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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 4 is objected to because of the following informalities: the claim should be amended to recite “the outer surface” in line 1 since the outer surface was previously introduced in claim 2. Appropriate correction is required.
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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abitabilo (US 20200009366).
Regarding claim 1, Abitabilo discloses a catheter system (fig. 3), comprising:
a needleless connector (see below), comprising a distal end, a proximal end (see below), and a valve disposed between the distal end of the needleless connector and the proximal end of the needleless connector (compression seal 192 in fig. 13A; fig. 13A/B shows at least a portion of the valve is disposed between the proximal and distal ends and is entirely between the proximal and distal ends in the compressed condition in fig. 13B);
a vent assembly (needleless connector 118 and vent cap 120 in fig. 13A), comprising:
a proximal component (vent cap 120 in fig. 13A), comprising a male luer adapter comprising a male luer (nose 196 in fig. 13A); and
a distal component (needleless connector 118 in fig. 13A), comprising:
a distal end coupled to the proximal end of the needleless connector (fig. 13A shows the distal component 118 and the needless connector denoted below is fixedly engaged so that the distal end of 118 is operatively coupled to the proximal end of the needleless connector above); and
a proximal end coupled to the male luer adapter (fig. 13A),
wherein the proximal component is movable between a proximal position (fig. 13A) and a distal position with respect to the distal component (fig. 13B), wherein in response to movement of the proximal component from the proximal position to the distal position, the male luer of the male luer adapter opens the valve (fig. 13B).
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Regarding claim 2, Abitabilo discloses an inner surface of the proximal component comprises a first protrusion (see below), wherein an outer surface of the distal component comprises a second protrusion and a third protrusion distal to the second protrusion (see below), wherein in response to movement of the proximal component from the proximal position to the distal position, the first protrusion moves distal to the third protrusion (fig. 13B).
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Regarding claim 3, Abitabilo discloses in response to the proximal component being in the distal position, the first protrusion is distal to the second protrusion (fig. 13B).
Regarding claim 4, Abitabilo discloses an outer surface of the distal component further comprises a channel (see below; a channel is comprised between the outer surface of the needleless connector 118 and the vent cap 120), wherein the second protrusion and the third protrusion are disposed within the channel (fig. 13A/B), wherein in response to movement of the proximal component from the proximal position to the distal position, the first protrusion moves distally within the channel (fig. 13A/B).
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Regarding claim 5, Abitabilo discloses a catheter assembly coupled to the distal end of the needleless connector (fig. 3), wherein the catheter assembly comprises: a catheter adapter (hub 110 in fig. 3), comprising a distal end, a proximal end (fig. 3), and a side port (see below); an extension tube extending from the side port (extension tube 114 in fig. 4B); an adapter coupled to the extension tube (clamp 116 in fig. 4B), wherein the distal end of the needleless connector is coupled to the adapter (the distal end of the needleless connector designated above is operationally coupled to the clamp 116); and a catheter extending from the distal end of the catheter adapter (catheter tube 108 in fig. 4B).
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Claim Rejections - 35 USC § 103
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.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abitabilo in view of Christensen (US 20080200903).
Regarding claim 6, Abitabilo discloses a method comprising:
activating a vent assembly (needleless connector 118 and vent cap 120 in fig. 13A; figs. 13A/B shows the vent assembly being “activated” by moving cap 120 distally) coupled to a needleless connector (see below), wherein the needleless connector is coupled to a catheter assembly (fig. 3), wherein the needleless connector comprises a distal end, a proximal end (see below), and a valve disposed between the distal end of the needleless connector and the proximal end of the needleless connector (compression seal 192 in fig. 13A; fig. 13A/B shows at least a portion of the valve is disposed between the proximal and distal ends and is entirely between the proximal and distal ends in the compressed condition in fig. 13B),
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wherein the vent assembly comprises:
a proximal component (vent cap 120 in fig. 13A), comprising a male luer adapter comprising a male luer (nose 196 in fig. 13A); and
a distal component (needleless connector 118 in fig. 13A), comprising:
a distal end coupled to the proximal end of the needleless connector (fig. 13A shows the distal component 118 and the needless connector denoted below is fixedly engaged so that the distal end of 118 is operatively coupled to the proximal end of the needleless connector above); and
a proximal end coupled to the male luer adapter (fig. 13A),
wherein the proximal component is movable between a proximal position (fig. 13A) and a distal position with respect to the distal component (fig. 13B), wherein activating the vent assembly comprises moving the proximal component from the proximal position to the distal position (fig. 13A/B), wherein in response to moving the proximal component from the proximal position to the distal position, the male luer of the male luer adapter opens the valve (fig. 13B);
inserting the catheter assembly into vasculature of a patient and priming the catheter assembly with blood (paragraph 112 discloses blood enters catheter tube and other portions of the catheter assembly 100 to purge air).
However, Abitabilo does not teach or disclose flushing the blood back into the vasculature.
Christensen teaches a similar method and device of venting a catheter assembly prior to administering drugs (fig. 1; paragraph 38) which comprises the step of flushing the blood back into the vasculature (paragraph 38). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of Abitabilo to include the step of flushing the blood back into the vasculature, as taught by Christensen, for the purpose of clearing the catheter assembly prior to delivery of medicament.
Regarding claim 7, in the modified method of Abitabilo, Abitabilo discloses an inner surface of the proximal component comprises a first protrusion (see below), wherein an outer surface of the distal component comprises a second protrusion and a third protrusion distal to the second protrusion (see below), wherein in response to movement of the proximal component from the proximal position to the distal position, the first protrusion moves distal to the third protrusion (fig. 13B).
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Regarding claim 8, in the modified method of Abitabilo, Abitabilo discloses in response to the proximal component being in the distal position, the first protrusion is proximal to the second protrusion (fig. 13B).
Conclusion
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/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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