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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 29 and 35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 29 [which depends from claim 19] recites: "the drug delivery device comprises a dose dispense member configured to be operated by a user in order to dispense a drug dose and the dispense process comprises the dose dispense member is configured to move relative to the second element." The phrase "the dispense process comprises the dose dispense member is configured to move relative to the second element" is grammatically incoherent. It is unclear whether the claim intends to recite that the dispense process comprises a step of the dose dispense member moving relative to the second element, or whether the mechanism unit comprises a dose dispense member that is configured to move relative to the second element. A person of ordinary skill in the art could not determine the scope of this limitation with reasonable certainty.
Claim 35 recites "the energy member provides energy for moving a plunger rod in a
distal direction." The term "a plunger rod" lacks antecedent basis in independent claim 19
or in the body of claim 35 itself. Neither claim 19 nor the preamble of claim 35 introduces a plunger rod. The claim is therefore indefinite because a person of ordinary skill in the art cannot determine the scope of the limitation with reasonable certainty.
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.
Claims 19-23, 26, 29, 32, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Kietzmann et al. (US 2014/0330243A1; hereinafter “Kietzmann”) in view of Bode et al. (US 2013/0012885A1; hereinafter “Bode”).
Independent claim 19 recites a drug delivery device comprising a mechanism unit comprising:
a first movable element;
a second element,
wherein: the first movable element is configured to be movable with respect to the second element and
the mechanism unit is configured to be operatively coupled with a drug reservoir unit and enable a dispense process for dispensing a drug dose, and
the dispense process is associated with a movement of the first movable element relative to the second element in a first direction, and
an electromechanical actuator which, when operated, is configured to move an actuator element between a first position and a second position,
wherein the mechanism unit is further configured to:
block movement of the first movable element relative to the second element in the first direction when the actuator element is in the first position in order to prevent dispensing a drug dose, and
allow movement of the first movable element relative to the second element in the first direction when the actuator element is in the second position as a precondition for dispensing a drug dose.
In relation to independent claim 19, Kietzmann discloses a drug delivery device (Abstract: "The present invention relates to a drive mechanism for a drug delivery device") comprising a mechanism unit (drive mechanism 20) comprising a first movable element (drive member 23) and a second element (housing 12), wherein the first movable element is configured to be movable with respect to the second element. Kietzmann discloses at ¶ [0163]: "FIG. 5 is further illustrative of a non-limiting example to implement a mechanical interlock member 50. There, the drive member 23 of the drive mechanism 20 is threadedly supported in a correspondingly threaded insert 52. By setting the drive member 23 in a screwing motion, e.g. by way of the dose dial 18 interconnected therewith, the drive member 23 will become subject to an axial displacement, either in proximal direction 3 or distal direction 2." Kietzmann further discloses at ¶ [0135]: "The pen-type injector 10 as shown in FIGS. 1 and 2 comprises a proximal body or housing component 12 and a distally located cartridge holder 16 that serves to accommodate a cartridge 22 being at least partially filled with a medicament to be injected." Kietzmann discloses the dispense process is associated with a movement of the first movable element relative to the second element in a first direction at ¶ [0137]: "depressing the dose button 17 in distal direction 2 may induce a rotative and/or sliding motion of the piston rod 25, thereby displacing the piston of the cartridge 22 in distal direction 2." Kietzmann discloses an electromechanical actuator (electrically operated drive 58) which, when operated, is configured to move an actuator element (locking sleeve 54) between a first position (locking position) and a second position (release position) at ¶ [0168]: "Moreover, axial displacement of the locking sleeve 54 can be attained by way of an electrically operated drive 58. The drive 58, typically to be controlled by the control 36 is mechanically coupled with a drive shaft 61 arranged in a bearing 62 located proximally from the drive 58. The drive shaft 61 comprises an axially elongated gear 60, which is engaged with a corresponding inner thread 64 of the locking sleeve 54. By rotating the shaft 61 and its gear 60, the locking sleeve 54 is set in rotational movement with respect to the housing 12, which comes along with an axial displacement of the locking sleeve 54 relative to the housing 12." Kietzmann discloses blocking movement of the first movable element in the first direction when the actuator element is in the first position in order to prevent dispensing a drug dose at ¶ [0164]: "The drive member 23 further has a distal stop element 56 extending radially outwardly from the drive member 23 at a distal end thereof. When the drive member 23 is for instance displaced in proximal direction 3, the stop element 56 is correspondingly displaced in proximal direction until its outer rim buts with the locking sleeve 54 being engaged with and fixed to the housing 12." Kietzmann discloses allowing movement of the first movable element in the first direction when the actuator element is in the second position as a precondition for dispensing at ¶ [0038]: "the control is particularly configured to transfer the interlock member in a release mode only when the at least one condition of use is fulfilled." Kietzmann does not explicitly disclose the mechanism unit is configured to be operatively coupled with a drug reservoir unit as a separate, removably coupled unit.
