DETAILED ACTION
The present office action represents a final action on the merits.
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
This application claims the priority date of foreign application JP2021-054090, of March 26, 2021 and is a CON of PCT/JP2022/014624.
Status of Claims
Claims 1 and 7 are amended, claim 2 is cancelled, and claims 1, 4-5, and 7-8 are pending.
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, 4-5, and 7-8 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, 4-5, and 8 are drawn to a medication information management system for allowing for information data transmission, which is within the four statutory categories (i.e., machine). Claim 7 is drawn to a medication information management method executed by an information management system that allows for information data transmission, which is within the four statutory categories (i.e., process).
Claims 1, 4-5, and 8 recite a medication information management system for allowing for information data transmission via a network between a user terminal used by a target recipient of medication and an organization terminal used by an organization to which medication certification information relating to the medication is to be submitted, the medication information management system comprising:
processing circuitry configured to
obtain medication completion information that indicates a fact of the medication having been administered to the target recipient and store the obtained medication completion information in association with unique identification information of the target recipient;
obtain post-medication information that indicates a condition of the target recipient after the medication including a status of adverse reactions, and is obtained after a predetermined period has elapsed since administration of the medication, from the user terminal and store the obtained post-medication information in association with the medication completion information;
create the medication certification information based on the medication completion information and the post-medication information; and
control a process of submitting the medication certification information from the target recipient to the organization, wherein the user terminal transmits the medication certification information along with a hash value to the organization terminal, when the user terminal is co-located with the organization terminal, via a code displayed on the user terminal or via a low-power wireless transmission standard,
conduct an authentication process upon the target recipient and a consent process for confirming consent of the target recipient to use of the medication certification information by the organization,
the system further comprising a blockchain platform, in which a plurality of distributed ledgers are connected via a peer-to-peer(P2P) network, configured to implement a verification procedure on the medication certification information submitted to the organization by generating and storing trail information in which a history of changes to the medication completion information and the post-medication information is recorded, the blockchain platform being configured to conduct verification regarding whether or not an unauthorized change has been made to the medication certification information, based on the hash value included in a stored token, wherein each time the issued vaccination certification data is used, for at least both of (i) when the user terminal transmits the medication certification information to the organization terminal when the user terminal is co-located with the organization terminal and (ii) when the organization terminal uses the medication certification information based on the consent of the target recipient when the target recipient is not co-located with the organization terminal, the blockchain platform updates an attribute value of the stored token and stores information indicating a history of changes as a transaction.
Claim 7 recites a medication information management method executed by an information management system that allows for information data transmission via a network between a user terminal used by a target recipient of medication and an organization terminal used by an organization to which medication certification information relating to the medication is to be submitted, the medication information management method comprising:
obtaining medication completion information that indicates a fact of the medication having been administered to the target recipient and storing the obtained medication completion information in association with unique identification information of the target recipient;
obtaining post-medication information, that indicates a condition of the target recipient after the medication including a status of adverse reactions, and is obtained after a predetermined period has elapsed since administration of the medication, from the user terminal and storing the obtained post-medication information in association with the medication completion information;
creating the medication certification information based on the medication completion information and the post-medication information; and
controlling a process of submitting the medication certification information from the target recipient to the organization, wherein the user terminal transmits the medication certification information along with a hash value to the organization terminal, when the user terminal is co-located with the organization terminal, via a code displayed on the user terminal or via a low-power wireless transmission standard,
conducting an authentication process upon the target recipient and a consent process for confirming consent of the target recipient to use of the medication certification information by the organization
the system further comprising a blockchain platform, in which a plurality of distributed ledgers are connected via a peer-to-peer(P2P) network, that implements a verification procedure on the medication certification information submitted to the organization by generating and storing trail information in which a history of changes to the medication completion information and the post-medication information is recorded, the blockchain platform conducting verification regarding whether or not an unauthorized change has been made to the medication certification information, based on the hash value included in a stored token, wherein each time the issued vaccination certification data is used, for at least both of (i) when the user terminal transmits the medication certification information to the organization terminal when the user terminal is co-located with the organization terminal and (ii) when the organization terminal uses the medication certification information based on the consent of the target recipient when the target recipient is not co-located with the organization terminal, the blockchain platform updates an attribute value of the stored token and stores information indicating a history of changes as a transaction.
