Patent Description:
The present subject matter relates to a time-temperature tracking and indicator system used to monitor and record information associated with a perishable product and indicate if the product is suitable for its intended use. More specifically, the present subject matter relates to time-temperature tracking and recording labels, and related computer applications, used in combination to monitor temperature exposure of pharmaceuticals and to determine if the pharmaceuticals are acceptable for use and provide an indication thereof.

The use of radio frequency identification (RFID) tags to track, identify and locate goods has grown significantly in recent years. RFID tags allow manufacturers, distributors and retailers, amongst others, to regulate products and inventory, quickly determine production, manufacture, distribution or retail needs and efficiently intake and remove items utilizing RFID tags from inventory or other supply chain situations. The RFID tags themselves can provide any desired product data and may be scanned or read in any of a variety of manners through the use of any device that has a reader or scanner.

Near-field communication (NFC) is a type of radio frequency communication technology, which allows for read-only and read-write communications between a NFC-enabled RF tag reader and a NFC-enabled tag. NFC operation is based on inductive coupling between two loop antennas, which allows for sharing of power and data between NFC-enabled devices.

Systems using bar codes or RFID devices have been used to track articles such as in parcel delivery or inventory management systems. However, such devices and associated systems are typically proprietary or designed for very specific applications and do not adequately indicate if the time-temperature threshold of a product has been exceeded. Although a variety of tracking systems are known in the art, a need still remains for a cost effective method of tracking information associated with a product having a time-temperature threshold.

<CIT> describes an online temperature monitoring type insulation box capable of monitoring the temperature of the insulation box. The insulation box comprises an insulation box body and a temperature monitoring device mounted on the insulation box body. The temperature monitoring device comprises a CPU (Central Processing Unit) module, a Flash memory module, an RFID (Radio Frequency Identification Device) module, a GPRS (General Packet Radio Service) communication module, a display screen, a temperature sensor and a power supply module.

<CIT> describes a semi-active RFID temperature measuring label composed of a microcontroller, a temperature sensor, a real-time clock, an I2C and wireless dual-port storage device and display equipment. As a control hub of the entire semi-active label, the microcontroller is connected with other components of the label. When in running, the microcontroller first reads time information of the real-time clock, and then awakens and controls the temperature sensor according to the preset time period so as to collect temperature data. At the same time, the microcontroller writes the temperature and time information into the I2C and wireless dual-port storage device. Finally, the microcontroller judges whether temperature or time goes beyond the set range, wherein if the temperature or time goes beyond the set range, the display equipment can send out cautions.

The difficulties and drawbacks associated with previously known means and strategies are addressed in the present subject matter and related combinations and methods as defined in the independent claims.

According to the present invention there is provided a time-temperature tracking and indicator label, and a method of determining if a time-temperature threshold of a perishable product has been exceeded in accordance with independent claim <NUM> and <NUM>. Preferred embodiments are defined in claims <NUM>-<NUM>, <NUM>-<NUM>. Further embodiments which are not covered by the subject-matter of claims <NUM>-<NUM> are there for a better understanding of the present invention.

The present subject matter provides a time-temperature tracking system that is easily operable and configured to allow convenient monitoring of a perishable product through various stages of transportation, delivery, and use of the product.

As will be realized, the subject matter described herein is capable of other and different embodiments and its several details are capable of modifications in various respects, all without departing from the claimed subject matter. Accordingly, the drawings and description are to be regarded as illustrative and not restrictive.

These, as well as other features, aspects, and advantages of the present subject matter, will be more completely understood and appreciated by referring to the following more detailed description of the exemplary embodiments of the present subject matter in conjunction with the accompanying drawings.

The present subject matter provides a tracking and indicator system for perishable products having a time-temperature threshold. Pharmaceuticals are one type of perishable product having a time-temperature threshold, such that they are subject to degradation and become unsuited for an intended use when exposed to temperatures outside a recommended temperature range for more than a predetermined amount of time. The tracking and indicator system of the present subject matter tracks and records information that relates to the time-temperature threshold of the product and indicates whether the time-temperature threshold of the product has been exceeded and is unsuited for its intended use.

By "time-temperature threshold" it is meant a threshold established for the product that is based on various combinations, relationships, and/or computations relating to a time component and a temperature component associated with the product. The time-temperature threshold of a product will be discussed in more detail herein. By "intended use" it is meant the recommended use of the product as established by the manufacturer or distributor.

According to the invention, the system of the present subject matter includes a laminated label. The laminated label is configured to track and/or record the information associated with the product, such as for example, the time and temperature to which the product is exposed. In certain embodiments, the laminated label is configured to perform calculations on the information. The laminated label is configured to be attached to the product, or to packaging for the product, for tracking and recording the information. In one aspect, the laminated label is configured to display whether or not the product is suitable for its intended use based on the information.

In another embodiment the system further includes a computer application. In this embodiment, the laminated label is configured to communicate the information to the computer application, such that the computer application is able process or manipulate the recorded information. The computer application then outputs the manipulated information for analysis in order to indicate whether the time-temperature threshold of the product has been exceeded. In this embodiment, the laminated label may or may not also be configured to display if the product is suitable for its intended use.

In certain embodiments where the label is configured to transfer the information to the computer application, the tracking and indicator system of the present subject matter includes a computing device that is configured to execute the computer application, and is able to communicate with the label for accessing the information recorded by the label. The information recorded by the label is communicated to the computing device, wherein the computer application processes the information. The computer application is configured to manipulate the information and output the manipulated information for display on the computing device, or by other means such as by another computing device or by generating a printed report for example.

In certain embodiments, the label is the only component that provides indication as to whether or not the time-temperature threshold of the product has been exceeded. In other words, the label acts as an indicator for the current status of the product, wherein the microchip tracks and records time-temperature data associated with the product, and triggers the indicator to display an unacceptable product indication if the time-temperature threshold has been exceeded. In other embodiments, the computer application is the only component provides an indication as to whether or not the time-temperature threshold of the product has been exceeded. In other words, the label acts to track the time-temperature information associated with the product, and communicates such information to the computer application so that the computer application can indicate an unacceptable product indication if the time-temperature threshold has been exceeded. In still other embodiments, both the label and the computer application provide such indication. In other words, the label has the dual function of acting as an indicator for the current status of the product and for tracking the time-temperature information associated with the product for communication to computer application.

The system can also optionally include the product having a time-temperature threshold, and if necessary or desired, packaging for the product. The various components of the time-temperature tracking and indicator system of the present subject matter will be described in more detail herein in reference to the figures.

In one embodiment and in reference to <FIG>, the system <NUM> includes a plurality of labels <NUM>, one or more optional computing devices <NUM>, an optional central computing device <NUM>, and an optional computer application <NUM>. In accordance with the present subject matter, the labels can be associated with a product, or with product packaging. The labels <NUM> may be in communication with the one or more computing devices via communication channels <NUM>. Further, the computer application <NUM> is schematically depicted by solid lines <NUM> to be executed on each computing device <NUM> and optionally the central computing device <NUM>. The several computing devices <NUM> that are in direct communication with the labels <NUM> are also in communication with the central communication device <NUM> via communication channels <NUM>.

The central computer device <NUM> or the computer application <NUM> may include artificial intelligence and perform automatic data analysis, and can provide supply chain adjustments or trigger re-orders based on the uploaded data from the labels <NUM> via computing devices <NUM>. Additionally, the central computer device or computer application may alternatively or additionally provide assurance and pricing information/recommendations for the insurance industry based on the uploaded data from the labels <NUM> via the computing devices <NUM>.

In one embodiment, the product of the present subject matter to which the one or more labels <NUM> is associated, comprises a perishable product; and in one aspect, is a pharmaceutical drug or other temperature sensitive biologic. However, the products are not particularly limited by the present subject matter, and can include other consumable or non-consumable products having time-temperature thresholds and other thresholds.

The time-temperature threshold of the product will be explained in more detail in reference to <FIG>. Therein, an example of a product's recorded temperature <NUM> graphed relative to time is depicted. The time-temperature plot depicted in <FIG> includes an upper temperature threshold <NUM>, an extreme upper temperature threshold <NUM>, a lower temperature threshold <NUM>, and a recommended temperature <NUM> established for the product. <FIG> also includes an upper temperature time threshold <NUM>, an extreme upper temperature time threshold <NUM>, and a lower temperature time threshold <NUM> established for the product.

The upper temperature threshold <NUM> for the product comprises a temperature, above which the product cannot measure (or be exposed) for more than the upper temperature time threshold <NUM> without being rendered unsuited for its intended purpose. The extreme upper temperature threshold <NUM> comprises a temperature above which the product cannot measure (or be exposed) for more than the extreme upper temperature time threshold <NUM> without being rendered unsuited for its intended purpose. The lower temperature threshold <NUM> for the product comprises a temperature, below which the product cannot measure (or be exposed) for more than the lower temperature time threshold <NUM> without being rendered unsuited for its intended purpose. In one embodiment, the upper temperature threshold, the extreme upper temperature threshold, the lower temperature threshold, the upper temperature time threshold, the extreme upper temperature time threshold, and the lower temperature time threshold can be adjusted or modified as desired for a particular application.