Bode discloses the mechanism unit is configured to be operatively coupled with a drug reservoir unit at ¶ [0034]: "The drug delivery device 1 comprises a housing having a first cartridge retaining part 2, and a dose delivery module or dose setting mechanism 4." Bode further discloses at ¶ [0036]: "A first end of the cartridge retaining means 2 and a second end of the dose setting mechanism 4 are secured together by connecting features. For disposable devices, these connecting features would be permanent and for reusable devices, these connecting features would be releasable." Bode further discloses at ¶ [0048]: "If the drug delivery device 1 comprises a resettable device, the cartridge proximal end 26 is removably connected to the dose setting mechanism 4."
Motivation to Combine: It would have been obvious to a person of ordinary skill in the art at the time of the invention to modify the drug delivery device of Kietzmann to include the operatively coupled drug reservoir unit of Bode. Both references are directed to pen-type drug delivery devices for self-administration of medicaments. The motivation to combine would have been to provide a reusable mechanism unit that can be operatively coupled with a replaceable drug reservoir unit, thereby reducing waste and cost for the user. Bode explicitly teaches that such releasable connecting features are desirable for reusable devices (¶ [0036]). A person of ordinary skill in the art would have recognized that combining the electromechanical locking mechanism of Kietzmann with the releasably coupled drug reservoir unit of Bode would yield a predictable result — a drug delivery device in which the electromechanical interlock mechanism controls dispensing access while the drug reservoir unit remains replaceable.
Claim 20 recites the drug delivery device according to claim 19, wherein the mechanism unit is
configured to enable setting a drug dose to be dispensed.
In relation to claim 20, this claim depends from claim 19, which is rejected as discussed above. Kietzmann discloses the mechanism unit is configured to enable setting a drug dose to be dispensed at ¶ [0136]: "The drive mechanism 20 further comprises a dose dial 18 as well as an injection button 17, by way of which a dose of the medicament can be set and dispensed." Based on the demonstrated conventionality of the enhancement, for an artisan skilled in the art, its implementation in the invention would have been considered an obvious alternative in the design of the drug delivery device.
Claim 21 recites the drug delivery device according to claim 19, wherein the mechanism unit is
configured to prevent setting the drug dose when the actuator element is in the first
position.
In relation to claim 21, this depends from claim 19, which is rejected as discussed above. Kietzmann discloses the mechanism unit is configured to prevent setting the drug dose when the actuator element is in the first position at ¶ [0039]: "Furthermore and according to another preferred embodiment, the interlock member is particularly adapted to releasably obstruct a user-initiated dose setting and/or a dose dispensing actuation if the condition of use is not
fulfilled. In particular with mechanically implemented drive mechanisms, such like pen-type
injectors, non-fulfillment of the condition of use may automatically lead to a complete obstruction and blocking of the drive mechanism. In this case, even a dose setting to be
conducted prior to a dose dispensing, may be effectively prevented." Based on the demonstrated conventionality of the enhancement, for an artisan skilled in the art, its implementation in the invention would have been considered an obvious alternative in the design of the drug delivery device.
Claim 22 recites the drug delivery device according to claim 19, wherein setting the drug dose is associated with a movement of the first movable element relative to the second element
in a second direction, and the mechanism unit is configured to block movement of the
first movable element relative to the second element in the second direction when the
actuator element is in the first position.
In relation to claim 22, this claim depends from claim 19, which is rejected as discussed above. Kietzmann discloses setting the drug dose is associated with a movement of the first movable element relative to the second element in a second direction at ¶ [0137]: "when rotating the dose dial 18 clockwise or counter-clockwise relative to the housing 12, the dose button 17 together with the dose dial 18 and an optional dose dial sleeve 23 may extend or displace in proximal direction 3 relative to the housing 12." Kietzmann discloses the mechanism unit is
configured to block movement of the first movable element in the second direction when
the actuator element is in the first position at ¶ [0039]: "the interlock member is
particularly adapted to releasably obstruct a user-initiated dose setting and/or a dose
dispensing actuation if the condition of use is not fulfilled... even a dose setting to be
conducted prior to a dose dispensing, may be effectively prevented." Based on the demonstrated conventionality of the enhancement, for an artisan skilled in the art, its implementation in the invention would have been considered an obvious alternative in the design of the drug delivery device.
