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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/30/2025 has been entered.
Formal Matters
Applicant’s response, filed 30 September 2025, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Status of the Application
Claims 1 and 6-19 are currently pending in this case and have been examined and addressed below. Claims 1, 14, and 15 have been amended. Claims 17-19 have been added.
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 and 6-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Step 1: Claims 1, 6-13, 15 and 16-19 are drawn to a machine. Claim 14 is drawn to a process. As such, claims 1 and 6-19 are drawn to one of the statutory categories of invention (Step 1: YES).
Step 2A - Prong One: In prong one of step 2A, the claim(s) is/are analyzed to evaluate whether it/they recite(s) a judicial exception.
Independent Claim 1: A medical information processing device, comprising:
a graphical user interface (GUI) configured to receive user input:
a memory storing risk criterion information therein;
and processing circuitry configured to:
acquire first medical data that is time-series data regarding a first parameter and second medical data that is time-series data regarding a second parameter different from the first parameter, and store the first and second medical data in the memory;
identify a first risk range regarding the first parameter and a second risk range regarding the second parameter based on risk criteria preset depending on types of parameters in the risk criterion information stored in the memory;
generate display information indicating the first medical data and the second medical data in association with each other on a display area which the first risk range and the second risk range are associated;
calculate a standardized risk and a standardized threshold for each piece of the first medical data and the second medical data based on the risk criteria; and
generate the display information indicating one standardized risk range by associating the first risk range with the second risk range by aligning positions of the calculated standardized thresholds, and normalizing the first risk range and the second risk range, the display information causing the first medical data and the second medical data to be displayed simultaneously, and information on a relationship between the first medical data and the second medical data to be displayed: and
display, on a display, the generated display information, wherein the displayed first and second medical data are related to each other and relate to a particular disease, and
the processing circuitry is further configured to receive, via the GUI, a particular user input selecting one of the first and second medical data displayed on the display, and in response to the particular user input highlight the other of the first and second medical data that was not selected by the user, so that a fact that the first and second medical data are related can be ascertained.
Independent Claim 14: A medical information processing method, implemented using a computer having a graphical user interface (GUI) configured to receive user input and a memory storing risk criterion information therein, the method comprising:
acquiring first medical data that is time-series data regarding a first parameter and second medical data that is time-series data regarding a second parameter different from the first parameter and storing the first and second medical data in the memory;
identifying a first risk range regarding the first parameter and a second risk range regarding the second parameter based on risk criteria preset depending on types of parameters in the risk criterion information stored in the memory;
generating display information indicating the first medical data and the second medical data in association, with each other on a display area in which the first risk range and the second risk range are associated;
calculating a standardized risk and a standardized threshold for each piece of the first medical data and the second medical data based on the risk criteria;
generating the display information indicating one standardized risk range by associating the first risk range with the second risk range by aligning positions of the calculated standardized thresholds, and normalizing the first risk range mid the second risk range, the display information causing the first medical data and the second medical data to be displayed simultaneously, and information on a relationship between the first medical data and the second medical data to be displayed; and
displaying, on a display, the generated display information, wherein the displayed first and second medical data are related to each other and relate to a particular disease, and
the method further comprises receiving, via the GUI, a particular user input selecting one of the first and second medical data displayed on the display, and in response to the particular user input, highlighting the other of the first and second medical data that was not selected by the user, so that a fact that the first and second medical data are related can be ascertained.
Independent Claim 15: A non-transitory computer-readable storage medium storing a program causing a computer, which has a graphical user interface (GUI) configured to receive user input, to:
acquire first medical data that is time-series data regarding a first parameter and second medical data that is time-series data regarding a second parameter different from the first parameter;
and store the first and second medical data in a memory:
identify a first risk range regarding the first parameter and a second risk range regarding the second parameter based on risk criteria preset depending on types of parameters in the risk criterion information stored in the memory;
generate display information indicating the first medical data and the second medical data in association with each other on a display area in which the first risk range and the second risk range are associated;
calculate a standardized risk and a standardized threshold for each piece of the first medical data and the second medical data based on the risk criteria; and
generate the display information indicating one standardized risk range by associating the first risk range with the second risk range by aligning positions of the calculated standardized thresholds, and normalizing the first risk range and the second risk range, the display information causing the first medical data and the second medical data to be displayed simultaneously, and information on a relationship between the first medical data and the second medical data to be displayed; and
display, on a display, the generated display information, wherein the displayed first and second medical data are related to each other and relate to a particular disease,
and the program further causes the computer to receive, via the GUI, a particular user input selecting one of the first and second medical data displayed on the display, and in response to the particular user input, highlight the other of the first and second medical data that was not selected by the user, so that a fact that the first and second medical data are related can be ascertained.
