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 .
DETAILED ACTION
This is the first action on the merits. Claims 1-12 are currently pending.
Priority
This application claims foreign priority to 2023-114472, filed 07/12/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/11/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to for the following informality: “…at least one processor; and a memory configured to store at least one command that the processor is configured to execute, wherein in a case where the at least one command is executed by the processor…” should read “…at least one processor; and a memory configured to store at least one command that the at least one processor is configured to execute, wherein in a case where the at least one command is executed by the at least one processor …”
The Examiner encourages the use of consistent terminology.
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 1-12 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.
Claims 1, 11 and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites a device, method and non-transitory computer readable storage medium for processing and displaying information, which are within a statutory category.
Regarding claims 1, 11 and 12, the limitation of (claim 1 being representative) physiological information on a subject is input; classifies the physiological information input into a first physiological information group and a second physiological information group, the first physiological information group including the physiological information during at least a first period, the second physiological information group including the physiological information during a second period different from the first period; and generates display data including the first physiological information group, the second physiological information group, a first line that is a timeline, and a second line that indicates a value related to the physiological information; and the display data is generated in a form in which the first physiological information group and the second physiological information group are displayed in a state where the first lines overlap each other and the second line is common as crafted, is are processes that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. That is, other than reciting an information processing device, at least one processor, processor and a memory (Claim 1), an information processing device (Claim 11) and a non-transitory computer readable storage medium, a processor and an information processing device (Claim 12), the claimed invention amounts to managing personal behavior or interaction between people. For example, but for the information processing device, at least one processor, processor, memory and non-transitory computer readable storage medium, the claims encompass a person following a set of rules or instructions to input physiological information on a subject, classifies the physiological information input into a first and second physiological information group and generate display data including the first and second physiological information group in the manner described in the identified abstract idea, supra. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, claim 1 recites the additional elements of an information processing device, at least one processor, processor and a memory. Claim 11 recites the additional elements of an information processing device. Claim 12 recites the additional elements of a non-transitory computer readable storage medium, a processor and an information processing device. These additional elements are not exclusively defined by the applicant and are recited at a high-level of generality (i.e., a generic computer components for enabling access to medical information or for performing generic computer functions- see Specification at para. [0014], [0017], [0018] and [0028]) such that they amounts to no more than mere instructions to apply the exception using a generic computer component. As set forth in MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Claims 1, 11 and 12 further recite the additional element of an input interface. This additional element is recited at a high level of generality (i.e. a general means to input data) and amount to extra solution activity. MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. Accordingly, even in combination, this additional element does not 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 integration of the abstract idea into a practical application, the additional elements of the information processing device, at least one processor, processor, memory and non-transitory computer readable storage medium to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). Moreover, using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention”). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Also as discussed with respect to integration of the abstract idea into a practical application, the additional element an input interface was considered extra-solution activity. This has been re-evaluated under “significantly more” analysis and determined to be well-understood, routine and conventional in the field of healthcare. MPEP 2016.05(d)(II) indicates that receiving and/or transmitting data over a network has been held by the courts to be well-understood, routine, conventional activity (citing Symantec, TLI Communications, OIP Techs., and buySAFE). Well-understood, routine and conventional activity cannot provide an inventive concept (“significantly more”). As such the claim is not patent eligible.
The examiner notes that: A well-known, general-purpose computer has been determined by the courts to be a well-understood, routine and conventional element (see, e.g., Alice Corp. v. CLS Bank; see also MPEP 2106.05(d)).
Claims 2-10 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Claim(s) 2 and 10 further merely describe(s) different display modes. Claim(s) 3 further merely describe(s) the first period and the second period and calculating a comparison value and comparing to a threshold value. Claim(s) 4 further merely describe(s) using colors to distinguish between the portions. Claim(s) 5 further merely describe(s) the first period and setting a threshold value. Claim(s) 6 further merely describe(s) setting a threshold value based on at least one of previous history information, attribute information, condition information, or administration information of the subject. Claim(s) 7 further merely describe(s) calculating a change value of the previous physiological information. Claim(s) 8 further merely describe(s) generating supplementary physiological information. Claim(s) 9 further merely describe(s) determining quality of the physiological information, replacing the physiological information having the quality equal to or lower than the predetermined level, and generating supplementary physiological information. Claims 2-10 further define the abstract idea and are rejected for the same reason presented above with respect to claims 1, 11 and 12.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3 and 5-12 are rejected under 35 U.S.C. 103 as being unpatentable over Lopez Lopez (US 2023/0139196) and in further view of Tognetti (US 2023/0039091).
