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 .
DETAILED ACTION
In the amendment dated 23 December 2025, the following occurred: Claims 1, 11, and 18 have been amended.
Claims 1-20 are pending.
Priority
This application does not claim priority to any other patent document and is thus afforded a priority date corresponding to the filing date of 31 May 2024.
Specification
The Abstract is objected to because it exceeds 150 words. See. MPEP 608.01(b).
Claim Objections
Claims 11 and 18 are objected to because “the at least one medical records cloud-based database” in the “deriving” step lacks antecedent basis. Appropriate correction/clarification is required.
Claims 1, 11, and 18 are objected to because “NPL” should read “NLP” which is known in the art to be an abbreviation for natural language processing. Appropriate correction/clarification is required.
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.
Claims 1, 11, and 18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim recites a system, method, and computer-readable medium (“CRM”) method for automated medical data processing based on patient-related data, which are within a statutory category.
Step 2A1
The limitations of (Claim 18 being representative) acquiring a user account creation and input data […]; analyzing patient intake data derived from the input data by […] analysis of the intake data; processing user insurance data by […] generation of an insurance verification verdict; acquiring recommended lab test and triage data of the user and ingesting the lab test and the triage data […an performing…] analysis of the lab tests; receiving treatment and medication suggestions and generating a feature vector based on the treatment and medication suggestions; providing the feature vector […] to generate at least one clinical outcome model; deriving clinical documentation data from the patient intake data and from a at least one medical records datastore and applying […] processing to the clinical documentation data; and acquiring revenue cycle data from the clinical documentation data and ingesting the revenue cycle data […] to generate billing parameters, as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. That is, other than reciting a system, method, or CRM implemented by a server or processor/memory (computer), the claimed invention amounts to managing personal behavior or interaction between people. For example, but for the data server or processor/memory, the claims encompass rules for a person or persons to collect patient data and deriving clinical documentation data in the manner described in the identified abstract idea, supra. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of a server having a processor and memory or a CRM that implements the identified abstract idea. The server or CRM are not described by the applicant and are recited at a high-level of generality (i.e., a generic server or CRM performing generic computer functions) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim further recites the additional element of using AI and ML modules to perform various data analysis tasks. The recited modules represent mere instructions to implement the abstract idea on a generic computer. Implementing an abstract idea using a generic computer or components thereof does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. See, e.g., Recentive Analytics, Inc. v. Fox Corp., No. 2023-2437 at 10 (Fed. Cir. April 18, 2025) (finding that claims that do no more than apply established methods of machine learning to a new data environment are ineligible). Alternatively, or in addition, the implementation of the AI/ML modules to perform various data analysis tasks merely confines the use of the abstract idea (i.e., the trained model) to a particular technological environment or field of use and thus fails to add an inventive concept to the claims. The Examiner notes that there is no description of the particular AI or ML algorithms that are used by the present invention.
The claim further recites the two additional elements of (1) to at least one medical records cloud-based database, (2) at least one patient entity node, (3) a network / secure network, (4) an OCR module, and (5) NLP. Items (1) and (2) are recited at a high level of generality and represent locations from which data is received or to which data is transmitted, which is a form of extra-solution activity. MPEP 2106.04(d)(I) indicates that extra-solution data gathering/outputting activity cannot provide a practical application.
Items (3)-(5) generally links the abstract idea to a particular technological environment or field of use (i.e., a computer connected via a network). MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, the additional elements do not integrate the abstract idea into a practical application.
Step 2B
The claim does not include additional elements that 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 elements of using a server having a processor and memory or a CRM to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
As discussed above with respect to integration of the abstract idea into a practical application, the additional element of u using AI and ML modules to perform various data analysis tasks was found to represent mere instructions to implement the abstract idea on a generic computer and/or confine the use of the abstract idea (i.e., the trained model) to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and determined to be insufficient to provide significantly more. MPEP 2106.05(I) indicates that mere instructions to implement the abstract idea on a generic computer and/or confining the use of the abstract idea to a particular technological environment or field of use cannot provide significantly more. See also Recentive Analytics, Inc. v. Fox Corp., No. 2023-2437 at 17 (Fed. Cir. April 18, 2025) (finding that applying machine learning to an abstract idea does not transform a claim into something significantly more).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of (1) to at least one medical records cloud-based database and (2) at least one patient entity node were considered to represent extra-solution activity. This has been re-evaluated under the “significantly more” analysis and determined to be well-understood, routine, conventional activity in the field. MPEP 2016.05(d)(II) indicates that receiving and/or transmitting data to/from locations over a network has been held by the courts to be well-understood, routine, conventional activity (citing Symantec, TLI Communications, OIP Techs., and buySAFE). Well-understood, routine, conventional activity cannot provide an inventive concept (“significantly more”). As such the claim is not patent eligible.
