DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This action is in reply to the amendment filed on 10/15/25.
Claims 1-15 have been amended and are hereby entered.
Claims 1-15 are currently pending and have been examined.
This action is made final.
Foreign Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. JP2021-087307 filed on 05/25/21. Accordingly, a priority date of 05/25/21 has been given to this application.
Claim Objections
Claim 1 as amended contains recitation of “a patient side terminal”. Dependent claim 5 recites “a patient-side information processing terminal”. Similarly, Claims 7 and 8 recite “the patient-side information processing terminal”. For purposes of examination, recitation of “patient side information processing terminal” of Claims 5, 7, 8 is being interpreted as referring to the “patient side terminal” in Claim 1. Examiner recommends streamlining claim language to either recite “patient side terminal” or “patient side information processing terminal” across all claims for improved coherence and consistency.
Claims 2-13, 15 are subsequently objected to as they inherit the deficiencies of Claim 1.
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 1-15 are rejected under 35 U.S.C.101 because the claimed invention is directed to a judicial exception (an abstract idea) without significantly more.
Step 1
Claims 1-13, 15 are drawn to a system, and Claim 14 is drawn to a method, both of which are within the four statutory categories. Claims 1-15 are further directed to an abstract idea on the grounds set out in detail below.
Step 2A Prong 1
Claims 1 and 14 recites implementing the steps of:
acquiring a measured value related to biometric information of a patient;
comparing the measured value with an improvement target reference set in advance;
determining that the measured value has not achieved the improvement target reference based on the comparing of the measured value with the improvement target reference set in advance
acquiring dosing information including at least information on a dosing frequency of the patient based on the determining that the measured value has not achieved the improvement target reference;
generating a medicinal effect confirmation support image in which both measured value transition information indicating a change in the measured value of the patient at each first predetermined period and the dosing information are browsable when the measured value has not achieved the improvement target reference;
generating warning information thereon when the measured value has not achieved the improvement target reference;
outputting the warning information when the measured value has not achieved the improvement target reference; and
outputting the medicinal effect confirmation support image when the measured value has not achieved the improvement target reference.
These steps amount to managing personal behavior or relationships or interactions
between people and therefore recite certain methods of organizing human activity. The claims recite various data collection, analysis and output steps which may be performed by a healthcare provider. More specifically, collecting patient biometric measured values to compare to an improvement target reference, determining that a measured value has not achieved an improvement target reference, collecting dosing information when the measured values do not achieve the target range, generating an image to show a change in the measured patient value and dosing information, providing a warning when the measured value has not reached the target reference, and providing the image when the measured value has not achieved the reference target, are personal behaviors that may be performed by healthcare providers.
Claims 1 and 14 are therefore directed to an abstract idea
Step 2A Prong 2
Regarding Claim 14: Claim 14 does not recite any additional elements by which to integrate the judicial exception into a practical application.
Regarding Claim 1: This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
Claim 1 additionally recites:
a doctor-side terminal including a doctor-side terminal processor as the entity to which the warning information is output when the measured value has not achieved a target reference range;
a sensor that monitors removal of medication in a medication bottle as implementing the step of acquiring dosing information;
a patient side terminal including a patient side terminal processor configured to communicate, via a network, with the doctor-side terminal, and further configured to communicate with the sensor as the entity from which a measured value related to a biometric information of a patient is acquired and from which the dosing information is acquired via the sensor; and
a server, configured to communicate with the doctor-side terminal and the patient side terminal, the server including a processor as implementing the steps of the abstract idea.
The broad recitation of general purpose computing elements at a high level of generality only amounts to mere instructions to implement the abstract idea using computing components as tools.
Regarding a doctor-side terminal including a doctor-side terminal processor, per paras. [0090]-[0091] as published, this is understood to be a general purpose computing device ([0090], “The doctor-side terminal 200 is a general computer, such as a fixed personal computer, a portable notebook-type personal computer, or a tablet device, and includes a control unit 210”; [0091] “The control unit 210 is means for controlling the doctor-side terminal 200, and is constituted of, for example, a CPU”).