Claim 23 recites the drug delivery device according to claim 19, wherein the mechanism unit is
configured to enable setting the drug dose irrespective of the position of the actuator
element.
In relation to claim 23, this claim depends from claim 19, which is rejected as discussed above. Kietzmann discloses the mechanism unit is configured to enable setting the drug dose irrespective of the position of the actuator element at ¶ [0166]: "Moreover, when positioning the locking sleeve 54 at a predetermined axial position, a dose size limit can be provided. Hence,
proximally directed displacement of the drive member 23 can be effectively delimited." Kietzmann further discloses at ¶ [0165]: "Preferably, the locking sleeve 54 is displaceably mounted in the housing 12. When positioned near the distally located stopper 56 of the drive member 23, the locking sleeve provides a kind of mechanical interlock, effectively impeding and preventing any proximally directed displacement of the drive member 23, e.g. for setting a dose." The alternative configuration in which the locking sleeve only blocks distal (dispensing) movement while allowing proximal (dose-setting) movement is disclosed as an alternative embodiment. Based on the demonstrated conventionality of the enhancement, for an artisan skilled in the art, its implementation in the invention would have been considered an obvious alternative in the design of the drug delivery device.
Claim 26 recites the drug delivery device according to claim 19, wherein the first movable element is rotated and/or moved axially relative to the second element when being moved in the first direction for the dispense process.
In relation to claim 26, this claim depends from claim 19, which is rejected as discussed above. Kietzmann discloses the first movable element is rotated and/or moved axially relative to the second element when being moved in the first direction for the dispense process at ¶ [0137]: "depressing the dose button 17 in distal direction 2 may induce a rotative and/or sliding motion of the piston rod 25, thereby displacing the piston of the cartridge 22 in distal direction 2."
Kietzmann further discloses at ¶ [0163]: "the drive member 23 of the drive mechanism 20 is
threadedly supported in a correspondingly threaded insert 52. By setting the drive member
23 in a screwing motion... the drive member 23 will become subject to an axial
displacement, either in proximal direction 3 or distal direction 2." Based on the demonstrated conventionality of the enhancement, for an artisan skilled in the art, its implementation in the invention would have been considered an obvious alternative in the design of the drug delivery device.
Claim 29 recites the drug delivery device according to claim 19, wherein the drug delivery device
comprises a dose dispense member configured to be operated by a user in order to dispense a drug dose and the dispense process comprises the dose dispense member is configured to move relative to the second element.
In relation to claim 29, this claim depends from claim 19, which is rejected as discussed above. Claim 29 is also rejected under 35 U.S.C. § 112(b) as discussed above. Kietzmann discloses the drug delivery device comprises a dose dispense member configured to be operated by a user in
order to dispense a drug dose at ¶ [0136]: "The drive mechanism 20 further comprises a dose dial 18 as well as an injection button 17, by way of which a dose of the medicament can be set and dispensed." Kietzmann further discloses the dose dispense member moves relative to the second element at ¶ [0137]: "depressing the dose button 17 in distal direction 2 may induce a rotative and/or sliding motion of the piston rod 25." Based on the demonstrated conventionality of the enhancement, for an artisan skilled in the art, its implementation in the invention would have been considered an obvious alternative in the design of the drug delivery device.
Claim 32 recites the drug delivery device according to claim 19, wherein the electromechanical actuator comprises an electric motor for moving the actuator element.
In relation to claim 32, this claim depends from claim 19, which is rejected as discussed above. Kietzmann discloses the electromechanical actuator comprises an electric motor for moving the actuator element at ¶ [0168]: "Moreover, axial displacement of the locking sleeve 54 can be attained by way of an electrically operated drive 58. The drive 58, typically to be controlled by the control 36 is mechanically coupled with a drive shaft 61 arranged in a bearing 62 located
proximally from the drive 58. The drive shaft 61 comprises an axially elongated gear 60, which is engaged with a corresponding inner thread 64 of the locking sleeve 54. By rotating the shaft 61 and its gear 60, the locking sleeve 54 is set in rotational movement." The electrically operated drive 58 that rotates a shaft to move the locking sleeve constitutes an electric motor for moving the actuator element. Based on the demonstrated conventionality of the enhancement, for an artisan skilled in the art, its implementation in the invention would have been considered an obvious alternative in the design of the drug delivery device.
Claim 36 recites the drug delivery device according to claim 19, wherein the drug delivery device is a variable dose device configured to allow different drug doses to be set or dialed by a user.
