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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Acknowledgement is made of Applicant’s claim for foreign priority to 15 December 2021 under 35 U.S.C. 119(a)-(d).
Response to Amendment
Claims 16-28 were previously pending in this application. The amendment filed 29 October 2025 has been entered and the following has occurred: No claims have been cancelled. Claim 29 has been added.
Claims 16-29 remain pending in the application.
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 16-29 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.
The claims recite subject matter within a statutory category as a machine (claims 16-27 & 29), and manufacture (claim 28) which recite steps of:
acquire a measured value related to biological information of a patient;
acquire medication information that is related to medicine prescribed to the patient, and includes information of a first prescription start date that is an earliest date of prescription of medicine with at least one prescription content;
calculate an average measured value that is an average value of the measured value of the patient in each predetermined period;
determine whether the average measured value has a predetermined reliability based on whether the number of times the biological information is measured in the predetermined period satisfies a predetermined criterion;
generate a medicinal effect confirmation support image including measured value transition information indicating transition of the average measured value in time series, in each of the predetermined periods before and after the first predetermined period; and
output the medicinal effect confirmation support image, wherein the measured value transition information in the medicinal effect confirmation support image indicates, in a distinguishable manner, the reliability of each of the average measured values.
These steps of acquiring biological information values/medication information, calculating an average measured value, determining whether the average measured value has a predetermined reliability, and generating a medicinal effect confirmation support image, as drafted, under the broadest reasonable interpretation, includes performance of the limitation in the mind but for recitation of generic computer components. That is, other than reciting steps as performed by the generic computer components, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for acquiring medication information related to medicine prescribed to the patient, and using the prescription data to calculate an average measured value and determine whether the average measured value has a predetermined reliability, acquiring data relating to medications, and subsequently calculating and/or determining an average measured value of predetermined reliability in the context of this claim encompasses a mental process of the user calculating and determining treatment efficacy for certain treatment parameters/plans. Similarly, the limitation of generating a medicinal effect including measured value transition information and outputting the medicinal effect confirmation support, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, such as a user reporting results of their determinations/calculations and applying said results to generation of a medical care/medication assistance plan. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 17-29, reciting particular aspects of how determinations, values, and/or prescriptions of medical care assistance plans may be performed in the mind but for recitation of generic computer components).
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception (such as a processor, a non-transitory computer-readable recording medium, and a computer, amounts to invoking computers as a tool to perform the abstract idea, see Applicant’s Specification [0049] for a processor, see Applicant’s Spec [0051] for a non-transitory computer-readable recording medium, see Applicant’s Spec [0060] for a computer, see MPEP 2106.05(f));
add insignificant extra-solution activity to the abstract idea (such as recitation of acquiring a measured value related to biological information of a patient, acquiring medication information that is related to medicine prescribed to the patient, including information of a first prescription start date that is an earliest date of prescription of medicine with at least one prescription content amounts to mere data gathering, recitation of calculating an average measured value that is an average value, determining whether the average measured value has a predetermined reliability amounts to selecting a particular data source or type of data to be manipulated, recitation of generating a medical effect confirmation support image including measured value transition information indicating transition of the average measured value and outputting the medicinal effect confirmation support image amounts to insignificant application, see MPEP 2106.05(g));
generally link the abstract idea to a particular technological environment or field of use (such as the recitation of a “medical care assistance” system or applying the system for use in determining medical care assistance plans, see MPEP 2106.05(h)).
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 17-29, which generally recite limitations relating to additional limitations which amount to invoking computers as a tool to perform the abstract idea, such as recitation of a processor and/or non-transitory computer readable recording medium; claims 17 & 20-29, which generally recite limitations relating to acquiring varying information or data such as blood pressure/biological information, additional limitations which add insignificant extra-solution activity to the abstract idea which amounts to mere data gathering; claims 18-19, which generally recite limitations relating to determining or calculating various aspects based on received data, additional limitations which add insignificant extra-solution activity to the abstract idea by selecting a particular data source or type of data to be manipulated; claims 17-29, which generally recite limitations relating to medical information and/or medical care assistance determinations, additional limitations which generally link the abstract idea to a particular technological environment or field of use). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as acquiring a measured value related to biological information of a patient, acquiring medication information that is related to medicine prescribed to the patient, including information of a first prescription start date that is an earliest date of prescription of medicine with at least one prescription content, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); calculating an average measured value that is an average value, determining whether the average measured value has a predetermined reliability, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii); maintaining one or more records of medication/prescription information, e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii); storing biological information of a patient, storing medication information, e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv); acquiring measured values of biological information and/or medication information which under BRI could include extraction/parsing from documents, e.g., electronic scanning or extracting data from a physical document, Content Extraction, MPEP 2106.05(d)(II)(v))
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 17-29, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, claims 17 & 20-29, which generally recite limitations relating to acquiring varying information or data, such as blood pressure/biological information of the patient and transmitting said acquired measured value over a network, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); claims 18-19, which generally recite limitations relating to determining or calculating various aspects based on received data, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii); claims 17 & 20-28, which generally recite limitations relating to maintaining one or more records of data relating to medical information, medication information, and/or medical care assistance, e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii); claims 17 & 20-28, which generally recite limitations relating to extracting data from one or more stored records of data relating to medical information, medication information, and/or medical care assistance, e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv); claims 17 & 20-28, which generally recite limitations relating to extracting data from one or more stored records of data relating to medical information, medication information, and/or medical care assistance, which under BRI, include extraction/parsing from documents/records, e.g., electronic scanning or extracting data from a physical document, Content Extraction, MPEP 2106.05(d)(II)(v)). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
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 16-19 & 21-29 are rejected under 35 U.S.C. 103 as being unpatentable over Sato et al. (U.S. Patent Publication No. 2019/0385723), hereinafter “Sato”, in view of Kitagawa et al. (U.S. Patent Publication No. 2016/0085918), hereinafter “Kitagawa”.
