(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2008/0184719 A1
`(43) Pub. Date:
`Aug. 7, 2008
`LOWenstein
`
`US 2008O184719A1
`
`(54)
`
`(75)
`
`INTELLIGENT REFRGERATOR FOR
`STORING PHARMACEUTICAL PRODUCT
`CONTAINERS
`
`Inventor:
`
`Alan J. Lowenstein, New
`Providence, NJ (US)
`Correspondence Address:
`LAW OFFICES OF GRADY L. WHITE, LLC
`10605 Concord Street, SUITE 440
`Kensington, MD 20895
`
`(73)
`
`Assignee:
`
`Merck & Co., Inc., Rahway, NJ
`(US)
`
`(21)
`
`Appl. No.:
`
`11/913,096
`
`(22)
`
`(86)
`
`PCT Fled:
`
`Jan. 12, 2007
`
`PCT NO.:
`
`PCT/US07/60524
`
`S371 (c)(1),
`(2), (4) Date:
`
`Oct. 30, 2007
`
`(60)
`
`Related U.S. Application Data
`Provisional application No. 60/759,738, filed on Jan.
`18, 2006.
`
`Publication Classification
`
`(51) Int. Cl.
`(2006.01)
`F2SB 49/00
`(52) U.S. Cl. .......................................................... 62/127
`(57)
`ABSTRACT
`Intelligent refrigerator system for storing pharmaceutical
`product containers, such as vials, ampules, Syringes, bottles,
`medication tubes, blister packs and cartons, at the point of
`dispensing. Embodiments of the invention use product iden
`tification technology, Such as radio-frequency identification
`(RFID) tags and readers, to uniquely identify containers as
`they are added to or removed from the cold storage compart
`ment of the refrigerator, and automatically retrieve from a
`local or remote database a variety of details associated with
`the containers and their contents, such as manufacturing data,
`expiration dates, time out of refrigeration, inventory levels,
`safety information, usage statistics, known contraindications
`and warnings, etc. If the details indicate that there is a prob
`lem with a particular pharmaceutical (e.g., that it is counter
`feit, expired, Suspect, spoiled, recalled or almost depleted),
`then a message or warning is automatically delivered to a
`human operator via an attached output device. Such as a
`display Screen, speaker or printer. Embodiments of the inven
`tion may also be configured to monitor and report tempera
`ture faults, power failures and other anomalies associated
`with the refrigerator or cold storage compartment.
`
`
`
`1115
`
`1 O
`
`Page 1 of 25
`
`Health Care Logistics, Inc.
`Exhibit 1008
`
`

`

`Patent Application Publication
`
`Aug. 7, 2008 Sheet 1 of 11
`
`US 2008/O184719 A1
`
`COLD STORAGE COMPARTMENT
`110
`
`INPUT/OUTPUT DEVICES
`112
`
`100
`
`TEMPERATURE
`SENSOR
`120
`
`
`
`
`
`
`
`TOUCHPAD
`DISPLAY
`122
`
`
`
`KEYPAD
`130
`
`PRINTER g BIOMETRIC
`
`132
`
`SENSOR
`134
`
`SPEAKER
`126
`
`
`
`AUTHENTICATION
`DEVICES
`1.28
`
`
`
`
`
`EVENT
`MANAGER
`140
`
`EVENT
`MONITOR
`138
`
`EXT READER
`
`RE-ORDERING
`FILE
`142
`
`NETWORK
`INTERFACE
`146
`
`PROCESSOR COMPARTMENT 114
`
`146
`
`148
`
`DATA
`COMMUNICATIONS
`NETWORK
`
`
`
`Page 2 of 25
`
`Health Care Logistics, Inc.
`Exhibit 1008
`
`

`

`Patent Application Publication
`
`Aug. 7, 2008 Sheet 2 of 11
`
`US 2008/0184719 A1
`
`HOME
`2O7
`
`REFRIGERATOR
`212
`
`
`
`
`
`MOBILE CLINC
`220
`REFRIGERATOR
`216
`
`PHYSICAN'S OFFICE
`205
`
`REFRIGERATOR
`21 O
`
`HOSPITAL
`215
`
`REFRIGERATOR
`214
`
`
`
`
`
`
`
`ONS
`
`
`
`DATA
`COMMUNICATIONS
`NETWORK
`265
`
`ONS
`292
`
`
`
`
`
`
`
`PHARMACEUTICAL
`PRODUCT DBASE
`235
`EPCIS 237
`
`
`
`
`
`
`
`
`
`
`
`PHARMACEUTICAL
`PRODUCT DBASE
`240
`
`EPCIS 242
`
`RESEARCH
`INSTITUTION
`250
`
`
`
`
`
`
`
`PHARMACY
`225
`REFRIGERATOR
`21.8
`
`
`
`FOOD AND DRUG
`ADMINISTRATION
`260
`
`PHARMACEUTICAL
`PRODUCT DBASE
`245
`EPCIS 247
`
`
`
`
`
`NATIONAL
`INSTITUTE OF
`HEALTH
`255
`
`FIG 2
`
`Page 3 of 25
`
`Health Care Logistics, Inc.
`Exhibit 1008
`
`

