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 the Claims
The office action is in response to the claims filed on December 18, 2024 for the application filed December 18, 2024 which claims priority to a provisional application filed on May 12, 2021. Claims 1-20 are currently pending and have been examined.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention,
Claim 1 recites the limitation "the drug regimen encoded files" in lines 31-32. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-6 are rejected at least based on their dependency on claim 1
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McNannay et al. (U.S. Pub. No. 2020/0024047).
Regarding claim 1, McNannay discloses a system for creating an authenticated drug storage apparatus for detecting and tracking drug extractions using a central server, a storage unit and a drug consumer’s computer (Paragraph [0052], sensor-enabled package may obtain a network connection via the communication hub, which in turn has a WAN connection that supports communication to the manifest repository where digital packaging manifests can be stored, referenced, and managed. The servers that comprise the manifest repository coordinate data transactions with the distributed base of sensor-enabled packages.), comprising:
a central serving (Paragraph [0037], the server that hosts the manifest repository, rules engine, notifications & communication algorithm, and interfaces to healthcare data sources.) having:
a database for storing device-identities values for storage units (Paragraph [0041], The package's content manifest enables the content profile and usage information to be uniquely associated with each package and the individual content compartment(s) through a system of unique digital and visual compartmental identifiers. The manifest may reside as a file on a cloud-based server. Paragraph [0050], The rules governing the usage of the enclosed contents are created and stored in a digital manifest that is tied to the unique identifier embedded in every provisioned sensor-enabled package.);
a user input for assigning storage units to drug consumers (Paragraph [0065], the goal of this security schema is to enable the eventual user/“provisioner” to establish an indelible bond between the user's identity, the rule set established in the manifest, and the association to a specific sensor-enabled package. Paragraph [0132], The person or organization provisioning the sensor-enabled packaging completes this digital manifest profile. In some cases, it may be the consumer who has purchased the packaging and is taking responsibility for provisioning their own contents (i.e., medications) and will have total control of setting the rules, permissions, security levels and all other parameters for that specific manifest and associated sensor-enabled package. Paragraph [0088], the distribution authority will use a software program or interface to complete the packaging process by completing the digital manifest to include the recipient's profile, contents of each compartment, reminder and escalation rules, trusted contacts and digital modes of communication, trusted third-parties, privacy provisions, etc. Also see paragraph [0205].);
a communication device (Paragraph [0062], cloud-based server that hosts the manifest repository, notifications and communication server, rules engine and healthcare data source interface server. Paragraph [0126], the cloud-based communication server coordinates the bidirectional distribution of system messages, notifications, feedback and other system-generated communication.) that:
receives an authentication request to authenticate a drug storage apparatus, an identity captured message and drug access detection trigger signals (Paragraph [0056], The end-user may confirm delivery of the sensor-enabled package by electronically relaying the unique identifier (such as a human-readable serial number, machine-readable serial number including bar code, combination of serial number & lot number, etc.) to the manifest repository. Other methods may be used to verify the correct user has received the package, such as biometric, personal identification number (PIN), password, and/or passphrase confirmation. Paragraph [0073], In one embodiment the rule sets within the manifest could be constructed to force users to validate their identity. Paragraph [0074], the security algorithm could combine the embedded unique digital identifier with password protection, hardware identifiers, biometric identification or other measures to ensure the data stream is originating from an authenticated user or caregiver. Paragraph [0078], Packaging usage data is received from the SEP, via the communication module, which transmits the data to the remote server via the communication hub. Paragraph [0113], the sensors integrated into the sensor-enabled lid detect when a packaging compartment(s) has been opened, thus and triggering either a passive or active signal to the processor chip and other electronics within the communication module to relay a signal to the communication hub and reporting the usage event. Also see paragraph [0068]-[0069].);
sends an authentication verified confirmation message and a commence dosing message (Fig. 2 and paragraphs [0068]-[0069] show and discuss the server sending a message indicating that the SEP has been authenticated. Paragraph [0179], Once an activity or usage event (e.g. package activation or compartment accessed/breached) has been received, the manifest repository uses the rules set described and recorded in that SEP's digital manifest to respond based on the stored parameters. These responses could include, but are not limited to the escalation logic needed to prepare the necessary notifications, manufacturer's warnings, messages, etc. Paragraph [0219], The first notification type may take the form of an initial notification that includes a reminder to take a medication. Paragraph [0061], These responses can range from simple notifications such as “Time to take your synthroid from compartment 1” to more complex responses involving multiple system responses and notification escalations. Also see paragraph [0124].);
