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 Application
This action is in reply to the correspondence received through December 17, 2025.
Claims 15, 16, and 18 are cancelled.
Claims 21-23 are new.
Claims 1-14, 17, and 19-23 are pending.
Information Disclosure Statement
The information disclosure statement submitted February 22, 2024 and its contents have been considered.
Claim Rejections - 35 U.S.C. § 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 1-14, 17, and 19-23 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to non-statutory subject matter. Claims 1-20 are directed to an abstract idea without significantly more as required by the Alice test as discussed below.
Step 1
Claims 1-14, 17, and 19-23 are directed to a process, machine, manufacture, or composition of matter.
Step 2A
Claims 1-14, 17, and 19-23 are directed to abstract ideas, as explained below.
Prong one of the Step 2A analysis requires identifying the specific limitation(s) in the claim under examination that the examiner believes recites an abstract idea; and determining whether the identified limitation(s) falls within at least one of the groupings of abstract ideas of mathematical concepts, mental processes, and certain methods of organizing human activity.
The claims recite the following limitations that are directed to abstract ideas. Claim 1 recites receiving, from a user of a health management application on a user device, a search query requesting a search for biological information specific to a patient; accessing a health profile of a patient storing biomarkers determined for the patient based on biosignals collected for the patient over a given time period; searching one or more hierarchical data structures to identify one or more health parameters related to the search query, each hierarchical data structure comprising a plurality of nodes organized into one or more levels of a biological ontology related to the search query, wherein each node corresponds to a health parameter belonging to the biological ontology; determining measurements for one or more biomarkers stored within the health profile of the patient corresponding to the one or more identified health parameters; generating a set of search results for the search query comprising the identified one or more health parameters related to the search query and determined measurements corresponding to each health parameter. Claims 11 and 20 recite similar features as claim 1. Claims 2-10, 12, 14-, 17, 19, and 21-23 further specify features of the algorithms identified abstract ideas or characteristics of the data used thereby.
These limitations describe abstract ideas that correspond to concepts identified as abstract ideas by the courts as mental processes—such as concepts performed in the human mind (including an observation, evaluation, judgment, or opinion)—because the claimed features identified above are concepts performed in the human mind (including an observation, evaluation, judgment, or opinion).
These limitations describe abstract ideas that correspond to concepts identified as abstract ideas by the courts as certain methods of organizing human activity—such as fundamental economic principles or practices (including hedging, insurance, mitigating risk), commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations), managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions)—claimed features identified above manage personal behavior or relationships or interactions between people including following rules or instructions.
Thus, the concepts set forth in claims 1-14, 17, and 19-23 recite abstract ideas.
Prong two of the Step 2A requires identifying whether there are any additional elements recited in the claim beyond the judicial exception(s), and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. “Integration into a practical application” requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception. Further, “integration into a practical application” uses the considerations laid out by the Supreme Court and the Federal Circuit to evaluate whether the judicial exception is integrated into a practical application, such as considerations discussed in M.P.E.P. § 2106.05(a)-(h).
The claims recite the following additional elements beyond those identified above as being directed to an abstract idea. Claim 1 recites a health management application on a user device and transmitting for display via a graphical user interface search results to the user device. Claim 11 recites similar features as claim 1 and further recites a non-transitory computer-readable storage medium and a processor. Claim 20 recites similar features as claims 1 and 11 and further recites a wearable sensor. Claim 21 recites accessing information from the wearable sensor and a client device. Several dependent claims recite that other information is displayed via the graphical user interface (e.g., generating a visualization of claim 23).
The identified judicial exception(s) are not integrated into a practical application for the following reasons.