`

`Patent Application Publication
`
`Aug. 7, 2008 Sheet 3 of 11
`
`US 2008/O184719 A1
`
`POWER
`ON
`MACHINE
`3O5
`
`STATUS
`LOG
`31 O
`
`
`
`
`
`FLOW 3
`INITIALIZATION
`
`1 N
`STATUS
`k ANOMALY)-YES
`N 31 5.-1
`
`NO
`
`FL8
`N /
`
`^
`
`
`
`YN
`m
`ryPE OF
`IN PUR
`Ya EVENT)->< EVENT )
`N320-NO N345
`res
`1
`1 N.
`- QUIT
`—{prS3RANY
`N325
`N 1
`NO
`
`
`
`
`
`GENERATE
`FL4
`ADDED ITEM
`EVENT CODE N
`355
`
`
`
`YES
`
`NO-
`
`w
`END
`
`N
`(
`)
`--m-
`
`PRINT
`- -< REPORT)
`N330-
`YES
`
`
`
`
`
`PRI
`RE
`335
`
`
`
`GENERATE
`|REMOVED ITEM
`EVENT CODE
`360
`
`GENERATE
`TIMER EVENT
`CODE
`35O
`
`-o-
`
`FL6
`-
`
`FIG 3
`
`N -
`/
`
`
`
`GENERATE
`EXTERNAL
`-e READ EVENT
`CODE
`365
`
`
`
`
`
`Page 4 of 25
`
`Health Care Logistics, Inc.
`Exhibit 1008
`
`

`

`Patent Application Publication
`
`Aug. 7, 2008 Sheet 4 of 11
`
`US 2008/0184719 A1
`
`
`
`FLOW 4.
`IDENTIFICATION OF
`ADDED ITEM
`
`CALCULATE
`DELTA FOR
`TIME OUT OF
`REFRIG AND
`UPDATE
`LOCAL DBASE
`415
`
`
`
`-1N LOCAN
`YES (BESE - No
`N435
`y
`PREQADER
`SAVAILABLE - YES
`- N425-1
`r
`NO
`
`1 MFR DATA Y
`
`
`
`
`
`
`
`
`
`
`
`ADD TAG
`TO OCAL
`DATABASE
`420
`
`CHECK FOR
`TAG IN
`PRELOADED
`DATA
`450
`
`INTERNET
`AVAIL? )--NO -(EXISTS?)
`NC; 5
`N430 -
`N.1
`N
`YES
`y
`LOOK UP DETAILS IN
`PRODUCT DBASE
`435
`
`
`
`COPY DETAILS
`TO LOCAL
`DBASE FROM
`PRELOADED
`DATA
`460
`
`y
`-DATA
`–(EXISTS?)
`449
`
`N
`
`/
`
`NO
`
`NO
`
`
`
`
`
`STORE
`MARKER
`INDICATING
`CONTAINER
`AS SUSPECT
`47O
`
`
`
`
`
`
`
`
`
`
`
`
`
`FIG 4
`
`
`
`COPY DETAILS TO LOCAL
`DBASE FROM PRODUCT DBASE
`445
`
`INCREMENT
`INVENTORY
`465
`
`Page 5 of 25
`
`Health Care Logistics, Inc.
`Exhibit 1008
`
`