In relation to claim 36, this claim depends from claim 19, which is rejected as discussed above. Kietzmann discloses the drug delivery device is a variable dose device configured to allow different drug doses to be set or dialed by a user at ¶ [0136]: "The drive mechanism 20 further comprises a dose dial 18 as well as an injection button 17, by way of which a dose of the medicament can be set and dispensed" and at ¶ [0137]: "when rotating the dose dial 18 clockwise or counterclockwise relative to the housing 12, the dose button 17 together with the dose dial 18 and an optional dose dial sleeve 23 may extend or displace in proximal direction 3 relative to the housing 12." Based on the demonstrated conventionality of the enhancement, for an artisan skilled in the art, its implementation in the invention would have been considered an obvious alternative in the design of the drug delivery device.
Claims 24, 25, 31, 37, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Kietzmann et al. (US 2014/0330243A1; hereinafter “Kietzmann”) in view of Bode et al. (US 2013/0012885A1; hereinafter “Bode”), as discussed above, and in further view of Hautaviita et al. (US 2018/0008773A1; hereinafter “Hautaviita”).
Claim 24 recites the drug delivery device according to claim 19, wherein the mechanism unit is
configured to: prevent an operation of the actuator element unless a selected drug reservoir unit is coupled with the mechanism unit, and couple the mechanism unit with the selected drug reservoir unit as a precondition for the operation of the electromechanical actuator.
In relation to claim 24, this claim depends from claim 19, which is rejected as discussed above.
Kietzmann in view of Bode discloses the limitations of claim 19 as discussed above.
Kietzmann in view of Bode does not explicitly disclose the mechanism unit is configured
to prevent an operation of the actuator element unless a selected drug reservoir unit is
coupled with the mechanism unit, and couple the mechanism unit with the selected drug
reservoir unit as a precondition for the operation of the electromechanical actuator.
Hautaviita discloses the mechanism unit is configured to prevent an operation of the actuator element unless a selected drug reservoir unit (identification module) is coupled with the mechanism unit at ¶ [0009]: "an activation preventing mechanism operably arranged to prevent said activation mechanism to be activated. Thereby the activation preventing mechanism will not permit the delivery of a dose until certain criteria are met." Hautaviita further discloses at ¶ [0010]: "an identification module may be arranged to be operated by a user. The identification module may be designed to be unique to a specific medicament delivery device, such that, when the identification module is operated and is identified by the specific medicament delivery device as unique, the activation preventing mechanism will be deactivated to allow operation of the activation mechanism." Hautaviita further discloses at ¶ [0012]: "the identification module may be designed as an attachable unit to the medicament delivery device. With this feature, the same identification module may be used for several medicament delivery devices."
Motivation to Combine: It would have been obvious to a person of ordinary skill in the art to modify the drug delivery device of Kietzmann in view of Bode with the selected drug reservoir unit coupling as a precondition for operation of Hautaviita. The motivation to combine would have been to prevent the use of the medicament delivery device unless the correct, authorized drug reservoir unit is coupled, thereby reducing the risk of unintentional activation and possible wasting of medicament that may be very expensive and/or vital. Hautaviita explicitly teaches that this solution "greatly reduces the risk of e.g. unintentional activation and possible wasting of medicament that may be very expensive and/or vital" (¶ [0011]). A person of ordinary skill in the art would have recognized that combining the electromechanical locking mechanism of Kietzmann with the identification-based coupling precondition of Hautaviita would yield a predictable result — a drug delivery device in which the electromechanical actuator is only operated when the correct drug reservoir unit is coupled.
Claim 25 recites the drug delivery device according to claim 19, wherein: the mechanism unit further comprises a communication module for communicating with an external device, and the mechanism unit is configured to prevent an operation of the actuator element unless an
enabling signal from the external device is received via the communication module.
In relation to claim 25, this claim depends from claim 19, which is rejected as discussed above. Kietzmann discloses the mechanism unit further comprises a communication module for communicating with an external device at ¶ [0153]: "Additionally, the drive mechanism 20 may comprise a communication and/or authorization module 34. The communication module 34 may be implemented wireless and may provide communication, preferably according to standard communication protocols, like RFID, Bluetooth or the like. By way of the communication and/or authorization module 34, the drive mechanism 20 and/or the drug delivery device 10 may communicate with an external transponder 46." Kietzmann does not explicitly disclose the mechanism unit is configured to prevent an operation of the actuator element unless an enabling signal from the external device is received via the communication module. Hautaviita discloses the mechanism unit is configured to prevent an operation of the actuator element unless an enabling signal from the external device is received via the communication module at ¶ [0018]: "the identification module may comprise communication circuits. These circuits may be arranged to communicate with communication elements in the medicament delivery device and/or with external communication elements. For instance, the medicament delivery device may be arranged with sensors and circuits internally that are capable of sensing different states and conditions of the medicament delivery device and its components. Further, if the identification module is arranged to communication externally, then it may be able to transmit information and data from the medicament delivery device as well as obtaining information and data from external sources. This transmitted information and data could be used to further strengthen the identification process of specific users."
