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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/30/2025 are in accordance with the provisions of 37 CFR 1.97 and are considered by the Examiner.
Priority
Claim KOREA, REPUBLIC OF 10-2022-0188758 12/29/2022 is/are acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 is rejected under lack of antecedent basis because previously talk about predicting or determining a change, but not a FINAL determining step.
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.
Non-Statutory Categories Rejection
The claim 10 do not fall within any of the four statutory categories (process, machine, manufacture, composition) because under BRI, "hardware" is not positive claimed, is mentioned as another elements that performed the method, therefore is software or signal per se, which is outside the statutory categories; therefore Step 1 = NO. For the purpose of compact prosecution, the examiner continues with the 35 U.S.C. § 101 subject matter analysis in assumption of a future amendment to correct the non-transitory rejection.
Subject Matter Eligibility Rejection 35 U.S.C. § 101
Claims 1-10 are rejected under 35 U.S.C. § 101 because the claimed subject matter is directed to a judicial exception (an abstract idea) without reciting elements that integrate the exception into a practical application or provide an inventive concept amounting to significantly more than the exception itself.
Step 1: Statutory Categories Analysis
The claims are directed to statutory subject matter, encompassing the following statutory categories:
Process (Claims 1-8): The language reciting defines a series of acts or steps, aligning with the definition of a process in MPEP § 2106.03.
Machine (Claims 9): The language reciting describes a concrete thing consisting of parts, aligning with the definition of a machine in MPEP § 2106.03.
Manufacture (Claims 10): The language reciting describes a tangible article given a form through artificial efforts, aligning with the definition of a manufacture in MPEP § 2106.03.
For compact prosecution, the analysis proceeds to Step 2A assuming claim 10 is amended to positively recite a statutory non-transitory computer-readable recording medium. Under that assumed amendment, claim 10 would be treated as a manufacture because it would recite a tangible article storing instructions.
Step 2A, Prong One: Judicial Exception Evaluation
The objective of 35 U.S.C. § 101 Step 2A Prong One is to determine whether a claim recites a judicial exception such as an abstract idea.
The representative independent claim 1 recites the following non-bold abstract idea, bold mean additional elements in the purpose to be evaluated in prong two and step 2B:
Claim 1.
A service provision method for determining activity of a disease performed by a computing device, the method comprising:
1.acquiring information on a user's disease;
2.collecting symptom information about various diseases;
3.generating a plurality of pieces of question information and a plurality of answer lists for evaluating activity of each of the various diseases on the basis of the collected symptom information;
4.providing the user with question information and answer lists corresponding to the user's disease; and
5.determining activity of the user's disease on the basis of answers to the question information acquired from the user.
Under the broadest reasonable interpretation (BRI) consistent with the specification, claim 1 recites abstract ideas. Limitation(s) 1-5, requires evaluation and organizing human activity. This falls within the USPTO grouping of mental processes and certain methods of organizing human activity - Managing Personal Behavior or Relationships or Interactions Between People because the claim can be practically performed in the human mind or with pen and paper and claim manages human conduct or interpersonal interaction, including social activities, teaching, and following rules or instructions.
For example, claim 1 can reasonably be read to cover actions a doctor could perform mentally or with ordinary communication during a patient evaluation. A doctor may:
obtain information about the patient’s disease through observation or by questioning the patient;
prepare questions and answer options for evaluating different diseases based on reported symptoms; and
determine the activity of the patient’s disease based on the patient’s answers.
Accordingly, this example supports the conclusion that limitations 1–5 of claim 1 can be performed using identified abstract idea above.
Dependent Claims Analysis
Claims 2, 5, 6, 7, and 8 incorporate the abstract idea of Claim 1 and narrow the same information-evaluation workflow. Claim 2 classifies symptom questions and answer lists by disease. Claim 5 predicts disease activity from a key question and auxiliary questions. Claim 6 separates common symptoms by severity and evaluates whether another disease may be present. Claim 7 compares current and prior measurement values. Claim 8 provides the determined activity to the user, hospital, or doctor. These limitations remain mental evaluation or management of healthcare interactions.
Claims 3 and 4 additionally recite mathematical concepts. Claim 3 recites calculating a score, integrating the calculated scores, and comparing the integrated score with a prior or reference score. Claim 4 recites extracting weights, applying weights to scores, and integrating weighted scores. These limitations use mathematical calculations as the rule for determining disease activity.
Claims 9 and 10 recite the same abstract idea in device and program form because they merely implement the method of Claim 1 using processor, memory, program, recording-medium, and computer-hardware language.