`

`Patent Application Publication
`
`Aug. 7, 20
`08 Sheet 5 of 11
`
`US 2008/0184719 A1
`
`FLOW 5
`REMOVED ITEM
`
`FL5
`
`-
`
`READ TAG
`505
`
`RETRIEVE DETAILS FOR
`TAG FROM LOCAL DBASE
`51. O
`
`RECORD TIME
`AND NOTE IN
`LOCAPPASE
`CONTAINER
`OUT OF
`REFRIDGE
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`DECREMENT
`INVENTORY
`525
`
`1N
`PETAIts
`>< EXIST?
`N515
`N
`YES
`y
`MARKED
`NO-K SUSPECT? >
`N520
`NS Y
`
`1 N S2,
`-EXPIRED, )
`
`YES
`
`YES
`
`NO
`
`5ISPLAY/
`/
`ANNOUNCE
`WARNING
`MESSAGE
`57O
`
`N
`
`/
`
`YES
`
`-
`
`NO y
`2, Gs
`- EXCEEDEDN
`NMAX TOR2
`N549
`NO
`y
`-1 N
`<RECALLED2>—-YES
`is sys
`NO
`V
`DISPLAY/
`ANNOUNCE
`RODUCT HAS
`P
`BEEN
`REMOVED
`N-550
`
`
`
`/
`
`PRI
`H-D-g LABEL2>-YE
`
`FIG 5
`
`Page 6 of 25
`
`Health Care Logistics, Inc.
`Exhibit 1008
`
`

`

`Patent Application Publication
`
`Aug. 7, 2008 Sheet 6 of 11
`
`US 2008/O184719 A1
`
`FL6
`
`FLOW 6
`TIMER
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`V
`605
`READ TEMPERATURE
`SENSOR
`
`
`
`61 O
`ENVIRONMENT
`DBASE
`
`DISPLAY, PRINT AND/
`OR ANNOUNCE
`TEMPERATURE
`ERROR MESSAGE
`N N
`
`M
`1.
`
`N-
`
`1.
`
`N
`
`1 615 N
`< TEMPERATURE )—YES
`N FAULT2 -- M M
`N -
`NO
`
`n
`
`*
`
`625
`LOOP UNT ALL
`TEMPERATURE
`SENSORS READ
`
`F.G. 6
`
`Page 7 of 25
`
`Health Care Logistics, Inc.
`Exhibit 1008
`
`

`

`Patent Application Publication
`
`Aug. 7, 2008 Sheet 7 of 11
`
`US 2008/O184719 A1
`
`FLOW 7 - TIMER CONTD
`
`
`
`
`
`1.
`
`N
`
`NO Y
`1NTERNETS
`N AVAIL? .
`N715-1 YES
`
`/ N.
`
`FL7
`
`READ TAG
`AND CHECK
`LOCAL DBASE
`7O5
`
`LOOK UP ITEM
`INFORMATION IN
`PRODUCT DBASE
`72O
`
`
`
`
`
`
`
`
`
`
`
`MARK
`CONTAINER
`AS SUSPECT
`A30
`
`no
`Dá
`- EFAF:
`ATA
`|->{IN LOCAL)
`NDBASE2/ (EXISTS?
`>-NO
`725-1
`10^
`YES -
`V
`COPY DETAILS TO LOCAL
`DBASE FROM PRODUCT
`DBASE
`735
`
`INCREMENT
`INVENTORY
`DBASE
`74O
`
`YES
`
`
`
`
`
`
`
`
`
`CHECK
`INVENT-
`ORY
`745
`
`1DISPLAY \
`-N
`N
`-
`IriveNTORY YES / INVENTORY
`-
`< SHORTFALLP)
`SHORTAGE
`N 750 1
`MESSAGE
`N
`-1
`N -
`s 755 -
`NO
`V
`
`ORDER
`PRODUCT
`FROM MFR
`76O
`
`y
`CHECK TIME OUT
`OF REFRIGERATION
`765
`
`-N
`1
`N
`-EXCEEDSN
`NMAX TOR2-YES
`N770-
`N1,
`, No
`
`-DISPLAYITEM
`HAS EXCEEDED
`MAX TOR
`775
`
`N
`
`--
`
`CHECK
`EXPIRATION
`78O
`ar, a
`-OOP UNTILA
`TAGS IN COLD
`STORAGE
`COMPARTMENT
`ARE READ
`795
`
`
`
`1s,
`-(?tr Gs
`-EXPRED? - yes
`s/85 -
`a.
`
`1DISPLAY
`7
`ITEM HAS
`EXPRED
`790
`
`NO
`y
`
`V
`
`Y
`
`FIG. 7
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Page 8 of 25
`
`Health Care Logistics, Inc.
`Exhibit 1008
`
`

