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 the Claims
Claims 15-33 are pending and under consideration in this action. Claims 1-14 have been canceled in the preliminary amendment filed 10/24/2022.
Priority
The instant application is 371 of PCT/US2020/052112, filed 9/23/2020, which claims priority to U.S. Provisional Application number 62/904,220, filed 9/23/2019 and U.S. Provisional Application number 62/937,064, filed 11/19/2019, as reflected in the filing receipt mailed 11/21/2022. The claim for domestic benefit for claims 15-33 is acknowledged. As such, the effective filing date of claims 15-33 is 9/23/2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/23/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner.
Drawings
The drawings are objected to because of the following informalities:
The client device “112” in Fig. 1 is also referred to as the client device “208” in Para. [0058] of the specification.
Reference character “208” refers to both the client device in Para. [0058] of the specification and memory in Fig. 2.
The database “106” in Fig. 1 is also referred to as the database “206” in Para. [0059] of the specification.
Reference character “206” refers to both the database in Para. [0059] of the specification and the processor in Fig. 2.
The processor “206” in Fig. 2 is also referred to as the processor “205” in Para. [0065] of the specification.
The processor “304” in Fig. 3 is also referred to as the processor “305” in Para. [0075] of the specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because it contains reference characters. It is suggested to remove the reference characters, as design details of an apparatus should not be included in the abstract (see MPEP § 608.01(b)(I)(B)). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The use of the term “Truven (Health Analytics) MarketScan” in Para. [0049]/[0060]/[0077]/[0079] and Fig. 5A, which is a trade name or mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 15, 30 and 32 are objected to because of the following informalities:
Claims 15, 30, and 32 recite the phrase “constructing an estimator based on the statistical model” in line 15, 15, and 16 of the claims, respectively, which should be corrected to “constructing an estimator based on the statistical models” for clarity.
Appropriate correction 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 15-33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite both (1) mathematical concepts (mathematical relationships, formulas or equations, or mathematical calculations) and (2) mental processes, i.e., concepts performed in the human mind (including observations, evaluations, judgements or opinions) (see MPEP § 2106.04(a)).
Step 1:
In the instant application, claims 15-29 are directed towards a method, claims 30-31 are directed towards a manufacture, and claims 32-33 are directed towards a machine, which falls into one of the categories of statutory subject matter (Step 1: YES).
Step 2A, Prong One:
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong One). The following instant claims recite limitations that equate to one or more categories of judicial exceptions:
Claims 15, 30, and 32 recite a mathematical concept in “building a model relating elements of the unprocessed raw data”; a mental process (i.e., an evaluation of the disease spectrum in view of categories) in “partitioning a human disease spectrum into one or more categories”; a mathematical concept (i.e., the HMMs described in Para. [0009]/[0085]) in “constructing a set of statistical models representing the one or more categories”; a mathematical concept (see specification Para. [0087] for example formula) in “determining, for each of the one or more categories, a sequence likelihood defect (SLD) value”; a mathematical concept in “training a tree-based classifier based on one or more features extracted from the unprocessed raw data”; a mathematical concept in “assigning a weight to each of the one or more features based at least in part on the SLD values”; a mathematical concept in “constructing an estimator based on the statistical model and the weighted one or more features”; a mathematical concept (i.e., using cross-validation as described in Para. [0063] of the specification) in “validating the estimator”; and a mental process (i.e., evaluating the output of the model to predict disease) in “predicting a likelihood of a disease diagnosis for the at least one patient using the model based upon the received patient-specific data”.
Claims 16 and 33 recite a mental process (i.e., an evaluation of the likelihood to determine intervention) in “generating/generate one or more intervention possibilities based on the predicted likelihood”.
Claim 18 recites a mental process (i.e., an observation of the contents of the raw data) in “wherein the unprocessed raw data consists essentially of records of diagnostic codes generated during past medical encounters of the plurality of patients”.
Claim 19 recites a mathematical concept in “wherein the set of statistical models are further constructed to represent genders, a treatment cohort, and a control cohort based on the unprocessed raw data”.
Claim 20 recites a mental process (i.e., an evaluation of the disease diagnosis) in “wherein the disease diagnosis is related to Autism Spectrum Diagnosis (ASD) and is at least one of the following: Angelman Syndrome, Fragile X Syndrome, Landau-Kleffner Syndrome, Prader-Willi Syndrome, Tardive Dyskinesia, and Williams Syndrome”.
