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 .
Claims 1-20 are cancelled.
Claims 21-40 are new.
Claims 21-40 are being examined in this Office Action.
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.
Claim(s) 21, 22, 24, 25, 27, 33 -36, 39 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanofi (EP 3669912 A1) in view of Schabbach et al. (Pub. No. US 20180236172 A1, herein Schabbach).
Regarding Claim 21, Sanofi discloses an injection device for injecting of a dose of a medicament (Fig. 1), the injection device comprising:
a drive mechanism (40) configured to operably engage with a medicament container (10, Fig. 1);
a housing (21) of elongated shape and extending along a longitudinal direction (Fig. 1), the housing comprising a distal housing component (23) configured to accommodate the medicament container (Paragraph [0121]);
an electronic unit (22) coupled to the drive mechanism (Fig. 1); and
an electric sensor (50) provided at or near a distal end of the proximal housing component (Fig. 1), the electric sensor electrically connected to the electronic unit and configured to contactlessly detect an electric identifier (52, “The drug delivery device 20 comprises a container identification arrangement 50 that is configured to detect and/or to identify the container identification 52 provided on the drug container 10 when the drug container 10 is arranged inside the receptacle 23 of the drug delivery device. The container identification 52 comprises one of a mechanical, optical, capacitive, magnetic and/or electromagnetic encoding that can be detected and read by the container identification arrangement 50. The container identification arrangement 50 is further configured to communicate at least with a delivery device interface 24 of the drug delivery device 20. In this way, a container identification 52 retrieved or detected by the container identification arrangement 50 can be transmitted or transferred to the delivery device interface 24.” – Paragraph [0121]) provided on or in one of the medicament container and the distal housing component (Fig. 1).
Sanofi does not expressly disclose a proximal housing component configured to accommodate or to support the drive mechanism to operably engage with the medicament container for expelling or withdrawing of the dose of the medicament from the medicament container.
Schabbach teaches a proximal housing component (20) configured to accommodate or to support the drive mechanism (5) to operably engage with the medicament container for expelling or withdrawing of the dose of the medicament from the medicament container (Paragraph [0171]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection device disclosed by Sanofi to include a proximal housing component configured to accommodate or to support the drive mechanism to operably engage with the medicament container for expelling or withdrawing of the dose of the medicament from the medicament container as taught by Schabbach so that there may be an area for a drive mechanism where a user may interact with to expel a dose of medication (Schabbach, Paragraph [0172]).
Regarding Claim 22, modified Sanofi in view of Schabbach discloses the injection device of claim 21, wherein the drive mechanism comprises at least one interlock configured to disable at least one of setting of the dose of the medicament and dispensing of the dose of the medicament (Sanofi, “Once a drug container replacement or drug container insertion has been detected by the drug delivery device the drive mechanism may be blocked per default until the container identification of the new drug container has been identified.” – Paragraph [0072]).
Regarding Claim 24, modified Sanofi in view of Schabbach discloses the injection device of claim 21, wherein the distal housing component comprises a connecting end for detachably connecting to a connecting end of the proximal housing component (Schabbach, Figs. 5-6, “a proximal end of the cartridge holder 30 is connectable to a distal end of the body 20.” – Paragraph [0168]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection device disclosed by Sanofi wherein the distal housing component comprises a connecting end for detachably connecting to a connecting end of the proximal housing component as taught by Schabbach so that a depleted medicament container may be replaced (Schabbach, Paragraph [0051]).
Regarding Claim 25, modified Sanofi in view of Schabbach discloses the injection device of claim 24, wherein the electric identifier is arranged on or in one of the connecting end of the distal housing component and a proximal end of the medicament container (Sanofi, 50 arranged on proximal end of receptacle 23 in Fig. 1).
Regarding Claim 27, modified Sanofi in view of Schabbach discloses the injection device of claim 21, wherein the electric sensor is configured to contactlessly detect a presence and/or a type of the electric identifier (Sanofi, “The drug delivery device 20 comprises a container identification arrangement 50 that is configured to detect and/or to identify the container identification 52 provided on the drug container 10 when the drug container 10 is arranged inside the receptacle 23 of the drug delivery device. The container identification 52 comprises one of a mechanical, optical, capacitive, magnetic and/or electromagnetic encoding that can be detected and read by the container identification arrangement 50. The container identification arrangement 50 is further configured to communicate at least with a delivery device interface 24 of the drug delivery device 20. In this way, a container identification 52 retrieved or detected by the container identification arrangement 50 can be transmitted or transferred to the delivery device interface 24.” – Paragraph [0121]).