a storage unit (Paragraph [0086], sensor-enabled packaging.) having:
a containment area for packaged drugs (Paragraph [0090], compartments that contain ancillary contents, such as ancillary medications, diagnostics (e.g., test strips), and/or devices (e.g., injectors, etc.) to be used in conjunction with medications contained in compartments.);
an access detection computer circuit indicating a change in state of the packaged drugs (Paragraph [0087], a circuit-based embodiment with an array of compartment sensors that are affixed to a lid or cover with a pre-designated set of compartment openings. Paragraph [0090], the monitoring of compartment states (e.g., open or closed) via electrically conductive pathways may support different functions, including determining the compartment state of a compartment (e.g., 420) containing an opioid-based medication and determining the compartment state of a compartment (e.g., 410) containing ancillary contents.);
a direct communication protocol support for sending the device-identity value and the drug detection access signals to a communication device (Paragraph [0086], a data processing/communication module. Paragraph [0052], a wireless signal (such as Bluetooth, Bluetooth low energy, Bluetooth Smart, Wi-Fi (including Wi-Fi Direct), radio frequency identification (RFID), Near Field Communication (NFC), ZigBee, 802.15.4, ANT, cellular or proprietary solution) is transmitted by the communication module attached to the sensor-enabled packaging to the communications hub.);
a drug consumer’s computer (Paragraph [0217], computing device such as a special-purpose communication hub or a mobile device (e.g., smart phone).), having:
an identity input circuit to capture the identity of a drug consumer (Paragraph [0073], rule sets within the manifest could be constructed to force users to validate their identity with the biometric capabilities within in an embedded biometric technology within the communication module (e.g. through touch screen on face of communication module) or a biometric feature resident within a separate technology platform (e.g. apple's new iPhone fingerprint reader). Other biometric methods could include but are not limited to: retinal, voice, biologic or facial recognition. Paragraph [0074], the security algorithm could combine the embedded unique digital identifier with password protection, hardware identifiers, biometric identification or other measures to ensure the data stream is originating from an authenticated user or caregiver. Also see paragraph [0056].);
an output mechanism for displaying one or more notification signals for drug consumption (Paragraph [0219], the computing device initiates the first notification type, for example, by displaying or otherwise outputting a message or other audio/visual/haptic indication. Paragraph [0052], The communication hub might have a display and or it might have communication to another device (smart TV, smart phone, table, PC, etc.) that has a display.);
a direct communication protocol support for receiving the device-identity value to relay onto the central server and drug detection access signals (Paragraph [0062], A communication hub includes any receive & transmission device (e.g. smartphone) that serves as the first point of communications connectivity capable of relaying sensor event data from the SEP's communication module to the cloud-based server that hosts the manifest repository, notifications and communication server, rules engine and healthcare data source interface server. Paragraph [0078], Packaging usage data is received from the SEP, via the communication module, which transmits the data to the remote server via the communication hub. Paragraph [0052], a wireless signal (such as Bluetooth, Bluetooth low energy, Bluetooth Smart, Wi-Fi (including Wi-Fi Direct), radio frequency identification (RFID), Near Field Communication (NFC), ZigBee, 802.15.4, ANT, cellular or proprietary solution) is transmitted by the communication module attached to the sensor-enabled packaging to the communications hub (e.g. base station, router, cell phone, smart watch, access-point, Wi-Fi hotspot, cellular tower), thereby gaining network access.);
a wireless network support to communicate with the central server (Paragraph [0125], In order to transmit data from the package to the manifest repository server(s), the communication hub can support one or more communication protocols and physical interfaces such as IP, IPV6, Wi-Fi, Cellular, LAN, WiMAX, or other future forms or standards for digital communication when forwarding packaging event data to the manifest repository.) for:
sending the device-identity, identity captured and drug consumption messages (Paragraph [0056], electronically relaying the unique identifier (such as a human-readable serial number, machine-readable serial number including bar code, combination of serial number & lot number, etc.) to the manifest repository. For example, a smart-phone NFC reader may have registered the application that should be spawned when a particular meta-message in the NFC packet is received. If the meta-message indicates that the SEP application, then the SEP application is started and it processes the data including steps such as displaying the ID on the display of the smartphone and transmitting it to the manifest server. Paragraph [0073], Security can also be enhanced by implementing a separate layer of biometric identification to, either control access to digital manifests and other security provisions, or to confirm the identity of a user as a requirement of the content usage validation. In one embodiment the rule sets within the manifest could be constructed to force users to validate their identity with the biometric capabilities within in an embedded biometric technology within the communication module (e.g. through touch screen on face of communication module) or a biometric feature resident