The portion of the line representing the product's recorded temperature <NUM> that abuts the three shaded areas <NUM> (including area <NUM>), <NUM>, and <NUM> depicts that the product's temperature was above the upper temperature threshold <NUM> for times <NUM> (including time <NUM>), <NUM>, and <NUM>. The portion of the line representing the product's recorded temperature <NUM> that abuts the shaded area <NUM> depicts that the product's temperature was above the extreme upper temperature threshold <NUM> for time <NUM>. The portion of the line representing the product's recorded temperature <NUM> that abuts the shaded area <NUM> depicts that the product's temperature was below the lower temperature threshold <NUM> for time <NUM>.

In one embodiment, and in accordance with the present subject matter, the time-temperature threshold of a product is established as a combination of an upper temperature threshold <NUM>, for example <NUM>, with an upper temperature time threshold <NUM>, for example <NUM> days. In this embodiment, and with reference <FIG>, the time-temperature threshold of the product is exceeded if the product is exposed to a temperature over <NUM> for a cumulative amount of time longer than <NUM> days. That is, if times <NUM> (including time <NUM>), <NUM>, and <NUM> are added together and exceed <NUM> days, then the time-temperature threshold is exceeded and the product is considered unsuited for its intended purpose.

In another embodiment, and in accordance with the present subject matter, the time-temperature threshold of a product is established as a combination of an extreme upper temperature threshold <NUM>, for example <NUM>, with an extreme upper temperature time threshold <NUM>, for example <NUM> day. In this embodiment, and with reference <FIG>, the time-temperature threshold of the product is exceeded if the product is exposed to a temperature over <NUM> for a cumulative amount of time longer than <NUM> day. That is, if time <NUM> exceeds <NUM> day, then the time-temperature threshold is exceeded and the product is considered unsuited for its intended purpose.

In another embodiment, and in accordance with the present subject matter, the time-temperature threshold of a product is established as a combination of a lower temperature threshold <NUM>, for example <NUM>, with a lower temperature time threshold <NUM>, for example <NUM> days. In this embodiment, and with reference <FIG>, the time-temperature threshold of the product is exceeded if the product is exposed to a temperature below <NUM> for a cumulative amount of time longer than <NUM> days. That is, if time <NUM> exceeds <NUM> days, then the time-temperature threshold is exceeded and the product is considered unsuited for its intended purpose.

In another embodiment, the time-temperature threshold of the product is established as a predetermined area value (A1), wherein the time-temperature threshold of the product is exceeded if the area that lies above the upper temperature threshold <NUM> and below the product's recorded temperature <NUM> is cumulatively greater than the predetermined area value (A1). In this embodiment, and in reference to <FIG>, if the cumulative area of shaded areas <NUM> (including area <NUM>), <NUM>, and <NUM> is greater than the predetermined area value (A1), then the time-temperature threshold of the product has been exceeded and the product is considered unsuited for its intended purpose.

In another embodiment, the time-temperature threshold of the product is established as a predetermined area value (A2), wherein the time-temperature threshold of the product is exceeded if the area that lies above the extreme upper temperature threshold <NUM> and below the product's recorded temperature <NUM> is cumulatively greater than the predetermined area value (A2). In this embodiment, and in reference to <FIG>, if the area of shaded area <NUM> is greater than the predetermined area value (A2), then the time-temperature threshold of the product has been exceeded and the product is considered unsuited for its intended purpose.

In another embodiment, the time-temperature threshold of the product is established as a predetermined area value (A3), wherein the time-temperature threshold of the product is exceeded if the area that lies below the lower temperature threshold <NUM> and above the product's recorded temperature <NUM> is cumulatively greater than the predetermined area value (A3). In this embodiment, and in reference to <FIG>, if the area of shaded area <NUM> is greater than the predetermined area value (A3), then the time-temperature threshold of the product has been exceeded and the product is considered unsuited for its intended purpose.

Other conventions relating to time and temperature can be used to establish the time-temperature threshold of a product. Further, various combinations of these, and other time-temperature thresholds can be utilized to determine if a product is suited for its intended use. Additionally, thresholds based on variables other than time and temperature can be utilized; such as for example, thresholds based on exposure to various types of radiation, turbulence, pressure variations, atmospheric contamination, moisture, and the like.

In one embodiment in accordance with the present subject matter, and in reference to <FIG>, <FIG>, and <FIG>, the laminated label <NUM> can comprise various components including a face stock <NUM>, a microchip <NUM>, a communication apparatus <NUM>, an indicator <NUM>, a power source <NUM>, and at least one adhesive layer <NUM>. For purposes of clarity, only a single adhesive layer <NUM> is shown in the schematic view of <FIG>. The adhesive layer <NUM> of the label <NUM> can be a clean-removable and re-usable pressure sensitive adhesive configured for application on a variety of substrates, including the metal surfaces.

The laminated label can be used as a stand-alone product, or can be used as part of the tracking and indicator system in accordance with the present subject matter. When used alone, the label includes visual indicators to indicate the current status of the product, including a visual indication as to whether the time-temperature threshold of the product has been exceeded. When used as part of the tracking and indicator system, the label may be configured to communicate the recorded information to a computing device for use by the computer application and may also optionally include visual indicators.

In one embodiment, the label comprises flexible components such that the label can be attached to various shaped and contoured substrates. In this embodiment, the facestock <NUM>, indicator <NUM>, power source <NUM>, and adhesive layers <NUM> are flexible. The flexible power source can include a flexible battery. The flexible power source <NUM> may be incorporated into the facestock <NUM> and may be a light energy harvesting device that captures solar energy, including a device based on amorphous-silicon spray technologies. Alternatively, the light energy harvesting device can also be used as sunlight or light-period detectors. The power source <NUM> may also include a power storage component, including capacitors, super-capacitors, traditional and re-chargeable batteries, and external power sources (including radio-frequency based wireless charging and energy harvesting, magnetic induction, solar power, thermal energy, wind energy, osmotic power, chemical potential and kinetic energy. The various layers and components of the laminate label will be discussed in more detail below.

In one embodiment, as depicted in <FIG>, the label <NUM> can be a laminated label comprising several layers and defining a front/top/outer portion <NUM> of the label and an opposite back/bottom/inner portion <NUM> of the label. In one embodiment, the label includes a face stock <NUM>; a component layer <NUM> comprising a microchip <NUM>, and one or both of a communication apparatus <NUM>, and an indicator <NUM>; a power source <NUM>; and a release liner <NUM>. As depicted in <FIG>, the label can be laminated, whereby the various layers of the label <NUM> are laminated with one or more adhesive layers <NUM>. Alternatively, the microchip <NUM> of the component layer <NUM> can also be attached on the back side of the component layer <NUM> and still be connected to the other components (e.g. the indicator <NUM> and communication apparatus <NUM>) on the top side of the component layer <NUM> and the electrical connections <NUM> by assembly techniques, such as the through-hole technology. Other forms of connection arrangements and assembly techniques allowing the equivalent should be included also.

In aspects where the indicator <NUM> is included and the communication apparatus <NUM> is excluded, the label can be used to provide a visual indication whether the product's time-temperature threshold has been exceeded. In aspects where the communication apparatus <NUM> is included and the indicator <NUM> is excluded, a computer application <NUM> or computing device <NUM> can be used to communicate with the label to provide an indication whether the product's time-temperature threshold has been exceeded. In aspects where both the communication apparatus <NUM> and the indicator <NUM> are included, one or both of the label <NUM> and the computing device <NUM> can be used to provide an indication whether the product's time-temperature threshold has been exceeded.

In one embodiment as shown in <FIG>, the label includes a face stock <NUM> having indicia <NUM> printed thereon, one or more windows/apertures <NUM>, and in one aspect, a temperature scale <NUM>. The face stock can also include one or more indicators <NUM> that are used in conjunction with the temperature scale <NUM> to provide an indication of the product's current temperature. The indicators <NUM> can be made by the printing of thermochromic ink, electrochromic ink, or other thermochromic materials such as cholesteric liquid crystal inks and pigments, for example. As the temperature of the product or of the surrounding environment changes, the thermochromic ink will indicate the current temperature of the product on the temperature scale <NUM>. Where electrochromic ink is used, the computer chip can control an amount of electricity delivered to the ink so that the electrochromic ink will indicate the current temperature of the product on the temperature scale <NUM>. Although <FIG> depicts a label <NUM> including both an indicator <NUM> and a communication apparatus <NUM>, it will be understood that labels in accordance with the present subject matter may optionally include only one of the indicator and communication apparatus and may, but does not necessarily, include both an indicator <NUM> and a communication apparatus <NUM>.

In one non-claimed embodiment, the label comprises the communication apparatus and does not comprise a visual indicator. In another non-claimed embodiment, the label comprises the indicator and does not comprise a communication apparatus. According to the invention, the label comprises both the indicator and the communication apparatus.

