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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
In the amendment dated 5/26/2026, the following has occurred: Claims 1, 3 – 8, 11, 13 – 18, 21, and 23 – 28 have been amended
Claims 1 – 30 are pending.
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 – 30 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.
The claims, understood as a whole, recites subject matter within a statutory category as a process (claims 1 – 10), machine (claims 21 – 30), and manufacture (claims 11 – 20) which recite the abstract idea steps of
accessing an utterance, the utterance comprising one or more tokens,
wherein the one or more tokens correspond to one or more medical entities;
keeping utterance that comprise a medication order intent;
generating a labeled utterance, wherein generating the labeled utterance comprises:
associating the one or more tokens with a hierarchical entity type comprising a set of sub-entity types, wherein the hierarchical entity type is associated with a first medical coding system;
generating medication order information based on the data, wherein generating medication order information based on the data comprises:
selecting a processing pipeline for processing the data from among a set of processing pipelines, wherein the processing pipeline is selected based on latencies associated with the set of processing pipelines; and
providing a medication order to a health record.
These steps of claims 1 – 30, as drafted, under the broadest reasonable interpretation, includes performance of the limitation in the mind but for recitation of generic computer components. That is, other than reciting steps as performed by the generic computer components, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the processing language, accessing in the context of this claim encompasses a mental process of the user. Similarly, the limitation of providing, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, but for the computer language, identifying in the context of this claim encompasses a mental process of the user. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
These steps of claims 1 – 30, as drafted, under the broadest reasonable interpretation, includes methods of organizing human activity. The claims are understood, as a whole, in light of the Specification. Here, the claim itself is directed towards providing a medication order. As explained in the Specification
[0037] For example, a healthcare provider (e.g., a doctor) may have a query (or utterance), "Show me Mary Alice's (a patient's name) recent visit, including her blood pressure." The processing pipeline may identify the intent of the end-user, and extract entities, such as the patient's name "Mary Alice" and "blood pressure." Based on the extracted medical entity (e.g., blood pressure) that is associated with medical entity type "vitals, the pipeline may identify the SNOMED CT coding system specialized in the medical entity type. A medical code in the SNOMED CT coding system may be found and linked to the medical entity (e.g., blood pressure). The FHIR-compliance data structure may be generated based on the above information, and used to obtain Mary Alice's record containing the measurement information (e.g., blood pressure) from an EHR system.
[0038] In some embodiments, an additional medication order pipeline may be used to facilitate medication orders by identifying the medication ordering intent from a natural language utterance, and using the FHIR-compliance data structure to generate medication order information to fulfill medication orders through an EHR system. The medication order information may be a concise search phrase containing the medical entities extracted from the data structure, or converted EHR system-specific medical codes based on the standard medical codes in the data structure.
The abstract idea is applied to technology to achieve all the benefits of applying the abstract idea to technology. The invention, as disclosed in the Specification, is not directed towards a technological improvement. The result of the invention is data that has a potential application and not a practical application.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2 – 10, 12 – 20, and 22 – 30, reciting particular aspects of how generating medication orders may be performed in the mind but for recitation of generic computer components).
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception (such as recitation of cause the systems to perform amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of accessing an utterance amounts to mere data gathering, recitation of providing the medication order amounts to insignificant application, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2 – 10, 12 – 20, and 22 – 30, additional limitations which amount to invoking computers as a tool to perform the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as claims 1 – 30; accessing, generating, and providing, e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii))
Additional Elements
Computer – paragraph 182 – 187 and figure 12 #1200
Storage – paragraph 189
Software – paragraph 121
Machine learning model – paragraph 84 may be a machine learning (ML) model (e.g., bidirectional encoder representations from Transformers (BERT)) that is trained using unsupervised learning techniques. Paragraph 99 using a first machine learning model and a second machine learning model. For example, in FIG. 2, two machine learning models, medical NER model 250 and linking and resolution module 252, as part of the NLU pipeline 230, may be used
Natural language processing – paragraph 55 name entity recognition and natural language utterance paragraph 75
application programming interface (API) – paragraph 34 which may utilize APIs such as…
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2 – 10, 12 – 20, and 22 – 30, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, enabling the EHR, e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii)). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Response to Arguments
The Claims Do Not Recite a Mental Process or Certain Method of Organizing Human Activity
The Applicant states, “Applicant respectfully submits that a human mind cannot practically evaluate real-time application programming interface (API) latencies to dynamically route data structures through distinct software processing pipelines.” The Examiner separates the abstract idea from the abstract idea applied to technology.
The Applicant further states, “Measuring computational network traffic, processing delays, or API response times is a strictly machine-centric operation.” The claim does not require measuring network traffic or processing delays. How the timing is determined is not claimed.
The Applicant further states, “Furthermore, a human does not mentally map spoken words into a specialized digital data schema structured by a hierarchical entity type tied to a medical coding system to resolve programmatic API routing paths.” The Applicant is again reading features into the claims that are not there.
The Applicant states, “Under MPEP § 2106.04(a)(2), the "certain methods of organizing human activity" grouping of abstract ideas is strictly limited to fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people.” The Examiner notes that interaction between people includes the interaction of a single person and a computer. Additionally, obtaining medication relates to a commercial transaction.