Regarding Claim 33, modified Sanofi in view of Schabbach discloses the injection device of claim 21, wherein the electric identifier comprises a passive electronic identifier (Sanofi, “As in the previous examples, specific medication identifiers provided on a primary drug container, such as RFID tags, NFC labels, data-matrix codes, or mechanic features, can trigger device functions or data processing.” – Paragraph [0096], NFC label being an example of a passive electronic identifier).
Regarding Claim 34, modified Sanofi in view of Schabbach discloses the injection device of claim 33, wherein the passive electronic identifier comprises a near field communication (NFC) tag configured to communicate with the electric sensor implemented as a corresponding near field communication interface of the electronic unit (Sanofi, “The electromagnetic encoding provided on the drug container may include one of an RFID tag or NFC tag. The electromagnetic sensor of the container identification arrangement then comprises a correspondingly configured RFID reader or NFC reader.” – Paragraph [0050]).
Regarding Claim 35, modified Sanofi in view of Schabbach discloses the injection device of claim 33, wherein the passive electronic identifier comprises a non-volatile memory to store at least one of a medicament name, a medicament manufacturing date, a medicament expiry date, a lot number of the medicament, and a unique medicament container ID (Sanofi, “the electronic circuit 46 and hence the drug delivery device comprises a delivery device storage 26. The delivery device storage 26 may be implemented as a non-volatile memory. The delivery device storage 26 is typically configured or operable to store at least one or more of at least a portion or the entirety of the container identification 52” – Paragraph [0141]).
Regarding Claim 36, modified Sanofi in view of Schabbach discloses the injection device according to claim 35, wherein the non-volatile memory is at least one of erasable or writable by the near field communication interface (Sanofi, Paragraph [0141], Fig. 1).
Regarding Claim 39, modified Sanofi in view of Schabbach discloses the injection device of claim 21, wherein the medicament container filled with the medicament is arranged inside the housing (Sanofi, 12, Fig. 1).
Regarding Claim 40, Schabbach discloses a method of unlocking operation of an injection device (20) for at least one of setting and injecting of a dose of a medicament (Paragraphs [0167]-[0169]), wherein the injection device comprises a drive mechanism (40) configured to operably engage with a medicament container (10, Fig. 1), a housing (21)comprising a distal housing component (23) configured to accommodate the medicament container (Fig. 1), an electronic unit (22) coupled to the drive mechanism (Fig. 1), an electric sensor (50) electrically connected to the electronic unit and configured to detect an electric identifier (52, “The drug delivery device 20 comprises a container identification arrangement 50 that is configured to detect and/or to identify the container identification 52 provided on the drug container 10 when the drug container 10 is arranged inside the receptacle 23 of the drug delivery device. The container identification 52 comprises one of a mechanical, optical, capacitive, magnetic and/or electromagnetic encoding that can be detected and read by the container identification arrangement 50. The container identification arrangement 50 is further configured to communicate at least with a delivery device interface 24 of the drug delivery device 20. In this way, a container identification 52 retrieved or detected by the container identification arrangement 50 can be transmitted or transferred to the delivery device interface 24.” – Paragraph [0121]) provided on or in one of the medicament container and the distal housing component (Fig. 1), and at least one interlock configured to disable at least one of setting of the dose and dispensing of the dose (“Once a drug container replacement or drug container insertion has been detected by the drug delivery device the drive mechanism may be blocked per default until the container identification of the new drug container has been identified.” – Paragraph [0072]), wherein the method comprises:
detecting at least one of a presence and a type of an electric identifier by the electric sensor (“The capacitive sensor of the container identification arrangement is typically configured to detect an electrostatic field provided on and by a respective capacitive encoding attached to or integrated into the drug container. Likewise, the drug container may be equipped or provided with a magnetic encoding detectable and readable by a correspondingly configured magnetic sensor of the container identification arrangement. When implemented as an electromagnetic sensor the container identification arrangement is particularly operable to transmit and/or to receive electromagnetic radiation, such as radio-frequency signals or electromagnetic signals of any other frequency band. Here, the encoding provided on the drug container may comprise an electronic circuit configured for wireless signal transmission. The electromagnetic encoding provided on the drug container may include one of an RFID tag or NFC tag. The electromagnetic sensor of the container identification arrangement then comprises a correspondingly configured RFID reader or NFC reader.” – Paragraph [0050]);