Motivation to Combine: It would have been obvious to a person of ordinary skill in the art
at the time of the invention to modify the drug delivery device of Kietzmann in view of Bode with the enabling signal from an external device of Hautaviita. The motivation to combine would have been to further strengthen the identification process of specific users to prevent unauthorized dispensing of medication, as taught by Hautaviita (¶ [0018]). Both Kietzmann and Hautaviita are directed to drug delivery devices with safety mechanisms to prevent unauthorized use, and combining the wireless communication module of Kietzmann with the enabling signal requirement of Hautaviita would yield a predictable result — a drug delivery device in which the electromechanical actuator is only operated when an enabling signal from an authorized external device is received.
Claim 31 recites the drug delivery device according to claim 19, wherein: the electromechanical actuator comprises a magnet and an electromagnet, a magnetization of which is changed when the electromechanical actuator is operated, and magnetic interaction between the magnet and the electromagnet results in movement of the actuator element between the first position and the second position when the electromechanical actuator is operated and/or magnetic interaction holds the actuator element in the first position.
In relation to claim 31, this claim depends from claim 19, which is rejected as discussed above. Kietzmann in view of Bode discloses the limitations of claim 19 as discussed above. Kietzmann in view of Bode does not explicitly disclose the electromechanical actuator comprises a magnet and an electromagnet, a magnetization of which is changed when the electromechanical actuator is operated, and magnetic interaction between the magnet and the electromagnet results in movement of the actuator element between the first position and the second position.
Hautaviita discloses the electromechanical actuator comprises a magnet and an electromagnet, a magnetization of which is changed when the electromechanical actuator is operated, and magnetic interaction between the magnet and the electromagnet results in movement of the actuator element between the first position and the second position at ¶ [0065]: "The drive member may be operated by electromagnets, wherein the drive member is specifically designed and positioned to be moved by a magnetic field generated by the electromagnets. The electromagnets are in this solution preferably arranged in the identification module especially if the only power source is placed in the identification module."
Motivation to Combine: It would have been obvious to a person of ordinary skill in the art
at the time of the invention to modify the drug delivery device of Kietzmann in view of Bode
with the electromagnetic actuator of Hautaviita. The motivation to combine would have
been to provide a contactless, reliable means of operating the locking mechanism across
physical boundaries within the device, as taught by Hautaviita (¶ [0065]). A person of
ordinary skill in the art would have recognized that using electromagnets to move the
actuator element would provide a reliable, low-maintenance locking mechanism that does
not require physical contact between the actuator and the actuator element, thereby
reducing wear and improving reliability.
Independent claim 37 recites a drug delivery system comprising: a mechanism unit comprising: a first movable element; a second element, wherein: the first movable element is configured to be movable with respect to the second element and the mechanism unit is configured to be
operatively coupled with a drug reservoir unit and enable a dispense process for dispensing a drug dose, and the dispense process is associated with a movement of the first movable element relative to the second element in a first direction, and an electromechanical actuator which, when operated, is configured to move an actuator element between a first position and a second position; and a control unit configured to transmit a signal to control the operation of the electromechanical actuator.
In relation to claim 37, this claim is an independent claim directed to a drug delivery system. Kietzmann in view of Bode discloses the limitations of claim 37 substantially as discussed above with respect to claim 19. Additionally, Kietzmann discloses a control unit configured to transmit a signal to control the operation of the electromechanical actuator at ¶ [0038]: "the control is particularly configured to transfer the interlock member in a release mode only when the at least one condition of use is fulfilled." Kietzmann further discloses at ¶ [0168]: "The drive 58, typically to be controlled by the control 36 is mechanically coupled with a drive shaft 61."
Motivation to Combine: It would have been obvious to a person of ordinary skill in the art at the time of the invention to modify the drug delivery device of Kietzmann to include the operatively coupled drug reservoir unit of Bode. Both references are directed to pen-type drug delivery devices for self-administration of medicaments. The motivation to combine would have been to provide a reusable mechanism unit that can be operatively coupled with a replaceable drug reservoir unit, thereby reducing waste and cost for the user. Bode explicitly teaches that such releasable connecting features are desirable for reusable devices (¶ [0036]). A person of ordinary skill in the art would have recognized that combining the electromechanical locking mechanism of Kietzmann with the releasably coupled drug reservoir unit of Bode would yield a predictable result — a drug delivery device in which the electromechanical interlock mechanism controls dispensing access while the drug reservoir unit remains replaceable.