Accordingly, Claims 1-10 recite an abstract idea. Step 2A, Prong One: YES
The analysis shows that all claims recite a judicial exception. The analysis must proceed to Step 2A Prong Two to determine if these elements integrate the exception into a practical application.
Step 2A, Prong Two: Integration into a Practical Application
Prong Two evaluates whether the claim, as a whole, applies the exception in a manner that imposes a meaningful limit on the exception.
The claim 1 recites the following additional element beyond the abstract idea: computing device.
The computing device does not integrate the exception into a practical application because the claim uses it only as a tool to perform the abstract steps of limitations 1-5 of claim 1. The claim does not recite a specific processor architecture, a particularized technical operation, or a change in computer functionality. Instead, the claim requires ordinary computer execution of the abstract idea, which amounts to mere instructions to apply the exception using a computer under MPEP 2106.05(f).
Dependent Claims
Claims 2-6 and 8 do not add new tangible additional elements beyond the computing device already addressed for Claim 1. These claims use the same computing-device environment to further define the abstract disease-evaluation workflow by specifying symptom classification, question generation, score calculation, weighted scoring, severity matching, another-disease evaluation, and providing the disease-activity result to a user, hospital, or doctor. Because these limitations only refine the abstract idea identified in Prong One, they do not integrate the exception into a practical application.
Claim 7 adds the only dependent-claim tangible element, namely a measurement device owned by the user. This element does not integrate the exception into a practical application because it is used only to acquire a measurement value for comparison with a previously acquired value. Refer to MPEP 2106.05(g)
Claims 9 and 10 also add tangible computer-form elements, but they are independent/device-program form claims tied to the same method “apply it”.
When considered individually and as an ordered combination, claim 1-10 does not integrate the recited judicial exception into a practical application. The claims 1-10 does not recite how these elements operate in a non-generic manner, does not require a specific technical mechanism, does not improve the functioning of a computer, network, database, medical device, or healthcare technology, does not transform an article, and does not apply the exception to effect a particular treatment or prophylaxis. Instead, the claim uses the additional elements as tools or an environment for applying the abstract idea.
Step 2B: Inventive Concept
Step 2B evaluates whether the additional elements, individually or as an ordered combination, add significantly more than the judicial exception. The additional elements carried over from Prong Two are the computing device of Claim 1, the measurement device of Claim 7, and the memory, processor, recording-medium, and computer-hardware form of Claims 9 and 10.
Independent Claim 1
The computing device of Claim 1 does not provide an inventive concept. The claim uses the computing device only to execute the abstract disease-activity workflow: acquiring disease information, collecting symptom information, generating questions and answer lists, providing them to the user, and determining disease activity from answers. The claim does not require a non-conventional computer arrangement, a specific processor architecture, or a technical improvement to computer functionality.
The specification supports this determination. The service provision device is described as including ordinary computer components: processor, memory, bus, communication interface, and storage. The processor may be a central processing unit CPU, a micro-processor unit MPU, a micro-controller unit MCU, a graphics processing unit GPU, or any form of processor well known in the technical field. The communication interface supports wired or wireless Internet communication and may include a communication module well known in the technical field. The storage may include ROM, EPROM, EEPROM, flash memory, hard disk, removable disk, CD-ROM, or any form of computer-readable recording medium well known in the technical field. See Spec., paras. [0047]-[0055].
Accordingly, Claim 1 does not add significantly more than the abstract idea. The ordered combination is the abstract disease-evaluation process performed by a computing device, without changing how the computer operates. Step 2B for Claim 1: NO.
Dependent Claims
Claims 2-6 and 8 do not add an inventive concept because they do not add new tangible structure or a specific technology. These claims further define the abstract rules for classifying symptoms, generating disease-specific questions, calculating and comparing scores, applying weights, using key and auxiliary questions, matching symptom severity to diseases, evaluating another disease, and providing the disease-activity result to a user, hospital, or doctor. These limitations refine the abstract idea identified prong one.
Claim 7 adds a measurement device owned by the user, but this element does not provide an inventive concept because it merely supplies another input for the same abstract disease-activity evaluation. See Spec., paras. [0098]-[0102].
Claim 9 adds a memory and a processor, but these elements do not provide an inventive concept because they only execute instructions to perform the method of Claim 1. See Spec., paras. [0048]-[0051] and [0056]-[0057].
Claim 10, assuming amendment to statutory form, adds a recording medium and computer hardware, but these elements do not provide an inventive concept because they store and execute instructions for the same abstract method. The specification describes software modules, program instructions, and computer-readable media broadly, including generic storage media and ordinary processor execution. See Spec., paras. [0055]-[0059].
