FORM -

THE PATENTS ACT, 1970
(39 OF 1970)
PROVISIONAL SPECIFICATION
(See Section 10)
TITLE OF INVENTION
"A multi-functional Package System"
(a) Bilcare Limited (b) a company registered under the companies Act 1956 and (c) having its office at 601 ICC Trade Tower, Pune 411 016, India
The following specification particularly describes the nature of the invention and the manner in which it is to be performed.

Field of the Invention
The present invention relates to an integrated package system comprising of a dispensing system coupled with a sensing / monitoring system, a product authentication means and a communication capability with external device^), wherein a signal is activated upon dispensing of a product / batch of products from the said package, thereby sensing and quantitatively recording the product removal from the package, transmitting and or transferring the product to an external device for product authentication, prompting the consumer to consume the product as per a prescribed plan, real time recording of the history of product dispensed from the package including user compliance performance. Further, rendering a compromised package as an unauthentic package.
Background of the Invention
Packaging of products influences product shelf-life, usage patterns by consumers, product safety etc. It is desirable to provide products in packages that not only facilitates easy product identification, authentication, dispensation but also has built-in features that help the consumer to achieve higher product compliance. Further it would be useful to capture real time product usage data automatically and integrate the same especially into a healthcare system so that online and off line assistance can be extended to the user as and when necessary.
Several efforts have been made in the past to provide packaging systems for medical dispensation to address the above-mentioned needs.
US Patent 7072738 discloses medicament dispenser comprising a refill container which is insertable in said medicament dispenser in order to perform dispensing from said refill container, said dispenser comprising: (a) a memory for storing one or more parameters relating to the functioning of said dispenser; (b) means for storing authentication data for authenticating data for controlling a function of said dispenser; (c) means, in said refill container, for receiving control data for said dispenser; (d) means, in said refill container, for performing authentication of the control data using said stored authentication data; (e) means for, in dependence on a result of the authentication, activating one or more parameters in said
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memory to control functioning of said dispenser in accordance with said control data characterized in that in use, said refill container stores said control data and following said authentication, and said control data is transferred from said refill container to said dispenser.
United States Patent 20060184271 discloses an automatic prescription pill dispensing unit using a cartridge in which prescription drugs are pre-loaded, preferably by a pharmacist, according to the user's medication regimen. This tamper-proof cartridge can only be unlocked by a pharmacist using a specially designed loading dock, or by inserting the cartridge into the user's dispensing unit.
A unit dose compliance monitoring and reporting device and system is disclosed in United States Patent 6973371. It includes a dispenser shell formed with dose compartments. A retainer sheet affixed to the shell seals each compartment and partially bursts upon dispensing. A sensor network and monitoring and reporting circuitry records dispensing times and determines an average time interval, which can be reported with other data on an integral data display. The system can thereby monitor and report patient compliance with prescription regimens.
United States Patent 20050030163 discloses a medicine dispenser. It comprises of dispensing device for dispensing medication including a habitually used mechanism for being used habitually by a patient and a medication dispensing mechanism for dispensing medication at the times of the use of the habitually used device.
A smart automatic medication dispenser is disclosed in United States Patent 5752621. The specific purpose of this computer controlled dispenser device is to provide a convenient vehicle and means by which properly proportioned medication doses are housed and automatically delivered to a patient in single complete doses. Contained within the dispenser device is the ability to dial out and receive telephone messages to inform health care personnel of the dispenser's status, usage and to change internal dispenser programs.
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A medication container-holding device indicating usage time is disclosed in United States Patent 5170380. It comprises of a holding device for medication containers of essentially any size or shape providing the patient information on with the last time the medicine was taken. The device includes a housing with a cylindrical cup shape opening with a micro switch member extending through an access opening into the cavity form one side of the opening. Individual positioning devices in the form of vertical open cylindrical tubes are sized to fit particular containers with the cylinders positioned proximate the switch member with an opening to allow the switch member to extend into the cylindrical bore opening. A bushing and interlocking tab index the position of each cylindrical tube in the correct position each time the positioning device is inserted into the base section of holding device. The sensor signals that a container is placed in the base, which is used to provide through numerical display the time the last medication was taken, the elapsed time since that dose and the number of times the medication was accessed in one day. A settable alarm is provided to alert the patient as to the next time to take the medicine.
