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 filed 3/23/2026 have been fully considered.
Regarding the 112 rejection, Applicant’s arguments are convincing. Cancellation of claim 10 and 20 overcome the rejection and the rejection is therefore withdrawn.
Applicant argues that Fabian teaches a temperature sensor on the outer shell, and does not disclose or suggest an opening in the housing through which both the medicament contained within a container and the temperature indicator are visible. The examiner does not agree with this characterization of Fabian. As noted in the prior office action, Fabian teaches that the temperature sensor may be on the reservoir of the syringe, the reservoir of the syringe being the claimed “container”, and the syringe being visible through a window in the shell, the shell being the “housing”. See page 8, para. 0154. The examiner also points to figs. 48b-e which show the reservoir visible through a window in the housing, and further wherein the piston plunger within the reservoir is also visible meaning that the container is transparent and therefore medicament contained within the container is also visible through the window.
Applicant further argues that Chung does not disclose or suggest a device with a container disposed within a housing. First, the examiner notes that Chung is not relied upon to teach this feature, as it is taught by Fabian as discussed above, but rather to teach the temperature sensor directly adhered or integrally formed with the outer surface of the container. Second, the examiner does not agree with this characterization of Chung, as Chung discloses a thermochromic indicator marked on the outer surface of the container which is housed within an autoinjector (housing). See pages 2, paras. 0025, 0030; Fig. 2. Applicant argues that one would not be motivated to add any openings to the device of Chung. This argument is moot as this is not a modification being suggested in the prior rejection.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 7, 8, 11, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fabien et al (US 20130317433 A1) in view of Chung et al (US 2015/0051579).
Regarding claim 1, Fabien discloses a drug delivery device (Fig. 1, para. 0081, autoinjector) comprising: a housing (Fig. 1, external shell 22) defining an inner volume (see Fig. 1, other components of the autoinjector are placed within a cavity of external shell 22) and including at least one opening (Fig. 2a, para. 0144, the external shell can comprise several display windows 221, 222, 223); a container (Fig. 1, reservoir A) at least partially disposed within the housing (see Fig. 1, para. 0083), the container having an outer surface (see Fig. 1) and containing a medicament (para. 0083); an activation mechanism (Fig. 1, actuating sleeve 11) at least partially disposed within the housing (see Fig. 1), the activation mechanism adapted to exert a force to urge the medicament out the container (para. 0087-0088); a needle assembly (see Fig. 1, para. 0083, the reservoir A comprises a needle) having a needle and/or a cannula to deliver the medicament (para. 0083); and a temperature indicator being positioned within the opening (para. 0154, the temperature indicator can be visible through a window of the shell) and thermally coupled with the outer surface of the container (para. 0154, a temperature indicator could be provided on the reservoir), the temperature indicator being responsive to a change in temperature of the container (para. 0154), and wherein when the container is at least partially disposed within the housing, the medicament and the temperature indicator are visible through the opening (page 8, para. 0154; fig. 48b).
Claim 1 calls for the temperature indicator to be directly adhered to and/or integral with the outer surface of the container. Fabien teaches that the temperature indicator is a label on the reservoir, but fails to specifically disclose that the temperature sensor is directly adhered to and/or integral with the outer surface of the container. Chung teaches a syringe barrel for use with an autoinjector, the syringe barrel including a temperature indicator in the form of thermochromic ink directly adhered to the outer surface of the syringe barrel (page 2, para. 0024). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the temperature indicator label of Fabien to include a thermochromic ink directly marked on the syringe barrel as taught by Chung to ensure that the temperature indicator remains fixed to the barrel and to streamline manufacture of the device.
Regarding claim 7, Fabien and Chung fail to specifically disclose that the temperature indicator is constructed from a material having a high thermal conductivity, however it is understood that a thermochromic temperature sensor must be thermally conductive such that the color of the sensor accurately reflects the temperature of the contents of the container.
