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.
Claims 1-4, 5-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Pedersen et al. (USPGPub 2013/0211330) in view of Roervig et al. (USPGPub 2015/0174335) and Dunne (USPGPub 2017/0173263).
Re Claim 1, Pederson teaches an auto-injector (100) having a proximal end and a distal end (as seen in Pederson Figs. 2a and 2b) comprising: an outer casing (300) holding a cartridge (600) consisting of a barrel with a drug contents being contained by a movable plunger (630) at a first end and a seal (620) at a second end (Pederson ¶ 0073); biased means (330) that pushes against the movable plunger (630) of the cartridge (600) for pressurizing the drug contents (Pederson ¶ 0097); a needle shuttle (380) being held within the outer casing (300) comprising two needles that are attached and connected to each other (as seen in Pederson Fig. 3a), a first needle (510) of the two needles being an injection needle and a second needle (520) of the two needles being a septum needle (Pederson ¶ 0074, 0124); means to retain the cartridge (600) in a correct position when inserted (Pederson ¶ 0077 - describing a cartridge holder); a needle guard (350) and a spring (340) held to the outer casing (300) (Pederson ¶ 0080), wherein the needle guard (350) is being biased distally by the spring (340) and, when the auto injector (100) has finished injecting, the needle guard (350) is pushed distally by the spring (340) such that the first needle (510) of the two needles is covered by the needle guard (350) (as seen in Pederson Figs. 6a and 6b).
Pederson fails to teach the needle guard configured such that during injection, when the auto-injector is pressed against an injection site, the needle guard is pushed against the injection site, is pushed proximally relative to the casing against the spring, and thereby directly pushes proximally the needle shuttle to pierce the seal. Roervig teaches an auto-injector (1) comprising an outer casing (2, 3) holding a cartridge (105) with a seal (106) (Roervig ¶ 0098-0099; Fig. 12), a needle shuttle (30) being held within the outer casing (2, 3) and comprising two needles (103, 104) that are attached and connected to each other (Roervig ¶ 0083; Fig. 12), a needle guard (20) and a spring (B) held to the outer casing (2, 3) (Roervig ¶ 0109), the needle guard (20) configured such that during injection, when the auto-injector (1) is pressed against an injection site (Roervig ¶ 0124-0137), the needle guard (20) is pushed against the injection site, is pushed proximally relative to the casing against the spring (B), and thereby directly pushes proximally the needle shuttle (30) to pierce the seal (106) (Roervig ¶ 0124-0129), wherein such an embodiment permits maintaining the cartridge in a sealed state while permitting the user to control needle insertion (Roervig ¶ 0004-0007).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the auto-injector of Pederson such that during injection, when the auto-injector is pressed against an injection site, the needle guard is pushed against the injection site, is pushed proximally relative to the casing against the spring, and thereby directly pushes proximally the needle shuttle to pierce the seal as disclosed by Roervig for maintaining the cartridge in a sealed state while permitting the user to control needle insertion (Roervig ¶ 0004-0007).
Pederson also fails to teach the cartridge comprising a metal crimp. Dunne teaches an auto injector comprising: an outer casing (23, 27) holding a cartridge (10) consisting of a barrel (11) with a drug contents (15) being contained by a movable plunger (12) at a first end and a seal (14) and metal crimp (13) at a second end, the metal crimp for retaining the seal in place (as seen in Dunne Fig. 1; ¶ 0057-0060). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the cartridge comprising a metal crimp at the second end as disclosed by Dunne, the metal crimp for retaining the seal in place (as seen in Dunne Fig. 1; ¶ 0057-0060).
Re Claim 2, Pedersen in view of Roervig and Dunne teach all of the limitations of Claim 1. Pedersen teaches a locking mechanism (351) configured to prevent the needle guard (350) from being pushed proximally a second time for preventing unauthorized reuse of the auto-injector (Pedersen ¶ 0100).
Re Claims 3 and 4: Pedersen in view of Roervig and Dunne teach all of the limitations of Claim 2. Pederson teaches the outer casing (300) comprising a transparent portion (302) configured to monitor at least one of an injection progress and a status of the injection progress (Pederson ¶ 0070). Pederson fails to teach an indicator rod that is attached to the movable plunger; and wherein the indicator rod has a closed end containing the biased means in a form of a spring. Dunne further teaches an indicator rod (102) that is attached to the movable plunger (12) (as seen in Dunne Fig. 4); and wherein the indicator rod (102) has a closed end (1211) containing the biased means (121) in a form of a spring, the indicator rod for holding the spring in a compressed state and when the retaining arm is released, releasing the spring (Dunne ¶ 0071, 0077; Fig. 4). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included with the auto-injector of Pederson in view of Roervig and Dunne, an indicator rod that is attached to the movable plunger; and wherein the indicator rod has a closed end containing the biased means in a form of a spring, the configuration as disclosed by Dunne for holding the spring in a compressed state and when the retaining arm is released, releasing the spring (Dunne ¶ 0071, 0077; Fig. 4).