The bolded limitations, given the broadest reasonable interpretation, cover a certain method of organizing human activity, but for the recitation of generic computer components (e.g., obtaining patient information; managing patient information, in this case medication information management apparatus for allowing for information data transmission). The underlined limitations are not part of the identified abstract idea (the method of organizing human activity) and are deemed “additional elements,” and will be discussed in further detail below.
Dependent claims 4-5 and 8 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. These limitations only serve to further limit the abstract idea (or contain the same additional elements found in the independent claim), and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 1 and 7.
The dependent claims include additional limitations, but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 1 and 7.
The additional elements from claim 1 include:
medication information management system (apply it, MPEP 2106.05(f)).
processing circuitry (apply it, MPEP 2106.05(f)).
store the obtained medication completion information in association with unique identification information of the target recipient (apply it, MPEP 2106.05(f)).
store the obtained post-medication information in association with the medication completion information (apply it, MPEP 2106.05(f)).
The additional elements from claims 1 and 7 include:
via a network (apply it, MPEP 2106.05(f)).
a user terminal (generally linking, MPEP 2106.05(h)).
an organization terminal (generally linking, MPEP 2106.05(h)).
plurality of distributed ledgers are connected via a peer-to-peer (P2P) network (apply it, MPEP 2106.05(f)).
a blockchain platform (apply it, MPEP 2106.05(f)).
a low-power wireless transmission standard (apply it, MPEP 2106.05(f)).
The additional elements from claim 7 include:
an information management system (apply it, MPEP 2106.05(f)).
storing the obtained medication completion information in association with unique identification information of the target recipient (apply it, MPEP 2106.05(f)).
storing the obtained post-medication information in association with the medication completion information (apply it, MPEP 2106.05(f)).
The additional elements in claim 8 include:
non-transitory computer-readable medium for storing a program that causes a processing circuitry of a medication information management system (apply it, MPEP 2106.05(f)).
These additional elements, in the independent claims are not integrated into a practical application because the additional elements (i.e., the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of “system”, “a network”, “processing circuitry”, “a computer program”, “blockchain”, which amounts to merely invoking a computer as a tool to perform the abstract idea e.g., see Specification Paragraphs [0026], [0031]-[0045], (See MPEP 2106.05(f)); and
generally link the abstract idea to a particular technological environment or field of use – for example, “user terminal”, “organizational terminal”, see MPEP 2106.05(h).
Furthermore, the claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e., the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification discloses that the additional elements are well-understood, routine, and conventional in nature (i.e., the Specification Paragraphs [0026], [0031]-[0045] discloses that the additional elements (i.e., apparatus, a network, processing unit, a computer program) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions that are well understood routine, and conventional activities previously known to the pertinent industry (i.e., healthcare, a medication information management method executed by an information management apparatus);
Relevant court decisions: The following example of court decision demonstrating well understood, routine and conventional activities, e.g., see MPEP 2106.05(d)(II): Receiving medication use data, e.g., see Intellectual Ventures v. Symantec – similarly, the current invention receives data for user vaccinations.
Dependent claims 4-5 and 8 include other limitations, but none of these functions are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims similarly represent no more than receiving or transmitting/indicate data over a system (e.g., receive medication use data, claims 4 and 5.).
Thus, taken alone, the additional elements do not amount to “significantly more” than the above identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves any other technology, and their collective functions merely provide conventional computer implementation.
The application, is an attempt to organize human activity, using a medication information management method executed by an information management system to receive and transmit user medication data. The inventive concept is the medication information management method executed by an information management system, which is not patentable. Therefore, whether taken individually or as an ordered combination, claims 1, 4-5, and 7-8 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Subject Matter Free from Prior Art
Examiner acknowledges the limitations in claims 1 and 7:
obtain medication completion information that indicates a fact of the medication having been administered to the target recipient and store the obtained medication completion information in association with unique identification information of the target recipient;
obtain post-medication information that indicates a condition of the target recipient after the medication including a status of adverse reactions, and is obtained after a predetermined period has elapsed since administration of the medication, from the user terminal and store the obtained post-medication information in association with the medication completion information;
create the medication certification information based on the medication completion information and the post-medication information; and
control a process of submitting the medication certification information from the target recipient to the organization, wherein the user terminal transmits the medication certification information along with a hash value to the organization terminal, when the user terminal is co-located with the organization terminal, via a code displayed on the user terminal or via a low-power wireless transmission standard,
conduct an authentication process upon the target recipient and a consent process for confirming consent of the target recipient to use of the medication certification information by the organization,
the system further comprising a blockchain platform, in which a plurality of distributed ledgers are connected via a peer-to-peer(P2P) network, configured to implement a verification procedure on the medication certification information submitted to the organization by generating and storing trail information in which a history of changes to the medication completion information and the post-medication information is recorded, the blockchain platform being configured to conduct verification regarding whether or not an unauthorized change has been made to the medication certification information, based on the hash value included in a stored token, wherein each time the issued vaccination certification data is used, for at least both of (i) when the user terminal transmits the medication certification information to the organization terminal when the user terminal is co-located with the organization terminal and (ii) when the organization terminal uses the medication certification information based on the consent of the target recipient when the target recipient is not co-located with the organization terminal, the blockchain platform updates an attribute value of the stored token and stores information indicating a history of changes as a transaction.
