Title of Invention

INTERACTIVE SMART PACKAGE-ASSOCIATED DEVICE FOR ANTI-COUNTERFEIT AND COMPLIANCE MEASURES

Abstract The present invention relates to a smart system comprising product package with signal generating means and chip along with an associated device that facilitates detection of the presence or absence of product/s in the package. The signal generating mean is disposed in the package such that removal of product/s from the package generate signal and / or alter the signal detected by a signal sensing means in the said associated device. This synergistic combination of the product package with signal generating means and an associated device facilitates detection of presence / absence of product in the package. Further, the interactive smart package and the associated device ensures user registration and identification, authentication & registration of the package, user interactive capabilities for real time feed back to and / or by the user and/or with an integrated system connecting various user entities to ensure effective and secured user compliance measures.
Full Text FORM - 2
THE PATENTS ACT, 1970
(39 OF 1970)
PROVISIONAL SPECIFICATION
(See Section 10)
TITLE OF INVENTION
"Interactive Smart Package - Associated Device for anti-counterfeit and
compliance measures "
(a) Bilcare Limited (b) a company registered under the companies Act 1956 and (c) having its registered office at 1026, Shiroli, Rajgurunagar, Khed, Pune -410505, India
The following specification describes the nature of the invention.

Field of the Invention
The present invention relates to a smart system comprising product package with signal generating means and an associated device that facilitates detection of the presence or absence of product/s in the package.
The interactive smart package and the associated device further ensures user registration and identification, authentication & registration of the package, user interactive capabilities for real time feed back to and /or by the user and/or with an integrated system connecting various user entities to ensure effective and secured user compliance measures.
Background of the invention
Counterfeiting is a growing social menace plaguing markets globally. Tracking the authenticity of packages and the products is of immediate relevance. It is reported that counterfeiting and sale of spurious products continue to grow at 5-7% (US $ 250-350 billion) of world trade. It may be noted that during 1990 -1995 world trade grew by 47% whereas counterfeits grew by 150% (Briefing on Counterfeiting, AIM® Paper 1999).Consumers must be empowered with easy means of detection of counterfeit packages / products, and further enable and ensure the consumer to achieve the desired product compliance. Present day options available to the consumer are by way of prescriptions, or information provided in the product package. It is common for the user to rely on his memory with regard to the product dosage, usage frequency etc in the absence of any user-interactive system. Some of the desirables of a full proof system are:
• Establishing authenticity of the product vis-a-vis information about its manufacturer, date of manufacture, date of expiry, etc;
• Product information and instructions for its effective use,
• Prescription and dosage instructions, its recommended consumption frequency, and relevant precautionary measures as applicable;
• Recording product usage history for follow-up and support services
• Real time professional support when required.
Several initiatives by way of security labels on the product or packaging, holographic markers on unit product package, unique colored unit product package, color changing inks, multi color printing etc have already been employed but there are no systems that ensure full- proof authentication.
Further, it is desirable to make real-time professional help available to the user using systems, which automatically capture real-time product usage and user feedback data. For follow and professional support, such real-time user related feedback is of importance to the manufacturers and/or researchers of a product that is under consumer / clinical trials to arrive at better understanding the
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product features and functions especially in terms of their effectiveness, side effects, claimed efficacy of the medication, etc.
Several efforts have been made in the past to achieve some of the above-mentioned features.
US patent no. 6961285 discloses a drug delivery management system to guide users / patients to take their medication and to assist third parties to collect information with regard to the patient medication intake. The system includes a portable medication monitor used in association with an instrumented medication package to provide intake data acquisition and patient support functions. The system may further be connected to a computer or computer network allowing information distribution between the medication monitor and third parties, such as physicians or pharmacists. This prior art details a monitoring system more specifically for use in medication monitoring, which has medication packaged in a specific blister format and the said blister having capability of monitoring access to medication and relaying it to a separate monitor. The system is not capable of authenticating the packaged medication product nor is it capable of capturing user-feedback on real-time basis with respect to his / her observations, indications and feelings on the consumed product, etc.
