DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see pages 7-8, filed 05/27/2025, with respect to the rejection(s) of claim(s) 16, 31, and 34 under 35 U.S.C 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Plumptre (United States Patent Application Publication No. US 2016/0206820 A1) and further in view of Basile (United States Patent Application Publication No. US 2017/0007766 A1), Avery et al (United States Patent Application Publication No. US 2014/0290792 A1; herein, Avery), and Raghavachari et al. (United States Patent No. US 4,048,997 A) for claim 1, and Plumptre in view of Avery, Raghavachari, and Foucher et al. (United States Patent Application Publication No. US 2017/0333634 A1; herein, Foucher) for claim 31, and Plumptre in view of Basile, Avery, Raghavachari, and Foucher for claim 34.
Claim Objections
Claim 16 objected to because of the following informalities: The use of the word “it” in the limitation “…wherein the heat shrinkable label is heat shrunk on the housing and the cartridge holder such that it at least partially covers…” leads to speculation regarding what is the structure that is partially covering the housing and cartridge holder. Appropriate correction is required. Correct to “…wherein the heat shrinkable label is heat shrunk on the housing and the cartridge holder such that the heat shrinkable label at least partially covers…” to clarify any ambiguity. For examination purposes, the limitation is being examined as meaning the heat shrinkable label at least partially covers the housing and cartridge holder.
Claim 31 objected to because of the following informalities: The phrasing of the limitation "attaching a heat shrinkable label to by heat shrinking the heat shrinkable label on a housing of the injection device and a cartridge holder of the injection device" leads to speculation as to where the heat shrinkable label is being attached to. Appropriate correction is required. Correct to “attaching a heat shrinkable label to the injection device by heat shrinking the heat shrinkable label on a housing and a cartridge holder of the injection device”. For examination purposes, the limitation is being examined as meaning the heat shrinkable label is being attached to the injection device.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 16-18, 23, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Plumptre (United States Patent Application Publication No. US 2016/0206820 A1) and further in view of Basile (United States Patent Application Publication No. US 2017/0007766 A1), Avery et al (United States Patent Application Publication No. US 2014/0290792 A1; herein, Avery), and Raghavachari et al. (United States Patent No. US 4,048,997 A).
Regarding claim 16, Plumptre discloses an injection device (drug delivery device 1), comprising
a housing containing a dose setting mechanism (outer housing part 10 holds components for button 70 (dose dial grip)),
a cartridge holder containing a cartridge with a medicament (cartridge holder 80 for receiving a cartridge 81).
Plumptre does not disclose wherein the cartridge holder is inseparably locked to the housing, and a heat shrinkable label comprising information and/or symbols about the medicament, wherein the heat shrinkable label is heat shrunk on the housing and the cartridge holder such that it at least partially covers the housing and the cartridge holder.
However, Basile teaches wherein the cartridge holder is inseparably locked to the housing ([0074], “…projecting features can be swaged or thermally welded to create a secure attachment between the drug container and the drug delivery device.”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cartridge holder and outer housing disclosed by Plumptre to be thermally welded to one another as taught by Basile in order that a secure attachment be created between the cartridge holder and outer housing, as thermal welding is known in the art to have high mechanical strength.
Furthermore, Plumptre in view of Basile still does not disclose a heat shrinkable label comprising information and/or symbols about the medicament
However, Avery teaches a heat shrinkable label (label 270, [0198], “label may comprise a heat shrink label”) comprising information and/or symbols about the medicament ([0198], “…the label could be color-coded so as to provide indicia of cartridge contents, manufacturing information or the like.”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device of Plumptre to incorporate a heat shrink label comprising information as taught by Avery in order to provide the user with necessary device information directly on the device.
Moreover, Plumptre in view of Basile and Avery still does not disclose the heat shrinkable label is heat shrunk on the housing and the cartridge holder such that it at least partially covers the housing and the cartridge holder.
However, Raghavachari teaches the heat shrinkable label is heat shrunk on the housing and the cartridge holder such that it at least partially covers the housing and the cartridge holder (Fig. 4, col. 4 lines 16-36, label portion of sheath 41 can have heat-shrink fit covering housing components 16,17 and tube 15). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device of Plumptre to incorporate a heat shrinkable label shrunk around housing and cartridge components of a device as taught by Raghavachari in order that the components of the device maintain positioning while also allowing the user the ability to visually inspect the contents of the cartridge for tampering or any other issue prior to use.
