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 .
Specification
The disclosure is objected to because of the following informalities: Pg. 11 line 4 there should be a period before “Alternatively”.
Appropriate correction is required.
Claim Objections
Claims 1 and 29 are objected to because of the following informalities: The preambles to claims 1 and 29 should recite “An electromechanical cap remover…” Appropriate correction is required. Claim 1 recites “the protective cap and a portion of a housing of the medicament delivery device is placed” requires grammar correction.
Claim Rejections - 35 USC § 103
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) 15-21 and 23-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radmand et al. (US 2020/0230327 A1) in view of Kistler (DE 10 2015 214 087 A1) and Miller (US 2019/0201631 A1).
With regard to claims 15-21, 23-26, Radmand et al. teach an electromechanical cap remover for removing a protective cap from a medicament delivery device, the electromechanical cap remover comprising: a cap remover housing having an opening configured to receive the protective cap removably attached to the medicament delivery device (Figs. 5, 6, and 10 housing 50 and 60, opening in the area of 52), a motor system (Fig. 5 member 51), a gripping device configured to be actuated by the motor system and to grip the protective cap when received in the opening (Figs. 6 and 7 including at least first gripping members 300 and 31 and second gripping members 45 and 48, [0030], [0031], [0033], [0035]), a sensor unit ([0036]), a control unit ([0036]), wherein the control unit is configured to control the motor system to actuate the gripping device to grip the protective cap ([0036]). Radmand et al. teach using sensor and control electronics to initiate actuation of the clamping ([0036]) but do not explicitly disclose what is sensed or a communication module. However, Kistler teaches an electromechanical cap remover which uses a sensor to detect the position of the cap relative to the holder to control use and reduce injury risk (last paragraph on Pg. 2 onto PG. 3, see translation claim 6). Further, Miller teaches a device for extracting a needle which may include a cover which uses RFID sensors on both the needle and housing to track device components and the device may transmit and receive data to/from an external device to aid in ensuring proper disposal ([0003]-[0005], [0037], [0042], [0044]-[0046], [0076]-[0078], [0087]). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to use sensors on the cap and housing to control activation and a communication module to receive and send data in Radmand et al. as Radmand et al. at the outset teaches using sensors in conjunction with control electronics to actuate the device and Kistler teaches sensors to determine the position of the cap relative to the gripping device to control use to reduce injury and further Miller teaches is it beneficial to detect various components via RFID tags additionally including the medicament delivery device and communicating via transmission and receipt of data with an external device to properly track and document device information to ensure proper use and disposal. As individual components are tracked the device is able to detect separate locations of the housing and the cap.
With regard to claim 27, depending on the size of the cap a cap of nay shape may be inserted into the opening.
With regard to claim 28, as the device has a motor and electronics there is necessarily a power source.
With regard to claims 29-32, Radmand et al. teach an electromechanical cap remover for removing a protective cap from a medicament delivery device, the electromechanical cap remover comprising: a cap remover housing having an opening configured to receive the protective cap when removably attached to the medicament delivery device (Figs. 5, 6, and 10 housing 50 and 60, opening in the area of 52); a motor system (Fig. 5 member 51); a gripping device operatively connected to the motor system (Figs. 6 and 7 including at least first gripping members 300 and 31 and second gripping members 45 and 48, [0030], [0031], [0033], [0035]); a sensor unit ([0036]); a control unit ([0036]), wherein the gripping device comprises first gripping members that grip the protective cap automatically when the protective cap is placed within the opening and where second gripping members grip a portion of an outer housing of the medicament delivery device, wherein the motor system is configured to drive the first and second gripping members so that at least one of the first and second gripping members are able to move transversally and longitudinally in relation to a longitudinal axis (L) of the opening (Figs. 6 and 7 including at least first gripping members 300 and 31 and second gripping members 45 and 48, [0030], [0031], [0033], [0035]). Radmand et al. teach using sensor and control electronics to initiate actuation of the clamping ([0036]) but do not explicitly disclose what is sensed or a communication module. However, Kistler teaches an electromechanical cap remover which uses a sensor to detect the position of the cap relative to the holder to control use and reduce injury risk (last paragraph on Pg. 2 onto PG. 3, see translation claim 6). Further, Miller teaches a device for extracting a needle which may include a cover which uses RFID sensors on both the needle and housing to track device components and the device may transmit and receive data to/from an external device to aid in ensuring proper disposal ([0003]-[0005], [0037], [0042], [0044]-[0046], [0076]-[0078], [0087]). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to use sensors on the cap and housing to control activation and a communication module to receive and send data in Radmand et al. as Radmand et al. at the outset teaches using sensors in conjunction with control electronics to actuate the device and Kistler teaches sensors to determine the position of the cap relative to the gripping device to control use to reduce injury and further Miller teaches is it beneficial to detect various components via RFID tags additionally including the medicament delivery device and communicating via transmission and receipt of data with an external device to properly track and document device information to ensure proper use and disposal.
With regard to claim 33, as the device has a motor and electronics there is necessarily a power source.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radmand et al. (US 2020/0230327 A1), Kistler (DE 10 2015 214 087 A1) and Miller (US 2019/0201631 A1) as applied to claim 20 above, and further in view of McCullough et al. (US 2017/0124284 A1).
With regard to claim 22, as combined sensor data is sent to both the external device and control, device information is communicated between the device and external device. Miller teaches data includes drug and patient information ([0047], [0077]). Further, McCullough et al. teach preventing use if an unauthorized party is attempting to use a device ([0187]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to confirm patient and drug data before use to ensure proper delivery as in McCullough et al. to prevent accidental operation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783