US patent no. 5412372 discloses a portable medication dispenser aid which monitors dispensing times including regimen-conforming use of medications provided in standard as-marketed blister packages. A standard blister package and a separate, disposable sensor sheet are loaded onto a compact housing containing supervisory electronics, visual indicators, and an audible alarm. The sensor sheet consists of electrical or optical sensing regions corresponding to each individual compartment of the blister package. An electrically conductive or optical connector in the dispenser housing allows periodic scanning of the sensor sheet circuitry by the control circuitry in the dispenser housing without adding connector components to disposable sensor sheet. When a medication is ejected through the backing layer of the standard blister package, an electrical or optical parameter associated with a corresponding region of the sensor sheet is altered, thereby permitting the control circuitry to monitor the dispensing event. Stored patient compliance data may then be reported remotely through an optical or electrical interface between the dispenser and an external system for review by the pharmacist/physician. The system addresses the issue of reminding the user of when to take a medication from a specific unit dose package containing the medication but is not capable of authenticating the product, capturing user interaction and feedback. The system is specific to a type of package and lacks the desired flexibility for use in diverse types of packages containing different types, forms, sizes and shapes of medication.
US patent nos. 6839304 and 6411567 describe a drug delivery management system for managing delivery of pharmaceutical drugs from a blister package that includes a plurality of cells arranged in a grid. Each of the cells is sealed by a
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breakable wall and holds a unit-dose of medication. A user gains access to the medication in a given cell by puncturing the breakable wall associated with the given cell. A severable conductor is positioned proximate to each breakable wall. The severable conductor associated with a given cell ruptures upon puncturing of the breakable wall associated with the given cell. A computer chip is electrically connected to the severable conductors. The computer chip senses the puncturing of each cell in the grid by monitoring the rupturing of each of the severable conductors. An RF transmitter is coupled to the computer chip. The RF transmitter sends information corresponding to usage of each of medications stored in the blister package to a remote information transceiver. The system is specific to blister type packages. The key limitation results from the use of non-insulating layer to incorporate the severable conductors. As the non-insulating layer is in direct touch with the medication, it becomes imperative to get the material approved by the regulatory authorities prior to its use. The manufacturing process also gets complicated The system also is limited to and focused on user- compliance but lacks the aspects of capturing the much desired user interaction and feedback. Incorporating remote devices on the package for receiving and transmitting makes the pack unwieldy and unviable for commercial exploitation. The other limitation of this system is that it does not address authentication of the product package through a customized encoding which becomes unique for that specific package.
It may be noted that the drug delivery management systems disclosed above primarily focus on monitoring / tracking delivery / dosing of medication to patients and assisting patients to medical compliance. Further, sensing the presence/ absence of product in the package is not possible in the aforementioned devices. The construction of the packages disclosed in the prior art lack the provision of signal generation that facilitates to sense presence/absence of product in the package easily.
Indian patent application number 171/mum/2006 overcomes several weaknesses of the prior art and discloses package-companion-user interactive system wherein an array of signal generating means and signal sensing means are provided in the companion device to receive and reflect signals generated by the signal generating means to sense presence/absence of product in the package. In this system it is essential to provide an array of signal generating means in the companion device working in conjunction with signal sensing means. In this device the said plurality of generated signal (by the signal generating means) is reflected to sense the presence / absence of product in the package.
The present invention provides an interactive smart package- associated device that obviates the use of the array of signal generating and corresponding reflecting means as is disclosed in the Indian patent Application 171/MUM/2006 to detect presence / absence of product in the package and achieve the desirable features.
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Summary of the Invention

