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 .
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Reynolds (US 2004/0024354) in view of Genese (US 4,226,236).
Regarding claim 1, Reynolds discloses a vial-to-syringe converter comprising:
a plunger rod (Fig. 1, 18);
an adapter including a body (Figs. 1 and 22, 34) having a piercing spike disposed at a first end (cannula 44 at a lower end of hub 34 in Fig. 22), a receiver (Fig. 1, 38) disposed at a second end opposite the first end (see Fig. 22 where hub 34 comprises spigot 38 at an upper end of hub 34, opposite cannula 44, for receiving socket 41 of needle 40), and a lumen extending between the spike and the receiver (hub 34 has a hollow needle or cannula 44 projecting from its end opposite the spigot 38 and in communication with a central passage in the spigot, ¶[0060]), and
a needle (needle 40, Fig. 1) in communication with the receiver and configured to deliver a medicament to a patient's body (see Fig. 22 showing hub 34 comprising spigot 38 at an upper end of hub 34, opposite cannula 44, for receiving socket 41 of needle 40, such that needle 40 is in communication with spigot 38 for delivering a medicament to a patient's body).
Reynolds does not specifically teach the body further including at least one laterally-extending flange.
Genese teaches an adapter and syringe combination designed for delivery. Genese teaches the body further including at least one laterally extending flange (Fig. 2, 44, 34 from Genese). The device of Genese and the device of Reynolds serve a similar purpose and this modification would not alter the function of Reynolds. Including flanges on a device such as Reynolds would be considered a well-known practice in the art.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Reynolds to include the body further including at least one laterally extending flange (Fig. 2, 44, 34 from Genese).
Regarding claim 2, the combination of Reynolds and Genese teaches the vial-to-syringe converter of claim 1, and Reynolds further teaches wherein the plunger rod includes an actuating base (see Figs. 1 and 3 showing plunger 18 having a actuating base for pushing plunger 18 with a user's hand), an elongated shaft (see Figs. 1 and 2 showing plunger 18 comprising an elongated shaft for inserting into syringe socket 24 ), and a vial contacting member (vial shown as bottomless vial 4, Fig. 2, shown in Fig. 1 comprising body 6; vial contacting member defined as upper surface of plunger 18 comprising piston 14 and means 16 for contacting vial 4)
Regarding claim 3, the combination of Reynolds and Genese teaches the vial-to-syringe converter of claim 1, and Genese further teaches wherein the at least one laterally-extending flange includes two flanges (Fig. 2, 44, 34).
Regarding claim 4, the combination of Reynolds and Genese teaches the vial-to-syringe converter of claim 1, and Reynolds further teaches wherein the adapter further comprises a plurality of circumferentially extending wings disposed about the piercing spike (Fig. 22, 35).
Regarding claim 5, the combination of Reynolds and Genese teaches the vial-to-syringe converter of claim 1, and Reynolds further teaches wherein the needle comprises a hub coupleable with the receiver of the adapter (see Fig. 22 showing needle 44 having a hub with tapered body 42 comprising socket 41 for coupling with receiver spigot 38 of adapter 34 ).
Regarding claim 6, the combination of Reynolds and Genese teaches the vial-to-syringe converter of claim 5, and Reynolds further teaches wherein the hub and the receiver comprise a luer fitting (Cannula 40 is retained within hub shoulder 42 coupled to socket connector 41. The cannula may either be staked within the hub assembly. In the embodiment of FIGS. 31 - 32, socket connector 41 is a press or friction fit onto luer 38 of syringe 66. Other connection means are contemplated, including, for example, threadingly mating socket connector 41 and luer 38, ¶[0099]).
Regarding claim 7, the combination of Reynolds and Genese teaches the vial-to-syringe converter of claim 1, and Reynolds further teaches a passageway providing fluid communication between the piercing spike and the distal end of the needle (hub 34 has a hollow needle or cannula 44 projecting from its end opposite the spigot 38 and in communication with a central passage in the spigot, ¶[0060]).
Claim(s) 8-20 are rejected under 35 U.S.C. 103 as being unpatentable over Genese (US 4,226,236) in view of Kimura et al. (US 2024/0115461).
Regarding claim 8, Genese teaches a system of delivering a medicament (Fig. 1-3) comprising:
a vial-to-syringe converter (Fig. 2, 59) including a plunger rod (Fig. 2, 57), an adapter (Fig. 2, 23) including a body (Fig. 2, 27) having a piercing spike (Fig. 2, 30), a receiver (Fig. 2, 41) and a lumen extending between the spike and the receiver (Fig. 2, where the part 23 has a lumen that extends through 30 and 41), the body further including at least one laterally-extending flange (Fig. 2, 44, 34) and a needle (Fig. 4, 60) in communication with the receiver (Fig. 4, where the needle 60 communicates with 41 and 61) and configured to deliver a medicament to a patient's body (Col. 3, lines 1-6, where delivery is intended for a patient); and
a stopper (Fig. 2, 55) disposed within the glass body and translatable relative thereto (Fig. 1-3, where the stopper can translate), and a septum (Fig. 2, 20) disposed opposite the stopper (Fig. 2, where 20 is opposite of 55).