generating at least one detection signal indicative of the electric identifier and transmitting the at least one detection signal to the electronic unit (“the container identification arrangement comprises at least one of a mechanical sensor, an optical sensor, a capacitive sensor, a magnetic sensor and an electromagnetic sensor, e.g. a radio frequency (RF) sensor. The container identification arrangement is operable to generate and to transmit an electronic identification signal being indicative of the container identification when the drug container is arranged in the receptacle of the drug delivery device” – Paragraph [0047]);
validating the at least one detection signal (“The electromagnetic encoding provided on the drug container may include one of an RFID tag or NFC tag. The electromagnetic sensor of the container identification arrangement then comprises a correspondingly configured RFID reader or NFC reader.” – Paragraph [0050]); and
at least one of temporarily deactivating or re-activating the at least one interlock based on a validation of the at least one detection signal (“Once a drug container replacement or drug container insertion has been detected by the drug delivery device the drive mechanism may be blocked per default until the container identification of the new drug container has been identified.” – Paragraph [0072]).
Sanofi does not expressly disclose a proximal housing component configured to accommodate or to support the drive mechanism.
Schabbach teaches a proximal housing component (20) configured to accommodate or to support the drive mechanism (5, Fig. 5).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Method of unlocking operation of an injection injection device disclosed by Sansofi to include a proximal housing component configured to accommodate or to support the drive mechanism as taught by Schabbach so that there may be an area for a drive mechanism where a user may interact with to expel a dose of medication (Schabbach, Paragraph [0172]).
Claim(s) 26, 28-30, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanofi in view of Schabbach, further in view of Carlsson (US 10804971 B2).
Regarding Claim 26, modified Sanofi in view of Schabbach discloses the injection device of claim 24.
Modified Sanofi in view of Schabbach does not expressly disclose wherein the electric sensor is arranged on or in the connecting end of the proximal housing component.
Carlsson teaches wherein the electric sensor (38, Col. 4 Lines 25-30) is arranged on or in the connecting end (50) of the proximal housing component (8, Fig. 4).
Therefore, it would be obvious to one of ordinary skill in the art to modify the injection device disclosed by modified Sanofi in view Schabbach wherein the electric sensor is arranged on or in the connecting end of the proximal housing component as taught by Carlsson so that the sensor is within reading distance of the identifier (Carlsson, Col. 4 Lines 25-30).
Regarding Claim 28, modified Sanofi in view of Schabbach discloses the injection device of claim 21.
Modified Sanofi in view of Schabbach does not expressly disclose wherein the electric identifier comprises an inductive coil or a solenoid coil with a coil axis extending substantially parallel to the longitudinal direction of the housing.
Carlsson teaches wherein the electric identifier (30) comprises an inductive coil (“The information carrier 28 comprises an antenna 30 that enables reading of stored data from the tag by an information carrier reader. The information carrier may for example be an RFID-tag or NFC-tag.” – Col. 4 Lines 15-19, Fig. 4, NFC tag being an example of an inductive coil to communicate with antenna 38) with a coil axis extending substantially parallel to the longitudinal direction of the housing (Fig. 4).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection device disclosed by modified Sanofi in view of Schabbach wherein the electric identifier comprises an inductive coil or a solenoid coil with a coil axis extending substantially parallel to the longitudinal direction of the housing as taught by Carlsson so that the identifier may enable wireless communication (Carlsson, Col. 4 Lines 15-21).
Regarding Claim 29, modified Sanofi in view of Schabbach and Carlsson injection device of claim 28, wherein the electric identifier comprises a floating coil (Carlsson, 30 being a standalone coil connected to nothing in Fig. 4, Col. 4 Lines 15-21).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection device disclosed by modified Sanofi in view of Schabbach wherein the electric identifier comprises a floating coil as taught by Carlsson so that the identifier may be easily positioned within the distal housing portion (Carlsson, Col. 4 Line 66 through Col. 5 Line 8).
