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 .
Applicant’s election without traverse of the invention of Group I, claims 1-10, in the reply filed on 7/30/25 is acknowledged. As to the Group I invention, applicant's further election in the reply of the species thereof of Group 1 represented by Figs. 1-6, without traverse, is also acknowledged. The examiner also acknowledges applicant’s indication that the claims of invention Group I that are also readable on elected species 1 are claims 1-6.
In spite of applicant’s indication that claims 1-6 read on the elected species, the examiner finds as follows. First, there is no description of the features of claim 6 in the specification Detailed Description of Figs. 1-6. Second, Figs 1-6 themselves do not illustrate the features of claim 6. In fact, the sleeve 24 in Figs 1-6 appears from these figures to have a loose fit to an outer surface of the sterilized medical device as opposed to closely conforming to such outer surface as required in claim 6. Still further, it appears that the only mention in the specification of the claim 6 features is in the specification Summary, and it appears from this description that the features of claim 6 belong to an embodiment that is different from that of Figs 1-6. Note specification Summary [0012]’s description of “In an embodiment of the invention, the flexible tubular sleeve comprises a stretchable elastic material such that the flexible tubular sleeve closely conforms to an outer surface of the sterilized medical device”. See also the similar language used to describe the Figs 7-11 embodiment (species Group 2) in the next paragraph, specification [0013]. For these reasons claim 6 is found to be directed to a species other than elected Group 1 represented by Figs 1-6.
Claims 6-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/30/25.
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) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cianci et al. (4,140,127). Cianci discloses a packaging system (Fig 1) on which the claimed packaging system reads. Thus, the claimed sterilized medical device can be catheter 28, the claimed sleeve can be sleeve or shield 26 and the claimed peel-open pouch can be package 22. In addition to Fig 1, see also column 2 lines 50-60.
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.
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cianci et al. as applied above.
Regarding claim 3 although Cianci discloses shortening from its nominal length via folding (note Fig 1 left side), Cianci may not show shortening from its nominal length via accordion folding (at least not in the Cianci packaging system). On the other hand, the expedient of shortening catheter sleeves by accordion folding within a packaging system is conventional as shown by multiple ones of the prior art of record including O’Flynn et al. (2017/0056622). See, for example, the accordion folded sleeves such as sleeve 24 in O’Flynn Figs 1-4 and in the packaging system of Fig 19 thereof. Note also the teaching in [0046] of providing the sleeve in either folded or bunched (example concertina) configuration. Therefore, it would have been obvious in view of the prior art of record to provide the sleeve of Cianci with accordion folds to shorten it, in order to provide an alternative mean of shortening the sleeve (other than folding it as disclosed in the reference).
Regarding claim 4, Cianci discloses what look like (to one of ordinary skill in the relevant art) juxtaposed free tabs providing a peel-open proximal end for the Cianci peel open pouch. Note Fig 1 right side. On the other hand, since the reference does not expressly describe the feature, Cianci may be deemed to be missing this feature of the claim. On the other hand, the prior art of record shows such juxtaposed free tabs to be notorious. Note Dacey (2011/0308981) at Fig 3A (top) and Matthison-Hansen (2011/0114520) at flaps 8 and 9, for example only. Therefore, it would have been obvious in view of the prior art of record to provide the pouch of Cianci with juxtaposed free tabs, at the right side thereof, for example, in order to make it convenient to open the Cianci peel-open pouch.
Regarding claim 5, Cianci appears to be missing only that the peel open pouch is made from material that is transparent or translucent. However, in this case also, the prior art of record shows the missing feature to be well known. For example, see pouch 1755, Fig. 106 in Gillespie (2014/0046125). Or, see Kavanagh et al. (6,578,709) in which the teaching of a transparent pouch includes translucent pouches. Or, see Gemma (5,615,766) that expressly teaches transparent or translucent sheets for the disclosed pouch. Etc. Therefore, it would have been obvious in view of the prior art of record to provide for the material of the Cianci pouch to have the missing feature, for the purpose of advantageously facilitating at least some viewing and/or verification of the contents of the pouch from outside the pouch.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB K ACKUN whose telephone number is (571)272-4418. The examiner can normally be reached Monday-Thursday 11am-7pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Orlando E. Aviles can be reached at (571) 270-5531. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACOB K ACKUN/ Primary Examiner, Art Unit 3736