US Patent no 5826217 discloses a Programmable Medicine Dispenser and Storage Device for allowing for user or physician programming of a medication administration schedule, alerting the user, by means of an audible alarm, of a scheduled medication administration time, opening a corresponding medication compartment upon user acknowledgment of the alarm and instructing the user on the proper method of taking the medication. The device includes a real time clock for generating real time signals, a keypad for setting each medication administration time, an acknowledgment key for generating an acknowledgment signal, a programmable controller for activating the alarm in response to the medication administration schedule when each medication administration time is the same as the real time signal and for processing the acknowledgment signal, and at least one medication compartment having a lower compartment and a lid hingedly and latchedly attached thereto, each medication compartment further having an unlatching mechanism for unlatching the lid from the lower compartment when each medication administration time corresponds to the real time signal and in response to the acknowledgment signal, the unlatching mechanism being connected to the programmable controller.
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A dispenser is disclosed in the international patent application number WO 2005/004786. The invention comprises of a storing area for storing the unit products, an outlet opening, a dispensing mechanism actuable to dispense unit product through the outlet opening and dispensing indicator integrated with dispenser such that it is automatically updated in response to the dispensing of the unit product.
European Patent EP1495746 discloses a medical dispenser, a blister card for use in the dispenser and a method of dispensing medical doses It is adapted to inform a user of when to take medication, detect when the user accesses the medication and inform the user of his/hers compliance to a medication schedule. The dispenser may inform the user with differing manners of informing (sound, light, vibration, higher of lower frequency or intensity) depending on the users compliance. Blister cards for use in the dispenser may be coded in order to inform the dispenser of a medication schedule, a desired compliance level, etc. The user may himself code the blister card. The dispenser may hold a blister card or may be adapted for providing medical doses for inhalation or injection.
European Patent EP1006982 discloses a medicament dispense sensing device to register the dispensing of medicaments comprising sensing devices located at the medicament side to detect the dispensing thereof. The device is comprised of a sheet-like envelope of a one-way material and being a continuous, foldable way adapted to enclose the medicaments. There is an electronic printed circuit applied on the envelope and is stretched over foldable areas of the sheet-like envelope. It is also operatively connected to the sensing devices and to an electronic unit
European Patent EP1389083 discloses a medicine dispenser. The invention relates to the art of dispensing medicine to a user of medicine, and relates in particular to a medicine dispenser for dispensing doses of medicaments, a loader for loading doses of medicine into the medicine dispenser, a medicine distribution box, a packing device for packing medicaments in predefined doses, a Central Medication Database and a system comprising all these objects. Furthermore, the invention relates to a method of dispensing doses of medicaments, a method of loading medicine into a medicine dispenser, a method of distributing medicine, a method of packing medicaments in predefined doses, a method of carrying out
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various aspects related to dispensing medicine as well as a method integrating all the above mentioned methods.
European Patent EP0855894 discloses a method for controlling a drug dispensing system. It is an automated drug dispensing system including, a cabinet adapted to store a variety of prepackaged pharmaceuticals in a plurality of bins for filling patient prescriptions. Each bin stores a particular variety of packaged multiple-dose pharmaceutical. Each variety of pharmaceutical is associated with a particular code. A controller receives request signals and in response generates dispense signals. Each bin includes a dispenser coupled to the controller for dispensing the packaged pharmaceuticals therefrom in response to a dispense signal sent from the controller. After a package is dispensed, a code reader determines the code of the dispensed package and verifies whether the code on the dispensed package matches the code of the requested package.
European Patent EP0656200 discloses an apparatus for dispensing medication. It comprises a medication dispenser for use in a hospital or other medical setting comprises a plurality of containers for holding medication units, packaging apparatus for containing one or more medication units in a package and robotics for manipulating a selected container to transfer one or more medication units from the container directly to said package. Since medication is directly transferred from the container to the package, no cross-contamination occurs
The study of the prior art reveals that there are no packages and / or devices that provide integrated solutions for product authentication, prompting the consumer to consume a product from the package as per a prescribed plan, sensing and quantitatively recording the product removal from the package, real time recording of the history of product dispensed from the package, and communicating the data to an external device which is a growing need. Further analysis of prior art indicates that there is no multi-functional package system that intimates the user of a compromise of the package rendering it non-authentic / tampered with.
