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 1-6, 9-14, and 17-19 are currently pending. Claims 7-8, 15-16, and 20 are canceled in the Claims filed on October 2, 2025.
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 1-6, 9-14, and 17-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
Claims 1-6, 9-14, and 17-19 are within the four statutory categories. Claims 1-6 are drawn to a system for generating a personalized patient questionnaire, which is within the four statutory categories (i.e. machine). Claims 9-14 are drawn to a method for generating a personalized patient questionnaire, which is within the four statutory categories (i.e. process). Claims 17-19 are drawn to a non-transitory medium for generating a personalized patient questionnaire, which is within the four statutory categories (i.e. manufacture).
Prong 1 of Step 2A
Claim 1, which is representative of the inventive concept, recites: A remote patient monitoring system, comprising:
a memory encoding processor-executable routines; and
a processing system configured to access the memory and to execute the processor-executable routines, wherein the processor-executable routines, when executed by the processing system, cause the processing system to:
obtain feedback from one or more sensors, wherein the feedback relates to one or more health parameters of a subject;
obtain past medical records of the subject;
obtain a clinical guideline specific to a condition of the subject; and
generate, via a question generation module, a personalized patient reported outcome questionnaire based at least on the feedback, the past medical records of the subject, and the clinical guideline, wherein the personalized patient reported outcome questionnaire is compatible with the clinical guideline;
receive, at a report generation module, an entirety of responses from the subject to the personalized patient reported outcome questionnaire;
analyze, via the report generation module, the entirety of the responses from the subject in context of both the past medical records of the subject and the clinical guideline;
generate, via the report generation module, a personalized patient reported outcome questionnaire report based on the analysis, wherein facts within the personalized patient reported outcome questionnaire report are ranked in terms of relevancy and novelty and presented in a concise manner with the facts that are most relevant and novel presented at a beginning of the personalized patient reported outcome questionnaire report;
log, via a usage and feedback logging module, edits to the personalized patient reported outcome questionnaire report; and
provide, via the usage and feedback logging module, the edits to a finetuning layer of a language model utilized by the question generation module in generating questions for subsequently generated personalized patient reported outcome questionnaires.
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract idea of a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions – in this case, the steps of obtaining feedback, past medical records, and a clinical guideline for the subject, generating a personalized patient questionnaire based on the obtained data, receiving responses for the questionnaire, analyzing the responses, generating a personalized patient reported outcome questionnaire report, and logging edits to the report are reasonably interpreted as following rules or instructions to diagnose or treat a patient, and reporting the results of the diagnosis or treatment), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for Claims 9 and 17 is identical as the abstract idea for Claim 1, because the only difference between Claims 1, 9, and 17 is that Claim 1 recites a system, whereas Claim 9 recites a method, and Claim 17 recites a non-transitory computer-readable medium.
Dependent Claims 2-6, 10-14, and 18-19 include other limitations, for example Claims 2 and 10 recite obtaining questionnaires for similar subjects and using the obtained questionnaires to generate the questionnaire for the subject, Claims 3-4, 11-12, and 18 recite obtaining subject responses to the questions of the questionnaire, corroborating the responses to other subject responses, and updating remaining questions of the subject questionnaire based on the corroboration, and generating follow-up questions if inconsistencies are detected via the corroboration, and Claims 5-6, 13-14, and 19 recite receiving patient responses that are outside the scope of questionnaire, and generating follow up questions, but these only serve to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g. see MPEP 2106.04, and/or do not further narrow the abstract idea and instead only recite additional elements, which will be further addressed below. Hence dependent Claims 2-6, 10-14, and 18-19 are nonetheless directed towards fundamentally the same abstract idea as independent Claims 1, 9, and 17.
Hence Claims 1-6, 9-14, and 17-19 are directed towards the aforementioned abstract idea.