`

`Patent Application Publication
`
`Aug. 7, 2008 Sheet 8 of 11
`
`US 2008/0184719 A1
`
`FLOW 8
`ANOMALY
`
`-O-
`
`READ TAG
`820
`
`de
`
`
`
`DETERMINE
`ANOMALY
`805
`
`1. N
`NO- POWERN
`SOUAGE2
`810
`
`YES
`y
`DETERMINE
`POWER
`OUTAGE
`DURATION
`8.5
`
`--
`DOO
`AJAR, NO
`MORE
`CAPACITY,
`ETC.
`855
`
`
`
`
`
`
`
`1RANSMIT
`ERROR
`MESSAGE
`860
`Sl
`
`
`
`RETRIEVE
`TAG DETAILS
`FROM LOCAL
`DBASE
`825
`
`
`
`TOTAL TOR
`COUNTER
`835
`
`- TORN
`- w
`- COUNTERN
`- TRANSMIT
`WARNING RE yes - EXCEEDS Y.
`TOR
`N SPECIFIED -
`N 845
`N MAX? -
`--
`840 -
`
`N ty ;
`
`- OOP UNTIL ALN
`TAGS ARE
`CHECKED
`85O
`
`1.
`END
`—>{ w
`
`F.G. 8
`
`Page 9 of 25
`
`Health Care Logistics, Inc.
`Exhibit 1008
`
`

`

`Patent Application Publication
`
`Aug. 7, 2008 Sheet 9 of 11
`
`US 2008/O184719 A1
`
`FLOW 9
`EXTERNAL READ
`
`
`
`FL9 /
`
`N - /
`
`FL4
`ADDED
`NITEM / /
`
`^
`
`F5
`REMOVED
`ITEM
`
`
`
`ASK IF CONTAINER
`CONTENTS ARE
`BEING USED OR
`DISCARDED
`9 O5
`
`
`
`
`
`-N
`a?
`N
`1.
`N
`-f
`- self. EOR
`<
`DISCARDED -
`N
`1 YES
`910
`-
`Y -
`
`cc
`-5
`-15LEASE N
`PROPERLY
`DISPOSE
`CONTAINER
`No15
`Y---
`/
`
`REMOVE TAG AND
`ASSOCIATED
`DETAILS FROM
`LOCAL DBASE
`92O
`
`
`
`
`
`NOTIFY
`MANUFACTURE
`PRODUCTIS
`DISCARDED
`93O
`
`NO
`
`(
`
`END
`
`FIG 9
`
`Page 10 of 25
`
`Health Care Logistics, Inc.
`Exhibit 1008
`
`

`

`Patent Application Publication
`
`Aug. 7, 2008 Sheet 10 of 11
`
`US 2008/O184719 A1
`
`FL1 O
`
`15ISPLAY
`REPORT
`MENU
`N 1005
`
`---
`WHICH
`REPORTP
`
`
`
`1 Y.
`-INVENTORY
`< REPORT )-YES
`•
`1015-
`N / y
`NO
`
`N
`
`
`
`
`
`YES-o-
`
`-USAGE
`< REPORT ).
`N1030-1
`s:-
`NO
`if
`yes
`-INFORMATION
`N REPORT -
`N1045-
`\ -
`r
`NO
`
`FLOW 10
`PRINT REPORT
`
`
`
`
`
`ESSESS,
`REPORT
`1 O2O
`
`INVENTORY
`1O25
`---...--
`
`USAGE
`REPORT
`1.O35
`
`USAGE
`1040
`u->
`
`PRODUCE NEW
`|INFORMATION
`REPORT
`O5O
`
`
`
`w
`
`
`
`
`
`
`
`
`
`NEW
`INFOMATION
`1055
`
`------
`
`QUITs
`<REPORTS >
`N1069-
`YES
`( END
`Y
`
`NO
`
`V
`LOOP To Y
`REPORT MENU
`O65
`
`FIG 10
`
`Page 11 of 25
`
`Health Care Logistics, Inc.
`Exhibit 1008
`
`

`

`Patent Application Publication
`
`Aug. 7, 2008 Sheet 11 of 11
`
`US 2008/O184719 A1
`
`
`
`113 OA
`
`113 OB
`
`1 O
`
`FIG 11
`
`Page 12 of 25
`
`Health Care Logistics, Inc.
`Exhibit 1008
`
`

