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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-15 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-8 and 11-14 of Poola; Rajesh et al. (US 12201585 B2) in view of Ivosevic; Milan et al. (US 20140276649 A1).
Regarding pending claim 1, Poola claims substantially all limitations in patented claims 1, 13 and 14, namely a method of reconstitution of a pharmaceutical composition (claim 1, A medical device configured to be connectable with a vial; claim 13, A medical device assembly comprising … the medical device according to claim 1; claim 14, A method of reconstitution of a pharmaceutical composition);
comprising: providing a medical device (claim 1, A medical device);
comprising: a tubular body defining a container for containing a composition (claim 1, the medical device comprising: a tubular body defining a container for containing a composition);
a spike extending from a distal end of the body, the spike having at least one through hole in fluid communication with the container (claim 1, a spike located at a distal end of the body and configured to pierce the vial, the spike having at least one through hole in fluid communication with the container); and
an adapter configured to connect to a vial, wherein the adapter comprises a wall extending distally from and unitary with the body, an annular-shaped base portion (claim 1, an adapter for connection of the medical device to the vial … wherein the adapter comprises a wall extending distally from the body, an annular-shaped base portion); and
a number of attachment portions extending from the base portion to the wall (claim 1, a number of attachment portions extending from the base portion of the adapter, wherein each attachment portion is connected to the spike or the wall);
wherein the base portion surrounds the spike (claim 1, the adapter being disposed at or about the spike);
connecting the adapter to the vial such that the spike pierces the vial (claim 1, a spike located at a distal end of the body and configured to pierce the vial);
the vial containing a solid drug (claim 14, connecting the adapter with the vial, the vial containing a solid drug);
injecting a quantity of diluent from the tubular body into the vial; mixing the diluent and the solid drug in the vial to create a reconstituted pharmaceutical composition (claim 14, injecting a quantity of diluent from the medical device assembly into the vial; mixing the diluent and the solid drug in the vial to create a reconstituted pharmaceutical composition);
aspirating the reconstituted pharmaceutical composition from the vial into the tubular body (claim 14, aspirating the reconstituted pharmaceutical composition from the vial into the body);
rotating the adapter with respect to the tubular body such that the attachment portions irreversibly detach from the wall (claim 1, wherein the attachment portions are configured to be irreversibly detached from the spike or wall responsive to rotation of the adapter with respect to the body);
wherein the spike remains extending from the distal end of the tubular body after the attachment portions are irreversibly detached (claim 1, wherein the spike remains connected to the body after the attachment portions are detached); and
separating the adapter from the tubular body (claim 14, detaching the adapter from the body).
Poola does not explicitly claim that the spike pierces a septum of the vial. Ivosevic discloses a medical device and method for connecting to a vial (¶ [0003], [0006], [0015], [0016], [0084] Referring to FIGS. 15-18, injector adapter 12);
connecting an adapter to the vial such that the spike pierces a septum of the vial (¶ [0119], Referring to FIGS. 20A and 20B, vial 90 may be a standard drug vial of any type having an open head portion 93 covered by a pierceable septum 94 of an elastomeric material. Walls 95 of vial 90 define vial chamber 96 for containing a substance 98. Vial septum 94 is engaged with head portion 93 of vial 90 to seal the substance 98 within vial chamber 96; ¶ [0140], As vial adapter 14 is assembled with the vial 90, the piercing tip 348 of the spike member 346 is pierced through a septum 94 of the vial 90).
Ivosevic explains how to seal a drug vial with a common type of self-sealing closure. One would be motivated to modify Poola’s claims with Ivosevic’s septum since Poola claims a spike configured to pierce the vial (claim 1, a spike located at a distal end of the body and configured to pierce the vial). Therefore, it would have been obvious to modify Poola’s claims with Ivosevic’s septum in order to provide a pierceable vial closure.
Regarding pending claims 2-13, Poola claims all limitations in patented claims 1-8 and 11-14 as shown in table 1.
Table 1: Poola double patenting
Pending claim
Poola
Pending claim
Poola
2
1, 2, 13, 14
8
1, 11, 12, 13, 14
3
1, 2, 3, 13, 14
9
1, 2, 5, 13, 14
4
1, 8, 13, 14
10
1, 2, 5, 6, 13, 14
5
1, 2, 4, 13, 14
11
1, 2, 5, 7, 13, 14
6
1, 11, 13, 14
12
1, 13, 14
7
1, 11, 13, 14
13
1, 11, 12, 13, 14
Regarding pending claim 14, Poola does not explicitly claim that the needle hub is press fit to the tubular body. However, Poola claims that the device is formed in separate parts and then assembled (claim 10, wherein the body and the adapter are separately formed and subsequently assembled).
This suggests that press-fitting is an acceptable way to join various components in Poola’s system. A skilled artisan would have been able to modify Poola’s claims with a press-fit connection by configuring the needle hub and tubular body with complementary interlocking shapes.
Regarding pending claim 15, Poola does not explicitly claim that the medical device is a syringe. However, Poola claims that the medical device comprises a tubular body which stores a composition (claim 1, a tubular body defining a container for containing a composition); and
also that the device assembly includes a plunger (claim 13. A medical device assembly comprising: a plunger).
Poola further claims steps of injecting and aspirating compositions into or from the vial (claim 14, injecting a quantity of diluent from the medical device assembly into the vial … aspirating the reconstituted pharmaceutical composition from the vial into the body).
This implies that the medical device is syringe, since it comprises the same elements as a syringe and performs the same functions as a syringe.
Conclusion
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
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