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
The status of the claims as of the response filed 6/24/2026 is as follows: Claims 2-3 and 7-8 remain cancelled. Claim 1 is currently amended. Claims 4-6, 9-12, 14, 16-23, and 25 are as previously presented. Claims 13, 15, and 24 are original. Claims 1, 4-6, and 9-25 are currently pending in the application and have been considered below. The corresponding Remarks have been fully considered by the Examiner.
Response to Arguments
Rejection Under 35 USC 101
On pages 10-11 of the response Applicant argues that amended independent claim 1 “recites a specific technical solution to a problem in medical informatics,” namely the lack of universal outcome measures and uncertainty of evaluating treatments as identified in the specification. Applicant further asserts that “claim 1 addresses this technical problem by reciting a specific data-processing architecture that integrates heterogenous medical data from multiple structured electronic databases to objectively evaluate treatment provider effectiveness” with limitations that “define a structured computational architecture that processes heterogeneous medical data sources provided on varying scales in a manner that imposes meaningful limits on any alleged abstract idea.” Applicant further submits that claim 1 “describe[s] a specific way to solve the problem of evaluating treatment provider effectiveness, rather than merely claiming the idea of a solution or outcome” and thus “provides a particular solution to the technical problem of objectively evaluating treatment provider effectiveness using disparate healthcare data.”
Applicant’s arguments are fully considered, but are not persuasive. Examiner respectfully disagrees that a lack of universal health outcome measures and uncertainty in medical decision-making are technical problems as Applicant alleges; the cited portions of the specification explain drawbacks with current business or administrative practices of evaluating quality and effectiveness of clinical providers (see [0003]). Examiner notes that soliciting questionnaire feedback from patients and then analyzing and correlating data from the questionnaires and other clinical recordkeeping sources to derive new metrics for evaluating quality and effectiveness of clinical providers is not a technical improvement to a computer or other technical field, and are instead part of the abstract idea itself, as explained in previous Office actions as well as in the updated 35 USC 101 rejections below. Because these functions are part of the abstract idea itself, they do not amount to a technological improvement or practical application and thus do not confer eligibility (see MPEP 2106.05(a): “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements.” See also 2106.05(a)(II): “it is important to keep in mind that an improvement in the abstract idea itself… is not an improvement in technology.”). The fact that such abstract processes are being carried out in an electronic computing environment (e.g. with a server and electronic databases) does not provide an improvement to a computer or other technical field, and instead merely apply the abstract clinical data evaluation and quality benchmarking steps such that they are automated and/or digitized by using the computer as a tool (see MPEP 2106.05(f)).
On page 11 Applicant argues that the steps of claim 1 could not be performed by a human actor managing their personal behavior and interactions with others because they recite “a specific data-processing pipeline that requires iterative processing ‘for each treatment provider of a plurality of providers’” which is a “closed-loop, rule-based processing across multiple indexed databases [that] reflects a technological data-evaluation system rather than a fundamental human activity.” Applicant’s arguments are fully considered, but are not persuasive. Examiner maintains that a human actor could manage their personal behavior and/or interactions with others to perform the recited data processing/ analysis steps in an iterative manner for each of a plurality of clinical treatment providers as part of an abstract clinical quality analytics management operation. For example, a person could determine a plurality of effectiveness indicators for multiple treatments (e.g. by making determinations or judgements about metrics from patient questionnaires), aggregate those indicators into a provider-level effectiveness score (e.g. by mathematically combining different indicators into an overall score for a provider), comparing the score to a predetermined threshold (e.g. by judging whether the score is higher or lower than a given threshold), and generating and providing a notification when the threshold condition is met (e.g. by writing up and sending a report and/or speaking with an administrator colleague about a given provider whose overall score did not satisfy the threshold). The performance of such steps in an automated manner by a server does not preclude the claim from reciting an abstract idea, and instead are evaluated as additional elements under Steps 2B – Prong 2 and 2B. In the instant case, the server automation is invoked as a tool with which to digitize and/or automate the otherwise-abstract functions such that they occur in a computing environment and thus do not provide integration into a practical application or significantly more than the abstract idea itself.