Regarding claim 17, in the modified device of Plumptre, Avery teaches the heat shrinkable label has a form of a jacket at least partially encasing the housing and the cartridge holder (Fig. 10). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device of Plumptre to incorporate a heat shrink label that wraps around the two connecting components as a jacket as taught by Avery in order that the device remain in the set position and reduced the risk of tampering in the connecting area.
Regarding claim 18, in the modified device of Plumptre, Plumptre discloses a window in the housing (Fig. 2, window insert 130 contains an aperture). Avery teaches the heat shrinkable label comprises at least a transparent or translucent portion ([0198], “Preferably, the label may be predominantly clear. Such a clear label would allow a user to view the contents of the cartridge…”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device of Plumptre with a predominantly clear label as taught by Avery in order that users be able to view the contents provided within the window insert.
Regarding claim 23, in the modified device of Plumptre, Raghavachari teaches the heat shrinkable label comprises a layer inhibiting a transmission of actinic light (col. 3 lines 52-57, “Sheath 41 is formed of a material which inhibits the transmission of actinic light…”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to alter the modified drug delivery device of Plumptre to have the heat shrinkable label comprised of a layer which inhibits the transmission of actinic light as taught by Raghavachari in order to protect the drug from the effects of actinic radiation.
Regarding claim 30, Plumptre discloses the medicament is an insulin or a growth hormone ([0024], “The drug delivery device may be configured to deliver a liquid medication. The medication may be, for example, insulin.”).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Plumptre and further in view of Foucher et al. (United States Patent Application Publication No. US 2017/0333634 A1; herein, Foucher), Avery, and Raghavachari.
Regarding claim 31, Plumptre discloses a method of labeling ([0132], “The front face is printed with a dose number scale.”) an injection device (drug delivery device 1), the method comprising: a housing of the injection device (outer housing part 10) and a cartridge holder of the injection device (cartridge holder 80).
Plumptre does not disclose attaching a heat shrinkable label to by heat shrinking the heat shrinkable label on the housing and cartridge holder, the heat shrinkable label at least partially covers the housing and the cartridge holder, and wherein the heat shrinkable label comprises information and/or symbols about a medicament stored within the cartridge holder.
However, Foucher teaches attaching a heat shrinkable label (Fig. 4, heat-shrinkable film 9) to by heat shrinking ([0045], “the heat-shrinkable film is heated until it shrinks and tightly covers said part of said container and said part of said adaptor”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device of Plumptre with a heat-shrinkable film that attaches to the drug delivery device by heat shrinking as taught by Foucher in order to specify a manner in which the heat-shrinkable film is applied to the drug delivery device.
Furthermore, Plumptre in view of Foucher does not disclose wherein the heat shrinkable label comprises information and/or symbols about a medicament stored within the cartridge holder.
However, Avery teaches wherein the heat shrinkable label comprises information and/or symbols about a medicament stored within the cartridge holder ([0198], “…the label could be color-coded so as to provide indicia of cartridge contents, manufacturing information or the like.”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device of Plumptre to incorporate a heat shrink label comprising information as taught by Avery in order to provide the user with necessary device information directly on the device.
Moreover, Plumptre in view of Foucher and Avery does not disclose the heat shrinkable label on the housing and cartridge holder and the heat shrinkable label at least partially covers the housing and the cartridge holder.
However, Raghavachari teaches the heat shrinkable label on the housing and cartridge holder and the heat shrinkable label at least partially covers the housing and the cartridge holder (Fig. 4, col. 4 lines 16-36, label portion of sheath 41 can have heat-shrink fit covering housing components 16,17 and tube 15). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device of Plumptre to incorporate a heat shrinkable label shrunk around housing and cartridge components of a device as taught by Raghavachari in order that the components of the device maintain positioning while also allowing the user the ability to visually inspect the contents of the cartridge for tampering or any other issue prior to use.
Claim(s) 34 & 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Plumptre and further in view of Basile, Avery, Raghavachari and Foucher.
Regarding claim 34, Plumptre discloses a method of dose setting ([0144-0146]) for an injection device (drug delivery device 1), the method comprising: an interface for attaching a needle (Fig. 6, [0132], “The threaded distal end 84 is used to attach disposable pen needles.”), a housing of the injection device (outer housing part 10) and a cartridge holder attached to the housing (Figs. 17-19, cartridge holder 80), attaching the needle on a cartridge holder of the injection device ([0140], “…when the user removes and attaches a needle…”), wherein the cartridge holder comprises a cartridge with a medicament (cartridge holder 80 for receiving a cartridge 81); a dose setting member of a dose setting mechanism (button 70 (dose dial grip)); and setting a dose of the medicament by using the dose setting member of the dose setting mechanism ([0145]).