The main object of the invention is to provide a smart package- associated
device that obviates the use of the array of signal generating and corresponding sensing means to sense the said generated signal/s in the device.
Another object of the invention is to provide versatile product packages that would have inbuilt features that enable the detection of the presence / absence of products in the package via interactive working means with the associated device.
Yet another object of the invention is to provide a smart package capable of generating magnetic fields.
Yet another object of the invention is to provide a smart package capable of generating signals based on electrical and/or electromagnetic fields.
Yet another object of the invention is to provide a smart package capable of generating acoustic / sonic signals.
Another object of the invention is to provide an associated device that interacts with the smart package to detect presence / absence of product in the package.
Another object of the invention is to facilitate user interaction with the said associated device and package to provide user registration and identification, authentication & registration of the package, user interactive capabilities for real time feed back to and/or by the user.
Yet another object of the invention is to provide a smart package capable of generating electrical, electromagnetic, light, laser, video, image etc.
Thus in accordance with the invention the said system comprises of:
a smart package with a chip encoded with product information, and one or plurality of enclosures to contain product/s with means for accessing the said product/s, wherein the package has signal generating means to indicate the presence or absence of the said product/s;
an associated device comprising a housing with a package holding provision; one or plurality of sensor/s that can get activated to sense and process the said signals generated by the smart package. Further the associated device has a user interactive and/or user input means; powered time tracking means; data decoding means, data processing, data storage means so configured to register user, authenticate, register product package when housed / located in the said housing and optionally carry out transient data collection or communicate with
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and /or through an integrated system for collection / transmission / collation / archival / dissipation of transient data or user feed back or combinations thereof.
DETAILED DESCRIPTION OF THE INVENTION
Features and advantages of this invention will become apparent in the following detailed description and the preferred embodiments with reference to the accompanying drawings.
Figure 1 Schematic of the system and package (sheet 1)
Figure 2 Schematic of the carding system (sheet 2)
Figure 3 Schematic of the package with carding system and magnetic sheet
(Sheet 3)
Figure 4 Schematic of the package embodiments (sheet 4)
The system comprising associated device and the package is illustrated in Figure 1, Figure 1a and Figure 1b. The associated device comprises of a provision 5 formed between portion 1 and portion 2 to receive the product package 20. One or plurality of sensors 3 is provided in the portion 1 of the said associated device. The said sensors sense signals such as magnetic fields but not restricted to it generated by a signal generating means of the smart package when the product package is inserted in the provision 5. The product package comprises of one or plurality of enclosures to contain products with means for accessing the said products. One or plurality of the signal generating means is provided on the portion, preferably closure of the package such that removal of product/s from the package from one or plurality of its containment/s leads to the partial and / or complete removal, detachment, elimination, activation / deactivation of the signal generating means. When the product is present / absent in the package, the signal generated by the signal generating means is detected by the said sensor/s 3 to sense / indicate product presence / absence in the package. When the product is removed from the package, the enclosure is also removed / ruptured and / or activated / deactivated and hence the signal generating means.
One of the embodiments of package 20 is shown in the Figure 1 (a) and Figure 1 (b). The package comprises of first lamina /sheet in which one or plurality of enclosed spaces (receptacles) 21 are formed to contain the product(s); the means for accessing the product is in the form of second rupturable lamina (closure) 22 that encloses the said receptacle wherein portion of the enclosing lamina corresponding / superimposed to the receptacle portion is ruptured/ removed while removing the product. The said enclosing lamina is bonded / affixed / attached to the unformed portion of the first lamina to seal the products in the receptacle. When pressure is applied on the receptacle to remove the product contained in it, the portion of the rupturable closure of the second lamina deforms and breaks to let product out of the receptacle. A chip 24 affixed /