On pages 11-12 Applicant argues that the amended normalization step “addresses a technical interoperability problem in medical informatics” by permitting computed wellness scores to “be more easily compared and understood.” Applicant analogizes this subject matter to that found eligible in Example 42, submitting that “the correlation of EMR-extracted outcome measurements with improvement scores generates new derived metrics that did not previously exist in the underlying databases, representing a defined technical workflow that produces machine-derived data structures.” Applicant’s arguments are fully considered, but are not persuasive. The present claims differ from those of Example 42 at least because they do not provide remote format standardization with updated messaging capabilities; in Example 42, the crux of the invention was a technical improvement related to specific formatting conversions and remote accessibility. Normalizing a score to a common scale so that it may be easily compared with other scores is an abstract numerical conversion process that a human actor could undertake in the course of performing administrative clinical effectiveness evaluations of medical providers (e.g. by converting scores on a 1-10 scale to a 1-100 scale by multiplying the scores by 10), and does not represent a technical formatting conversion between different computerized file formats for the purposes of technical interoperability and remote accessibility as in Example 42. Because this feature is part of the abstract idea itself, it does not provide an improvement to a computer or other technical field, as explained above.
On page 12 Applicant argues that “automatic generation and provision of a notification to a treatment facility administrator when a computed effectiveness score falls below a predetermined threshold demonstrates a practical application in which computed data directly triggers machine-executed administrative action.” Applicant’s arguments are fully considered, but are not persuasive. Examiner maintains that the function of generating and providing a notification to a treatment facility administrator when a computed effectiveness score falls below a predetermined threshold is part of the abstract idea itself, because it describes steps that a human actor managing their personal behavior and interactions with another person (e.g. an administrator colleague) could achieve. For example, a person could make a determination that a certain treatment provider has not met a quality threshold and write up and hand over a report to an administrator colleague to notify them that the provider has not satisfied the performance metric, or otherwise communicate this performance review information to the administrator (e.g. by speaking with them directly). The performance of this function in an automated manner by a server amounts to instructions to apply the exception because it merely digitizes this otherwise-abstract administrative data sharing/notification step such that it occurs in an electronic environment.
For the reasons outlined above, the 35 USC 101 rejections are upheld for claims 1, 4-6, and 9-25.
Priority
Applicant’s claim of priority to provisional patent applications 62/929766, 62/308107, and 62/376829 are acknowledged by virtue of this application’s status as a continuation of US patent application 15/427962 (now Pat. No. 11355247). However, Applicant has not complied with one or more conditions for receiving the benefit of the earlier filing dates of some of these provisional applications as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 62/929766 and 62/308107 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. For example, the ‘766 and ‘107 provisional applications do not disclose the following limitations of amended claim 1:
comparing, by the server, the effectiveness score for the treatment provider to a predetermined threshold; and
upon determining that the effectiveness score is below the predetermined threshold, automatically generating and providing, by the server, a notification to a treatment facility administrator.
The ‘766 and ‘107 applications make no mention of comparing effectiveness scores of a treatment provider to a threshold, nor of providing notifications to an administrator. However, these functions do appear to be broadly supported by at least para. [000102] of the ‘829 provisional application.
The disclosure of the prior-filed applications, Application Nos. 62/929766, 62/308107, and 62/376829 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. For example, the ‘766, ‘107, and ‘829 provisional applications do not disclose the following limitations of amended claim 1:
normalizing, by the server, the post-treatment score to a normalized scale, wherein the post-treatment score is computed on a first scale determined by the one or more scoring procedures, and wherein normalizing the post-treatment score comprises converting the post-treatment score from the first scale to a standardized scale to enable comparison with scores computed using different scoring procedures having different native scales, thereby generating a normalized post-treatment score; and
determining, by the server, an improvement score for the patient’s medical condition using the pretreatment score and the normalized post-treatment score.
The ‘766, ‘107, and ‘829 applications make no mention of normalizing post-treatment scores prior to determining an improvement score in the specific manner recited, nor of determining an improvement score specifically based on a pretreatment score and a normalized post-treatment score. However, these functions do appear to be broadly supported by at least paras. [00016] & [000187] of parent case 15/427962. Accordingly, claims 1, 4-6, and 9-25 are afforded the effective filing date of the ‘962 application: 2/8/2017.
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, 4-6, and 9-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
In the instant case, claims 1, 4-6, and 9-25 are directed to a method (i.e. a process) and thus each of the claims falls within one of the four statutory categories. Nevertheless, the claims fall within the judicial exception of an abstract idea.