Regarding claim 8, Fabien in view of Chung discloses wherein the temperature indicator is in the form of a label that at least partially surrounds the outer surface of the container (Fabien: para. 0154).
Regarding claim 11, Fabien discloses a drug delivery device comprising the elements described below, and therefore necessarily discloses the method of assembling those elements as claimed. Fabien discloses a housing (Fig. 1, external shell 22) defining an inner volume (see Fig. 1, other components of the autoinjector are placed within a cavity of external shell 22) and including at least one opening (Fig. 2a, para. 0144, the external shell can comprise several display windows 221, 222, 223); a container (Fig. 1, reservoir A) at least partially disposed within the housing (see Fig. 1, para. 0083), the container having an outer surface (see Fig. 1) and containing a medicament (para. 0083); an activation mechanism (Fig. 1, actuating sleeve 11) at least partially disposed within the housing (see Fig. 1), the activation mechanism adapted to exert a force to urge the medicament out the container (para. 0087-0088); a needle assembly (see Fig. 1, para. 0083, the reservoir A comprises a needle) having a needle and/or a cannula to deliver the medicament (para. 0083); and a temperature indicator being positioned within the opening (para. 0154, the temperature indicator can be visible through a window of the shell) and thermally coupled with the outer surface of the container (para. 0154, a temperature indicator could be provided on the reservoir), the temperature indicator being responsive to a change in temperature of the container (para. 0154), wherein when the container is at least partially disposed within the housing, the medicament and the temperature indicator are visible through the opening (page 8, para. 0154; fig. 48b).
Claim 11 calls for the temperature indicator to be directly adhered to and/or integral with the outer surface of the container. Fabien teaches that the temperature indicator is a label on the reservoir, but fails to specifically disclose that the temperature sensor is directly adhered to and/or integral with the outer surface of the container. Chung teaches a syringe barrel for use with an autoinjector, the syringe barrel including a temperature indicator in the form of thermochromic ink directly adhered to the outer surface of the syringe barrel (page 2, para. 0024). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the temperature indicator label of Fabien to include a thermochromic ink directly marked on the syringe barrel as taught by Chung to ensure that the temperature indicator remains fixed to the barrel and to streamline manufacture of the device.
Regarding claim 17, Fabien and Chung fail to specifically disclose that the temperature indicator is constructed from a material having a high thermal conductivity, however it is understood that a thermochromic temperature sensor must be thermally conductive such that the color of the sensor accurately reflects the temperature of the contents of the container.
Claim(s) 2, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fabien in view of Chung as applied to claims 1 or 11 above, and further in view of Pommereau et al (WO 2011/032956 A2).
Claim 2 calls for the temperature indicator to comprise a reversible thermochromic sensor having a first operation temperature range. Chung teaches a thermochromic sensor having a first operational temperature range (page 2, paras. 0024, 0025) as discussed above with regard to claim 1 in order to provide the user with indication that the drug is within the optimal temperature range for delivery. However, Fabien and Chung fails to disclose that the sensor is reversible. Pommereau teaches that thermochromic sensors change color due to changes in temperature and this process is reversible (page 6, lines 10-13). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the thermochromic sensor of Fabien in view of Chung would be reversible because Pommereau teaches that thermochromic color changes are reversible.
Claim 12 calls for the temperature indicator to comprise a reversible thermochromic sensor having a first operation temperature range. Chung teaches a thermochromic sensor having a first operational temperature range (page 2, paras. 0024, 0025) as discussed above with regard to claim 111 in order to provide the user with indication that the drug is within the optimal temperature range for delivery. However, Fabien and Chung fails to disclose that the sensor is reversible. Pommereau teaches that thermochromic sensors change color due to changes in temperature and this process is reversible (page 6, lines 10-13). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the thermochromic sensor of Fabien in view of Chung would be reversible because Pommereau teaches that thermochromic color changes are reversible.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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