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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 16-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cerman et al. (US 2013/0345641 A1).
With regard to claim 16, Cerman discloses A drug delivery device (Fig. 2a-2c and Fig. 3a-3c) for administering of a dose of a medicament, the drug delivery device comprising: an elongated housing (Fig. 2b and 3b) configured to accommodate the medicament and defining a longitudinal direction (axis that is left to right in the Figures); and a device component (Fig. 2a, Fig. 3a), wherein the first device component is movable relative to the housing along the longitudinal direction from a first positional state (prior to insertion into the housing) to a second predefined positional state (when inserted into the housing as shown in Fig. 2c and 3c) for at least one of dose setting of the dose and dispensing of the dose (by inserting the cartridge into the cartridge holder this allows for the housing to be attached to the dose setting mechanism and allows for the dose setting to occur [0003], [0144], [0160]. By inserting the cartridge into the cartridge housing allows for a dose amount to be set and therefore the movement of the device component relative to the housing allows for setting of the dose, without this step, a dosing could not be set), wherein the device component comprises a first outer surface (inherent, 120), wherein the housing comprises a second outer surface (inherent), wherein at least one of the first outer surface and the second outer surface comprises a first code portion (150/250) of a code (154/254), and wherein the code is visually identifiable from outside the drug delivery device only when the device component is in the second predefined positional state relative to the housing (shown in Fig. 2c and 3c).
(ALTNERNATE INTERPRETATION)
With regard to claim 16, Cerman discloses A drug delivery device (Fig. 8a and 8b) for administering of a dose of a medicament, the drug delivery device comprising: an elongated housing (512) configured to accommodate the medicament and defining a longitudinal direction (axis that is left to right in the Figures); and a device component (506), wherein the device component is movable relative to the housing along the longitudinal direction from a first positional state (prior to insertion into the housing) to a second predefined positional state (when inserted into the housing as shown in Fig. 8b) for at least one of dose setting of the dose and dispensing of the dose (by inserting the dose setting mechanism 506 into the housing 512 allows for the housing to be attached to the dose setting mechanism and allows for the dose setting to occur [0038, [0040], [0144], [0160]). By inserting the device component/dose setting mechanism into the housing allows for a dose amount to be set and therefore the movement of the device component relative to the housing allows for setting of the dose, without this step, a dosing could not be set), wherein the device component comprises a first outer surface (inherent, generally at 502), wherein the housing comprises a second outer surface (inherent, generally at 510), wherein at least one of the first outer surface and the second outer surface comprises a first code portion (502 and 508) of a code (the word LANTUS in this example) and wherein the code is visually identifiable from outside the drug delivery device only when the device component is in the second predefined positional state relative to the housing (shown in Fig. 8b).
With regard to claim 17, Cerman discloses wherein the code (154/254) is non-discernible from outside of the drug delivery device when the device component is in the first positional state (when the cartridge is separated from the housing, the code is not viewable as shown in Figs 2a-2b and Figs. 3a-3b).
With regard to claim 18, Cerman discloses wherein the first code portion (150/250) or the code (154/254) is provided on the first outer surface (150/250 is provided on 120), and wherein at least a part of the first code portion or the code is concealed by the housing when the device component is outside the second predefined positioned state (the code 154/254 is considered concealed by the housing when the device component is outside the second predefined positional state because the housing only shows a partial code 152/252 and not the actual code itself).
With regard to claim 19, Cerman discloses wherein the first outer surface (120) is provided with one of the first code portion (150/250) and the code, wherein the first outer surface is further provided with a first concealing code portion that is indistinguishable from the first code portion (as shown in Fig. 3a, there are 3 parts of a flower which form the code, therefore one of these “flowers” or pieces can be considered a first concealing code portion that is indistinguishable from the first code portion, another of the 3 flower parts) or from the pairing code, wherein an indistinguishable composition of at least a portion of the first concealing code portion and at least one of the first code portion and the pairing code is discernible from outside the drug delivery device when the device component is outside the second predefined positional state (each of the three flower parts is considered discernible from outside the drug delivery device when the component is outside the second predefined positional state (Fig. 2a and 3a).
