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 .
Election/Restrictions
Applicant’s election of Group I (claims 1-5) in the reply filed on 08 April 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 6-24 have been canceled and claims 25-33 (directed to Group I) have been added. As such, the pending claims are 1-5 and 25-33.
Claim Objections
Claim 30 is objected to because of the following informalities: in line 10, “the stopper” should be “the vacuum stopper”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5 and 25-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1, 25, and 30, the limitation “a stopper detachably coupled to the distal opening” is indefinite because, based on the instant disclosure and the dependent claims, the stopper interacts with elements at the proximal opening in contrast to a seal being provided at the distal opening. For the sake of furthering prosecution, the stopper will be interpreted as detailed in the instant specification. The stopper will be interpreted as being detachably coupled to the proximal opening (instant ¶0033, dependent claims 3-5, 27-29, and 32-33). Claims 2-5, 26-29, and 31-33 are rejected for incorporating this limitation due to their respective dependencies on the independent claim.
Examiner notes that because of this interpretation, no drawing objections are being made in view of the claimed stopper and seal. Because the instant specification properly discloses the stopper being connected to the proximal opening and the seal being connected to the distal opening, the drawings have no objections.
Claim 27 recites the limitation "the distal end portion" in 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 29, the limitation “the actuating rod is threadably coupled to the plunger” is indefinite because it is unclear if the actuating rod is now being positively claimed OR if the plunger is configured to be threadably coupled to the functionally claimed actuating rod. For examination purposes, the claim will be interpreted such that the plunger is configured to be threadably coupled to the functionally claimed actuating rod, for example by the plunger having threading to couple to an actuating rod.
Claim 32 recites the limitation "the distal end portion" in 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 33, it is unclear if the dependency of this claim is intended to be to claim 25. The subject matter of claim 33 is already claimed in claim 29, making claim 33 as is a duplicate claim. However, if the dependency is intended to be to claim 30, then claim 33 merely has an objection. Based on the pattern of similar claims in the claimset, for examination purposes, claim 33 will be interpreted as depending on claim 30.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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 the distal end portion (9) 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 the distal end portion (9) and configured to cover the pierceable septum (10).
Regarding claim 33, Van Der Jagt discloses:
The cartridge of claim 25, 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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 “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
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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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
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