Plumptre does not disclose wherein the cartridge holder is inseparably locked to the housing of the injection device, a heat shrinkable label, the heat shrinkable label comprises information and/or symbols about a medicament, the heat shrinkable label at least partially covering the housing and the cartridge holder, removing a first cap portion of a heat shrinkable label of the injection device, the first cap portion covering an interface for attaching a needle, and wherein the heat shrinkable label is heat shrunk on a housing of the injection device and a cartridge holder attached to the housing, and removing a second cap portion of the heat shrinkable label covering a dose setting member.
However, Basile teaches wherein the cartridge holder is inseparably locked to the housing ([0074], “…projecting features can be swaged or thermally welded to create a secure attachment between the drug container and the drug delivery device.”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cartridge holder and outer housing disclosed by Plumptre to be thermally welded to one another as taught by Basile in order that a secure attachment be created between the cartridge holder and outer housing, as thermal welding is known in the art to have high mechanical strength.
Furthermore, Plumptre in view of Basile still does not disclose a heat shrinkable label, the heat shrinkable label comprises information and/or symbols about the medicament.
However, Avery teaches a heat shrinkable label (label 270, [0198], “label may comprise a heat shrink label”), the heat shrinkable label comprises information and/or symbols about a medicament ([0198], “…the label could be color-coded so as to provide indicia of cartridge contents, manufacturing information or the like.”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device of Plumptre to incorporate a heat shrink label comprising information as taught by Avery in order to provide the user with necessary device information directly on the device.
Moreover, Plumptre in view of Basile and Avery does not disclose the heat shrinkable label…on a housing of the injection device and a cartridge holder attached to the housing and the heat shrinkable label at least partially covering the housing and the cartridge holder.
However, Raghavachari teaches the heat shrinkable label…on a housing of the injection device and a cartridge holder attached to the housing and the heat shrinkable label at least partially covering the housing and the cartridge holder (Fig. 4, col. 4 lines 16-36, label portion of sheath 41 can have heat-shrink fit covering housing components 16,17 and tube 15). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device of Plumptre to incorporate a heat shrinkable label shrunk around housing and cartridge components of a device as taught by Raghavachari in order that the components of the device maintain positioning while also allowing the user the ability to visually inspect the contents of the cartridge for tampering or any other issue prior to use.
Additionally, Plumptre in view of Basile, Avery, and Raghavachari still does not disclose removing a first cap portion of a heat shrinkable label of the injection device, the first cap portion covering an interface for attaching a needle, and wherein the heat shrinkable label is heat shrunk on.
However, Foucher teaches removing a first cap portion of a heat shrinkable label of the injection device ([0044], “…heat-shrinkable film 9 is provided with an annular breakable line 13, like a dot-line or perforation line, which must be broken in order to remove the plug 10 and open the adaptor.”), the first cap portion covering an interface for attaching a needle (Fig. 5, adaptor 5 is housed within the heat-shrinkable film 9, which must be removed before accessing the adaptor), and wherein the heat shrinkable label is heat shrunk on ([0045], “the heat-shrinkable film is heated until it shrinks and tightly covers said part of said container and said part of said adaptor”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device of Plumptre to incorporate a heat shrinkable label that attaches to the drug delivery device by heat shrinking as taught by Foucher in order to specify a manner in which the heat shrinkable label is applied to the drug delivery device. Further, it would also have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device of Plumptre which has incorporated the heat shrinkable label to have a removable portion of the label covering an adaptive end as taught by Foucher in order to allow access to the adaptive end when time comes for the device to be used.
Lastly, Plumptre in view of Basile, Avery, Raghavachari, and Foucher does not explicitly disclose removing a second cap portion of the heat shrinkable label covering a dose setting member. Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to add an additional annular breakable line as taught by Foucher to the heat shrinkable label as taught by Avery which covers the housing and cartridge holder of the disclosed Plumptre device because the Applicant has not disclosed that the second cap portion provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, the specification states “the heat shrinkable label comprises a second cap portion covering the dose setting member and wherein the at least one weakened line is positioned permitting severance and removal of the second cap portion.” Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device of Plumptre to add an additional annular breakable line as taught by Foucher to an extended heat shrinkable label as taught by Avery to cover the dose dial grip in order that the position of the button not be moved prior to time of use, but also include the breakable line to access the part when time to use the mechanism.