within a separate technology platform (e.g. apple's new iPhone fingerprint reader). Other biometric methods could include but are not limited to: retinal, voice, biologic or facial recognition. Paragraph [0074], The two-identifier system allows the distributing party to use a combination of the external code (in the clear) and the embedded code (secret) to establish a secure methodology of authenticating which unique package is attempting to establish a link with the manifest repository or other system server. Based on user preference, variable levels of system security can be implemented. In one embodiment, the security algorithm could combine the embedded unique digital identifier with password protection, hardware identifiers, biometric identification or other measures to ensure the data stream is originating from an authenticated user or caregiver. Paragraph [0078], Packaging usage data is received from the SEP, via the communication module, which transmits the data to the remote server via the communication hub. Paragraph [0091], Any packaging solution that has ability to detect when a medication was accessed is within the scope and spirit of the invention.);
receiving the authentication verified confirmation message, the commence dosing message and the drug regimen encoded files (Fig. 2 and paragraphs [0068]-[0069] show and discuss the user computing device receiving a message indicating that the SEP has been authenticated. Paragraph [0075], The user might provide data to the server in an encrypted format using the user's own encryption key (where the decryption key is unknown to the server). This allows any of the user's devices that know the decryption key to use and update the manifest and rules with the manifest still stored on the system cloud server and therefore accessible anywhere by the user's various devices. Paragraph [0219], the computing device receives a first notification type from a remote computing system hosting a service. The first notification type may take the form of an initial notification that includes a reminder to take a medication. In at least some implementations, the remote computing system and/or the local computing device may communicate and initiate the first notification type based on a predefined medication treatment schedule. At 1112, the computing device initiates the first notification type, for example, by displaying or otherwise outputting a message or other audio/visual/haptic indication. Paragraph [0052], The communication hub may have knowledge of the rules for the SEP. This is helpful in the case where the communication with the rules engine fails for some reason. Paragraph [0070], If there is a local copy of the manifest, an application on the phone could read the contents and by comparing the local copy of the manifest to the copy from the server, the application can provide an automatic content verification. Paragraph [0124], the communications hub can communicate bi-directionally with the sensor-enabled package via the communication module to either forward data or receive updated software, manifest data, notifications.).
Regarding claim 2, McNannay discloses wherein the drug consumer’s computer captures the drug consumer’s identity and sends an identity captured message to the central server (Paragraph [0073], Security can also be enhanced by implementing a separate layer of biometric identification to, either control access to digital manifests and other security provisions, or to confirm the identity of a user as a requirement of the content usage validation. In one embodiment the rule sets within the manifest could be constructed to force users to validate their identity with the biometric capabilities within in an embedded biometric technology within the communication module (e.g. through touch screen on face of communication module) or a biometric feature resident within a separate technology platform (e.g. apple's new iPhone fingerprint reader). Other biometric methods could include but are not limited to: retinal, voice, biologic or facial recognition. Paragraph [0074], The two-identifier system allows the distributing party to use a combination of the external code (in the clear) and the embedded code (secret) to establish a secure methodology of authenticating which unique package is attempting to establish a link with the manifest repository or other system server. Based on user preference, variable levels of system security can be implemented. In one embodiment, the security algorithm could combine the embedded unique digital identifier with password protection, hardware identifiers, biometric identification or other measures to ensure the data stream is originating from an authenticated user or caregiver.).
Regarding claim 3, McNannay discloses wherein the central server sends a commence dosing message after receiving an identity captured message (Paragraph [0073], rule sets within the manifest could be constructed to force users to validate their identity with the biometric capabilities within in an embedded biometric technology within the communication module (e.g. through touch screen on face of communication module) or a biometric feature resident within a separate technology platform (e.g. apple's new iPhone fingerprint reader). Other biometric methods could include but are not limited to: retinal, voice, biologic or facial recognition. Paragraph [0074], The two-identifier system allows the distributing party to use a combination of the external code (in the clear) and the embedded code (secret) to establish a secure methodology of authenticating which unique package is attempting to establish a link with the manifest repository or other system server. Based on user preference, variable levels of system security can be implemented. In one embodiment, the security algorithm could combine the embedded unique digital identifier with password protection, hardware identifiers, biometric identification or other measures to ensure the data stream is originating from an authenticated user or caregiver.).
