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 Amendment
This office action is responsive to the amendment filed on 27 August 2026. As directed by the amendment: claims 1, 25, 27, 29-30, and 32-33 have been amended; no claims have been canceled or added. Thus, claims 1-5 and 25-33 are presently pending in this application. Applicant’s amendments to the claims have overcome each and every objection and 112b rejection made in the previous office action.
Response to Arguments
Applicant's arguments filed 27 August 2026 have been fully considered but they are not persuasive. Applicant argues that Van Der fails to disclose the limitation “a volume disposed in the bore between the pierceable septum and the plunger, the volume having a reduced pressure, the reduced pressure being less than atmospheric pressure.” Applicant specifies that the vacuum of Van Der would be between the plunger 4 and item 10. However, the pierceable septum of Van Der is interpreted as item 10, as seen in Figures 3A-3C. As such, the rejection in view of Van Der anticipates the limitation “a volume disposed in the bore between the pierceable septum and the plunger, the volume having a reduced pressure, the reduced pressure being less than atmospheric pressure” and the rejection is maintained as detailed below.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-5, 25, 27-28, 30, and 32-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van Der Jagt et al (EP 1825878, provided by applicant).
Regarding claim 1, Van Der Jagt discloses:
A cartridge (Fig. 1) for receiving an injectable drug (Abstract – active material), comprising: a body (2) comprising: a proximal end portion (6) comprising a proximal opening; a distal end portion (9) comprising a distal opening; a bore coupling the proximal opening and the distal opening (interior of body 2); a pierceable septum (10) coupled to the distal opening (9); a plunger (4) movably carried within the bore (¶0026); a volume disposed in the bore between the pierceable septum (10) and the plunger (4), the volume having a reduced pressure (¶0018, 0020 – the cartridge 3 is assembled and sealed within a vacuum chamber, resulting in the volume within the cartridge 3 having a vacuum within), the reduced pressure being less than atmospheric pressure (¶0020 - vacuum); and a stopper (5) detachably coupled to the proximal opening (6).
Regarding claim 3, Van Der Jagt discloses:
The cartridge of claim 1, further comprising a seal (11) coupled to the distal end portion (9) and covering the pierceable septum (10).
Regarding claim 4, Van Der Jagt discloses:
The cartridge of claim 1, further comprising a nut (8) detachably coupled to the proximal end portion (6) and securing the stopper (5) between the nut (8) and the plunger (4).
Regarding claim 5, Van Der Jagt discloses:
The cartridge of claim 1, wherein the plunger (4) is configured to couple to an actuating rod upon detachment of the stopper from the body (the plunger 4 is demonstrated as being coupled to an actuating rod 22 from the distal opening, and so is fully capable of being coupled to an actuating rod from the proximal open end if the stopper 5 were removed).
Regarding claim 25, Van Der Jagt discloses:
A cartridge (Fig. 1) for receiving an injectable drug (Abstract – active material), comprising: a body (2) comprising a proximal opening (6) and a distal opening (9), and a bore (interior of body 2) coupling the proximal opening (6) and the distal opening (9); a pierceable septum (10) coupled to the distal opening (9); a plunger (4) movably carried within the bore (¶0026); a volume disposed in the bore between the pierceable septum (10) and the plunger (4), the volume having a reduced pressure that is less than atmospheric pressure (¶0018, 0020 – the cartridge 3 is assembled and sealed within a vacuum chamber, resulting in the volume within the cartridge 3 having a vacuum within); and a stopper (11) detachably coupled to the proximal opening (6), wherein the plunger (4) is configured to couple to an actuating rod upon detachment of the stopper from the body (the plunger 4 is demonstrated as being coupled to an actuating rod 22 from the distal opening, and so is fully capable of being coupled to an actuating rod from the proximal open end if the stopper 5 were removed).
Regarding claim 27, Van Der Jagt discloses:
The cartridge of claim 25, further comprising a seal (11) coupled to a distal end portion (9) of the cartridge (2) and configured to cover the pierceable septum (10).
Regarding claim 28, Van Der Jagt discloses:
The cartridge of claim 25, further comprising a nut (8) detachably coupled to a proximal end portion (6) of the body (2), the nut configured to secure the stopper (5) between the nut (8) and the plunger (4)
Regarding claim 30, Van Der Jagt discloses:
A cartridge (Fig. 1) for receiving an injectable drug (Abstract – active material), comprising: a body (2) comprising a proximal opening (6) and a distal opening (9), and a bore (interior of body 2) coupling the proximal opening (6) and the distal opening (9); a pierceable septum (10) coupled to the distal opening (9); a plunger (4) movably carried within the bore (¶0026); a volume disposed in the bore between the pierceable septum (10) and the plunger (4), the volume having a reduced pressure that is less than atmospheric pressure (¶0018, 0020 – the cartridge 3 is assembled and sealed within a vacuum chamber, resulting in the volume within the cartridge 3 having a vacuum within); a vacuum stopper (11) detachably coupled to the proximal opening (6); and a nut (8) detachably coupled to a proximal end portion (6) of the body (2), the nut (2) configured to secure the stopper between the nut and the plunger.
Regarding claim 32, Van Der Jagt discloses:
The cartridge of claim 31, further comprising a seal (11) coupled to a distal end portion (9) of the cartridge (2) and configured to cover the pierceable septum (10).
Regarding claim 33, Van Der Jagt discloses:
The cartridge of claim 30, wherein the plunger (4) is configured to couple to an actuating rod upon detachment of the stopper from the body (the plunger 4 is demonstrated as being coupled to an actuating rod 22 from the distal opening, and so is fully capable of being coupled to an actuating rod from the proximal open end if the stopper 5 were removed), the actuating rod configured to move the plunger to expel gas (examiner notes that the actuating rod is functionally claimed and as such is fully capable of moving the plunger to expel gas if the device is filled with gas).
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.
Claims 2, 26, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Van Der Jagt in view of Kuhn (US 2015/0013827).
Regarding claim 2, Van Der Jagt discloses the cartridge of claim 1 but is silent regarding “the volume comprises a gas having the reduced pressure.” However, Kuhn teaches a reservoir for drug delivery, thus being in the same field of endeavor, that is filled to provide a reduced pressure within the reservoir such that the gas pressure within the reservoir is at a pressure less than 200 mbar and may even create a vacuum (¶0007-0010). A pressure of 200 mbar is less than atmospheric pressure. Such a reduced pressure reduces gas or air within the drug itself (¶0015). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the cartridge of Van Der Jagt with a gas having the reduced pressure as taught by Kuhn rather than a vacuum because such a modification would be the result of a simple substitution of one known element (a filling process that results in having a gas at the reduced pressure of Kuhn) for another known element (a filling process that results in a vacuum of Van Der Jagt) to obtain predictable results (providing a cartridge with a drug with minimized air). Claims 26 and 31 would be similarly obvious to modify to incorporate “a gas having the reduced pressure.”
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Van Der Jagt in view of Cohen (US 3577980).
Regarding claim 29, Van Der Jagt discloses the cartridge of claim 25 but is silent regarding “comprising the actuating rod, wherein the actuating rod is threadably coupled to the plunger.” However, Cohen teaches a cartridge (10; Fig. 3) for drug delivery, thus being in the same field of endeavor, with a plunger (24) that is connected to an actuating rod (26) using a threaded connection (Col. 2:12-19). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided a threaded connection between the plunger and an actuating rod as taught by Cohen to provide sufficient structure to connect the two elements during drug delivery.
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 TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571)272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
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