THE PATENTS ACT, 1970
PROVISIONAL SPECIFICATION
Section 10
"A Secured Memory Device"


Span Biotronics Private Limited, an Indian company, of Appt 2, VATIKA, 14 Baptista Road,
Vile Parle (West), Mumbai - 400056, India.
The following specification particularly describes the nature of this invention:


A SECURED MEMORY DEVICE
Field of the Invention
The present invention relates to memory devices, and more specifically to a secured memory device to validate/qualify and debit the consumables/chemicals used in the product depending on the quantity of usage and/or type of usage of instrument. The invention can be used in various applications, such as automated chemical analyzer, blood analyzer, diagnostics tester, and in general any application where value of service can be counted on each usage of instrument or type of usage of instrument.
Background of the Invention
FIGURE 1 and 2 illustrate a conventional technique utilizing barcode or 2D code for labeling containers for consumables/chemicals used in diagnostics analyzers. A barcode or 2D code reader is included in the instrument to identify the consumable/chemical. Often, such barcodes or 2D codes are used to ensure that only consumables/chemicals of a matching/specific pattern can be used in the analytic/diagnostics instrument. Such barcodes or 2D codes have the following disadvantages: Firstly, duplication of barcodes or 2D codes is easily possible and allows counterfeit consumables/chemicals to be labeled with copied codes. Secondly, "Top up" of used containers of consumables/chemicals is easily feasible such that an end-user can "refill" the empty containers with counterfeit consumables/chemicals. Additionally, competitor companies are free to produce counterfeit consumables/chemicals. The usage of counterfeit consumables/chemicals not only leads to revenue loss to the original manufacturer who spent a lot of money in R & D but also risks the quality of analysis resulted by the use of counterfeit consumables/chemicals in diagnostics/analytics.
Therefore, there is a need of a system to restrict usage of counterfeits. This need is met by the present invention by incorporating a secured memory device to validate/qualify
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and debit the consumables/chemicals used in the product. When such a device is used, it will force the end-users to stop use of counterfeit consumables/chemicals.
Summary of the Invention
It is an embodiment of the present invention to provide a secured memory device to recharge the instruments. This will help to reduce/eliminate usage of counterfeit consumables/chemicals in diagnostics/analytics and to discourage end-users from using counterfeit consumables/chemicals. The core of the invention is usage of secured memory device and readers which are plugged in to the instruments to protect the usage of the instruments. The invention enables instrument manufacturers to monitor the usage and recharge the equipment. This will reduce loss of revenue due to counterfeit consumables/chemicals supplied by competitors. The invention includes a master card, a personalization system, a user card, a card reader, and an instrument incorporating micro¬controller, measurement unit and consumables. The system also includes a firmware. The firmware encrypts the information and communicates with the secured memory device which makes the device more secure.
Brief Description of Drawings
The aforementioned aspects and other features of the present invention will be explained in the following description, taken in conjunction with the accompanying drawings, wherein:
FIGURE 1 illustrates a conventional barcode for labeling containers for consumables/ chemicals used in diagnostics analyzers.
FIGURE 2 illustrates another conventional 2D labels used for labeling containers for consumables/chemicals used in diagnostics analyzers.
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FIGURE 3 illustrates a block diagram of a system utilizing a secured memory device according to an embodiment of the present invention and secure information.
FIGURE 4 illustrates a flow diagram of a method of operation according to an exemplary embodiment of the present invention.
Detailed Description of the Invention
The embodiments of the present invention will be described in detail with reference to the accompanying drawings. However, the present invention is not limited to the embodiments. The present invention can be modified in various forms. The embodiments of the present invention are only provided to explain more clearly the present invention to the ordinarily skilled in the art of the present invention. In the accompanying drawings, like reference numerals are used to indicate like components.
FIGURE 3 illustrates a block diagram of a system according to an embodiment of the present invention. The instrument sold to end-user has a secured memory device incorporated in diagnostics/analytical products to validate/qualify and debit the consumables/chemicals used in the product depending on the quantity of usage and/or type of usage. A secured memory device will be used to recharge the instrument consumables. The core of the invention is usage of secured memory device and readers which are plugged in to the instruments to protect the usage of the instruments. The