Claim 38 recites the drug delivery system of claim 37, wherein: the signal to control the operation of the electromechanical actuator is received by the control unit from an external device, and the control unit is configured to prevent the operation of the electromechanical actuator unless the signal received by the control unit is an enabling signal from the external
device.
Claim 38 depends from claim 37, which is rejected as discussed above. Kietzmann in view
of Bode and Hautaviita discloses the signal to control the operation of the electromechanical actuator is received by the control unit from an external device, and the control unit is configured to prevent the operation of the electromechanical actuator unless the signal received by the control unit is an enabling signal from the external device, as discussed above with respect to claim 25. Specifically, Kietzmann discloses the communication module 34 communicating with an external transponder 46 (¶ [0153]), and Hautaviita discloses the activation preventing mechanism is only deactivated when the identification module is identified as unique (¶ [0010]). Based on the demonstrated conventionality of the enhancement, for an artisan skilled in the art, its implementation in the invention would have been considered an obvious alternative in the design of the drug delivery device.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Kietzmann et al. (US 2014/0330243A1; hereinafter “Kietzmann”) in view of Bode et al. (US 2013/0012885A1; hereinafter “Bode”) and Hautaviita et al. (US 2018/0008773A1; hereinafter “Hautaviita”), as discussed above, and in further view of Rasmussen et al. (US 2012/0101470A1; hereinafter “Rasmussen”).
Claim 34 recites the drug delivery device according to claim 24, wherein the mechanism unit comprises a first conductor path which is interrupted unless the selected drug reservoir unit is
coupled with the mechanism unit.
In relation to claim 34, this claim depends from claim 24, which is rejected as discussed above. Kietzmann in view of Bode and Hautaviita discloses the limitations of claim 24 as discussed above. Kietzmann in view of Bode and Hautaviita does not explicitly disclose the mechanism
unit comprises a first conductor path which is interrupted unless the selected drug reservoir unit is coupled with the mechanism unit. Rasmussen discloses the mechanism unit comprises a first conductor path which is interrupted unless the selected drug reservoir unit is coupled with the mechanism unit at ¶ [0008]: "a cartridge is engageable with a medical device, the cartridge comprising an ordered arrangement of N electrical components each with different respective values of an electrical property, and an ordered arrangement of N conductors operably coupled to the ordered arrangement of the N electrical components." Rasmussen further discloses at ¶ [0011]: "A medical device arranged to receive a cartridge comprises for each of N conductors on the cartridge at least a first respective contact arranged to electrically couple with the corresponding conductor when the cartridge is engaged with the medical device; the medical device also comprises an evaluation means operable to evaluate the different respective values of an electrical property of N electrical components on the cartridge." Rasmussen further discloses at ¶ [0056]: "The medical device can then alert the user and/or prevent full engagement of the cartridge (for example by actuation of a blocking mechanism), enabling the user to remove the cartridge and attempt to clean off the contaminant."
Motivation to Combine: It would have been obvious to a person of ordinary skill in the art
at the time of the invention to modify the drug delivery device of Kietzmann in view of Bode
and Hautaviita with the first conductor path of Rasmussen. The motivation to combine
would have been to provide a robust encoding of information about the contents of the
cartridge in a compact manner to ensure the correct drug reservoir unit is coupled before
allowing operation of the electromechanical actuator, as taught by Rasmussen (¶ [0024]).
Both Rasmussen and the combination of Kietzmann/Bode/Hautaviita are directed to drug
delivery devices that verify the identity of the drug reservoir unit before allowing operation,
and combining the conductor path identification mechanism of Rasmussen with the
electromechanical locking mechanism of Kietzmann would yield a predictable result — a
drug delivery device in which the conductor path is only closed when the correct drug
reservoir unit is coupled, thereby enabling operation of the electromechanical actuator.
Claims 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Kietzmann et al. (US 2014/0330243A1; hereinafter “Kietzmann”) in view of Bode et al. (US 2013/0012885A1; hereinafter “Bode”), as discussed above, and in further view of Hutchinson et al. (US 2012/0101470A1; hereinafter “Hutchinson”).
Claim 27 recites the drug delivery device according to claim 19, wherein: the mechanism unit further comprises an intermediate element displaceable between a lock position and a release
position, movement of the actuator element from the first position into the second
position enables a movement of the intermediate element from the lock position into the
release position and/or vice versa, and the intermediate element in the lock position is
configured to block movement of the first movable element relative to the second
element in the first direction.
