FORM - 2
THE PATENTS ACT, 1970 (39 OF 1970)
PROVISIONAL SPECIFICATION
(See Section 10)


■ TITLE OF INVENTION
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rij "A Packaged-product System with Multi-operational Access Control"
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(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

I06«l!i|2008

FieJd of the invention
The present invention relates to a child safe packaged-product system with multi-operational access control. The invention further relates to packaged^product system that facilitates interaction with the user so as to render child safe state of the package after use. Further, the invention relates to packaged-product system provided with unique identification information.
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.
Prior art reveals typically three design features on which child resistant packages are configured. One such design includes enclosure / carrier and package, wherein the package is removably enclosed in an enclosure having child resistant features. However in such designs, the package has to be removed from the enclosure for accessing the product resulting in separation of the package from the enclosure. Another design involves linkage of the package with the enclosure/ carrier in a manner wherein the linkage is maintained even while the product is accessed. Yet another design comprises of a combination package wherein a portion of the package has restricted access zone while the other portion has a general access zone. Such a design is incapable of providing child resistant features in its entirety.
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Further, some of these designs suffer from a drawback that in certain orientations such as vertically placed with the enclosure opening facing downwards, mere operation of the initial child resistant feature such as
depression of a lever can result in release of the non child resistant blister package with negligible effort.
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 there from, 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.
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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 an 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.
EP Patent 1685 034 discloses child resistant packaging system and method for making same. It is essentially a combination pack wherein the same blister pack is provided with free access portion and child resistant portion wherein access to some medications is restricted. Thus it is not a completely child resistant package system.
US Patent 6679381 discloses one hand opening child resistant blister pack container comprising top and bottom tray preferably connected by a hinge. The top and bottom trays have a tab extending there from. Blister pack is contained in this container.
The review of the prior art reveals following drawbacks:
Incapability of providing child resistant features in entirety.
Mere operation of the initial child resistant feature such as depression of a
lever can result in release of the non child resistant blister package with
negligible effort.
Lack of dedicated and permanent pairing of the package and the tray
leading to the danger of misuse of the support / tray / enclosure after of the
consumption of the product in the package
Lack of provision to remind user to reposition the package in the child
resistant enclosure after use
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Additional openings in the package holding provisions such as tray and lack of single mould construction because of the child resistant hinging cap Isolation of the package from the child resistant enclosure while accessing product from the package resulting in the danger of separation of the package from the child resistant enclosure
There is a longstanding need in the pharmaceutical industry to provide a child-safe packaged-product system with multi-operational access control that is child resistant and yet senior friendly
Summary of the Invention
The main object of the invention is to provide a child-safe packaged-product system with multi-operational access control having restrictive means for accession of the package after completion of the activities related to child resistant features thereby effectively eliminating the direct involvement of the blister package in activities related to child resistant features. It is a further object of the invention to provide a means to remind / alert user of reengaging / repositioning the package in the child-safe state after use.
Another object of the invention is to provide a packaged-product system with a dedicated / permanent pairing of the package with the child safe carrier / support / tray / enclosure so as to avoid reuse of the system after consumption of the products from the package.
Another object of the invention is to provide a uniquely identifiable package.
Yet another object of the invention is to provide a means for uniquely identifying the package to authenticate the same.
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 and communicate to the external device.
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Thus one aspect of the invention provides a system comprising:
package, package holding provision in which the package is hingably mounted,
wherein the said package holding provision comprises
a substantial flat lamina with partial edge portions protruding upwards to form a
tray like structure, a reciprocable member protruding out of the lamina, a
pressable member preferably both integrated in the said lamina, an optional
sensing means is provided to sense the presence of the package on the surface
of the said lamina wherein the said means is configured with power source and
user interactive audio /visual and sensory means;
a package fixing provision comprising first stripe adapted for fixing the package
and a second stripe adapted to fix the package and rotatably fixed lengthwise to
the said first stripe wherein the said first stripe is provided with hingable mounting
provision on the edges along the length;
wherein
the first stripe of the said package fixing provision is hingably connected at the
end of the said tray where edge portion is not protruded;
package adapted to fix between the said first and second stripe wherein the
package comprises of an opening to receive the said protruding reciprocating
member of the said lamina, optional unique identification information wherein the
package is adapted to fit on the said first stripe of the said package fixing
provision;
the said package fixing provision is provided with restrictive means enabling it to operably engage or couple to the said package holding provision;
wherein
the package is fixed in the said package fixing provision that is rotatable around
the said end of the tray such that the package overlays / rests on the surface of
the lamina of the package holding provision and the said restrictive means is
engaged or coupled to the said lamina of the package holding provision
wherein
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in operation the user has to reciprocate the said reciprocable means and simultaneously press the said pressable member to partially disengage the said package from the said package holding provision to complete child resistant activity, further the user has to perform yet another activity to decouple or disengage the assembly of package and package fixing provision that is operably coupled or engaged by the restrictive means with the said lamina of the package holding provision to access the package resulting in the technical effect of obviating the problem of package access as a apart of the child resistant activity.