Step 2A – Prong 1
Independent claim 1 recites steps that, under their broadest reasonable interpretations and but for the recitation of generic computer components, describe certain methods of organizing human activity such as selecting and distributing medical surveys to elicit patient feedback and facilitate reporting follow-up care metrics, which falls into the category of managing personal behavior, relationships, or interactions between people. That is, other than reciting that the method is “computer-implemented” and performed “by a server,” nothing in the claim limitations preclude the steps from occurring as a method of organizing human activity among multiple human actors. Specifically, the claim recites:
accessing, by a server, a pretreatment score database to retrieve a pretreatment score for a medical condition of a patient, the pretreatment score assessing one or more aspects of the medical condition of the patient prior to the patient receiving a treatment for the medical condition;
receiving, by the server, an indication of a scheduling of performance of the treatment for the patient prior to receipt of the pretreatment score;
determining, by the server, a pretreatment medical questionnaire to provide to the patient prior to performance of the treatment;
facilitating, by the server, provision of the pretreatment medical questionnaire to the patient prior to receipt of the pretreatment score
facilitating, by the server, provision of a medical questionnaire to the patient following the patient receiving the treatment for the medical condition provided by a treatment provider, the medical questionnaire being associated with one or more scoring procedures stored in a scoring-procedures database and indexed to the medical questionnaire;
receiving, by the server, responses to the medical questionnaire from the patient, the responses indicating a state of the medical condition following the treatment;
accessing, by the server, the scoring-procedures database to retrieve the one or more scoring procedures indexed to the medical questionnaire;
evaluating, by the server, the received responses using the retrieved one or more scoring procedures;
determining, by the server, a post-treatment score for the medical condition based on the evaluation;
normalizing, by the server, the post-treatment score to a normalized scale, wherein the post-treatment score is computed on a first scale determined by the one or more scoring procedures, and wherein normalizing the post-treatment score comprises converting the post-treatment score from the first scale to a standardized scale to enable comparison with scores computed using different scoring procedures having different native scales, thereby generating a normalized post-treatment score;
determining, by the server, an improvement score for the patient's medical condition using the pretreatment score and the normalized post-treatment score;
indexing, by the server, the patient to an electronic medical record stored in an electronic-medical-record-database, the electronic medical record including information regarding the patient’s medical history with regard to the treatment;
accessing, by the server, the electronic medical record of the patient;
extracting, by the server, one or more treatment outcome measurements from the accessed electronic medical record;
correlating, by the server, the extracted one or more treatment outcome measurements with the improvement score;
determining, by the server, an effectiveness indicator for the treatment provider based on the correlated improvement score and extracted one or more treatment outcome measurements, the effectiveness indicator indicating a degree of effectiveness for the treatment provider at providing the treatment;
storing, by the server, the effectiveness indicator in a treatment-provider database, the storing including indexing the effectiveness indicator to the treatment and the treatment provider;
for each treatment provider of a plurality of providers:
determining, by the server, a plurality of effectiveness indicators for a plurality of treatments performed by the treatment provider, each of the plurality of effectiveness indicators being stored in the treatment-provider database and indexed to the treatment provider;
accessing, by the server, the treatment-provider database to retrieve the effectiveness indicators for the treatment provider;
determining, by the server, an effectiveness score for the treatment provider based on an analysis of the retrieved effectiveness indicators;
storing, by the server, the effectiveness score in the treatment-provider database;
comparing, by the server, the effectiveness score for the treatment provider to a predetermined threshold; and
upon determining that the effectiveness score is below the predetermined threshold, automatically generating and providing, by the server, a notification to a treatment facility administrator.