<FIG> depicts one embodiment in accordance with the present subject matter, wherein label <NUM> is depicted as it would appear in common use, adhered to a substrate such that the front portion <NUM> of the label <NUM> is visible. As shown, the label <NUM> can include various indicia <NUM> printed on the face stock <NUM>. The indicia can include instructions for using the product, instruction for using or reading the label, company identification information, information about the supplier of the product, the manufacturer of the product, a communication apparatus indicator <NUM> for indicating that the label includes a communication apparatus <NUM>, product information such as a lot number or production date for example, instructions for reading the label, and the expiration date of the label or battery.

<FIG> depicts the face stock including one or more indicators <NUM>, such as thermochromic ink or electrochromic ink for example, herein depicted as a thermometer having Celsius and Fahrenheit temperature scales associated thereto. On the left hand side of the label as shown, a window <NUM> is provided such that an indicator <NUM> included in the component layer <NUM>, can be seen from the front <NUM> of the label through the facestock <NUM>. The number of windows <NUM>, indicators <NUM>, <NUM>, and type and styling of indicia <NUM> is not limited to those depicted in <FIG>, but can encompass various alterations, combinations, additions, and subtractions from those depicted.

The laminated label of the present subject matter can also include functions to track other information associated with the product. For example, the label can include other sensors within the label to measure information associated with the product, such as turbulence, mineral sensing, exposure to solar or UV radiation, pressure, moisture, etc. The other tracking components can communicate the tracked information to the microchip for recording and transmittal to the computing device by the computing apparatus.

In accordance with the present subject matter, the label can also be reused for another product or on another package, wherein the microchip is configured to be reprogrammed, such as by deleting the information recorded thereon and rewriting or replacing an algorithm that controls the microchip. Further, the power source can be configured to be recharged or replaced; and the indicator, which provides the permanent visual indication, can be reset or replaced for subsequent use.

The face stock <NUM> of the laminated label is not particularly limited, and can comprise one or more film layers comprising one or more polymers or copolymers, paper, metal foils, or textiles. Suitable polymers may include polypropylene, polyethylene, polyethylene terephthalate, acrylonitrile butadiene styrene, nylon, polystyrene, and other extrudable thermo-plastics. The facestock can include fillers, stabilizers, colorants, or other additives in order to enhance certain characteristics of the film such as chemical resistance, color, durability, anti-blocking, or the like.

The polymeric components of the facestock can be machine direction oriented, transverse direction oriented, or biaxially oriented. Biaxially oriented film will be more resistant to tearing, ripping, or otherwise being damaged. The thickness facestock of the facestock is not particularly limited can range from about <NUM> microns to about <NUM> microns.

The facestock can optionally include other layers or coatings for specific intended uses including printing receptive layers or coatings, hydrophobic layers or coatings, additional facestock layers, or the like.

In an embodiment, the facestock comprises the upper portion of the laminated label and can be printable or contain printing, images, or other indicia. In one aspect, the face stock includes printed indicia <NUM>, indicators <NUM>, and one or more apertures <NUM>, as previously described. Other indicia, indicators, and apertures can be included as desired in accordance with the present subject matter. In several embodiments, the face stock <NUM> acts as a protective front layer for the underlying component layer <NUM>.

As shown in <FIG>, the label <NUM> also includes a microchip <NUM>. The microchip is configured to control certain functions of the laminated label. In one embodiment the microchip of the present subject matter includes a real time clock, a temperature sensor, data memory, and algorithms for controlling functions of the microchip and label, and for computing information (i.e. performing calculations on the information). In combination, the various components of the microchip allow it to track and record the information associated with the product, such as temperature and/or time data, and to perform calculations on the information. This information is stored/recorded in the data memory of the microchip for accessing, computing, and communicating purposes. For purposes of example, the microchip may be the SL13A and SL900A available from ams AG, Tobelbbader Strasse <NUM>, <NUM> Unterpremstaetten, Austria; the NHS3100 available from NXP Semiconductors NV, High Tech Campus <NUM>, Eindhoven, <NUM> AG, The Netherlands; the THOR available from DELTA Microelectronics, Venlighedsvej <NUM>, <NUM> Horsholm, Denmark; the RF430FRL152H available from Texas Instruments, <NUM> TI Boulevard, Dallas, Texas, and equivalents and or combinations thereof.

In one embodiment, the embedded microchip <NUM> has sufficient capacities to support recording and logging of information associated with the product for at least about <NUM> years of operation after the label is activated. Such information may relate to time-temperature data logging and computation. In one aspect, the memory capacity of the microchip can be increased by adding memory microchips to the device circuit either before or after the label is assembled.

The embedded microchip <NUM> supports on-board computation of the stored time-temperature data as desired, such computation being based on software and/or data calculation algorithms stored in the microchip. The software and data calculation algorithms can be preinstalled in the microchip before the label <NUM> is assembled. Alternatively or additionally, the microchip <NUM> can be programmable, wherein the software and data calculation algorithms can be installed, modified, erased, or replaced after assembly of the label <NUM>. For example, the microchip may be programmable through communication with a programming device, such as by near field-communication (NFC) with an RFID programming device.

The microchip <NUM> can contain a unique identification (UID); and the computing device <NUM> can also contain a UID and provide the global positioning system (GPS) function. The central computing devices <NUM> can receive the UIDs of the microchip <NUM> and computing device <NUM>, time and location information of the label <NUM> and computing device <NUM> when the computing device <NUM> communicate with the label <NUM>. These features can be applied for the track and trace of product shipments, and also can be applied for the serialization in pharmaceuticals, including the new regulations on supply chain security and the chain-of-custody. It is also envisioned that the UID of microchip <NUM> can be used for anti-counterfeiting applications.

In one embodiment, the data calculation algorithms provide a mean kinetic temperature (MKT) calculation as disclosed in United States Pharmacopeia, <NUM>, <<NUM>> Good Storage and Distribution Practices for Drug Products. As disclosed therein, the mean kinetic temperature (MKT) is the single calculated temperature at which the total amount of degradation of a product over a particular period is equal to the sum of the individual degradations that would occur at various temperatures, and may be represented by the following equation: <MAT>.

In another embodiment, and with specific reference to the time-temperature plot in <FIG>, the data calculation algorithms provide a value (i.e. area) for one or more of the shaded areas <NUM> (including or excluding area <NUM>), <NUM>, <NUM>, <NUM> (exclusive of area <NUM>), and <NUM>, by performing an integration of the area between the line <NUM> and one of the lines <NUM>, <NUM>, and <NUM>. Such calculations of these shaded areas generally correspond to the amount of time and magnitude of temperature deviation above the upper temperature threshold <NUM> or extreme upper temperature threshold <NUM>; or below the lower temperature threshold <NUM>.

Such data calculation algorithms used to calculate the value of the shaded areas <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> can include performing a Riemann Sum calculation, i.e. trapezoidal rule calculation, which is a rudimentary integration that can be used to calculate the shaded areas in the time-temperature plot (<FIG>). For example a total area (AU) in a temperature-time plot that corresponds to an exposure time (ti) of merchandise at temperature (Ti) higher than an upper temperature threshold (TU) can be calculated with the following equation: <MAT> In one aspect, and in reference to <FIG>, total area (AU) can be the combined total of shaded areas <NUM> (including area <NUM>), <NUM>, and <NUM>; exposure time (ti) can be the combined total of time <NUM> (including time <NUM>), <NUM>, and <NUM>; temperature (Ti) can be the temperature of the product <NUM>; and the upper temperature threshold (TU) can be upper temperature threshold <NUM>. In one embodiment, when time (ti) is zero, i.e. ti = t<NUM>, this will be understood to be the first time that the merchandise reaches a temperature equal to the upper temperature threshold Tu, i.e. T<NUM> = T(t<NUM>) = Tu.

A total area (AE) in a temperature-time plot that corresponds to an exposure time (ti) of the merchandise at a temperature (Ti) higher than an extreme upper temperature threshold (TE) can be calculated, for example, with the following equation: <MAT> In one aspect, and in reference to <FIG>, total area (AE) can be the shaded area <NUM>; exposure time (ti) can be the time <NUM>; temperature (Ti) can be the temperature of the product <NUM>; and the extreme upper temperature threshold (TE) can be extreme upper temperature threshold <NUM>.

A total area (AL) in a temperature-time plot that corresponds to an exposure time (ti) of the merchandise at a temperature (Ti) lower than an lower temperature threshold (TL) can be calculated, for example, with the following equation: <MAT> In one aspect, and in reference to <FIG>, total area (AL) can be the shaded area <NUM>; exposure time (ti) can be the time <NUM>; temperature (Ti) can be the temperature of the product <NUM>; and the lower temperature threshold (TL) can be lower temperature threshold <NUM>. In one embodiment, when time (ti) is zero, i.e. ti = t<NUM>, this will be understood to be the first time that the merchandise reaches a temperature equal to the lower temperature threshold TL, i.e. T<NUM> = T(t<NUM>) = TL.

In one embodiment, the microchip can be reprogrammed and reused at a later time such that data memory is erased, the real time clock is reset, and the algorithm is changed or reprogrammed.

The temperature sensor can be a digital or analog sensor and can be included in a microelectromechanical systems (MEMS) device on the microchip. The temperature sensor can comprise thermocouples, thermistors, resistance temperature detectors, infrared sensors, surface acoustic wave RFID sensors, or the like. The temperature sensor can be a contact or noncontact type sensor.

