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 .
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 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 2A, Prong One asks: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? See MPEP 2106.04 Part I. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. See MPEP 2106.04(a).
With respect to claims 1, 8 & 11, the limitation of “accessing an analytic method definition, the definition specifying a set of pages….one or more pages each including a swimlane control”, “determining a combination of possible answers”, and “causing to be displayed visual indications of at least a portion of the combinations of possible answers determined for the swimlane control”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, nothing in the claim element precludes the step from practically being performed in the mind. For example, “determining” and “identifying” in the context of this claim encompasses the user mentally analyzing data. Similarly, the limitation of “accessing an analytic method definition ……each lane identifying a combination of possible answers to two or more questions…. ”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, “identifying a combination” in the context of this claim encompasses the user mentally compiling skills. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
At step 2a, prong two, this judicial exception is not integrated into a practical application. Claim 8 recites one ort more instances of computer-readable media to execute the operations, however, this is recited as a high-level of generality (i.e., as a generic computer-readable media performing a generic computer function) such that it amounts to no more than mere instructions to apply the exception using a generic computer component. Additionally, the claim recites “contents of the data structure are usable to generate notification of lanes missing from any of the swimlane controls included among the pages of the set” These elements do not integrate the abstract idea into a practical application because they do not impose a meaningful limit on the judicial exception and provide only insignificant extra solution activity that is mere data gathering in conjunction with the abstract idea.
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 amount to no more than mere instructions to apply an exception using generic computer components. Mere instructions to apply an exception using generic computer components cannot provide an inventive concept.
Considering the additional elements individually and in combination and the claim as a whole, the additional elements do not provide significantly more than the abstract idea. The claim is not patent eligible.
With respect to claims 2, 3, 12, 13 and 14, the claims are directed towards displaying and activating visual indications with respect to the combinations of possible answers identified. This claim does not recite further abstract ideas under step 2a prong one and instead recite additional elements. These elements do not integrate the abstract idea into a practical application because they do not impose a meaningful limit on the judicial exception and provide only insignificant extra solution activity that is mere data gathering in conjunction with the abstract idea. Under step 2B, with respect to “activated to add to the corresponding swimlane”, the courts have found limitations directed towards data gathering to be well-understood, routine, and
conventional. See MPEP 2106.05(d)(II). 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). With respect to “fine- tuning”, this is simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. See Haokun Liu, Derek Tam, Mohammed Muqeeth, Jay Mohta, Tenghao Huang, Mohit Bansal, and Colin Raffel. 2022. Few-shot parameter-efficient fine-tuning is better and cheaper than in-context learning. In Proceedings of the 36th International Conference on Neural Information Processing Systems (NIPS '22). Curran Associates Inc., Red Hook, NY, USA, Article 142, 1950–1965. This reference provides a variety of ways that these steps have been performed in the prior art.
With respect to claim 6, 7, the limitations further define the document position and do not integrate the abstract idea into a practical application because they do not impose a meaningful limit on the judicial exception and provide only insignificant extra solution activity that is mere data gathering in conjunction with the abstract idea.
With respect to claim 4, 5, 9, 10, 15, 16, 17 and 18, the limitations further define algorithmically matching the skill-centric digital representation of the user with the skill-centric digital representation of the document. This describes further mental processes because under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, nothing in the claim element precludes the step from practically being performed in the mind. For example, “algorithmically matching” in the context of this claim encompasses the user mentally determining if data matches.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-18 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Huyn et al. (U.S. Pub 2002/0035486) hereinafter Huyn.