Claim 21 recites a mental process (i.e., an observation of the contents of the raw data) in “wherein the unprocessed raw data includes diagnostic history of at least some of the plurality of patients”.
Claim 22 recites a mental process (i.e., an evaluation of the likelihood prediction) in “wherein the likelihood is predicted for different cohorts of the plurality of patients at different time-points”.
Claim 23 recites a mental process (i.e., an evaluation of the likelihood prediction) in “wherein the likelihood provides one or more cues to other disorders misdiagnosed as a different disorder for the at least one patient”.
Claim 24 recites a mental process (i.e., an observation of the contents of the raw data) in “wherein the unprocessed raw data includes one or more individual diagnostic codes from prior doctor visits made by one or more of the plurality of patients”.
Claim 25 recites a mental process (i.e., an observation of the patient-specific data) in “wherein the patient-specific data includes one or more sequences of diagnostic codes from past doctor's visits by the at least one patient”.
Claim 26 recites a mental process (i.e., an evaluation of how the likelihood was predicted) in “wherein the likelihood is predicted without any new blood work for the at least one patient”.
Claim 27 recites a mathematical concept (see creation of time series in Para. [0083] of the specification) in “wherein the model further comprises a representation of each patient of the plurality of patients by a mapped trinary series to infer one or more population-level models”.
Claim 28 recites a mental process (i.e., an evaluation of the trinary series) in “wherein each of the mapped trinary series is stratified by gender, disease-category, and disease diagnosis status”.
Claim 29 recites a mental process (i.e., an evaluation of how the model was run) in “wherein each of the inferred population-level models includes a modeling of treatment and control for each gender in each disease category separately”.
Claim 31 recites a mathematical concept (see creation of time series in Para. [0083] of the specification) and a mental process (i.e., an evaluation of the trinary series and how the model was run) in “wherein the model further comprises a representation of each patient of the plurality of patients by a mapped trinary series to infer one or more population-level models, each of the mapped trinary series is stratified by gender, disease-category, and disease diagnosis status, and each of the inferred population-level models includes a modeling of treatment and control for each gender in each disease category separately”.
These recitations are similar to the concepts of collecting information, and displaying certain results of the collection and analysis is Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)), and organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) that the courts have identified as concepts that can be practically performed in the human mind or mathematical relationships.
The abstract ideas recited in the claims are evaluated under the broadest reasonable interpretation (BRI) of the claim limitations when read in light of and consistent with the specification, and are determined to be directed to mental processes that in the simplest embodiments are not too complex to practically perform in the human mind. Additionally, the recited limitations that are identified as judicial exceptions from the mathematical concepts grouping of abstract ideas are abstract ideas irrespective of whether or not the limitations are practical to perform in the human mind. The instant claims must therefore be examined further to determine whether they integrate the abstract idea into a practical application (Step 2A, Prong One: YES).
Step 2A, Prong Two:
In determining whether a claim is directed to a judicial exception, further examination is performed that analyzes if the claim recites additional elements that when examined as a whole integrates the judicial exception(s) into a practical application (MPEP § 2106.04(d)). A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claimed additional elements are analyzed to determine if the abstract idea is integrated into a practical application (MPEP § 2106.04(d)(I)). If the claim contains no additional elements beyond the abstract idea, the claim fails to integrate the abstract idea into a practical application (MPEP § 2106.04(d)(III)). The following claims recite limitations that equate to additional elements:
Claim 15 recites “a computing device”, “retrieving unprocessed raw data associated with a plurality of patients”, “generating one or more categorical time series based on the unprocessed raw data”, and “receiving patient-specific data associated with at least one patient”.
Claim 17 further recites “wherein the unprocessed raw data is received from an insurance claims database, a health records database, or both”.
Claim 30 recites “a non-transitory computer-readable medium comprising instructions”, “executed by a processor”, “retrieving unprocessed raw data associated with a plurality of patients”, “generating one or more categorical time series based on the unprocessed raw data”, and “receiving patient-specific data associated with at least one patient”.