REGARDING CLAIM 1
Lopez Lopez discloses an information processing device comprising: an input interface to which physiological information on a subject is input; at least one processor; and a memory configured to store at least one command that the processor is configured to execute, wherein in a case where the at least one command is executed by the processor (Lopez Lopez at [0015] teaches an input interface for receiving measurement data comprising measured values of physiological parameters of a patient at consecutive time instances (interpreted by examiner as an input interface to which physiological information on a subject is input)), and generates display data including the first physiological information group, the second physiological information group, a first line that is a timeline, and a second line that indicates a value related to the physiological information; and the display data is generated in a form in which the first physiological information group and the second physiological information group are displayed in a state where the first lines overlap each other and the second line is common (Lopez Lopez at [0139] and Fig. 6 teach a longitudinal visualization 510 of measurement data of the patient, e.g., a trend view 510 and physiological parameters overlap. [0026] teaches a display that provides a longitudinal visualization of the measurement data by setting out the measured values of a first set of the physiological parameters (interpreted by examiner as the first physiological information group during at least a first period of Tognetti below) at the consecutive time instances against a common timeline and [0035] teaches a longitudinal visualization of the measurement data in which the measured values of a second set of the physiological parameters (interpreted by examiner as the second physiological information group during at least a second period of Tognetti below) are set out against a common timeline (interpreted by examiner as generates display data including the first physiological information group, the second physiological information group, a first line that is a timeline, and a second line that indicates a value related to the physiological information, the display data is generated in a form in which the first physiological information group and the second physiological information group are displayed in a state where the first lines overlap each other and the second line is common)).
Lopez Lopez does not explicitly disclose, however Tognetti discloses:
the information processing device is configured to: classifies the physiological information input to the input interface into a first physiological information group and a second physiological information group, the first physiological information group including the physiological information during at least a first period, the second physiological information group including the physiological information during a second period different from the first period (Tognetti at [0074] teaches physiological parameters may be measured during a first time period (interpreted by examiner as the first physiological information group including the physiological information during at least a first period) and a second time period after the first time period (interpreted by examiner as the second physiological information group including the physiological information during at least a second period different from the first period) and [0118] teaches classifying physiological data as healthy or infected);
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the physiological information of Lopez Lopez to incorporate classifying the physiological information into a first physiological information group during a first time period and a second physiological information group during a second period as taught by Tognetti, with the motivation of providing additional methods, device, and systems for detecting and identifying viral infection. (Tognetti at [0003]).
REGARDING CLAIM 3
Lopez Lopez and Tognetti disclose the limitation of claim 1.
Tognetti does not explicitly disclose, however Lopez Lopez further discloses:
he information processing device according to claim 1, wherein the first period and the second period have the same length, the information processing device is configured to calculate a comparison value between a first value based on the first physiological information group and a second value based on the second physiological information group, and in a case where the comparison value is compared to a threshold value, the information processing device is configured to generate alert information for prompting confirmation of a condition of the subject (Lopez Lopez at [0002] teaches in patient monitoring, the measured values may be compared to static or dynamic thresholds so detect abnormalities in the physical parameters, and if such abnormalities are detected, an alarm may be triggered, e.g., to attract the attention of medical personnel. For example, on an intensive care unit (ICU), a patient's vital signs (heart rate (HR), respiration rate (RR), core body temperature (CBT), oxygen saturation (SpO2) and blood pressure (BP)) may be closely monitored.).
Lopez Lopez does not explicitly disclose that the comparison value is equal to or greater than a threshold, however Tognetti further discloses:
the comparison value is equal to or greater than a threshold value (Tognetti at [0011] teaches determining whether the predictive value (interpreted by examiner as the comparison value) is greater than a predefined threshold value, and in response to the predictive value being greater than the predefined threshold value, determining that the patient is infected.)
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the comparison value against a threshold value of Lopez Lopez to incorporate the comparison value being equal to or greater than a threshold value as taught by Tognetti, with the motivation of determining that a patient is infected. (Tognetti at [0011]).
