DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This action is in reply to the claims filed on 02 July 2025. Claims 1, 3, 5, 11-12, and 15 were amended. Claims 4, 8-10, and 13 were canceled. Claims 1-3, 5-7, 11-12, and 14-15 currently pending and have been examined.
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 1-3, 5-7, 11-12, and 14-15 are rejected under 35 USC § 101
Step 2A Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1-3, 5-7, 11-12, and 14-15 recite an abstract idea. Representative claim 1 recites:
… generate a medical questionnaire item;
… generate an auxiliary answer to the medical questionnaire item on the basis of patient medical record information;
… transmit the medical questionnaire item and the auxiliary answer to the medical questionnaire terminal and to receive answer information input by a patient from the medical questionnaire terminal; and
store the answer information of the patient,
wherein, in response to the answer information input for the medical questionnaire item by the patient not matching the auxiliary answer:
… [generate] an additional medical questionnaire item based on the answer information input by the patient.
Therefore, the claim as a whole is directed to “filling out a medical questionnaire,” which is an abstract idea because it is a method of organizing human activity. “Filling out a medical questionnaire” is considered to be a method of organizing human activity because it is an example of managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The broadest reasonable interpretation of the claims includes the interaction between a healthcare provider and a patient.
Alternatively, the claims are directed to a mental process, because it recites concepts capable of being performed in the human mind (including an observation, evaluation, judgment, opinion), with the aid of pen and paper.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This judicial exception is not integrated into a practical application. In particular, claim 1 recites the following additional element(s):
a medical questionnaire server comprising a processor and a memory; and
a medical questionnaire terminal;
a medical questionnaire item generation unit;
an auxiliary answer generation unit;
a communication interface;
a medical questionnaire result storage unit;
the medical questionnaire terminal displays the additional medical questionnaire item.
The additional elements individually or in combination do not integrate the exception into a practical application. These additional elements merely recite the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Claim 1 is directed to an abstract idea.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Claim 1 does not include additional elements, considered individually or in combination, 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 element(s), individually and in combination, merely recite the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, claim 1 is ineligible.
Dependent claim 2 recites the method of claim 1, wherein:
the medical questionnaire item generation unit generates the medical questionnaire item on the basis of the patient medical record or a request from a medical staff
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 2 is considered to be ineligible.
Dependent claim 3 recites the method of claim 1, wherein:
the patient medical record information includes at least one of patient medical record information stored in an electronic medical record server, previously performed medical questionnaire result information, and information received from a personal device of the patient.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 3 is considered to be ineligible.
Dependent claim 5 recites the method of claim 1, wherein:
a reference information generation unit configured to generate reference information displayed to the patient through a medical questionnaire terminal so that the patient is able to refer to the reference information while creating a medical questionnaire,
wherein the reference information comprises one or more records extracted from the patient medical record information, and
wherein the reference information generation unit generates the reference information on the basis of information associated with the medical questionnaire item in the patient medical record information.
The additional elements present in this claim merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). These types of additional elements are not enough to integrate the abstract idea into a practical application, nor do they amount to significantly more than the judicial exception. Accordingly, claim 5 is ineligible.
Dependent claim 6 recites the method of claim 1, wherein:
a medical questionnaire result stored in the medical questionnaire result storage unit includes answer information of the patient for the medical questionnaire item and the auxiliary answer generated by the auxiliary answer generation unit.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 6 is considered to be ineligible.
Dependent claim 7 recites the method of claim 1, wherein:
the medical questionnaire terminal includes an interface for displaying medical questionnaire items generated by the medical questionnaire item generation unit, and input cells to which a patient inputs answers to the medical questionnaire items, and
the interface displays the auxiliary answer generated by the auxiliary answer generation unit to a user.
The additional elements present in this claim merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). These types of additional elements are not enough to integrate the abstract idea into a practical application, nor do they amount to significantly more than the judicial exception. Accordingly, claim 7 is ineligible.
Claim 11-12 and 14 are parallel in nature to claims 1-3 and 5-7. Accordingly claims 11-12 and 14 are rejected as being directed towards ineligible subject matter based upon the same analysis above.
Claim 15 recites the method of claim 11. Accordingly claim 15 is rejected as being directed towards ineligible subject matter based upon the same analysis above.
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.
