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
Status of the Application
Claims 1-20 are currently pending in this case and have been examined and addressed below. This communication is a Final Rejection in response to the Amendments to the Claims and Remarks filed on 06/26/2026.
Claims 1, 6, 8, 13-14, and 19 are currently amended.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 6, 13, and 19 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.
The term “frequently occurring” in claims 6, 13, and 19 is a relative term which renders the claim indefinite. The term “frequently occurring” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what magnitude of occurrences of indications of concepts are required to be frequently occurring. Therefore, the claim is indefinite.
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 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1-7 fall within the statutory category of an apparatus or system. Claims 8-13 fall within the statutory category of an article of manufacture as a computer-readable medium. Claims 14-20 fall within the statutory category of a process.
Step 2A, Prong One
As per Claims 1, 8, and 14, the limitations of determining, based on a condition care program associated with the clinical decision support event, a set of conditions associated with the clinical decision support event; creating a dynamic assessment that includes at least one question having an order characteristic dependent on a response to a prior question, wherein creating the dynamic assessment comprises determining the question and the order characteristic, based on one or more clinical concepts and the clinical decision support event, and assembling the at least one question into the dynamic assessment and contextualizing the dynamic assessment based on the particular condition; converting the supplemental information and/or the non-coded clinical format data element to the coded clinical format by codifying each of one or more question answer pairs associated with the supplemental information as a single concept of a clinical nomenclature, such that the codified question answer pairs are consumable by the condition care program, and deriving one or more new clinical concept relationships between the codified question-answer pairs and the set of conditions; dynamically updating, based on the new clinical concept relationships and the supplemental information and/or the non-coded clinical format data element in the coded clinical format, the first set of risk factors with a second set of risk factors corresponding to the set of conditions; and generating an order for a particular treatment procedure to be administered to the target patient in association with treating the particular condition based at least partially on the second set of risk factors corresponding to the set of conditions, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. The steps of determining a set of conditions associated with the clinical decision support event, creating a dynamic assessment comprising determining the question and the order characteristic, and assembling the at least one question into the dynamic assessment and contextualizing the dynamic assessment based on the particular condition, converting the supplemental information to the coded clinical format by codifying question answer pairs as a single concept and deriving new clinical concept relationships, dynamically updating the first set of risk factors with a second set of risk factors corresponding to the set of conditions, and generating an order for a particular treatment are concepts performed including observation, evaluation, judgement and opinion in the human mind. The determining, converting, and updating steps are recited broadly such that they can be performed in any manner and such can be performed as a mental process. If a claim limitation, under its broadest reasonable interpretation, covers the 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 claims recite an abstract idea.
Step 2A, Prong Two
The judicial exception is not integrated into a practical application because the additional elements and combination of additional elements do not impose meaningful limits on the judicial exception. In particular, the claims recite the additional elements:
system having hardware processors (claim 1), where the hardware processors are recited at a high-level of generality, such that it amounts to no more than mere instructions to apply the exception using a generic computer component.
non-transitory media having computer-readable instructions executed by hardware processors (claim 8), where the non-transitory media having computer-readable instructions are recited at a high-level of generality, such that it amounts to no more than mere instructions to apply the exception using a generic computer component.
storing a set of clinical information in a coded clinical format relating to a particular condition of a target patient in one or more network-based storage devices having a collection of medical records stored thereon, wherein the set of clinical information includes (a) an initial preliminary likelihood associated with a clinical decision support 4vent and (b) first set of risk factors associated with the clinical decision support event, which amounts to mere instructions to apply the exception because the use of a general purpose computer, i.e. the processor, in its ordinary capacity for tasks such as receiving, storing, transmitting data does not integrate the abstract idea into a practical application, as per MPEP 2106.05(f)(2). The description of the clinical information is not function but merely description and does not integrate the abstract idea into a practical application.
incorporating the codified question-answer pairs into a mapped content repository of an ontology framework comprising a contextual ontology associated with a particular condition which, as described by the specification in [0194] amounts to incorporating the data into mapped health information for future use. This amounts to storing data in a repository which amounts to mere instructions to apply the exception because the use of a general purpose computer, i.e. the processor, in its ordinary capacity for tasks such as receiving, storing, transmitting data does not integrate the abstract idea into a practical application, as per MPEP 2106.05(f)(2).