`

`US 2008/O 184719 A1
`
`Aug. 7, 2008
`
`INTELLIGENT REFRGERATOR FOR
`STORING PHARMACEUTICAL PRODUCT
`CONTAINERS
`
`being added or removed from the refrigerator, as well as a
`variety of significant details concerning the status and opera
`tion of the refrigerator itself.
`
`TECHNICAL FIELD
`
`0001. The present invention relates generally to cold stor
`age systems for pharmaceutical product containers.
`
`BACKGROUND ART
`0002 Refrigerated pharmaceutical products, such as vac
`cines, are very sensitive to rises in temperature and the pas
`sage of time. Professionals who dispense these products
`know that their quality, effectiveness and safety depends, to a
`very large extent, on the temperature conditions at the loca
`tion where they are stored, the length of time they are stored
`at the location before being used, as well as the total amount
`of time the products have been outside of refrigeration since
`they were manufactured.
`0003 Generally speaking, refrigerated pharmaceutical
`products are also valuable and expensive, which attracts a
`large number of companies and individuals interested in mar
`keting and distributing generic and counterfeit versions of
`high-demand pharmaceutical products for financial gain.
`Therefore, for health, safety and liability reasons, profession
`als who dispense branded pharmaceutical products must also
`be very concerned with maintaining the appropriate level of
`inventory on hand, acquiring additional products only from
`authorized sources, Verifying the authenticity of the products
`received from authorized sources, and keeping track of the
`location or dispensing of every authorized product container.
`0004 Pharmaceutical product containers are usually
`marked with a product’s name, manufacturer and expiration
`date. But these details are usually checked manually and only
`by visual inspection, which can lead to mistakes. These mis
`takes can have severe, long-lasting or permanent conse
`quences. Moreover, the product’s name, manufacturer and
`expiration date are only three of potentially dozens of very
`significant details associated with a particular pharmaceutical
`product container, which details the dispensing professional
`may need to take into account at the point of dispensing the
`product.
`0005 For instance, in addition to knowing the product’s
`name and expiration date, a dispensing professional often
`needs or wants to know how long the particular product can
`stay outside of refrigeration without spoiling or losing its
`effectiveness. She may also want or need to know how long
`the product actually has been outside of refrigeration, either
`because the product was temporarily removed from the
`refrigerator or because the refrigerator in which it was kept
`temporarily loss power. She may also wish to know whether
`the pharmaceutical product has been recalled, whether it is
`authentic or counterfeit, whether the refrigerator where the
`product is kept is working properly, as well as a variety of
`other significant details too numerous to track manually.
`0006 Unfortunately, the conventional refrigerators for
`pharmaceutical product containers provide no way for phy
`sicians and other health care professionals to accurately and
`precisely ascertain these additional product details. There
`fore, there is considerable need in the healthcare industry for
`a refrigerator for pharmaceutical product containers which
`provides a variety of pertinent details about the individual
`product containers that are inside the refrigerator, or that are
`
`DISCLOSURE OF INVENTION
`0007. The present invention addresses the above-de
`scribed needs, as well as other shortcomings associated with
`the conventional pharmaceutical product refrigerators, by
`providing an intelligent refrigerator for storing pharmaceuti
`cal product containers, such as vials, ampules, Syringes,
`bottles, jars, medication tubes, blister packs and cartons,
`which, among other things, uniquely identifies pharmaceuti
`cal product containers as they are added to or removed from
`the cold storage compartment, and reports to a human opera
`tor a variety of informative details and/or warnings associated
`with the uniquely-identified pharmaceutical product contain
`ers. Embodiments of the invention may also be configured to
`monitor and report to the human operator status anomalies
`associated with the cold storage compartment, and to perform
`certain functions necessitated by of the occurrence of Such
`anomalies.
`0008 More specifically, embodiments of the invention
`automatically retrieve from a local or remote database a vari
`ety of details associated with the pharmaceutical product
`containers and their contents, such as manufacturing data,
`expiration dates, time out of refrigeration, inventory levels,
`safety information, usage statistics, and known contraindica
`tions and warnings. If the set of details indicates that there is
`a problem with a particular pharmaceutical (e.g., that it is
`counterfeit, expired, Suspect, spoiled, recalled or almost
`depleted), then a message or warning may be automatically
`delivered to a human operator via an attached output device,
`Such as a display Screen, speaker or printer. Embodiments of
`the invention may also be configured to monitor and report
`temperature faults, power failures and other anomalies asso
`ciated with the refrigerator or cold storage compartment.
`Embodiments of the invention may include one or more input
`devices, such as a touchpad, keyboard or mouse, which the
`human operator may use to provide operational instructions
`or print reports. Some embodiments also may be configured
`to automatically reorder pharmaceuticals when the product
`details indicate that a current inventory of any particular
`pharmaceutical has fallen below a specified level.
`0009. In general, embodiments of the invention comprise
`a cold storage compartment, a produce identifier, a local
`database, an interface to a pharmaceutical product database,
`and one or more processors configured to monitor and man
`age certain events related to the pharmaceutical product con
`tainers. An event occurs, for example, when a pharmaceutical
`product container is added to or removed from the refrigera
`tor's cold storage compartment, or when sensors indicate that
`there has been a power failure or an adverse temperature
`change.
`0010. The local database and the pharmaceutical product
`database are both configured to store a set of pertinent details
`associated with the pharmaceutical product container, such as
`the name of the vaccine, biologic, antitoxin or other com
`pound it contains, the name of the manufacturer, the lot num
`ber, the date of manufacture, an expiration date, storage and
`refrigeration requirements, warnings, dosage, use instruc
`tions, etc. The pharmaceutical product database, which is
`typically pre-populated and provided by the manufacturer of
`the pharmaceutical, may reside on a remote computer system
`connected to an interconnected data communications net
`
`Page 13 of 25
`
`Health Care Logistics, Inc.
`Exhibit 1008
`
`