Claims 1-3, 5-7, 11-12, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Deno et al. (U.S. 2021/0134403), hereinafter “Deno,” and further in view of Selim (U.S. 2011/0225000), hereinafter “Selim.”
Regarding claim 1, Deno discloses a patient-customized electronic medical questionnaire system comprising:
a medical questionnaire item generation unit configured to generate a medical questionnaire item (template data. Medical interview items differ for each clinical department, and thus a plurality of types of medical questionnaire template data are prepared. [0052] on the basis of each of this acquired data and the medical questionnaire template data, medical questionnaire basic data pertaining to the patient are created. See also Fig. 5.);
a medical questionnaire server comprising a processor and a memory (See Deno Fig. 2 and [0057] the system employs the use of EMR servers connected to physician terminals and medical questionnaire creation assist terminal.); and
a medical questionnaire terminal (See Deno Fig. 2 and [0057] the system employs the use of EMR servers connected to physician terminals and medical questionnaire creation assist terminal.);
wherein the medical questionnaire server comprises:
an auxiliary answer generation unit configured to generate an auxiliary answer to the medical questionnaire item on the basis of patient medical record information (See Deno [0090]-[0092] the system can collect EMR and PHR data about the patient for use in filling out the medical questionnaire. [0093] the system then edits the data to be used in the medical questionnaire template. [0052] on the basis of each of this acquired data and the medical questionnaire template data, medical questionnaire basic data pertaining to the patient are created. See also Fig. 5.);
a communication interface configured to transmit the medical questionnaire item and the auxiliary answer to the medical questionnaire terminal and to receive answer information input by a patient from the medical questionnaire terminal (See Deno [0100] the system can indicate what information is incomplete and information is further required from the patient. [0099] the medical questionnaire basic data is transmitted and display to the patient. See also Fig. 5.); and
a medical questionnaire result storage unit configured to store the answer information of the patient (See Deno [0107] the system stores the final result of the questionnaire in a storage unit. See also Fig. 5.),
wherein, in response to the answer information input for the medical questionnaire item by the patient not matching the auxiliary answer: [perform an action] See Deno [0100] the system can indicate what information is incomplete and information is further required from the patient. [0105] the user can elect an interview item that has diverged from the current condition of the patient or is preferably not to be entered (i.e. the input does not match the patient’s answer).).
Deno does not disclose:
the medical questionnaire item generation unit generates an additional medical questionnaire item based on the answer information input by the patient, and
the medical questionnaire terminal displays the additional medical questionnaire item.
Selim teaches:
the medical questionnaire item generation unit generates an additional medical questionnaire item based on the answer information input by the patient (See Selim [0073] During the generalized collection process additional information may become beneficial and as such the system may generate additional screens for collecting the additional information from the patient. [0074] during the information collection process a predefined trigger or condition may occur which will allow the system to generate additional screens or forms from the form repository.), and
the medical questionnaire terminal displays the additional medical questionnaire item (See Selim [0073] During the generalized collection process additional information may become beneficial and as such the system may generate additional screens for collecting the additional information from the patient. These questionnaire screens are understood to be displayed to the user for collection of the requested information on the screens.).
The system of Selim is applicable to the disclosure of Deno as they both share characteristics and capabilities, namely, they are directed to the collection patient information with generated questionnaires. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Deno to include the generation of additional questionnaire items in response to triggers as taught by Selim. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Deno in order to support the evolving model of health care that includes medical payment providers and patients becoming more actively involved in the health care process (see Selim [0005]).
Regarding claim 2, Deno in view of Selim discloses the system of claim 1 as discussed above. Deno further discloses a system, wherein:
the medical questionnaire item generation unit generates the medical questionnaire item on the basis of the patient medical record or a request from a medical staff (See Deno [0042] the system uses medical questionnaire template data. Medical interview items differ for each clinical department, and thus a plurality of types of medical questionnaire template data are prepared. [0052] on the basis of each of this acquired data and the medical questionnaire template data, medical questionnaire basic data pertaining to the patient are created. See also Fig. 5.).
