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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 7/28/23;8/28/25;9/25/25;10/6/25;1/15/26 are in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDSs are being considered by the Examiner.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 16-22, 30-33,35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McCullough et al. (US 2017/0124284) (“McCullough”).
(claims 16,30) 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]
Claim 17: the user device is further configured to receive operational information comprising temperature (via temperature sensor 760).
Claim 18: the user device is configured to receive operational information from at least one of the following: the injection device; a storage device configured to store the injection device; or the Internet. [0223]
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]
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]
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: 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]
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 23-29, 34 are rejected under 35 U.S.C. 103 as being unpatentable over McCullough in view of Edwards et al. (US 8,361,026) (“Edwards”).
(claim 23) 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 C75L57-63)
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).
Conclusion
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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/DEANNA K HALL/Primary Examiner, Art Unit 3783