DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
The office action is in response to the claims filed on June 18, 2026 for the application filed May 28, 2024 which claims priority to a provisional application filed on November 30, 2021. Claims 1-4 and 6-17 are currently pending and have been examined.
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 and 6-17 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.
Eligibility Step 1:
Under step 1 of the 2019 Revised Patent Subject Matter Eligibility Guidance, claims 1-4 and 6-17 are directed towards a computerized method (i.e. a process), which is a statutory category. Since the claims are directed toward statutory categories, it must be determined if the claims are directed towards a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea). In the instant application, the claims are directed towards an abstract idea.
Eligibility Step 2A, Prong One:
Under step 2A, prong one of the 2019 Revised Patent Subject Matter Eligibility Guidance, independent claim 1 is determined to be directed to an judicial exception because an abstract idea is recited in the claims which fall within the subject matter groupings of abstract ideas. The abstract idea (identified in bold) recited in the claim 1 is identified as:
A computerized method for identifying a patient subjects for inclusion in a clinical trial, the method comprising:
accessing data indicative of times of a plurality of healthcare visits of a patient over time during an observation period;
determining a metric based on the times of the plurality of healthcare visits of the patient over time during the observation period, wherein determining the metric comprises applying a non-linear compression function to a plurality of time intervals, the plurality of time intervals comprising at least each time interval between the plurality of healthcare visits, wherein the non-linear compression function compresses larger values more than smaller values; and
identifying the patient for inclusion in the clinical trial when the metric exceeds a metric threshold.
The identified limitation of “wherein determining the metric comprises applying a non-linear compression function to a plurality of time intervals… wherein the non-linear compression function compresses larger values more than smaller values” is a mathematical calculation of a metric using a non-linear compression function and thus falls within the subject matter grouping of mathematical concepts, such as mathematical relationships, mathematical formulas or equations, and mathematical calculations.
The identified limitations of “accessing data indicative of times of a plurality of healthcare visits of a patient over time during an observation period”; “determining a metric based on the times of the plurality of healthcare visits of the patient over time during the observation period”; and “identifying the patient for inclusion in the clinical trial when the metric exceeds a metric threshold” fall within the subject matter grouping of certain methods of organizing human activity related and the sub grouping of managing personal behavior or relationships or interactions between people, (including social activities, teaching, and following rules or instructions). The claims recite the human activity of identifying patient subjects for inclusion in a clinical trial, regularly performed by healthcare professionals. The defined data, metric and thresholding are merely rules the healthcare professional should follow in order to identifying a patient subjects for inclusion in a clinical trial
The identified limitations of “determining a metric based on the times of the plurality of healthcare visits of the patient over time during the observation period, wherein determining the metric comprises applying a non-linear compression function to a plurality of time intervals, the plurality of time intervals comprising at least each time interval between the plurality of healthcare visits, wherein the non-linear compression function compresses larger values more than smaller values”; and “identifying the patient for inclusion in the clinical trial when the metric exceeds a metric threshold” fall within the subject matter grouping of mental processes. If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea. Determining a metric using a non-linear compression function and identifying a patient when the metric exceeds a metric threshold can be performed in the human mind using observations, evaluations, judgments and opinions.
Accordingly, claim 1 recites an abstract idea under step 2A, prong one.
Eligibility Step 2A, Prong Two:
Under step 2A, prong two of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether the identified abstract ideas are integrated into a practical application. After evaluation, there is no indication that any additional elements or combination of elements integrate the abstract idea into a practical application, such as through: an additional element that reflects an improvement to the functioning of a computer, or an improvements to any other technology or technical field; an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition; an additional element that implements the judicial exception with, or uses the judicial exception in connection with, a particular machine or manufacture that is integral to the claim; an additional element that effects a transformation or reduction of a particular article to a different state or thing; or an additional element that applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. As shown below, the additional elements, other than the abstract idea per se, when considered both individually and as an ordered combination, amount to no more than a recitation of: generally linking the abstract idea to a particular technological environment or field of use; insignificant extra-solution activity to the judicial exception; and/or adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea as evidenced below.
