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 Claims
Claims 21-40 are pending.
This communication is in response to the communication filed July 30, 2025.
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 21-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite systems, apparatuses, and methods for evaluation of clinical trial data, which are statutory categories of inventions.
Specifically, the independent claims, taking claim 21 as exemplary, recite selecting, based on one or more lookup parameters associated with a set of medical records of a clinical trial, a set of indicators for evaluation of the medical records, wherein each indicator included in the set of indicators specifies a different condition representing a likely anomaly for a medical record included in the set of medical records, wherein the set of medical records comprise data from a first set of records represented in a first data format and data from a second set of records represented in a second data format, and wherein each medical record of the set of medical records is represented in a standardized data format…recognizing, from among the set of medical records, a subset of medical records that satisfy at least one of the conditions specified by the set of indicators; determining…a score for each medical record included in the subset of medical records; and providing data indicating the scores for output.
The limitations directed to determining a score is interpreted as a mathematical concept, because the scoring is based on performing a calculation with a given function. The limitations directed to recognizing a subset of medical records that satisfy conditions are directed towards mental processes, because a doctor skilled in the art may mentally make such determinations. Using broadest reasonable interpretation the standardized medical records may be in any printed or pdf format for reading by a medical professional. The totality of the limitations is interpreted as being grouped within the certain methods of organizing human activity grouping of abstract ideas, because the claims involve a series of steps for evaluating data for clinical trials by collecting and analyzing data, and outputting the results of the collection and analysis. See MPEP 2106.04. The claims are interpreted to recite concepts relating to tracking or organizing information. Accordingly, the claims recite an abstract idea.
The dependent claims also recite the abstract idea from the independent claims. The dependent claims recite limitations that further explain the scoring, lookup parameters, indicators, subset of medical records, dosage of medication, and expected treatment plan. The totality of the limitations is interpreted as being grouped within the certain methods of organizing human activity grouping of abstract ideas, because the claims involve a series of steps for evaluating data for clinical trials by collecting and analyzing data, and outputting the results of the collection and analysis. The claims recite additional elements that are interpreted as not being part of the abstract idea.
This judicial exception is not integrated into a practical application. Integration into a practical application requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception. Here, the additional elements of the claims use a non-transitory computer-readable storage medium, trained model, computers, and devices.
The claims merely use the additional elements as tools to perform abstract ideas and generally link the use of a judicial exception to a particular technological environment. The use of the additional elements as tools to implement the abstract idea and generally to link the use of the abstract idea to a particular technological environment does not render the claim patent eligible, because it requires no more than a computer performing functions that correspond to acts required to carry out the abstract idea. Specifically, the computers and devices may include non-transitory computer-readable storage medium using computer programs to carry out functions. The functions may be implemented in a high-level procedural and/or object-oriented programming language, and/or in assembly/machine language. Moreover, any computer program product, apparatus and/or device, e.g., magnetic discs, optical disks, memory, Programmable Logic Devices (PLDs), may be used to provide machine instructions and/or data to a programmable processor, including a machine-readable medium that receives machine instructions as a machine-readable signal (specification p. 37-40). The trained model is recited at a high level of generality and may be any trained model performing data analysis that may operate on any computer program product.
The additional elements do not show an improvement to the functioning of a computer or to any other technology, rather the additional elements perform general computing functions and do not indicate how the particular combination improves any technology or provides a technical solution to a technical problem. See Apple v. Ameranth, 842 F.3d 1229, 1240 (Fed. Cir. 2016). The additional elements do not use the exception to affect a particular treatment or prophylaxis for a disease, do not apply the exception using particular machines, and do not effect a transformation or reduction of a particular article to a different state or thing, rather the computer elements are generally stated as to their structure and function and are only used to evaluate clinical trial data instead of directly providing specific treatment or prophylaxis. Therefore, the additional elements do not impose any meaningful limits on practicing the abstract idea and the additional limitations are not indicative of materializing into a practical application. Accordingly, the claim is directed to an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements performing the steps of the claims amount to no more than using computer related devices to automate or implement the abstract idea for evaluating clinical trial data.
Generic computer elements recited as performing generic computer functions that are well-understood, routine, or conventional activities amount to no more than implementing the abstract idea with a computerized system (Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network and performing repetitive calculations); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims."); See MPEP 2106.05(d) and July 2015 Update: Section IV). Here, the claim limitations directed to determining a score are similar to performing repetitive calculations and the limitation directs to selecting, recognizing, and outputting data are similar to sending and receiving information.
The use of a computer or processor to merely automate or implement the abstract idea cannot provide significantly more than the abstract idea itself. (See MPEP 2106.05(f) where mere instructions to apply an exception does not render an abstract idea patent eligible). There is no indication that the additional limitations alone or in combination improves the functioning of a computer or any other technology, improves another technology or technical field, or effects a transformation or reduction of a particular article to a different state or thing. Therefore, the claims are not patent eligible.
In conclusion, the claims are directed to the abstract idea for evaluating clinical data by collecting data, analyzing it, and outputting the results of the collection and analysis. The claims do not provide an inventive concept, because the claims do not recite additional elements or a combination of elements that amount to significantly more than the judicial exception of the claims. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and the collective functions merely provide conventional computer implementation. Therefore, whether taken individually or as an order combination, the claims are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments and Amendments
Applicant’s arguments and amendments filed on 7/30/2025 have been fully considered and are addressed below.
Applicant’s arguments have been fully considered but are not persuasive.
Applicant asserts that the claims integrate the abstract idea into a practical application and impose meaningful limitations on the abstract idea by providing an improvement to technology and the functionality of a computing device, drawing factual comparisons to Example 42 Claim 1 of the 2019 Patent Subject Matter Eligibility Examples 37-42 (Jan 7, 2019). Examiner does not agree with the comparisons drawn and finds Example 42 distinguishable from the instant claims. Example 42's abridged background provides the technical problem of latency and incompatibility between remote devices stating "medical providers must continually monitor a patient’s medical records for updated information, which is often-times incomplete since records in separate locations are not timely or readily-shared or cannot be consolidated due to format inconsistencies as well as physicians who are unaware that other physicians are also seeing the patient for varying reasons" wherein the technical solution is reflected in the claim language.
The instant application, however, present a non-technical problem of evaluation of clinical trial data. The solution to the problem is rooted in an improvement to the abstract idea itself and not a technical failure of a computer system. The invention is not performing any standardization or formatting in real time, moreover it is merely using standardized data format in search. The additional elements can best be characterized as tools to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer. MPEP § 2106.05(f)(2) Requiring the use of software to tailor information and provide it to the user on a generic computer within the “Other examples., v.”.
Examiner respectfully submits that the burden of establishing that the claimed subject matter falls under a judicial exception to patent eligibility has been met, along with a showing of how the additional elements are not significantly more than the judicial exception, therefore the claims remain rejected under 101.
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 JAY M. PATEL whose telephone number is (571)272-6793 and email is jay.patel2@uspto.gov. The examiner can normally be reached on Monday-Friday 8AM-4:30PM.
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/JAY M. PATEL/Primary Examiner, Art Unit 3686