Claim 16 –
Regarding Claim 16, Sato discloses a medical care assistance system comprising:
a processor (see Sato Par [0038]-[0039] & Fig. 2 which discloses a server computer, e.g. medical support server, and functional configuration of a medical support server including a processor) configured to:
acquire a measured value related to biological information of a patient (See Sato Par [0006] which discloses acquiring blood pressure measurement information of a patient obtained by a blood pressure monitor and includes measurement date and time);
acquire medication information that is related to medicine prescribed to the patient and includes information of a first prescription start date that is an earliest date of prescription of medicine with at least one prescription content (See Sato Par [0006] which discloses acquiring medication information including types and amounts of medicine prescribed for the patient i.e. prescription content, and includes medication date and time);
calculate an average measured value that is an average value of the measured value of the patient in each predetermined period (See Sato Par [0068] which discloses a blood pressure transition management unit calculating the weekly average of blood pressure values measured during the period every week);
determine whether the average measured value has a predetermined reliability based on whether the number of times the biological information is measured in the predetermined period satisfies a predetermined criterion (See Sato Par [0068] which discloses a blood pressure transition management unit calculating the weekly average of blood pressure values measured during the period every week and further comparing the blood pressure average value of this week with the blood pressure average value of the previous week based on the foregoing blood pressure transition information to determine whether the change amount is equal to or more than a threshold, and upon an abnormal blood pressure change being detected upon exceeding the threshold, the blood pressure transition management unit adds information indicating the amount of the change and the change direction (increase or decrease) to the blood pressure average value of that week);
generate a medicinal effect confirmation support image including measured value transition information indicating transition of the average measured value in time series, in each of the predetermined periods before and after the first predetermined period (“image”, in light of Applicant’s Specification, is understood to constitute any interface or display of details that represent medicinal effects and/or other measured values, such as an outputted medical report, therefore see Sato Par [0009]-[0010] which discloses display information generation unit detecting a change exceeding a preset amount of the blood pressure value from the transition of blood pressure value based on the blood pressure measurement information, and generates the medication treatment result information to display information indicating details of the change to be added to at a corresponding position in a time line of a graph indicating the transition of the blood pressure; See Sato Par [0068] which discloses a blood pressure transition management unit calculating the weekly average of blood pressure values measured during the period every week and stores the calculated value in the blood pressure database as blood pressure transition information, and further discloses comparing the previous week based on the foregoing blood pressure transition information); and
output the medicinal effect confirmation support image (“image”, in light of Applicant’s Specification, is understood to constitute any interface or display of details that represent medicinal effects and/or other measured values, such as an outputted medical report, therefore see Sato Par [0009]-[0010] which discloses display information generation unit detecting a change exceeding a preset amount of the blood pressure value from the transition of blood pressure value based on the blood pressure measurement information, and generates the medication treatment result information to display information indicating details of the change to be added to at a corresponding position in a time line of a graph indicating the transition of the blood pressure), wherein
the measured value transition information in the medicinal effect confirmation support image indicates, in a distinguishable manner, the reliability of each of the average measured values (See Sato Par [0009]-[0010] which discloses display information generation unit detecting a change exceeding a preset amount of the blood pressure value from the transition of blood pressure value based on the blood pressure measurement information, and generates the medication treatment result information to display information indicating details of the change to be added to at a corresponding position in a time line of a graph indicating the transition of the blood pressure; See Sato Par [0010] & [0079] which discloses a background of the line graph representing blood pressure transition, a band-like region indicating a high blood pressure stage is display, so that results can be checked at a glance, and allows recognition of abnormal changes in blood pressure values).
While Sato discloses detecting a change exceeding a preset amount of the blood pressure value from the transition of weekly average blood pressure values based on the blood pressure measurement information, and generating the medication treatment result information to display information indicating details of the change for the doctor to recognize abnormal changes in blood pressure values, Sato is relatively silent on explicitly generating the “reliability” per se of each of the average measured values as given by the following limitation:
the measured value transition information in the medicinal effect confirmation support image indicates, in a distinguishable manner, the reliability of each of the average measured values.
However, Kitagawa discloses the measured value transition information in the medicinal effect confirmation support image indicates, in a distinguishable manner, the reliability of each of the average measured values (See Kitagawa Par [0109] which discloses a range of input data for the output of the reliable diagnostic assistance information by the diagnostic assistance program, and further discloses reliability of diagnostic information being indicated, e.g. indicates as low compared with that in a case in which the medical data of the first recommended data range is input as input data; See Kitagawa Par [0138] & [0167] which discloses when there is a difference between the designated data range and the first recommended data range, similar to the case in which there is no difference between the designated data range and the first recommended data range, the second diagnostic assistance information is transmitted from the program control unit to the screen generation unit and further describes the medical data display screen in which the second diagnostic assistance information and the message are displayed in the various information display region is generated based on the second diagnostic assistance information and the automatic setting notification, such that automatic setting notification output unit outputs the automatic setting notification to the screen generation unit; See Kitagawa Par [0170] which discloses a doctor being notified by the message that the reliability of the diagnostic assistance information is low through the message; See Kitagawa Par [0194] which discloses calculating the average value or medical data and setting the average value as estimated data and since the estimated data is estimated from the medical data of a target patient unlike default data, it is possible to further improve the reliability of the diagnostic assistance information when there is non-acquired data). The disclosure of Kitagawa is directly applicable to the disclosure of Sato because both disclosures share limitations and capabilities, such as being directed towards medical data processing efforts and determinations of data signal abnormalities.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Sato, which already discloses the determination of average measured values and transitions/changes thereof, to further include indicating the reliability of each of the average measured values, as disclosed by Kitagawa, because this prevents the doctor from performing diagnosis by mistakenly believing that their diagnostic assistance information is reliable when data is unreliable, since the doctor knows that the reliability of the diagnostic assistance information is low through the indications presented to the doctor (see Kitagawa Par [0170]).