Regarding claim 4, McNannay discloses wherein the direct communications protocol is one or more of USB, Bluetooth, NFC or proprietary (Paragraph [0052], a wireless signal (such as Bluetooth, Bluetooth low energy, Bluetooth Smart, Wi-Fi (including Wi-Fi Direct), radio frequency identification (RFID), Near Field Communication (NFC), ZigBee, 802.15.4, ANT, cellular or proprietary solution) is transmitted by the communication module attached to the sensor-enabled packaging to the communications hub (e.g. base station, router, cell phone, smart watch, access-point, Wi-Fi hotspot, cellular tower).).
Regarding claim 5, McNannay discloses wherein the access detection computer circuit uses RFID, barcode, QR code or weight detection mechanism for proximity detection of changes to the packaged drugs (Paragraph [0117], A compartment opening event might also be detected using a wireless sensor. The wireless signal might be an impulse that is detected by the communication module or it might be a modulated RF signal. The modulation itself might encode the data, for example, the frequency indicates which compartment was breached. Each compartment might have its own radio such as RFID, NFC, ANT, BT, BTLE, Wi-Fi, cellular, 802.15.4, or other standards-based radio or a proprietary radio to communicate wirelessly either to another component on the system or to an external device. A solar cell can detect light upon opening a compartment. A pressure transducer may detect both environmental changes and the opening of a compartment, including air pressure changes and pressure due to the extraction of the medication.).
Regarding claim 6, McNannay discloses wherein the drug storage apparatus comprises components selected from the group of cell phones, tablet computers, wearable computers or a combination of these computers (Paragraph [0062], communications hubs are possible and could include desk-top computer, laptop computer, tablet computer, personal digital assistant (PDA), wireless router, local area network, smart-watch, smart TV or other next generation wireless and digital communication devices that are within the transmission range of the sensor-enabled packaging's communication module.).
Regarding claim 7, McNannay discloses a method for creating an authenticated drug storage apparatus for detecting and tracking drug extractions using a central server, a storage unit and a drug consumer’s computer, the method comprising:
at a central server (Paragraph [0037], the server that hosts the manifest repository, rules engine, notifications & communication algorithm, and interfaces to healthcare data sources.):
assigning a storage unit to a drug consumer using a user input and a database storing device-identities (Paragraph [0041], The package's content manifest enables the content profile and usage information to be uniquely associated with each package and the individual content compartment(s) through a system of unique digital and visual compartmental identifiers. The manifest may reside as a file on a cloud-based server. Paragraph [0050], The rules governing the usage of the enclosed contents are created and stored in a digital manifest that is tied to the unique identifier embedded in every provisioned sensor-enabled package. Paragraph [0065], the goal of this security schema is to enable the eventual user/“provisioner” to establish an indelible bond between the user's identity, the rule set established in the manifest, and the association to a specific sensor-enabled package. Paragraph [0132], The person or organization provisioning the sensor-enabled packaging completes this digital manifest profile. In some cases, it may be the consumer who has purchased the packaging and is taking responsibility for provisioning their own contents (i.e., medications) and will have total control of setting the rules, permissions, security levels and all other parameters for that specific manifest and associated sensor-enabled package. Paragraph [0088], the distribution authority will use a software program or interface to complete the packaging process by completing the digital manifest to include the recipient's profile, contents of each compartment, reminder and escalation rules, trusted contacts and digital modes of communication, trusted third-parties, privacy provisions, etc. Also see paragraph [0205].);
receiving an authentication request from a drug consumer’s computer to authenticate the drug storage apparatus and replying with an authentication verified confirmation message (Paragraph [0056], The end-user may confirm delivery of the sensor-enabled package by electronically relaying the unique identifier (such as a human-readable serial number, machine-readable serial number including bar code, combination of serial number & lot number, etc.) to the manifest repository. For example, a smart-phone NFC reader may have registered the application that should be spawned when a particular meta-message in the NFC packet is received. If the meta-message indicates that the SEP application, then the SEP application is started and it processes the data including steps such as displaying the ID on the display of the smartphone and transmitting it to the manifest server. Fig. 2 and paragraphs [0068]-[0069] show and discuss the user sending a message indicating that the SEP has been authenticated to a user computing device.);
