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 without traverse of Group I and Species N in the reply filed on 6/29/2026 is acknowledged. Accordingly, claims 4, 6-8 and 11-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (claims 4 and 6-8) and/or invention (claims 11-20), there being no allowable generic or linking claim.
Claim Objections
Claim 1 is objected to because of the following informalities: The phrase “a contamination-barrier manner” on line 2 should be amended to recite “a contamination-barrier providing manner” to match the language of line 9. The phrase “the environment” lacks proper antecedent basis; term “the” in this phrase should be replaced with the term “an” since this is the first time this feature is being recited in the claim. The phrase “the syringe” on line 4 lacks proper antecedent basis; this phrase should be amended to recite “the syringe barrel” to match the language of line 3 since it is clear that the “syringe” and the “syringe barrel” are intended to be the same structure. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: The phrase “the syringe outlet” on line 2 lacks proper antecedent basis; this should be amended to recite “the syringe outlet portion” to match the language of claim 1 since it is clear that the “syringe outlet” of claim 10 is intended to be the same as the “syringe outlet portion” of claim 1. Appropriate correction is required.
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.
Claims 1-3, 5, 9 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Novacek et al. (US Pat 5,205,827).
Re claim 1, Novacek discloses a medical container (as seen in Fig 55; it is noted that all reference characters cited below refer to Fig 55 unless otherwise noted) with a needle 155 (seen in Fig 55, but not labeled; labeled in Fig A below and Fig 34) situated within a volume (within cover 304a) enclosed in a contamination-barrier manner from the environment (Col 29, Lines 4-8), comprising: a syringe barrel 300a with a piston 302a (“plunger portion 302a” – Col 28, Line 64) slidably disposed therewithin; said syringe having a syringe outlet portion (the distal section of syringe barrel 300a labeled in annotated Fig A below + the adapter 200 labeled in Fig A below (and labeled in Fig 52)) at a forward end (to the left in Fig 55) thereof; said needle coupled with said syringe outlet portion (as seen in Fig 55, the needle is coupled with the syringe outlet portion via reinforcing sleeve 156 (labeled in Fig A below and Fig 34)); a needle cover 304a being removably coupled to said syringe outlet portion and defining said volume (as seen in Fig 55); a barrier element 308 coupled to said syringe outlet portion in a contamination-barrier providing manner (Col 29, Lines 4-8), such that entrance of contaminants into said volume from the environment is prohibited when said barrier element is coupled to said syringe outlet portion (Col 29, Lines 4-8).
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Re claim 2, Novacek discloses that a luer portion (Col 5, Lines 30-32) is formed at the syringe outlet portion (as seen in Fig 55)).
Re claim 3, Novacek discloses that said barrier element is removably attached to said luer portion (Col 9, Lines 6-8).
Re claim 5, Novacek discloses that said barrier element is mounted over said needle cover (as seen in Fig 55 and Fig A above) and engages an outer portion (the outer surface of the distal section of body 300a labeled in Fig A above) of the luer portion (as seen in Fig 55 and annotated Fig A).
Re clam 9, Novacek discloses a reinforcing sleeve 156 (seen in Fig 55, but not labeled; labeled in Fig 52 and Fig A above) received by said barrier element (since the sleeve 156 resides partially inside the barrier element, it is “received by” the barrier element as claimed).
Re claim 10, Novacek discloses the barrier element being mounted onto at least one of the syringe outlet and the needle cover in a pressure-fit manner (via heat shrinking – Col 28, Lines 60-63).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Pat 2,677,373 to Barradas, US Pat 4,929,232 to Sweeney et al., US Pat 4,944,397 to Miller, PG PUB 2004/0116874 to Lourenco et al., PG PUB 2010/0286619 to Abry, PG PUB 2011/0092915 to Olson et al., PG PUB 2012/0310170 to Liversidge, PG PUB 2016/0015905 to Fournier et al., PG PUB 2017/0095619 to Baker et al., PG PUB 2017/0246403 to Cowe et al., PG PUB 2019/0217020 to Okihara, PG PUB 2019/0298924 to Gibson et al. each disclose a syringe comprising a needle, a needle cover, and a barrier element similar to that which is claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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