The microchip is powered by the power source <NUM> and is also in communication with the communication apparatus <NUM> and the indicator <NUM> via connections <NUM>. The microchip is configured to control the functions of the indicator <NUM>, and optionally the functions of the communication apparatus <NUM>. The microchip is configured to communicate the recorded information to the communication apparatus, such that the communication apparatus can communicate the information to a separate computing device <NUM> for manipulation by the computer application <NUM>.

In one embodiment, the microchip records time only when the tracked temperature is above or below a recommended temperature for the product, as determined by the algorithm. For example and as shown in <FIG>, the product's recommended temperature <NUM> ranges between the lower temperature threshold (e.g. <NUM>) and the upper temperature threshold (e.g. <NUM>), such that when the temperature sensor in the microchip tracks a temperature above the upper temperature threshold and/or below the lower temperature threshold, the microchip records the time. In one aspect, a cumulative time recorded by the microchip and associated with the product being above the upper temperature threshold (e.g. <NUM>) and exceeding the upper temperature time threshold (e.g. <NUM> days), is the basis for the algorithm in the microchip to cause the indicator <NUM> to display an unacceptable product indication. In another aspect, a cumulative time recorded by the microchip and associated with the product being above the extreme upper temperature threshold (e.g. <NUM>) and exceeding the extreme upper temperature time threshold (e.g. <NUM> day), is the basis for the algorithm in the microchip to cause the indicator <NUM> to display an unacceptable product indication. In another aspect, a cumulative time recorded by the microchip and associated with the product being below the lower temperature threshold (e.g. <NUM>) and exceeding the lower temperature time threshold (e.g. <NUM> days), is the basis for the algorithm in the microchip to cause the indicator <NUM> to display an unacceptable product indication. If the time-temperature threshold is not exceeded, the algorithm in the microchip causes the indicator <NUM> to display an acceptable product indication. It will be understood that the various aspects of this embodiment can be combined, wherein the algorithm in the microchip is configured to parse out the various time-temperature information associated with the upper, the extreme upper, and the lower temperature thresholds such that the information for each is separately considered as the basis for the algorithm in the microchip to cause the indicator <NUM> to display an unacceptable product indication. As applied to any of these aspects, the algorithm in the microchip may optionally include an adjustable delay for the start of recording the time, for example a delay of up to about <NUM> hours.

In one embodiment, the status displayed by the indicator <NUM> is able to be changed automatically by the control of the microchip <NUM> according to the algorithm contained in the microchip, or upon manually depressing a switch on the label so that the indicator <NUM> displays an unacceptable product indication, for example a blinking light signal. In another embodiment, the indicator can be manually changed (e.g. by a press-button) from an unacceptable product indication back to the original acceptable product indication. Optionally, there may be a fixed number of times, a variable number of times, or an unlimited number of times that the indicator can be changed between the acceptable and unacceptable product indication.

In another embodiment, the microchip continually records the time, and optionally the temperature, beginning from actuation of the label. In this embodiment, the algorithm in the microchip may be configured to parse out the continually recorded time and temperature, from the recorded time associated with the upper, the extreme upper, and the lower temperature time thresholds, which were previously described.

In several embodiments, the microchip is configured, to stop recording time and temperature when the temperature of the label returns to the recommended temperature range <NUM>, or when an unacceptable product indication has been displayed by the indicator.

The microchip is configured to cause the indicator <NUM> to display an unacceptable product indication in the event that a time-temperature threshold for the product has been exceeded; in the event that the power source cannot adequately power the label; or in the event that the recording capabilities of the microchip are inactive. In another embodiment, the label may be used as a timer label, wherein the microchip is configured to cause the indicator <NUM> to display an alert or other indication, in the event that a particular predetermined time frame or cycle has elapsed or has been exhausted. For example, the microchip may be configured to change the status of the indicator to display a secondary status, or alternatively an initial status when a time interval has elapsed, for example, when seven days has passed. In one aspect, the indicator can be manually or automatically reverted to indicate an initial status, e.g. an acceptable product indication, for another seven-day cycle or other time interval or cycle length as desired. The number of times that the indicator can be reverted to indicate an initial status, e.g. an acceptable product indication, may be limited or unlimited. In one embodiment, the indicator may be reverted from the secondary status to the initial status, or vice versa, by manually depressing or otherwise triggering a switch or button on the label. The manually operated switch or button can be flexible or rigid. In one aspect, the timer label can be disposable, and have an inactive shelf-life of about <NUM> years, and an operational life of about <NUM> days, for example. The timer label may be operational at temperatures from about <NUM> to about <NUM> (<NUM> °F to about <NUM> °F). The predetermined time interval may be programmable (e.g., selected or adjustable) after assembly of the label, or may be pre-set during assembly of the label.

The microchip is configured to communicate the recorded information, through the communication apparatus, to the computing device for manipulation by the computer application. In this regard, the microchip is in communication and can at least partially control the communication apparatus for communicating the information to the computing device.

It is also envisioned that the microchip <NUM> may include a biomarker sensor for authentication applications, including the sensing of inks with engineered DNA, or the sensing of biomarkers in a secretion, including perspiration, generated from/induced by edible substances or pills taken into an organism. Further, the microchip <NUM> may include a microfluidic lock with destructive channels that can be applied for verifications, including the Yes/No verification. Still further, the microchip <NUM> may include a mineral sensor for traceability, including the farm-to-table traceability or a particle counter for monitoring and recording the amount of particles, or the amount and size of particles, of the ambient environment.

Still further, the microchip may include sensors configured to detect, without limitation, acceleration, vibration, shock; acoustic/ultrasonic/mechanical waves; chemical/gas; electric/magnetic energy; fluid flow; force/load/torque/strain; humidity/moisture; leak/level; machine vision; electromagnetic waves, including visible light, ultraviolet radiation, infrared radiation, radio waves, microwaves, x-rays and gamma rays; motion/velocity/displacement; position/presence/proximity; pressure; temperature; biologics; biomarker, including DNA; radar; turbidity; presence of minerals; bodily excretions, including sweat; heartbeat, including the heartbeat signatures; radiation, including the radiation sensitive inks; chemical sensors, including phosgene, and chemicals in solid, liquid and gas; particles, including aerosol particles, liquid particles, and solid particles. Accordingly, the visual indicator <NUM> may show indications triggered by one or combinations of the aforementioned sensor functions provided by the microchip <NUM> with programmable thresholds for such triggers.

In several embodiments, the label <NUM> may include a communication apparatus <NUM> for communicating the information recorded on the microchip <NUM> to a computing device <NUM> that is separate and independent from the laminated label. The communication apparatus <NUM> has a size and form suitable for incorporating into the label, and to the product and its packaging. The communication apparatus <NUM> may be included in the component layer <NUM> and connected to the microchip <NUM> via electrical connections <NUM> as shown in <FIG>. The communication apparatus transfers the information stored in the microchip, to a computing device <NUM> for manipulation by the computer application.

The communication apparatus may be may be provided in the label with or without including the indicator <NUM> in the label. More specifically, the label can include one or both of the indicator <NUM> and the communication apparatus <NUM>, such that the label may communicate the status of the product. If the communication apparatus is included in the label, then the status of the product may be assessed using the computing device and computer application.

The communication apparatus of the present subject matter is not particularly limited, and in one embodiment includes a high frequency ("HF", ISO standard <NUM>, ISO/IEC <NUM> Type A & B), radio frequency identification ("RFID") component, an ultra-high frequency ("UHF", EPC Class <NUM> Gen <NUM>, ISO/IEC <NUM>-<NUM>) RFID component, a Bluetooth component, a Bluetooth low energy (BLE, Bluetooth <NUM>) component, or a wireless local area network (WLAN & Wi-Fi) component that is configured to wirelessly communicating the recorded information to a separate computing device <NUM>. Such wireless platform may be supported by the microchip <NUM> or an additional wireless microchip & antenna system connected to the microchip <NUM>. In one aspect, the radio frequency identification component comprises a near field communication apparatus (i.e. NFC tag).

In open commercial environments, an end user, or any other person along the chain of distribution for the product, can use an NFC enabled device to interrogate the NFC electronic tag in label, in order to receive a variety of useful content and information.

Typically, interrogation is performed by "tapping" the NFC tag using an NFC mobile device such as a smart phone. General content which can be delivered to the mobile device includes the information relating to the product that is recorded on the microchip. Often, other unique identifying information associated with the product is stored on the microchip besides the recorded data, such as information associated with the manufactured product including a batch number, serial number or the like. This information can be used for a variety of logistical or regulatory uses. This information is referred to herein as "item variable data" ("IVD") and can be captured digitally, for example with the use of a vision system and electronically stored in a database as a reference to the specific product.

The recorded information will be manipulated by the computer application and displayed on the mobile device, along with the identifying information relating to the product.