In relation to claim 27, this claim depends from claim 19, which is rejected as discussed above. Kietzmann in view of Bode discloses the limitations of claim 19 as discussed above. Kietzmann in view of Bode does not explicitly disclose an intermediate element that is separate from the actuator element and that is displaceable between a lock position and a release position, wherein movement of the actuator element enables movement of the intermediate element.
Hutchinson discloses an intermediate element (ratchet claw 1240) displaceable between a
lock position and a release position at ¶ [0063]: "Inside the housing 1120, a motor 1250 and
spring 1260 are provided to hold the ratchet claw 1240." Hutchinson further discloses
movement of the actuator element (motor 1250) from the first position into the second
position enables a movement of the intermediate element from the lock position into the
release position at ¶ [0065]: "This device sends a message to the pump via an RF (radio
frequency) link that tells the pump to unlock the mechanical drive mechanism by
disengaging the ratchet claw 1240 from the control gear 1210." Hutchinson further
discloses the intermediate element in the lock position is configured to block movement of
the first movable element relative to the second element in the first direction at ¶ [0066]: "a
locking mechanism engages, disabling further delivery of medication... the controller instructing the motor 1250 to re-engage the ratchet claw 1240 with the control gear 1210, disabling further delivery of medication."
Motivation to Combine: It would have been obvious to a person of ordinary skill in the art
to modify the drug delivery device of Kietzmann in view of Bode with the intermediate element (ratchet claw) of Hutchinson. The motivation to combine would have been to provide a secure mechanical interlock that translates the electromechanical actuation into a robust physical block of the dose setting and dispensing mechanism. Hutchinson teaches that such a ratchet claw mechanism provides reliable mechanical blocking of the delivery mechanism (¶ [0066]). A person of ordinary skill in the art would have recognized that incorporating an intermediate mechanical element between the electromechanical actuator and the first movable element would provide a more robust and reliable blocking mechanism, as the intermediate element provides a positive mechanical stop that is not dependent on the continued operation of the
electromechanical actuator.
Claim 28 recites the drug delivery device according to claim 27, wherein a path along which the actuator element moves between the first and the second position is different from a path along which the intermediate element moves between the lock position and the release position.
In relation to claim 28, this claim depends from claim 27, which is rejected as discussed above. Hutchinson discloses a path along which the actuator element moves between the first and the second position is different from a path along which the intermediate element moves between the lock position and the release position at ¶ [0063]: "Inside the housing 1120, a motor 1250
and spring 1260 are provided to hold the ratchet claw 1240." The motor 1250 (actuator
element) rotates about its axis, while the ratchet claw 1240 (intermediate element) pivots radially to engage and disengage from the control gear 1210, such that the path of the motor output is different from the path of the ratchet claw movement. Based on the demonstrated conventionality of the enhancement, for an artisan skilled in the art, its implementation in the invention would have been considered an obvious alternative in the design of the drug delivery device.
Claims 30 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Kietzmann et al. (US 2014/0330243A1; hereinafter “Kietzmann”) in view of Bode et al. (US 2013/0012885A1; hereinafter “Bode”), as discussed above, and in further view of Smith (US 2012/0101470A1).
Claim 30 recites the drug delivery device according to claim 19, wherein an energy source and/or a control unit for operating the electromechanical actuator and/or the actuator element are moved during the dispense process.
In relation to claim 30, this claim depends from claim 19, which is rejected as discussed above. Kietzmann in view of Bode discloses the limitations of claim 19 as discussed above.
Kietzmann in view of Bode does not explicitly disclose an energy source and/or a control unit for operating the electromechanical actuator and/or the actuator element that are moved during the dispense process. Smith discloses an energy source (spring motor) that is moved during the dispense process at ¶ [0067]: "FIG. 3A shows a schematic view of a motor mechanism 15 for the drug delivery device 10 in a relaxed state. The motor mechanism 15 contains a strip 16 of spring sheet metal, e.g. made of spring steel. Two drums are provided—a storage drum 17 and a torque drum 18." Smith further discloses at ¶ [0068]: "FIG. 3B shows the motor mechanism 15 in a charged state. The motor mechanism 15 is charged by rotating the torque drum 18...If the drums 17, 18 are released at this point the strip 16 tends to return to its original relaxed state on the storage drum 17 and thus causes both drums 17, 18 to rotate until the strip 16 is completely transferred back onto the storage drum 17."