REGARDING CLAIM 5
Lopez Lopez and Tognetti disclose the limitation of claim 1.
Tognetti does not explicitly disclose, however Lopez Lopez further discloses:
The information processing device according to claim 3, wherein the first period is a period temporally later than the second period, and the information processing device is configured to set the threshold value, based on a change tendency of the first physiological information group (Lopez Lopez at [0008] teaches the measured values of physiological parameters may change over time, with some physiological parameters fluctuating within minutes or hours and others showing only considerable changes over days or months. Changes over time may be particularly relevant to be able to see if a patient is getting better, is stable, or is deteriorating, or to see if certain interventions (medication/fluids) have an effect (interpreted by examiner as means to set the threshold value, based on a change tendency of the first physiological information group)).
REGARDING CLAIM 6
Lopez Lopez and Tognetti disclose the limitation of claim 1.
Lopez Lopez does not explicitly disclose, however Tognetti further discloses:
The information processing device according to claim 3, wherein the information processing device is configured to set the threshold value, based on at least one of previous history information, attribute information, condition information, or administration information of the subject (Tognetti at [0004] teaches determining patient-specific historical baseline metrics for a predetermined period of time. As physiological parameters are measured, the user device identifies measurements deviating from the baseline metrics. In response to a predetermined deviation a notification of infection is provided (interpreted by examiner as means to set the threshold value, based on at least one of previous history information)).
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the method for setting the threshold value of Lopez Lopez to incorporate setting the threshold value, based on at least one of previous history information as taught by Tognetti, with the motivation of determining that a patient is infected. (Tognetti at [0011]).
REGARDING CLAIM 7
Claim 7 is analogous to Claims 3, 5 and 6 thus Claim 7 is similarly analyzed and rejected in a manner consistent with the rejection of Claims 3, 5 and 6.
REGARDING CLAIM 8
Lopez Lopez and Tognetti disclose the limitation of claim 1.
Tognetti does not explicitly disclose, however Lopez Lopez further discloses:
The information processing device according to claim 1, wherein in a case where the first physiological information group includes missing information indicating that the physiological information is missing during at least a portion of the first period, the information processing device is configured to generate supplementary physiological information for compensating for the missing physiological information based on the physiological information input to the input interface (Lopez Lopez at [0149] teaches using a so called ‘digital twin’ which may be a simulation model of the patient which may allow virtual measurements. While the simulation model may be based on actual measured physiological values of a patient, such virtual measurements may allow the selection of time instances in the future, e.g., to estimate changes in the patient's condition in the future, or to select time instances in the past, e.g., where actual measurement values were not available, are missing or have been corrupted (interpreted by examiner as generate supplementary physiological information for compensating for the missing physiological information)).
REGARDING CLAIM 9
Lopez Lopez and Tognetti disclose the limitation of claim 1.
Tognetti does not explicitly disclose, however Lopez Lopez further discloses:
The information processing device according to claim 1, wherein the information processing device is configured to: determined quality of the physiological information, based on the physiological information and a quality reference value for evaluating the quality of the physiological information, and in a case where the quality of the physiological information during at least a portion of the first period is equal to or lower than a predetermined level: replace the physiological information having the quality equal to or lower than the predetermined level with missing information indicating that the physiological information is missing, and generate supplementary physiological information for compensating for the missing physiological information based on the physiological information input to the input interface (Lopez Lopez at [0149] teaches where actual measurement have been corrupted (interpreted by examiner as having a quality equal to or lower than the predetermined level)).
REGARDING CLAIM 10
Lopez Lopez and Tognetti disclose the limitation of claim 1.
Tognetti does not explicitly disclose, however Lopez Lopez further discloses:
The information processing device according to claim 8, wherein a display mode corresponding to the supplementary physiological information is different from a display mode corresponding to the physiological information input to the input interface (Lopez Lopez at [0149] teaches that the so called ‘digital twin’ can be a simulation model of the patient which may allow virtual measurements (interpreted by examiner as a different display mode based on the difference in measurements)).
REGARDING CLAIMS 11 and 12
Claims 11 and 12 are analogous to Claim 1 thus Claims 11 and 12 are similarly analyzed and rejected in a manner consistent with the rejection of Claim 1.