The Applicant states, “Evaluating software API latencies to dynamically select an internal computational execution path is a technical machine routing operation.” However, it is an extra-solution activity.
The Claims Are Integrated into a Practical Application
The Applicant states, “The Specification explicitly identifies a technical problem regarding data interoperability and processing delays across disparate computer systems. As described in paragraph [0035], "different EHR systems may use ... different digital standards (e.g., Fast Healthcare Interoperability Resources (FHIR) standard, Health Level Seven (HL7) standard, Consolidated Clinical Document Architecture (CCDA) standard)." The phrase, “different EHR systems may use” does not appear within the Specification. The phrase, “different digital standards” does not appear within the Specification. The discussion of the FHIR, HL7, and CCDA are in paragraph 34 and not paragraph 35.
[0034] The language model may process a transcript by extracting entities and classifying the end user's intent based on the entities and the context of those entities within the utterance. In a clinical setting, the entities often include medical entities such as the symptoms, medications, vital signs, and the like. Additionally, EHR systems often use medical entities that are specific to the respective EHR system. For example, one particular EHR may use the Fast Healthcare Interoperability Resources (FHIR) standard for exchanging health care information electronically and another EHR may use the Health Level 7 (HL 7) or Clinical Document Architecture (CCDA) formats. FHIR may refer to a standard for exchanging healthcare information electronically between different systems, which may utilize modern web technologies such as RESTful APIs and JSON/XML format to facilitate the exchange.
The Applicant further states, “The Specification states that "due to this variability and different standards, recognizing these entities ... is challenging," which "further complicates downstream tasks such as fulfilling medical orders." Spec. para. [0035].” The phrase, “due to this variability and different standards” also does not appear within the Specification.
[0035] Due to the variability of medical entities across clinical settings, in different geographic regions, and the different standards, recognizing these entities in end user utterances is challenging. As such, it becomes challenging to determine the end user's intent when an utterance includes one or more of these entities, which further complicates downstream tasks such as fulfilling medical orders, populating EHR for patients, and the like. Additionally, the medication order process typically uses form filling, which may be inefficient and error-prone. For example, the medication to be ordered may be written on a physician's order form (becoming part of a patient's medical record), and then be delivered to a pharmacy to review the order. The ordering process may involve many parties, and back-and-forth communication to finalize the order. Thus, there is a need to address these challenges and others. Embodiments described herein address these and other problems, individually and collectively.
The actual language describes the different entities, the different geographic regions, and the different standards. Further, the paragraph goes on to describe human factors. In context, the problem described is not a problem of technology but rather a problem of coordination.
The Examiner notes the repeated argument about claimed features that are not claimed and the repeated arguments about Specification language that does not appear.
The Applicant states, “Claim 1 recites a specific technological solution to this problem.” Claim 1 describes the application of technology to an abstract idea to achieve all the benefits of applying that technology to the abstract idea.
The Applicant states, “In Desjardins, the Appeals Review Panel concluded that claims successfully integrated an abstract idea into a practical application by making internal operational adjustments that provided tangible technological improvements, including optimizing system performance, streamlining computational execution, and reducing system complexity.” However, in the instant Specification, no technological improvement is claimed or disclosed. Therefore, further arguments related to Desjardins are moot.
The Ordered Combination Provides an Inventive Concept
The Applicant states, “Finally, should the analysis reach Step 2B, Applicant respectfully submits that the claim elements, evaluated both individually and as an ordered combination, add significantly more to the alleged abstract ideas and recite a patent-eligible inventive concept.” As the claimed and disclosed invention is not a technological improvement, the Examiner disagrees.
The Applicant states, “Here, the Office Action contains no rejections under 35 U.S.C. § § 102 or 103, but also does not identify what the courts have recognized, or those in the art would recognize, as elements that are well-understood, routine, and conventional activity in the relevant field.” In the instant rejection and the prior rejection the Examiner has included an “Additional Elements” section. Please see above.
The Applicant further states, “Also, the Office Action fails to consider whether the combination of additional elements may amount to an inventive concept.” In the instant rejection and the prior rejection the Examiner has done so. Please see #12 and #15 above.
The Applicant further states, “Consequently, because the Office Action failed to supply the requisite evidentiary support, and because the computational architecture recited by Claim 1 alters and optimizes platform operations based on measurable network conditions (API latencies) to ensure "faster processing" (Spec., para. [0115]), the amended claims recite an inventive concept.” The Examiner notes that the Applicant is arguing the benefits of applying the technology to the abstract idea.
The Applicant states, “Accordingly, by relying entirely on these sweeping bulk assertions, the Office Action completely glossed over the specific technical elements housed in the dependent claims, elements of which are now incorporated into amended independent Claim 1.” The Applicant is entitled to his opinion regarding what is required. The Examiner’s rejections have been reviewed by the PTAB several times and have been found sufficient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sethi et al Patent No.: US 11,862,305 Analyzing patient health records and providing structured patient health records for treatment and research,
Huang et al Pub. No.: US 2019/0102380 mapping clinical terminology with natural language processing
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 Neal R Sereboff whose telephone number is (571)270-1373. The examiner can normally be reached M - T, M - F 8AM - 6PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at (571)272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NEAL SEREBOFF/
Primary Examiner
Art Unit 3626
Prosecution Insights