FORM - 2
THE PATENTS ACT, 1970
(39 OF 1970)
PROVISIONAL SPECIFICATION
(See Section 10)
TITLE OF INVENTION
"Restricted Product Access 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 a child access restricted / child safe packaged-product system. The invention further relates to child resistant closures for packaged-product.
Background of the invention
Products such as medicaments are primarily but not exclusively packaged in blister packs comprising one or plurality of deformable protrusions formed in a flexible sheet with a closure for each of the protrusions. An area of concern with regard to blister packs has been the uncontrolled ease with which products can be dispensed. This becomes particularly important when blister packs are handled by children and / or physically challenged. . Further, establishing the authenticity and genuineness of a packaged product before use is essential as counterfeited products when consumed can cause grave harm to the patients.
Various attempts to achieve the above objectives are reported in literature
United States Patent 7201274 discloses a package having a simultaneous stop, alignment, and enhanced tamper-resistant feature, wherein the package has an outer sleeve and a slide card slidably disposed within the outer sleeve. A stop panel is disposed on an inside surface of the outer sleeve and has an extension panel extending away therefrom, wherein the extension panel enhances the tamper-resistant nature of the package. A guide panel extends along a longitudinal edge of the outer sleeve and has a length equal to or greater than a combined length of the stop panel and extension panel. The guide panel being folded over the extension panel to defined a channel between an edge of the guide panel and a score line separating first and second panels of the outer sleeve.
United States Patent 7325689 discloses a pharmaceutical package assembly that includes a tether having a fold-over card mating feature, and a fold-over card configured to house one or more pharmaceutical blisters, wherein the fold-over card includes a tether mating feature. One exemplary method of coupling the fold-over card to a tether includes forming a tether receiving recess in the front side of

the fold-over card, folding the front side of the fold-over card adjacent to the back side of the fold-over card so that the tether receiving recess reveals an exposed portion of the fold-over card front side, and coupling the tether to the revealed portion of the card front side. Another exemplary method of coupling a fold-over card to a tether having a front side and a back side includes forming a fold-over card receiving recess in the tether such that when the front side of the tether is folded adjacent to the back side of the tether, the fold-over card receiving recess reveals an exposed portion of the tether, and coupling the fold-over card to the revealed portion of the tether.
United States Patent 7188728 discloses a child-resistant senior-friendly blister card packaging that is cheap and easy to manufacture. The packaging requires a push-peel-push method for opening, which is cognitively and physically challenging for children and mentally impaired adults. Yet, competent adults can easily open the package, especially after reading instructions. More specifically, opening the package requires the user to: 1) Push through a aperture to create a pull tab; 2) Pull on the pull tab to remove a panel; and 3) Push the blister to force the contents through the blister's seal. Advantageously, the present invention is designed such that information such as instructions and product information can be easily printed directly on the packaging. Moreover, users may also record information directly on the packaging. Thus, the present invention not only provides child-resistant and senior-friendly features, but also provides convenience for viewing and recording information.
The need is felt to develop a child-safe package system / closure in the form of closure/s and/ or package configuration such that combination capability in terms of removable engagement of package with the closure such that combination capability is necessary to disengage and remove the said package from the closure to access the product in the package, in particular blister package along with the capability of uniquely identifying the package using external device / means.

Summary of the Invention
The main object of the invention is to provide a uniquely identifiable child-safe package system such that combination capability is necessary to access the product in the package.
Another object of the invention is to provide a package system with a child safe closure to a product package such that combination capability is necessary to access the package and thereby product in the package.
Another object of the invention is to provide a uniquely identifiable package for the child-safe package system.
Yet another object of the invention is to provide a uniquely identifiable package such that combination capability is necessary to access the product from the package.
Yet another object of the invention is to provide means on the package for providing effective solution to anti-counterfeiting.
Yet another object of the invention is to provide unique identifying information on the product package and / or closure.
Yet another object of the invention is to provide at least two sets of identification information on the product package.
Another object of the invention is to detect and record access of the product package from the closure.
Thus one aspect of the invention provides a system comprising: a closure means provided with engaging member/s / provision adapted to removably receive and engage package wherein combination of multiple operations is necessary to access the product by disengaging the package from

the said closure; package with a provision to removably receive the said engaging member/s.
In another aspect of the invention the said package is provided with identification information to uniquely identify the package.
In another aspect of the invention the said package comprises of sheet with deformable protrusion/s formed; closure for the said sheet; combination of sheets with openings disposed such that combination capability is necessary to access the product from the said package.
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 package system (Sheet 1)
Figure 2 Configuration of the system (Sheet 2)
Figure 3 Configuration of the system (Sheet 3)
Figure 4 Configuration of the system (Sheet 4)
Figure 1 depicts one of the embodiments of the package system. It comprises of a closure means comprising at least two flexible sheets 1, 2. The portion of the sheet near edges 3 is substantially flat wherein the two sheets are hinged / attached at one of the edges 4. The sheets are disposed over each other so as to form a cavity because of the respective protrusions 5 and 6 in the first and second sheet to receive the product package 7.. The first sheet 1 comprises of a pin like provision 8 provided on the deformed surface. The second sheet 2 comprises of a provision 9 provided corresponding to the said pin like provision of the same first sheet to removably receive the said pin like provision. The said package is provided with openings 10 and 11 corresponding to the said pin like provisions. The second sheet further is provided with support 10 for the product package 7. Grooves 12 and 13 are provided on both the sheets so as to provide