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of (3) a network / secure network, (4) an OCR module, and (5) NLP were determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. Accordingly, even in combination, this additional element does not provide significantly more. As such the claim is not patent eligible.
Claims 2-10, 12-17, 19, and 20 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claim(s) 2, 12, 20 merely describe(s) generating patient insights.
Claim(s) 3, 13, 19 merely describe(s) performing predictive analytics.
Claim(s) 4, 14 merely describe(s) combining and converting data.
Claim(s) 5, 15 merely describe(s) connecting the devices.
The additional element of a secured network is analyzed in the same manner as the network of Claim 1 and does not provide a practical application or significantly more for the same reasons.
Claim(s) 6, 16 merely describe(s) recording data.
The additional element of an API call generally links the claimed invention to a particular technological environment or field of use which does not provide a practical application or significantly more for the same reasons presented in Claim 1.
The additional element of a central secured database is interpreted to be part of the server (i.e., a generic computer component).
Claim(s) 7, 17 merely describe(s) how data is recorded.
The additional element of an image-based file generally links the claimed invention to a particular technological environment or field of use which does not provide a practical application or significantly more for the same reasons presented in Claim 1.
Claim(s) 8, 9 merely describe(s) recording data.
Claim(s) 10 merely describe(s) receiving data and generating data based on the received data.
Response to Arguments
Specification
Regarding the objection(s) to the Specification, the Applicant has provided a substitute abstract; however, the abstract still exceeds 150 words and the objection is maintained.
Claim Objections
Regarding the objection(s) to Claims 1, 11, and 18, the Applicant has amended the claims to overcome the basis/bases of objection.
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 1-20, the Examiner has considered the Applicant’s arguments; however, the arguments are not persuasive. Applicant argues:
What is claimed in this application is not an "abstract idea" at all within the meaning of Alice.
Regarding (a), the Examiner respectfully disagrees. The identified abstract idea represents a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to perform healthcare data processing (see Spec. Para. 001).
The Office Action appears to take only some features from the independent claim I to make it sound as a human activity or mental process (i.e., concepts in the abstract category of commercial/legal interactions) with no technological innovation behind it. Applicant respectfully disagrees with this approach and points out that any claims should be asserted as a whole (not partially) based solely on the precise technical limitations of the claim and not on an interpretation used to fit a certain narrative.
Regarding (b), the Examiner notes Applicant’s disagreement; however, this is the procedure required by MPEP 2106. The Examiner has identified the abstract idea and has analyzed the remaining features of the claim (the additional elements). The additional elements, when taken individually or as an ordered combination do not provide a practical application or significantly more by any measure in MPEP 2106.
In particular, the use of the claimed AI module configured to analyze the intake data, an insurance AI module, AI module configured to analyze the lab tests, ML module configured to generate at least one clinical outcome model and AI module configured to generate billing parameters go way beyond any mental process or methods of organizing human activity.
Regarding (c), the Examiner respectfully submits that the various functions argued, i.e., analyze intake data, analyze lab data, etc., are the abstraction. See Spec. Para. 002 describing that the process of analyzing patient medical data is a human task. The various AI modules used to perform these are the additional elements and represent instructions to implement the abstract idea on a generic computer (“apply it”). Notably, the claims do not provide any details as to how the AI modules operate or how they perform the recited functions. Rather, the limitations only recite the outcome of “analyzing…processing…ingesting…generat[ing]” and do not include any details about how these functions are performed. See, e.g., Example 47 of the July 2024 Subject Matter Eligibility Examples.
As can be clearly understood from the description of the above network-based system 100, the system includes modules within the application program hosted on the computer system. This automated network-bound system and process cannot be equated to any type of human activity or organizing human activity as alleged by the Office Action using even broadest possible interpretation.