NFC is a set of short range wireless communication technologies, typically requiring a distance of <NUM> or less between the NFC enable device and the NFC tag. NFC operates at <NUM> on ISO/IEC <NUM>-<NUM> air interface and at rates ranging from <NUM> kbit/s to <NUM> kbit/s. NFC involves an initiator device and a target device. The initiator actively generates an RF field that can power a passive target. This enables NFC targets to take very simple forms, such as labels, stickers, key fobs, or cards that do not require batteries. NFC peer-to-peer communication is possible, provided both devices are powered.

NFC tags can access data and are typically read-only, but may be rewriteable. They can be custom encoded by their manufacturers or can use the specifications provided by the NFC Forum, an industry association charged with promoting the technology and setting key standards. The NFC Forum defines four types of tags that provide different communication speeds and capabilities in terms of configurability, memory, security, data retention and write endurance. Tags currently offer between <NUM> and <NUM>,<NUM> bytes of memory.

As with proximity card technology, near-field communication uses magnetic induction between two loop antennas located within the near field of each of the initiator and the target devices, effectively forming an air-core transformer. Near-field communication operates within the globally available and unlicensed radio frequency ISM band of <NUM>. Most of the RF energy is concentrated in the allowed ±<NUM> bandwidth range, but the full spectral envelope may be as wide as about <NUM> when using ASK modulation. Supported data rates include <NUM>, <NUM> or <NUM> kbit/s (the bit rate <NUM> kbit/s is not compliant with the standard ISO/IEC <NUM>).

There are two modes for NFC. In a passive communication mode, the initiator device provides a carrier field and the target device answers by modulating the existing field. In this mode, the target device may draw its operating power from the initiator-provided electromagnetic field, thus making the target device a transponder. In an active communication mode; both initiator and target device communicate by alternately generating their own fields. A device deactivates its RF field while it is waiting for data. In this mode, both devices typically have power supplies. As described herein, the present subject matter typically involves an NFC-enabled (or HF-enabled) device as an initiator, and an unpowered NFC tag incorporated into the label, which is attached to a product, and/or on related packaging as a target. Hence communication occurs via a passive mode, wherein the communication apparatus <NUM> is not required to be powered by the power source <NUM>. However, the present subject matter also includes systems using an active communication mode wherein the communication apparatus <NUM> is powered by the power source <NUM> and controlled by the microchip <NUM>. In several embodiments, the embedded microchip <NUM> supports all NFC-enabled devices and NFC standards, including the ISO14443A and ISO15693 standards.

In certain embodiments of the present subject matter, a system as described herein is provided for products, or items using labels having NFC communication capabilities. Generally, one or more NFC-enabled tags are incorporated into the laminated label <NUM> and affixed to a product or packaging for the product. In many embodiments of the present subject matter, upon interrogation of an NFC tag by an NFC computing device, information recorded on the microchip is communicated to the NFC computing device for manipulation by the computer application. The manipulated information is then displayed on the computing device to indicate if the time-temperature threshold has been exceeded.

In other embodiments, the NFC function of the label <NUM> is able to provide information to the NFC computing device related to the authenticity of the product, such as information that the product is from a particular manufacturer or distributor. Further, the NFC function of the label may also provide marketing information relating to the product that is contained in the package having a label <NUM>, or marketing or identifying information relating to the manufacturer or distributor of the product.

In certain embodiments, a database or other record retention means on one or more central computers <NUM> is updated upon an NFC computing device or other high frequency-enabled device interrogating the NFC tag in the laminated label. In a particular embodiment of the present subject matter, the NFC tag also transmits a directing Uniform Resource Locator (URL) or other information to the mobile device. Upon communication between the mobile device <NUM> and the database in the central computer <NUM>, information regarding the product is transferred from the device <NUM> to the central computer <NUM>, and the database is updated. Record(s) of the transfer and/or update are optionally established.

In yet another example of documenting a series of important events there are supply systems, such as food, that require monitoring in order to assure that critical practices during the chain of events are conducted and documented. The use of NFC can enable the creation of a trail of events, such as taking temperature of frozen food shipping containers, or by uploading an interaction between a mobile device and a database established for tracking events. Time and date stamps occurring during the interrogation of the NFC tag along with the user's device identification can be used as an assessment of proper handling. Once the information, along with the time date and user ID is uploaded to the database, such information represents a permanent and unalterable record of a product's history in a supply chain. Further, unlike passive devices that record and store time and temperature information for uploading at the completion of the journey, the mobile device can require that the user input a personal ID code or other secure information that provides active accountability that the proper actions were taken.

There are currently systems that utilize bar codes, and in some cases RFID devices, to track physical items such as is used by the US Postal Service. The readers used for this kind of service are usually special purpose readers that are provided to employees authorized to scan items and record such things as time and date. Although satisfactory in certain aspects, a need remains for a more flexible and user-friendly tracking system.

The present subject matter enables a broader set of users to interact with objects or documents of interest. In the case of pharmaceuticals for example, it would be impractical and/or expensive for a manufacturer to issue special readers to all distributors, doctors, patients, and others involved in the delivery and use of the product. By using near field communications, anyone with an HF-enabled mobile phone can interrogate the label, thereby reducing the complexity of the reading device.

In certain embodiments, when interrogated by an enabled phone, such as a smart phone for example, an NFC tag in the label uploads a specialized directing URL (Uniform Resource Locator or web address) to the phone. As known, the URL is a specific character string which can be recognized by a web browser program. The connection is established through conventional and known mobile telecommunications network(s) to a secure database. In addition, information about the specific phone being used, its location, time/date, and additional information may optionally be passed along to the site of the URL establishing a record of the point of contact in the database of the central computer. By using electronic signature technology, such as is available from companies such as DocuSign, a secure linkage can be created between the record contained in a secure database and the product which cannot be stored in a secure electronic database.

Bar code technology could potentially be used as the directing instruction for the mobile phone. This can be accomplished by QR codes for example. The use of bar codes requires that the code be visually acceptable to the phone. However, in many instances, due to lighting or other environmental conditions, the codes may not be effectively read. NFC does not require that any environmental conditions be met and therefore can be more effective. And because the only necessary condition of use is that the mobile device be in close proximity to the NFC tag, it can be quicker and easier to use and offers an improvement to bar code technology. In many circumstances, bar code technology may be an appropriate directing instruction but lacks some of the memory storage and other capabilities of electronic NFC technology.

Exemplary embodiments utilizing data transfer may allow for the transmission of data from a device, such as a radio frequency identification (RFID) tag or other device capable of transmitting data, for example utilizing near field communication (NFC), such as a NFC RFID tag. In some further exemplary embodiments, a computing device, which may be a mobile phone, a smart phone, tablet, PC or other device with a scanner or reader, may be capable of reading a NFC RFID tag, collecting information and data from the microchip, through the NFC RFID tag, and to a user of the mobile device executing the computer application, Further, the computer application can redirect a user to a particular server, database, website, or software application.

In several embodiments, the label <NUM> of the present subject matter may include one or more indicators for communicating information regarding the status of the product. The indicator may be provided in the label with or, in a non-claimed embodiment, without including the communication apparatus <NUM> in the label. More specifically, the label as claimed includes both of the indicator <NUM> and the communication apparatus <NUM>, such that the label may communicate the status of the product. As the indicator is included in the label, the status of the product may be assessed by simply looking at the indicator on the label.

The indicators can be in the component layer, such as indicator <NUM>, or on the facestock layer, such as indicator <NUM> shown in <FIG>. The one or more indicators provide visual indication regarding the status of the product. The indication can be permanent visual indication, or dynamic visual indication. By permanent visual indication, it is meant a visible display that once actuated to a secondary status does not revert to the initial status unless the indicator is reset. In one embodiment, the initial status of the indicator comprises an acceptable product indication, comprising an indication that the time-temperature threshold of the product has not been exceeded and that the product is suitable for its intended use. Further, the secondary status of the indicator comprises an unacceptable product indication by displaying that the time-temperature threshold of the product has been exceeded. By the term "dynamic visual indication," it is meant a visual display that shows the current status of the associated product and changes when the current status of the product changes. In one embodiment, the current status of the product comprises the current temperature of the product, wherein the dynamic visual indication shows the current temperature of the product and changes as the current temperature changes.

Permanent visual indication can include light emitting diodes that are turned on or off to indicate the status of the associated product. Dynamic visual indication can include thermochromic or electrochromic ink that provides or indicates a current temperature of the associated product. One or both of these types of indicators can be incorporated on the face stock, or can be incorporated in the label such that they are visible through the face stock.

The one or more indicators that may be included in the label provide a convenient visual reference indicating the status, including the current status, of the associated product. For example, when the permanent visual indication of the indicator <NUM> is not actuated to a secondary status (i.e. displays an initial status), then it can be easily determined by looking at the label that the associated product is acceptable for use. Also, by referencing the dynamic visual indication of the indicator <NUM>, the current temperature of the associated product can easily be determined. When the permanent visual indication has been actuated to a secondary state, wherein an unacceptable product indication is triggered, it can be determined that the time-temperature threshold of the product has been exceeded and the product can be rejected. As previously mentioned and in one embodiment, the indicator can be reverted from the secondary status (unacceptable product indication) back to the initial status (acceptable product indication), for example by manually triggering a switch or other component on the label, or by communicating a command to the microchip to accomplish the same. Further, the microchip may be programmed to limit the number of time the indicator can be reverted between the initial status and the secondary status.