Genese does not specifically teach a vial comprising a borosilicate glass body. Kimura teaches that borosilicate glasses have high chemical durability and visibility for packaging. The use of borosilicate glass is a well-known practice in the art and would not change the function of the body of the device of Genese. By modifying the device of Genese, it would improve the chemical durability and visibility of the device’s body (¶[0002] from Kimura).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Genese to include a borosilicate glass body for a vial (¶[0002] from Kimura).
Regarding claim 9, the combination of Genese and Kimura discloses the system of claim 8, and Genese further teaches wherein the plunger rod of the vial-to-syringe converter is coupleable to the stopper of the vial (Fig. 2, 57, 55).
Regarding claim 10, the combination of Genese and Kimura discloses the system of claim 8, and Genese further teaches wherein the piercing spike (Fig. 2, 30) of the vial-to-syringe converter is engageable with a septum of the vial (Fig. 2, 20).
Regarding claim 11, the combination of Genese and Kimura teaches the system of claim 8, and Genese further teaches wherein the vial (Fig. 2, 12) is disposed between the plunger rod (57) and the adapter of the vial-to-syringe converter (59).
Regarding claim 12, the combination of Genese and Kimura teaches the system of claim 8, and Genese further teaches wherein the plunger rod includes an actuating base (Col. 3, lines 43-50, where the movement of the plunger is done by an actuating base, plungers are well-known in the art so this is a common feature), an elongated shaft (Fig. 2, where 57 extends longitudinally with a shaft), and a vial contacting member (Fig. 2, 58)
Regarding claim 13, the combination of Genese and Kimura teaches the system of claim 8, and Genese further teaches wherein the at least one laterally-extending flange includes two flanges (Fig. 2, 44, 34).
Regarding claim 14, the combination of Genese and Kimura teaches the system of claim 8, and Genese further teaches wherein the adapter further comprises a plurality of circumferentially extending wings (Fig. 1, 22) disposed about the vial when the vial (12) is coupled to the adapter (Fig. 1, 27).
Regarding claim 15, the combination of Genese and Kimura teaches the system of claim 8, and Genese further teaches wherein the chamber of the vial (12) is in fluid communication with the needle (60) when the vial, the adapter and the needle are coupled together (Fig. 4, where the adapter, needle and vial are coupled together and the needle is in fluid communication through the lumen).
Regarding claim 16, Genese discloses a system of delivering a medicament (Fig. 2 & 4) comprising:
a vial-to-syringe converter (Fig. 2, 59) including a plunger rod (Fig. 2, 57), an adapter (Fig. 2, 23) including a body (Fig. 2, 27) having a piercing spike (Fig. 2, 30), a receiver (Fig. 2, 41) and a lumen extending between the spike and the receiver (Fig. 2, where the part 23 has a lumen that extends through 30 and 41), the body further including at least one laterally-extending flange (Fig. 2, 44, 34), and a needle (Fig. 4, 60) in communication with the receiver (Fig. 4, where the needle 60 communicates with 41 and 61) and configured to deliver a medicament to a patient's body (Col. 3, lines 1-6, where delivery is intended for a patient); and
a first stopper (Fig. 2, 55) disposed within the glass body and translatable relative thereto (Fig. 1-3, where the stopper can translate), a second stopper (Fig. 2, 51) disposed inside the glass body and translatable (Fig. 1-3, where the stopper can translate) relative thereto, the second stopper being spaced from the first stopper and defining a first chamber on one side and a second chamber on an opposite side (Fig. 2, where 51 and 55 are spaced apart and define separate chambers), a septum (Fig. 2, 20) disposed on one side of the glass body, and a bypass disposed adjacent the second stopper (Fig. 2, 50, where the bypass is adjacent to 51).
Genese does not specifically teach a vial comprising a borosilicate glass body. Kimura teaches that borosilicate glasses have high chemical durability and visibility for packaging. The use of borosilicate glass is a well-known practice in the art and would not change the function of the body of the device of Genese. By modifying the device of Genese, it would improve the chemical durability and visibility of the device’s body (¶[0002] from Kimura).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Genese to include a borosilicate glass body for a vial (¶[0002] from Kimura).
Regarding claim 17, the combination of Genese and Kimura teaches the system of claim 16, Genese further teaches wherein the bypass includes a bulge in the glass body (Fig. 2, where 50 is a bulge in the body).
Regarding claim 18, the combination of Genese and Kimura teaches the system of claim 16, Genese further teaches wherein the bypass is disposed approximately halfway along a length of the glass body (Fig. 2, where 50 is approximately halfway disposed on 11).
Regarding claim 19, the combination of Genese and Kimura teaches the system of claim 16, Genese further teaches wherein the first chamber and the second chamber are equal in volume (Fig. 2, where the chambers are approximately equal in volume, the stoppers can move so the chamber volume can be equal based on the position of each stopper).
Regarding claim 20, the combination of Genese and Kimura teaches the system of claim 16, Genese further teaches wherein the bypass allows fluid communication between the first chamber and the second chamber when the second stopper is displaced (Col. 3, lines 54-57).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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