Prong 2 of Step 2A
Claims 1, 9, and 17 are not integrated into a practical application because the additional elements (i.e. the non-underlined limitations above – in this case, the memory, the processing system executed by the processor, the sensors, the various modules of the processing system, and the language model) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of the memory, the processing system, the question generation module, and the language model, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see [0021]-[0022], [0034]-[0037], and [0078] of the as-filed Specification, and see MPEP 2106.05(f);
generally link the abstract idea to a particular technological environment or field of use – for example, the claim limitation of obtaining health information from sensors, which amounts to limiting the abstract idea to the field of healthcare, e.g. see MPEP 2106.05(h); and/or
add insignificant extra-solution activity to the abstract idea – for example, the recitation of the feedback relating to health parameters, the past medical records, and the clinical guideline, which amounts to selecting a particular data source or type of data to be manipulated, e.g. see MPEP 2106.05(g).
Additionally, dependent Claims 2-8, 10-16, and 18-20 include other limitations, but these limitations do not include any additional elements beyond those already recited in independent Claims 1 and 9, and hence also do not integrate the aforementioned abstract idea into a practical application.
Hence Claims 1-20 do not include additional elements that integrate the judicial exception into a practical application.
Step 2B
Claims 1, 9, and 17 do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the non-underlined limitations above – in this case, the memory, the processing system, the sensors, the various modules of the processing system, and the language model), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, generally link the abstract idea to a particular technological environment or field of use, and/or add insignificant extra-solution activity to the abstract idea, wherein the additional elements comprise limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The present Specification expressly disclosing that the structural additional elements are well-understood, routine, and conventional in nature:
[0021]-[0022], [0034]-[0037], and [0078] of the as-filed Specification discloses that the additional elements (i.e. the memory, the processing system, the various modules of the processing system, the language model) comprise a plurality of different types of generic computing systems;
Relevant court decisions: The functional limitations interpreted as additional elements are analogized to the following examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention receives feedback data, past medical records, and clinical guidelines over a network, e.g. see [0079]-[0082] of the as-filed Specification;
Electronic recordkeeping, e.g. see Alice Corp v. CLS Bank – similarly, the current invention merely recites the maintaining of past subject medical records, clinical guidelines, and feedback;
Storing and retrieving information in memory, e.g. see Versata Dev. Group, Inc. v. SAP Am., Inc. – similarly, the current invention recites storing past subject medical records, clinical guidelines, and feedback data, and retrieving the past subject medical records, clinical guidelines, and feedback data from storage in order to generate the personalized questionnaire;
Dependent Claims 2-6, 10-14, and 18-19 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims do not recite any additional elements not already recited in independent Claims 1, 9, and 17, and hence do not amount to “significantly more” than the abstract idea.
Hence, Claims 1-6, 9-14, and 17-19 do not include any additional elements that amount to “significantly more” than the judicial exception.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 1-6, 9-14, and 17-19 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 9, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Buisman (US 2012/0232931) in view of Ribbing (US 2012/0063657), further in view of Poovey (US 2024/0194315) and Martin (US 2009/0217189).
Regarding Claim 1, Buisman teaches the following: A remote patient monitoring system, comprising:
a memory encoding processor-executable routines (The system includes a memory storing programs configured to be executed by one or more processors, e.g. see Buisman [0021].); and
a processing system configured to access the memory and to execute the processor-executable routines (The system includes one or more processors that execute one or more programs stored on the memory, e.g. see Buisman [0021].), wherein the processor-executable routines, when executed by the processing system, cause the processing system to:
obtain feedback from one or more sensors, wherein the feedback relates to one or more health parameters of a subject (The system includes a diagnostic medical device that periodically measures vital signs of the patient, e.g. see Buisman [0028].);
obtain past medical records of the subject (The system includes a patient database that stores electronic health records for patients, e.g. see Buisman [0018].);
obtain a clinical guideline specific to a condition of the subject (The system includes a domain model comprising a knowledge base for a medical condition, e.g. see Buisman [0018], wherein the domain model includes guidelines for diseases and drugs, e.g. see Buisman [0112].); and
generate, via a question generation module, a personalized patient reported outcome questionnaire based at least on the feedback, the past medical records of the subject, and the clinical guideline, wherein the personalized patient reported outcome questionnaire is compatible with the clinical guideline (The system constructs at least one question using the knowledge base (i.e. based on the clinical guideline), e.g. see Buisman [0022], [0073], wherein the knowledge base is based on a disease or medical condition, wherein the disease or medical condition is based on the patient vital sign data (i.e. the feedback) and electronic health record (i.e. the past medical records), e.g. see Buisman [0028]-[0029].).