In one embodiment, the label can provide other visual, audible, tactile, or other sensory indication regarding the status of the product in combination with the visual indication. In one example, the label provides an audible beeping sound to indicate that the time-temperature threshold of the product has been exceeded.

The indicator <NUM> on the facestock can comprise thermochromic or electrochromic ink, dye, or pigment for indicating the current temperature of the associated product, i.e. dynamic visual indication of the status of the product. Thermochromic inks, pigments, or dyes are temperature sensitive compounds that change color in response to a change in temperature. The indicator <NUM> can comprise more than one thermochromic ink, dye, or pigment, such that changes to the temperature of the product through various temperature ranges can be indicated. Electrochromic inks are inks that reversibly change color in response to an electrical charge being applied to the ink. Other types of indicators can be used for the indicator <NUM> on the facestock.

The indicator <NUM> in the component layer <NUM> can comprise a flexible or a rigid light emitting diode ("LED") or liquid crystal display ("LCD") underneath or positioned directly below the window <NUM> in the face stock <NUM> such that the LCD or LED indicator <NUM> is visible through the window <NUM> in face stock, from the front <NUM> of the label <NUM>. The indicator <NUM> included in the component layer <NUM>, can provide the permanent visual indication through a change in color or opacity of the indicator <NUM>. In one embodiment, the indicator comprises a flexible component. One such flexible indicator is an LCD electronic skin, available from Kent Displays, Inc, <NUM> Portage Blvd, Kent, Ohio <NUM>, USA. The LCD electronic skins are thin (approximately <NUM> microns) and flexible for incorporation into a flexible label in accordance with the present subject matter, and can maintain either the initial status or the secondary status as the visual indication without power from the power source. This particular type of LCD is known as a bi-stable, or reflex LCD. Reflex, or bi-stable LCDs can display both a bright reflecting state and a dark non-reflecting state without requiring power to maintain the states, and can thereby indefinitely retain a displayed image without requiring power. Only a minimal amount of power is required to change the displayed image, for example when changing between the acceptable product indication and the unacceptable product indication. Other types of indicators can be used for indicator <NUM>. In one embodiment, the indicator <NUM> comprises a flexible component. One such flexible indicator is an electrochromic display, including the poly(<NUM>,<NUM>-ethylenedioxythiophene) poly(styrenesulfonate) (PEDOT:PSS) conductive polymers, available from Acreo Swedish ICT AB, Box <NUM>, Norrkoping, SE-<NUM><NUM>, Sweden. In another embodiment, the indicator comprises a rigid, i.e. non-flexible, component as the indicator. Alternatively or additionally, the indicator <NUM> includes a thermochromic material, such as thermochromic inks, films, coatings or thermal paper, in single or multiple layers, that overlays a conductive material, such as metal foils (including aluminum foils and copper foils) or conductive inks (including silver inks and carbon inks), and the conductive material can act as a resistive heating element that induces the color change for the indicator <NUM>. The indicator <NUM> may also include an electrochromic material, such as electrochromic inks, films, coatings, or displays, in single or multiple layers, that may include layers of conductive materials, transparent electrodes, and electrolytes in addition to or as an alternative to the poly(<NUM>,<NUM>-ethylenedioxythiophene) poly(styrenesulfonate) (PEDOT:PSS) for inducing the color changes for the indicator <NUM>.

The indicator <NUM> may display the secondary status when a time-temperature threshold of the product has been exceeded, when the battery is low on power, when the sensors are faulty, or when certain amount of time has been exceeded. The indicator may be reset to the initial status a limited or unlimited number or times, by using a press-button on the label or by communicating such a command to the microchip using the computing device, for example. Other means to reset the display of the indicator to the initial status may be used.

The label also includes a power source <NUM> to power the various components of the label. In one embodiment, the power source is configured to provide power for operating the microchip <NUM>, the indicator <NUM>, and in one aspect, the communication apparatus <NUM>, and the electrochromic or thermochromic ink <NUM> included on the face stock <NUM>. In one embodiment, the power source <NUM> is capable of powering the label <NUM> and the associated functions thereof for at least <NUM> years of active operation, including the functions of temperature sensing, time-temperature data logging and computation, and visual indication.

The power source is not particularly limited, and can include a battery, a photovoltaic cell, or other suitable power source for powering the microchip, the indicator, and optionally the communication apparatus for peer-to-peer NFC communication. In one aspect, the power source is a battery, either a one-time use battery, or a rechargeable battery. The power source can comprise a flexible component, such as a flexible battery. For example, the power source can comprise a flexible printed battery having a thickness of about <NUM> microns, available from Blue Spark Technologies, <NUM> Sharon Drive, Suite G, Westlake Ohio <NUM> USA. In this embodiment, the flexible battery is included with other flexible or rigid components and layers to comprise a flexible label, such that the label can be applied to various substrates having contoured surfaces. The power source can also include a RFID induce power source, such as a magnetic coupling and backscatter power source. In another embodiment, the power source can comprise a rigid, i.e. non-flexible, component which can be included with other flexible or rigid components and layers to comprise a label.

If the laminated label is intended to be reusable and reconfigured for different types of products, the power source can be a rechargeable battery or photovoltaic cell, such that the battery can be recharged or reused for a different product after an initial use of the label.

In one embodiment, the laminated label is actuatable either before or after being applied to a product or associated packaging. In other words, the power source is initially not providing power to the various components of the label, but upon actuation, delivers power for operating the components. An electrical connection between the power source and one of the microchip, the communication apparatus, and the indicators can be made upon actuation of the label. Actuation of the label when desired, ensures that power provided by the power source is conserved until the label is actuated for use. In this embodiment, the lifespan of the label is extended because the power in the battery is not being drained before the label is applied to a product.

In one embodiment, the power source <NUM> may be physically connected to the various components of the label device by one or more electronic circuits, through which the power source provides power to the one or more components (e.g. the microchip <NUM>, the communication apparatus <NUM>, and the indicator <NUM>). In one aspect, the embedded electronic circuitry includes a non-conductive strip separator or a press-switch, or other circuit interrupting mechanism that can be used to selectively connect and/or disconnect the power source from the various components of the label. In this way, power stored in the power source can be conserved by using the press-switch or non-conductive strip separator to selectively connect or disconnect the power source to the various label components as desired. For example, the press-switch or non-conductive strip separator can be used to disconnect the power source from the various components of the label when the label is not being used. In this example, the various components of the label will be prevented from drawing power from the power source when disconnected therefrom, such that electrical leakage from the power source will be prevented or minimized. When it is desired to use the label, the press-switch or non-conductive strip separator can be used to connect the power source to the various components of the label for powering the components.

In one embodiment, the power source and various components are physically connected or disconnected by the embedded electronic circuitry of the label through manually depressing the press-switch or by removing a non-conductive strip separator from the circuitry.

In one embodiment, and as depicted in <FIG>, the label <NUM> includes one or more adhesive layers <NUM>. The adhesive layers are used to laminate the various components and layers together to form the laminated label, and the bottom adhesive layer is used to adhere the label to a substrate, such as to the product or to packaging for the product.

The label includes adhesive layers, such as depicted in <FIG>, between various layers of the laminated label in order to hold the laminated layers together. As shown in <FIG>, three adhesive layers <NUM> are included in the laminated label, two of which are used to laminate the various layers of the label together, and the bottom adhesive layer configured to adhere the label to a substrate. The adhesive layer at the bottom <NUM> of the label <NUM> is used primarily for attaching the laminated label to a product or associated packaging. For clarity, <FIG> only shows this bottom adhesive layer and omits the other adhesive layers used to laminate the components and layers of the label together. The laminated label can include more or less adhesive layers as that depicted in <FIG> and <FIG>.

The adhesives used in the one or more adhesive layers <NUM> of the laminated label are not particularly limited and can include various pressure sensitive adhesives, drying adhesives, contact adhesives, hot melt adhesives, reactive adhesives, or the like including combinations thereof. In one embodiment, the various adhesive layers of the laminated label comprise pressure sensitive adhesive (PSA). In one aspect, the label comprises a pressure sensitive adhesive label, capable of being applied to a substrate simply by pressing the bottom adhesive layer against a substrate. The PSA is not particularly limited and can include a variety of polymers; for example, acrylic and methacrylic ester homo- or copolymers, butyl rubber-based systems, silicones, nitriles, styrene block copolymers, ethylene-vinyl acetate, urethanes, vinyl esters and amides, olefin copolymer materials, natural or synthetic rubbers, and the like. Other adhesives can be used; such as a polyurethane adhesive, a rubber adhesive, or the like.

The adhesive is not particularly limited as long as the adhesive is capable of sufficiently laminating together the various layers and components of the label and sufficiently adhering the label to a substrate. In one embodiment, the adhesive used is a flexible adhesive so as to maintain the flexibility of the laminated label.