Regarding claim 3, Deno in view of Selim discloses the system of claim 1 as discussed above. Deno further discloses a system, wherein:
the patient medical record information includes at least one of patient medical record information stored in an electronic medical record server (See Deno [0090] system collects EMR data from a EMR server.), previously performed medical questionnaire result information (See Deno [0091] the collected data can be based on previous visits. See also [0027].), and information received from a personal device of the patient (See Deno [0092] PHR is collected from the mobile terminal of the patient. [0043] the PHR data can be acquired form a smart phone possessed by the patient.).
Regarding claim 5, Deno in view of Selim discloses the system of claim 1 as discussed above. Deno further discloses a system, comprising:
a reference information generation unit configured to generate reference information displayed to the patient through a medical questionnaire terminal so that the patient is able to refer to the reference information while creating a medical questionnaire (See Deno [0102] that system can provide list information of input candidates for information missing from the questionnaire.),
wherein the reference information comprises one or more records extracted from the patient medical record information (See Deno [0044] the system acquires the EHR data or the EMR data of the patient from an EHR server or an EMR server. See also [0103].), and
wherein the reference information generation unit generates the reference information on the basis of information associated with the medical questionnaire item in the patient medical record information (See Deno [0103] the list can be of potentially relevant symptoms for the user to considered, based on information connected to the user (such as medical history and time/location for disease trends). See also [0114].).
Regarding claim 6, Deno in view of Selim discloses the system of claim 1 as discussed above. Deno further discloses a system, wherein:
a medical questionnaire result stored in the medical questionnaire result storage unit includes answer information of the patient for the medical questionnaire item and the auxiliary answer generated by the auxiliary answer generation unit (See Deno [0107] the system stores the final result of the questionnaire in a storage unit. This includes the automatically provided information and the patient provided information. See also Fig. 5).
Regarding claim 7, Deno in view of Selim discloses the system of claim 1 as discussed above. Deno further discloses a system, wherein:
the medical questionnaire terminal includes an interface for displaying medical questionnaire items generated by the medical questionnaire item generation unit, and input cells to which a patient inputs answers to the medical questionnaire items (See Deno [0099] the medical questionnaire data is displayed for the user to fill out. [0041] the system can include an input function using a display and touch panel. See also Figs. 5-6), and
the interface displays the auxiliary answer generated by the auxiliary answer generation unit to a user (See Deno [0099] the medical questionnaire data is displayed for the user to fill out. [0041] the system can include an input function using a display and touch panel. See also Figs. 5-6).
Regarding claim 11, Deno discloses a medical questionnaire method performed by an electronic medical questionnaire system comprising:
a medical questionnaire terminal and a medical questionnaire server comprising a processor and a memory (See Deno Fig. 2 and [0057] the system employs the use of EMR servers connected to physician terminals and medical questionnaire creation assist terminal.), the method, comprising:
generating, by a medical questionnaire item generation unit of the medical questionnaire server, a medical questionnaire item for a patient on the basis of information stored in a medical questionnaire item storage unit of the medical question server (See Deno [0042] the system uses medical questionnaire template data. Medical interview items differ for each clinical department, and thus a plurality of types of medical questionnaire template data are prepared. [0052] on the basis of each of this acquired data and the medical questionnaire template data, medical questionnaire basic data pertaining to the patient are created. See also Fig. 5.);
generating, by an auxiliary answer generation unit of the medical questionnaire server, an auxiliary answer to be suggested to the patient for the generated medical questionnaire item, on the basis of patient medical record information stored in a database (See Deno [0090]-[0092] the system can collect EMR and PHR data about the patient for use in filling out the medical questionnaire. [0093] the system then edits the data to be used in the medical questionnaire template. [0052] on the basis of each of this acquired data and the medical questionnaire template data, medical questionnaire basic data pertaining to the patient are created. See also Fig. 5.);
transmitting, by a communication interface of the medical questionnaire server, the medical questionnaire item and the auxiliary answer to the medical questionnaire terminal (See Deno [0100] the system can indicate what information is incomplete and is further required from the patient. [0099] the medical questionnaire basic data is transmitted and display to the patient. See also Fig. 5.);
displaying, by the medical questionnaire terminal, the medical questionnaire item and the auxiliary answer to the patient (See Deno [0100] the system can indicate what information is incomplete and is further required from the patient. [0099] the medical questionnaire basic data is transmitted and display to the patient. See also Fig. 5.);
receiving, by the medical questionnaire server through the medical questionnaire terminal an answer result input through the medical questionnaire terminal (See Deno [0100] the system can indicate what information is incomplete and is further required from the patient. [0099] the medical questionnaire basic data is transmitted and display to the patient. See also Fig. 5.) and
storing, by the medical questionnaire server, the answer result in a medical questionnaire result storage unit of the medical questionnaire server (See Deno [0107] the system stores the final result of the questionnaire in a storage unit. See also Fig. 5.),
wherein, in response to the answer information input for the medical questionnaire item not matching the auxiliary answer: [perform an action] (See Deno [0100] the system can indicate what information is incomplete and information is further required from the patient. [0105] the user can elect an interview item that has diverged from the current condition of the patient or is preferably not to be entered (i.e. the input does not match the patient’s answer).).
