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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/25/25 has been entered.
Acknowledgments
This office action is in response to the reply filed on 8/25/25. In the reply, the applicant amended claims 1, 8, 15, 21. Claims 1-4, 7-15, 17-22 are pending.
The 112 rejection of claim 8 is withdrawn due to applicant’s amendment.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 7-15, 17-22 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Dahmani et al. (US 11,077,255).
(claims 1,15) Dahmani discloses: A drug delivery device 100 and method of delivering a drug product (Figs.2,5) comprising: a housing 102; a reservoir 210 removably disposed within the housing and having a sidewall defining an interior for containing a drug 202; a temperature sensor 240 configured to measure a current temperature relating to at least one of the reservoir, the sidewall of the reservoir, the housing, or the drug (C4L1-6); a drug data portion 238 (RFID tag), 150 (memory) associated with the reservoir, the drug data portion including information configured to convey a temperature-based viscosity profile of the druq disposed within the interior of the reservoir C5L42-53, C2L43-59, C7L29-62; a reader 154 configured to read the drug data portion to determine drug delivery data associated with the drug; and an output device 161, 150 configured to output data relating to the current temperature. See C5L5-56, C3L62-C4L6, C10L32-49, Fig.11
Claims 2,17: a controller 156 coupled to the temperature sensor and the output device, the controller being programmed to compare the current temperature to a predetermined target temperature. C6L18-44, block 604, C5L5-24
Claim 3: the controller is further programmed to receive and/or output data relating to the current temperature and the predetermined target temperature. C5L5-24, C10L5-9
Claim 4, the controller is further programmed to provide a signal to a user in response to determining that the current temperature corresponds to the predetermined target temperature. C5L25-35
Claim 7: a controller 156 coupled to the reader and the temperature sensor, the controller being programmed to receive input from the reader and to compare the current temperature to a predetermined target temperature from the reader. C6L18-44, block 604, C5L5-24
Claims 8,19: the drug data portion comprises a machine readable code (RFID tag 238); and the reader 154 comprises a scanner configured to read the machine readable code.
Claims 9,20: the housing further comprises a bay 102 configured to removably receive the reservoir therein. Fig.5
Claim 10: the temperature sensor 160 is disposed adjacent to the bay. Fig.5
Claim 11: the housing comprises a door 249 movable between an open position and a closed position, the door configured to receive the reservoir in the open position and align the reservoir with the temperature sensor within the bay in the closed position.
Claim 12: further comprising a cassette 230 configured to receive the reservoir therein, the cassette defining a window providing access for the temperature sensor to measure the current temperature. C4L1-6
Claims 13,18: the output device comprises a display (mobile device or computer) including a scale portion providing a visual indication of the current temperature. C5L5-24, C10L5-9
Claim 14: further comprising the drug disposed in the reservoir. C3L16-22
Claim 21: the drug delivery data comprises at least one of an optimum delivery temperature, an identification of the drug, or an age of the drug C6L18-44, block 604, C5L5-53
Claim 22: the optimum delivery temperature comprises a particular temperature, a range of temperatures, or a threshold temperature. C6L18-44, block 604, C5L5-53
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record.
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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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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