sending drug regimen encoded files to indicate commencement of drug tracking activities after authenticating the drug storage apparatus (Paragraph [0037], the communications gateway also has software features for formatting messages appropriate to the receiving medium as described later and facilitating a connection between the communication module, communications hub or alternative communication to other devices with the user's digital environment. Paragraph [0073], rule sets within the manifest could be constructed to force users to validate their identity with the biometric capabilities within in an embedded biometric technology within the communication module (e.g. through touch screen on face of communication module) or a biometric feature resident within a separate technology platform (e.g. apple's new iPhone fingerprint reader). Other biometric methods could include but are not limited to: retinal, voice, biologic or facial recognition. Paragraph [0074], The two-identifier system allows the distributing party to use a combination of the external code (in the clear) and the embedded code (secret) to establish a secure methodology of authenticating which unique package is attempting to establish a link with the manifest repository or other system server. Based on user preference, variable levels of system security can be implemented. In one embodiment, the security algorithm could combine the embedded unique digital identifier with password protection, hardware identifiers, biometric identification or other measures to ensure the data stream is originating from an authenticated user or caregiver. Paragraph [0179], Once an activity or usage event (e.g. package activation or compartment accessed/breached) has been received, the manifest repository uses the rules set described and recorded in that SEP's digital manifest to respond based on the stored parameters. These responses could include, but are not limited to the escalation logic needed to prepare the necessary notifications, manufacturer's warnings, messages, etc. Paragraph [0219], The first notification type may take the form of an initial notification that includes a reminder to take a medication. Paragraph [0061], These responses can range from simple notifications such as “Time to take your synthroid from compartment 1” to more complex responses involving multiple system responses and notification escalations. Also see paragraph [0124].);
receiving activity messages from the authenticated drug storage apparatus and relaying drug consumption information and alarm messages to defined authorized drug monitoring entities (Paragraph [0079], Once an activity or usage event (e.g. package activation or compartment accessed/breached) has been received, the manifest repository uses the rules set described and recorded in that SEP's digital manifest to respond based on the stored parameters. These responses could include, but are not limited to the escalation logic needed to prepare the necessary notifications, manufacturer's warnings, messages, etc. to be transmitted back to the user's various electronic devices, including the packaging itself, through the communication hub. Paragraph [0078], The digital manifest records the incoming usage data, and based on such comparisons, trigger the appropriate communication to the correct recipient (e.g. patient, caregiver, relative, or administrator) and digital delivery device (e.g. cell phone, television, tablet).);
at a storage unit using a direct communications protocol (Paragraph [0052], a wireless signal (such as Bluetooth, Bluetooth low energy, Bluetooth Smart, Wi-Fi (including Wi-Fi Direct), radio frequency identification (RFID), Near Field Communication (NFC), ZigBee, 802.15.4, ANT, cellular or proprietary solution) is transmitted by the communication module attached to the sensor-enabled packaging to the communications hub (e.g. base station, router, cell phone, smart watch, access-point, Wi-Fi hotspot, cellular tower).):
sending a device-identity message to identify the assigned drug consumer’s identity as assigned at the central server (Paragraph [0056], The end-user may confirm delivery of the sensor-enabled package by electronically relaying the unique identifier (such as a human-readable serial number, machine-readable serial number including bar code, combination of serial number & lot number, etc.) to the manifest repository. Any one of many methods (e.g. bar code reader, digital camera, reading the identifier and manually entering it, reading the identifier from an RFID/NFC chip, reading the identifier stored in a memory via an interface to the packaging, etc.) may be used to import the SEP's unique identifier into a software application or interface that relays the data to the manifest server. Some solutions, such as NFC support a meta-message indicating what application should be used to process the data; for example, a smart-phone NFC reader may have registered the application that should be spawned when a particular meta-message in the NFC packet is received. If the meta-message indicates that the SEP application, then the SEP application is started and it processes the data including steps such as displaying the ID on the display of the smartphone and transmitting it to the manifest server. Paragraph [0065], The goal of this security schema is to enable the eventual user/“provisioner” to establish an indelible bond between the user's identity, the rule set established in the manifest, and the association to a specific sensor-enabled package.);
detecting state changes to packaged drugs when brought into proximity to an access detection computer circuit and relaying state change information to the drug consumer’s computer (Paragraph [0087], a circuit-based embodiment with an array of compartment sensors that are affixed to a lid or cover with a pre-designated set of compartment openings. Paragraph [0090], the monitoring of compartment states (e.g., open or closed) via electrically conductive pathways may support different functions, including determining the compartment state of a compartment (e.g., 420) containing an opioid-based medication and determining the compartment state of a compartment (e.g., 410) containing ancillary contents. Paragraph [0052], a wireless signal (such as Bluetooth, Bluetooth low energy, Bluetooth Smart, Wi-Fi (including Wi-Fi Direct), radio frequency identification (RFID), Near Field Communication (NFC), ZigBee, 802.15.4, ANT, cellular or proprietary solution) is transmitted by the communication module attached to the sensor-enabled packaging to the communications hub.);