Claim 17 –
Regarding Claim 17, Sato and Kitagawa disclose the medical care assistance system of claim 16 in its entirety. Sato further discloses a system, wherein:
the processor is further configured to (see Sato Par [0038]-[0039] & Fig. 2 which discloses a server computer, e.g. medical support server, and functional configuration of a medical support server including a processor; See Sato Par [0044] which discloses an associated processor/CPU for performing steps recited):
acquire information related to a time period and/or a location at which the biological information is measured (See Sato Par [0068] which discloses a blood pressure transition management unit calculating the weekly average of blood pressure values measured during the period every week and stores the calculated value in the blood pressure database as blood pressure transition information, and further discloses comparing the previous week based on the foregoing blood pressure transition information),
calculate the average measured value for each time period and/or location at which the biological information is measured (See Sato Par [0068] which discloses a blood pressure transition management unit calculating the weekly average of blood pressure values measured during the period every week and stores the calculated value in the blood pressure database as blood pressure transition information, and further discloses comparing the previous week based on the foregoing blood pressure transition information), and
the measured value transition information in the medicinal effect confirmation support image indicates a change in the average measured value for each time period and/or location at which the biological information is measured (See Sato Par [0068] which discloses a blood pressure transition management unit calculating the weekly average of blood pressure values measured during the period every week and stores the calculated value in the blood pressure database as blood pressure transition information, and further discloses comparing the previous week based on the foregoing blood pressure transition information; See Sato Par [0010] & [0079] which discloses a background of the line graph representing blood pressure transition, a band-like region indicating a high blood pressure stage is display, so that results can be checked at a glance, and allows recognition of abnormal changes in blood pressure values).
Claim 18 –
Regarding Claim 18, Sato and Kitagawa disclose the medical care assistance system of claim 16 in its entirety. Sato further discloses a system, wherein:
the processor is further configured to (see Sato Par [0038]-[0039] & Fig. 2 which discloses a server computer, e.g. medical support server, and functional configuration of a medical support server including a processor; See Sato Par [0044] which discloses an associated processor/CPU for performing steps recited):
determine whether an improvement target of the biological information of the patient set in advance for each of the average measured values is achieved (See Sato Par [0084] which discloses calculating an achievement score for the target value on a weekly basis, for each of the medication management information, i.e. the weekly average of blood pressure values as in Sato Par [0068], the blood pressure transition information, the drug-taking adherence information, and the patient life information), wherein
the measured value transition information in the medicinal effect confirmation support image indicates information on whether the improvement target is achieved for each of the average measured values (See Sato Par [0084] which discloses calculating an achievement score for the target value on a weekly basis, for each of the medication management information, i.e. the weekly average of blood pressure values as in Sato Par [0068], the blood pressure transition information, the drug-taking adherence information, and the patient life information).
Claim 19 –
Regarding Claim 19, Sato and Kitagawa disclose the medical care assistance system of claim 16 in its entirety. Sato further discloses a system, wherein:
the processor is further configured to (see Sato Par [0038]-[0039] & Fig. 2 which discloses a server computer, e.g. medical support server, and functional configuration of a medical support server including a processor; See Sato Par [0044] which discloses an associated processor/CPU for performing steps recited):
calculate an increasing/decreasing change amount of the average measured value in one of the predetermined periods from the average measured value in an immediately preceding one of the predetermined periods (See Sato Par [0068] which discloses a blood pressure transition management unit calculating the weekly average of blood pressure values measured during the period every week and stores the calculated value in the blood pressure database as blood pressure transition information, and further discloses comparing the previous week based on the foregoing blood pressure transition information), wherein
the measured value transition information in the medicinal effect confirmation support image visibly indicates the increasing/decreasing change amount for each of the average measured values, with increase and decrease being distinguishable from each other (“image”, in light of Applicant’s Specification, is understood to constitute any interface or display of details that represent medicinal effects and/or other measured values, such as an outputted medical report, therefore see Sato Par [0009]-[0010] which discloses display information generation unit detecting a change exceeding a preset amount of the blood pressure value from the transition of blood pressure value based on the blood pressure measurement information, and generates the medication treatment result information to display information indicating details of the change to be added to at a corresponding position in a time line of a graph indicating the transition of the blood pressure; See Sato Par [0010] & [0079] which discloses a background of the line graph representing blood pressure transition, a band-like region indicating a high blood pressure stage is display, so that results can be checked at a glance, and allows recognition of abnormal changes in blood pressure values).