First, evaluated individually, the additional elements do not integrate the identified abstract ideas into a practical application. The additional computer elements identified above—the application, user/client device, non-transitory computer-readable storage medium, processor, and wearable sensor—are recited at a high level of generality. Inclusion of these elements amounts to mere instructions to implement the identified abstract ideas on a computer. See M.P.E.P. § 2106.05(f). The use of conventional computer elements to access information or transmit for display via a graphical user interface search results to the user device (e.g., generating a visualization) is the insignificant, extra-solution activity of mere data gathering or outputting in conjunction with a law of nature or abstract idea. See M.P.E.P. § 2106.05(g). To the extent that the claims transform data, the mere manipulation of data is not a transformation. See M.P.E.P. § 2106.05(c). Inclusion of computing system in the claims amounts to generally linking the use of the judicial exception to a particular technological environment or field of use. See M.P.E.P. § 2106.05(h). Thus, taken alone, the additional elements do not amount to significantly more than a judicial exception.
Second, evaluating the claim 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. See M.P.E.P. § 2106.05(a). Their collective functions merely provide an implementation of the identified abstract ideas on a computer system in the general field of use of searching biological information. See M.P.E.P. § 2106.05(h).
Thus, claims 1-14, 17, and 19-23 recite mathematical concepts, mental processes, or certain methods of organizing human activity without including additional elements that integrate the exception into a practical application of the exception.
Accordingly, claims 1-14, 17, and 19-23 are directed to abstract ideas.
Step 2B
Claims 1-14, 17, and 19-23 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.
The analysis above describes how the claims recite the additional elements beyond those identified above as being directed to an abstract idea, as well as why identified judicial exception(s) are not integrated into a practical application. These findings are hereby incorporated into the analysis of the additional elements when considered both individually and in combination. Additional features of these analyses are discussed below.
Evaluated individually, the additional elements do not amount to significantly more than a judicial exception. In addition to the factors discussed regarding Step 2A, prong two, these additional computer elements also provide conventional computer functions that do not add meaningful limits to practicing the abstract idea. Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. The use of generic computer components to access information or transmit for display via a graphical user interface search results to the user device (e.g., generating a visualization) is the well-understood, routine, and conventional computer functions of receiving or transmitting data over a network, e.g., the Internet, and does not impose any meaningful limit on the computer implementation of the identified abstract ideas. See M.P.E.P. § 2106.05(d)(II). Thus, taken alone, the additional elements do not amount to significantly more than a judicial exception.
Evaluating the claim limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. In addition to the factors discussed regarding Step 2A, prong two, there is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely amount to mere instructions to implement the identified abstract ideas on a computer.
Thus, claims 1-14, 17, and 19-23, taken individually and as an ordered combination of elements, are not directed to eligible subject matter since they are directed to an abstract idea without significantly more.
Statement Regarding the Prior Art
The independent claims recite features for receiving, from a user of a health management application on a user device, a search query requesting a search for biological information specific to a patient; accessing, through the health management application, a health profile of a patient storing biomarkers determined for the patient based on biosignals collected for the patient over a given time period; searching, by the health management application, one or more hierarchical data structures to identify one or more health parameters related to the search query, each hierarchical data structure comprising a plurality of nodes organized into one or more levels of a biological ontology related to the search query, wherein each node corresponds to a health parameter belonging to the biological ontology; determining, by the health management application, measurements for one or more biomarkers stored within the health profile of the patient corresponding to the one or more identified health parameters; and generating a set of search results for the search query comprising the identified one or more health parameters related to the search query and determined measurements corresponding to each health parameter..
Leighton (U.S. Pub. No. 2011/0047169 A1) discloses a scalable infrastructure for searching multiple disparate textual databases by mapping their contents onto a structured ontology, e.g., of medical concepts. This framework can be leveraged against any database where free-text attributes are used to describe the constituent records. In Leighton, an information retrieval method begins in a first step by processing the free-text associated with various types of source data (e.g., clinical narrative from an electronic health record, a description of condition and treatment associated with a clinical assay, etc.) and mapping that text onto UMLS, which is a hierarchical representation of medical knowledge. A hierarchical structure of the UMLS ontology (an index) is then created such that references to the data records processed during the first step are stored at the vertices of this index. This data structure supports efficient lookups of records that match a concept of any of its subordinates. To that end, preferably a system that implements this approach provides a Simple Object Access Protocol (SOAP) interface (or the like) that allows Web 2.0 applications to query the index. Preferably, search queries are likewise mapped onto UMLS in the same manner so that the system can search for relevant documents in the structured space. In this manner, multiple synonymous terms that appear in both source documents and queries are mapped onto the same structured ontology. However, Leighton does not disclose the features recited in the independent claims.