use of a first software agent collaborating with a second software agent to carry out the abstract idea and use of an ontology framework to execute the steps of the abstract idea including deriving new clinical concept relationships, which generally links the use of the abstract idea to a particular technological environment or field of use. As per MPEP 2106.05(h), limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application. The first and second software agents are described in the specification at a high-level of generality as software routines ([0004]). The specification further describes the use of agents in a multi-agent system providing enhanced decision support by using collaboration among other properties ([0070]). Enhanced decision support is not a technical improvement, but rather an improvement to the abstract idea itself. The specification does not provide a clear description of what improvement over prior systems is provided by this particular technical architecture as the specification provides for a high-level description of many types of architectures with many options of agents and many possible advantages. The ontology framework is not specifically described or define in the specification beyond framework services which are discussed at a high-level of generality such as BigData platforms operable for providing a distributed file system and cloud based services such as Cerner Healthe Intent ([0040]). These are merely examples of the technological environment in which the abstract idea is applied.
receiving supplemental information associated with the target patient and the set of conditions via the dynamic assessment, the supplemental information corresponding to at least one clinical concept in a non-coded clinical format data element which amounts to insignificant extra-solution activity, as in MPEP 2106.05(g), because the steps of receiving supplemental information associated with the target patient and the set of conditions is mere data gathering in conjunction with the abstract idea where the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output).
providing the one or more new clinical concept relationships to the condition care program amounts to insignificant extra-solution activity, as in MPEP 2106.05(g), because the steps of providing the relationships to the condition care program is mere data outputting in conjunction with the abstract idea where the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output).
Because the additional elements do not impose meaningful limitations on the judicial exception, the claim is directed to an abstract idea.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. As discussed above with the respect to integration of the abstract idea into a practical application, the additional element of a system having hardware processors and non-transitory media having computer-readable instructions executed by hardware processors to perform the method of the invention amounts to no more than mere instructions to apply the exception using a generic computing component. The hardware processors and non-transitory media are recited at a high level of generality and are not specified beyond the high-level computing components recited in the claims, which do not add meaningful limitations to the abstract idea beyond mere instructions to apply an exception. The claims also recite the additional element of storing a set of clinical information in a coded clinical format relating to a particular condition of a target patient in one or more network-based storage devices having a collection of medical records stored thereon and also incorporating the codified question-answer pairs into a mapped content repository of an ontology framework comprising a contextual ontology associated with a particular condition, which are well-understood, routine and conventional computer functions in the field of data management because they are claimed at a high level of generality and include storing and retrieving information from memory, which has been found to be well-understood, routine and conventional computer functions by the Court (MPEP 2106.05(d)(II)(iv) Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claims recite the additional elements of use of a first software agent collaborating with a second software agent and use of an ontology framework to execute the abstract idea which does not meaningfully limit the claim, similar to MPEP 2106.05(h) (vii) Language specifying that the abstract idea of budgeting was to be implemented using a "communication medium" that broadly included the Internet and telephone networks, because this limitation merely limited the use of the exception to a particular technological environment, Intellectual Ventures I v. Capital One Bank, 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1640 (Fed. Cir. 2015), (ix) Specifying that the abstract idea of using advertising as currency is used on the Internet, because this narrowing limitation is merely an attempt to limit the use of the abstract idea to a particular technological environment, Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716, 112 USPQ2d 1750, 1755 (Fed. Cir. 2014). The claims also include the additional element of receiving supplemental information associated with the target patient and the set of conditions and providing the one or more new clinical concept relationships to the condition care program which are well-understood, routine and conventional computer functions in the field of data management because they are claimed at a high level of generality and include receiving or transmitting data as well, which have been found to be well-understood, routine and conventional computer functions by the Court (MPEP 2106.05(d)(II)(i) Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); 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); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added). 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 the computer or improves another technology. The claims do not amount to significantly more than the underlying abstract idea.
Dependent Claims
Dependent Claims 2-7, 9-13, and 15-20 add further limitations which are also directed to an abstract idea. For example, Claims 2, 9, and 15 include automatically generating an updated preliminary likelihood of the clinical decision support event which is directed to a mental process for the same reasons as the independent claims. Claims 3, 10, and 16 include transmitting an electronic encoded signal to a clinician interface of a clinician device which amounts to transmitting data which is mere instructions to apply the exception, and also display the updated likelihood which is mere data outputting that is insignificant extra-solution activity which is well-understood, routine, and conventional similar to presenting offers. Claims 4, 11, and 17 include directing a message to a clinician which amounts to transmitting data which is mere instructions to apply the exception. Claims 5, 12, and 18 include electronically writing content corresponding to the non-coded clinical format data element in the collection of medical records in the coded clinical format which is storing data in a database, which as per MPEP 2106.05(f)(2) is mere instructions to apply the exception. Claims 6-7, 13, and 19-20 include a description of data which is not a functional step and is therefore directed to the same abstract idea as the independent claims. Because the additional elements do not impose meaningful limitations on the judicial exception and the additional elements are well-understood, routine and conventional functionalities in the art, the claims are directed to an abstract idea and are not patent eligible.