But for the recitation of generic computing components like a server and electronic medical records, the italicized functions, when considered as a whole, describe an operation for disseminating and evaluating clinical surveys to make determinations about procedural outcomes and treatment provider efficacy that fit into the certain methods of organizing human activity subgrouping of managing personal behavior, interactions, and/or relationships between people. For example, a human actor is reasonably capable of accessing various databases (e.g. paper records, tables, reports, etc.) to look up information like a pretreatment score of a patient, a scoring procedure for a medical questionnaire, and past scheduling indications of a certain treatment, providing an appropriate medical questionnaire to a patient based on the scheduled treatment, receiving corresponding responses from the patient, using the obtained scoring procedure to make normalized scoring calculations/determinations about the questionnaire responses, indexing a patient to a medical record, accessing and extracting outcomes from the indexed patient record, making determinations about improvement and effectiveness of the treatments and treatment providers based on the questionnaire-based scores and extracted patient outcomes, and storing such data in a treatment-provider database (e.g. by writing up a report, a table summarizing provider scores, or some other means of manual recordkeeping). A human actor could also determine a plurality of effectiveness indicators for each of a plurality of providers and use similar recordkeeping methods to store the effectiveness indicators in the treatment-provider database and perform further data accessing and determining steps related to the effectiveness indicators, such as comparing derived treatment provider effectiveness scores to a threshold and generating and providing a notification to an administrator (e.g. via verbally communicating with them, sending them a written report, etc.) when the effectiveness score is below the threshold. Accordingly, claim 1 recites an abstract idea in the form of a certain method of organizing human activity.
Dependent claims 4-6 and 9-25 inherit the limitations that recite an abstract idea from their dependence on claim 1, and thus these claims also recite an abstract idea under the Step 2A – Prong 1 analysis. In addition, claims 4-6, 9-14, and 16-25 recite further limitations that merely further describe the abstract idea identified in claim 1.
For example, claim 4 recites receiving a request for the effectiveness score, accessing the treatment-provider database to retrieve the requested effectiveness score, and facilitating display of the retrieved effectiveness score to the user. This process could be achieved by managing interactions between human actors, for example by a patient asking a doctor, administrator, or other authority for effectiveness ratings for a given provider followed by the authority looking up a determined effectiveness rating for a provider and facilitating the display of this information to the patient (e.g. via a written report, illustrated chart or graph, etc.).
Claim 5 specifies facilitating display of the effectiveness score in a geographic map, which a human actor could achieve by drawing on a geographic map to represent effectiveness scores.
Claims 6 and 23 recite the patient being indexed to a medical record and accessing the medical record to retrieve or extract information about the patient’s medical condition or treatment outcomes to make determinations about the effectiveness indicator, which a human actor could accomplish by looking through patient records to glean such information and use it as a basis for treatment effectiveness determinations.
Claims 9-11, 16-18, 21-22, and 24-25 recite receiving additional patient data, selecting and facilitating provision of various corresponding questionnaires/questions to the patient, and evaluating responses to the questionnaire/questions via appropriate scoring procedures which can be accomplished by a human actor as explained for similar steps in claim 1 above.
Claims 12-13 recite generating and facilitating provision of a notification with patient contact information to a healthcare provider when an improvement score is below a threshold, which a human actor could achieve by comparing the improvement score to a known threshold and alerting or notifying a healthcare provider (e.g. via verbal communication) with the patient’s contact information when the score is below the threshold.
Claim 14 recites additional details about determining, storing, and indexing information in the database, which a human actor could achieve by implementing such recordkeeping practices in their records or reports.
Claim 19 specifies that each of the plurality of treatment providers are associated with a treatment facility, and storing the effectiveness score in a treatment-facility database with the effectiveness score indexed to the treatment facility, which a human actor could achieve by noting treatment facility affiliations in a provider’s profile and using recordkeeping methods to index provider effectiveness scores to affiliated treatment facilities.
Claim 20 recites providing the effectiveness indicator to a treatment facility administrator, which a human actor could achieve by speaking with a colleague to communicate such information.
However, recitation of an abstract idea is not the end of the analysis. Each of the claims must be analyzed for additional elements that indicate the abstract idea is integrated into a practical application to determine whether the claim is considered to be “directed to” an abstract idea.
Step 2A – Prong 2
The judicial exception is not integrated into a practical application. In particular, independent claim 1 does not include additional elements that integrate the abstract idea into a practical application. The additional elements of claim 1 include that the method is “computer-implemented,” that each step is performed “by a server,” and specifying electronic medical records stored in an electronic medical record database, although Examiner will also consider the other databases as intending to be electronic databases as well as the notification as being an electronic notification provided to some kind of user device in the interest of compact prosecution. These additional elements are recited at a high level of generality and merely invoke computer components as tools with which to digitize and/or automate an otherwise-abstract process (as explained above), such that they amount to instructions to “apply” the abstract idea with a computer (see MPEP 2106.05(f)). For example, the server and electronic elements merely digitize and/or automate the otherwise-abstract functions of administering, managing, and evaluating clinical questionnaires to track and notify users of patient improvement and provider effectiveness metrics over time such that these functions occur in an electronic environment. Accordingly, claim 1 as a whole is directed to an abstract idea without integration into a practical application.