Claim 21 –
Regarding Claim 21, Sato and Kitagawa disclose the medical care assistance system of claim 16 in its entirety. Sato further discloses a system, wherein:
the medication information includes information related to a name of the prescribed medicine and an amount of the prescribed medicine (See Sato Par [0006] which discloses acquiring medication information including types and amounts of medicine prescribed for the patient, i.e. prescription content, and includes medication date and time; see Sato Par [0009]-[0010] which discloses display information generation unit detecting a change exceeding a preset amount of the blood pressure value from the transition of blood pressure value based on the blood pressure measurement information, and generates the medication treatment result information to display information indicating details of the change to be added to at a corresponding position in a time line of a graph indicating the transition of the blood pressure; See Sato Par [0007] which specifically discloses the medication treatment result information is generated to display the types and amounts of medicine included in the medication information acquired from a terminal of a prescriber such as a doctor), and
the medicinal effect confirmation support image indicates medicine-related information including the medication information in addition to the measured value transition information (“image”, in light of Applicant’s Specification, is understood to constitute any interface or display of details that represent medicinal effects and/or other measured values, such as an outputted medical report, therefore see Sato Par [0009]-[0010] which discloses display information generation unit detecting a change exceeding a preset amount of the blood pressure value from the transition of blood pressure value based on the blood pressure measurement information, and generates the medication treatment result information to display information indicating details of the change to be added to at a corresponding position in a time line of a graph indicating the transition of the blood pressure; See Sato Par [0006] which discloses acquiring medication information including types and amounts of medicine prescribed for the patient, i.e. prescription content, and includes medication date and time; See Sato Par [0007] which specifically discloses the medication treatment result information is generated to display the types and amounts of medicine included in the medication information acquired from a terminal of a prescriber such as a doctor).
Claim 22 –
Regarding Claim 22, Sato and Kitagawa disclose the medical care assistance system of claim 21 in its entirety. Sato further discloses a system, wherein:
the medication information includes, when there is a medicine prescribed to the patient with another content in addition to the medicine prescribed with the one prescription content, information related to a name and an amount of the medicine with the other content (See Sato Par [0006] which discloses acquiring medication information including types and amounts of medicine prescribed for the patient, i.e. prescription content, and includes medication date and time; See Sato Par [0007] which specifically discloses the medication treatment result information is generated to display the types and amounts of medicine included in the medication information acquired from a terminal of a prescriber such as a doctor), and
when a period indicated by the measured value transition information displayed in the medicinal effect confirmation support image includes a period during which the medicine is prescribed with the other content, the medicine-related information further indicates information related to the name and the amount of the medicine in the period during which the medicine is prescribed with the other content (“image”, in light of Applicant’s Specification, is understood to constitute any interface or display of details that represent medicinal effects and/or other measured values, such as an outputted medical report, therefore see Sato Par [0009]-[0010] which discloses display information generation unit detecting a change exceeding a preset amount of the blood pressure value from the transition of blood pressure value based on the blood pressure measurement information, and generates the medication treatment result information to display information indicating details of the change to be added to at a corresponding position in a time line of a graph indicating the transition of the blood pressure; See Sato Par [0006] which discloses acquiring medication information including types and amounts of medicine prescribed for the patient, i.e. prescription content, and includes medication date and time; See Sato Par [0007] which specifically discloses the medication treatment result information is generated to display the types and amounts of medicine included in the medication information acquired from a terminal of a prescriber such as a doctor; See Sato Par [00017] which discloses the types and amounts of medicine included in the acquired medication information in a time line in association with each other based on medication date and time and drug-taking date and time respectively included in the medication information and the drug-taking information, and transmits the medication treatment result information to the first terminal as the request source via the network).
Claim 23 –
Regarding Claim 23, Sato and Kitagawa disclose the medical care assistance system of claim 22 in its entirety. Sato further discloses a system, wherein:
the medication information includes information of a second prescription start data that is earliest date of the prescription of the medicine with the other content (See Sato Par [0006] which discloses acquiring medication information including types and amounts of medicine prescribed for the patient, i.e. prescription content, and includes medication date and time, and is understood to constitute one or more medications/prescriptions; See Sato Par [0007] which specifically discloses the medication treatment result information is generated to display the types and amounts of medicine included in the medication information acquired from a terminal of a prescriber such as a doctor; See Sato Par [00017] which discloses the types and amounts of medicine included in the acquired medication information in a time line in association with each other based on medication date and time and drug-taking date and time respectively included in the medication information and the drug-taking information, and transmits the medication treatment result information to the first terminal as the request source via the network), and when a period displayed in the medicinal effect confirmation support image includes the second prescription start date, a mark indicating the second prescription start date is displayed in the medicinal effect confirmation support image (“image”, in light of Applicant’s Specification, is understood to constitute any interface or display of details that represent medicinal effects and/or other measured values, such as an outputted medical report, therefore see Sato Par [0009]-[0010] which discloses display information generation unit detecting a change exceeding a preset amount of the blood pressure value from the transition of blood pressure value based on the blood pressure measurement information, and generates the medication treatment result information to display information indicating details of the change to be added to at a corresponding position in a time line of a graph indicating the transition of the blood pressure; See Sato Par [0006] which discloses acquiring medication information including types and amounts of medicine prescribed for the patient, i.e. prescription content, and includes medication date and time, and is understood to constitute one or more medications/prescriptions; See Sato Par [0007] which specifically discloses the medication treatment result information is generated to display the types and amounts of medicine included in the medication information acquired from a terminal of a prescriber such as a doctor; See Sato Par [00017] which discloses the types and amounts of medicine included in the acquired medication information in a time line in association with each other based on medication date and time and drug-taking date and time respectively included in the medication information and the drug-taking information, and transmits the medication treatment result information to the first terminal as the request source via the network, and is therefore understood to include a “mark” indicating the start date via the beginning of the timeline and/or one or more medications being started).