Regarding claim 35, Plumptre discloses setting the dose of the medicament comprises rotating the dose setting member with respect to the housing ([0145]).
Claims 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Plumptre in view of Basile, in view of Avery, in view of Raghavachari as applied to claim 16 above, and further in view of Foucher.
Regarding claim 26, in the modified device of Plumptre, Plumptre does not disclose the heat shrinkable label comprises at least one weakened line permitting severance and removal of a portion of the heat shrinkable label. However, Foucher teaches the heat shrinkable label comprises at least one weakened line permitting severance and removal of a portion of the heat shrinkable label (annular breakable line 13). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device of Plumptre to add an annular breakable line to the heat shrinkable label as taught by Foucher in order to identify if the device has been tampered with, as well as providing access to the adaptive end when time comes for the device to be used.
Regarding claim 27, in the modified device of Plumptre, Plumptre discloses an interface for attaching a needle on the cartridge holder (Fig. 6, [0132], “The threaded distal end 84 is used to attach disposable pen needles.”). Plumptre does not disclose wherein the heat shrinkable label comprises a first cap portion covering the interface for attaching a needle and wherein the at least one weakened line is positioned permitting severance and removal of the first cap portion. However, Foucher teaches wherein the heat shrinkable label comprises a first cap portion covering the interface for attaching a needle (Fig. 5, adaptor 5 is housed within the heat-shrinkable film 9, which must be removed before accessing the adaptor) and wherein the at least one weakened line is positioned permitting severance and removal of the first cap portion (annular breakable line 13). Therefore, it would also have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device of Plumptre which has incorporated the heat shrinkable label to have a removable portion of the label covering an adaptive end as taught by Foucher in order to allow access to the adaptive end when time comes for the device to be used.
Regarding claim 28, in the modified device of Plumptre, Plumptre discloses a dose setting member protruding from the housing (button 70 (dose dial grip)). Plumptre in view of Avery and Foucher does not explicitly disclose the heat shrinkable label comprises a second cap portion covering the dose setting member and wherein the at least one weakened line is positioned permitting severance and removal of the second cap portion. Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to extend the label and add an additional annular breakable line as taught by Foucher to the heat shrinkable label as taught by Avery which covers the housing and cartridge holder of the disclosed Plumptre device because the Applicant has not disclosed that the second cap portion provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, the specification states “the heat shrinkable label comprises a second cap portion covering the dose setting member and wherein the at least one weakened line is positioned permitting severance and removal of the second cap portion.” Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device of Plumptre to add an additional annular breakable line as taught by Foucher to an extended heat shrinkable label as taught by Avery to cover the dose dial grip in order that the position of the button not be moved prior to time of use, but also include the breakable line to access the part when time to use the mechanism.
Claims 19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Plumptre in view of Basile, in view of Avery, in view of Raghavachari as applied to claim 16 above, and further in view of Ingle (United States Patent No. US 4,727,667 A).
Regarding claim 19, in the modified device of Plumptre, Plumptre does not disclose the information and/or the symbols are printed on an inner surface of the heat shrinkable label. However, Ingle teaches the information and/or the symbols are printed on an inner surface of the heat shrinkable label (col. 3 line 67-col. 4 line 5, indicia 38 printed on the inner surface of strip-like label 10). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to alter the modified drug delivery device of Plumptre to incorporate indicia on the inner surface of the label as taught by Ingle in order to protect and preserve the printed material from harsh conditions during production, so the user can properly view them at time of use.
Regarding claim 21, in the modified device of Plumptre, Plumptre does not disclose an outer surface of the heat shrinkable label is partially lacquered. However, Ingle teaches an outer surface of the heat shrinkable label is partially lacquered (col. 3 lines 28-36, clear lacquer or ink covers areas that are not adhesive). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to alter the modified drug delivery device of Plumptre with lacquer on the non-adhesive surfaces on the label as taught by Ingle in order to protect and preserve the printed material from harsh conditions during production, so the user can properly view them at time of use.
Claims 20, 24, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Plumptre in view of Basile, in view of Avery, and in view of Raghavachari as applied to claim 16 above, and further in view of Radmer et al. (United States Patent Application Publication No. US 2016/0263327 A1; herein, Radmer).