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Summary of the Invention
The main object of the invention is to provide a package with a dispensing system that integrates the aspects of authentication, prompting the consumer to consume a product from the package as per a prescribed plan, real time recording of the history of product dispensed from the package, communicating / interacting with an external device, establishing and converting the package into a non-authentic package after the validity period / expiry period has elapsed or the package has been tampered with or after the entire contents of the package has been dispensed.
Another object of the invention is to provide a package system to authenticate the product and further sense, record and transmit real time product dispensing data from the package to an external device.
Yet another object of the invention is to provide a package that senses and records real time data of the product dispensed from the package.
Yet another object of the invention is to monitor product usage and to alert the user to take appropriate steps to procure replacement.
Yet another object of the invention is to establish and convert the package into a non-authentic package after the validity period / expiry period has elapsed or after the entire contents of the package has been dispensed
Yet another object of the invention is to establish and convert the package into a non-authentic package if the package is compromised or is not authenticated within a stipulated time after package activation.
Thus in accordance with the invention, the package system comprises:
a dispensing system with an optional product outlet provision;
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an operating system comprising data logging and storing means comprising optionally a data processing means, communication / interaction means;
a power source built-in or optionally induced;
non-accessible compartment for the said operating system;
a separate non-accessible product containment;
a means for authentication such as an encoded chip or a pattern or a random pattern or a marker or combinations thereof;
optional display / interactive means;
a sensing means that activates / deactivates upon dispensing of the product from the package;
means to establish connection of the power source with the said operating system;
wherein
the said operating system is configured with the sensing means and optionally with authentication means and is housed in the said compartment wherein the said compartment is operably connected with the said containment;
wherein
the said package is authenticated by an external device / system;
optionally prompting product consumption;
the said sensing means senses the product dispense, the said operating system records and transmits / communicates real time product dispense data via said interaction / communication means to an external device / system,
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rendering the package un-authentic in case of compromise / tampering.
Description of the Invention
Features and advantages of the invention will become apparent in the following
detailed description and the preferred embodiments with reference to the
accompanying drawings.
Figure 1 Schematic of the product package system (Sheet 1)
Figure 2 Product sensing means (Sheet 1)
Figure 3 Configuration of the package (Sheet 2)
Figure 4 Configuration of the package (Sheet 3)
Figure 5 Configuration of the package (Sheet 4)
Figure 6 Configuration of the package (Sheet 5)
Figure 1 is a schematic of one of the embodiments depicting various components of the package system wherein the package comprises of non-accessible product containment 1 with a product dispensing provision 5; non-accessible compartment 2 for operating system; product operating system 3 along with a communication means 4 included in the said package to communicate with an external device 50, a means for authentication such as an encoded chip or a pattern or a random pattern or a marker or combinations thereof (not shown).
The said product operating system 3 as illustrated in Figure 2 comprises of data processing means 10 with data logging and storing means configured with a communication means 4, an optional communication switch 17, a power source 12, a visual display such as LED 13, audio signal generating means 14, an oscillator 15. There is provided a product sensing means comprising signal generating provision 16 that gets activated upon dispensing of the product from the package and sends a signal to the said data processing means 10. The activation of the signal generating provision may be done by various means such as mechanical, optical, visual . In a specific embodiment, the said visual display 13 and the audio signal generating means 14 alerts the user of the time and date of the products to be consumed and also provides quantitative information about the number of products in the package. As the user dispenses the product a
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signal from the said signal generating provision 16 is sent to the said microcontroller 10 wherein the time & date of product dispensed is logged into the data logging provision of the said data processing means 10. Using the optional communication feature, the user may transfer the logged data to an external device by operating the communication switch 17.
In one of the embodiments said logged data in the said data processing 10 is transferred / transmitted via communication means 4 to an external device 50 with the aid of RF circuit wherein the said logged data to be transferred is superimposed on the RF field, generated by the RF circuit. In yet another variant of this embodiment the said logged data in the said data processing means 10 is transferred / transmitted via communication means 4 to the said external device 50 using an IR link wherein the said logged data to be transferred is in the form of coded pulses or frequency. In yet another variant of this embodiment the said logged data in the said data processing means 10 is transferred / transmitted via communication means 4 to the said companion device through wired and / or direct contact using protocols such as I2C, SPI, UART..