Regarding the sensor that monitors removal of medication in a medication bottle, no structural description or particulars appear to be provided. Para. [0032] discloses “a sensor that detects removal of a medicine may be provided in a container in which the patient stores the medicine, and the dosing information may be acquired from information (the amount of the medicine removed, and the date and time of the removal) acquired by the sensor”; para. [0124] contains similar disclosure. Therefore, this element is given its broadest reasonable interpretation as a general purpose sensor used to implement the step of monitoring medical removal from a bottle.
Regarding a patient side terminal including a patient side terminal processor configured to communicate, via a network, with the doctor-side terminal, and further configured to communicate with the sensor, per paras. [0100]-[0102], this is understood to be a general purpose computing device (see [0100], “The patient-side terminal 300 is, for example, a portable information processing terminal, such as a smartphone, a tablet terminal, or a wristwatch type wearable terminal”; [0101]-[0102], the control unit is a means for controlling patient-side terminal; it is constituted of, for example, a CPU); regarding “configured to communicate via a network”, no particulars of the network and/or communication appear to be provided; as such, these are given their broadest reasonable interpretation as general purpose computing elements which amount to mere instructions to applying the abstract idea.
Regarding a server, configured to communicate with the doctor-side terminal and the patient side terminal, the server including a processor, paras. [0078]-[0079] as published describe Fig. 3, which shows a configuration of the server device 100 which is part of the biometric information processing system 1 per para. [0069] as published. Para. [0078] discloses “The server device 100 is constituted of a general server computer and, as illustrated in FIG. 3 , includes a control unit 110, communication means 120, and storage means 130” – therefore, the server is understood to be a general purpose server computer functioning in its ordinary capacity to implement the steps of the abstract idea. Para. [0079] as published further discloses “The control unit 110 is means that manages the control of the server device 100, and is constituted of a processor, such as a Central Processing Unit (CPU) or a Digital Signal Processor (DSP)”; as such, the processor is understood to be a general purpose processor functioning in its ordinary capacity.
B. Insignificant Extra-Solution Activity. MPEP 2106.05(g)
Examiner notes that while the element of “a sensor that monitors removal of medication in a medication bottle” in Claim 1 was identified as falling under Instructions to Implement the Judicial Exception (MPEP 2106.05(f)) as discussed above, this element could also be classified as insignificant extra-solution activity in the form of mere data gathering; the step of “monitoring removal of medication in a medication bottle” serves as a step for gathering data to use later for generating the medicinal effect confirmation support image when the measured value has not achieved the improvement target reference.
These elements are therefore not sufficient to integrate the abstract idea into a practical application. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B
The present claims do not include additional elements that are sufficient to amount to
more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
Regarding Claim 1: As explained above, claim 1 only recites the aforementioned computing elements as tools for performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f).
B. Insignificant Extra-Solution Activity. MPEP 2106.05(g)
Likewise, as explained above, if the element of a sensor that monitors removal of medication in a medication bottle in Claim 1 is classified as Insignificant Extra-Solution Activity rather than Mere Instructions to Implement the Judicial Exception, the element of a sensor that monitors removal of medication in a medication bottle in Claim 1 only amounts to insignificant extra-solution activity in the form of mere data gathering, e.g., it is collecting data regarding the frequency of medication dispensation to later be used in generating a medicinal effect confirmation support image.
C. Well-Understood, Routine and Conventional Activities. MPEP 2106.05(d)
In addition to amounting to insignificant extra-solution activity, the element of “a sensor that monitors removal of medication in a medication bottle” in Claim 1 in Section B above constitutes well-understood, routine and conventional activity. Also as discussed above with respect to integration of the abstract idea into a practical application, this additional element of a sensor that monitors removal of medication in a medication bottle was considered extra-solution activity. This has been re-evaluated under the “significantly more” analysis and determined to be well-understood, routine, conventional activity in the healthcare field. As evidenced by the prior art of record, a sensor that monitors removal of medication in a medication bottle is a well-understood, routine, and conventional elements in the field of computerized healthcare (see Bickley reference at Abstract, paras. [0007]-[0008], [0056]; see Arric reference at Abstract, paras. [0008], [0009], [0071]; see Rothschild at para. [0019]). Well-understood, routine, conventional activity cannot provide an inventive concept (“significantly more”). As such the claim is not patent eligible.