at the drug consumer’s computer (Paragraph [0217], computing device such as a special-purpose communication hub or a mobile device (e.g., smart phone).):
receiving drug detection access signals and a device-identity from the storage unit using the direct communication protocol (Paragraph [0062], A communication hub includes any receive & transmission device (e.g. smartphone) that serves as the first point of communications connectivity capable of relaying sensor event data from the SEP's communication module to the cloud-based server that hosts the manifest repository, notifications and communication server, rules engine and healthcare data source interface server. Paragraph [0078], Packaging usage data is received from the SEP, via the communication module, which transmits the data to the remote server via the communication hub. Paragraph [0052], a wireless signal (such as Bluetooth, Bluetooth low energy, Bluetooth Smart, Wi-Fi (including Wi-Fi Direct), radio frequency identification (RFID), Near Field Communication (NFC), ZigBee, 802.15.4, ANT, cellular or proprietary solution) is transmitted by the communication module attached to the sensor-enabled packaging to the communications hub (e.g. base station, router, cell phone, smart watch, access-point, Wi-Fi hotspot, cellular tower), thereby gaining network access.);
outputting one or more notification signals for drug consumption activities using various output methods at the drug consumer’s computer (Paragraph [0078], The digital manifest records the incoming usage data, and based on such comparisons, trigger the appropriate communication to the correct recipient (e.g. patient, caregiver, relative, or administrator) and digital delivery device (e.g. cell phone, television, tablet). Paragraph [0219], the computing device receives a first notification type from a remote computing system hosting a service. The first notification type may take the form of an initial notification that includes a reminder to take a medication. In at least some implementations, the remote computing system and/or the local computing device may communicate and initiate the first notification type based on a predefined medication treatment schedule. At 1112, the computing device initiates the first notification type, for example, by displaying or otherwise outputting a message or other audio/visual/haptic indication.);
using a wireless network support to communicate with the central server for (Paragraph [0125], In order to transmit data from the package to the manifest repository server(s), the communication hub can support one or more communication protocols and physical interfaces such as IP, IPV6, Wi-Fi, Cellular, LAN, WiMAX, or other future forms or standards for digital communication when forwarding packaging event data to the manifest repository.):
sending the device-identity and drug consumption messages (Paragraph [0056], electronically relaying the unique identifier (such as a human-readable serial number, machine-readable serial number including bar code, combination of serial number & lot number, etc.) to the manifest repository. For example, a smart-phone NFC reader may have registered the application that should be spawned when a particular meta-message in the NFC packet is received. If the meta-message indicates that the SEP application, then the SEP application is started and it processes the data including steps such as displaying the ID on the display of the smartphone and transmitting it to the manifest server. Paragraph [0078], Packaging usage data is received from the SEP, via the communication module, which transmits the data to the remote server via the communication hub. Paragraph [0091], Any packaging solution that has ability to detect when a medication was accessed is within the scope and spirit of the invention.);
receiving drug regimen encoded files to indicate dosing can commence and the authentication verified confirmation message to create an authenticated drug storage apparatus (Fig. 2 and paragraphs [0068]-[0069] show and discuss the user computing device receiving a message indicating that the SEP has been authenticated. Paragraph [0075], The user might provide data to the server in an encrypted format using the user's own encryption key (where the decryption key is unknown to the server). This allows any of the user's devices that know the decryption key to use and update the manifest and rules with the manifest still stored on the system cloud server and therefore accessible anywhere by the user's various devices. Paragraph [0219], the computing device receives a first notification type from a remote computing system hosting a service. The first notification type may take the form of an initial notification that includes a reminder to take a medication. In at least some implementations, the remote computing system and/or the local computing device may communicate and initiate the first notification type based on a predefined medication treatment schedule. At 1112, the computing device initiates the first notification type, for example, by displaying or otherwise outputting a message or other audio/visual/haptic indication. Paragraph [0052], The communication hub may have knowledge of the rules for the SEP. This is helpful in the case where the communication with the rules engine fails for some reason. Paragraph [0070], If there is a local copy of the manifest, an application on the phone could read the contents and by comparing the local copy of the manifest to the copy from the server, the application can provide an automatic content verification. Paragraph [0124], the communications hub can communicate bi-directionally with the sensor-enabled package via the communication module to either forward data or receive updated software, manifest data, notifications.).
