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 .
Applicant filed a response dated 3/18/2026 in which claims 1, 10, and 18-19 have been amended. Thus, the claims 1-20 are pending in the application.
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 an abstract idea of displaying the predicted diagnosis classification code without significantly more.
Examiner has identified claim 1 as the representative claim that describes the claimed invention presented in independent claims 1, 10, and 18.
Claim 1 is directed to a method, which is one of the statutory categories of invention (Step 1: YES).
The claim 1 recites a series of steps, e.g., generating a machine learning instructions based on a structured data record associated with a patient encounter; providing the machine learning instructions to a machine learning component configured to perform a retrieval-augmented (RAG) machine learning (ML) operation; generating, by a RAG ML system implemented on one or more computing devices, a set of vector embeddings corresponding to the structured data record by creating numerical representations of data from the structured data record; performing, by the RAG ML system a vector similarity operation to identify a set of reference codes for use in the RAG ML operation by searching, based on the set of vector embeddings, a vector database that includes at least one additional set of vector embeddings; generating, using the machine learning component and based on the machine learning instruction and the set of reference codes, a predicted diagnosis classification code; determining, using the machine learning component, a service level classification based on the structured data record and a set of evaluation factors; generating, using the machine learning component, a suggested documentation modification comprising text configured to be inserted into the structured data record, wherein the suggested documentation modification is configured to cause the structured data record to satisfy a documentation requirement associated with a higher service level classification than the service level classification; and providing an output configured to cause a display of a user device to present a representation of the predicted diagnosis classification code and the suggested documentation modification. These limitations (with the exception of italicized limitations) recite an abstract idea of displaying the predicted diagnosis classification code which may correspond to a certain method of organizing human activity. The additional elements of a machine learning instructions, a machine learning component, a retrieval-augmented (RAG) machine learning (ML) operation/system, computing devices, vector embeddings, vector database, and a user device do not necessarily restrict the claim from reciting an abstract idea. Thus, the claim 1 recites an abstract idea (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application because the additional elements of a machine learning instructions, a machine learning component, a retrieval-augmented (RAG) machine learning (ML) operation/system, computing devices, vector embeddings, vector database, and a user device result in no more than simply applying the abstract idea. The additional elements of a machine learning instructions, a machine learning component, a retrieval-augmented (RAG) machine learning (ML) operation, vector embeddings, vector database, and a user device are recited at a high level of generality and under their broadest reasonable interpretation comprises a generic computer device. The presence of a generic computer device is nothing more than to implement the claimed invention by applying the exception using a generic element (MPEP 2106.05(f)). Therefore, the recitation of additional elements do not meaningfully apply the abstract idea and hence do not integrate the abstract idea into a practical application. Thus, the claim 1 is directed to an abstract idea (Step 2A-Prong 2: NO).
The claim 1 does not include additional elements that is sufficient to amount to significantly more than the judicial exception because the claim recites the additional element of a machine learning instructions, a machine learning component, a retrieval-augmented (RAG) machine learning (ML) operation/system, computing devices, vector embeddings, vector database, and a user device are recited at a high level of generality in that it result in no more than simply applying the abstract idea using a generic computer device. The additional elements when considered separately and as an ordered combination do not amount to add significantly more as these elements provide nothing more than to simply apply the exception in a generic manner. The additional elements do not transform an abstract idea into a practical application or amounts to add significantly more (Step 2B: NO). Thus, the claim 1 is not patent eligible.
Similar arguments can be applied to other independent claims 10 and 18 (claim 10 recites the additional elements of a memory and a processing system which are simply generic computer and applies the abstract idea in a manner similar to what is described above for claim 1), and dependent claim 19 and hence the claims 10 and 18-19 are rejected on similar grounds as claim 1.
Dependent claims 2-9, 11-17, and 20 further define the abstract idea that is present in their respective independent claims 1, 10, and 18, thus correspond to a Certain Methods of Organizing Human Activity, and hence are abstract in nature for the reason presented above. Dependent claims do not include any additional elements that integrate the abstract idea into a practical application or are sufficient to amount to significantly more than the judicial exception when considered both individually and as an ordered combination. Therefore, the claims 1-20 are not patent-eligible.