Regarding Claim 30, modified Sanofi in view of Schabbach and Carlsson discloses the injection device of claim 28.
Modified Sanofi in view of Schabbach and Carlsson does not expressly disclose wherein the inductive coil is provided on a flexible substrate configured for attachment or arrangement to a tubular-shaped sidewall of one of the distal housing component and the medicament container.
However, Carlsson teaches a flexible holder (60) in which the antenna (38) is arranged on that attaches to a tubular-shaped sidewall of the proximal housing component (8, Fig. 5, Col. 4 Line 66 through Col. 5 Line 2)
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection device disclosed by modified Schabbach in view of Sanofi wherein the inductive coil is provided on a flexible substrate configured for attachment or arrangement to a tubular-shaped sidewall of one of the distal housing component and the medicament container as taught by Carlsson so that the range of the antenna may extend to cover a portion of the engagement area of the distal housing component (Carlsson, Col. 4 Line 66 through Col. 5 Line 2).
Regarding Claim 32, modified Sanofi in view of Schabbach discloses the injection device of claim 21.
Modified Sanofi in view of Schabbach does not expressly disclose wherein the electric sensor comprises an inductive coil or a solenoid coil with a coil axis extending substantially parallel to the longitudinal direction of the housing.
Carlsson teaches wherein the electric sensor (38) comprises a solenoid coil with a coil axis extending substantially parallel to the longitudinal direction of the housing (Fig. 4).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection device disclosed by modified Sanofi in view of Schabbach wherein the electric sensor comprises an inductive coil or a solenoid coil with a coil axis extending substantially parallel to the longitudinal direction of the housing as taught by Carlsson so that electric sensor may cover a portion of the engagement area of the proximal housing component (Carlsson, Col. 4 Line 63 though Col. 5 Line 2).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanofi in view of Schabbach and Carlsson, further in view of Hansen et al. (Pub. No. US 20090318876 A1, herein Hansen).
Regarding Claim 31, modified Sanofi in view of Schabbach and Carlsson discloses the injection device of claim 28.
Modified Sanofi in view of Schabbach and Carlsson does not expressly disclose wherein the electric identifier is encoded by at least one of a number of windings of the inductive coil, a capacitor electrically connected to the inductive coil, and a microchip electrically connected to the inductive coil.
Hansen teaches wherein the electric identifier (5, Paragraphs [0036]-[0039]) is encoded by a at least one of a capacitor electrically connected to the inductive coil and a microchip electrically connected to the inductive coil (“The electronic circuit of the fourth and fifth aspects may comprise an inductor operatively coupled to a capacitor. Alternatively, the resonance frequency of the electronic circuit may be controlled by an oscillating crystal or a microprocessor “- Paragraph [0035]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify injection device disclosed by modified Sanofi in view of Schabbach and Carlsson wherein the electric identifier is encoded by a at least one of a capacitor electrically connected to the inductive coil and a microchip electrically connected to the inductive coil as taught by Hansen so that may be a capacitor capable of exchanging energy with the inductive coil to control the resonance frequency (Hansen, Paragraph [0035]).
Claim(s) 23, 37, and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanofi in view of Schabbach further in view of Kietzmann et al. (Pub. No. US 20140330243 A1, herein Kietzmann).
Regarding Claim 23, modified Sanofi in view of Schabbach discloses the injection device of claim 22.
Modified Sanofi in view of Schabbach does not expressly disclose wherein the electronic unit is operable to control the at least one interlock in response to signals received from the electric sensor.
Kietzmann teaches wherein the electronic unit is operable to control the at least one interlock in response to signals received from the electric sensor (“As indicated in FIG. 3, the drive mechanism 20 of the drug delivery device 10 comprises at least one interlock member 30 being coupled with a control or control unit 36 in order to mechanically obstruct displacement of the piston rod 25 if a condition of use of the drive mechanism is not fulfilled.” – Paragraph [0139]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection device disclosed by modified Sanofi in view of Schabbach wherein the electronic unit is operable to control the at least one interlock in response to signals received from the electric sensor as taught by Carlsson so that a dose is not delivered prematurely (Kietzmann, Paragraph [0039]).