`

`US 2008/O 184719 A1
`
`Aug. 7, 2008
`
`work, Such as the Internet or a corporate intranet, or on a
`permanent or removable memory storage area located within
`or attached to the refrigerator. If the pharmaceutical product
`database resides on a remote computer system attached to a
`data communications network, then the interface comprises a
`network interface to the data communications network. If the
`pharmaceutical product database resides in a local memory
`storage area, such as a CDROM or flash memory device, then
`the interface will typically comprise a bus and bus adaptor
`configured to provide a communications path between the
`memory storage area and one or more microprocessors
`executing the instructions provided by the one or more event
`monitoring and event managing processors.
`0011. The product identifier can be implemented using a
`variety of different product identification technologies,
`including but not limited to radio-frequency identification
`(RFID) tags and readers, barcode labels and readers and
`magnetic stripes and magnetic stripe readers. In some
`embodiments of the invention, for instance, an RFID reader
`and antenna are used to detect and decode a unique identifier
`(called a “tag”) transmitted from a transponder embedded in
`the pharmaceutical product container. When the pharmaceu
`tical product container with the transponder enters or leaves
`the antenna's read Zone (i.e., its reception range), the RFID
`reader decodes the transponder signal produced by the phar
`maceutical product container to determine the unique identi
`fier associated with the container. Then the one or more event
`processors use the unique identifier to perform a variety of
`actions, such as determining whether the container has
`exceeded a time out of refrigeration limit, updating the loca
`tion information for the container in the local database, send
`ing an alert to the human operator of the refrigerator, and the
`like. Depending on the unique identifier received and the set
`of details associated with the unique identifier, the event
`processor may, in some cases, do nothing in response to the
`event (for example, if a duplicate read of the same container
`has occurred).
`0012. The event monitoring and event managing proces
`sor(s) may be embodied, for example, in one or more software
`application programs, routines or modules configured to be
`executed by a general purpose microprocessor, in one or more
`hardware devices, such as a programmable logic controller
`(PLC), in one or more firmware devices, or in some combi
`nation of Software application programs, hardware and/or
`firmware devices. Typically, although not necessarily, the
`event monitoring processor (hereinafter referred to as the
`event monitor) is configured to monitor and detect new events
`associated with pharmaceutical product containers placed in
`or near the refrigerator, as well as to monitor and detect new
`events associated with the refrigerator itself. In some embodi
`ments, the event monitor will generate event codes indicating
`what type of event has occurred. The event managing proces
`Sor (hereinafter referred to as the event manager) typically
`carries out a series of instructions that are appropriate for the
`particular event that has just occurred. Notably, alternative
`embodiments of the invention may use fewer or more PLCs,
`computer Software programs, modules or routines to perform
`the same functions as the event monitor and event manager. In
`Some embodiments, for example, the functions of the event
`monitor and the event manager may be performed by the
`same hardware of software processor.
`0013 The product identifier and the event monitor will
`together determine the unique identifier for the container and
`what event has just occurred, such as whether the product
`
`container has been added or removed from the refrigerator. If
`event codes are used, then the event monitor will then gener
`ate an appropriate event code. The event manager receives the
`event code and the unique identifier from the event monitor
`and, depending on which event code was received, performs
`the appropriate action and/or transmits the appropriate mes
`sage or warning to the human operator via an output device
`attached to the refrigerator.
`0014 For example, when a human operator places a phar
`maceutical product container onto a shelf in the cold storage
`compartment, the container will necessarily pass into the read
`Zone of an antenna located on, in or near the shelf. The
`antenna picks up a self-identifying signal transmitted from
`the transponder embedded in the container and sends the
`signal to the RFID reader. The RFID reader decodes the
`self-identifying signal to determine the unique identifier (tag)
`for the container and passes this information to the event
`monitor. The event monitor generates an “added item” event
`code signifying the fact that a product container has been
`added to the refrigerator (as opposed to being removed) and
`passes this information to the event manager, which then
`executes a series of checks and/or other actions associated
`with adding items to the refrigerator.
`0015 For instance, in response to receiving the added item
`event code, the event manager will first determine whether the
`local database already contains the unique identifier and a set
`of details (e.g., product name, expiration date, time out of
`refrigeration, etc.) associated with that unique identifier. If the
`unique identifier and set of details do not exist in the local
`database, then the event manager knows that this is the first
`time the container has been put into the refrigerator (i.e., it
`was not put in the refrigerator at Some previous time and then
`temporarily removed). In this case, the event manager will
`access the pharmaceutical product database via the interface
`and search for the unique identifier. If the unique identifier is
`found in the pharmaceutical product database, then the event
`manager will copy the set of details associated with the
`unique identifier from the pharmaceutical product database to
`the local database via the interface.
`0016. If the unique identifier is not found in the local
`database or the pharmaceutical product database, or if the
`system cannot access the pharmaceutical database for any
`reason (such as a network connection being down), then the
`system will store a record in the local database indicating that
`there is a pharmaceutical product container in the cold storage
`compartment with a status that is unknown or Suspect (i.e., not
`verified). Some embodiments of the invention will also send
`a message to this effect to an output device, such as a display
`screen, speaker or printer. Preferably, the event manager is
`also configured to periodically attempt to re-check the phar
`maceutical product database to identify and/or verify contain
`ers that have been marked as unknown or Suspect.
`0017. On the other hand, if the event manager determines
`that the local database already contains the unique identifier
`and a set of details associated with the unique identifier, then
`the system knows that the container was placed in the refrig
`erator previously and was temporarily removed. In this case,
`the event manager will record the current time the pharma
`ceutical product container was added to the refrigerator, cal
`culate a time out of refrigeration value for the pharmaceutical
`product container based on the current time and a removal
`time value stored in the local database, and increment a
`counter or database item configured to track the total accu
`mulated time out of refrigeration for the container.
`
`Page 14 of 25
`
`Health Care Logistics, Inc.
`Exhibit 1008
`
`