Claim 24 –
Regarding Claim 24, Sato and Kitagawa discloses the medical care assistance system of claim 21 in its entirety. Sato further discloses a system, wherein:
the processor is further configured to acquire dosing related information acquisition means configured to acquire dosing information related to a dosing status of the patient and/or side effect information related to a side effect as a result of dosing by the patient (see Sato Par [0038]-[0039] & Fig. 2 which discloses a server computer, e.g. medical support server, and functional configuration of a medical support server including a processor; See Sato Par [0044] which discloses an associated processor/CPU for performing steps recited; “and/or” under broadest reasonable interpretation is understood to simply include “or” since this is the broader aspects of an “and/or”, therefore see Sato Par [0006] which discloses acquiring medication information including types and amounts of medicine prescribed for the patient, i.e. prescription content and dosing status, and includes medication date and time, and is understood to constitute one or more medications/prescriptions; See Sato Par [0007] which specifically discloses the medication treatment result information is generated to display the types and amounts of medicine included in the medication information acquired from a terminal of a prescriber such as a doctor), wherein
the medicine-related information in the medicinal effect confirmation support image indicates the dosing information and/or the side effect information (“and/or” under broadest reasonable interpretation is understood to simply include “or” since this is the broader aspects of an “and/or”, therefore see Sato Par [0006] which discloses acquiring medication information including types and amounts of medicine prescribed for the patient, i.e. prescription content and dosing status, and includes medication date and time, and is understood to constitute one or more medications/prescriptions; See Sato Par [0007] which specifically discloses the medication treatment result information is generated to display the types and amounts of medicine included in the medication information acquired from a terminal of a prescriber such as a doctor; “image”, in light of Applicant’s Specification, is understood to constitute any interface or display of details that represent medicinal effects and/or other measured values, such as an outputted medical report, therefore see Sato Par [0009]-[0010] which discloses display information generation unit detecting a change exceeding a preset amount of the blood pressure value from the transition of blood pressure value based on the blood pressure measurement information, and generates the medication treatment result information to display information indicating details of the change to be added to at a corresponding position in a time line of a graph indicating the transition of the blood pressure).
Claim 25 –
Regarding Claim 25, Sato and Kitagawa disclose the medical care assistance system of claim 16 in its entirety. Sato further discloses a system, wherein:
the measured value transition information includes a graph display indicating a transition of the average measured value of the biological information (See Sato Par [0068] which discloses a blood pressure transition management unit calculating the weekly average of blood pressure values measured during the period every week and further comparing the blood pressure average value of this week with the blood pressure average value of the previous week based on the foregoing blood pressure transition information to determine whether the change amount is equal to or more than a threshold, and upon an abnormal blood pressure change being detected upon exceeding the threshold, the blood pressure transition management unit adds information indicating the amount of the change and the change direction (increase or decrease) to the blood pressure average value of that week; see Sato Par [0009]-[0010] which discloses display information generation unit detecting a change exceeding a preset amount of the blood pressure value from the transition of blood pressure value based on the blood pressure measurement information, and generates the medication treatment result information to display information indicating details of the change to be added to at a corresponding position in a time line of a graph indicating the transition of the blood pressure).
Claim 26 –
Regarding Claim 26, Sato and Kitagawa disclose the medical care assistance system of claim 25 in its entirety. Sato and Kitagawa further disclose a system, wherein:
the measured value of the biological information includes a blood pressure value and a pulse rate, and the graph display displays average values of the blood pressure value and the pulse rate measured in the one predetermined period on the same axis (See Sato Par [0068] which discloses a blood pressure transition management unit calculating the weekly average of blood pressure values measured during the period every week and further comparing the blood pressure average value of this week with the blood pressure average value of the previous week based on the foregoing blood pressure transition information to determine whether the change amount is equal to or more than a threshold, and upon an abnormal blood pressure change being detected upon exceeding the threshold, the blood pressure transition management unit adds information indicating the amount of the change and the change direction (increase or decrease) to the blood pressure average value of that week; See Sato Par [0009]-[0010] which discloses display information generation unit detecting a change exceeding a preset amount of the blood pressure value from the transition of blood pressure value based on the blood pressure measurement information, and generates the medication treatment result information to display information indicating details of the change to be added to at a corresponding position in a time line of a graph indicating the transition of the blood pressure; See Kitagawa Par [0006] & [0015] which discloses the use of a plurality of items, e.g. vital data, being recorded in time series, and the range for the input data is at least one of a range of the item determined by designation of the item and Kitagawa Par [0069] & [0073] which discloses the use of blood pressure and heart rate as diagnostic content and being recorded in the same time series).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the already-combined disclosure of Sato and Kitagawa to further include the biological information including a pulse rate, and average values of blood pressure values and heart rate being measured on the same axis, as disclosed by Kitagawa, because this allows for the recording of a plurality of medical data items in time series and representing these items on the same graph in order to make assessments of the patient (e.g. risk, medicinal effect) of all relevant medical data of the period by a doctor (See Kitagawa Par [0006] & [0073]).
Claim 27 –
Regarding Claim 27, Sato and Kitagawa disclose a medical care assistance device, comprising:
the processor, wherein the medical care assistance device constitutes at least a part of the medical care assistance system according to claim 16 (See explanation for Claim 16 in view of Sato and Kitagawa found above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Sato, which already discloses the determination of average measured values and transitions/changes thereof, to further include indicating the reliability of each of the average measured values, as disclosed by Kitagawa, because this prevents the doctor from performing diagnosis by mistakenly believing that their diagnostic assistance information is reliable when data is unreliable, since the doctor knows that the reliability of the diagnostic assistance information is low through the indications presented to the doctor (see Kitagawa Par [0170]).