As per Claim 1, Huyn teaches A method in a computing system, comprising: accessing an analytic method definition, the definition specifying a set of pages, one or more of the pages of the set that each include one or more questions, having two or more possible answers, one or more of the pages each including a swimlane control, (Fig. 1, ¶14 wherien the present invention provides a computer-implemented method for obtaining clinical data, containing the following steps: obtaining medical questions and question linking conditions from a database, presenting at least one of the medical questions to a user, receiving response data from the user, and displaying additional questions to the user, depending upon the response data and question linking conditions. Preferably, each question has an associated linking condition (containing one or more expressions), and all conditions are evaluated each time new response data are received. For each condition that evaluates to true, its associated question is presented to the user. Preferably, questions are organized into forms of related questions, and forms are presented when associated form linking conditions, evaluated based on response data, are true. Similarly, question assembly conditions determine which questions are included in a particular form. Responses are preferably weighted, and the evaluation conditions depend on the response weights)
each swimlane control comprising one or more lanes, each lane identifying a combination of possible answers to two or more of the questions included among the pages and specifying routing in an iteration of the analytic method in which that combination of answers has been given; (¶15 wherien Questions are preferably organized into higher-level questions and lower-level questions. Positive responses to higher-level questions trigger presentation of lower-level questions. Typically, combinations of higher- and lower-level question responses represent medical pathways associated with predetermined medical conditions. Preferably, clinical alert conditions corresponding to the medical pathways are obtained from the database and compared with response data)
for each of the swimlane controls: among the included questions any of whose answers have been included in the combination of answers identified by a lane of the swimlane, determining any combinations of possible answers not identified by any lane of the swimlane; and (Fig. 6, ¶51 wherein A schematic diagram of the conceptual structure of a questionnaire according to the present invention is shown in FIG. 6. As implemented in the present invention, a questionnaire preferably consists of a number of forms F.sub.1 through F.sub.n, each containing a set of related potential questions Q.sub.i. For example, each form can focus on a particular organ system (e.g., pulmonary system or thyroid) or type of potential question (e.g., health insurance information or family history). Although the forms are shown as numbered for identification purposes, they can be presented in any order, and not all forms must be presented to each subject. In addition, each potential question can be associated with one or more response items (not shown) from which a user selects. Alternatively, a user can enter free text in response to a question.)
causing to be displayed visual indications of at a least a portion of the combinations of possible answers determined for the swimlane control. (Fig. 6, ¶52 wherien not all potential questions of a given form are presented to a subject; rather, the presented questions are selected dynamically based on the subject's response to previous questions, either on the same or on different forms. The set of presented questions can change as the subject responds to questions, and thus a given subject may or may not see a particular form change in response to his or her answers or other data received. As shown in FIG. 6, the links between a form F.sub.i and its questions Q.sub.i, and also to other forms, are not fixed, but are governed by conditional statements C.sub.Qi and C.sub.Fi containing references to particular questions and their responses. Conditional statements contain one or more Boolean expressions that can be evaluated as true or false, and a question or form is presented only if its associated condition evaluates to true. For example, a typical conditional statement is "if the subject responded positively to the question `have you lost weight in the last six months?`, present the question `how much weight have you lost?`." Of course, much more complex expressions that depend upon responses to more than one question can be used. In certain instances, the conditions can always evaluate to true or always evaluate to false)
As per Claim 2, the rejection of claim 1 is hereby incorporated by reference; Huyn further teaches further comprising: for each visual indication, causing to be displayed a control that can be activated to add to the corresponding swimlane control a lane identifying the indicated combination of possible answers. (Fig. 10A, ¶71 wherien FIG. 10A shows the Chief Complaint form that is initially presented to the subject. It contains a single primary question, "Are you currently being professionally treated for an illness or symptom?" and two mutually exclusive response items. If the subject selects the "No" response, the form does not change. However, if the subject selects the "Yes" response, eight secondary questions are presented, as shown in FIG. 10B. If the subject then selects the "Yes" response to the question, "Have you asked another doctor for their opinion on your diagnosis or treatment?", an additional question appears ("Did it agree with your regular doctor?"), as shown in FIG. 10C.)