The secured memory device can be a smart card, I C card, a memory card, a memory chip or any other secured memory device. Secured memory uses secure passwords or keys which makes secured memory device non-replicatable. To explain the present invention a
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concept of smart card has been depicted although other forms of memory devices can also be used.
The user card (item is a secured memory device which contains a security
system and tamper-resistant properties capable of providing security. They use passwords/keys and cryptography to protect data stored in the memory. These secured memory devices provide a means of effecting a transaction in a secure way with minimal human intervention.
The master card (item is similar to the secured memory device and includes master key for activating the personalization system making the personalization process secure. Just like the secured memory device, a master card could also be replaced by any other form of memory device. Personalization of master card is similar to personalization of user card. The master card could be completely eliminated and the master keys could instead be entered via software or manually or otherwise.
The personalization system (item personalizes a "blank" user card to configure personalized user card to make it ready for use in an application. The personalization system organizes and enables optimum utilization of the memory in the secured memory device. Personalization also loads the user card with encrypted master key. Loading of allowable consumable count/value is also considered part of personalization.
The card reader (item includes a device which has been loaded with firmware which has encrypted master key to authenticate the secured memory device and the instrument. The reader has an encryption key for encrypting communication with the instrument and user card. The card reader reads and writes information on the secured memory device after authentication.
The card reader may be permanently incorporated in the instrument (item or could be a detachable item. The instrument includes a microcontroller (item a measurement unit (item and may need some consumables/chemicals (item The instrument also
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includes a firmware loaded on the instrument microcontroller (item ®). The firmware interfaces with the secured memory device via reader and employs secured mechanism to allow the debit of a counter on the secured memory device based on the instrument usage. The firmware encrypts the information and communicates with reader. The firmware enables use of secured passwords or keys to authenticate the instrument, reader as well as the secured memory device hence making the entire system very secure.
The measuring unit (item ®) is the main functional unit of the diagnostic/analytical instrument needed to perform desired analysis or measurement on the sample-under-test. Usually, some consumables are needed to perform measurement or analysis on sample-under-test. However, it is possible to perform measurement without requiring any consumable.
The consumables/chemicals (item are items which are consumed for performing analytical or measuring function by the instrument. The present invention is to reduce usage of counterfeit consumables/chemicals. The method of operation is described below.
FIGURE 4 illustrates a flow diagram of a method of operation according to an exemplary embodiment of the present invention. Consider an instrument having a secured memory reader module either integrated in the design or as a detachable module having an interface. When any consumable/chemical for the instrument is supplied, it would be accompanied with a pre-loaded secured memory device having the product details along with the equivalent counts of the consumable/chemicals. The memory device is a secured memory device and the keys used for authentication and encryption process are injected by instrument manufacturer through memory device personalization software.
Before analysis/measurement on sample-under-test starts, the instrument checks availability of secured memory device. If the secured memory device is found absent, the analysis/measurement function is disabled. If a secured memory device is present, the instrument authenticates the reader and the secured memory device. If the reader and
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memory device are authentic, instrument checks available balance on the secured memory device. If balance is available, analysis/measurement can be performed on the sample-under-test by the instrument. After the analysis is completed, depending on the quantity or type of analysis performed, instrument will subtract the count or value from the secured memory device depending on the instrument product family. Instrument will also update additional details on the card, such as usage history.
If no balance is available before instrument use starts, analysis/measurement cannot be allowed. However, other functions of the instrument can be used.
This way, when the product is in use, the equivalent counts (equal to the number of times an operation is performed or the type of operation performed) decrements from the counter stored in the secured memory based on the consumption ration. When the count reaches an empty or zero level, it gets necessary to either top up the secured memory device or replace the secured memory device with a new one pre-loaded with a specific count to continue to utilize the instrument for analytical purposes. Since the memory device is secured, neither duplication nor tampering of the device is possible. Thus, the end-user has to revert to the instrument manufacturer or its authorized partners to purchase authentic consumables as well as secured memory device. This protects business of the instrument manufacturer. In certain instruments, where no consumables are needed for analysis or where authentic consumables/chemicals are available from partners of instrument manufacturer, the instrument manufacturer may allow purchase of secured memory device only without purchasing the consumables. This depends on the business case.
The secured memory device can be transferred from a Unit A to Unit B provided it belongs to the same product family. The secured memory device may or may not be transferable across the product families. If transferable, instrument specific identification and other information are stored in the secured memory device.
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The embodiment of the invention is related to a. system and method utilizing a secured memory device and can be used in various applications, such as automated chemical analyzer, blood analyzer, diagnostics tester, and in general any application where value of service can be counted on each usage or type of usage of instrument. .
The advantages of the system are that this discourages the end-user from using counterfeit consumables/chemicals. It is necessary to use a secured memory device to validate/quality and debit the consumables/chemicals used in the instrument. Without a valid secured memory device, the instrument cannot be used for analysis/measurement. Such a device also helps in providing integrated solutions from original instrument manufacturers resulting in better analytical performance which affect the quality of results in diagnostics/analytics.
The technology is also simple to use and understand. The secured memory device needs to be incorporated in the instrument and can be forgotten about until the value/count stored in the secured memory device becomes zero. At a lower minimum balance, the instrument warns the end-user about low balance hence giving enough notice to the end-user to "refill" or replace the secured memory device. By default, the secured memory device can not be reused. However, recycling of devices wherein reloading of a new value is possible.
Although the disclosure of system and method has been described in connection with the embodiment of the present invention illustrated in the accompanying drawings, it is not limited thereto. It will be apparent to those skilled in the art that various substitutions, modifications and changes may be made thereto without departing from the scope and spirit of the disclosure.
Dated this 16th day of July 2008


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of Anand and Anand, Advocates Attorney for the Applicants