(Examiner notes: The above claim terms underlined are additional elements that fall under Step 2A - Prong Two analysis section detailed below)
These steps amount to methods of organizing human activity which includes functions relating to interpersonal and intrapersonal activities, such as managing relationships or transactions between people, social activities, and human behavior; satisfying or avoiding a legal obligation; advertising, marketing, and sales activities or behaviors; and managing human mental activity (MPEP § 2106.04(a)(2)(II)(C) citing the abstract idea grouping for methods of organizing human activity for managing personal behavior or relationships or interactions between people). Therefore, acquire medical data, identify risk ranges regarding the medical data, generate display information indicating the medical data and the respective risk ranges are associated, calculate a standardized risk and standardized threshold for each piece of medical data, display the standardized risk range by aligning positions of the standardized thresholds, normalizing the risk ranges, display the medical data simultaneously, and display the relationship between the data are directed to managing personal interactions or personal behavior.
The dependent claim 6 is directed to when a threshold is set as the risk criteria, set the threshold as the standardized threshold, and calculate, as the standardized risk, values of the first medical data and the second medical data, or values obtained by symmetrically transforming the values of the first medical data and the second medical data based on the threshold.
The dependent claim 7 is directed to when a range is set as the risk criteria, calculate the standardized risk based on a midpoint value between an upper limit value and a lower limit value of the range.
The dependent claim 8 is directed to when two risk ranges are identified for one parameter based on the risk criteria, calculate a value of half a difference between the upper limit value and the lower limit value of the range as the standardized threshold.
The dependent claim 9 is directed to one risk range is identified for one parameter based on the risk criteria, calculate the lower limit value of the range as the standardized threshold.
The dependent claim 10 is directed to when both a threshold and a range are set as the risk criteria for one parameter, identify a quasi-risk range based on the threshold and the range, and calculate a smaller value between the threshold and a lower limit value of a risk range of the one parameter as the standardized threshold.
The dependent claim 11 is directed to generate the display information, which is a graph with a horizontal axis representing time and a vertical axis representing the standardized risk.
The dependent claim 12 is directed to generate the display information, which is a graph with a horizontal axis representing amounts of changes in the first medical data and the second medical data and a vertical axis representing the standardized risk.
The dependent claim 13 is directed to generate the display information indicating, on the graph, processed data obtained by performing predetermined processing on the standardized risk.
The dependent claim 16 is directed to generate the display information so that values of the first and second medical data that are respectively greater than the standardized thresholds indicate increased risk.
The dependent claim 17 is directed to generate and display a risk change trend graph illustrating an amount of change of risk per unit time, based on the standardized risk corresponding to the first medical data and the second medical data.
The dependent claim 18 is directed to display a same mark on different displayed data points in the risk change trend graph that correspond to a same time.
The dependent claim 19 is directed to display the first and second medical data with respect to a time axis, with data points up to a current time being displayed with a first line type, and data points representing future risk being displayed with a second line type different from the first line type.
Each of these steps of the preceding dependent claims 6-19 only serve to further limit or specify the features of independent claims 1, 14, and 15 accordingly, and hence are nonetheless directed towards fundamentally the same abstract idea as the independent claim and utilize the additional elements analyzed below in the expected manner.
As such, the Examiner concludes that the preceding claims recite an abstract idea (Step 2A – Prong One: YES).
Step 2A - Prong Two: In prong two of step 2A, an evaluation is made whether a claim recites any additional element, or combination of additional elements, that integrate the exception into a practical application of that exception. An “additional element” is an element that is recited in the claim in addition to (beyond) the judicial exception (i.e., an element/limitation that sets forth an abstract idea is not an additional element). The phrase “integration into a practical application” is defined as requiring an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
Claim 1 recites the use of a medical information processing device. The claim further recites the use of a graphical user interface (GUI), in this case to receive user input. The medical information processing device and graphical user interface (GUI) are only recited as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)).
Claims 1, 14, and 15 recite the use of a memory storing risk criterion information, store the first and second medical data in the memory, and display area. The memory storing risk criterion information, store the first and second medical data in the memory, and display area are only recited as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)).