With regard to claim 20, Cerman discloses wherein the first concealing code portion (150/250) is concealed by the housing when the device component is in the second predefined positional state (Fig. 2c and 3c, the housing covers over the device component considered concealing).
With regard to claim 21, Cerman discloses wherein the code (154/254) comprises the first code portion (150/250) and a second code portion (152/252), wherein the first code portion is provided on the first outer surface (Fig. 2a, 3a), and wherein the second code portion is provided on the second outer surface (Fig. 2b/3b).
With regard to claim 22, Cerman discloses wherein the first code portion (150/250) and the second code portion (152/252) mutually recombine and constitute the code (154/254) when the device component is in the second predefined positional state (Fig. 2c and 3c).
With regard to claim 23, Cerman discloses wherein at least one of the code (154/254) and the first code portion (150/250) extends along a first direction, and wherein the device component is movable along the first direction relative to the housing (the cartridge is inserted into the housing).
With regard to claim 24, Cerman discloses wherein the second outer surface (104) is further provided with a second concealing code portion (similar to above the second surface has 3 partial flower symbols Fig. 3b and one of those could be considered the second concealing code portion) that is indistinguishable from the second code portion (they are indistinguishable because they are all partial flower pieces), and wherein the first code portion aligns with the second code portion when the device component is in the second predefined positional state (Fig. 3c).
With regard to claim 25, Cerman discloses wherein the first code portion (150/250) or a fraction thereof aligns with the second concealing code portion when the device component is outside the second predefined positional state (see Fig. 2c and 3c).
With regard to claim 26, Cerman discloses wherein at least one of the second concealing code portion and the second code portion extends along a second direction (see Figs. 2b and 3b), and wherein the device component is movable along the second direction relative to the housing (the device component moves into and out of the housing thus comprising a first and second direction).
With regard to claim 27, Cerman discloses further comprising a first marker (Fig. 3a shows three separate partial flower pieces, one of these can be considered a first marker) and a second marker (Fig. 3b shows three partial flower pieces, one of them can be considered the second marker), wherein the first marker is provided by or is connected to the device component (Fig. 3a), wherein the second marker is provided by or is connected to the housing (Fig. 3b), wherein the first marker is subject to a movement relative to the second marker when the first device component moves relative to the housing, and wherein the first marker and the second marker visually align, visually overlap, or mechanically engage when the device component reaches the second predefined positional state relative to the housing (Fig. 3c).
With regard to claim 28, Cerman discloses wherein the device component is one of a dose dial, a dial extension, a number sleeve, and a protective cap of a pen-type injection device (while shown as a cartridge in Fig. 2a and 3a, it can be another structure such as a dose setting mechanism or a cap, [0144]).
With regard to claim 29, Cerman discloses wherein the housing is one of a housing (Fig. 2b and 3b is a cartridge housing), a body of the housing, and a cartridge holder (Fig. 2b, 3b is a cartridge holder) of a pen-type injection device.
With regard to claim 30, Cerman discloses further comprising a cartridge (122) filled with a medicament and arranged inside the housing ([0137]).
With regard to claim 31, Cerman discloses a method of concealing a revealing of a code of a drug delivery device (fig 2a-2c/Fig. 3a-3c) wherein the drug delivery device comprise an elongated housing (Fig. 2b/3b) defining a longitudinal direction (axis left to right in the Figs) and a device component (Fig. 2a, 3a) movable relative to a housing (Fig. 2b, 3b) wherein the device component comprises a first outer surface (120), wherein the housing comprises a second outer surface (104), wherein at least one of the first outer surface and the second outer surface comprises a first code portion (150/250) of a code (154/ 254), the code being visually identifiable from outside the drug delivery device only when the device component is in a second predefined positional state relative to the housing (Fig. 2c, 3c) and wherein the method comprises:
At least one of setting of the dose and dispensing the dose by moving the device component relative to the hosuing along a longitudinal direction (by inserting the cartridge into the cartridge holder this allows for the housing to be attached to the dose setting mechanism and allows for the dose setting to occur [0003], [0144], [0160]. By inserting the cartridge into the cartridge housing allows for a dose amount to be set and therefore the movement of the device component relative to the housing allows for setting of the dose, without this step, a dosing could not be set) from a first positional state (cartridge outside the housing) in which the code is non-discernable, into the second predefined positional stated (Fig. 2c, 3c); and visually identifying the code from outside the drug delivery device (Fig. 2c, 3c).