The label may also include a release liner <NUM>. In one embodiment, the release liner is a single- or multi-layer film material that is applied to cover the bottom adhesive layer, for protecting the bottom adhesive layer from premature exposure to contaminants or from being adhered to a substrate before intended. In one embodiment as depicted in <FIG>, the release liner covers the bottom adhesive layer, which is used to adhere the label to a substrate. The release liner can be removed from the laminated label in order to expose the bottom most adhesive layer, whereby the bottom adhesive layer can be placed in contact with the product or associated packaging and adhered thereto.

The release liner is not particularly limited and can include any material capable of being applied to and removed from the bottom adhesive layer without degrading the bottom adhesive layer, and inhibiting bonding of the label to a substrate. The release liner can include one or more additives or coatings to enhance certain attributes of the release liner, such as silicone or Teflon coatings to decrease bonding with the adhesive layer.

The time-temperature tracking and indicator system of the present subject matter may also include a computer application that is executable on a computing device and may be configured to manipulate the information stored in the microchip. The information stored in the microchip is communicated to the computing device by the communication apparatus, and is manipulated by the computer application by performing one or more operations or calculations on the information.

The computer application, and the operations performed by the computer application are not particularly limited. The operations can include one or more processes performed on the information, such that the manipulated information effectively communicates relevant facts relating to the suitability of the product for its intended use. The operations performed by the computer application can include those described herein as capable of being performed by the microchip.

The operations can include compiling the information, converting the information to a different format such as graphs or symbols, mathematical operations performed on the information, sequencing the information, arranging the information, statistical analysis of the information, generating an icon based on the information, and the like, along with combinations thereof.

The computer application is configured to be executable on the computing device <NUM>, and is configured to cause the computing device to output useful data relating to the suitability of the product for its intended use. Output of useful data is not particularly limited and can comprise a printed document, a computer display on a computing device, or any other means that effectively communicated whether the time-temperature threshold of the product has been exceeded.

In one embodiment, the computer application is also configured to control the computing device to provide a visual, audible, or other sensory indication or combination thereof, relating to the status of the product.

A manufacturer or distributor of the product can provide a proprietary or common computer application to the computing device by download through the internet so that the computing device can access the recorded information in the microchip. Further in this aspect, the computer application can be revised at any point in time, to provide updates to the application. For example, the application can be updated to provide a different recommended temperature or time-temperature threshold for the product, even after the product has been shipped.

The computer application can be configured to provide one or more alerts via the computing device. The alerts can be output by the computing device to an end user of the product. In one aspect, the alert is provided when one or more of the following is satisfied:.

The alerts can comprise, for example, notification that it is time to take or consume the product (e.g. to take a medication), that the package or product is at room temperature (e.g. above an upper temperature threshold), or that it is time perform a task associated with the product (e.g. that it is time to monitor blood glucose levels in the event the product is diabetes medication).

In one embodiment, such as that depicted in <FIG>, the computer application can also include a function for communicating manipulated information from a plurality of computing devices <NUM> to a database stored on one or more central computing devices <NUM>. In this embodiment, the various computing devices <NUM> that communicate directly with individual labels <NUM> via communication channels <NUM>, can in turn communicate with a central computing device <NUM> via communication channels <NUM> to update or contribute to a database of information associated with the product. Thereby, the central computing device <NUM> can compile all of the information associated with all of the labels <NUM> into the database and can compile a universal report associated with all the labels <NUM>. In this embodiment, all the information associated with a particular lot of manufactured product can be compiled in one database and analyzed for various purposes. This could be beneficial for example, to manufacturers who are trying to streamline their delivery system for a product, or to manufacturers who are collecting data on the transportation, delivery, or use of their product.

In a further embodiment, it is envisioned that a collection of individual labels <NUM> can work together as a temperature mapping network that each of the individual label <NUM> nodes can measure data in evenly or non-evenly time separations apart from one and other. The time separations can increase the overall data resolution recorded in the group of label <NUM> nodes in close proximity or distant spatial arrangements. For example, assume there are four label <NUM> nodes in a network, the 1st label will start the logging at time zero, and the 2nd label will start the logging at time = <NUM>, the 3rd label will start the logging at time = <NUM>, and the 4th label will start the logging at time = <NUM>, and all the labels will record one data point per hour; hence, the network will be able to provide the overall temperature measurement of data in every <NUM> minutes.

In accordance with the present subject matter, the system may include a computing device configured to wirelessly communicate with the label so as to access the information recorded in the microchip. The computing device of the present subject matter can include one or more computing devices. The one or more computing devices can include mobile devices, such as smart phones or the like, or proprietary devices such as label readers provided specifically to read a particular label from a particular manufacturer. In one embodiment, the computing device has NFC capabilities, such that passing the computing device in proximity to the label, or vice versa, allows the computing device to communicate with the label and access the information stored in the computer chip. In one embodiment, the computing device comprises one or more mobile phones equipped as NFC-enabled devices. It will be understood that in accordance with the present subject matter, the computing device can scan one or more labels and the system can include one or more computing devices, as shown in <FIG>. In another embodiment, the computing device may have UHF RFID capabilities, wherein the computing device may have an antenna/reader for more distant communication with the label than that provided in NFC enabled devices. Further the UHF RFID enabled device may be able to communicate with multiple labels in rapid succession, for example by reading labels at approximately <NUM> seconds/label.

The computing device is configured to execute the computer application, and can thereby communicate with the label having a communication apparatus, and thereby access the information recorded and stored in microchip. The information received from the label is then manipulated by the executed application on the computing device. The computing device can then display the manipulated information, or other data, for analysis as to whether the product is suited for its intended use.

In one embodiment, and based on the manipulated information, the computing device displays an indication on the status of the associated product. That is, the display indicates if the product is suited for its intended purpose and if the time-temperature threshold of the product has been exceeded.

The computing device of the present subject matter is not limited to mobile devices and can comprise any device that is capable of the function of executing the computer application, the function of communicating with the laminated label(s), and the function of displaying output of the computer application as the status of the product. In this regard, the computing device can comprise more than one computing device, wherein each function, or portion thereof, is performed by one or more separate computing devices.

In one embodiment, a mobile device communicates with one or more central computing devices, such that the manipulated information, or unmanipulated information, is transmitted for updating a database associated with the product, as depicted in <FIG>. The database of information can, for example, be accessible to the manufacturer or distributor of the product, or to anyone (including end users) who is provided access to the database. All the information related to the product can thereby be compiled and assessed to determine the current or historical status of the product. This can assist the manufacturer, for example, to streamline transportation, improve manufacturing of the product, or improve instructions on how to handle or use the product.

In yet another embodiment, it is also envisioned that the computing device may add variable information to the microchip <NUM>, or add variable information by covert, overt or both forms of printing on the facestock <NUM> of the label <NUM>.

In accordance with the present subject matter, the product having a time-temperature threshold may be included in various types of packaging for shipping, advertising, protection, identification, and the like. The packaging of the present subject matter is not particularly limited. In accordance with the present subject matter, the packaging for the product can include a bottle, a box, an envelope, or other type of container or combination thereof. It is also contemplated that the packaging does not need to fully surround the product, and can simply include a tag attached to the product.

In one embodiment, as depicted in <FIG>, the packaging <NUM> includes both an outer portion <NUM>, e.g. a box, and an inner portion <NUM>, e.g. a bottle. In such circumstances, or in various other circumstances, the laminated label <NUM> can include a label system comprising two or more labels.

A first label <NUM> can be attached to the outer portion <NUM> of the packaging <NUM>, and/or the inner portion <NUM> of the packaging <NUM> as shown in the top half of <FIG>. In another aspect, the first laminated label <NUM> can be attached to the outer portion <NUM> of the packaging, while a second laminated label <NUM> can be attached to the inner portion <NUM> of the packaging. In the bottom half of <FIG>, the first laminated label <NUM> is secured to the box, while the second laminated label <NUM> is secured to the bottle.

One or more of the first <NUM> and second <NUM> labels can communicate <NUM> via communication channels with the computing device <NUM> having the computer application being executed thereon. The computing device <NUM> can communicate <NUM> with one or more of the first <NUM> or second <NUM> labels and displays the output <NUM> of the computer application on the screen of the computing device <NUM> for indicating the current status of the product.

In one embodiment in accordance with the present subject matter, the first label <NUM> includes a communication apparatus for communicating <NUM> with the computing device <NUM>. This first label is referred to herein as a "smart label" such that the label can transmit information to the computing device for manipulation by the computer application. The second communication label <NUM> does not communicate with the computing device <NUM>. In this aspect, the second label does not comprise a communication apparatus, and simply provides an indication comprising whether the time-temperature threshold of the product has been exceeded.

This label system configuration may be useful where a plurality of inner packages <NUM> are placed in a single outer package <NUM> for shipment, wherein the product is first separated into a plurality of bottles (i.e. inner packages <NUM>) and then the plurality of bottles are placed into a box (i.e. outer package <NUM>) for shipment. In such circumstances, the first label <NUM> is able to communicate the information associated with the product on behalf of the more than one inner package <NUM>. Accordingly, in some regards to cost or other considerations, it may not be desirable for the label on the inner packages <NUM> to include a communication apparatus, such that a communication apparatus in the second label is not necessary for indicating if the product's time-temperature threshold has been exceeded.