Response to Arguments
Applicant’s arguments, see Pages 9-12, “Rejections Under 35 U.S.C. 101”, filed 06/26/2026 with respect to claims 1-20 have been fully considered but they are not persuasive.
Applicant argues that the claims of the present application do not recite a Mental Process because the operations of the claim cannot reasonably be performed in the human mind. Specifically, Applicant argues that the claims utilize a complex orchestration of computer and network technology functions that could not practically be performed by a human mind without the aid of a computer. Examiner respectfully disagrees. The claims recites the steps of determining a set of conditions associated with the clinical decision support event, creating a dynamic assessment that includes a question having an order characteristic dependent on a response to a prior question including determining the question and the order characteristic and assembling the question into the dynamic assessment and contextualizing the dynamic assessment, converting the supplemental information and/or non-coded clinical format data element to the coded clinical format by codifying each question answer pairs as a single concept of a clinical nomenclature, deriving new clinical concept relationships between the codified question answer pairs and the set of conditions, updating the first set of risk factors with a second set of risk factors, and generating an order for a particular treatment procedure to be administered to the target patient. These steps can be performed using human mental observation, evaluation, judgment, and opinion. Although the claims recited these as being executed by a combination of computer and network technology, applying these steps to the use of general purpose computer components amounts to mere instructions to apply the exception. The use of computers does not stop the functional steps from falling into the abstract idea of mental processes.
Applicant argues that the present claims integrate the abstract idea into a practical application because the claims recite a specific computer architecture of differentiated collaborating software agents, a specific data-interoperability and data-architecture improvement, and a concrete clinical output keyed to the technical operations. Examiner is not persuaded that the claims recite a computer architecture that provides a technical improvement over prior systems sufficient to integrate the abstract idea into a practical application. The claims recite a first software agent collaborating with a second software agent to carry out the abstract idea. As per the rejection above, the use of a first agent collaborating with a second agent to carry out the abstract idea generally links the abstract idea to the technological environment of field of use. The software agents are recited at a high-level of generality such as a software routine, and the use of more than one software program together to carry out computer functionality is merely the technological environment which is applied to the abstract idea. The specification does not provide a technological improvement that is achieved based on the use of two software routines together. The specification merely recites that the agents provide enhanced decision support ([0070]). Therefore, the claim is not integrated into a practical application or provide significantly more than the abstract idea.
Applicant’s arguments, see Page 12, “Rejections Under 35 U.S.C. 103”, filed 06/26/2026 with respect to claims 1-20 have been fully considered and they are persuasive. The cited references do not teach the specific combination of all of the elements in Claims 1, 8, and 14. Therefore, the rejections have been withdrawn.
Applicant’s arguments, see Page 13, “Rejections Under 35 U.S.C. 112(a)”, filed 06/26/2026 with respect to claims 1-20 have been fully considered and they are persuasive. Therefore, the rejection of 02/27/2026 has been withdrawn.
Applicant’s arguments, see Page 13, “Rejections Under 35 U.S.C. 112(b)”, filed 06/26/2026 with respect to claims 6, 13, and 19 have been fully considered but they are not persuasive. Applicant traverses the rejections and argues that the claims have been amended such that the rejection is overcome. Examiner respectfully disagrees. The claims have been amended to read “frequently occurring”. The term “frequently” is still indefinite, as it is unclear what magnitude of occurrences of indications of concepts are required to be frequently occurring.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Huyn et al. (US 2002/0035486 A1) teaches a clinical questionnaire system which presents medical questions and based on the responses, determines the next questions to present. Question and response pairs are weighted to allow for more precise evaluation of symptoms.
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 Evangeline Barr whose telephone number is (571)272-0369. The examiner can normally be reached Monday to Friday 8:00 am to 4:00 pm.
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/EVANGELINE BARR/Primary Examiner, Art Unit 3682
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