But Buisman does not teach and Ribbing teaches the following:
receive, at a report generation module, an entirety of responses from the subject to the personalized patient reported outcome questionnaire (The system receives a completed questionnaire from a patient, e.g. see Ribbing [0076] and [0129].);
analyze, via the report generation module, the entirety of the responses from the subject in context of both the past medical records of the subject and the clinical guideline (The system evaluates the patient responses and calculates domain summary scores for the responses, e.g. see Ribbing [0075]-[0076].); and
generate, via the report generation module, a personalized patient reported outcome questionnaire report based on the analysis, wherein facts within the personalized patient reported outcome questionnaire report are ranked in terms of relevancy and novelty and presented in a concise manner (The system automatically calculates scores from a completed questionnaire and displays the scores to a user (i.e. a personalized patient reported outcome questionnaire report), wherein the scores are grouped according to relevance and sorted by date and time, e.g. see Ribbing [0129].).
Furthermore, it would have been obvious to one ordinarily skilled in the art of healthcare to modify Buisman to incorporate scoring the completed questionnaire and presenting the results according to their relevance as taught by Ribbing in order to enable the system to perform statistical values for comparison of various patient groups, e.g. see Ribbing [0095].
But the combination of Busiman and Ribbing does not teach and Poovey teaches the following:
log, via a usage and feedback logging module, edits to the personalized patient reported outcome questionnaire report (The system obtains patient health data via a consult questionnaire (i.e. the completed consult questionnaire is interpreted as a “personalized patient reported outcome questionnaire report”), and further generates an Op note questionnaire (i.e. an edited questionnaire report) that includes one or more ICD codes based on the patient health data, e.g. see Poovey [0055], Fig. 2.); and
provide, via the usage and feedback logging module, the edits to a finetuning layer of a language model utilized by the question generation module in generating questions for subsequently generated personalized patient reported outcome questionnaires (The system provides the ICD codes from the Op note questionnaire to a platform, wherein the platform subsequently generates a listing of CPT codes associated with the list of ICD codes, e.g. see Poovey [0055], Fig. 2, wherein the platform implements artificial intelligence including machine learning, deep learning, and natural language processing (i.e. the platform is interpreted as incorporating a “finetuning layer of a language model”), and wherein the platform utilizes AI to generate questionnaires, e.g. see Poovey [0062].).
Furthermore, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Buisman and Ribbing to incorporate tracking the edits to the questionnaire report and utilizing AI to generate questionnaires as taught by Poovey in order to provide improved accounting and patient outcomes, e.g. see Poovey [0041] and [0079].
But the combination of Buisman, Ribbing, and Poovey does not teach and Martin teaches the following:
wherein the facts that are most relevant and novel are presented at a beginning of the personalized patient reported outcome questionnaire report (The system constructs a patient dashboard comprising a collection of patient data, e.g. see Martin [0028]-[0029], Fig. 2, wherein the patient dashboard initially presents a user with the most relevant information, e.g. see Martin [0032]-[0033] and [0045].).
Furthermore, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Buisman, Ribbing, and Poovey to incorporate displaying the most relevant data to a user initially in order to enable the user to view the information they want to see first without needing to sort through a mass of information, e.g. see Martin [0032]-[0033].
Regarding Claims 9 and 17, the limitations of Claims 9 and 17 are substantially similar to those claimed in Claim 1, with the sole difference being that Claim 1 recites a system, whereas Claim 9 recites a method and Claim 17 recites a non-transitory computer-readable medium. Specifically pertaining to Claims 9 and 17, Examiner notes that Buisman teaches that the invention may be embodied as instructions stored on a computer-readable medium that cause a computer processor to execute a method, e.g. see Buisman [0058], and hence the grounds of rejection provided above for Claim 1 are similarly applied to Claims 9 and 17.
Claims 2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Buisman, Ribbing, Poovey, and Martin in view of Knoop (US 2019/0096509).