When Claims 1-10 are viewed as an ordered combination, the additional elements perform expected information-processing roles: receiving disease, symptom, answer, score, or measurement information; storing information; executing the evaluation; comparing current and prior information; and providing the disease-activity result. The combination does not change the physical or logical operation of a computer, memory, storage medium, communication interface, measurement device, or healthcare technology. It also does not require a particular treatment, prophylaxis, device control, or technical remediation.
Accordingly, the additional elements, individually and as an ordered combination, do not amount to significantly more than the judicial exception. Step 2B: NO.
Therefore, Claims 1-10 are patent-ineligible under 35 U.S.C. § 101.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 6, and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huyn- US20020035486A1
[Claim 1]
Hyun teaches,
A service provision method for determining activity of a disease performed by a computing device, the method comprising: (Hyun, abstract, par. 0004)
acquiring information on a user's disease;(Hyun, par. 0013… obtaining clinical data from subjects… par. 0014… obtaining medical questions and question linking conditions from a database… presenting at least one of the medical questions to a user…. depending upon the response data and question linking conditions)
collecting symptom information about various diseases;(Hyun, par. 0039… gathering from a large number of subjects… gathering a large amount of data for storage in a database and subsequent data mining, the invention allows for new correlations to be made, potentially providing for disease mechanism elucidation and earlier disease diagnosis…. allows for identification of subtle patterns of symptoms that are currently unrecognized…)
generating a plurality of pieces of question information and a plurality of answer lists for evaluating activity of each of the various diseases on the basis of the collected symptom information;(Hyun, par. 0067… questionnaire designer creates and edits questionnaires…par. 0055… system evaluates conditions C12 and C13 based on responses to specific questions in form F1. If condition C12 evaluates to true, then form F2 is presented to the subject next. Otherwise, if condition C13…, Fig. 11A)
A person of ordinary skill in the art would understand that Hyun’s describe creates questionnaires intended for use across multiple diseases, because the forms shown in Figure 11A contain questions and answer lists designed to identify a variety of disease conditions.
providing the user with question information and answer lists corresponding to the user's disease;(Hyun, par. 0015.. The user can also be presented with a set of disease-specific questions corresponding to the identified medical pathway…)
and
determining activity of the user's disease on the basis of answers to the question information acquired from the user. (Hyun, par. 0059… The web browser evaluates all question linking conditions and displays the resulting questions to the user at state 130…. Par. 0007… health status, or any conclusions inferred from the patient's responses…par.0052, par. 0014… question linking conditions … receiving response data from the user… 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… Responses are preferably weighted, and the evaluation conditions (form assembly, question assembly, or question linking) depend on the response weights… par.0085…responses is indicative of a disease, par. 0098… determine the severity of the symptoms… but if the symptoms are not severe, the patient is simply informed of the condition…par.0099… a rapid increase in symptom severity may correspond to a medical condition, while a decrease in symptom severity over time will not trigger a warning…)
Hyun, increases in symptom answer-user-base severity or response weight correspond to increased disease activity.
[Claim 2] Hyun teaches, The service provision method of claim 1, wherein the generating of the plurality of pieces of question information and the answer lists comprises:
extracting symptom information common to several diseases from symptom information about the various diseases; (Hyun, par. 0013… detailed questions are presented that follow a medical pathway leading to a potential medical condition. However, a broad range of questions is generally presented to all users, regardless of responses….par.0039… a broad range of questions are presented, regardless of the subject's dominant symptoms or concerns…par.0043 data mining… common markers are identified…par.0054. 0072, 0084)
generating question information about symptom information not common to several diseases and the common symptom information in the symptom information;(Hyun, par. 0051… can focus on a particular organ system…)
generating a plurality of answer lists corresponding to the question information;(Hyun, par. 0067… designer assembles responses into lists… selects a form and potential questions and assigns a condition to each question… par. 0084)
and
classifying the generated question information and the answer lists by disease. (Hyun, par. 0069, 0051)
[Claim 3]
Hyun teaches,
The service provision method of claim 2, wherein the determining of the activity of the user's disease comprises:
receiving at least one selected from a plurality of answers to each piece of the question information from the user; (Huyn, receiving response data from the user, par. 0014; each potential question can be associated with one or more response items ... from which a user selects, par. 0051. )
when answers to the question information are input, calculating a score corresponding to an answer selected for each piece of the question information and integrating the calculated scores; (Huyn, responses are weighted ... a question is presented if the weighted sum of previous responses exceeds a set value, par. 0085. )
and comparing the integrated score with a score integrated on the basis of answers to the question information previously acquired from the user or a reference score for each disease and determining activity of the user's disease in accordance with a comparison result.( Huyn, If the total score is higher than a predetermined amount, the system is triggered, par. 0085; a rapid increase in symptom severity may correspond to a medical condition, par. 0099)
[Claim 4]
Hyun teaches,
The service provision method of claim 3, wherein the integrating of the calculated scores comprises:
extracting weights set for the question information; ( Huyn, question responses are weighted in dependence on the severity of the symptom, par. 0085; the weighting can be stored in the database, par. 0085.)