Claim 28 –
Regarding Claim 28, Sato and Kitagawa disclose a non-transitory computer-readable recording medium storing a program, executable by the processor for causing a computer to function as the medical care assistance device according to claim 27 (see Sato Par [0038]-[0039] & Fig. 2 which discloses a server computer, e.g. medical support server, and functional configuration of a medical support server and is therefore understood to constitute the remaining functional “means” recited hereinafter; See explanations for Claims 16 & 27 in view of Sato and Kitagawa found above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Sato, which already discloses the determination of average measured values and transitions/changes thereof, to further include indicating the reliability of each of the average measured values, as disclosed by Kitagawa, because this prevents the doctor from performing diagnosis by mistakenly believing that their diagnostic assistance information is reliable when data is unreliable, since the doctor knows that the reliability of the diagnostic assistance information is low through the indications presented to the doctor (see Kitagawa Par [0170]).
Claim 29 –
Regarding Claim 29, Sato and Kitagawa disclose the medical care assistance system of claim 16 in its entirety. Sato further discloses a system, further comprising:
a blood pressure monitor configured to measure a measured value related to a biological information of the patient and further configured to wirelessly transmit the measured value (See Sato Par [0006] & [0019] which discloses the use of a blood pressure monitor by the patient to obtain blood pressure measurement information, i.e. biological information, of the patient from the second terminal via a network, such that the medication support apparatus is capable of communicating via network between a first terminal and said second terminal to obtain blood pressure measurement information, i.e. wireless transmission of said biological information), wherein
the processor is further configured to acquire the measured value related to biological information of the patient from a blood pressure monitor (See Sato Par [0006] & [0019] which discloses the use of a blood pressure monitor by the patient to obtain blood pressure measurement information of the patient from the second terminal via a network, such that the medication support apparatus is capable of communicating via network between a first terminal and said second terminal to obtain blood pressure measurement information; Sato Par [0019] specifically states that the medication support apparatus, i.e. associated processor/CPU as described in Sato Par [0044], acquires blood pressure measurement information of the patient obtained by the blood pressure monitor from the second terminal via the network).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Sato, in view of Kitagawa, further in view of Zizzo et al. (U.S. Patent Publication No. 2008/0319331), hereinafter “Zizzo”.
Claim 20 –
Regarding Claim 20, Sato and Kitagawa disclose the medical care assistance system of claim 16 in its entirety. Sato and Kitagawa further disclose a system, wherein:
the processor is further configured to (see Sato Par [0038]-[0039] & Fig. 2 which discloses a server computer, e.g. medical support server, and functional configuration of a medical support server including a processor; See Sato Par [0044] which discloses an associated processor/CPU for performing steps recited):
acquire, when an abnormality occurs while the biological information is being measured, information on the abnormality together with the measured value (See Sato Par [0079] & [0098] which discloses the line graph representing the blood pressure transition, the abnormal value of blood pressure and the information indicating the amount of change and the direction of change are superimposed at the time position at which the abnormal value was measured),
calculate an average value of measured values in the predetermined period, while excluding a measured value corresponding to the occurrence of the abnormality (See Sato Par [0068] which discloses a blood pressure transition management unit calculating the weekly average of blood pressure values measured during the period every week and stores the calculated value in the blood pressure database as blood pressure transition information, and further discloses comparing the previous week based on the foregoing blood pressure transition information; See Sato Par [0079] & [0098] which discloses the line graph representing the blood pressure transition, the abnormal value of blood pressure and the information indicating the amount of change and the direction of change are superimposed at the time position at which the abnormal value was measured), and
determine whether the predetermined criterion is satisfied after calculating the number of measurements, by subtracting from the total number of measurements in the predetermined period, the number of measurements taken when the abnormality was detected (See Sato Par [0079] & [0098] which discloses detecting an abnormal value (outlier) of blood pressure, such that the medication support server generates medication treatment result information in which the information indicates the abnormal value, the amount of a change from the previous measurement value, and the direction of the change is superimposed on a line graph indicating blood pressure transition at an applied time position, and displays the medication treatment result information on the doctor terminals; See Kitagawa Par [0109] which discloses a range of input data for the output of the reliable diagnostic assistance information by the diagnostic assistance program, and further discloses reliability of diagnostic information being indicated, e.g. indicates as low compared with that in a case in which the medical data of the first recommended data range is input as input data; See Kitagawa Par [0138] & [0167] which discloses when there is a difference between the designated data range and the first recommended data range, similar to the case in which there is no difference between the designated data range and the first recommended data range, the second diagnostic assistance information is transmitted from the program control unit to the screen generation unit and further describes the medical data display screen in which the second diagnostic assistance information and the message are displayed in the various information display region is generated based on the second diagnostic assistance information and the automatic setting notification, such that automatic setting notification output unit outputs the automatic setting notification to the screen generation unit; See Kitagawa Par [0170] which discloses a doctor being notified by the message that the reliability of the diagnostic assistance information is low through the message; See Kitagawa Par [0219] which discloses a threshold value, i.e. predetermined criterion, being set to determine a recommended data range that is reliable, and upon this being satisfied, there is no difference between the designated data range and the first recommended data range indicating reliable data, albeit not explicitly reciting “subtracting from the total number of measurements in the predetermined period, the number of measurements taken when the abnormality was detected”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Sato, which already discloses the determination of average measured values and transitions/changes thereof, to further include indicating the reliability of each of the average measured values, as disclosed by Kitagawa, because this prevents the doctor from performing diagnosis by mistakenly believing that their diagnostic assistance information is reliable when data is unreliable, since the doctor knows that the reliability of the diagnostic assistance information is low through the indications presented to the doctor (see Kitagawa Par [0170]).
While the combined disclosure of Sato and Kitagawa generally disclose determine whether the predetermined criterion is satisfied after calculating the number of measurements, Sato and Kitagawa do not necessarily disclose subtracting from the total number of measurements in the predetermined period, the number of measurements taken when the abnormality was detected or some relevant analysis that utilizes said subtraction/difference in future processing steps to determine whether the predetermined criterion is satisfied.