Regarding Claim 2, the combination of Buisman, Ribbing, Poovey, and Martin teaches the limitations of Claim 1, but does not teach and Knoop teaches the following: The remote patient monitoring system of claim 1, wherein the processor-executable routines, when executed by the processing system, further cause the processing system to:
obtain questionnaires of other subjects with a similar medical history to the subject (The system presents patients with a questions for initial basic information, for example biometric information and symptoms (i.e. medical history), and utilizes the answers to the questions to group a patient into a patient group that matches the patient to a most similar patient group, e.g. see Knoop [0067].); and
generate, via the question generation module, the personalized patient reported outcome questionnaire based at least on the feedback, the past medical records of the subject, the clinical guideline, and the questionnaires of the other subjects (The system generates questions for a patient based on the grouping the patient is placed in (i.e. the questionnaires of other subjects), e.g. see Knoop [0067]-[0068], wherein the patient symptoms or biometric information (i.e. feedback) may be collected utilizing a monitoring device (i.e. sensors), e.g. see Knoop [0083]-[0084], wherein the system further utilizes a QA pipeline that incorporates knowledge about a medical domain (i.e. a clinical guideline), e.g. see Knoop [0051]-[0052], and wherein the system further initializes the process utilizing historical patient data (i.e. past medical records of the subject), e.g. see Knoop [0066] and [0085].).
Furthermore, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Buisman, Ribbing, Poovey, and Martin to incorporate utilizing data from similar patients to generate the questionnaire as taught by Knoop in order to generate an accurate assessment of the patient’s health risk, e.g. see Knoop [0015].
Regarding Claim 10, the limitations of Claim 10 are substantially similar to those claimed in Claim 2, with the sole difference being that Claim 2 recites a system, whereas Claim 10 recites a method. Specifically pertaining to Claim 10, Examiner notes that Buisman teaches that the invention may be embodied as instructions stored on a computer-readable medium that cause a computer processor to execute a method, e.g. see Buisman [0058], and hence the grounds of rejection provided above for Claim 2 are similarly applied to Claim 10.
Claims 3-4, 11-12, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Buisman, Ribbing, Poovey, and Martin in view of Thiese (US 2017/0262618).
Regarding Claim 3, the combination of Buisman, Ribbing, Poovey, and Martin teaches the limitations of Claim 1, but does not teach and Thiese teaches the following: The remote patient monitoring system of claim 1, wherein the processor-executable routines, when executed by the processing system, further cause the processing system to:
obtain, at a response understanding module, one or more responses from the subject to one or more questions from the personalized patient reported outcome questionnaire (The system receives a response to a question, e.g. see Thiese [0042] and [0051].);
corroborate, via a response corroboration module, the one or more responses with past responses to questions by the subject, the feedback, and the past medical records of the subject (The system determines if the patient response is inconsistent based on information already obtained by the system, for example previous responses, results from previous medical examinations (i.e. feedback), and responses from medical screening questions (i.e. past medical records), e.g. see Thiese [0042] and [0051].); and
update, via the question generation module, a remaining portion of the personalized patient reported outcome questionnaire based on a level of corroboration between the one or more responses with the past responses to questions by the subject, the feedback, and the past medical records of the subject (The system may insert and present additional questions (i.e. update a remaining portion of the questionnaire) based on it identifying that a patient’s response is inconsistent, e.g. see Thiese [0042] and [0051].).
Furthermore, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Buisman, Ribbing, Poovey, and Martin to incorporate updating the questionnaire based on the received patient responses as taught by Thiese in order to improve the ability of medical examiners to efficiently and completely determine and evaluate patient medical conditions, e.g. see Thiese [0023].
