arguments
Applicant's arguments filed March 30, 2026 have been fully considered but they are not persuasive.
The rejection of the claims under 35 USC 112b have been withdrawn in light of Applicant’s amendments.
Applicant argues on pg. 12 of the 3/30/26 Office Action that Examiner applied the abstract idea category at an impermissibly high level of generality and improperly characterized the claims as merely “determining if a patient would benefit from a trial.” Applicant further argues that the amended claims recite four distinct categories of digital data and require applying a weighting-and-aggregation algorithm to compute a machine-generated aggregated inclusion score. This argument is not persuasive. The Office Action did not ignore the claim limitations. The rejection identified that the claims recite receiving patient information, receiving clinical-trial/treatment information, and generating an assessment of whether the patient will benefit from inclusion in a clinical trial. The amendment to claims 1 and 17 adds that the assessment is generated by associating weights with multiple aspects, providing an aggregated inclusion score, and referencing the aggregated inclusion score to determine that the patient will benefit. However, these added limitations further define the analysis/evaluation used to reach the claimed assessment. They do not change the character of the claim from an abstract evaluation of information.
The claims, as amended, still recite a mental process because the limitations involve observation, evaluation, judgment, and analysis of patient and trial information. A health practitioner, trial coordinator, or administrator could review patient physiological information, subjective health information, expected treatment effects, and treatment duration, assign relative importance or weights to different factors, combine those weighted factors into a score, and determine whether the patient would benefit from trial inclusion. The fact that the claim recites “digital data,” a “controller,” or “software” does not remove the claim from the mental-process grouping where the underlying analysis is claimed at a high level of generality.
Applicant also argues on pg. 13 of the 3/30/26 Remarks that the amended claims cannot practically be performed in the human mind because the claims require processing multiple heterogeneous digital data streams, such as biomarker data, vital signs, wearable sensor outputs, proteomics data, laboratory metrics, and clinical notes processed by an AI engine. This argument is not commensurate with the scope of the claims. The pending claims do not recite the alleged volume of data, the specific examples of proteomics, genomic data, wearable telemetry, AI-engine processing, or the specific technical processing depicted in the figures and described in the remarks. Instead, the claims broadly recite receiving digital data comprising physiological metrics, receiving a subjective health assessment, receiving potential physiological effects, receiving treatment duration, and computing an aggregated inclusion score from weighted aspects. The claims do not require any particular amount of data, any particular sensor data stream, any particular AI model, any particular data format, or any particular computational complexity that would make the claimed analysis incapable of being practically performed mentally or with pen and paper.
Further, even if some embodiments in the specification may process large quantities of digital data, the claims are not limited to such embodiments. The mental-process inquiry is based on the claim language. At the level of generality claimed, the steps of weighing multiple patient factors and aggregating them into an inclusion score remain evaluative and mathematical steps that could practically be performed by a human using ordinary judgment or pen-and-paper calculations.
Applicant further argues that the amendment adding a weighted aggregated inclusion score forecloses the mental-process characterization as a matter of law.This argument is not persuasive. Merely reciting a score, weights, and aggregation does not foreclose treatment as a mental process. Scoring and weighing factors are common forms of human judgment and mathematical/evaluative reasoning. The claims do not recite a particular unconventional computation, a specific algorithm that improves computer functionality, or a particular technical implementation that prevents the claimed steps from being characterized as mental processes at the present level of generality. Accordingly, the amended claims continue to recite an abstract idea under Step 2A, Prong One.
Next on pg. 14, Applicant argues that, even if the claims recite an abstract idea, the claims integrate the alleged abstract concept into a practical application because the claims use a controller, processor, digital storage, and communications device to receive four specific categories of digital clinical data and generate a machine-computed aggregated inclusion score. This argument is not persuasive. The recited controller, processor, digital storage, communications device, and executable software are generic computer components performing their ordinary functions of receiving, storing, processing, and outputting data. The recited “four categories” of data are information used in the abstract evaluation. Receiving such information is mere data gathering. Generating and referencing the aggregated inclusion score is the abstract analysis itself. The claims do not recite a technological improvement to the computer components, to data storage, to communications, to medical sensors, or to clinical-informatics infrastructure.
Applicant argues that the claims provide improved and more efficient clinical trial participant identification and solve problems such as labor-intensive, slow, or biased participant identification. However, improving a clinical-trial selection decision or making a decision-support process more efficient does not, by itself, integrate an abstract idea into a practical application. The claims do not recite a specific technological solution to a technological problem. Rather, the asserted improvement lies in the content and result of the abstract analysis—identifying patients who may benefit from participation. This is an improvement to an abstract decision-making process, not an improvement to technology.
Applicant also asserts that the claimed system is an “AI-driven controller” that processes heterogeneous digital data streams. This argument is not commensurate with the claim language. The independent claims do not recite artificial intelligence, a machine learning model, a neural network, a training process, a particular AI architecture, a specific feature extraction pipeline, or any specific AI-based technical operation. Accordingly, the claims cannot be found eligible based on unclaimed AI features described in the remarks or in exemplary embodiments.