Motivation to Combine: It would have been obvious to a person of ordinary skill in the art
at the time of the invention to modify the drug delivery device of Kietzmann in view of Bode
with the energy source that moves during dispensing of Smith. The motivation to combine
would have been to provide automatic injection capability to make self-administration
easier for patients, particularly those who are elderly or have dexterity problems, as taught
by Smith (¶ [0003]-¶ [0004]: "Autoinjectors require some form of energy input in order to
operate. Typically, this is achieved by the user performing a 'priming' or 'cocking' action
prior to the injection. This may make the device more complicated to use, as it increases
the number of user steps. Also, the actions required, for example pulling, pushing or
twisting to charge a spring, may be difficult for a user to perform, particularly if the user is
elderly or has dexterity problems."). A person of ordinary skill in the art would have
recognized that incorporating a spring motor energy source into the drug delivery device of
Kietzmann would provide automatic dispensing capability without requiring the user to
apply force during the injection.
Claim 35 recites the drug delivery device according to claim 19, wherein: the mechanism unit comprises a dispense mechanism, the dispense mechanism comprises an energy member in order to provide energy for dispensing a drug dose, and the energy member provides energy for
moving a plunger rod in a distal direction.
In relation to claim 35, Claim 35 depends from claim 19, which is rejected as discussed above. Smith discloses the mechanism unit comprises a dispense mechanism, the dispense mechanism comprises an energy member in order to provide energy for dispensing a drug dose, and the energy member provides energy for moving a plunger rod in a distal direction at ¶[0026]: "The rotational movement may be transferred into a translative movement of a piston rod and a bung of a syringe by a screw thread on the piston rod, the translative movement of the bung resulting in delivery of a dose of the drug." Smith further discloses at ¶ [0027]: "it is preferred to bias the rotatable component by an energy source, such as a spring motor so it starts rotating as
soon as the latch arm is disengaged from the catch."
Motivation to Combine: The motivation to combine is the same as set forth above with
respect to claim 30.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Kietzmann et al. (US 2014/0330243A1; hereinafter “Kietzmann”) in view of Bode et al. (US 2013/0012885A1; hereinafter “Bode”), as discussed above, and in further view of Veasey et al. (US 2014/0316347A1; hereinafter “Veasey”).
Claim 33 recites the drug delivery device according to claim 19, wherein: the actuator element is coupled to the first movable element, the second element is a second movable element
configured to be movable with respect to a housing element of the mechanism unit, and
the mechanism unit is configured to enable setting a drug dose to be dispensed without a
relative movement between the first movable element and the second movable element.
In relation to claim 33, this claim depends from claim 19, which is rejected as discussed above. Kietzmann in view of Bode discloses the limitations of claim 19 as discussed above. Kietzmann in view of Bode does not explicitly disclose the second element is a second movable element configured to be movable with respect to a housing element of the mechanism unit, and the mechanism unit is configured to enable setting a drug dose to be dispensed without a relative movement between the first movable element and the second movable element.
Veasey discloses the second element is a second movable element (drive sleeve) configured to be movable with respect to a housing element of the mechanism unit, and the mechanism unit is configured to enable setting a drug dose to be dispensed without a relative movement between the first movable element (dose dial sleeve) and the second movable element (drive sleeve) (Abstract: "A drive mechanism suitable for use in drug delivery devices is disclosed. The drive mechanism may include a housing, a dose dial sleeve, and a drive sleeve. A clutch is configured to permit rotation of the drive sleeve and the dose dial sleeve with respect to the housing when the dose dial sleeve and drive sleeve are coupled through the clutch. Conversely, when the dose dial sleeve and drive sleeve are in a de-coupled state, rotation of the dose dial sleeve with respect to the housing is permitted and rotation of the drive sleeve with respect to the housing is prevented.").
Motivation to Combine: It would have been obvious to a person of ordinary skill in the art
at the time of the invention to modify the drug delivery device of Kietzmann in view of Bode
with the clutch mechanism of Veasey. The motivation to combine would have been to allow
the dose setting and drive components to move together during dose setting to prevent
unintended dispensing, and to decouple during dispensing to allow the drive mechanism
to advance the piston, as taught by Veasey (Abstract). A person of ordinary skill in the art
would have recognized that incorporating a clutch mechanism between the first movable
element (dose dial sleeve) and the second movable element (drive sleeve) would provide a
predictable result — a drug delivery device in which dose setting can be performed without
relative movement between the two movable elements, while dispensing involves relative
movement between them.
Conclusion
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Respectfully submitted,
/MANUEL A MENDEZ/Primary Examiner, Art Unit 3783
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