Thus, taken alone, the additional elements of Claim 1 do not amount to significantly more than the above-identified judicial exception. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Their collective functions merely provide conventional computer implementation.
Claim 14 does not recite any additional elements; as such, it does not recite any additional elements that are sufficient to amount to more than the abstract idea.
Depending Claims
The dependent claims have been given the full two-part analysis including analyzing the additional limitations both individually and in combination. Dependent claims 3, 10, 12 recite additional subject matter which further narrows or defines the abstract idea embodied in the claims. Claims 2-9, 11 recite limitations that are also directed to certain methods of organizing human activity including managing personal behaviors, as they are behaviors that may be performed by healthcare providers.
The dependent claims, when analyzed individually, and in combination, are also held to be patent ineligible under 35 U.S.C. 101 as they include all of the limitations of claim 1. The additional recited limitations of the dependent claims fail to establish that the claims do not recite an abstract idea because the additional recited limitations of the dependent claims merely further narrow the abstract idea. Beyond the limitations which recite the abstract idea, the claims recite additional elements consistent with those identified above with respect to the independent claims which encompass adding the words “apply it” (or an equivalent) with the judicial exception (e.g., processor in Claims 2-9, 11; recitation of patient-side information processing terminal in Claims 5, 7, 8 amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f)). Regarding Claim 13, recitation of “a biometric information processing device, comprising: the measured value acquisition device; the comparison device; the dosing information acquisition device; the medicinal effect confirmation support image generation device; and the warning information generation device, wherein the biometric information processing device constitutes at least a part of the biometric information processing system according to claim 1”, and specifically, recitation of “a biometric information processing device” only amounts to mere instructions to implement the abstract idea. Paras. [0041]-[0042] as published disclose “In addition, the present invention can also be considered as a program for causing a computer to function as such a biometric information processing device, and a computer-readable recording medium including such a program recorded therein in a non-transitory manner”. Therefore, “biometric processing device” is interpreted as having the computing architecture described at paras. [0078]-[0081] as published and only amounts to mere instructions to apply the abstract idea on a general purpose computer. Regarding Claim 15, recitation of “a program recording medium for causing a computer to function as a biometric processing device according to claim 13” further amounts to mere instructions to apply the abstract idea per paras. [0041]-[0042] as published as previously stated. Accordingly, 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.
Dependent claims 2-13, 15 recite additional subject matter which amounts to additional elements consistent with those identified in the analysis of Claim 1 above. As discussed above with respect to Claim 1 and integration of the abstract idea into a practical application, recitation of these additional elements only amounts to invoking computers as a tool to perform the abstract idea. 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.
Dependent claims 2-13, 15, when analyzed as a whole, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
For the reasons stated, Claims 1-15 fail the Subject Matter Eligibility Test and are consequently rejected under 35 U.S.C. 101.
Response to Applicant’s Remarks/Arguments
Please note: When referencing page numbers of Applicant’s response, references are to page numbers as printed.
35 USC 112(f) Claim Interpretation
The interpretation of the claims under 35 USC 112(f) detailed at pages 3-7 of Non-Final Action dated 7/15/25 are withdrawn in view of Applicant’s amendments to the claims.
35 USC 112(b) Rejections
The rejections of the claims under 35 USC 112(b) detailed in Non-Final Action dated 7/15/25 are withdrawn in view of Applicant’s amendments to the claims.