Deno does not disclose:
the medical questionnaire item generation unit generates an additional medical questionnaire item based on the answer information input by the patient, and
the medical questionnaire terminal displays the additional medical questionnaire item.
Selim teaches:
the medical questionnaire item generation unit generates an additional medical questionnaire item based on the answer information input by the patient (See Selim [0073] During the generalized collection process additional information may become beneficial and as such the system may generate additional screens for collecting the additional information from the patient. [0074] during the information collection process a predefined trigger or condition may occur which will allow the system to generate additional screens or forms from the form repository.), and
the medical questionnaire terminal displays the additional medical questionnaire item (See Selim [0073] During the generalized collection process additional information may become beneficial and as such the system may generate additional screens for collecting the additional information from the patient. These questionnaire screens are understood to be displayed to the user for collection of the requested information on the screens.).
The system of Selim is applicable to the disclosure of Deno as they both share characteristics and capabilities, namely, they are directed to the collection patient information with generated questionnaires. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Deno to include the generation of additional questionnaire items in response to triggers as taught by Selim. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Deno in order to support the evolving model of health care that includes medical payment providers and patients becoming more actively involved in the health care process (see Selim [0005]).
Regarding claim 12, Deno in view of Selim discloses the method of claim 11 as discussed above. Deno further discloses a method, comprising:
generating reference information on the basis of information associated with the generated medical questionnaire item in the patient medical record information stored in the database (See Deno [0102] that system can provide list information of input candidates for information missing from the questionnaire.),
wherein the reference information comprises one or more records extracted from the patient medical record information (See Deno [0044] the system acquires the EHR data or the EMR data of the patient from an EHR server or an EMR server. See also [0103].), and
wherein the generated reference information is transmitted to the medical questionnaire terminal and displayed together with the medical questionnaire item (See Deno [0103] the list can be of potentially relevant symptoms for the user to considered, based on information connected to the user (such as medical history and time/location for disease trends). See also [0114].).
Regarding claim 14, Deno in view of Selim discloses the method of claim 11 as discussed above. Deno further discloses a method, wherein:
in the storing of the medical questionnaire result, the medical questionnaire result includes the answer information of the patient and the auxiliary answer for the medical questionnaire item (See Deno [0107] the system stores the final result of the questionnaire in a storage unit. This includes the automatically provided information and the patient provided information. See also Fig. 5).
Regarding claim 15, Deno in view of Selim discloses the method of claim 11 as discussed above. Claim 15 recites a computer program stored in a non-transitory computer-readable a medium, for executing the method of claim 11. Accordingly, claim 15 is rejected based on the same analysis.
Response to Arguments
Applicant's arguments filed 02 July 2025, with respect to the 35 U.S.C. §101 rejection of the claims, have been fully considered but they are not persuasive. Applicant argues that the inclusion of a medical questionnaire terminal and server provides a practical application to the abstract idea (see Applicant Remarks page 6-7). This is not persuasive. The additional elements present in this claim amount to using general purpose computer hardware and software to perform the abstract idea. This amounts to merely reciting the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). These types of additional elements are not enough to integrate the abstract idea into a practical application.
Applicant's arguments filed 02 July 2025, with respect to the 35 U.S.C. §103 rejection of the claims, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of the newly cited Selim reference.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Beckley (U.S. 2014/0229199) discloses a system and method for dynamic medical questionnaire generation.
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 BENJAMIN L HANKS whose telephone number is (571)270-5080. The examiner can normally be reached Monday-Friday 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached at (571) 270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.L.H./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684