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 Amendment
The amendment filed on 06/16/2026 has been entered. Claims 16 and 31 have been amended. Claims 17-30 and 32-35 are in the original/previously presented form. Claims 1-15 remain cancelled. Thus, claims 16-35 remain pending in the application.
Response to Arguments
Applicant's arguments filed 06/16/2026, pages 6-10, have been fully considered but they are not persuasive.
Regarding claims 16, 31, and 34, applicant argues on pg. 7-8 of the Remarks that “Plumptre teaches that the cartridge holder 80 is removable from the drug delivery device 1 to facilitate the cartridge 81 being replaced...If the cartridge holder 80 of Plumptre were locked to the drug delivery device 1, one would no longer be able to replace an empty cartridge 81 and reset the drug delivery device 1, as described in Plumptre. Thus, modifying Plumptre in view of Basile such that the cartridge holder 80 of Plumptre would be inseparably locked to the drug delivery device 1 would make Plumptre unsuitable for its intended purpose (e.g., as a reusable drug delivery device) and change the principle of operation of Plumptre.”. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the particular problem that is of concern is there is no motivation to modify the primary reference of Plumptre to teach “wherein the cartridge holder is inseparably locked to the housing” because Plumptre discloses “removal of the cartridge holder” ([0150]). This argument is not persuasive because Plumptre also discloses “…the drug delivery device may be a disposable device. The term “disposable” means that the drug delivery device cannot be reused after an available amount of medication has been delivered from the drug delivery device.” ([0024]). Regardless if the Plumptre device has the capability to replace a cartridge, since the device can be made as either a reusable device or a disposable device, one having ordinary skill in the art would have motivation to modify the Plumptre device with “wherein the cartridge holder is inseparably locked to the housing” given the disposable option exists. Therefore, the use of Plumptre stands in the final rejection and the rejection as recited below is maintained.
Regarding claim 19, applicant argues on pg. 8 of the Remarks that “Ingle allegedly teaches indicia 38 printed on an inner surface of a strip-like label 10… However, the indicia 38 of Ingle is only observable when the label 10 is manipulated to peel back the label 10 from the bottle 12. Such differs from Applicant's arrangement. Applicant's information and/or symbols are visible to an observer without the observer having to peel back the label. Such is shown in Applicant's Fig. 3, for example, and described in Applicant's specification at page 12, lines 33-34, for example.” In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that the “applicant’s information and/or symbols are visible to an observer without the observer having to peel back the label”) are not recited in the rejected claim. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The applicant’s argument cites Fig. 3, which from the examiner’s point of view does not give clear reference as to whether the information and/or symbols are printed on the inside or outside of the label (see Drawing Objection below). Applicant’s argument also cites to a section of the specification (page 12, lines 33-34) that reads “label 8 such that the scale 9 is visible through the transparent label 8. Further, the transparent label 8 allows a user to read the dose numbers visible through the window or aperture 6 of the”, which puts preference on the label being transparent in order to read the information and/or symbols. However, claim 19 does not include nor depend on any claim that included the limitation of a transparent label. Therefore, the use of Ingle stands in the final rejection and the rejection as recited below is maintained.
Regarding claim 20, applicant argues on pg. 8-9 of the Remarks that “Applicant does not claim that that the scale and medicament are located on the device itself, but rather that the scale and medicament information are on a heat shrinkable label, which is then positioned on the device such that the portion of the heat shrinkable label including the scale is positioned on the cartridge holder and the portion of the heat shrinkable label including the medicament is positioned on the housing.”. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, the particular problem that is of concern is Radmer does not disclose or suggest all elements of Applicant's claim because Radmer allegedly discloses "scale tick marks on the cartridge holder and medicament information on the housing can be seen on the device" according to Figs. 16.1-16.3. However, the use of Radmer by the examiner is not to modify the original device of Plumptre to place scale tick marks directly onto the Plumptre device. Rather, Radmer is being used to modify the “modified drug delivery device of Plumptre” (claim 20 rejection), which refers back to the modifications made in claim 16 to the original device of Plumptre. Of these modifications, it is Avery which modifies the Plumptre device to include a heat shrinkable label (Avery-label 270, [0198], “label may comprise a heat shrink label”) comprising information and/or symbols about the medicament (Avery-[0198],”…the label could be color-coded so as to provide indicia of cartridge contents, manufacturing information or the like.”). Thus, Avery is being modified by Radmer, changing the indicia provided by Avery to be scale tick marks as taught by Radmer, in order to meet the limitations of claim 20. Therefore, the use of Radmer stands in the final rejection and the rejection as recited below is maintained.
Regarding claim 28, applicant argues on pg. 9 of the Remarks that “Applicant's specification explains that by covering the threaded interface 7 with the first cap portion 11, and the dose setting member 5 with the second cap portion 12, the label 8 forms a tamper-evident closure for the injection device 1…Thus, contrary to the Office's assertions, Applicant's specification does disclose that the recited second cap portion provides an advantage, is used for a particular purposed, and/or solves a stated problem.”. This argument is not persuasive because Foucher discloses “…the 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 breakable line 13 therefore acts as a tamper evident means of the opening of the adaptor.” ([0044]), which provides a purpose in having a heat shrinkable film with an annular breakable line. The cited purpose of Foucher is similar to that of the current application, in which the applicant’s specification states “The respective weakened lines 10 are designed to permit the severance and removal of the cap portions 11, 12 from the rest of the label 8. In other words, the label 8 further forms a tamper-evident closure for the injection device 1.” (page 13 lines 8-10). The court has held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (MPEP 2144.04.VI.B.). Foucher teaches a functional end of a device which has been covered by a heat-shrinkable film having a breakable line acting as a tamper evident means. Accordingly, it would have been obvious to one having ordinary skill in the art to apply the heat-shrinkable film having a breakable line acting as a tamper evident means to any functional end of a device, in the case of the current application and the device of Plumptre, if the result remains the same between ends. Seeing as there is no new or unexpected result between the first and second cap portions and their weakened lines, the use of Foucher stands in the final rejection and the rejection as recited below is maintained.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to because in Figure 3, according to the specification “the scale 9 is printed on the inner side of the label 8 such that the scale 9 is visible through the transparent label 8.” (page 12 lines 33-34). From the examiner’s point of view, Figure 3 does not appropriately depict whether the information and/or symbols are printed on the inside or outside of the label. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 16, 19, 20, 24, 29, 31, and 34 is objected to because of the following informalities: Each of the claims state at least once “and/or”. The use of “and/or” leads to an indefinite interpretation of the claim as it presents such a broad understanding of what limitations are being claimed. For the purposes of examination, the examiner will interpret any use of “and/or” within the claims to mean “one, the other, or both”. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: Between the words "label" and "comprises" in the second line of the claim, there appears to be an extra space. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 the heat shrinkable label 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 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.
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 the injection device 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 the injection device 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.
Claims 34 & 35 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.
Claims 22 & 29 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
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights