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 § 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.
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 26 is rejected under 35 U.S.C. 103 as being unpatentable over Sjolund et al. (US 20190184093 A1) in view of Mizota et al. (US 20200280844 A1) and Byerly et al. (US 20210330891 A1).
Regarding claim 26, Sjolund teaches a wireless data communication accessory (Fig. 7, accessory/pen cap 122 and Par. 92) configured for attachment to a drug delivery device (Par. 297, reusable accessory is adapted to be reversibly attached to a medication insulin/injection pen (drug delivery device)) comprising: an interface for data exchange between the accessory and the drug delivery device (Fig. 1B and Pars. 93, 100, insulin pen includes an interface for wired/wireless communication with the pen cap (i.e. the pen cap also must have an interface for wired/wireless communication with the insulin pen); a wireless communication device (Par. 62) configured to communicate with an external device paired with the wireless communication device via wireless communication (Fig. 7 and Par. 100, the pen cap wirelessly communicate pen capping information to mobile device 140 (external device)); and a controller (Par. 62, processor & it is very well-known that the processor (controller) coupled to the interface and the wireless communication device) and being configured to control operation of the interface and the wireless communication device such that data received from the drug delivery device via the interface are processed (Par. 100, dosing action/amount of insulin delivered is captured at the insulin pen and provided to the pen cap) for transmission to the external device via the wireless communication (wirelessly communicate pen capping information to mobile device (Pars. 94, 100)).
Sjolund lacks on the teaching of the processor (controller) coupled to the interface and the wireless communication device.
However, it is very well-known that the processor (controller) coupled to the interface and the wireless communication device as evidence by Mizota (Fig. 2).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the above teaching as taught by Mizota into Sjolund for controlling wireless communications.
However, the modified Sjolund lacks on the teaching of the accessory further comprising: a detection device configured to detect a usage of the drug delivery device and to active a power supply of the accessory upon a detected usage when the accessory being attached to the drug delivery device.
Byerly teaches such feature (Fig. 1 and Pars. 73, 77).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the above teaching as taught by Byerly into the modified Sjolund to automatically detect the dose delivered.
Regarding claim 43, the modified Sjolund teaches previous claim. The modified Sjolund further teaches the accessory of claim 26, wherein the detection device are configured to detect a dosage selection on and/or a dosage delivery by the drug delivery device as a usage of the drug delivery device (Pars. 96, 100).
Claims 27, 30, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Sjolund et al. (US 20190184093 A1) in view of Mizota et al. (US 20200280844 A1) and Byerly et al. (US 20210330891 A1) and in further view of Nielsen et al. (US 20110295215 A1).
Regarding claim 27, the modified Sjolund teaches previous claim. Sjolund further teaches the accessory of claim 26, wherein the interface comprises second wireless communication device configured for (Pars. 93-95, 100, dosing action/amount of insulin delivered is captured at the insulin pen and provided to the pen cap).
However, the modified Sjolund lacks on the teaching of second wireless communication device configured for generating a radio frequency field for powering passive short-range wireless communication device of the drug delivery device.
Nielsen teaches “coil” (second wireless communication device) in the cap provides electrical energy to a coil in the insulin pen (passive short-range wireless communication device of the drug delivery device) wirelessly through a magnetic field by induction) (Fig. 15 and Pars. 100-102).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the above teaching as taught by Nielsen into the modified Sjolund to reduce energy/power consumption.
Regarding claim 30, the modified Sjolund teaches previous claim. The modified Sjolund further teaches the accessory of claim 26, wherein the interface comprises wired communication device and interface circuitry configured for data exchange via the at least one contact (Pars. 93-95).
However, the modified Sjolund lack on the teaching of the interface comprising at least one contact for electrically connecting to at least one contact of the drug delivery device when the accessory being attached to the drug delivery device.
Nielsen teaches such feature (Fig. 15 and Pars. 64, 100-102, electrical contacts/connectors).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the above teaching as taught by Nielsen into the modified Sjolund to reduce energy/power consumption.