Regarding claim 20, in the modified device of Plumptre, Plumptre does not disclose the information and/or the symbols comprises a scale positioned on the cartridge holder and medicament information about the medicament positioned on the housing. However, Radmer teaches the information and/or the symbols comprises a scale positioned on the cartridge holder and medicament information about the medicament positioned on the housing (Figs. 16.1-16.3, scale tick marks on the cartridge holder and medicament information on the housing can be seen on the device). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to alter the modified drug delivery device of Plumptre with a scale on the cartridge holder and information on the housing as taught by Radmer in order that the user be aware and can visibly see the amount of drug in the cartridge, and any additional information necessary on the housing of the device.
Regarding claim 24, in the modified device of Plumptre, Plumptre does not disclose the heat shrinkable label comprises an electronic component and/or maintains the electronic component on the housing and/or on the cartridge holder. However, Radmer teaches the heat shrinkable label comprises an electronic component and/or maintains the electronic component on the housing and/or on the cartridge holder (Figs. 15.18-15.21, electronic label 700). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to alter the modified drug delivery device of Plumptre with and electronic component of the heat shrinkable label as taught by Radmer in order to give the user more helpful information regarding the state of the drug that is to be administered.
Regarding claim 25, in the modified device of Plumptre, Plumptre does not disclose the heat shrinkable label comprises a temperature measuring strip. However, Radmer teaches the heat shrinkable label comprises a temperature measuring strip ([0114], a temperature sensor may be added to the electronic label capabilities as an additional feature). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to alter the modified drug delivery device of Plumptre to include a temperature sensor as part of the heat shrinkable label as taught by Radmer in order to warn against exposure to excessive temperatures which might degrade the integrity of the drug.
Claim(s) 22 & 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Plumptre in view of Basile, Avery, and Raghavachari as applied to claim 16 above, and further in view of Murray et al. (United States Patent No. US 10,661,030 B1).
Regarding claim 22, in the modified device of Plumptre, Plumptre does not disclose the heat shrinkable label comprises PET or OPP. However, Murray teaches the heat shrinkable label comprises PET or OPP (col. 11 lines 3-39). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to alter the modified drug delivery device of Plumptre to have the heat shrinkable label be made PET or OPP as taught by Murray in order for the label to reliably shrink each time it is applied, as PET and OPP are known in the art as suitable thermoplastics for heat shrinking.
Regarding claim 29, in the modified device of Plumptre, Plumptre does not disclose the heat shrinkable label is glued or welded onto the housing and/or onto the cartridge holder. However, Murray teaches the heat shrinkable label is glued or welded onto the housing and/or onto the cartridge holder (col. 13 lines 4-13, label can be adhesive-bonded or a combination of shrink-wrapping and adhesive-bonding). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to alter the modified drug delivery device of Plumptre to have the heat shrinkable label adhesively-bonded to the housing and/or cartridge holder as taught by Murray in order to ensure that the label is placed in the proper location on the device as the shrinking occurs.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Plumptre in view of Foucher, in view of Avery, and in view of Raghavachari as applied to claim 31 above, and further in view of Radmer.
Regarding claim 32, in the modified device of Plumptre, Plumptre does not disclose detecting a temperature of the medicament by using a temperature measuring strip of the heat shrinkable label. However, Radmer teaches detecting a temperature of the medicament by using a temperature measuring strip of the heat shrinkable label ([0114], a temperature sensor may be added to the electronic label capabilities as an additional feature). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to alter the modified drug delivery device of Plumptre to include a temperature sensor as part of the heat shrinkable label as taught by Radmer in order to warn against exposure to excessive temperatures which might degrade the integrity of the drug.
Claims 33 is rejected under 35 U.S.C. 103 as being unpatentable over Plumptre in view of Foucher, in view of Avery, and in view of Raghavachari as applied to claim 31 above, and further in view of Murray.
Regarding claim 33, in the modified device of Plumptre, Plumptre does not disclose attaching the heat shrinkable label to the injection device comprises applying an adhesive. However, Murray teaches attaching the heat shrinkable label to the injection device comprises applying an adhesive (col. 13 lines 4-13, label can be adhesive-bonded or a combination of shrink-wrapping and adhesive-bonding). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to alter the modified drug delivery device of Plumptre to attach the heat shrinkable label to the housing and/or cartridge holder using adhesive as taught by Murray in order to ensure that the label is placed in the proper location on the device as the shrinking occurs.
Conclusion
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/EVELYN A THOMAN/ Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783