Regarding Claim 4, the combination of Buisman, Ribbing, Poovey, Martin, and Thiese teaches the limitations of Claim 3, and Thiese further teaches the following: The remote patient monitoring system of claim 3, wherein the processor-executable routines, when executed by the processing system, further cause the processing system to:
notify, via the response corroboration module, the question generation module when the one or more responses are not consistent with the past responses to the questions by the subject, the feedback, and/or the past medical records of the subject (The system determines if the patient response is inconsistent based on information already obtained by the system, for example previous responses, results from previous medical examinations (i.e. feedback), and responses from medical screening questions (i.e. past medical records), and, when the response is inconsistent, inserts and presents additional questions e.g. see Thiese [0042] and [0051].); and
generate, via the question generation module, one or more follow-up questions to clarify any inconsistency when the one or more responses are not consistent with the past responses to the questions by the subject, the feedback, and/or the past medical records of the subject (The system may insert and present additional questions (i.e. follow-up questions) based on it identifying that a patient’s response is inconsistent, e.g. see Thiese [0042] and [0051].);
Furthermore, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Buisman, Ribbing, Poovey, and Martin to incorporate updating the questionnaire based on the received inconsistent patient responses as taught by Thiese in order to improve the ability of medical examiners to efficiently and completely determine and evaluate patient medical conditions, e.g. see Thiese [0023].
Regarding Claims 11-12 and 18, the limitations of Claims 11-12 and 18 are substantially similar to those claimed in Claims 3-4, with the sole difference being that Claims 3-4 recite a system, whereas Claims 11-12 recite a method and Claim 18 recites a non-transitory computer-readable medium. Specifically pertaining to Claims 11-12 and 18, Examiner notes that Buisman teaches that the invention may be embodied as instructions stored on a computer-readable medium that cause a computer processor to execute a method, e.g. see Buisman [0058], and hence the grounds of rejection provided above for Claims 3-4 are similarly applied to Claims 11-12 and 18.
Claims 5, 13, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Buisman, Ribbing, Poovey, and Martin in view of Huyn (US 2002/0035486).
Regarding Claim 5, the combination of Buisman, Ribbing, Poovey, and Martin teaches the limitations of Claim 1, but does not teach and Huyn teaches the following: The remote patient monitoring system of claim 1, wherein the processor-executable routines, when executed by the processing system, further cause the processing system to:
obtain, at a response understanding module, one or more responses from the subject to one or more questions from the personalized patient reported outcome questionnaire, wherein the one or more responses are outside a scope of the personalized patient reported outcome questionnaire but relevant to subsequent clinical decisions (The system administers questions to a user, wherein the user’s responses to the questions define which branches the system proceeds to, e.g. see Huyn [0055], Fig. 8A, wherein the questions may be for diseases and/or general clinical content, e.g. see Huyn [0069]-[0070] and [0074]. For example, a user answer to form F1 causes the system to evaluate conditions C12 and C13, where condition C12 being true causes the system to present form F2 to the user, and wherein the user answer to form F2 causes either condition C25 or condition C24 to be presented to the user, e.g. see Huyn [0055], Fig. 8A – that is, a user response to form F2 being true or false may be interpreted as “outside the scope of the questionnaire but relevant to subsequent clinical decisions.”); and
generate, via the question generation module, one or more follow-up questions based on the one or more responses (The system determines which subsequent (i.e. follow-up) questions should be presented to the user based on the user responses, e.g. see Huyn [0055], Fig. 8A.).
Furthermore, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Buisman, Ribbing, Poovey, and Martin to incorporate changing the content presented to the user in response to answers outside of the scope of the questionnaire as taught by Huyn in order to acquire broad, unbiased, and longitudinal data from patients for use in clinical and research applications, e.g. see Huyn [0012].
Regarding Claims 13 and 19, the limitations of Claims 13 and 19 are substantially similar to those claimed in Claim 5, with the sole difference being that Claim 5 recites a system, whereas Claim 13 recites a method and Claim 19 recites a non-transitory computer-readable medium. Specifically pertaining to Claims 13 and 19, Examiner notes that Buisman teaches that the invention may be embodied as instructions stored on a computer-readable medium that cause a computer processor to execute a method, e.g. see Buisman [0058], and hence the grounds of rejection provided above for Claim 5 are similarly applied to Claims 13 and 19.
Claims 6 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Buisman, Ribbing, Poovey, Martin, and Huyn in view of Cox (US 2017/0235895).