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embedded in/on the package. The said chip is pre-encoded offline or online during packaging of the said product with information such as manufacturer source, date, batch of manufacture and information regarding the product etc.
Figure 1 (a) shows front view and sectional side view (along section BB) of the package. As seen in the sectional side view, one or plurality of magnets 23 are positioned / affixed to the closure 22 corresponding to the product in the receptacle as shown in the figure. The said magnets generate signal in terms of magnetic field of particular strength (measured in Gauss). When the product in the receptacle is taken out, the closure is broken the corresponding magnet gets removed along with the closure resulting in absence of signal (magnetic) in the particular area of the removed product.
Figure 1 (b) shows another variant of the package. It shows front view and side view as seen from direction D. The closure 22 is provided with magnetic ink having specific strength on areas 25 corresponding to the product in the receptacle as shown in the Figure. The said magnetic inked areas generate signal in terms of magnetic field of particular strength (measured in Gauss). When the product in the receptacle is taken out, the closure is broken resulting in breakage and removal of the inked area resulting in absence of signal (magnetic) in the particular area of the removed product. The said sensor 3 in the associated device senses the magnetic field corresponding to each of the product in the package and sends signal to the processor. When the product is present in the package, the magnetic field will be detected / not detected by the hall sensor depending on the polarization pattern of the magnets. When the product is removed, the sensor will not detect / detect magnetic field, as no magnetic field is present. Thus presence/absence of the product in the package is sensed without using array of signal generating means by virtue of unique design of the product package that has capability of generating signal. In one of the variants of this embodiment the rupturable closure area is printed by magnetic ink. In yet other variants of this embodiment the said closure area is partially / completely coated with magnetic ink.
Yet another embodiment of the package is shown in Figure 2 illustrating carding of the package wherein the said package is walletized in the carding. It comprises of laminas 30 and 31. Openings / slots 32 are provided on lamina 30 according to the receptacle 33 on the package so that the said receptacles pass through the said openings when the said lamina 30 is placed on the package from the receptacle side. The lamina 31 is provided with perforated peelable portions 34 corresponding / superimposed to the said rupturable closures 35 of the package so that when the product in the package is removed, the perforated portion on the lamina corresponding to that product is also removed. In a variant of this embodiment multi-polar pre-magnetized sheet having south and north poles on the same side is used.
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In another embodiment the package is sandwiched between laminas 30 and 31 wherein magnets are positioned between closure of the package and lamina 31 of the carding corresponding to the rupturable closures of the package so that when the product in the package is removed, the said magnet is also removed along with the perforated portion on the lamina 31.
In yet another embodiment as shown in Figure 3 a uni-polar pre-magnetized sheet 36 of which one surface is a north pole and other is south pole with perforations 37, superimposed / corresponding to said rupturable closures 35 of the package is provided between the said lamina 31 and closure of the package along with the sheet 30 such that when the product in the package is removed, the portion of the said magnetic sheet is removed along with the perforated portion on the lamina 31. In yet another variant of this embodiment a nonmagnetic sheet is used that is further magnetized.
In another embodiment the said chip 24 is affixed/ embedded in the lamina 30 or 31 of the said carding.
In another embodiment uni-polar / multi-polar pre-magnetized plastoferrite or any materials capable of getting magnetized is incorporated into the package such that the removal of product/s from the package leads to the removal, detachment or elimination of the plastoferrite or other magnetized materials.
In one of the variants of this embodiment a uni-polar / multi-polar pre-magnetized plastoferrite or any materials capable of getting magnetized with perforations superimposed to the said rupturable closure of the package is affixed to the closure of the said package such that removal from the product from the receptacle breaks the said magnetized material.
In another embodiment a non-magnetized uni-polar / multi-polar plastoferrite or any materials capable of getting magnetized is incorporated into the package such that the removal of product/s from the package leads to the removal, detachment or elimination of the plastoferrite or other magnetized materials.