An exemplary life cycle of a product, in a method of use in association with the time-temperature tracking and indicating system of the present subject matter, is depicted in <FIG>. In the exemplary life cycle <NUM>, the product is manufactured <NUM> at a production facility and packaged <NUM> and labeled <NUM> by attaching a laminated label <NUM> to the packaging <NUM> for the product; to either or both of the inner packaging <NUM> or the outer packaging <NUM>. The label is activated <NUM>, in order that the battery powers the various components of the label, such that the information relating to the product can be tracked, recorded, and communicated. The label <NUM> can be activated <NUM> either before or after being attached <NUM> to the packaging <NUM> for the product. In one aspect, the label may be activated by pulling an activation tab, or by pressing a button on the label, for example.

The life cycle <NUM> also includes transporting <NUM> the product, and delivering <NUM> the product to a retailer or other distributor. After delivery <NUM>, the product can be maintained for a period of time by the retailer in the original packaging <NUM> having the label <NUM>, or can distributed <NUM> to an end user.

The status of the product can be monitored <NUM> by either the retailer or the end user at any stage, as shown. It will be understood that monitoring <NUM> the status of the product can include communication <NUM> between the label and a computing device that is executing the computer application, and/or can include simply looking at the label to determine if the visual indicator shows that the time-temperature threshold of the product has been exceeded. It will be understood that when the label includes the communication apparatus <NUM>, that the current status of the product may be assessed by communication between the label and the computing device. It will also be understood that when the label includes the indicator <NUM>, that the current status of the product may be assessed by looking at the indicator on the label. In one embodiment, the label includes the communication apparatus and does not include the indicator. In another embodiment, label includes the indicator and does not include the communication apparatus. In still another embodiment, the label includes both of the communication apparatus and the indicator.

Where the label includes the communication apparatus, monitoring <NUM> may include scanning <NUM> the smart label <NUM> on the outer packaging <NUM> and either accepting <NUM> or rejecting <NUM> the product. If the output <NUM> of the computer application displays an unsuitable product indication <NUM> on the computing device <NUM>, the product will be rejected <NUM> because the time-temperature threshold of the product has been exceeded. If the output <NUM> of the computer application displays a suitable product indication <NUM> on the computing device <NUM>, the product will be accepted <NUM> because the time-temperature threshold of the product has not been exceeded. The product may then be stored <NUM> in a proper environment, such as a refrigerator for example, in order to prevent or inhibit the time-temperature threshold of the product from being exceeded. When desired, the product may be removed from storage and consumed or used <NUM>, as long as the label <NUM> on the inner packaging <NUM> displays an acceptable product indication <NUM> by the indicator, showing that the time-temperature threshold of the product has not been exceeded.

It is envisioned that the communication apparatus may also allow device-to-device communications between the individual and groups of label <NUM> to form a wireless sensor network (WSN) by wireless personal area network (WPAN) technologies, such as ZigBee and IEEE standard <NUM>. <NUM>, which the WSN includes the proximity sensing for applications in vehicular automation.

During transport <NUM>, delivery <NUM>, distribution <NUM>, and storing <NUM>, it will be understood that the product may be stored in an environment such that the time-temperature threshold of the product will not be exceeded.

In another exemplary embodiment, the life cycle of a pharmaceutical product, in a method of use in association with the time-temperature tracking and indicating system of the present subject matter is depicted in <FIG>. The pharmaceutical product has a time-temperature threshold, comprising for example, an upper temperature threshold of <NUM> and an upper temperature time threshold of <NUM> days. In other words, if the product is exposed to a temperature above <NUM> for a cumulative period of time greater than <NUM> days, the product will be unsuitable for use by an end user. The present subject matter is not limited to such time-temperature thresholds but can include other temperature thresholds, other time thresholds, and other conventions used for the time-temperature threshold as desired for a specific product.

In the exemplary life cycle as depicted in <FIG>, the product is manufactured <NUM> at a production facility and packaged <NUM> into one or more packaging components <NUM>, <NUM>. The packaging includes for example a bottle and a box, into which the bottle is inserted. Thereafter, a laminated label <NUM> is activated <NUM> and applied <NUM> to the outer portion <NUM> of the packaging, i.e. the box.

It will be understood that in accordance with the present subject matter, the label can be applied also to the bottle, or directly to the product. The label is then monitored <NUM> at various stages during the life cycle <NUM>, and such monitoring is accomplished by scanning the label with a computing device <NUM> to communicate <NUM> with the label <NUM>, and by visually monitoring the indicator <NUM> on the label. In this embodiment, the pharmaceutical medication is transported <NUM> and scanned <NUM> with the computing device <NUM> for data collection at each step of the transportation process.

The data communicated <NUM> from the labels to the computing device can be transmitted <NUM> to a database, for example a database on a central computing device <NUM>, in order to compile a report <NUM> on the product or lot of the product. The product is then transported <NUM> for either wholesale distribution <NUM> or for pharmaceutical distribution <NUM>, and monitored <NUM> (including scanning <NUM>) with a computing device. The product can be delivered to an end user by doctor administration <NUM> or prescription, or directly <NUM> from the wholesale distribution to the end user. The end user then receives the product and can monitor <NUM>, <NUM> the status of the product by accessing information stored within the label <NUM> through a computing device <NUM>, and by assessing the visual indicator <NUM> on the label. The pharmaceutical can be used or consumed as recommended, as long as the indicator <NUM> on the label has an acceptable product indication <NUM>, or the computing device <NUM> displays a suitable product indication <NUM>.

In this aspect, the end user can also receive alerts <NUM> after a time interval as previously described, communicated from the microchip to the computing device of the end user. These alerts can include an indication when it is time to consume or use the product, when the product is not measuring at the recommended <NUM> temperature, or an indication that a certain task should be performed in relation to the medication, for example, instructions for an end user to track glucose levels.

<FIG> also depicts that during the life cycle <NUM>, the product is exposed to environmental conditions which are tracked and recorded <NUM>. When the exposure does not exceed the time-temperature threshold of the product, the indicator <NUM> on the label <NUM> will be in an initial status and display an acceptable product indication <NUM>. When the threshold is exceeded <NUM>, such that the product has been exposed to temperatures over <NUM> for more than <NUM> days, the indicator <NUM> on the label <NUM> will be actuated to a secondary status and display an unacceptable product indication <NUM>. Further, by scanning <NUM> the label with a computing device <NUM>, the computing device will indicate an unsuitable product indication <NUM> as the output <NUM> of the computer application. The scanned information can be communication to a database, for example a database on a central computing device <NUM>, where the data will be collected <NUM> and compiled into a report <NUM> on the production lot.

If the product is exposed to time and temperature variables that do not exceed the time-temperature threshold, as the label includes an indicator <NUM>, then the label may visually indicate that the product is acceptable for use. If the time-temperature threshold has been exceeded, the label will visually indicate that the product is unacceptable for use.

As the label includes a communication apparatus <NUM>, the label may be configured to communicate the recorded information to the computing device, thereby indicating that the product is unsuitable for use. The computing device will display the output of the computer application as a visual indication to the end user that the product should not be consumed or used for its intended purpose. During each stage of monitoring, the information communicated to the computing devices can be thereafter transferred to a central computing device, which can be accessible by the manufacturer in order to prepare a report on the production lot of the product. Such means of communication between the individual computing devices and the central computing device of the manufacturer are depicted in <FIG> by communication channels <NUM>.

Among the applications in which the label <NUM> may be used include in military uses that the visual indicator <NUM> can provide health and life signs or friend-enemy identifications; as a data-carrier sticker device, including functions similar to the flash memory; as an add-on and removable NFC-enable senor label for smartphones; in surveillance and intelligent labels; as behavior monitor labels, including the use as driving data loggers/monitors for behavior-based insurance programs; as behavior/condition monitors for rental services, including the on-demand, short term or peer-to-peer rentals of cars and bikes; in multiple sensors configurations, including the sensors to improve the reliability of modality for medical imaging; in waste management; in vendor management, including the uses as sensors for plastic pellets tank level and the trigger mechanism for re-orders at the vendor end; and as detectable sensors for autonomous driving.

Many other benefits will no doubt become apparent from future application and development of this technology.

Claim 1:
A time-temperature tracking and indicator label (<NUM>) for a product having a time-temperature threshold, the label (<NUM>) consisting of:
a facestock (<NUM>),
a microchip (<NUM>) configured to store information associated with the product including at least one of time data and temperature data associated with the product,
a communication apparatus (<NUM>) configured to wirelessly communicate the information stored in the microchip (<NUM>) to a computing device (<NUM>),
an indicator (<NUM>) configured to provide a visual indication that the time-temperature threshold of the product has been exceeded, and
a power source (<NUM>) for powering the microchip (<NUM>), the indicator (<NUM>) , and the communication apparatus (<NUM>);
wherein the label (<NUM>) is configured to be attached to at least one of the product and packaging for the product,
wherein the facestock (<NUM>), the microchip (<NUM>), the communication apparatus (<NUM>), the indicator (<NUM>), and the power source (<NUM>) are in contact with an adhesive to form the label (<NUM>), the label (<NUM>) being a laminated label.