Regarding claim 8, McNannay discloses receiving at the central server an identity captured message from the drug consumer’s computer and replying with drug regimen encoded files and a commence dosing message (Paragraph [0056], The end-user may confirm delivery of the sensor-enabled package by electronically relaying the unique identifier (such as a human-readable serial number, machine-readable serial number including bar code, combination of serial number & lot number, etc.) to the manifest repository. Other methods may be used to verify the correct user has received the package, such as biometric, personal identification number (PIN), password, and/or passphrase confirmation. Paragraph [0073], In one embodiment the rule sets within the manifest could be constructed to force users to validate their identity. Paragraph [0074], the security algorithm could combine the embedded unique digital identifier with password protection, hardware identifiers, biometric identification or other measures to ensure the data stream is originating from an authenticated user or caregiver. Paragraph [0078], Packaging usage data is received from the SEP, via the communication module, which transmits the data to the remote server via the communication hub. Paragraph [0113], the sensors integrated into the sensor-enabled lid detect when a packaging compartment(s) has been opened, thus and triggering either a passive or active signal to the processor chip and other electronics within the communication module to relay a signal to the communication hub and reporting the usage event. Fig. 2 and paragraphs [0068]-[0069] show and discuss the server sending a message indicating that the SEP has been authenticated. Paragraph [0179], Once an activity or usage event (e.g. package activation or compartment accessed/breached) has been received, the manifest repository uses the rules set described and recorded in that SEP's digital manifest to respond based on the stored parameters. These responses could include, but are not limited to the escalation logic needed to prepare the necessary notifications, manufacturer's warnings, messages, etc. Paragraph [0219], The first notification type may take the form of an initial notification that includes a reminder to take a medication. Paragraph [0061], These responses can range from simple notifications such as “Time to take your synthroid from compartment 1” to more complex responses involving multiple system responses and notification escalations. Also see paragraph [0068]-[0069] and [0124.).
Regarding claim 9, McNannay discloses at the central server, sending a commence dosing message after receiving an identity captured message (Paragraph [0073], rule sets within the manifest could be constructed to force users to validate their identity with the biometric capabilities within in an embedded biometric technology within the communication module (e.g. through touch screen on face of communication module) or a biometric feature resident within a separate technology platform (e.g. apple's new iPhone fingerprint reader). Other biometric methods could include but are not limited to: retinal, voice, biologic or facial recognition. Paragraph [0074], The two-identifier system allows the distributing party to use a combination of the external code (in the clear) and the embedded code (secret) to establish a secure methodology of authenticating which unique package is attempting to establish a link with the manifest repository or other system server. Based on user preference, variable levels of system security can be implemented. In one embodiment, the security algorithm could combine the embedded unique digital identifier with password protection, hardware identifiers, biometric identification or other measures to ensure the data stream is originating from an authenticated user or caregiver.).
Regarding claim 10, McNannay discloses at the storage unit, using one or more of USB, Bluetooth, or NFC for the direct communications protocol (Paragraph [0052], a wireless signal (such as Bluetooth, Bluetooth low energy, Bluetooth Smart, Wi-Fi (including Wi-Fi Direct), radio frequency identification (RFID), Near Field Communication (NFC), ZigBee, 802.15.4, ANT, cellular or proprietary solution) is transmitted by the communication module attached to the sensor-enabled packaging to the communications hub (e.g. base station, router, cell phone, smart watch, access-point, Wi-Fi hotspot, cellular tower).).
Regarding claim 11, McNannay discloses at the storage unit, using RFID, barcode, QR code or weight detection mechanism when brought into proximity to the access detection computer circuit for proximity detection of changes to the packaged drugs (Paragraph [0117], A compartment opening event might also be detected using a wireless sensor. The wireless signal might be an impulse that is detected by the communication module or it might be a modulated RF signal. The modulation itself might encode the data, for example, the frequency indicates which compartment was breached. Each compartment might have its own radio such as RFID, NFC, ANT, BT, BTLE, Wi-Fi, cellular, 802.15.4, or other standards-based radio or a proprietary radio to communicate wirelessly either to another component on the system or to an external device. A solar cell can detect light upon opening a compartment. A pressure transducer may detect both environmental changes and the opening of a compartment, including air pressure changes and pressure due to the extraction of the medication.).
Regarding claim 12, McNannay discloses wherein the drug storage apparatus comprises components selected from the group of cell phones, tablet computers, wearable computers or a combination of these computers (Paragraph [0062], communications hubs are possible and could include desk-top computer, laptop computer, tablet computer, personal digital assistant (PDA), wireless router, local area network, smart-watch, smart TV or other next generation wireless and digital communication devices that are within the transmission range of the sensor-enabled packaging's communication module.).