However, Zizzo discloses determining whether the predetermined criterion is satisfied after calculating the number of measurements by subtracting from the total number of measurements in the predetermined period, the number of measurements taken when the abnormality was detected (See Zizzo Par [0014] which discloses applying a validation procedure when determining whether a measure is normal or abnormal, such as by comparing the number of abnormal events to the number of normal events in a specified time window, i.e. predetermined period, and therefore while not explicitly “subtracting” the number of measurements taken when the abnormality was detected from the total number of measurements in the predetermined period, this comparison effectively compares the number of abnormal events to the number of normal events to make a total number of events and if there is more than a threshold number of abnormal events when compared to the total number of events, then the measure and/or medical signal is determined to be abnormal; See Zizzo Par [0064] which specifically discloses a counter is implemented to count abnormal events as a positive integer and normal events as a negative integer such that if a threshold is reached within a time-window, the system determines the signal is abnormal). The disclosure of Zizzo is directly applicable to the combined disclosure of Sato and Kitagawa, because the disclosures share limitations and capabilities, such as being directed towards medical data signal processing and determinations of data signal abnormalities.
Therefore, while Zizzo does not specifically recite “subtracting from the total number of measurements… the number of measurements taken when the abnormality was detected”, it is understood by Examiner that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined disclosure of Sato and Kitagawa to try any mode of comparison (i.e. addition, subtraction, ratio, etc., of the number of abnormal measurements to the total number of measurements and/or normal amount of measurements), such as counting and adding abnormal events as a positive integer and normal events as a negative integer to determine whether a predetermined criterion, e.g. the abnormality threshold in Zizzo, is satisfied and thereby reflecting whether the received signal is normal or abnormal (See Zizzo Par [0014] & [0064]).
Response to Arguments
Applicant's arguments filed 29 October 2025 have been fully considered but they are not persuasive:
Regarding 35 U.S.C. 112(f) interpretation for claims 16-28, Applicant argues on p. 7 of Arguments/Remarks that the claims have been amended to replace the generic placeholders with structural claim terms to avoid invoking 35 U.S.C. 112(f). Examiner agrees with Applicant’s arguments. Therefore, the 35 U.S.C. 112(f) invocations/interpretations for claims 16-28 are withdrawn.
Regarding 35 U.S.C. 112(b) rejections of claim 20, Applicant argues on p. 7-8 of Arguments/Remarks that claim 20 has been amended to cure the deficiencies found therein. Examiner agrees with Applicant’s arguments. Therefore, the 35 U.S.C. 112(b) rejection of claim 20 has been withdrawn.
Regarding 35 U.S.C. 101 rejections of claims 16-28, Applicant argues on p. 8 of Arguments/Remarks that claim 28 has been amended to cure the deficiencies found therein regarding the claim being directed to non-statutory subject matter. Examiner agrees with Applicant’s arguments. Therefore, this portion of the 35 U.S.C. 101 rejection for claim 28 has been withdrawn. However, claim 28 remains rejected under 35 U.S.C. 101 for being directed towards a judicial exception, without significantly more.
Regarding 35 U.S.C. 101 rejections of claims 16-28, Applicant argues on p. 8-10 of Arguments/Remarks that in light of the claimed features, as discussed in the Advantageous Effects of Invention portion of Applicant’s specification, a medical professional can reliably and easily confirm the effect of medication, which amounts to a practical application of, and significantly more than, the purported abstract idea. Applicant further argues that the 35 U.S.C. 101 rejections of claims 16-28 should therefore be withdrawn. Examiner respectfully disagrees with Applicant’s arguments. Regarding the claimed features purportedly amounting to a practical application, Examiner contends that “a medical professional can reliably and easily confirm the effect of medication” does not constitute a practical application under the Alice/Mayo framework’s definition of practical applications. That is, assuming arguendo that the claimed system does, in fact, improve a medical professional’s efforts of “confirming the effect of medication”, this is not necessarily an improvement to the technology or technical field, and instead reads as an improvement to the already-characterized abstraction. As per MPEP 2106.05(a), the judicial exception, i.e. abstraction, alone cannot provide the improvement. That is, an improvement to an abstraction still constitutes the abstraction itself, and therefore does not amount to a practical application. Regarding the claimed features purportedly amounting to significantly more than the recited abstract idea, Examiner contends that each and every limitation recited in the claims were determined to represent insignificant, extra-solution activity and/or well-understood, routine, and conventional activity found in prior art systems. That is, a medical professional reliably and easily confirming the effect of medication could be achieved by any prior art system that monitors the effects of medication over time and presents the results to said medical professional, i.e. receiving data, analyzing results, and displaying the results are not novel or an improvement over prior art systems, even if a certain species of data being analyzed, types of analyses performed (i.e. reliability analytics), and/or modes of displaying said data/analyses are recited, these aspects still represent insignificant, extra-solution activity and/or well-understood, routine, and conventional activity found in prior art systems. Therefore, claims 16-28 and newly pending claim 29 remain rejected under 35 U.S.C. 101.