As per Claim 3, the rejection of claim 1 is hereby incorporated by reference; Huyn further teaches further comprising: causing to be displayed a control that can be activated to add to each corresponding swimlane control a lane identifying each of the indicated combination of possible answers. (Fig. 7, ¶53 wherien Questions, forms, conditions, and response items are represented as database objects. Object models are shown schematically in the entity-relationship diagram of FIG. 7, in which objects are represented as rectangles, relationships among objects as diamonds, and attributes as ovals. Questions and responses are stored as strings identified by question identifiers and response identifiers, respectively. They can alternatively be represented by specific data types. Conditions are any Boolean combination of atomic expressions of a user response to questions (e.g., Q376="Yes"). The conditions shown represent two different types of logic that are evaluated at run time. At the highest level is form linking logic, which determines which form to present next, i.e., the next set of potential questions. For example, the evaluation of condition 104 determines whether form 105 will be presented next. Question linking logic determines which of the potential questions in a given form will be presented to the subject. For each question 106 in a form, a condition 108 is evaluated, and all questions whose conditions evaluate to true are presented)
As per Claim 4, the rejection of claim 1 is hereby incorporated by reference; Huyn further teaches wherein the analytic method definition further specifies directed connections each connecting a source page among the set of pages to a different destination page among the set of pages, the method further comprising: (Fig. 9A-9C, ¶58 wherien If the user is authenticated, at state 118, the questionnaire options available to the specified user ID are provided to the web server from the database server and then transferred via the web server to the web browser. The user then selects the desired questionnaire (state 120), and at state 122, all eligible forms with associated form linking logic, question linking logic, and question assembly logic are sent from the database to the web server. Initially, only the root form and its question assembly and question linking logic are sent to the web server. On subsequent iterations, the database sends all forms that may be presented after the most recently presented form, as determined by the form linking logic)
identifying a group of pages of the set among which connections establish a loop, such that, for each member of the group, a series of connections can be followed to leave from the member, then return to the member; and causing to be displayed a visual indication identifying the pages of the group. (¶60 wherien At state 132 the subject inputs one of three options: (1) abandon the current form and return to a previous form; (2) specify a new response or modify an existing response to a question on the current form; or (3) indicate that the current form has been completed. At decision state 134, the web browser determines whether the user specified a new response or modified an existing response to a question on the current form. If so, at state 136, the web browser reevaluates the question linking logic for all questions most recently transmitted from the web server (i.e., for the current form) and, at state 138, adjusts the presentation to reflect the new response data. The process then returns to state 132 to await further user input. Preferably, the browser maintains all user responses to all forms in the current session in a stack. Transitions between forms are denoted in the stack so that the stack pointer can be moved directly to the beginning of a previous form if necessary.)
As per Claim 5, the rejection of claim 1 is hereby incorporated by reference; Huyn further teaches wherein the analytic method definition further specifies directed connections each connecting a source page among the set of pages to a different destination page among the set of pages, and (Fig. 9B, ¶60 wherien At state 132 the subject inputs one of three options: (1) abandon the current form and return to a previous form; (2) specify a new response or modify an existing response to a question on the current form; or (3) indicate that the current form has been completed. At decision state 134, the web browser determines whether the user specified a new response or modified an existing response to a question on the current form. If so, at state 136, the web browser reevaluates the question linking logic for all questions most recently transmitted from the web server (i.e., for the current form) and, at state 138, adjusts the presentation to reflect the new response data. The process then returns to state 132 to await further user input. Preferably, the browser maintains all user responses to all forms in the current session in a stack. Transitions between forms are denoted in the stack so that the stack pointer can be moved directly to the beginning of a previous form if necessary.)
wherein the analytic method definition further designates a page among the set of pages as a root page at which each iteration of the analytic method begins, the method further comprising: identifying a page among the set of pages that cannot be reached by following connections from the root page; and causing to be displayed a visual indication of the identified page. (Fig. 9B, ¶62 wherien At decision state 140, the web browser determines whether the user has elected to abandon the current form and return to the previous form (e.g., by selecting the browser's Back button). If so, at state 142, the web browser erases all responses collected in the current form and, at state 144, displays the previous form containing the previously submitted response data. The process then returns to state 132 to wait for additional user input on the currently displayed form. In the response stack in client memory, the pointer is repositioned at the beginning of the responses to the now-current form (i.e., lower in the stack). When the current form is resubmitted, the browser rewrites all responses to the stack. From the user's point of view, however, the previous responses remain unless he or she changes them.)