In another aspect of the invention the said restrictive means is a peg with profiled protrusions fixed or integrated with / on the said package fixing provision and operably engaged or coupled with the said lamina of the package holding provision.
In another aspect of the invention the said sensing means is provided on the surface of the said lamina in the form of a pressable switch configured with power source and audio/visual/sensory means, when the package is rotated it overlays / rests on the surface of the lamina and presses the said switch wherein upon removing the package from the said rest position at the time of consuming the product in the package, the switch is depressed resulting in providing audio / visual indication to the user so as to remind him / her of repositioning the said package on the said lamina to render child resistant state.
In another aspect of the invention a reader device is provided to identify and read the unique identification information on the said package.
In another aspect of the invention a reader means is provided to identify and read the unique identification information on the said package wherein the reader means is suitably able to detect the identification information relating to the product package and conveys the information or generates a signal in response to the information which is communicable to the external device. Suitably, the information is encoded and preferably is optical, electronic or magnetic wherein the reader means comprises of
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one or more reading elements arranged to correspond to the position of each set of identification information on the package for reading the at least two sets of identification information;
wherein the said reader means is adapted to read a signal from the at least one identification feature of each of the at least two sets of identification information arranged on or incorporated within different surfaces, sides or planes of the package, and wherein the reading device is configured such that it defines the spatial relationship between a first discrete area of the first set of identification information to be read and a second discrete area of the second set of identification information to be read, and determining, using the reading device, at least one characteristic of a property of the at least one identification feature of the first set of identification features, thereby obtaining a first signal, determining, using the reading device, at least one characteristic of a property of the at least one identification feature of the second set of identification features, thereby obtaining a second signal, using a processing unit to derive/form/generate at least one signature for the object, using said first and said second signals (and thereby inherently or explicitly the features' spatial relationship).
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 packaged-product system (Sheet 1)
Figure 2 Assembly of the packaged-product system (Sheet 2)
Figure 3 Assembly view of the packaged-product system (Sheet 2)
Figure 1 depicts one of the embodiments of the system. It comprises of a package 1 and a package holding provision 2 in which the package is hingably mounted. The package holding provision 2 comprises a substantial flat lamina 3 with partial edge portions (4, 5, 6) protruding upwards to form a tray like structure. The lamina is adapted to fit a reciprocable member 7 that protrudes out of the lamina as shown in the figure and a pressable member 8 preferably both integrated in the
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said lamina. Further the lamina is provided with one or plurality of engaging provision/s 21. In one of the embodiments, a means is provided to sense the presence of the package on the surface of the said lamina 3 wherein the said means is configured with power source and user interactive audio /visual and sensory means. In one of the variants of this embodiment is shown in the Figure 1 wherein a pressable switch 9 is disposed on the surface of the said lamina and configured with power source and audio /visual user interactive means (not shown). The switch 9 is pressed when the package rests on it. In another variant there can be plurality of such switched disposed on the said lamina. In another variant a proximity switch (not shown) is disposed in the vicinity of the said reciprocable member 7 wherein the said switch is configured with the power source and user interactive means.
The package holding provision 2 is operably connected to a package fixing provision 10 comprising first stripe 11 provided with slots / depressions 12 for receiving and fixing the package 1 and a second stripe 13 rotatably connected lengthwise to the said first stripe wherein the said first stripe is provided with hingable mounting provision 14, 15 on the edges along the length. In one of the embodiments the said second strip 13 is provided with a restrictive means such as pegs on the other surface facing (elaborated in the description of the Figure 2)
As shown in the Figure 1, the first stripe 11 of the said package fixing provision is hingably connected at the end of the said package holding provision 2 where edge portion is not protruded. The package 1 comprises of an opening 16 to receive the said protruding reciprocable member 7 of the said lamina. The package is adapted to fit on the said first stripe of the said package fixing provision and is provided with region 25 for providing unique identification information. Further the said package is provided with optional unique identification information.
Figure 2 depicts assembly of the package with the package holding and package fixing provision wherein the package is fixed in the said package fixing provision. As a representation, one of the variants of restrictive means in the form of pegs is
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elaborated hereunder. The package 1 is fixed between the first and second stripes 11 and 13 wherein the stripe 13 is seen in the Figure 2. The stripe 13 overlays the stripe 11 (the first stripe 11 is behind the stripe 13). The second stripe 13 is provided with one or plurality of pegs 20 on its surface facing the lamina as seen in the Figure 2 (a). The exploded view of one of the variants of the said pegs is depicted in Figure 2 (b). The peg is provided with of a profiled surface 40 as shown in the figure comprising one or plurality of projections that facilitates interference fit and disengagement of the peg in at least two steps wherein the peg gets partially disengaged from the provision 21 upon pressing of the said pressable member 8 of the said lamina and further force is needed to disengage the peg completely and thereby lift the package assembly to access the package from the said package holding provision. The package is rotated around the said hingable provisions 14, 15 connected to the package holding provision in the direction 22 indicated by the arrow so that the package overlays, rests on the lamina causing the said switch 9 to be pressed, engaging peg the 20 in 21 and positioning and engaging of the package opening 16 in the said reciprocable member 7.
