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
This action is in response to the application filed 12/17/2024.
Claims 1-20 are currently pending and have been examined.
Claim Objections
Claims 1 and 13 are objected to because of the following informalities: “a lists of terms” is grammatically incorrect. Appropriate correction is required.
Claims 3 and 15 are objected to because of the following informalities: “an HER database” is not spelled correctly. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
Claims 1 and 13 and therefore their dependent claims are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as based on a disclosure which is not enabling. The disclosure does not enable one of ordinary skill in the art to practice the invention without describing how the LLMs are processing the patient data from a computing device, which is/are critical or essential to the practice of the invention but not included in the claim(s). See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976). The specification does not recite the claimed limitations of a system or a computer implementing one or more services of inputting to a first LLM and inputting to a second LLM. The specification recites a computing system (Figure 10), however it does not recite how the computing system is communicating with the LLMs to process the data (such as shown in Figure 5B). It is unclear how the LLMs relate to the system architecture and if the computing system is merely communicating with the LLMs. It appears that the data is communicated without secure protocols (such as using Anthropic’s Claude 3.5 Sonnet (paragraph 77) which is known to one of ordinary skill in the art to not securely transfer data as it has been discontinued) and would violate HIPAA which teaches away from tokenizing the EHR document and presenting them to a health care professional (paragraphs 63 and 140).
Further in claim 1, the claimed invention recites that the system comprises a computing system and at least one computing device, however it appears that the specification recites that the claimed invention is implemented onto a computing system or computing devices may be used (paragraph 146). However the specification is silent on a system comprising a computing system and at least one computing device (paragraph 10 and Figure 10). It appears that computing devices or computing systems can be used but the specification is silent on both computing devices and computing systems being used in the system.
Claim Rejections - 35 USC § 112(b)
Claims 1 and 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 13 recite the limitation "the output from LLM". There is insufficient antecedent basis for this limitation in the claim.
Claims 1 and 13 recite the limitation "the patient". There is insufficient antecedent basis for this limitation in the claim.
Claims 1 and 13 recite the limitation "the database query assembler". There is insufficient antecedent basis for this limitation in the claim.
Claims 11 and 19 recite the limitation “the first set of AI techniques”. There is insufficient antecedent basis for this limitation in the claim.
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 1-20 are drawn to a method and a device which are statutory categories of invention (Step 1: YES).
Independent claims 1, 13 recite: access, a set of electronic health record documents relating to a set of patients, inputting a general directive, a more specific directive for particular data related to medical relevance; an output format request; a summary of the patient’s condition and past therapies; inputting a prompt formed by a single output directive and the output from the first inputs; outputting a lists of terms that reflect a patient’s presenting illnesses, active diagnoses, current treatments, family history, and demographic data; communicating the list of terms to the database query assembler module which uses standard text-processing operations to assemble SQL queries; retrieving, a set of resource locators, each resource locator for a retrieved medical-literature publication from at least that are relevant; to determine a set of resource locators to present to a user; and presenting the subset of the set of the resource locators to the user.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity between a health care professional (user) and a patient, as reflected in the specification, which states that “These diagnosis and treatment facts might relate to an individual patient, to a subset of patients in the HCP's practice (e.g., the patients that the HCP will see today or this week), or to all of the patients in the HCP's practice.” (see: specification paragraph 68). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The present claims cover certain methods of organizing human activity because they address “In yet another augmentation, contextual information from the HCP's practice might influence the search-term expansions of the database search queries used by the recommender system. If a patient has a disease that the HCP rarely encounters, the system should probably return different medical-literature recommendations than if the patient has a disease that the HCP encounters frequently. For example, in the former case the recommendation of current standardof-care guidelines might be useful; whereas in the latter case, the recommendation of recent novel research publications might be better.” (see: specification paragraph 41). Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).”
The judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including “system”, “network interface”, “computing system”, “at least one computing device configured to implement one or more services”, “a network”, “a first LLM”, “a second LLM”, “medical database”, “a second data store”, “third set of AI techniques”, “computing system’s display”, ”document database” are recited at a high level of generality (e.g., that the inputting and displaying is performed using generic computer components and generic machine learning tools with instructions are executed to perform the claimed limitations). Such that they amount to no more than mere instructions to apply the exception using generic computer components. See: MPEP 2106.05(f).
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
The claims do 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, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic component cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion at Figure 1, Figure 10 and
Paragraph 146, where “According to one embodiment, the techniques described herein are implemented by one or generalized computing systems programmed to perform the techniques pursuant to program instructions in firmware, memory, other storage, or a combination. Special-purpose computing devices may be used, such as desktop computer systems, portable computer systems, handheld devices, networking devices or any other device that incorporates hard-wired and/or program logic to implement the techniques.”
Paragraph 154, where “A modem or network interface local to computer system (1000) can receive the data. Bus (1002) carries the data to main memory (1006), from which processor (1004) retrieves and executes the instructions. The instructions received by main memory (1006) may optionally be stored on storage device (1010) either before or after execution by processor (1004).”