Various configurations of the dispensing provision integrated with the sensing system and their functional relation is illustrated hereunder using non-limiting examples.
A variant of the package is illustrated in Figure 3. The sectional view is depicted in Figure 3 (a) and 3 (b). The package comprises of non-accessible product containment 20 comprising product dispense region 22, spring 25, operating system 3 comprising an authentication means used for authentication, signal sensing means comprising signal generating provision 16, a movable element in the form of a reciprocable element 23 wherein the said operating system is housed in the same. The said product containment 20 is adapted to slide in the package body 26. The said product dispense region 22 reciprocates in the passage 27 formed in the said package body 26. The said reciprocable element 23 is in connection with the said containment 20 so as to transmit reciprocal movement of 23 to 20.
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When the said element 23 is pressed after unlocking (not shown), it moves downwards as indicated by arrow 100 which results in the downward movement of the said containment 20 (indicated by arrow 100) and in turn of the product dispense region 22 in the said passage 27 resulting in dispense of a product. During the downward movement of 20, the signal generating provision 16 that is in the form of an electromechanical switch is activated and the signal is sent to 3 indicating that the product is dispensed. Further the said sensing system 3 functions as mentioned above. When the said element 23 is released, 20 is regained to original position by virtue of spring 25. It is to be noted that the product sensing system 3 is completely isolated from the product in the said containment 20. The two distinct operations of unlocking and pressing the said element 23 offer child resistant and senior friendly aspect to the package.
Yet another variant of the package is illustrated in Figure 4. Front and top view of the package is depicted in the Figure 4. The package comprises of containment region 40 comprising a combination of tapered and profiled regions 41 wherein unit product is allowed to pass through the opening 42 in the desired orientation in the direction shown by the arrow 43, the said containment region is adapted to fit in the housing 45. The dispensing system comprises of a product magazine in the form of a rotatable wheel with profiled arms 46 in the radial direction shown in the top and front view wherein product (shown as 48) can accommodate between two arms. The said wheel is disposed below the said containment and in particular opening 42 such that unit product from the said opening 42 falls between the arms 46. The said wheel is fitted with a gear 47 that is engaged with another rotatable wheel 48. The wheel 48 is disposed in the said housing 45 such that it is operable by the user. The sensing means 3 is disposed in the housing 45 as shown in the figure.
The signal generating provision 16 is disposed in the passage 49 formed in the said housing 45 below the said wheel (having arms 46) such that the opening 52 of the passage coincides with the distance between two consecutive arms 46. In one of the variants the provision 16 is in the form of an optical switch. In yet another variant 16 is proximity switch. In operation, upon rotation of the said wheel 48 by the user, the gear 47 also rotates resulting in the rotation of the arms
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46 in the direction indicated by 50. This results in the displacement of the product 48 between the arms in the horizontal direction as indicated by the arrow in the figure. During the rotation, when the said two arms (and the product between the same) coincide with the opening 52, the product falls in the said passage 49 and the product dispense is sensed by the said provision 16. Slider means 53 is provided at the said opening 52 to avoid dispense of two products at a time.
Yet another variant of the package is illustrated in Figure 5. It comprises of substantially flat product containment region 55 provided with a opening 58, the dispensing system is in the form of a rotatable member 57 provided with atleast two radial profiled arms 59 disposed in the said containment as shown in the figure wherein a product 56 can be accommodated between two consecutive arms 59, the said rotatable member 57 is fitted with a cylinder 61 and a second rotatable wheel 63 that is operable by the user. The said cylinder 61 protrudes out of the body 55. The sensing means 3 is disposed above the said containment region 55. The said sensing means includes the signal generating means (not shown) disposed in the vicinity of the said opening 58. There is provided an optional display means 62 disposed above the sensing means closure. In operation, the user has to press the said cylinder 61 and further rotate the said wheel 63. This results in rotation of the said rotatable member 57 thereby rotating the arms 59 and the product therein. When the said product coincides with the opening 58, it gets dispensed in the passage 58. The dispensing of the product is sensed by the said signal generating means that is in the form of a proximity sensor. The sensing means further operates as described above.