Figure 3 depicts the packaged-product system wherein package is positioned in the said package holding provision. As shown in the figure the said reciprocable member 7 is engaged in the package. To access the product, user has to reciprocate the said member 7 and press the pressable member 8 of the lamina to dislodge the said package. Further, user has to apply slight force to disengage the said pegs from the provision 21 so that the package rotates around the said hingable provisions. Further the package is provided with a uniquely identifiable information and /or combination of information on the region 25 that hangs out of the said package holding provision.
In the operation the package is fixed in the said package fixing provision that is rotatable around the said end of the tray such that the package overlays / rests on the surface of the lamina,when rotated and presses the said switch wherein upon removing the package from the said rest position at the time of consuming the product in the package, the switch is depressed resulting in providing audio /
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visual indication to the user so as to remind him / her of repositioning the said package on the said lamina to render child resistant state.
In one of the embodiments the said package is provided with hingable provisions integrated with it wherein the said hingable provision of the package is rotatably connected to the said package holding provision 2 where edge portion is not protruded. Thus instead of the package fixing provision the package with the hingable provision is mounted / connected to /on the package holding provision 2. In another variant of this embodiment, the package 1 comprises of first and second stripes 11 and 13 respectively wherein the package is fixed between them to form a separate assembly wherein the said assembled package is rotatably connected / coupled to the said package holding provision 2.
In another embodiment the said package holding and package fixing provision are made out of cardboard. In another variant of this embodiment the'said package holding and package fixing provision are made out of biodegradable material. In yet another variant of this embodiment the said package holding and package fixing provisions are made out of plastic.
In another embodiment a reader means is provided to identify and read the unique identification information on the said package wherein the reader means is suitably able to detect the identification information relating to the product package and conveys the information or generates a signal in response to the information which is communicable to the external device. Suitably, the information is encoded and preferably is optical, electronic, magnetic or a combination thereof.
In yet another embodiment the said package holding provision may comprise any conventional reader means to detect the encoding information identifying the product package. The information or signal may be stored in the package holding provision.
In one of the embodiment of the package system, a uniquely identifiable information and /or combination of information is provided on the package.
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In yet another embodiment product package is provided with an identification tag for identifying the package for authentication. The tag comprises at least two sets of identification information, said at least two sets of identification information comprising a first set of identification information and a second set of identification information each arranged within a different surface, side or plane of the identification tag, and identification features of said first set of identification information and identification features of said second set of identification information are arranged at a fixed relative spatial position with respect to each other, said fixed spatial relationship being used for identifying the object.
In yet another embodiment the identifiers are present in a tag on the product package wherein one identifier comprises a readable layer of randomly distributed material which is capable of encoding identification information, for example a conductive material, magnetized or magnetisable material, semi-conductive particle and optically active particles; the second identifier suitably comprises optical information, for example a 1-D or 2-D bar code.
In yet another embodiment at least two sets of identification information is provided on the product package and / or package holding provision. In another variant of this embodiment unique identifying information is suitably included on the package in the form of oriented or orientable particles and may relate to for example, the manufacturer of the package or to an individual. Preferably the identification information comprises information derived from a magnetic field and/or an electric field and optionally optical or magneto-optical information. In yet another variant of this embodiment nano / micro particulate materials and/or material composites with measurable material metrics are used on the package for identification information.
In a preferred embodiment, the product package suitably comprises a substantially non-magnetic host material having pores, wherein at least some of the pores contain a substantially magnetic material which is codeable to encode identification information for identifying the product package or a unit dose
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package. The product package may comprise a substantially electrically-insulating host material having pores, wherein at least some of the pores contain a substantially electrically-conducting material which is codeable to encode identification information for identifying the unit dose package. Desirably, the electrically-conducting material is connectable to a voltage source.
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 present invention that the synergistic operational combination of the said package holding provision, package fixing provision, an assembly of the package and package fixing provision operably connected or engaged by the said restrictive means results in a multi-operational access control to access the package after the completion of the child resistant activity obviating the problem of package access as a part of the child resistant activity. Further provision of the said means to remind / alert user of reengaging / repositioning the package in the child-safe state after use renders child resistant state to the package after use enhancing the effectiveness of the child resistant function of the package.
Date: 19th May 2008
Applicant
Bilcare Limited
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