In one of the variants of this embodiment a non-magnetized uni-polar / multi polar plastoferrite or any materials capable of getting magnetized with perforations superimposed to the said rupturable closure of the package is affixed to the closure of the said package such that removal of the product from the receptacle breaks the said material.
Figure 4 illustrates yet another embodiment of the package with the signal
generating system. Figure 4(a) shows package comprising product
containment / holding cavity 40 in the form of a container and a closure 41. Temporary holding provision 42 for product is provided in the closure 41. When the said container 40 is tilted / shaken / pressed to remove the product from the container 40 for accession, the product from the container 40 comes / rests in the
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product entrapment provision 42. The signal is generated from this provision. When product occupies the said provision, there is a signal generation or elimination or change, which is sensed by the sensor/s 3 of the associated device. The dispensing provision 44 is provided in the closure 41 to dispense the product, which is present in the provision 42. The closure is provided with a means that appropriately fits in the associate device. The chip 45 is affixed to the package as shown. It may be provided on the product containment / holding cavity 40.
Figure 4(b) shows package comprising product containment / holding cavity 50 formed by flexible material 51 wherein part of the same material is sealed at location 52 to form a pouch. The dispensing system 53 comprises of product entrapment provision 55. The signal is generated from this provision based on presence / absence of the product in this provision. The closure is provided with a means that appropriately fits in the associate device. The product dispensing provision 56 is provided in connection with the passage 57. When the said pouch is tilted to access the product contained in cavity 50, product from the cavity comes to the entrapment provision 55. When product occupies the provision 55, there is a signal generation or elimination or change, which is sensed by the sensor/ 3 of the associated device. The chip 58 is affixed to the package as shown. It may be provided on 51.
In yet another embodiment the package comprises of product containment / holding cavity in the form of a container provided with open side to remove product and a means for accessing the product is in the form of closure fitting provision; a removable closure that is fitted on the said container.
In yet another embodiment the package comprises of product containment / holding cavity formed by flexible material wherein part of the same material is sealed to form a pouch and a means for accessing the product comprises of product entrapment and dispensing provision.
Decoder, processing unit, connectivity means, real time measuring means, power source, user input means, user interaction means, memory (not shown in figure) are configured in portion 2 of the device as shown in Figure 1. An activation means is provided to activate the Hall sensors according to the location of the receptacles of the product. Further display means is provided on portion 2. When the said package 20 is positioned in provision 5 in such a way that the pre-encoded chip 24 is in the vicinity or in contact of the decoder device(not shown), the decoding process of the encoded data in the said chip 24 gets initiated in and the decoded data is sent to the processing unit (not shown). The said decoded data is processed for authentication and appropriate message is displayed on the display means.
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In a preferred embodiment of the invention, the associated device contains Hall Sensors to sense the magnetic fields generated by the package when the package is introduced in the device.
In yet another embodiment electromagnetic system is provided on the package / carding to generate electromagnetic field that can be sensed by the sensors in the associated device.
In yet another embodiment package is provided with sonic signal generating means that is sensed by the sensors in the associated device.
In yet another embodiment package is provided with a means to generate signals in the form of electrical, , electromagnetic, light, mechanical, pressure, laser, video, measurement of capacitance, image, etc outputs.
In yet another embodiment the said associated device is provided with sensors to sense signals such as electrical, mechanical, pressure, electromagnetic, light, laser, video, image etc generated by the said signal generating means of the said package.
Thus it is evident from the present invention that the synergistic combination of the product package with a provision to generate signal magnetic field with the associated device with a provision to sense the generated signal by the package results in the technical effect of obviating the use of array of signal generating and corresponding sensing means to sense the said generated signal in the device to detect presence / absence of product in the package.