Regarding claim 13, McNannay discloses at the central service, sending messages to request biometric information (Paragraph [0056], Other methods may be used to verify the correct user has received the package, such as biometric, personal identification number (PIN), password, and/or passphrase confirmation. For example, after the communication module is activated, other system components that support rich user interface may prompt the user for a PIN; receipt of this PIN by the user may verify receipt by the proper recipient. Other verification methods including detection of a known electronic device, such as the user's cell-phone; Wi-Fi Media Access Control (MAC) address, BT address, or cellular electronic serial number may also be used. Paragraph [0073], rule sets within the manifest could be constructed to force users to validate their identity with the biometric capabilities within in an embedded biometric technology within the communication module (e.g. through touch screen on face of communication module) or a biometric feature resident within a separate technology platform (e.g. apple's new iPhone fingerprint reader).).
Regarding claim 14, McNannay discloses capturing and confirming the biometric information by an associated cell phone, tablet computer, or wearable watch computer (Paragraph [0073], rule sets within the manifest could be constructed to force users to validate their identity with the biometric capabilities within in an embedded biometric technology within the communication module (e.g. through touch screen on face of communication module) or a biometric feature resident within a separate technology platform (e.g. apple's new iPhone fingerprint reader).).
Regarding claims 15-19: all limitations as recited have been analyzed and rejected with respect to claims 1-14. Claims 15-19 pertain to a non-transitory machine readable medium, corresponding to the system 1-6 and method of claims 7-14. Claims 15-19 do not teach or define any new limitations beyond claims 1-14; therefore claims 15-19 are rejected under the same rationale.
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over McNannay et al. (U.S. Pub. No. 2020/0024047) in view of Benzel et al. (U.S. Pub. No. 2019/0267125).
Regarding claim 20, McNannay further discloses that any packaging solution that has ability to detect when a medication was accessed is within the scope and spirit of the invention (Paragraph [0091]), but does not appear to explicitly disclose wherein at least a portion of the drug consumption activities result from detecting state changes to packaged drugs when brought into proximity to a barcode reader operating as the access detection computer circuit.
Benzel teaches that it was old and well known in the art of medication management at the time of the filing wherein at least a portion of the drug consumption activities result from detecting state changes to packaged drugs when brought into proximity to a barcode reader operating as the access detection computer circuit (Benzel, paragraph [0152], In identify medication container step 425 of FIG. 5, the system management server 130 (i.e., the data processing device system 210 thereof) or the digital companion device 10 (i.e., the data processing device system 210 thereof) is configured to receive (e.g., via the input-output-device system 220) an input identification code, e.g., from the reader 36 of the digital companion device 10, according to some embodiments. In some embodiments, the reader 36 reads the identification code associated with a medication set. For example, the identification code may be an RFID tag, a bar code (e.g., 92 in FIG. 8B) or other indicia, or a magnetic strip, as described earlier in relation to FIG. 2 on or integrally formed with a medication container containing the medication set. Paragraph [0153], In “correct container?” test 430 in FIG. 5, the system management server 130 (i.e., the data processing device system 210 thereof) or the digital companion device 10 (i.e., the data processing device system 210 (e.g., central processor 20) thereof) is configured to determine (e.g., via the input-output-device system 220) whether the input identification code corresponds to the particular medication set (identified by the medication message from step 420) based upon an analysis of at least a portion of the medication schedule and the input identification code from step 425, according to some embodiments. For example, if the input identification code matches an identification code previously stored in association with the particular medication set in the medication schedule (e.g., in non-volatile storage 22 in FIG. 2), it is determined that the user has selected the correct medication set that needs to be taken at that time at step 430, according to some embodiments. In this case, a confirmation message indicating that the correct medication set has been selected by the user may be presented (e.g., by display 40 or audio speaker(s) 44) at step 440. Paragraph [0157], tracking is performed at least in part by the system management server 130. In this regard, the data processing device system 210 (e.g., the central processor 20) of the digital companion device 10 may be configured to transmit, via the network interface 34 and the Internet 120 to the system management server 130, the input confirmation, which provides the system management server 130 with an indication of the home user taking the required medication set (e.g., shown in whole or part in FIG. 7D).) to ensure that the home user(s) take(s) the proper medications at the proper times (Benzel, paragraph [0077]).
Therefore, it would have been obvious to one of ordinary skill in the art of medication management at the time of the invention to modify the access detection computer circuit of McNannay such that at least a portion of the drug consumption activities result from detecting state changes to packaged drugs when brought into proximity to a barcode reader operating as the access detection computer circuit, as taught by Benzel, in order to ensure that the home user(s) take(s) the proper medications at the proper times.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Devin C. Hein whose telephone number is (303)297-4305. The examiner can normally be reached 9:00 AM - 5:00 PM M-F MDT.
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/DEVIN C HEIN/Examiner, Art Unit 3686