The judicial exception recited in dependent claims 4-6 and 9-25 is also not integrated into a practical application under a similar analysis as above. Claims 4-6, 9-14, and 16-25 are performed with the same additional elements as parent claim 1 without introducing any new additional elements of their own, such that these claims do not provide integration into a practical application. Claim 15 specifies that facilitating provision of the medical questionnaire to the patient includes providing the medical questionnaire to a personal electronic device operated by the patient, which similarly amounts to instructions to “apply” the judicial exception with a computer because a high-level computing device is merely being utilized as a tool with which to digitize the otherwise-abstract step of communicating a questionnaire to a patient.
Thus the judicial exceptions recited in claims 1, 4-6, and 9-25 are not integrated into a practical application because the claims do not recite additional elements that impose any meaningful limits on practicing the abstract ideas. Claims 1, 4-6, and 9-25 are 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. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of computer implementation, a server, electronic records and databases, electronic notifications, and a personal electronic device to perform the accessing, receiving, determining, facilitating, evaluating, normalizing, indexing, extracting, correlating, storing, comparing, generating, providing, etc. steps of the invention amount to mere instructions to apply the exception using generic computer components. As evidence of the generic nature of the above recited additional elements, Examiner notes the following portions of Applicant’s specification:
[000363]-[000368] and Fig. 25, where a generic computer for implementing any and all of the recited computer components is described nonspecifically; generic examples of computer hardware systems for performing the functions of the invention are given such as a smartphone, a desktop, a laptop, a mainframe computer, an embedded system, etc. in paragraph [000363];
[00065], where the patient device is described as possibly being “any device (e.g., a smartphone, a laptop computer, a tablet computer, a desktop computer, etc.) that enables communication between a patient and other components of the system.”
Many of these processes also amount to activities that are recognized as being well-understood, routine, and conventional computing functions such as receiving or transmitting data over a network, performing repetitive calculations, electronic recordkeeping, and storing and retrieving information in memory (see MPEP 2106.05(d)(II)) such that they do not provide an inventive concept. Analyzing these additional elements as an ordered combination adds nothing that is not already present when considering the elements individually; the overall effect of the computer implementation, server, electronic elements, and personal electronic device in combination is to digitize and/or automate a questionnaire management and clinical efficacy/quality analytics operation that could otherwise be achieved as a certain method of organizing human activity. In addition, the combination of a computer server, electronic databases, and a user device used to provide medical questionnaires and/or notifications to users is well-understood, routine, and conventional in the art as evidenced by at least Hussam et al. (US 20110093481 A1) Fig. 1; Ethington et al. (US 20160210442 A1) Fig. 1; Chen et al. (US 20150286787 A1) Fig. 2; and Bogue et al. (US 20180330800 A1) Fig. 1 & [0141]-[0145]. As such, whether taken singly or in combination, these elements do not provide an inventive concept and claims 1, 4-6, and 9-25 are thus not patent eligible.
Subject Matter Free from Prior Art
The prior art of record fails to expressly teach or suggest, either alone or in combination, each and every feature of independent claim 1, as explained in detail in paras. 37-38 of the non-final rejection mailed 3/24/2026. Upon performance of an updated prior art search, Examiner submits that Schneider (US 20160260190 A1), Forthman (US 20140207478 A1), and Fillmore (US 20140122100 A1) are relevant to the field of Applicant’s disclosure (e.g. describing systems for quality/performance scoring of healthcare providers with normalized scoring capabilities), but fail to disclose or render obvious each and every limitation of independent claim 1. Accordingly, the prior art, either alone or in combination, does not disclose or render obvious all the features of independent claim 1 and it is found to recite subject matter free from prior art, as are the claims depending therefrom.
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 KAREN A HRANEK whose telephone number is (571)272-1679. The examiner can normally be reached on M-F 8:00-4:00 ET.
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/KAREN A HRANEK/ Primary Examiner, Art Unit 3684
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