As per Claim 6, the rejection of claim 1 is hereby incorporated by reference; Huyn further teaches wherein the analytic method definition further designates a page among the set of pages as a root page at which each iteration of the analytic method begins, and (Fig. 9A-9C, ¶58 wherien If the user is authenticated, at state 118, the questionnaire options available to the specified user ID are provided to the web server from the database server and then transferred via the web server to the web browser. The user then selects the desired questionnaire (state 120), and at state 122, all eligible forms with associated form linking logic, question linking logic, and question assembly logic are sent from the database to the web server. Initially, only the root form and its question assembly and question linking logic are sent to the web server. On subsequent iterations, the database sends all forms that may be presented after the most recently presented form, as determined by the form linking logic)
wherein the determining is performed by a calling a function with respect to the root page, which recursively calls itself with respect to other pages of the set of pages. (¶59 wherien Moving to state 124, the web server selects the next form for presentation. If only the root form has been downloaded, then the web server automatically presents the root form. On subsequent iterations, the form is selected by evaluating one or more form linking conditions and selecting the form whose condition evaluates to true. The web server then dynamically assembles the questions by evaluating the question assembly condition for each potential question in the form. Continuing with FIG. 9B, at state 128, the assembled form, question linking condition for each included question, and any additional logical dependencies are downloaded to the web browser. The web browser evaluates all question linking conditions and displays the resulting questions to the user at state 130)
As per Claim 7, the rejection of claim 1 is hereby incorporated by reference; Hyun further teaches wherein each call to the function provides values of a first parameter identifying a page among the set of pages with respect to which the function is to be performed, and (¶63 wherien After completing all questions on the current form, the user may request to move to the next form (state 146). The current form's response data are written to the browser stack and sent to the web server at state 148 (FIG. 9C). The web server then determines at state 150 whether more forms are available for this questionnaire. If so, the method returns to state 124 (FIG. 9A), at which the next set of potential forms and associated form linking logic are downloaded from the database)
a second parameter identifying a combination of possible answers to which the function is to be performed. (Fig. 11C, ¶75 wherien A positive response to the screening questions 160 is indicative of a disease or symptom that may warrant medical attention or about which further information should be obtained. Questions 170 elicit further information from the subject in order to identify the appropriate disease pathway. Positive answers to the additional questions 170 trigger additional "drill-down" or lower-level questions 180a-180e, as shown in FIGS. 11D-11F. Yet further levels of questions 182a-182c are presented in response to positive responses to questions 180. As shown, each question level can be further indented to indicate its level. Preferably, the subservience relationships among questions (FIG. 7) determines the indenting and also defines the question level.)
As per Claim 8, Hyun teaches One or more instances of computer-readable media collectively containing a data structure relating to an analytic method definition, the definition specifying a set of pages, one or more of the pages of the set that each include one or more questions, having two or more possible answers, one or more of the pages each including a swimlane control, (Fig. 1, ¶14 wherien the present invention provides a computer-implemented method for obtaining clinical data, containing the following steps: obtaining medical questions and question linking conditions from a database, presenting at least one of the medical questions to a user, receiving response data from the user, and displaying additional questions to the user, depending upon the response data and question linking conditions. Preferably, each question has an associated linking condition (containing one or more expressions), and all conditions are evaluated each time new response data are received. For each condition that evaluates to true, its associated question is presented to the user. Preferably, questions are organized into forms of related questions, and forms are presented when associated form linking conditions, evaluated based on response data, are true. Similarly, question assembly conditions determine which questions are included in a particular form. Responses are preferably weighted, and the evaluation conditions depend on the response weights)
each swimlane control comprising one or more lanes, each lane identifying a combination of possible answers to two or more of the questions included among the pages and specifying routing in an iteration of the analytic method in which that combination of answers has been given, the data structure comprising: one or more first entries, each first entry comprising: (Fig. 6, ¶51 wherein A schematic diagram of the conceptual structure of a questionnaire according to the present invention is shown in FIG. 6. As implemented in the present invention, a questionnaire preferably consists of a number of forms F.sub.1 through F.sub.n, each containing a set of related potential questions Q.sub.i. For example, each form can focus on a particular organ system (e.g., pulmonary system or thyroid) or type of potential question (e.g., health insurance information or family history). Although the forms are shown as numbered for identification purposes, they can be presented in any order, and not all forms must be presented to each subject. In addition, each potential question can be associated with one or more response items (not shown) from which a user selects. Alternatively, a user can enter free text in response to a question.)
