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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 16, 18, 19, 21-26, 28, 30-32 and 34-35 have been considered but are moot due to the newly amended independent claims.
New Claims 36-40 are addressed below.
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.
Claim(s) 16, 18, 19, 21-26, 28, 30-32, and 34-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shaban (US 9,022,988 B1), as cited in the IDS 07/14/2022 and Hjelm et al. (US 2011/0022411 A1).
Regarding Claim 16, equivalent wireless data communication accessory Claim 28, and equivalent method Claim 32, Shaban teaches a system comprising:
a drug delivery device (injection device 102) comprising a dial knob (112) and an NFC loop antenna (using 116),
a wireless data communication accessory configured
to be attached to the drug delivery device (where 114 includes the RX/TX 116, and where 114 is attached to the body of the injection device 102) by coupling with the dial knob (Col. 4, lines 46-52),
to exchange data with the drug delivery device (Col. 3, lines 16-26: “control signals” and Col. 5, lines 25-32 “data”), and to secure data received from the drug delivery device by using cryptographic information assigned to the drug delivery device (Col. 3, lines 48-54),
to communicate with an external device via a wireless communication link (using RX/TX 116), and
to secure the wireless communication link for transmitting the data received from the drug delivery device using the cryptographic information assigned to the drug delivery device (Col. 3, lines 48-54), wherein at least a part of the cryptographic information is stored in a storage of the drug delivery device and is readable by the wireless data communication accessory (Col. 4, lines 14-35; Col. 5, line 66 through Col. 6, line 4),
but does not explicitly teach to exchange data with the drug delivery device using an NFC reader of the wireless data communication accessory,
wherein at least a part of the cryptographic information is stored in a storage of the drug delivery device and is readable by the NFC reader of the wireless data communication accessory
wherein at least one of the drug delivery device or the wireless data communication accessory comprises a storage for storage for storing data related to selected and delivered drug dosages, and
wherein the at least one of the drug delivery device or the wireless data communication accessory is configured to protect the stored data related to the selected and delivered drug dosages by using the cryptographic information.
Hjelm et al. teaches a system in Figure 2 comprising:
to exchange data with the drug delivery device using an NFC reader of the wireless data communication accessory (26; see also [0023] and Figure 3, Step 108),
wherein at least a part of the cryptographic information is stored in a storage of the drug delivery device and is readable by the NFC reader of the wireless data communication accessory ([0023] wherein an “NFC reader or transceiver 26 in the individual’s mobile station 10 reads medical data from the devices’ 30 NFC transmitters via a secure (encrypted) link (block 108)”; see also Figure 3: Step 108: Mobile station reads medical data from NFC transmitters via secure link)
wherein at least one of the drug delivery device or the wireless data communication accessory comprises a storage for storage for storing data related to selected and delivered drug dosages,([0023] wherein “the reading and storage of medical data at the mobile station 10 comprises an atomic, two-phase commit operation, a well-known, robust transaction protocol that provides some immunity against corruption due to transmission failures”; see also Shaban: Col. 4, lines 14-29) and
wherein the at least one of the drug delivery device or the wireless data communication accessory is configured to protect the stored data related to the selected and delivered drug dosages by using the cryptographic information ([0023] by using “a well-known, robust transaction protocol that provides some immunity against corruption due to transmission failures”; see also Shaban: Col. 3, line 48-54: through the authentication process; Col. 4, lines 2-3: “encrypted prior to being sent”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the NFC reader teachings of Hjelm et al. with the system of Shaban for the purpose of using “NFC communications (or other wireless communication technology, such as Bluetooth) to control the actuation of … drug delivery devices”. Hjelm, [0005].
Regarding Claim 18, Shaban and Hjelm, as a whole, teach all the limitations of the present invention, wherein Shaban further teaches the system, wherein at least a part of the cryptographic information is stored in a storage of the drug delivery device and is readable by the external device (Col. 4, lines 14-35).