Re Claim 5, Pedersen in view of Roervig and Dunne teach all of the limitations of Claim 1. Pederson further teaches a modular auto-injector, wherein the modular auto-injector comprises three sub-assemblies comprising: a cartridge sub-assembly (300); a power source and an indicator assembly (200); and a needle and a needle guard assembly (500) (Pederson ¶ 0070).
Re Claim 6, Pedersen in view of Roervig and Dunne teach all of the limitations of Claim 5. Pederson teaches wherein the cartridge sub-assembly (300) comprises the barrel (barrel of cartridge 600) and a drug volume of the drug contents being bounded by the movable plunger (630) and a crimped septum (Pederson ¶ 0073).
Re Claims 7 and 8: Pedersen in view of Roervig and Dunne teach all of the limitations of Claim 6. Pederson teaches wherein the power source and the indicator sub-assembly (200) comprises the biased means (330) (Pederson Fig. 3a). However, Pederson fails to disclose the power source and the indicator sub-assembly comprises an indicator rod that is held within a rear casing; and wherein the indicator rod may be connected to the movable plunger such that the indicator rod is movable with the moveable plunger. Dunne teaches wherein the power source and the indicator sub-assembly (Dunne Fig. 7) comprises the biased means (121) and an indicator rod (102) that is held within a rear casing (23) (Dunne Figs. 2 and 5); and wherein the indicator rod (102) may be connected to the movable plunger (12) such that the indicator rod (102) is movable with the moveable plunger (12) (as seen in Dunne Figs. 5-6), the indicator rod for holding the spring in a compressed state and when the retaining arm is released, releasing the spring (Dunne ¶ 0071, 0077; Fig. 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the power source and the indicator sub-assembly of Pederson in view of Roervig and Dunne to comprise an indicator rod that is held within a rear casing; and wherein the indicator rod may be connected to the movable plunger such that the indicator rod is movable with the moveable plunger, the configuration as disclosed by Dunne, the indicator rod for holding the spring in a compressed state and when the retaining arm is released, releasing the spring (Dunne ¶ 0071, 0077; Fig. 4).
Re Claims 9 and 10: Pedersen in view of Roervig and Dunne teach all of the limitations of Claim 7. Pederson fails to teach wherein the biased means of the power source and the indicator sub-assembly is at least one first spring further comprising a spring locking member; and wherein the power source and the indicator sub-assembly further comprises at least one second spring that is weaker than the at least one first spring and configured to pressurize the drug contents prior to an injection while the at least one first spring is locked by the spring locking member. Dunne teaches wherein the biased means (121) of the power source and the indicator sub-assembly is at least one first spring (as seen in Dunne Fig. 7) further comprising a spring locking member (22) (Dunne Fig. 2; ¶ 0058, 0064-0066); and wherein the power source and the indicator sub-assembly further comprises at least one second spring (101) that is weaker than the at least one first spring (121) and configured to pressurize the drug contents (15) prior to an injection while the at least one first spring (121) is locked by the spring locking member (22) (Dunne ¶ 0071), the spring locking member providing an oxygen and humidity barrier (Dunne ¶ 0064) and the first spring and second spring configuration for maintaining the liquid contents of the auto-injector in a pressurized state (Dunne ¶ 0071).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the biased means of the power source and the indicator sub-assembly of Pederson in view of Roervig and Dunne be at least one first spring further comprising a spring locking member; and wherein the power source and the indicator sub-assembly further comprises at least one second spring that is weaker than the at least one first spring and configured to pressurize the drug contents prior to an injection while the at least one first spring is locked by the spring locking member, the embodiment as disclosed by Dunne wherein the spring locking member provides an oxygen and humidity barrier (Dunne ¶ 0064) and the first spring and second spring configuration for maintaining the liquid contents of the auto-injector in a pressurized state (Dunne ¶ 0071).