information identifying one of the swimlane controls included among the pages of the set; and information identifying a combination of possible answers that is not identified by any of the lanes of the swimlane control identified by the first entry, each answer of the identified combination corresponding to a question any of whose answers has been included in any lane of the identified swimlane control, (Fig. 11C, ¶75 wherien A positive response to the screening questions 160 is indicative of a disease or symptom that may warrant medical attention or about which further information should be obtained. Questions 170 elicit further information from the subject in order to identify the appropriate disease pathway. Positive answers to the additional questions 170 trigger additional "drill-down" or lower-level questions 180a-180e, as shown in FIGS. 11D-11F. Yet further levels of questions 182a-182c are presented in response to positive responses to questions 180. As shown, each question level can be further indented to indicate its level. Preferably, the subservience relationships among questions (FIG. 7) determines the indenting and also defines the question level.)
such that the contents of the data structure are usable to generate a notification of lanes missing from any of the swimlane controls included among the pages of the set. (¶76 wherein Note that the medical pathway structure of the questions, although useful for recommending potential diagnoses, is primarily designed for thorough information-gathering purposes. That is, the structure enables the invention to acquire detailed information about symptoms that are not currently known to be correlated with medical conditions wherein if a particular type of headache is a currently unrecognized symptom of a certain disease that the patient has or will develop, the correlation can only be made if sufficient details of the headache are obtained)
Claim 9 is similar in scope to Claim 4; therefore, Claim 9 is rejected under the same rationale as Claim 4.
Claim 10 is similar in scope to Claim 5; therefore, Claim 10 is rejected under the same rationale as Claim 5.
Claim 11 is similar in scope to Claim 1; therefore, Claim 11 is rejected under the same rationale as Claim 1.
Claim 13 is similar in scope to Claim 2; therefore, Claim 13 is rejected under the same rationale as Claim 2.
Claim 14 is similar in scope to Claim 3; therefore, Claim 14 is rejected under the same rationale as Claim 3.
Claim 15 is similar in scope to Claim 4; therefore, Claim 15 is rejected under the same rationale as Claim 4.
Claim 16 is similar in scope to Claim 5; therefore, Claim 16 is rejected under the same rationale as Claim 5.
Claim 17 is similar in scope to Claim 6; therefore, Claim 17 is rejected under the same rationale as Claim 6.
Claim 18 is similar in scope to Claim 7; therefore, Claim 18 is rejected under the same rationale as Claim 7.
Related Art
Related art not relied upon Green, JR. et al. (U.S. Pub 2011/0301982) for teaching a medical software system that integrates all aspects of practice management, managed care, and medical research. More particularly, the present invention relates to an integrated medical software system with clinical decision support for consuming standardized documents to support clinical decisions with the system. Frost et al. (U.S. Pub 2020/0372109) for teaching a mechanism is provided for routinely evaluating an accuracy of a request processing pipeline. A set of questions is executed through the request processing pipeline, producing a list of answers, supporting documents, and accuracy metrics.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANGIE BADAWI whose telephone number is (571)270-7590. The examiner can normally be reached Monday thru Wednesday 9:00am - 5:00pm EST with Thursdays and Fridays off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fred Ehichioya can be reached at (571) 272-4034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANGIE BADAWI/ Primary Examiner, Art Unit 2179
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