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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03 December 2025 has been entered.
Claim Objections
Claims 3, 4, and 7-19 are objected to because of the following informalities: The preamble should start with “The” instead of “A”. 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 7-10 and 12-19 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. Claim 7 recites “setting the length” a previous step to setting has not been recited, it is not clear how the setting step differs from the adjusting step. For purposes of examination, they are considered as the same step.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 3, and 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Knudsen et al. (WO 2019/072826 A1).
With regard to claim 1, Knudsen et al. teach a method of assembling a pre-filled syringe comprising: adjusting a length of a plunger rod of a plunger rod assembly (Pg. 11 line 33-Pg. 12 line 2, Pg. Pg. 13 lines 12-16, Pg. 14 lines 15-16), fixing the length of the plunger rod (length is considered as fixed after adjustment, Pg. 11 line 33-Pg. 12 line 2, Pg. Pg. 13 lines 12-16, Pg. 14 lines 15-16); and fitting the plunger rod assembly to a barrel of the syringe, the barrel having an opening at a forward end thereof and comprising a bung positioned therein and creating a volume between the bung and the opening, the volume at least partially filled with a substance for delivery from the syringe (Pg. 12 lines 3-12, Fig. 1 syringe 89 bung shown but not numbered), wherein the plunger rod comprises a first portion and a second portion, wherein one of the first and second portions is telescopically received in the other of the first and second portions, wherein a maximum outer diameter of the telescopically combined first and second portions is less than an inner diameter of the barrel (Figs. 1-3B first portion 6/100 second portion 85/110), wherein at least one of a distal end of the first portion and or a distal end of the second portion is inserted into the barrel (Fig. 2 distal end of 6/100 is inserted into the barrel), and wherein adjusting the length of the plunger rod assembly comprises: rotating at least one of the first portion and second portion with respect to the other of the first portion and the second portion (6/100 is rotated prior to 85/110 being inserted over 6/100, however, one member is rotated while the other is present); and at least partially inserting the plunger rod into the barrel such that a forward end of the plunger rod contacts the bung, the method further comprising moving the plunger rod rearward after adjusting the length of the plunger rod and after the forward end of the plunger rod contacts the bung for defining a separation between the bung and the forward end of the plunger rod, such that, after assembly and before substance delivery, the length of the plunger rod defines a separation between the bung and the forward end of the plunger rod (assembly positions vary and if after connection an air gap is not present the plunger is retracted to define a separation, Pg. 3 lines 1-2, Pg. 5 lines 1-4, Pg. 12 lines 5-7 and 18-21, Pg. 14 lines 5-16 and 33-36).
With regard to claim 3, see Pg. 13 line 31.
With regard to claim 4, see Pg. 11 lines 12-19.
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783