DETAILED ACTION
The following is a FINAL office action upon examination of the application number 18/610822.
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 .
Response to Amendment
Claims 1-4 and 6-20 have been amended.
Claims 1-20 are pending in the application and have been examined on the merits discussed below.
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 1-20 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.
(Step 1) Claims 1-10 are directed to a method; thus these claims are directed to a process, which is one of the statutory categories of invention. Claims 11-19 are directed to a system comprising one or more processors; thus the system comprises a device or set of devices, and therefore, is directed to a machine which is a statutory category of invention. Claim 20 is directed to a non-transitory computer-readable storage medium, which is a manufacture, and this a statutory category of invention.
(Step 2A) The claims recite an abstract idea instructing how to determine candidate eligibility based on augmented health data, which is described by claim limitations reciting:
receiving, … a plurality of data objects associated with a plurality of users, the plurality of data objects providing a documentation-based eligibility status of the plurality of users, wherein a first data object associated with a first user includes a first parameter initially set to a first value indicating an initial eligibility status of the first user;
determining, … using a plurality of trained … models, an altered eligibility status from the initial eligibility status of the first user based on determining that one or more of (1) a second value of the first parameter overrides the first value or (2) a second parameter, not included in the first data object, is to be added to the first data object;
generating, … an augmented first data object that indicates the altered eligibility status by modifying the first data object to one or more of replace the first value with the second value or include the second parameter based on the determining; and
determining, … whether one or more of the plurality of users are eligible candidates, including whether the first user is an eligible candidate based on the augmented first data object.
The identified limitations in the claims describing determining candidate eligibility based on augmented health data (i.e., the abstract idea) fall within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas, which covers fundamental economic practices or, alternatively, the “Mental Processes” grouping of abstract ideas since the identified limitations can be performed by a human, mentally or with pen and paper. Dependent claims 2, 5, 7, 8, 9, 10, 12, and 16-19 recite limitations that further narrow the abstract idea (i.e., determining candidate eligibility based on augmented health data); therefore, these claims are also found to recite an abstract idea.
This judicial exception is not integrated into a practical application because additional elements such as the one or more processors in claim 1, the one or more processors; one or more non-transitory computer readable media storing processor-executable instructions that, when executed by the one or more processors, cause the one or more processors to perform operations in claim 11, and the one or more non-transitory computer-readable media storing instructions in claim 20, do not add a meaningful limitation to the abstract idea since these elements are only broadly applied to the abstract ideas at a high level of generality; thus, none of recited hardware offers a meaningful limitation beyond generally linking the abstract idea to a particular technological environment, in this case, implementation via a processor/computer.
Additional elements such as receiving, by one or more processors… do not yield an improvement in the functioning of the computer itself, nor do they yield improvements to a technical field or technology; further, these limitations only add insignificant extra-solution activities (data gathering). Additional elements reciting using a plurality of trained machine learning models… do not provide an improvement; these additional elements are recited at a high level of generality and only generally link the abstract idea to a technological environment. Similarly, additional elements in claims 3, 4, 6, 13, 14, and 15, related to …trained machine learning model of the plurality of trained machine learning models… add additional elements that do not yield an improvement and only generally link the abstract idea to a technological environment. Accordingly, these additional element do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
(Step 2B) 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 hardware additional elements amount to no more than mere instructions to apply the exception using a generic computer component (see Spec. 96-98). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Additional elements such as receiving, by one or more processors… do not yield an improvement in the functioning of the computer itself, nor do they yield improvements to a technical field or technology; further, these limitations only add insignificant extra-solution activities (data gathering). With respect to data gathering limitations, the courts have recognized the use of computers to receive and transmit data as a well-understood, routine, and conventional, 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). Additional elements reciting using a plurality of trained machine learning models… do not provide an improvement; these additional elements are recited at a high level of generality and only generally link the abstract idea to a technological environment. Similarly, additional elements in claims 3, 4, 6, 13, 14, and 15, related to …trained machine learning model of the plurality of trained machine learning models… add additional elements that do not yield an improvement and only generally link the abstract idea to a technological environment. In addition, when taken as an ordered combination, the ordered combination adds nothing that is not already present as when the elements are taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology.
Response to Arguments
Applicant's arguments filed 4/10/2026 have been fully considered but they are not persuasive.
With respect to the rejection under 35 USC 101, Applicant argues that the claims do not fall within the grouping of abstract ideas.
Examiner respectfully disagrees. Examiner maintains that limitations in the claims describing determining candidate eligibility based on augmented health data (i.e., the abstract idea) fall within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas, which covers fundamental economic practices. The term "fundamental" is not used in the sense of necessarily being "old" or "well-known." See, e.g., OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1364, 115 U.S.P.Q.2d 1090, 1092 (Fed Cir. 2015) (a new method of price optimization was found to be a fundamental economic concept); In re Smith, 815 F.3d 816, 818-19, 118 USPQ2d 1245, 1247 (Fed. Cir. 2016) (describing a new set of rules for conducting a wagering game as a "fundamental economic practice"); In re Greenstein, 774 Fed. Appx. 661, 664, 2019 USPQ2d 212400 (Fed Cir. 2019) (non-precedential) (claims to a new method of allocating returns to different investors in an investment fund was a fundamental economic concept).
With respect to the rejection under 35 USC 101, Applicant argues that the claims are integrated into a practical application.
Examiner respectfully disagrees. The identification and addition of health conditions to health records in order to augment the selection of trial members does not provide an improvement to the computer or technology. Examiner notes that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology. Additional elements reciting using a plurality of trained machine learning models… do not provide an improvement; these additional elements are recited at a high level of generality and only generally link the abstract idea to a technological environment.
Claim 3 from Example 47 was eligible because the claims reflected an improvement in the technical field of network intrusion detection which was described in the background/Specification. In contrast, additional elements in the present claims do not provide an improvement to the computer or technology and do not provide a practical application. The identification and addition of health conditions to health records in order to augment the selection of trial members does not provide an improvement to the computer or technology. The machine learning model is recited at a high level of generality and only generally links the abstract idea to a technological environment or field of use.
With respect to the rejection under 35 USC 101, Applicant argues that the claims recite an inventive concept by adding limitations that are not well-understood, routine, or conventional activity in the field.
Examiner respectfully disagrees. Examiner acknowledges the requirement to provide support for conclusions regarding elements being well-understood, routine, and conventional from Berkheimer. However, the support is only required when Examiner concludes certain limitations are well-understood, routine, and conventional. Examiner notes that the Claim Rejections - 35 USC § 101 does not make any conclusion of additional elements in the claims being well-understood, routine or conventional; therefore, the rejection does not require said support.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 11328796 – discloses a system that changes the cohort for a clinical trial.
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 ALAN TORRICO-LOPEZ whose telephone number is (571)272-3247. The examiner can normally be reached M-F 10AM-5PM.
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/ALAN TORRICO-LOPEZ/ Primary Examiner, Art Unit 3625
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