are free from prior art when considered in combination with the other limitations, and are not subject to any prior art rejections under 103. The closest prior art is:
Kim (U.S. Pub. No. 2024/0185994 A1) (Paragraphs [0007]-[0008] discuss a method and system for vaccination management transmitting, by the medical institution device, a vaccination certificate issuance request including vaccination information, and transmitting, by the trusted institution server, the vaccination certification VC to the user device.).
Kim (U.S. Pub. No. 2024/0185994 A1) (Paragraphs [0041], [0075], and [0201]-[0203] discuss the vaccination management server that includes a processor and the medical institution electronic device may identify an individual who is a vaccinated person, receive an identity certificate stored in the personal electronic device and identify an individual based on the received identity certificate and after vaccination is completed, the medical institution electronic device may transmit the identified vaccine information, the identified personal information, and the vaccinated information to the vaccination management server and the registry may store a unique identifier for the vaccination certificate associated with a user.).
Kim (U.S. Pub. No. 2024/0185994 A1) (Paragraphs [0007]-[0008], [0041], [0192], Table 3 discuss vaccination management and after vaccination is completed, the medical institution electronic device that provide feedback reflecting medical information updated in real time to hospitals or vaccinated persons, and to provide a follow-up management after vaccination, the vaccine information may include formation necessary for reporting the inoculation fact, such as a vaccination time, location, and a status of the vaccinated person, allergies, side effects.).
Kim (U.S. Pub. No. 2024/0185994 A1) (Paragraphs [0027], [0041]-[0042], and Table 5 discuss a vaccination certificate that certificates a status of vaccination may be issued in the form of a digital certificate, may be a data set including data associated with vaccination and may include sensitive information about an individual related to vaccination, after vaccination is completed, the medical institution electronic device may transmit the identified vaccine information, the identified personal information, and the vaccination information to the vaccination management server necessary for reporting the inoculation fact, such as a vaccination time, a vaccination location, and a status of the vaccinated person. And the vaccination management server may issue a vaccination certificate based on the received vaccine information, personal information, and vaccination information.).
Kim (U.S. Pub. No. 2024/0185994 A1) (Paragraphs [0030]-[0034], [0042], [0063], [0155] discuss the vaccination management server may transmit the issued vaccination certificate to the personal electronic device and personal electronic device may submit the identity certification vaccination certificate to the vaccination management agency by transmitting the identity certification VP to the vaccination management server and the identity certificate authority and the vaccination management agency may be integrated. For example, one trusted institution may serve as the identity certificate authority and the vaccination management agency; further the identity certification VC may be converted into a QR code and output through the display of the personal electronic device. The medical institution electronic device may acquire the VC by recognizing the displayed QR code.).
Kim (U.S. Pub. No. 2024/0185994 A1) (Paragraphs [0007], [0048], [0051], [0082], [0129], [0137]-[0138], [ 0185], [0201], and Table 5 discuss vaccination certification to provide feedback reflecting medical information updated in real time and a decentralized peer-to-peer (P2P) network such as a federated ID management system or a distributed ledger of a plurality of trusted institutions, the blockchain network may store ID registries and the vaccination management server, the medical institution electronic device, and the personal electronic device may be stored in the ID registries; the vaccination certificate issuance module may store, in the first ID registry, a DID of an individual, a DID of a medical institution, and a fact of the issuing of the certificate included in the vaccination certificate; the vaccination agency database, and the vaccination history database of the vaccination management server may be periodically updated; certificates are issued and verified based on the blockchain network, further the vaccination certificate may have a unique identifier, and the unique identifier may be a hash value for all contents of the vaccination certificate. When the certificate is invalidated, information indicating the fact that the certificate is invalid may be recorded in the blockchain network for the unique identifier of the certificate, for example a deleted practitioner will be deleted from the blockchain network and not have access; vaccination management server may receive and store a push notification token from the first application of the medical institution electronic device.).