Yet another embodiment of the package is depicted in Figure 6. The package comprises of a housing 65, containment portion 67, truncated profile region 66 so as to guide a product in the desired orientation to the dispense zone 70, dispensing system in the form of a partially rotatable element 69 that is operable by the user wherein the said element 69 is provided with an arm 73 that closes the said dispense zone 70, spring adapted to fit on the said element 69, locking lever 68 disposed on the housing and operable by the user, sensing means 3 provided with a signal generating provision 74 is adapted to fit on the said element 69 in the vicinity of the said dispense zone 70. During the operation, the user has
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to tilt the said package and unlock the said locking lever 68 first to partially rotate the said element 69 as shown in Figure 6 (b). Partial rotation of the element 69 results in displacing the product in the said dispensing zone 70 by one of the faces of the said member 69 to dispense the product. In operation, when the said rotatable element 69 is partially rotated to dispense the product in the zone 70, the said signal sensing generating provision 74 comes in proximity with the wall of the said housing as shown in Figure 6 (b) , senses the dispense of the said product.
The sensing means further operates as described above
In one of the embodiments the signal generating means is based on mechanical Trigger. In one of the variants of this embodiment the signal generating means is a lever switch. In another variant it is Micro Push Button. In yet another variant, it is a cam switch.
In one of the embodiments the signal generating means is based on Optical switch. In one of the variants of this embodiment the said signal generating means is Reflective LED _ Transistor. In another variant it is LDR ( Light Intensity ). In yet another variant it is Color. In yet another variant it is Optical Encoder that includes Circular Disc. In yet another variant it is Optical Encoder based on linear detection.
In one of the embodiments the signal generating means is based on Material Detection such as detecting Sugar Coating or Specific metal.
In another embodiment the signal generating means is a Pressure Sensor.
In another embodiment the signal generating means is based on Resistance measurement.
In yet another embodiment the signal generating means is an Accelerometer based on velocity Measurement.
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In another embodiment the said closure swivels around the said product
containment.
In yet another embodiment the closure comprises of a movable element that
activates the said product sensing system upon dispensing of the product from
the said containment.
In another embodiment the package comprises of containment adapted with the dispensing provision, product sensing system and data receiver / transmitter system.
In yet another embodiment a dispense system is used to dispense pills from the blister pack.
An interaction / communication from external device(s) that is capable of decoding the said encoded chip which writes over / erases the encoded data resulting in irreversible non-authentication of the said chip leading to recognition of the package as non-authentic package after the validity period / expiry period has elapsed or after the entire contents of the package has been dispensed.
An interaction / communication from external device(s) that is capable of decoding the said encoded chip which writes over / erases the encoded data resulting in exclusive registration of the said package with the said external device / system and rendering it incapable of registration with any other external device / system.
A means by which an external device writes over / erases the encoded data in the chip optionally through the said operating system resulting in irreversible non-authentication of the said chip leading to recognition of the package as non-authentic package if the time elapsed in the said timer device in the said package is beyond a stipulated time as defined in the external device thereby safeguarding / intimating the user of pilferage of the said package.
In one of the embodiments the package is rendered as un-authenticated by measuring time difference between the said connection of the power source with
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the said operating system and package authentication is more than a stipulated time as defined in the external device / system.
In yet another embodiment there is provided an irreversible means to establish connection of the power source with the said operating system. In one of the variants of this embodiment the irreversible means is a removable non conducting separator between the power source and the operating system wherein the said separator gets removed at the time of first dispense of the product. In yet another variant of this embodiment the power source is hosed in an irreversible snap fit arrangement which on the first act of dispensation gets irreversibly locked to bring power source in contact with the operating system.
In yet another embodiment the said package is provided with a means configured with the said microcontroller 10 to measure physical property / properties of the said package and compute relative difference between the same to estimate product replenishment time / status of the said package. In one of the variants of this embodiment, the said physical property is weight of the said package.
It is evident that the present invention provides a multifunctional package system that not only overcomes all the problems in related prior art but also provides an integrated package system that integrates the aspects of:
• authentication,
. prompting the consumer to consume a product from the package as per a
prescribed plan, . real time recording of the history of product dispensed from the package, . communicating / interacting with an external device,
• establishing and converting the package into a non-authentic package after
the validity period / expiry period has elapsed or the package h as been
tampered with or after the entire contents of the package has been
dispensed.
The above technical effects are achieved by tailored coupling of the dispensing
system, product sensing system, data processing system and communicating /
interacting with an external device / system.

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