Regarding Claims 19 and 30, Shaban and Hjelm, as a whole, teach all the limitations of the present invention, wherein Shaban further teaches the system, wherein the wireless data communication accessory is configured to secure the exchange of data between the wireless data communication accessory and the drug delivery device using the cryptographic information assigned to the drug delivery device (Col. 3, lines 48-54: using the authentication; see also Col. 3, line 55 through Col. 4, line 8).
Regarding Claim 21, Shaban and Hjelm, as a whole, teach all the limitations of the present invention, wherein Shaban further teaches the system, wherein the drug delivery device comprises a passive short-range wireless communication device comprising the storage storing the at least a part of the cryptographic information (using MEM 120, MP 118 and RX/TX 116).
Regarding Claim 22, Shaban and Hjelm, as a whole, teach all the limitations of the present invention, wherein Shaban further teaches the system, wherein at least a part of the cryptographic information is visibly applied to the drug delivery device (Col. 3, lines 48-54: using authentication).
Regarding Claim 23, Shaban and Hjelm, as a whole, teach all the limitations of the present invention, wherein Shaban further teaches the system, wherein at least a part of the cryptographic information is stored in a storage of the external device (Col. 4, lines 4-13: as uploaded and stored by the health care service provider servicer).
Regarding Claim 24, Shaban and Hjelm, as a whole, teach all the limitations of the present invention, wherein Shaban further teaches the system, wherein at least a part of the cryptographic information is stored on a server for downloading (Col. 4, lines 4-13: using the health care service provider servicer).
Regarding Claim 25, Shaban and Hjelm, as a whole, teach all the limitations of the present invention, but does not explicitly teach the system, wherein the server is a cloud-based server of a cloud storage.
It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ 2d 1647 (1987).
Here, Shaban teaches a server (Col. 4, lines 4-13: health care service provider service), but does not provide additional design details.
It would have been an obvious matter of design choice to use a cloud-based server of a cloud storage, since applicant has not disclosed that the type of server solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with other types of servers.
Regarding Claim 26, Shaban and Hjelm, as a whole, teach all the limitations of the present invention, wherein Shaban further teaches the system, wherein the exchange of data between the wireless data communication accessory and the drug delivery device requires a pairing of the wireless data communication accessory with the drug delivery device, wherein the cryptographic information is required for the pairing (Col. 3, lines 48-54: as required by the authentication process).
Regarding Claims 31, 34, and 35, Shaban and Hjelm, as a whole, teach all the limitations of the present invention, wherein Shaban further teaches the wireless data communication accessory, further configured
to read the cryptographic information from a storage of a passive short-range wireless communication device of the drug delivery device by generating a radio frequency field to power the passive short-range wireless communication device (as transmitted from RX/TX 116), and
receiving the cryptographic information from the storage of the passive short-range wireless communication device via short-range communication link (using MEM 120, MP 118 and RX/TX 116; Col. 4, lines 2-3: as “encrypted prior to being sent”).
Regarding Claims 36, 38, and 40, Shaban and Hjelm, as a whole, teach all the limitations of the present invention, wherein Shaban further teaches the system, wherein the wireless data communication accessory is configured to be attached to the drug delivery device by clipping or pinning onto the dial knob (where 114 is attached to and communicates with the dosage control knob 112 using control signals; see Col. 4, lines 41-48).
Regarding Claims 37 and 39, Shaban and Hjelm, as a whole, teach all the limitations of the present invention, wherein Shaban further teaches the system, wherein the wireless data communication accessory is configured to exchange data with the drug delivery device using the NFC reader of the wireless data communication accessory by establishing an electromagnetic coupling between (i) the NFC reader of the wireless data communication accessory and (ii) the NFC loop antenna of the drug delivery device when the wireless data communication accessory is attached to the dial knob of the drug delivery device (using microprocessor 118 and control signals between 114 and 112).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Diana J Cheng whose telephone number is (571)270-1197. The examiner can normally be reached Monday - Friday 9 am - 5:30 pm ET.
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/DIANA J. CHENG/ Primary Examiner, Art Unit 2849