calculating scores by applying the weights set for the question information in accordance with diseases to scores corresponding to the selected answers to the question information; ( Huyn, positive responses to questions 182 ... receive a higher weight than positive responses to questions 180, par. 0086; the evaluating logic can assign various weights to combinations of responses, par. 0086)
and integrating the scores to which the weights are applied. (Huyn, the weighted sum of previous responses, par. 0085)
[Claim 6]
Huyn teaches,
The service provision method of claim 2, wherein the generating of the plurality of pieces of question information and the plurality of answer lists comprises:
separating the common symptom information into a plurality of sections in accordance with symptom severity; (Huyn, Questions are structured into hierarchical levels that reflect symptom severity or specificity, par. 0013; How severe is your headache? Extremely severe ... Moderately severe ... Mildly severe ... Minimally severe, FIG. 11B)
and
matching a disease to symptom severity corresponding to each section and storing corresponding data, (Huyn, a positive response for headaches is considered to be a frequency of "All Days," ... a severity of "Extremely severe," or "Moderately severe", par. 0073; Medical pathways are preferably stored in the database in two tables, par. 0095)
and the determining of the activity of the user's disease comprises:
extracting an answer to the question information corresponding to the common symptom information from the answers to the question information acquired from the user; (Huyn, Huyn, the same or similar questions are presented on different forms, and the responses are compared, par. 0084, Huyn pulls and compares responses to the same shared-symptom question across forms)
when the extracted answer corresponds to symptom severity of a disease other than the user's disease, providing question information and an answer list corresponding to the other disease to the user;(Huyn, Consider Rheumatoid Arthritis • Please complete Rheumatoid Arthritis questionnaire, FIG. 16; The user can also be presented with a set of disease-specific questions corresponding to the identified medical pathway, par. 0015, When responses trace a pathway to another condition, Huyn directs the user to complete that disease's questionnaire, FIG. 16 and par. 0015, reading on providing the other disease's questions and answer list..)
and determining whether the user has the other disease on the basis of an answer to the question information acquired from the user. (Huyn, Medical pathways can trigger clinical warnings to the patient or physician, par. 0096, The other-disease questionnaire feeds a medical pathway that triggers clinical warnings, identifying that condition, reading on determining whether the user has the other disease.)
[Claim 8]
Huyn teaches,
The service provision method of claim 1, further comprising:
providing the determined activity of the disease to the user; (Huyn, a summary analysis can be presented to the user or to a physician, par. 0014; the patient can use the summary to help determine whether he or she should seek medical attention, par. 0094,Huyn presents the summary analysis and graded clinical warnings to the user, par. 0014 and 0094, reading on providing the determined activity to the user.)
and providing the determined activity of the disease to a hospital or a doctor designated by the user in accordance with the activity of the disease. (Huyn, the web server links to an application that alerts the subject's identified physician or other designated person via, for example, email, telephone, or pager, par. 0097; if the symptoms are severe, the patient is advised to seek medical attention immediately, par. 0098, Huyn alerts the subject's identified physician or other designated person, par. 0097, and graduates that action to severity, par. 0098, reading on providing the activity to a doctor designated by the user in accordance with the activity.)