Applicant argues on pgs. 14-15 that the ordered combination of limitations amounts to significantly more than the alleged abstract idea under BASCOM. Applicant identifies the ordered combination as: receiving objective physiological metrics, receiving a subjective health assessment, receiving potential physiological effects of a specific health treatment, receiving treatment duration data, associating weights with multiple aspects, aggregating the weighted aspects into an aggregated inclusion score, and referencing the score to generate a benefit-from-inclusion assessment. This argument is not persuasive. The alleged ordered combination is the abstract idea itself implemented using generic computer components. Receiving categories of information, assigning weights, aggregating weighted values, and generating an assessment are ordinary analytical steps. The claims do not recite a non-conventional arrangement of computer components or a technical architecture comparable to BASCOM. In BASCOM, the Federal Circuit found a possible inventive concept in a specific, non-conventional arrangement of Internet filtering at a remote ISP server with individualized filtering at the user level. Here, the claims do not recite a comparable non-conventional arrangement of technical components. They merely recite generic computer components used to perform a scoring-based clinical-trial assessment.
Applicant argues on the bottom of pg. 15 that no prior art system performed the specific ordered combination and that the Examiner’s prior art discussion confirms that none of the closest prior art teaches the claimed benefit-of-inclusion assessment. This argument is not persuasive because novelty and nonobviousness are separate from eligibility under § 101. A claim may be novel and nonobvious under §§ 102 and 103 and still be directed to a judicial exception without significantly more. The absence of a prior-art rejection, or the identification of subject matter not taught by the closest prior art of record, does not establish that the claim recites an inventive concept under Step 2B. The Step 2B inquiry asks whether the additional elements, individually or in ordered combination, transform the abstract idea into patent-eligible subject matter. Here, the additional elements remain generic computer components and generic data-analysis operations.
Applicant’s reliance on McRO and Enfish is also not persuasive. In McRO, the claims recited a specific set of rules for automatically generating lip synchronization and facial expression animation that improved a particular technological process. In Enfish, the claims were directed to a specific self-referential table for a computer database that improved computer functionality. Here, the pending claims do not recite a specific rule set comparable to McRO, nor a specific data structure or computer-functionality improvement comparable to Enfish. The claimed weighting and aggregated score are recited generically and are used to make an assessment regarding clinical-trial inclusion. They do not improve the operation of the computer itself or any other technology.
Applicant’s arguments have been fully considered but are not persuasive. Claims 1-33 recite receiving patient and clinical-trial information, weighting and aggregating aspects of the information, and generating an assessment/recommendation/candidate list relating to clinical-trial participation. The claims are directed to abstract ideas, including mental processes and certain methods of organizing human activity. The additional computer elements are generic and do not integrate the abstract idea into a practical application or add significantly more. Accordingly, the rejection of claims 1-33 under 35 U.S.C. § 101 is maintained.
Subject Matter free from Prior Art
Hudson (7,711,580), the closest domestic prior art of record, teaches matching patient profile information to trial acceptance criteria to determine whether the patient “prequalifies” (i.e., prescreening/eligibility-style matching). The reference places the patient in contact with the trial site upon prequalification. However, Hudson is directed to prequalification/eligibility and does not teach or suggest generating a benefit-of-inclusion assessment.
Yong (WO2016203457A1) the closest foreign prior art of record, discusses clinical trial matching and includes a workflow in which a molecular signature discriminates responders vs. non-responders and is used to predict/match candidates who “may have response” to a drug. Yong teaches matching and generating candidate patient/trial lists and does not teach the claimed requirement of generating a benefit-from-inclusion assessment.
Ni et al. (Yizhao Ni, Stephanie Kennebeck, Judith W Dexheimer, Constance M McAneney, Huaxiu Tang, Todd Lingren, Qi Li, Haijun Zhai, and Imre Solti. “Automated clinical trial eligibility prescreening: increasing the efficiency of patient identification for clinical trials in the emergency department.” Journal of the American Medical Informatics Association, Volume 22, Issue 1, January 2015, Pages 166–178, https://doi.org/10.1136/amiajnl-2014-002887) the closest Non-Patent literature of record teaches automated eligibility screening: identifying patients whose profiles match trial criteria and identifying patients who meet eligibility characteristics to reduce the pool for staff screening. This is likewise eligibility determination / prescreening, not an individualized benefit-of-inclusion determination.
As per independent claims 1 and 17, the prior arts of record does not disclose or render obvious the claimed benefit-of-inclusion assessment as taught in the claims. As per claim 33, the “candidate list” is not merely a list of eligible matches, but rather a list filtered/selected by a benefit-of-inclusion assessment not taught or suggested by the art.
No final decision on patentability has been made in light of pending rejections.
Conclusion
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.
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LINH GIANG "MICHELLE" LE
PRIMARY EXAMINER
Art Unit 3686
/LINH GIANG LE/Primary Examiner, Art Unit 3686 6/12/2026
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