Claims 1 and 6-19 recite the use of a processing circuitry, in this case to acquire first medical data that is time-series data regarding a first parameter and second medical data that is time-series data regarding a second parameter different from the first parameter, identify a first risk range regarding the first parameter and a second risk range regarding the second parameter based on risk criteria preset depending on type of parameters in the risk criterion information, generate display information indicating the first medical data and the second medical data in association with each other, calculate a standardized risk and a standardized threshold for each piece of the first and second medical data based on the risk criteria, generate the display information indicating one standardized risk range by associating the first risk range with the second risk range by aligning positions of the calculated standardized thresholds, and normalizing the first risk range and the second risk range, display the generated display information, receive a particular user input selecting one of the first and second medical data and highlight the other first and second medical data that was not selected, set the threshold as the standardized threshold, calculate values of the first and second medical data as the standardized risk, calculate the standardized risk based on midpoint value between an upper limit value and lower limit value of the range, calculate a value of a difference between the upper limit value and the lower limit value of the range as the standardized threshold, calculate the lower limit value of the range as the standardized threshold, identify a quasi-risk range based on the threshold and the range, calculate a smaller value between the threshold and a lower limit value of a risk range of the one parameter as the standardized threshold, generate display information, generate and display a risk change trend graph, display a same mark on different displayed data points in the risk change trend graph that correspond to a same time, and display the first and second medical data with respect to a time axis, only recites the processing circuitry as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)).
Claim 14 recites the use of a computer having a graphical user interface (GUI), in this case to receive user input, only recites the computer having a graphical user interface (GUI) as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)).
Claim 15 recites The use of a non-transitory computer-readable storage medium storing a program causing a computer, which has a graphical user interface (GUI), only as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)).
The Examiner has therefore determined that the additional elements, or combination of additional elements, do not integrate the abstract idea into a practical application. Accordingly, the claim(s) is/are directed to an abstract idea (Step 2A – Prong two: NO).
Step 2B: In step 2B, the claims are analyzed to determine whether any additional element, or combination of additional elements, is/are sufficient to ensure that the claims amount to significantly more than the judicial exception.
As discussed above in “Step 2A – Prong 2”, the identified additional elements, such as the medical information processing device, graphical user interface (GUI), memory storing risk criterion information, processing circuitry, store the first and second medical data in the memory, display area, computer having a graphical user interface (GUI), and non-transitory computer-readable storage medium storing a program causing a computer, which has a graphical user interface (GUI) in independent claims 1, 14, and 15 and dependent claims 6-13 and 16-19 are equivalent to adding the words “apply it” on a generic computer. Each of these elements is only recited as a tool for performing steps of the abstract idea, such as the use of the computer and data processing devices to apply the algorithm. These additional elements therefore only amount to mere instructions to perform the abstract idea using a computer and are not sufficient to amount to significantly more than the abstract idea (MPEP 2016.05(f) see for additional guidance on the “mere instructions to apply an exception”). Each additional element under Step 2A, Prong 2 is analyzed in light of the specification’s explanation of the additional element’s structure. The claimed invention’s additional elements are directed to generic computer component and functions being used to perform the abstract idea.
Applicant’s own disclosure on page 6 acknowledges that the “processing circuitry 100 includes, for example, an acquisition function 101, an identification function 102, a calculation function 103, a generation function 104, and a provision function 105. The processing circuitry 100 realizes these functions by, for example, a hardware processor (computer) executing a program stored in the memory 120 (storage circuit). The hardware processor means, for example, circuit (circuitry) such as a central processing unit (CPU), a graphics processing unit (GPU), an application specific integrated circuit (ASIC), and a programmable logic device (for example, a simple programmable logic device (SPLD), a complex programmable logic device (CPLD), and a field programmable gate array (FPGA))". Additionally, the specification acknowledges on pages 6 and 9 that the "non-transitory storage medium such as a DVD or CD-ROM...These non-transitory storage media may be realized by other storage devices such as a network attached storage (NAS) and an external storage server device connected via the communication network NW. The memory 120 may also include non-transitory storage media such as a read only memory (ROM) and a register".
The Examiner has therefore determined that no additional element, or combination of additional claims elements is/are sufficient to ensure the claim(s) amount to significantly more than the abstract idea identified above (Step 2B: NO).
Therefore, claims 1 and 6-19 are not eligible subject matter under 35 USC 101.
Response to Arguments
Applicant's arguments, see pages 20-23, filed 09/30/2025, have been fully considered but they are not persuasive.
Applicant argues that Claim 1 integrates any asserted abstract ideas into a practical application by the improvements of checking risks of a plurality of types of medical data and support medical decision-making to reduce the oversight of various risk changes of patients. Examiner respectfully disagrees. The claims do not recite an improvement to medical decision-making technology. The applicant further argues that Claim 1 recites a practical application due to Claim 1 being analogous to the Federal Circuit case of In re Abele. Examiner disagrees. The Federal Circuit case of In re Abele was directed to a method for transforming X-ray data and displaying the result in grayscale. The claims merely recite acquire medical data, identify risk ranges regarding the medical data, generate display information indicating the medical data and the respective risk ranges are associated, calculate a standardized risk and standardized threshold for each piece of medical data, display the standardized risk range by aligning positions of the standardized thresholds, normalizing the risk ranges, display the medical data simultaneously, and display the relationship between the data, which are a part of the abstract idea. An improvement to the abstract ideas of acquire medical data, identify risk ranges regarding the medical data, generate display information indicating the medical data and the respective risk ranges are associated, calculate a standardized risk and standardized threshold for each piece of medical data, display the standardized risk range by aligning positions of the standardized thresholds, normalizing the risk ranges, display the medical data simultaneously, and display the relationship between the data does not amount to an improvement to technology or a technical field (see MPEP § 2106.05(a)(II) stating “it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology."). The courts indicated in TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48, that gathering and analyzing information using conventional techniques and providing the output is not sufficient to show an improvement to technology. The claim language and instant application fails to provide details regarding how a computer aids the method, the extent to which the computer aids the method, or the significance of a computer to the performance of the method. Here, the improvement is to acquire medical data, identify risk ranges regarding the medical data, generate display information indicating the medical data and the respective risk ranges are associated, calculate a standardized risk and standardized threshold for each piece of medical data, display the standardized risk range by aligning positions of the standardized thresholds, normalizing the risk ranges, display the medical data simultaneously, and display the relationship between the data. There is no indication in the disclosure that the involvement of a computer assists in improving the technology for the outlined problem statement. Merely adding generic computer components to perform the method is not sufficient.
Applicant argues that the invention recited in Claim 1 is analogous to the standardized information format in USPTO Example No. 42. Examiner maintains the position that Example 42 is distinguishable from the instant claims. As previously expressed, Example 42's abridged background provides the technical problem of latency and incompatibility between remote devices stating "medical providers must continually monitor a patient’s medical records for updated information, which is often-times incomplete since records in separate locations are not timely or readily-shared or cannot be consolidated due to format inconsistencies as well as physicians who are unaware that other physicians are also seeing the patient for varying reasons" wherein the technical solution is reflected in the claim language. The instant application, however, present a non-technical problem – determining whether an increase or decrease in each medical data value translates into an increase or decrease in a risk of a particular disease. The solution to the problem is rooted in an improvement to the abstract idea itself and not a technical failure of a computer system. The additional elements can best be characterized as tools to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2) see case requiring the use of software to tailor information and provide it to the user on a generic computer within the “Other examples., v.”).
Applicant’s arguments, see pages 11-20, filed 09/30/2025, with respect to Claims 1, 14, and 15 have been fully considered and are persuasive. The103 prior art rejection of 06/30/2025 has been withdrawn.
Applicant argues that the combination of Colman, Naga Sripada, Chaudhuri, Grimes, and Doyle does not teach or suggest the amended limitations. Examiner finds this persuasive. The amended Claim 1 recites the following limitations that overcame the prior art:
“Generate the display information indicating one standardized risk range by associating the first risk range with the second risk range by aligning positions of the calculated standardized thresholds, and normalizing the first risk range and the second risk range”
The prior art does not disclose display information where the respective standardized thresholds are aligned at the same position on a graph so that the risks of the various medical data are identifiable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Stocker (US 10636523) teaches a device, system, and method to generate time-dependent plots of two different patient-related parameters over time for common visualization in a common timing diagram.
Baronov et al. (US 20220115143 A1) teaches systems and methods on determining a patient’s clinical risk.
“Sibo Prasad Patro, Gouri Sankar Nayak, Neelamadhab Padhy, “Heart disease prediction by using novel optimization algorithm: A supervised learning prospective”, Informatics in Medicine Unlocked, Volume 26, 2021” teaches a method for heart disease prediction using risk factors based on various algorithms.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRYSTEN N WRIGHT whose telephone number is (571)272-5116. The examiner can normally be reached Monday thru Friday 8 - 5 pm, ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached on (571)270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N.W./Examiner, Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682