Kim (U.S. Pub. No. 2024/0185994 A1) in view of Fuerst (U.S. Pub. No. 2011/0029488 A1)Paragraphs [0242], FIGS. 7 , 20, and 21 discuss for example, the form enables the user to enter follow-up information that includes adverse reactions 1 day up to 28 days.).
Kim (U.S. Pub. No. 2024/0185994 A1) in view of Fuerst (U.S. Pub. No. 2011/0029488 A1) and Narusawa (U.S. Pub. No. 2017/0193187 A1) Paragraphs [0421] and [0426] discuss a hash value are associated with each of the individual-based terminal IDs associated with a personal identification ID and the communication unit transmits the personal identification ID, the usage suspension code, and the hash value supplied from the request processing unit, to the data center and requests recording of the hash value.).
It would not be obvious to combine all of the references, accordingly, the 103 rejection is withdrawn.
Response to Arguments
Applicant’s arguments filed 2/24/2026 have been fully considered.
Rejections under 35 U.S.C. 101:
With respect to claim 1 and the Prong 1 35 U.S.C. 101 rejection, Applicant’s amendment fails to overcome the previous rejection. Claim 1 recites an abstract idea, a method of organizing human activity. See MPEP 2106.04(a)(2)(II)(C) Managing Personal Behavior or Relationships or Interactions Between People. Applicant states, “The present claims provide a technique that realizes issuance of a medication certification that contains not only information indicating the completion of medication but also information indicating a post-medication condition, while also preventing an unauthorized change, such as tampering by the use of the blockchain platform.” (Remarks, page 9 ). Examiner agrees that the blockchain platform is not part of the abstract idea, but an additional element. However, here, Applicant’s claims are directed to certification of vaccination registered in a server, which is not a technical problem rooted in the technology. The improvement here, is to the abstract idea.
Practical application is a way to overcome the Prong 2 35 U.S.C 101 rejection, however, here, the claims do not recite additional elements that integrate the exception into a practical application. MPEP 2106.04(d)(1) and MPEP 2106.05(a) indicate that a practical application may be present where the claimed invention provides a technical solution to a technical problem. Applicant cites Desjardins et al., and states, “In this case, the Office should not evaluate the claims at a very high level of generality as being a method of obtaining patient information or managing information as suggested on page 5 of the Office Action in view of the many technical features included in amended Claim 1 as a whole. Furthermore, Ex Parte Guillaume Desjardins also showed that even if a claim recites an abstract idea, this does not mean that the claim as a whole is directed to an abstract idea, and thus cannot support the rejection. Id. at p. 10 (holding that while the independent claim may recite an abstract idea, it is not directed to an abstract idea, and that the independent claim, when considered as a whole, integrates an abstract idea into a practical application). Therefore, it is believed that the claims do recite the "improvement" at a proper level of specificity, especially in view of the recent decision of Ex Parte Desjardins.” (Remarks, page 10). Examiner respectfully disagrees and further, Ex Parte Desjardins is distinguishable from the Application. The Application, providing a technique that realizes issuance of a medication certification that contains not only information indicating the completion of medication but also information indicating a post-medication condition, while also preventing an unauthorized change, such as tampering by the use of the blockchain platform -is part of the abstract idea and the abstract idea cannot be used to integrate itself into a practical application. Here, the additional elements, including the “system”, “a network”, “processing circuitry”, “a computer program”, “blockchain”, do not result in a practical application or technical improvement, as they are recited at an apply it level, as stated above. The Application is an improvement to the abstract idea and does not improve any computer element.
All components in the claims are being used for their intended purpose and as written do not result in a practical application or significantly more than the abstract idea. Here, individually and in combination, the additional elements do not provide significantly more than the abstract idea. The claims recite features that are "well-understood, routine, conventional activities”. There is no technological improvement to any additional element. For the reasons stated above, claim 7 similarly fails to overcome the 35 U.S.C. 101 rejection.
Rejections under 35 U.S.C. 103:
Applicant’s arguments with regard to 103 are moot because the 103 rejection has been withdrawn.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWN TRINAH HAYNES whose telephone number is (571)270-5994. The examiner can normally be reached M-F 7:30-5:15PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Dunham can be reached on (571)272-8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAWN T. HAYNES/
Art Unit 3686
/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
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