Regarding Claim 6, the combination of Buisman, Ribbing, Poovey, and Huyn teaches the limitations of Claim 5, but does not teach and Cox teaches the following: The remote patient monitoring system of claim 5, wherein the processor-executable routines, when executed by the processing system, further cause the processing system to:
analyze, via the response understanding module, the one or more responses from the subject utilizing a natural language understanding model to determine any facts outside the scope of the personalized patient reported outcome questionnaire but relevant to subsequent clinical decisions (The system receives patient answers to questions and utilizes cognitive natural language processing (NLP) to analyze the answer and determine whether the answer is correct and/or various facts contained in the answer, e.g. see Cox [0152]-[0153] and [0266]-[0269].);
Furthermore, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Buisman, Ribbing, Poovey, and Huyn to incorporate utilizing NLP to analyze the patient answers as taught by Cox in order to verify the accuracy of the patient answers, e.g. see Cox [0269].
Regarding Claim 14, the limitations of Claim 14 are substantially similar to those claimed in Claim 6, with the sole difference being that Claim 6 recites a system, whereas Claim 14 recites a method. Specifically pertaining to Claim 14, Examiner notes that Buisman teaches that the invention may be embodied as instructions stored on a computer-readable medium that cause a computer processor to execute a method, e.g. see Buisman [0058], and hence the grounds of rejection provided above for Claim 6 are similarly applied to Claim 14.
Response to Arguments
Applicant’s arguments, see Remarks, filed October 2, 2025, with respect to the rejections of Claims 1-6, 9-14, and 17-19 under 35 U.S.C. 101 have been fully considered but are not persuasive.
Applicants allege that the claimed invention is patent eligible because it does not recite an abstract idea, specifically because none of the claimed features of Claims 1, 9, and 17 are limitations that can be performed by a human and cannot be interpreted as following rules or instructions to diagnose or treat a patient, e.g. see pgs. 12-13 of Remarks – Examiner disagrees.
The claimed limitations of Claims 1, 9, and 17, cannot be performed by a human only insofar as the claims recite generic hardware limitations executing certain operations. For example, Claims 1, 9, and 17 recite “[obtaining] feedback from one or more sensors, wherein the feedback relates to one or more health parameters of a subject.” As shown above, Examiner has not interpreted the sensors as part of the abstract idea, but instead as additional elements. However, the function of “receiving health parameter data” is eminently capable of being performed by a human, and has indeed been an operation performed by a healthcare provider since long before the advent of any type of sensing device and/or computer technology. Similarly, obtaining past medical records and a clinical guideline, generating a personalized patient questionnaire, receiving responses to the personalized patient questionnaire, analyzing the responses, generating a report based on the analysis, logging edits to the report, and providing the edits to a model for the purpose of generating subsequent questions, are all operations that a human, for example a healthcare provider, is eminently capable of performing. Furthermore, as shown above, the language model itself is not interpreted as part of the abstract idea, but is also treated as an additional element that is claimed at such a high level of generality that it is properly interpreted as mere instructions to apply the abstract idea on a generic computer.
Furthermore, with regards to evidentiary burden pertaining to prong 1 of step 2A of the two-step analysis, Examiner notes that the court does not require “evidence” that a claimed concept is a judicial exception, and generally decides the legal conclusion of eligibility without resolving any factual issues, and further there is no requirement for the examiner to rely on evidence, such as publications or an affidavit or declaration under 37 CFR 1.104(d)(2), to find that a claim recites a judicial exception, e.g. see MPEP 2106.07(a)(III). As shown above, Examiner has clearly identified which limitations (i.e. the underlined limitations) are considered to recite an abstract idea (i.e. a certain method of organizing human activities), and which limitations (i.e. the non-underlined limitations) are considered to be additional elements, and hence has satisfied the requirements for prong 1 of step 2A.
Applicants further allege that the claimed invention is patent eligible because it integrates the judicial exception into a practical application, specifically because the identified additional elements perform “specific technical operations in a dynamic manner to provider for the digitization of guidelines to enable the following patient over time with respect to a condition,” and to achieve various other improvements such as “[enabling] the digitized guidelines to adapt to any changes…without any effort from their end,” e.g. see pgs. 14-16 of Remarks – Examiner disagrees.
