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 .
Acknowledgments
This office action is in response to the reply filed on 4/23/26. In the reply, the applicant amended claims 16,18,22-23,29-30,33; canceled claim 17; added new claim 36. Claims 16, 18-36 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/23/26 is in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDS is being considered by the Examiner.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 16, 18-36 are rejected under 35 U.S.C. 103 as being unpatentable over McCullough et al. (US 2017/0124284) (“McCullough”).in view of Edwards et al. (US 8,361,026) (“Edwards”).
(claims 16,23,30) McCullough discloses: (Fig. 1, 3B, 13; 300) a user device and method 110 configured to determine (via temperature sensor 760, controller 750 and communication module 752) a threshold time for an injection device 100 to transition from a storage temperature to an operational temperature, the user device comprising a scanning device 112, wherein the user device is configured to: use the scanning device to scan the injection device; determine a local temperature 760; determine a threshold time, wherein the threshold time is based on the local temperature, the operational temperature, and a volume of a drug contained in the injection device; and alert a user that the threshold time has been reached. [0224,0123-0124,0170] Fig. 3B
McCullough discloses the invention as substantially claimed; however, in McCullough, the temperature sensor is on the injection device rather than in the storage device of the injection device.
Edwards, in the analogous art, teaches a storage device (20020, Fig. 87) with a wireless transceiver to send a signal to the user device when an injection device is removed from the storage device, (claims 24-25) the storage device also transmits information provided by a temperature sensor of the storage device to the user device C75L57-C78L14, C75L55-C76L10
As in McCullough, the user device is configured to receive the signal from the storage device as taught by Edwards and in response, output an alert; use the scanning device to scan the injection device; determine a local temperature; determine a threshold time, wherein the threshold time is based on the local temperature, an operational temperature, and a volume of a drug contained in the injection device; and alert a user that the threshold time has been reached. [0224,0123-0124]. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of McCullough with the temperature sensor on the storage device as taught by Edwards to ensure that compromised medicaments are not dispensed (Edwards C75L57-C76L6)
Claim 18: the user device is configured to receive additional operational information from at least one of the following: a storage device configured to store the injection device; or the Internet. [0223] (and see combination with Edwards C75L57-C76L6)
Claims 19,31: the user device is further configured to: receive an input from the user; based on the input received from the user, set an upper threshold temperature and/or a lower threshold temperature which the injection device should not exceed; and output an alert in case the upper threshold temperature and/or the lower threshold temperature is exceeded. [0017,0222,0124,0079] (and see combination with Edwards C75L57-C76L6)
Claims 20,32: the user device is further configured to output an alert in case the upper threshold temperature and/or the lower threshold temperature is exceeded for a predetermined period of time. [0123] (and see combination with Edwards C75L57-C76L6)
Claims 21,35: the user device is configured to calculate the threshold time based at least in part on one or more of the following: a type of the injection device, a type and volume of the drug in the injection device, a temperature of a room, or a forecast temperature for a location of the injection device. [0099,0124]
Claims 22,33,24,25: the user device is configured to scan the injection device before putting the injection device into the storage device and/or scan the injection device or environmental information of the storage device as the injection device is removed from the storage device, [0004,0124] (and see combination with Edwards C75L57-C76L6) (Edwards C75L57-C78L14, C75L55-C76L10)
Claim 26: the user device is further configured to: receive an input from the user; based on the input received from the user, set an upper threshold temperature and/or a lower threshold temperature which the injection device should not exceed; and output an alert in case the upper threshold temperature and/or the lower threshold temperature is exceeded. [0017,0222,0124,0079]
Claim 27: the user device is further configured to output an alert in case the upper threshold temperature and/or the lower threshold temperature is exceeded for a predetermined period of time. [0123]
Claim 28: the user device is configured to calculate the threshold time based at least in part on one or more of the following: a type of the injection device, a type and volume of the drug in the injection device, a temperature of a room, or a forecast temperature for a location of the injection device. [0099,0124]
Claim 29: the user device is configured to scan the injection device before putting the injection device into a storage device and/or scan the injection device as the injection device is removed from the storage device, and wherein the user device is further configured to obtain the operational information based on the scan of the injection device. [0004,0124]
With respect to claim 34: the combination of McCullough/Edwards further comprises outputting, by the injection device, a reminder for the user that the injection device must be left to reach the operational temperature for the threshold time. (Edwards C66L43-C67L14).
Claim 36: the user device is configured to render, on a display of the user device, a timing interface comprising a time until the threshold time is reached (Edwards, timer indicating stability of the injection which from the specification as a whole has to do with a proper temperature being reached C66L43-C67L14, C75L57-C76L6,C64L56-C65L3 (temperature problems substitutes for mixing longer than a predetermined time as a timer indicated problem) (C35L20-52,C9L54-66)
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection is in response to applicant’s amendments and new claim.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783
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