Jung et al. (U.S. Pub. No. 2018/0095969 A1) teaches techniques for capturing, integrating, organizing, navigating and querying large-scale data from high-throughput biological and chemical assay platforms. It provides a meta-analysis infrastructure for performing research queries across a large number of studies and experiments from different biological and chemical assays, data types and organisms, as well as systems to build and add to such an infrastructure. Jung also teaches interfaces for identifying genes that are potentially associated with a biological, chemical or medical concept of interest. However, Jung does not teach the features recited in the independent claims.
Janevski et al. (U.S. Pub. No. 2011/0077964 A1) teaches systems for effective diagnosis of patients and assisting clinicians in treatment planning. In particular, invention provides a medical analysis system that enables refinement of molecular classification. The system provides a molecular profiling solution that will allow improved diagnosis, prognosis, response prediction to provide the right chemotherapy, and follow-up to monitor for cancer recurrence. These techniques include use of a Gene Ontology (GO), which is a controlled vocabulary of terms organized as acyclic directed graphs. This ontology is split into three related ontologies covering basic areas of molecular biology: the molecular function of gene products, their role in multi-step biological processes, and their localization to cellular components. Researchers worldwide annotate gene products, i.e., characterize gene products using terms from the ontology, and submit them to the GO project to be included in gene annotation files. In a gene annotation file, each annotation is an association of a single gene product with a single GO term. A gene product can be annotated by terms indicating the cellular components it is located in, its molecular functions, and the biological processes it participates in. However, Janevski does not teach the features recited in the independent claims.
Heuttner et al. (U.S. Pub. No. 2022/0148679 A1) and Becker et al. (“From heterogeneous healthcare data to disease-specific biomarker networks: A hierarchical Bayesian network approach.” PLOS Computational Biology 17.2 (2021)) has been cited to further show the state of the art regarding searching biological information.
The closest art of record, including the combination of references discussed above, fails to teach, suggest, or render obvious each and every element of the claims as arranged in the claims. Further, one of ordinary skill in the art at the time of invention would not look to combine these references, or the other art of record, to arrive at the present claims.
Response to Arguments
The arguments submitted with the Reply have been fully considered but are not persuasive.
Applicant argues that “the pending claims are not directed to organizing human activity or a mental process” by characterizing “(i) identifying text matches […] (ii) traversing a hierarchical ontology structure […] and (iii) returning and displaying parameter measurements/ranges/trends” as “concrete technological steps.” Reply, p. 9. Applicant relies on similar assertions when presenting similar arguments regarding the identification of the claims as directed to organizing human activity or a mental process; that the information represented is a “concrete mechanism;” and that the types of data represented in new claims 21-23 are additional elements. Reply, pp. 9-12.
Examiner disagrees. Features (i) and (ii) are concepts directed to abstract ideas—not a particular technology or technological field. For example, these features correspond to generating a graph (e.g., one having 4 nodes corresponding to the required information) and inspecting to retrieve information from it. There is nothing technological about this mental process; a computer is certainly not required to implement these knowledge organizing techniques. Instead, the “ontology”—as represented by a graph—is an organized collection of data that demonstrates certain biological relationships in a manner completely divorced from technology. And although feature (iii) includes displaying information, the rejections explain why this additional element is insufficient to demonstrate a practical application or significantly more under the Alice test.
Similarly, the features of new claims 21-23 (aside from those features identified by the rejections as additional elements) are also directed to abstract ideas. To the extent that the claims transform data, the mere manipulation of data is not a transformation. See M.P.E.P. § 2106.05(c). Again, there is nothing technological about this mental process; a computer is certainly not required to implement these knowledge organizing techniques.
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 Christopher Tokarczyk, whose telephone number is 571-272-9594. The examiner can normally be reached Monday-Thursday between 6:00 AM and 4:00 PM Eastern.
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/CHRISTOPHER B TOKARCZYK/ Primary Examiner, Art Unit 3687