`

`US 2008/O 184719 A1
`
`Aug. 7, 2008
`
`0.018. One of the items in the set of details in the local
`database contains a maximum time out of refrigeration value
`for the pharmaceutical product container. Typically, this
`maximum time out of refrigeration value will be supplied by
`the manufacturer. If the total accumulated time out of refrig
`eration counter exceeds the specified maximum time out of
`refrigeration, then the event manager will transmit a warning
`message to the human operator, via the output device, indi
`cating this fact. Preferably, the event manager is also config
`ured to transmit instructions informing the human operator
`how to properly dispose of the product container.
`0019. If the human operator removes a pharmaceutical
`product container from the read Zone of the antenna, the RFID
`reader will detect the removal and determine the unique iden
`tifier for the container removed. The event monitor will then
`generate and pass to the event manager a “removed item'
`event code. In response to receiving the removed item event
`code, the event manager looks up the unique identifier in the
`local database, records the time that the pharmaceutical prod
`uct container with the unique identifier was removed from the
`read Zone of the antenna, and sends a message to the output
`device containing pertinent details about the container just
`removed, such as the product name, the time of removal,
`dosing or usage instructions, authenticity status, etc.
`0020. In some embodiments of the invention, the cold
`storage compartment includes one or more temperature sen
`sors that monitor the temperature in the vicinity of the phar
`maceutical product containers stored therein. If the tempera
`ture rises above or falls below a specified level (e.g., rises or
`falls to a level that will negatively affect the quality and
`efficacy of the compound in one or more pharmaceutical
`product containers), then the event monitor will generate and
`pass to the event manager a temperature event code indicating
`that there is a temperature fault. In response to receiving the
`temperature event code, the event manager will transmit a
`message and/or warning concerning the temperature fault to
`the human operator via the output device. Such a message or
`warning may comprise, for example, warning beeps or a
`recorded Voice message emanating from an attached speaker,
`a text message flashing on an attached display screen, or some
`combination of warning beeps, Voice recordings and flashing
`text. Some embodiments also may be configured to send an
`email message concerning the fault to a human operator via
`the network interface.
`0021. As previously noted, the product identifier may be
`implemented using a variety of different product identifica
`tion technologies. Some embodiments use one or more anten
`nas located within the cold storage compartment, and a radio
`frequency identification reader. The antenna is configured to
`convert a radio-frequency field produced by a transponder
`affixed to the pharmaceutical product container into alternat
`ing current, and the radio-frequency identification reader is
`configured to decode the alternating current to determine the
`unique identifier. In another embodiment, the product identi
`fier comprises a barcode reader that determines the unique
`identifier by decoding a light energy signal reflected from a
`barcode label affixed to the pharmaceutical product container.
`In yet another embodiment, the product identifier comprises a
`magnetic stripe reader that detects changes in a magnetic field
`produced by a magnetic stripe affixed to the pharmaceutical
`product container. In this case, the changes in the magnetic
`field represent the unique identifier.
`0022. Some embodiments of the refrigerator also include
`one or more input devices (e.g., keyboard, keypad, mouse,
`
`touch screen, etc.) that can be activated by a human operator
`to provide operational instructions. Such operational instruc
`tions may include, for example, instructions to print certain
`reports, to change the temperature of the cold storage com