[Claim 9]
Huyn taches,
A device, comprising:
a memory configured to store one or more instructions; (Huyn, fig. 1-fig.5)
and
a processor configured to execute the one or more instructions stored in the memory,
wherein the processor performs the method of claim 1 by executing the one or more instructions.(Huyn, fig. 1-fig.5)
[Claim 10] A computer program stored in a computer-readable recording medium to perform the method of claim 1 in combination with a computer which is hardware. (Huyn, fig. 1-fig.5, par.0045)
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huyn - US20020035486A1 and further in view of Tran - US8684922B2
[Claim 5]
Huyn teaches,
The service provision method of claim 1, wherein the determining of the activity of the user's disease comprises:
; for determining the activity of the disease; Huyn, How would you describe your headaches over the last month? ... It is getting worse ... No change ... It is getting better, FIG. 11B; a rapid increase in symptom severity may correspond to a medical condition, par. 0099. )
and when the activity of the user's disease is predicted to increase, determining a change in the activity of the user's disease,
wherein the final determining of the change in the activity of the disease
further comprises determining that the user's disease has worsened when the activity of the disease is determined to have increased as a result of analyzing answers to auxiliary questions,
and determining that the user's disease has improved when the activity of the disease is determined to have decreased.(Huyn, par. 0015, fig. 11B)
Huyn's higher-level questions trigger ... lower-level questions, mapping primary→auxiliary, and its change descriptors capture worse/better, FIG. 11B.
Huyn does not teach predicting the activity increase and then determining that the user's disease has worsened ... or ... improved as an automated verdict.
Tran teaches that missing feature, as shown by Certain cardiac conditions can be controlled, and in some cases predicted, before they actually occur, and observe trends in the data, such as a gradual increase or decrease in blood pressure, which may indicate a medical condition(Col.4, ll.10-40), and can ask a confirmatory question to the patient through text to speech software. (Col.17, ll.55-67). This reads on predicting a change and on determining ... worsened ... or ... improved through auxiliary questions, because Tran forecasts the condition, treats a rising value as deterioration and a falling value as improvement, and poses a confirmatory follow-up question to verify the change.
A person of ordinary skill in the art would have applied Tran's prediction-and-confirmation technique to Huyn's key-and-auxiliary questionnaire under KSR Rationale D applying a known technique to a known device ready for improvement integrating Huyn: Positive responses to higher-level questions trigger presentation of lower-level questions with Tran: can ask a confirmatory question to the patient, by using Huyn's primary question to predict an activity increase and Huyn's lower-level questions as the auxiliary questions that, per Tran's gradual increase or decrease ... which may indicate a medical condition (Col.22, ll.37-53), render the verdict, because Huyn already assesses whether a symptom is getting worse and is ready for the automated determination Tran supplies. Doing so would have predictably produced an automated determination that the user's disease worsened or improved, rather than leaving Huyn's worsening signal unresolved.
[Claim 7]
Huyn teaches,
The service provision method of claim 1, wherein the acquiring of the information on the user's disease further comprises:
acquiring a measurement value using a measurement device (Huyn, response data can be received directly from a medical instrument, par. 0014; medical instruments for noninvasive physical testing, such as a blood pressure cuff, pulse oximeter, thermometer, or inspirometer, par. 0046; a patient complaining of weakness can be asked to squeeze a deformable handle; the results, recorded electronically, become part of the data, par. 0082. )
and the determining of the activity of the user's disease further comprises . (. Huyn stores all time-varying data, par. 0088, and evaluates ranges of measurement values, par. 0083, supporting longitudinal use of measurements.)
Huyn teaches device-sourced measurement input keyed to the complaint, as shown above.
However, Huyn does not teach a measurement device owned by the user nor comparing the measurement value with a measurement value previously acquired from the user using the measurement device to determine activity.
Tran teaches that missing feature, as shown by a blood pressure monitor, heart rate monitor, weight scale, thermometer, spirometer ... a pulse oxymeter, a body fat monitor, a cholesterol monitor, by measurements are made at the patient's home or work, rather than in a medical office (Col.6, ll.45-67), and by the table then calculates the difference between the running average and suggested values (Col.24, ll. 1-25). This reads on a measurement device owned by the user and on comparing the measurement value with a measurement value previously acquired from the user ... to determine activity, because Tran's home/worn devices are operated and held by the patient and Tran compares the patient's running history of readings to gauge the patient's condition.
A person of ordinary skill in the art would have combined Huyn with Tran because Huyn itself invites device measurements, Huyn: response data can be received directly from a medical instrument and conditions can then include, e.g., ranges of measurement values detected during the tests, 0083, while Tran supplies the patient-owned device and the prior-reading comparison, Tran: the table then calculates the difference between the running average and suggested values, by having Huyn's disease-keyed questionnaire pull the reading from the patient's own home device of Tran and compare it to the patient's earlier reading. Doing so would have predictably yielded a disease-activity determination corroborated by the user's own objective home measurements tracked over time, which is the exact measurement-range use Huyn already contemplated.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DAMIAN RUIZ whose telephone number is (571)272-0409. The examiner can normally be reached 0800-1800.
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/JOSHUA DAMIAN RUIZ/Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684
Prosecution Insights