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Documents:

34-MUM-2007-ABSTRACT(12-3-2009).pdf

34-mum-2007-abstract(8-6-2007).pdf

34-mum-2007-abstract(granted)-(4-8-2010).pdf

34-mum-2007-annexture 1(12-3-2009).pdf

34-mum-2007-annexture 2(12-3-2009).pdf

34-MUM-2007-ANNEXURE 1 TO 2(12-3-2009).pdf

34-MUM-2007-ANNEXURE II(4-11-2008).pdf

34-MUM-2007-ANNEXURE III(4-11-2008).pdf

34-MUM-2007-CANCELLED PAGES(12-3-2009).pdf

34-mum-2007-cancelled pages(20-5-2009).pdf

34-MUM-2007-CLAIMS(12-3-2009).pdf

34-MUM-2007-CLAIMS(18-9-2008).pdf

34-MUM-2007-CLAIMS(4-11-2008).pdf

34-mum-2007-claims(8-6-2007).pdf

34-mum-2007-claims(amanded)-(12-3-2009).pdf

34-MUM-2007-CLAIMS(AMENEDE)-(20-5-2009).pdf

34-mum-2007-claims(granted)-(4-8-2010).pdf

34-mum-2007-correspondance-received.pdf

34-MUM-2007-CORRESPONDENCE(12-3-2009).pdf

34-MUM-2007-CORRESPONDENCE(18-9-2008).pdf

34-mum-2007-correspondence(2-4-2008).pdf

34-MUM-2007-CORRESPONDENCE(20-5-2009).pdf

34-MUM-2007-CORRESPONDENCE(4-11-2008).pdf

34-mum-2007-correspondence(5-1-2007).pdf

34-MUM-2007-CORRESPONDENCE(9-6-2009).pdf

34-mum-2007-correspondence(ipo)-(20-4-2009).pdf

34-mum-2007-correspondence(ipo)-(5-8-2010).pdf

34-mum-2007-correspondence1(20-5-2009).pdf

34-mum-2007-description (provisional).pdf

34-MUM-2007-DESCRIPTION(COMPLETE)-(12-3-2009).pdf

34-mum-2007-description(complete)-(8-6-2007).pdf

34-mum-2007-description(granted)-(4-8-2010).pdf

34-MUM-2007-DRAWING(12-3-2009).pdf

34-mum-2007-drawing(5-1-2007).pdf

34-mum-2007-drawing(8-6-2007).pdf

34-mum-2007-drawing(granted)-(4-8-2010).pdf

34-mum-2007-drawings.pdf

34-MUM-2007-EXAMINATION REPORT REPLY(12-3-2009).pdf

34-MUM-2007-FORM 1(12-3-2009).pdf

34-MUM-2007-FORM 1(20-5-2009).pdf

34-mum-2007-form 1(5-1-2007).pdf

34-mum-2007-form 13(6-7-2011).pdf

34-mum-2007-form 18(19-7-2007).pdf

34-mum-2007-form 2(12-3-2009).pdf

34-mum-2007-form 2(complete)-(8-6-2007).pdf

34-mum-2007-form 2(granted)-(4-8-2010).pdf

34-MUM-2007-FORM 2(TITLE PAGE)-(12-3-2009).pdf

34-MUM-2007-FORM 2(TITLE PAGE)-(20-5-2009).pdf

34-mum-2007-form 2(title page)-(complete)-(8-6-2007).pdf

34-mum-2007-form 2(title page)-(granted)-(4-8-2010).pdf

34-mum-2007-form 2(title page)-(provisional)-(5-1-2007).pdf

34-MUM-2007-FORM 3(12-3-2009).pdf

34-mum-2007-form 3(16-5-2007).pdf

34-MUM-2007-FORM 3(18-9-2008).pdf

34-mum-2007-form 3(31-3-2008).pdf

34-MUM-2007-FORM 3(4-11-2008).pdf

34-mum-2007-form 3(5-1-2007).pdf

34-mum-2007-form 3(8-6-2007).pdf

34-MUM-2007-FORM 3(9-6-2009).pdf

34-MUM-2007-FORM 5(12-3-2009).pdf

34-mum-2007-form 5(8-6-2007).pdf

34-mum-2007-form 9(19-7-2007).pdf

34-mum-2007-form-1.pdf

34-mum-2007-form-2.doc

34-mum-2007-form-2.pdf

34-mum-2007-form-26.pdf

34-mum-2007-form-3.pdf

34-MUM-2007-PCT POWER OF ATTORNEY(18-9-2008).pdf

34-MUM-2007-PCT(POWER OF ATTORNEY)-(18-9-2008).pdf

34-MUM-2007-PCT-IPEA-401(18-9-2008).pdf

34-MUM-2007-PCT-IPEA-401(4-11-2008).pdf

34-MUM-2007-PCT-IPEA-409(9-6-2009).pdf

34-MUM-2007-PCT-ISA-206(18-9-2008).pdf

34-MUM-2007-PCT-ISA-237(18-9-2008).pdf

34-MUM-2007-PCT-ISA-237(4-11-2008).pdf

34-mum-2007-petition under rule 137(2-4-2008).pdf

34-MUM-2007-POWER OF ATTORNEY(4-11-2008).pdf

abstract1.jpg


Patent Number 241985
Indian Patent Application Number 34/MUM/2007
PG Journal Number 32/2010
Publication Date 06-Aug-2010
Grant Date 04-Aug-2010
Date of Filing 05-Jan-2007
Name of Patentee BILCARE LIMITED
Applicant Address 307, NARAYAN PETH PUNE-411030
Inventors:
# Inventor's Name Inventor's Address
1 PRAFUL RAMACHANDRA NAIK C/O SHRI R.G.NAIK SANTRUPTI, PRABHAT NAGAR, VADAGERI, HONAVAR 581334
2 MOHAN HARAKCHAND BHANDARI Flat NO.604,Mantri Lawns, Anand Park,Anudh, Pune 411 008
PCT International Classification Number G09F3/02
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 NA