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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/24/26 has been entered.
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.
Claim 23 is 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 23 recites the limitation "the cavity of the stopper" in line 13. There is insufficient antecedent basis for this limitation in the claim. An internal cavity opening has been introduced but not the cavity itself.
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) 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shue et al. (US 2007/0179442 A1).
With regard to claim 23, Shue discloses A syringe (Fig. 3 and 4) comprising: a barrel (1) having a hollow interior (11), an orifice (at 12) and an opening (at 132) opposite to the orifice; a stopper (4) arranged in the hollow interior of the barrel thereby defining a sealed chamber in the interior of the barrel, wherein the stopper is displaceable in the interior of the barrel thereby varying a volume of the chamber; a plunger (3) extending through the opening of the barrel into the hollow interior of the barrel; and a gasket (50 is considered a gasket as not other specific structural limitations are recited in the claims. 50 is a sliding unit secured against the wall of the barrel and therefore is considered a gasket [0039]), wherein the plunger has a distal end outside of the barrel (see Fig. 4 where element 3 is pointing. Note: the term distal and proximal are used opposite their normal standard definition) and a proximal end inside the hollow interior of the barrel (see Fig. 4), the proximal end of the plunger having an abutting face (see annotated drawing below) and the plunger including a barb (70) proximally extending from the abutting face, the stopper has a distal face (where 43 is pointing in Fig. 3) directed towards the plunger, a proximal face (41 in Fig. 3) directed towards the chamber and an internal cavity opening (see Fig below) at the distal face, the cavity of the stopper having a channel portion (see Fig. below) and an interior chamber portion (see Fig below),the cavity of the stopper and the barb of the proximal end of the plunger are shaped to snap-fit (see Fig. 4) such that the abutting face of the proximal end of the plunger is adjacent to the distal face of the stopper (see Fig. 4) and the stopper is secured to the plunger (see Fig. 4), the syringe is equipped with a sealing structure (as described in the present application’s Specification [0061] the sealing structure is a combination of the neck and barb, thus because these structures are taught by the prior art, it is also considered to have a sealing structure without further definition of what is part of the sealing structure) sealing the cavity of the stopper such that the cavity of the stopper is microbiologically sealed ([0040]), and the gasket is arranged about the barb of the proximal end of the plunger and is contacting the abutting face of the stopper (see Fig. 4).
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Allowable Subject Matter
Claims 1, 5-22 are allowed.
Claims 1 and 6 recite allowable subject matter relating to the sealing structure, specifically describing changes in length and shape which form the sealing structure.
Claim 12 recites a method specifically for testing tightness between and stopper and a plunger. This is notable as most prior art found related to testing of the tightness between the stopper and the barrel of the syringe not the plunger itself. Further the limitation of opening the cavity of the stopper to the proximal face by forming a hole through the proximal face and into the cavity. Again to note, the terms proximal and distal are used opposite their standard definition in this application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 23 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.
Amendments to claims 1, 5-22 overcome the previous rejection and are withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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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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/Lauren P Farrar/Primary Examiner, Art Unit 3783
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