The additional elements recited in claim 1 are identified in italics as:
A computerized method for identifying a patient subjects for inclusion in a clinical trial, the method comprising:
accessing data indicative of times of a plurality of healthcare visits of a patient over time during an observation period;
determining a metric based on the times of the plurality of healthcare visits of the patient over time during the observation period, wherein determining the metric comprises applying a non-linear compression function to a plurality of time intervals, the plurality of time intervals comprising at least each time interval between the plurality of healthcare visits, wherein the non-linear compression function compresses larger values more than smaller values; and
identifying the patient for inclusion in the clinical trial when the metric exceeds a metric threshold.
The additional limitation of “computerized” is determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f). Specifying the method is “computerized” amount to no more than a recitation of the words "apply it" (or an equivalent) or no more than mere instructions to implement an abstract idea or other exception on a computer or no more than merely using a computer as a tool to perform an abstract idea.
Accordingly, claim 1 does not recite additional elements which integrate the abstract idea into a practical application.
Eligibility Step 2B:
Under step 2B of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether provide an inventive concept by determining if the claims include additional elements or a combination of elements that are sufficient to amount to significantly more than the judicial exception. After evaluation, there is no indication that an additional element or combination of elements 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 limitation “computerized” is determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f), which is do not amount to significantly more than the abstract idea.
Furthermore, 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 amounts to an inventive concept.
Dependent Claims:
The dependent claims merely present additional abstract information in tandem with further details regarding the elements from the independent claims and are, therefore, directed to an abstract idea for similar reasons as given above. None of these limitations are deemed to integrate the claims into a practical application or to amount to significantly more than the abstract idea as detailed below.
Regarding claims 1-4 merely define the metric and the determinations thereof and are also directed to the abstract ideas of certain methods of organizing human activity and mental processes.
Regarding claims 6-7, defining time intervals for used in determining the metric is directed to the abstract ideas of certain methods of organizing human activity and mental processes.
Regarding claim 8-14, the limitations are directed to mathematic calculations and therefore falls within the subject matter grouping of mathematical concepts which may also be performed in the human mind and therefore also fall within the subject matter grouping of mental processes.
Regarding claim 15-17, the limitations are determined to be directed to the abstract ideas of certain methods of organizing human activity and mental processes for similar reasons as detailed with respect to claim 1.
Therefore, whether taken individually or as an ordered combination, 1-17 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments
Applicant's arguments filed June 18, 2026 regarding claims 1-4 and 6-17 being rejected under 35 U.S.C. §101 have been fully considered but they are not persuasive.
Applicant argues that the amended claims integrates any abstract idea into a practical application by providing an improvement to the function of a computer or to another technology or technical field. Specifically, it is argued that the claims are similar to McRO and CardioNet as the claimed non-linear compression function provides a defined computational technique to yield a metric indicative of visit irregularity and possible disease flare.
In response, the claims of McRO were determined to provide an improvement to the function of a computer by enabling the automation of specific animation tasks that previously could only be performed subjectively by humans, thereby determining that the claims were directed to improvements in computer animation. The claims of CardioNet were detrmined to provide an improvement to the technology of devices that detect the occurrence of atrial fibrillation and atrial flutter. Conversley, the instant claims are directed to improving the identification of patient subjects for inclusion in a clinical trial, which is not an improvement to the function of a computer or to another technology or technical field, but an improvement to an abstract idea itself.
Applicant argues that applying the non-linear compression function to each of a patient’s inter-visit intervals and aggregating the compressed valued into a metric is a computation that cannot realistically be performed by observation, evaluation, judgments or opinion and thus cannot be a mental process.
In response, it is maintained that applying a non-linear compression function to interval data to determine a metric can be practically performed in the human mind with the aid of pen and paper.
Applicant argues under step 2B that the applying of the non-linear compression function is not well-understood, routine or conventional.
In response, this limitation is considered part of the abstract idea. Only additional elements in combination with the abstract idea are considered under step 2B
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Devin C. Hein whose telephone number is (303)297-4305. The examiner can normally be reached 9:00 AM - 5:00 PM M-F MDT.
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/DEVIN C HEIN/Examiner, Art Unit 3686
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