Regarding 35 U.S.C. 103 rejections of claims 16-28, Applicant argues on p. 10 of Arguments/Remarks that Kitagawa discusses indicating a reliability of diagnostic assistance information depending on conformity of input data ranges or presence of estimated data, but does not teach determining, for each predetermined period, a reliability per average value in the time-series transition information. Examiner respectfully disagrees with Applicant’s arguments. Sato discloses detecting a change exceeding a preset amount of the blood pressure value from the transition of weekly average blood pressure values based on the blood pressure measurement information, and generating the medication treatment result information to display information indicating details of the change for the doctor to recognize abnormal changes in blood pressure values, but Sato is relatively silent on explicitly generating the “reliability” per se of said average measured values, such as weekly average blood pressure values. Therefore, Kitagawa is relied upon to disclose the reliability of each of the average measured values being generated. However, Sato already discloses generating analytics for a per average value in the time-series transition information, and it is the combination of Kitagawa disclosing reliability metrics for one or more average values or medical data and setting the average value as estimated data and improving the reliability of the diagnostic assistance information that fully discloses the limitation argued by Applicant. Therefore, it is the combination of Sato and Kitagawa that fully discloses the limitation above. As such, claims 16-28 and newly pending claim 29 remain rejected under 35 U.S.C. 103. In particular, claims 16-19 & 21-28 remain rejected under a new ground of rejection made under 35 U.S.C. 103 over Sato in view of Kitagawa to read on newly amended limitations, and claim 20 remains rejected under a new ground of rejection made under 35 U.S.C. 103 over Sato, in view of Kitagawa, further in view of Zizzo to read on newly amended limitations.
Regarding 35 U.S.C. 103 rejections of claims 16-28, Applicant argues on p. 10 of Arguments/Remarks that the combination of Sato and Kitagawa would not yield the claimed per-period, count-based reliability determination and its distinguishable indication associated with each average value, and there is no articulated rationale to modify Sato’s trend-change annotation into a per-period data-quantity-based reliability labeling aimed at medication effect confirmation. Examiner respectfully disagrees with Applicant’s arguments. Regarding the first argument of “the combination of Sato and Kitagawa would not yield the claimed per period, count-based reliability determination and its distinguishable indication associated with each average value”, Sato discloses detecting a change exceeding a preset amount of the blood pressure value from the transition of weekly average blood pressure values based on the blood pressure measurement information, and generating the medication treatment result information to display information indicating details of the change for the doctor to recognize abnormal changes in blood pressure values, but Sato is relatively silent on explicitly generating the “reliability” per se of each of the average measured values. Therefore, Kitagawa is relied upon to disclose the reliability of each of the average measured values being generated. However, Sato already discloses generating analytics for a per average value in the time-series transition information, and it is the combination of Kitagawa disclosing reliability metrics for one or more average values or medical data and setting the average value as estimated data and improving the reliability of the diagnostic assistance information that fully discloses the limitation argued by Applicant. Therefore, it is the combination of Sato and Kitagawa that fully discloses the argued limitation. Regarding “there is no articulated rationale to modify Sato’s trend-change annotation into a per-period data-quantity-based reliability labeling aimed at medication effect confirmation”, Examiner points to the rationale provided in each of the independent claims stating “this prevents the doctor from performing diagnosis by mistakenly believing that their diagnostic assistance information is reliable when data is unreliable, since the doctor knows that the reliability of the diagnostic assistance information is low through the indications presented to the doctor (see Kitagawa Par [0170])” , therefore effectively constituting a motivation statement. As such, claims 16-28 and newly pending claim 29 remain rejected under 35 U.S.C. 103.
Regarding 35 U.S.C. 103 rejections of claims 16-28, Applicant argues on p. 10-11 of Arguments/Remarks that it is impermissible to use Applicant’s claimed invention as an instruction manual or template to piece together the teachings of the prior art so that the claimed invention is rendered obvious. Applicant further argues that “Examiner’s determination impermissibly uses Applicant’s invention to provide justification for the conclusion that the claimed invention is obvious”. Examiner respectfully disagrees with Applicant’s arguments. Kitagawa Par [0170] effectively sets forth the content provided by Examiner in the motivation statement “this prevents the doctor from performing diagnosis by mistakenly believing that their diagnostic assistance information is reliable when data is unreliable, since the doctor knows that the reliability of the diagnostic assistance information is low through the indications presented to the doctor”. That is, Examiner does not rely on Applicant’s invention to determine or piece tougher the teachings of the prior art so that the claimed invention is rendered obvious. Rather, Examiner effectively cites and the set-forth teachings, suggestions, and/or motivations provided by Kitagawa, which clearly states that the use of reliability metrics for data is important so that the doctor knows that the reliability of the diagnostic assistance information is low through the indications presented to the doctor if diagnoses are to be made using said unreliable data. That is, while Applicant argues that there is no motivation for those skilled in the art to combine the technology disclosed by Sato with the teachings of Kitagawa, Examiner instead argues that one of ordinary skill in the art would identify the importance of the reliability of the diagnostic assistance information to make accurate diagnoses, and if unreliable data is provided, the doctor should be aware/notified before diagnoses are made. As such, claims 16-28 and newly pending claim 29 remain rejected under 35 U.S.C. 103.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure:
Joffe et al. (U.S. Patent Publication No. 2005/0144042) discloses a system for managing biological data and data interpretation associated therewith, such that the system permits improved differentiation between normal and abnormal population subgroups in EEG and/or QEEG data;
Inam et al. (U.S. Patent Publication No. 2021/0343400) discloses a system that utilizes machine learning to analyze patient health data, e.g. dental data/records/images, to determine one or more integrity scores associated with the patient health data, including deriving a provider score representative of a potential integrity problem associated with a dental-care provider submitting the treatment data;
Asai et al. (U.S. Patent Publication No. 2020/0192324) discloses a system that, while directed towards more generalized data for manufacturing/factory environments, monitors integrity of device data obtained by detecting abnormalities in one or more monitored values.
Applicant's amendment necessitated the new grounds 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.
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/H.R./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684