grip for holding the system. The disposition of the said sheets is such that when the sheets are placed over each other with the product package placed in the cavity between the said sheets, the said pin like provision of the first sheet engages with the said counterpart 9 on the sheet 2. To access the package, one has to press (apply pressure) the two sheets at the said grooves from the edges inwards so that the pressure results in bulging of the said sheets resulting in disengaging the said provisions and further facilitating access to the product package by moving (rotating) the said first sheet around the said hinged edge 4.
Figure 2 depicts another embodiment of the invention. The package system comprises of first sheet 1 provided with supporting ribs 2 , 3 as shown in the Figure. The second sheet 4 is the top cover, it comprises of two engaging members in the form of pegs indicated in the figure as 5, 6 on the inner surface. The package is provided with slots 7, 8 corresponding to the said pegs 5, 6. The profile of the slots is a combination of a straight slot parallel to one of the edges and an inclined slot corresponding to the said pegs 5, 6. The pegs lock the package, that: restrictsmovement of the package. To access the package one has to apply pressure on the pegs wherein the said pegs upon application of the pressure spring in and align with the said straight slot of the package to disengage the package allowing it to slide out of the sheets.
Figure 3 depicts yet another embodiment of the invention. The package system comprises of closure 8, package 1 and the engaging member 3 of the package as indicated in Figure 3(a) in the form of assembly. The package is encased in the closure as seen in the figure. As shown in the Figure 3 (b), the package, preferably blister package but not limited to it is provided with an engaging provision 3 protruding in the same plane of the package from one of the edges of the package. The said engaging member is substantially flat having one of the tapered edge diverting away from the edge of the package wherein out of the two edges substantially perpendicular to the said diverting edge, one indicated as 15 in the figure is greater than the other thus almost forming an inverted L shaped lamina. As seen in the Figure 3 (b) the closure 8 comprises of top sheet 9 and bottom sheet 10 wherein the top sheet is deformed so as to create cavity to receive the package. Further, provision 11 and 12 is made in the sheets 9 and 12

respectively to removably engage part of the product package. . The said edge 15 of the said provision 3 engages the package in the provisions formed by 11 and 12 in the sheets. This is best seen in Figure 3 (a). The substantially flat portion 13 towards the side of the top sheet is attached / glued / fixed with the corresponding portion 14 of the bottom sheet 10 as shown in the Figure 3 (b). In operation one has to first press the said provision 3 of the package to disengage the package from the provision formed in 11 and 12 in the sheets followed by slideing the package to access the package and thereby product. Thus combination capability is necessary to access the package and product.
Figure 4 depicts yet another embodiment of the package system. Figure 4(a) depicts assembly of the system. It comprises of closure 1 and package 2 encased in the said closure. The said package is preferably a blister package but not limited to it. Figure 4(b) indicates front view of the package system. The said closure 1 comprises of first sheet 3 and second sheet assembly 4 wherein the said second sheet assembly 4 comprises of the front sheet provided with one or plurality of openings 6 preferably in the elliptical / oval / flat oval form adapted to receive thermoformed portion of the blister package as shown in the Figure 4(b) wherein the said thermoformed portion rests on side of the said opening thus engaging the product package with the sheet of the said closure. The back sheet 8 that corresponds to the closure of the blister package is indicated in the Figure 4 (c). It comprises of one or plurality of perforations 7 disposed such that they are aligned to the opposite side of the said openings 6. In operation one has to slide / move the blister package such that the thermoformed portion that was resting on one of the sides of the said opening 6 is moved towards opposite end. In this position, the closure of the blister corresponds / aligns with the said perforations of the back sheet 8. Stopping provision 9 is provided at the joining of the two sheets so as to restrict blister movement. The product in the blister can be accessed by pressing the thermoformed portion of the blister that results in dispense of the product by piercing the corresponding perforated portion of the back sheet 8. Thus accession of the product from the product package requires combination capability.

In one of the embodiment of the package system, a uniquely identifiable information and /or combination of information is provided on the package. In another embodiment unique identifying information is provided on the product package and / or closure.
In yet another embodiment at least two sets of identification information is provided on the product package and / or closure.
In yet another embodiment the package system is provided with a means to detect disengagement of the package from the closure to monitor and /or record of package and /or product access from the package system. In another variant of this embodiment the package system is provided with a wired / wireless communication means capable of interacting with external / remote device/s.
Thus it is evident from the invention that the synergistic combination of a closure means provided with engaging provisions adapted to removably receive and engage package wherein combination of multiple operations is necessary to access the product by disengaging the package from the said closure provides restricted product access system.