`partment, to revise or delete certain items from the local
`database, or to retry an attempt to connect to a particular
`manufacturer's pharmaceutical product database. The input
`devices may also include one or more biometric sensors (e.g.,
`fingerprint or retina Scanners) configured to Verify the iden
`tity and authorization level of the human operator.
`0023. If the human operator strikes keys on the keyboard
`or touches the touch screen, for example, the event monitor
`will generate and pass to the event manager an "input event
`code, which will cause the event manager to display a prompt
`and/or a menu on the display screen. The human operator can
`activate buttons on a keypad, keyboard, mouse or touch
`sensitive display Screen to specify what action she wishes to
`be performed. The event manager is configured to receive the
`human operator's instructions via the input device, execute
`the instructions, and then transmit an appropriate message or
`response to the operator via the output device.
`0024. In some embodiments of the invention, the event
`monitor is also coupled to a power fail circuit, which is
`configured to detect a power failure condition, such as a
`power outage. When this happens, the event monitor will
`generate and pass to the event manager a "power failure'
`event code, which causes the event manager to determine the
`starting time of the power outage, and then store the power
`failure event code and the starting time of the power outage in
`a status log. Preferably, the system is configured to accom
`plish these tasks on a high priority basis as soon as a drop in
`power is detected but before the power is depleted. Alterna
`tively, the system may be configured to accomplish these
`tasks while the system is operating under the Support of an
`emergency temporary power source. Such as a battery or
`uninterruptible power supply (UPS). Such an emergency
`power Source may also be used by the system to power an
`internal clock designed to keep track of the current time so
`long as the power failure condition persists.
`0025. When the regular power is restored, the event man
`ager is configured to warn the human operator that there has
`been a power failure and also check the time out of refrigera
`tion status of each pharmaceutical product container inside
`the refrigerator. In particular, the event manager will search
`the status log for the power failure event code. If the power
`failure event code is found in the status log, then the event
`manager will transmit the message concerning the power
`outage to an output device and then perform the following
`actions: (i) determine the duration of the power outage based
`on the current time and the recorded starting time of the power
`outage, (ii) cause the product identifier to read the signals
`produced by each pharmaceutical product container in the
`cold storage compartment to determine their unique identifi
`ers, (iii) search the local database for the time out of refrig
`eration counters associated with each unique identifier, and
`(iv) if the sum of the duration and the time out of refrigeration
`counter for a unique identifier exceeds a specified maximum,
`then transmit a message concerning the unique identifier to an
`output device. In alternative embodiments, the event manager
`may be configured to simply update the time out of refrigera
`tion counter in the local database for each pharmaceutical
`product container, and then check this counter at a later time
`as part of a periodic routine.
`
`Page 15 of 25
`
`Health Care Logistics, Inc.
`Exhibit 1008
`
`

`

`US 2008/O 184719 A1
`
`Aug. 7, 2008
`
`0026. As will be discussed in more detail below, embodi
`ments of the invention also may include one or more external
`product identifiers for detecting and reading unique identifi
`ers transmitted from transponders affixed to pharmaceutical
`product containers located near the refrigerator but not actu
`ally placed inside the refrigerator's cold storage compart
`ment. As will be discussed below, a human operator may use
`the