Regarding claim 35, the modified Sjolund teaches previous claim. The modified Sjolund further teaches the accessory of claim 26, further comprising: a housing being cap-like shaped (Figs. 3-5) for capping and uncapping” (Pars. 36, 39)) on one end of a pen-like shaped drug delivery device (Fig. 1B, pen 110/120).
However, the modified Sjolund fails to mention the “capping and uncapping” is “pinning”.
Nielsen teaches such feature (Fig. 14-15).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the above teaching as taught by Nielsen into the modified Sjolund for secure alignment.
Claims 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Sjolund et al. (US 20190184093 A1) in view of Mizota et al. (US 20200280844 A1) and Byerly et al. (US 20210330891 A1) and in further view of Nielsen et al. (US 20110295215 A1) and further in further view of Welle et al. (US 20210209433 A1).
Regarding claim 28, the modified Sjolund teaches previous claim.
However, the modified Sjolund lacks on the teaching of the accessory of claim 27, wherein the second wireless communication device are configured for generating the radio frequency field within a proximity on the order of centimetres and the wireless communication device are configured to communicate with the paired external device within a proximity on the order of meters.
However, it is very well-known that NFC range is a few centimetres and Bluetooth range is a few metres/meters as evidence by Welle (Pars. 7, 51).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the above teaching as taught by Welle into the modified Sjolund to ensure the communication is within the distance range of the standard of each protocol.
Regarding claim 29, the modified Sjolund teaches previous claim. The modified Sjolund further teaches the accessory of claim 28, wherein the wireless communication device comprise a Bluetooth® communication circuitry with an antenna configured for Bluetooth® communication and/or the second wireless communication means comprise NFC reader circuitry with an antenna configured for NFC communication (Welle, Pars. 7, 51).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Sjolund et al. (US 20190184093 A1) in view of Mizota et al. (US 20200280844 A1) and Byerly et al. (US 20210330891 A1) and in further view of Nielsen et al. (US 20110295215 A1) and further view of Bar-Zeev et al. (US 10997544 B1).
Regarding claim 33, the modified Sjolund teaches previous claim. The modified Sjolund further teaches the accessory of claim 30, wherein the wired communication device are configured to source an electric current via the at least one contact, wherein the electric current is generated to source an electric current in one or more contacts of an antenna of the drug delivery device such that the wired communication device can read a signal (Nielsen, Figs. 13-15 and Pars. 100-104, coil (antenna)).
the modified Sjolund lacks of teaches the signal is a signal modulation.
However, it is very well-known that NFC/RFID protocol the signal is in form of modulated signal as evidence by Bar-Zeev (Col. 5 Line 15-35, tag (accessory), reader (drug delivery device)).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the above teaching as taught by Bar-Zeev into the modified Sjolund to utilize RFID/NFC protocol for low power consumption.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Sjolund et al. (US 20190184093 A1) in view of Mizota et al. (US 20200280844 A1) and Byerly et al. (US 20210330891 A1), in further view of Nielsen et al. (US 20110295215 A1), further in further view of Bar-Zeev et al. (US 10997544 B1) and further in further view of Tomassini et al. (US 20170006414 A1).
Regarding claim 34, the modified Sjolund teaches previous claim. The modified Sjolund further teaches the accessory of claim 33, wherein the wired communication device comprise a NFC reader circuitry (See rejection of claim 33 & Also, it is very well-known NFC reader circuitry being configured to implement a physical layer by connected to the CPU as in Fig. 13 of Bar-Zeev or Fig. 2 of Mizota)).
However, the modified Sjolund lacks on the teaching of the NFC reader circuitry being configured to implement a physical layer of a communications protocol layer (Pars. 41-42, 75).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the above teaching as taught by Tomassini into the modified Sjolund for charging power.
Response to Arguments
Applicant's arguments with respect to claim 26 has been considered but are moot in view of new ground(s) of rejection.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CINDY HUYEN TRANDAI whose telephone number is (571)270-1914. The examiner can normally be reached 8am -4:30pm.
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/Cindy Trandai/Primary Examiner, Art Unit 2648 2/6/2026