Paragraph 155, where “Computer system (1000) also includes a communication interface (1018) coupled to bus (1002). Communication interface (1018) provides a two-way data communication coupling to a network link (1020) that is connected to a local network (1022). For example, communication interface (1018) may be an integrated services digital network (ISDN) card, cable modem, satellite modem, or a modem to provide a data communication connection to a corresponding type of telephone line. Wireless links may also be implemented. In any such implementation, communication interface (1018) sends and receives electrical, electromagnetic or optical signals that carry digital data streams representing various types of information.”
Paragraph 13, where “Generative AI (GenAI) refers to deep-learning AI models that can generate high-quality text, images, and other content based on the data they were trained on. A large language
model (LLM) is a particular kind of GenAI model that is designed for natural language processing tasks such as language generation. In another embodiment, the second set of AI techniques used to formulate a set of database queries based on the set of medical facts that are used to retrieve, over a network using the network interface, a set of retrieved medical-literature publications from at least a second data store that are relevant to the set of extracted medical facts, comprises a first LLM that takes as input a set of EHR and other medical documents that describe potentially a patient's diagnoses, therapies, comorbidities, adjuvant and alternative therapies, medical history, family history, genomic data, and any relevant social determinants of health, and generates from them a patient summary in a consistent format; and a second LLM that takes as input the patient summary in a consistent format and from it formulates the set of database queries. In one embodiment, the consistent format consists of lists in the syntax of Python, a popular programming language.”
Paragraph 77, where “Instead of formulating database queries with rules, the query module 208 may use generative AI (GenAI) to formulate queries. Specifically, a form of GenAI called a largelanguage model (LLM), such as Anthropic's Claude 3.5 Sonnet (https://www.anthropic.com/news/claude-3-5-sonnet), may be used to formulate a query to a medical database like PubMed. In a preferred embodiment, a pipeline of two LLMs may be used, as shown in FIG 5B. A first LLM B105 may take as input a prompt formed by the concatenation of a prompt prefix B102 and a prompt suffix B103.”
Paragraph 150, where “Computer system (1000) may be coupled via bus (1002) to a display (1012), such as a computer monitor, for displaying information to a computer user. An input device (1014), including alphanumeric and other keys, is coupled to bus (1002) for communicating information and command selections to processor (1004).”
Paragraph 3, where “Document databases containing medical literature, including publications, articles, guidelines, tutorials, and the like, can be a useful resource for a healthcare professional (HCP). In some instances, finding a particular document may be as easy as submitting a search query to a search engine and receiving search results.”
Paragraph 14, where “The embodiment might further provide that the third set of AI techniques used to determine which subset of the set of retrieved medical-literature publications to present to a user and how to present them, comprise one or more of these methods: term-matching and termweighting methods to rate the relevance of publications in the set of retrieved medical-literature publications, expert-system rules that consider the citation counts or download counts of publications in the set of retrieved medical-literature, expert-system rules that consider usersupplied feedback regarding the publications in the set of retrieved medical-literature publications, expert-system rules that promote variety in the subset of the set of retrieved medical-literature publications to present to a user, expert-system rules that apply pedagogical strategies in the selection of publications in the subset of the set of retrieved medical-literature publications to present to a user, the provision of automatically generated explanations associated with the subset of the set of retrieved medical-literature publications to present to a user, and document-clustering methods for visually organizing and presenting the subset of the set of retrieved medical-literature publications to a user.”
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with route, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claims 2-12 and 14-20 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are directed to an abstract idea without significantly more. Claim 2-12 and 14-20 recite inputting, transmitting, and displaying healthcare data from patient records on the generically recited computing device using the generically recited artificial intelligence as shown in the parent claims above.
Claims 3 and 15 further recite “HER” which is assumed to be an “EHR” database which is recited at a high level of generality (e.g., that the associating and correlating are performed using generic computer components with instructions are executed to perform the claimed limitations) as shown in the specification paragraph 70 and Figure 6. Such that they amount to no more than mere instructions to apply the exception using generic computer components. See: MPEP 2106.05(f).
Claims 11 and 19 further recite “the first set of AI techniques” and “natural language processing” which is recited at a high level of generality (e.g., that the inputting and outputting are performed using generic computer components and generic artificial intelligence with instructions are executed to perform the claimed limitations) as shown in the specification paragraph 11 and 58. Such that they amount to no more than mere instructions to apply the exception using generic computer components. See: MPEP 2106.05(f).
These claims fail to remedy the deficiencies of their parent claims above, and therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Allowable Subject Matter
Claims 1-20 are allowable over the prior art. Independent claims 1 and 13 have similar claim limitations with their parent case of 16/900,751 that overcome the prior art of record. These limitations include using several different AI techniques to input/output data and assembling SQL queries for multiple different data stores including a medical database and a medical-literature data store. The prior art of record of Lucas (US 20210151192 A1), Brody (US 11238125 B1), Xu (US 20180373754 A1), Wright (US 20200341987 A1), Fox (US 20140379708 A1), and Stankiewicz (WO 2015167852 A1). A further art search was conducted and found the prior art of Eggebraaten (US 20180137249 A1) that teaches using SQL queries on knowledge databases that include AI, however it did not explicitly teach using multiple AI techniques to process medical data.
Conclusion
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/KIMBERLY A. SASS/Examiner, Art Unit 3686
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