Regarding Claim 37, modified Sanofi in view of Schabbach discloses the injection device of claim 22.
Modified Sanofi in view of Schabbach does not expressly disclose comprising a first component and a second component, the first component is movable relative to the second component for at least one of setting of the dose and injecting of the dose;
wherein the at least one interlock comprises an electromechanical interlock configured to mechanically engage with the first component and with the second component; and
wherein the at least one interlock is operable to switch between an interlocked state, in which the first component is movably locked to the second component, and a release state, in which the first component is movable relative to the second component.
Kietzmann teaches an injection device comprising a first component (latch or clutch) and a second component (piston rod 25 or dose dial 18, injection button 17, and dose dial sleeve 23, Paragraph [0139]), the first component is movable relative to the second component for at least one of setting of the dose and injecting of the dose (Paragraph [0139]);
wherein the at least one interlock comprises an electromechanical interlock configured to mechanically engage with the first component and with the second component (Paragraph [0025]); and
wherein the at least one interlock is operable to switch between an interlocked state, in which the first component is movably locked to the second component (Paragraph [0038]), and a release state, in which the first component is movable relative to the second component (“the drive mechanism will be mechanically obstructed by means of an interlock member of the drug delivery device adapted to releasably engage with an arbitrary, but force- or torque transmitting component of the drive mechanism. However, in case the determined state parameter matches with the at least one predefined condition of use, actuation of the drive mechanism, e.g. for dose setting and/or dose dispensing is released and the device can be used in a rather conventional way.” – Paragraph [0047]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection device disclosed by modified Sanofi in view of Schabbach comprising a first component and a second component, the first component is movable relative to the second component for at least one of setting of the dose and injecting of the dose;
wherein the at least one interlock comprises an electromechanical interlock configured to mechanically engage with the first component and with the second component; and wherein the at least one interlock is operable to switch between an interlocked state, in which the first component is movably locked to the second component, and a release state, in which the first component is movable relative to the second component as taught by Kietzmann so that when a condition is filled, the interlock may be set in a release state, and if not, obstruct the delivery of a dose (Kietzmann, Paragraph [0038]).
Regarding Claim 38, modified Sanofi in view of Schabbach discloses injection device of claim 22.
Modified Sanofi in view of Schabbach does not expressly disclose wherein the drive mechanism comprises at least one clutch operable to switch the drive mechanism between a dose setting mode and a dose injecting mode; and
wherein the at least one interlock is operably engaged with the at least one clutch to selectively disable switching of the drive mechanism from one of the dose setting mode and the dose injecting mode into the other one of the dose setting mode and the dose injecting mode.
Kietzmann teaches wherein the drive mechanism comprises at least one clutch operable to switch the drive mechanism between a dose setting mode and a dose injecting mode (“The interlock member 30 may comprise a latch or clutch-mechanism and may mechanically engage with the piston rod 25 in order to obstruct a longitudinal displacement or rotation thereof relative to the housing 12. The interlock member 30 may also releasably engage with any other component of the drive mechanism. Hence, it is conceivable, that the interlock member 30 engages with either the dose dial 18, with the injection button 17 and/or with the dose dial sleeve 23.” – Paragraph [0139]); and
wherein the at least one interlock is operably engaged with the at least one clutch to selectively disable switching of the drive mechanism from one of the dose setting mode and the dose injecting mode into the other one of the dose setting mode and the dose injecting mode (Paragraph [0139]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection device disclosed by modified Sanofi in view of Schabbach wherein the drive mechanism comprises at least one clutch operable to switch the drive mechanism between a dose setting mode and a dose injecting mode; and wherein the at least one interlock is operably engaged with the at least one clutch to selectively disable switching of the drive mechanism from one of the dose setting mode and the dose injecting mode into the other one of the dose setting mode and the dose injecting mode as taught by Kietzmann so that when a condition is filled, the interlock may be set in a release state, and if not, obstruct the delivery of a dose (Kietzmann, Paragraph [0038]).
Conclusion
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/MARK GOLOVAN/ Patent Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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