Examiner notes that, as stated above, the sensors “[obtaining] feedback…wherein the feedback relates to one or more health parameters of a subject” is not a “technical operation” because the sensors are any sensors capable of receiving patient health data, the sensors are merely operating in any conventional way to obtain the patient health data, and moreover the aforementioned limitation represents operations a human, for example a healthcare provider, is eminently capable of performing. For example, [0035] of the as-filed Specification discloses that the obtained parameters include “heart rate or any other parameter.” A patient’s heart rate is capable of being measured by hand, for example by placing two fingers on the patient’s next and/or wrist, and this operation has been performed manually since well before the advent of electronic sensors.
Furthermore, with regards to the alleged improvements, even assuming, arguendo, that the claimed invention achieved the alleged improvements, the improvements represent improvements to the abstract idea itself rather than technological improvements, and an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology, e.g. see MPEP 2106.05(a)(II). For example, the improvement of making it more convenient for a healthcare provider to track patient responses to questionnaires, and the improvement of reducing the costs associated with providing healthcare represent improvements to the abstract idea of organizing human activities and/or financial/commercial improvements rather than technological improvements.
Applicants also allege that the claimed invention is patent eligible because it recites significantly more than a judicial exception, specifically because the additional elements are not well-understood, routine, or conventional, e.g. see pgs. 16-17 of Remarks – Examiner disagrees.
As shown above, the additional elements (the memory, the processing system executed by the processor, the sensors, the various modules of the processing system, and the language model) are well-understood, routine, and conventional because they are directed towards no more than limitations that amount to mere instructions to apply the exception, generally link the abstract idea to a particular technological environment or field of use, and/or add insignificant extra-solution activity to the abstract idea. Additionally, these assertions are supported by language recited in [0021]-[0022], [0034]-[0037], and [0078] of the as-filed Specification, which discloses that the additional elements comprise a plurality of different types of generic computing systems, and further supported by the cited legal precedent that is properly analogized to the specifics of the present claim language.
For the aforementioned reasons, Claims 1-6, 9-14, and 17-19 are rejected under 35 U.S.C. 101.
Applicant’s arguments, see Remarks, filed October 2, 2025, with respect to the rejections of Claims 1, 9, and 17 under 35 U.S.C. 102(a)(1) have been fully considered and, in combination with the claim amendments, are persuasive, as Buisman does not anticipate the features now amended into Claims 1, 9, and 17. Hence, the rejections of Claims 1, 9, and 17 under 35 U.S.C. 102(a)(1) have been withdrawn. However, as shown above and as will be further explained below, Claims 1, 9, and 17 are nonetheless rejected under 35 U.S.C. 103.
Applicant’s arguments, see Remarks, filed October 2, 2025, with respect to the rejections of the Claims under 35 U.S.C. 103 have been fully considered but are not persuasive.
Examiner notes that much of the claim language amended into Claims 1, 9, and 17 was previously recited in Claims 7-8, 15-16, and 20, which are now canceled. Accordingly, as shown above, Examiner has incorporated the previous grounds of rejection of Claims 7-8, 15-16, and 20 under 35 U.S.C. 103 as disclosed in the Non-Final Rejection mailed on July 14, 2025, into the current rejections of Claims 1, 9, and 17 under 35 U.S.C. 103.
Additionally, Applicants have not provided any specific arguments explaining why the cited portions/teachings of Ribbing and Poovey were previously deficient to teach the limitations of Claims 7-8, 15-16, and 20, and accordingly has not provided any specific arguments explaining how/why they are not properly applied to the now-amended Claims 1, 9, and 17.
Furthermore, regarding the limitations newly amended into Claims 1, 9, and 17 that were not imported from previous Claims 7-8, 15-16, and 20 (i.e. “the facts that are most relevant and novel presented at a beginning of the personalized patient reported outcome questionnaire report”), this limitation is taught by the newly-cited Martin reference, and hence any arguments pertaining to this limitation are moot because the arguments do not apply to any of the references being used in the current rejection. As stated above, the newly amended claim limitation has necessitated the new grounds of rejection, and Martin is now cited to address the newly amended claim limitation.
For the aforementioned reasons, Claims 1-6, 9-14, and 17-19 are rejected under 35 U.S.C. 103.
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 JOHN P GO whose telephone number is (703)756-1965. The examiner can normally be reached Monday-Friday 9am-6pm PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, PETER H CHOI can be reached at (469)295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN P GO/Examiner, Art Unit 3681