35 USC 101 Rejections
Applicant’s remarks have been fully considered but are not persuasive. Applicant argues:
As can be seen from amended claim 1, the system recites various hardware components that communicate in order to facilitate the claimed biometric information processing. The incorporation of the doctor-side terminal, sensor, patient side terminal, network, and server clearly demonstrate that the purported abstract idea is tied to hardware that is used to process the claimed functionality, thereby reciting a practical application of, and significantly more than the purported abstract idea. (Page 10)
Regarding (a), the Examiner respectfully disagrees. As shown above in the main 101 analysis section above, the addition elements to which Applicant cites (doctor-side terminal, network, sensor, etc.) are understood to be general purpose computing elements functioning in their ordinary capacities to implement the steps of the abstract idea, which does not provide a practical application of, or amount to significantly more than, the abstract idea. MPEP 2106.05(f). If the additional element of “a sensor that monitors removal of medication in a medication bottle” is considered to be extra-solution activity in the form of mere data gathering, it amounts to well-understood, routine and conventional activity in the healthcare field as evidenced by the cited prior arts.
Regarding practical application, MPEP 2106.04(d)(1) states that a practical application may be present where the claimed invention improves the functioning of a computer or another technology. See also MPEP 2106.05(a)(I) and 2106.05(a)(I). The technological environment of Applicant’s claim is general-purpose computers (see Spec. Paras. [0078]-[0079], [0090]-[0091], [0100]-[0102]). Applicant has not identified nor can the Examiner locate any physical improvement to the functioning of the computer that results from the implementation of Applicant’s claim. Applicant’s claimed invention recites the additional element(s) of a doctor-side terminal, patient-side terminal, sensor, and server including a processor. While these additional elements implement the steps of the abstract idea, there is no indication that these additional elements operate in a manner different than they normally operate (for example: outputting a warning information to a doctor-side terminal does not improve the doctor-side terminal. The terminal is operating as it normally operates). Operating a computing device in the manner it normally operates is insufficient to improve that other technology. As such, these additional elements are not improved through implementation of the abstract idea and a practical application is not present.
Regarding “significantly more”, MPEP 2106.05(d) states: “Another consideration when determining whether a claim recites significantly more than a judicial exception is whether the additional element(s) are well-understood, routine, conventional activities previously known to the industry (emphasis added).” As demonstrated in 101 analysis section above, the additional elements amount to general purpose computing elements functioning in their ordinary capacities, which is not sufficient to provide significantly more than the judicial exception.
The rejections of Claims 1-15 under 35 USC 101 are maintained.
35 USC 103 Rejections
Applicant’s remarks have been fully considered and are persuasive. The rejections of Claims 1-15 under 35 USC 103 are withdrawn in view of Applicant’s arguments regarding the deficiencies of the prior art applied in Non-Final Action dated 07/15/25 in combination with the amendments to the claims. The closest prior art is understood to be the art of record. Regarding the amended limitations, Rothschild teaches on using a sensor to monitor when a pill is being removed from a container (para. [0019]), but does not teach using the monitoring data of medication removal to determine dosing frequency when a patient’s measured value has reached a target range and using the acquired dosing information to generate a medicinal effect confirmation support image in which both measured value transition information indicating a change in the patient’s measured value and dosing information are browsable. A search of publicly available prior art fails to yield a reference or combination of references that would make the claimed combination of limitations obvious when considered as a whole.
Conclusion
Examiner respectfully requests that Applicant provides citations to relevant paragraphs of specification for support for amendments in future correspondence.
The following relevant prior art not cited is made of record:
US Publication 20130096444A1, teaching on a system and method for dynamically adjusting patient therapy
US Publication 20180289591A1, teaching on a medication compliance device which senses when an individual dose of medication has been removed from a medication storage container
US Publication 20190228851A1, teaching on a medication regimen adherence system in which a sensor detects when a lid or cap of a medication container is removed
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNE-MARIE K ALDERSON whose telephone number is (571)272-3370. The examiner can normally be reached on Mon-Fri 9:00am-5:00pm EST, and generally schedules interviews in the timeframe of 2:00-5:00pm EST.
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/ANNE-MARIE K ALDERSON/Primary Examiner, Art Unit 3682