(ALTERNATE INTERPRETATION)
With regard to claim 31, Cerman discloses a method of concealing a revealing of a code of a drug delivery device (Fig. 8a and 8b) wherein the drug delivery device comprise an elongated housing (512) defining a longitudinal direction (axis left to right in the Figs) and a device component (506) movable relative to a housing (Fig. 8a and 8b) wherein the device component comprises a first outer surface (generally at 502), wherein the housing comprises a second outer surface (generally at 510), wherein at least one of the first outer surface and the second outer surface comprises a first code portion (502/508) of a code (in this example the word LANTUS), the code being visually identifiable from outside the drug delivery device only when the device component is in a second predefined positional state relative to the housing (Fig. 8b) and wherein the method comprises:
At least one of setting of the dose and dispensing the dose by moving the device component relative to the housing along a longitudinal direction (by inserting the dose setting mechanism into the housing allows for the housing to be attached to the dose setting mechanism and allows for the dose setting to occur [0003], [0144], [0160]. By inserting the dose setting mechanism into the housing allows for a dose amount to be set and therefore the movement of the device component relative to the housing allows for setting of the dose, without this step, a dosing could not be set) from a first positional state (cartridge outside the housing) in which the code is non-discernable, into the second predefined positional stated (Fig. 2c, 3c); and visually identifying the code from outside the drug delivery device (Fig. 2c, 3c).
With regard to claim 32, Cerman discloses wherein the pairing code is non-discernible from outside of the drug delivery device when the device component is in the first positional state (shown in Fig. 1a, 2a).
With regard to claim 33, Cerman discloses wherein the first code portion or the pairing code is provided on the first outer surface 150/250 is positioned on 120), and wherein at least a part of the first code portion or the pairing code is concealed by the housing when the device component is outside the second predefined positional state (as the cartridge is being inserted the housing is placed over the cartridge and thus conceals a portion of the code until the cartridge is fully inserted revealing the code).
With regard to claim 34, Cerman discloses wherein the first outer surface (120) is provided with one of the first code portion (150/250) and the code, wherein the first outer surface is further provided with a first concealing code portion that is indistinguishable from the first code portion (as shown in Fig. 3a, there are 3 parts of a flower which form the code, therefore one of these “flowers” or pieces can be considered a first concealing code portion that is indistinguishable from the first code portion, another of the 3 flower parts) or from the pairing code, wherein an indistinguishable composition of at least a portion of the first concealing code portion and at least one of the first code portion and the pairing code is discernible from outside the drug delivery device when the device component is outside the second predefined positional state (each of the three flower parts is considered discernible from outside the drug delivery device when the component is outside the second predefined positional state (Fig. 2a and 3a).
With regard to claim 35, Cerman discloses wherein the code (154/254) comprises the first code portion (150/250) and a second code portion (152/252), wherein the first code portion is provided on the first outer surface (Fig. 2a, 3a), and wherein the second code portion is provided on the second outer surface (Fig. 2b/3b).
Response to Arguments
Applicant’s arguments with respect to claim(s) 16-35 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The claims have been amended to recite that the device component and the housing are movable for at least one of dose setting and dose dispensing. As explained above, by inserting a cartridge into the cartridge housing allows for the cartridge housing to then be attached to a dose setting mechanism for setting a dose. Without insertion of the cartridge into the cartridge holder the dose cannot be set. Therefore, the movement of the cartridge into the cartridge holder is movable for a dose setting.
Further an alternate interpretation is presented indicating that the code is located on a dose setting mechanism and a housing. Thus the connection of the dose setting mechanism with the housing allows for dose setting and dose dispensing to occur.
It is suggested that the device component and housing be further defined to identify which pieces of the drug delivery device is considered the “device component” in order to overcome the current rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783
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