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Lopez Lopez (US 2023/0139196), in view of Tognetti (US 2023/0039091) and in further view of McSweeney (US 2023/0063782).
REGARDING CLAIM 2
Lopez Lopez and Tognetti disclose the limitation of claim 1.
Lopez Lopez and Tognetti do not explicitly disclose the display mode of an overlapped portion and the display mode of a non-overlapped portion, however McSweeney further discloses:
The information processing device according to claim 1, wherein a display mode of an overlapped portion which is a portion where a first portion and a second portion overlap is different from a display mode of a non-overlapped portion which is a portion where the first portion and the second portion do not overlap, the first portion being surrounded by the first line and a first graph object indicating a size of each piece of the physiological information included in the first physiological information group, the second portion being surrounded by the first line and a second graph object indicating a size of each piece of the physiological information included in the second physiological information group (McSweeney at [0131], [0134] and Fig. 15 teach a displayed visualization (interpreted by examiner as the displayed visualization of the first and second physiological information groups of Lopez Lopez) and you can see from Fig. 15 overlapped and non-overlapped portion of heart rate values on a common timeline. The chart 1500 displays heart rate values and can display the physiological data values acquired from the physiological sensor (interpreted by examiner as a display mode of an overlapped portion which is a portion where a first portion and a second portion overlap is different from a display mode of a non-overlapped portion which is a portion where the first portion and the second portion do not overlap, the first portion being surrounded by the first line and a first graph object indicating a size of each piece of the physiological information included in the first physiological information group, the second portion being surrounded by the first line and a second graph object indicating a size of each piece of the physiological information included in the second physiological information group)).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention was made to combine the noted features of Lopez Lopez and Tognetti with teaching of McSweeney since known work in one field of endeavor may prompt variations in design in either the same field or a different field based on design incentives or other market forces if the variations would have been predictable to one of ordinary skill in the art. One of ordinary skill in the art of healthcare data processing would found it obvious to update the physiological information of the primary reference and the display of physiological information of the secondary reference using the display modes of an overlapped portion and a non-overlapped portion, as found in the third reference, in order to gain the commonly understood benefits of such adaptation, such as decreased size, increased reliability, simplified operation, and reduced cost. This update would be accomplished with no unpredictable results.
REGARDING CLAIM 4
Lopez Lopez and Tognetti disclose the limitation of claim 1.
Lopez Lopez and Tognetti do not explicitly disclose the non-overlapped portion in the first portion is colored with a first color, the non-overlapped portion in the second portion is colored with a second color different from the first color, and the overlapped portion is colored with a color different from the first color and the second color, however McSweeney further discloses:
The information processing device according to claim 2, wherein the non-overlapped portion in the first portion is colored with a first color, the non-overlapped portion in the second portion is colored with a second color different from the first color, and the overlapped portion is colored with a color different from the first color and the second color (McSweeney at [0140] and Fig. 15 teach a first, second, and third shades of color when overlayed on the heart rate values are overlapped with one another, and can be used to provide intuitive information that improves the operation of the monitor device. The overlapped portion in the chart 1500 is a darker shade of the color, and the not overlapped portion in the chart 1500 is a lighter or brighter shade of the color. This can help visualize expected targeted effects or side effects of treatment events on the physiological data values measured by the physiological sensor).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention was made to combine the noted features of Lopez Lopez and Tognetti with teaching of McSweeney since known work in one field of endeavor may prompt variations in design in either the same field or a different field based on design incentives or other market forces if the variations would have been predictable to one of ordinary skill in the art. One of ordinary skill in the art of healthcare data processing would found it obvious to update the physiological information of the primary reference and the display of physiological information of the secondary reference using the coloring technique for the overlapped portion and a non-overlapped portions, as found in the third reference, in order to gain the commonly understood benefits of such adaptation, such as decreased size, increased reliability, simplified operation, and reduced cost. This update would be accomplished with no unpredictable results.
Conclusion
The prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Michelson (US 2011/0257535) teaches a system and method for cardiac monitoring.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIZA TONY KANAAN whose telephone number is (571)272-4664. The examiner can normally be reached on Mon-Thu 9:00am-6:00pm ET.
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/LIZA TONY KANAAN/Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683