Claim 32 recites “the apparatus comprising at least one processor in communication with at least one memory device”, “retrieve unprocessed raw data associated with a plurality of patients”, “generate one or more categorical time series based on the unprocessed raw data”, and “receive patient-specific data associated with at least one patient”
Regarding the above cited limitations in claims 15, 17, 30, and 32 of (i) retrieving/retrieve unprocessed raw data associated with a plurality of patients (claims 15, 30, and 32); (ii) generating/generate one or more categorical time series based on the unprocessed raw data (claims 15, 30, and 32); (iii) receiving/receive patient-specific data associated with at least one patient (claims 15, 30, and 32); and (iv) wherein the unprocessed raw data is received from an insurance claims database, a health records database, or both (claim 17). These limitations equate to insignificant, extra-solution activity of mere data gathering because these limitations gather data before or after the recited judicial exceptions of using the model to predict a likelihood of a disease diagnosis (see MPEP § 2106.04(d)).
Regarding the above cited limitations in claims 15, 30, and 32 of (v) a computing device (claim 15); (vi) a non-transitory computer-readable medium comprising instructions (claim 30); and (vii) the apparatus comprising at least one processor in communication with at least one memory device (claim 32). These limitations require only a generic computer component, which does not improve computer technology. Therefore, these limitations equate to mere instructions to implement an abstract idea on a generic computer, which the courts have established does not render an abstract idea eligible in Alice Corp. 573 U.S. at 223, 110 USPQ2d at 1983. As such, claims 15-33 are directed to an abstract idea (Step 2A, Prong Two: NO).
Step 2B:
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that equate to well-understood, routine and conventional (WURC) limitations (MPEP § 2106.05(d)). The instant claims recite same additional elements described in Step 2A, Prong Two above.
Regarding the above cited limitations in claims 15, 17, 30, and 32 of (i) retrieving/retrieve unprocessed raw data associated with a plurality of patients (claims 15, 30, and 32); (iii) receiving/receive patient-specific data associated with at least one patient (claims 15, 30, and 32); and (iv) wherein the unprocessed raw data is received from an insurance claims database, a health records database, or both (claim 17). These limitations equate to receiving/transmitting data over a network, which the courts have established as a WURC limitation of a generic computer in buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014).
Regarding the above cited limitations in claims 15, 30, and 32 of (v) a computing device (claim 15); (vi) a non-transitory computer-readable medium comprising instructions (claim 30); and (vii) the apparatus comprising at least one processor in communication with at least one memory device (claim 32). These limitations equate to instructions to implement an abstract idea on a generic computing environment, which the courts have established does not provide an inventive concept (see MPEP § 2106.05(d) and MPEP § 2106.05(f)).
Regarding the above cited limitations in claims 15, 30, and 32 of (ii) generating/generate one or more categorical time series based on the unprocessed raw data. This limitation is considered to be insignificant extra-solution activity of mere data gathering. This step is incidental to the primary process of using the model to predict a likelihood of a disease diagnosis, wherein generated time series data are merely inputs for the prediction model (see MPEP § 2106.05(g)).
These additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the instant claims do not amount to significantly more than the judicial exception itself (Step 2B: NO). As such, claims 15-33 are not patent eligible.
Conclusion
No claims allowed.
Claims 15-33 are free from the prior art because the prior art does not fairly suggest or teach the determination of a sequence likelihood defect (SLD) value, and subsequent use of the SLD in assigning weights to features from a tree-based classifier or construction/validation of an estimator based on the SLD weighted features. The closest prior art is Vaughn et al. (U.S. Patent Application Publication 2017/0069216; cited in the IDS dated 3/23/2022). Vaughn et al. discloses a method of diagnosing a subject at risk of having a developmental disorder, including receiving subject data, training a decision-tree based machine learning model, weighing features, validating the model, and predicting the risk of disorder diagnosis. However, Vaughn et al. does not teach determining, for each of the one or more categories, an SLD value or assigning a weight to each of the one or more features based at least in part on the SLD values, as disclosed in instant claims 15, 30, and 32. Claims 16-29, 31, and 33 are free from the prior art due to their dependency on claims 15, 30 and 32.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANA P SANFORD whose telephone number is (571)272-6504. The examiner can normally be reached Mon-Fri 8am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karlheinz Skowronek can be reached at (571)272-9047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.P.S./Examiner, Art Unit 1687
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687