Response to Arguments
Examiner withdraws 35 U.S.C. 103 rejection of claims 1-20 in view of the amendment/argument.
Applicant's arguments filed dated 3/18/2026 have been fully considered but they are not persuasive due to the following reasons:
With respect to the rejection of claims 1-20 under 35 U.S.C. 101, Applicant states that under Step 2A, Prong One, the vector embedding operations recited in the amended claims are not merely a computerized implementation of a mental comparisons. The embedding engine transforms a structured data record – which may include patient demographics, symptoms, examination findings, diagnosis, and treatment plans – into a dense vector that captures the contextual meaning of the clinical encounter in a manner that preserves semantic proximity: encounters involving related conditions, similar symptoms profiles, or comparable treatment protocols are mapped to nearby regions of the vector space, even when described using entirely different natural language terminology. These elements, individually and in ordered combination, cannot practically be performed in the human mind, and therefore are not an abstract idea corresponding to a certain method of organizing human activity.
Examiner respectfully disagrees and notes that under this step, the claim is initially considered in the absence of additional elements to determine if the claim recites an abstract idea. In this case, it was determined that the claim recites an abstract idea of displaying the predicted diagnosis classification code. The additional elements are then considered to determine if the additional elements restrict the claim from reciting an abstract idea which it does not. The additional elements are further considered in more specific detail under Step 2A, Prong Two and Step 2B to determine if the claim is directed to an abstract idea.
With respect to Step 2A, Prong Two, Applicant states that the coordinated operation of the embedding engine, vector database, matching engine, machine learning component, and clinician interface constitutes a specific technological improvement to clinical workflow computing systems, The system addresses the technical problem of documentation insufficiency – a systematic data integrity problem, in clinical information systems where the electronic documentation does not accurately reflect the service actually rendered – through a specific technical solution that cannot be replicated by human mental processes. Accordingly, the additional elements, individually and in combination, and when analyzed with consideration to all of the recited claim limitations, integrate any judicial exception as may be identified for claim 1 under Step 2A, Prong One of the Alice/Mayo test into a practical application under MPEP 2106.04(d)(1).
Examiner respectfully disagrees and notes that the additional elements of embedding engine, vector database, matching engine, machine learning component, and clinician interface are recited at a high level of generality in that it amounts to simply applying the abstract idea. The technical solution of systematic data integrity is not a technical solution but an improvement to an abstract idea of documentation insufficiency. This improvement is associated with computer implementation, however, this improvement is not technical in nature. The improvement to an abstract idea is not sufficient to integrate the abstract idea into a practical application. Thus, these arguments are not persuasive.
With respect to Step 2B, Applicant states that the combination of elements produces a specific technical result – targeted, machine-generated natural language text calibrated to bridge a documentation gap between service level classifications – that is not well-understood, routine, or conventional in the art of clinical workflow computing. Thus, assuming arguendo (and thus without Applicant concession) that claim 1 recites a judicial exception that is not integrated into a practical application, it nevertheless recites significantly more than the judicial exception.
Examiner respectfully disagrees and notes that the additional elements producing a technical result that is no well-understood, routine, or conventional in the art does not amount to add significantly more as “’novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the §101 categories of possibly patentable subject matter.” In addition, the search for an inventive concept is different from an obviousness analysis under 35 U.S.C. 103. “The inventive concept inquiry requires more than recognizing that each claim element, by itself, was known in the art…[A]n inventive concept can be found in the non-conventional and non-generic arrangement of known, conventional pieces.” The additional elements are recited at a high level of generality in that it simply applies the abstract idea without transforming the abstract idea into a patent eligible subject matter.
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 RAJESH KHATTAR whose telephone number is (571)272-7981. The examiner can normally be reached M-F 8AM-5PM.
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RAJESH KHATTAR
Primary Examiner
Art Unit 3684
/RAJESH KHATTAR/Primary Examiner, Art Unit 3684
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