Regarding (d), the Examiner respectfully disagrees with Applicant’s characterization. The rejection did not state that the “automated network-bound system” was equated to “any type of human activity or organizing human activity.” The rejection stated that the identified abstract idea represents Certain Methods of Organizing Human Activity, i.e., rules or instructions for a person or persons to follow. The particular technological environment to which the claims are confined—a server having a processor and a memory—is merely confining the abstract idea to a general-purpose computer. See MPEP 2106.04(d)(I) states: “The courts have also identified limitations that did not integrate a judicial exception into a practical application: • Merely reciting the words ‘apply it’ (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea….”
The claimed processing is performed automatically and in parallel across multiple patient entity nodes over a network, including OCR based acquisition, intake analysis, insurance verification, documentation processing, and revenue cycle parameter generation
Regarding (e), the Examiner respectfully disagrees and notes that the claimed processing is not “performed [] in parallel across multiple patient entity nodes over a network.” The claimed invention (and thus the abstract idea) is performed on/by a generic server. The server may receive its information from different locations (database/nodes); however, this represents extra-solution data gathering activity.
All of the steps executed by the above system are not a "Mental Process" alleged by the Examiner.
Regarding (f), the Examiner respectfully submits that the abstract idea was not characterized as a mental process. “Mental process” does not appear in the current or prior rejection at all.
These actions performed by the claimed system cannot be performed by a process of organizing human activity in any way possible given computer-based AI processing.
Regarding (e), the Examiner respectfully disagrees. The claims do not provide any details as to how the AI modules operate or how they perform the recited functions. There is nothing about the vaguely-described functions that remove them from representing rules or instructions for a person to follow. For instance, Claim 1 recites “analyze patient intake data derived from the input data.” There is no indication as to how the intake data is analyzed or even what the outcome of the analysis is. As such, and given the broadest reasonable interpretation, this represents the analysis of patient intake data in (presumably) a certain manner. Analysis of patient intake data is a function performed by humans (i.e., doctors, administrators) and represents rules or instructions.
In fact, anything that involves automated data analytics and AI predictive modelling cannot be equated with the mental process or human activity that may be performed with pen and paper.
Regarding (h), the Examiner respectfully submits that this statement is facially incorrect.
The Office Action further states that the claims do not reflect an improvement in the functioning of a computer, or an improvement to other technology or technical field. Respectfully, this assumption is also completely incorrect.
Regarding (i), the Examiner respectfully disagrees. The Applicant has not identified nor can the Examiner locate any physical improvement to the functioning of the computer. Further, Applicant has not identified nor can the Examiner locate any improvement to the various AI modules. The Applicant is using AI modules as a tool (in an unspecified manner) to perform the recited functions without description as to how the AI modules perform their functions. See, e.g., Recentive Analytics, Inc. v. Fox Corp., No. 2023-2437 at 10 (Fed. Cir. April 18, 2025) (finding that claims that do no more than apply established methods of machine learning to a new data environment are ineligible).
In particular, the feature vector and clinical outcome model outputs are used by the system to drive automated downstream actions, including documentation processing and generation of billing and revenue cycle parameters.
Regarding (j), the Examiner respectfully submits that it is unclear how these features (which are part of the abstraction) provide an improvement to the computer or the AI modules.
These actions performed by the claimed system cannot be performed by a process of organizing human activity m any way possible given computer-based predictive (AI-based) analytics of large amounts of patient-related data involved in execution of the method steps.
Regarding (k), the Examiner respectfully submits that “large amounts of patient-related data” are not claimed and thus this argument is immaterial. Each piece of data claimed may literally be one piece of data.
In fact, anything that involves large data analytics using machine-learning process cannot be equated with the mental process or human activity.
Regarding (l), the Examiner respectfully submits that this statement is incorrect with regard to certain methods of organizing human activity. There is nothing in the MPEP or caselaw that says that the amount of data affects whether or not an abstract idea falls within certain methods of organizing human activity. Further, and as noted above, Applicant is not claiming large amounts of data.
Conclusion
Prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
DeFrank et al. (U.S. Pre-Grant Patent Publication No. 2020/0118164) which discloses and integrated mobile device management method that analyzes user information using an embedded algorithm.
Shope et al. (U.S. Pre-Grant Patent Publication No. 2024/0404669) which discloses a system for automatically generating physician’s notes using generative AI to analyze an encounter transcription.
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 JASON S TIEDEMAN whose telephone number is (571)272-4594. The examiner can normally be reached 7:00am-4:00pm, off alternate Fridays.
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/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683