Re Claim 11, Pedersen in view of Roervig and Dunne teach all of the limitations of Claim 5. Pederson further teaches wherein the needle and the needle guard assembly (500) comprises the outer casing (300) holding the needle shuttle (380) with an injection needle and a septum needle (Pederson ¶ 0074, 0124), the needle guard (350) and the spring (340), a locking mechanism (351) that prevents the needle guard (350) from being pushed proximally a second time, and a shoulder (inward extending arms as seen in Pederson Fig. 3b) to retain the cartridge (600) in the correct position when inserted.
Re Claim 13, Pedersen in view of Roervig and Dunne teach all of the limitations of Claim 5. Pederson further teaches a process for the assembly of a modular auto-injector, the process comprising: inserting the cartridge (600) into the needle and the needle guard assembly (500), and connecting the power source and the indicator assembly (200) via connection means to the needle and the needle guard sub-assembly (500) with the inserted cartridge (600) inserted therein such that the drug contents in the cartridge (600) are pressurized (Pederson ¶ 0084).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Pedersen et al. (USPGPub 2013/0211330) in view of Roervig et al. (USPGPub 2015/0174335) and Dunne (USPGPub 2017/0173263) as applied to Claim 11 above, and further in view of Kouyoumjian et al. (USPGPub 2013/0245561).
Re Claim 12, Pedersen in view of Roervig and Dunne teach all of the limitations of Claim 11. Dunne further teaches wherein the needle and the needle guard assembly (Dunne Fig. 2) comprises a needle cap (28) (Dunne ¶ 0063). However, Pedersen in view of Roervig and Dunne fail to teach wherein the needle and the needle guard assembly comprises a seal and wherein the needle and the needle guard assembly and the power source and the indicator assembly are reversibly connected by a bayonet fit or a screw or are hinged together. Kouyoumjian teaches an auto-injector (1) (Kouyoumjian Fig. 4) comprising a needle guard assembly (140) and a power source and indicator assembly (5) wherein the needle and the needle guard assembly (140) comprises a seal (160a) for hermetic sealing (Kouyoumjian Fig. 9; ¶ 0093) and wherein the needle and the needle guard assembly (140) and the power source and indicator assembly (5) are reversibly connected by a bayonet fit for connecting a new needle and the needle guard assembly or power source and indicator assembly if needed (Kouyoumjian ¶ 0083).
Therefore, it would have been obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to have configured the needle and the needle guard assembly of Pedersen in view of Roervig and Dunne to comprise a seal as disclosed by Kouyoumjian for hermetic sealing (Kouyoumjian Fig. 9; ¶ 0093). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the needle and the needle guard assembly and the power source and the indicator assembly of Pedersen in view of Roervig and Dunne to be reversibly connected by a bayonet fit as disclosed by Kouyoumjian for connecting a new needle and needle guard assembly or power source and indicator assembly if needed (Kouyoumjian ¶ 0083).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Pedersen et al. (USPGPub 2013/0211330) in view of Roervig et al. (USPGPub 2015/0174335) and Dunne (USPGPub 2017/0173263) as applied to Claim 13 above, and further in view of Wolf (USPN 5,842,326).
Re Claims 14 and 15: Pedersen in view of Roervig and Dunne teach all of the limitations of Claim 13. However, Pedersen in view of Roervig and Dunne fail to teach inserting a pre-assembled device in a blister or a pouch, and submitting the blister or the pouch to terminal sterilization; and wherein the terminal sterilization is carried out by ethylene oxide or nitrogen dioxide. Wolf teaches an injection device (3) (Wolf Fig. 1) that is pre-assembled and placed in a blister (4), followed by submission to terminal sterilization by ethylene oxide for flushing the packaged injection device with sterilizing ethylene oxide gas from the outside (Wolf Col. 1 Lines 22-30). Therefore, it would have been obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to have had the auto-injector of Pedersen in view of Roervig and Dunne be inserted in a blister or the pouch, and submitting the blister or the pouch to terminal sterilization; and wherein the terminal sterilization is carried out by ethylene oxide, as disclosed by Wolf for flushing the packaged injection device with sterilizing ethylene oxide gas from the outside (Wolf Col. 1 Lines 22-30).
Response to Arguments
Applicant’s arguments filed 05/19/2026 with respect to 112 indefinite rejection of Claim 1-15 have been fully considered and are persuasive. Due to clarifying amendments, the 112 indefinite rejection is hereinafter withdrawn.
Applicant’s arguments with respect to Claims 1-15 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 for any teaching or matter specifically challenged in the argument. Examiner concedes that secondary reference Bengtsson fails to operate in the manner as amended Claim 1 describes. Therefore, examiner no longer relies upon Bengtsson to make obvious amended portions of Claim 1.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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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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/WILLIAM R FREHE/Examiner, Art Unit 3783
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