DETAILED ACTION
This is a non-final rejection in response to application filed 10/2/23. Claims 1-22 are currently pending.
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) 1-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mansour (US 8298196) in view of Christensen (US 8070725).
Regarding independent claim 1 and 22, Mansour teaches a vent device for venting gas from a connector of an adapter 200, the connector comprising a valve 220, the vent device comprising:
a valve opener having a tip 401; an engagement body 230 retaining the valve opener; and a gas-permeable vent 212 formed with the valve opener; the valve opener is moveable from an initial non-venting condition, in which the tip is not pushed against the valve to open the valve, to a venting condition in which the tip of the valve opener deflects the valve to open the valve and gas passes (col. 5, l. 30-50).
While Mansour teaches valve opener having a tip 401 but is silent to a valve opener having a tip being part of the vent device and is not retained in a non-venting condition, and the valve opener is held in-register with the valve by the engagement body, and gas passes from within the adapter through the gas-permeable vent of the valve opener.
Christensen teaches a valve opener having a tip being part of the vent device and is not retained in a non-venting condition, and the valve opener is held in-register with the valve by the engagement body (col. 4, l. 1-10,40-55), and gas passes from within the adapter through the gas-permeable vent of the valve opener (col. 3, l. 50 – col. 4, l. 35).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify Mansour with the separate, attachable venting structure with a retained, moveable actuator taught by Christensen. Christensen teaches improved valve integrity and reduced leakage (col. 3, l. 10-25) as well as improved safety (col. 3. l. 50-65).
Regarding dependent claim 2, Mansour in view of Christensen teaches the invention as claimed and discussed above. Christensen further teaches wherein the gas-permeable vent comprises a semipermeable material (col. 3, l.50-65).
Regarding dependent claim 3, Mansour in view of Christensen teaches the invention as claimed and discussed above. Christensen further teaches wherein the valve opener has a body and the gas-permeable vent comprises a flow path formed through the body of the valve opener (col. 5, l.52-67).
Regarding dependent claim 4, Mansour in view of Christensen teaches the invention as claimed and discussed above. Christensen further teaches wherein the semipermeable material is located within the flow path (col. 3, l.50-65).
Regarding dependent claim 5, Mansour in view of Christensen teaches the invention as claimed and discussed above. Christensen further teaches wherein the engagement body engages the connector in both the initial non-venting condition and the venting condition of the valve opener (col. 5, l. 52- col. 6, l. 39).
Regarding dependent claim 6, Mansour in view of Christensen teaches the invention as claimed and discussed above. Christensen further teaches wherein the engagement body has a distal edge that extends distally of a distal end of the valve opener in the initial non-venting condition but not in the venting condition (see fig. 7-9).
Regarding dependent claim 7, Mansour in view of Christensen teaches the invention as claimed and discussed above. Christensen further teaches wherein the engagement body maintains a gap between the distal end of the valve opener and the valve when the valve opener is in the initial non- 30 venting condition (col. 5, l. 52- col. 6, l. 39).
Regarding dependent claim 8, Mansour in view of Christensen teaches the invention as claimed and discussed above. Christensen further teaches wherein the engagement body and the valve opener are axially fixed relative to one another in both the initial non-venting condition and the venting condition of the valve opener (col. 5, l. 52- col. 6, l. 39).
Regarding dependent claim 9, Mansour in view of Christensen teaches the invention as claimed and discussed above. Christensen further teaches wherein the engagement body comprises a distal section for engaging the connector, a proximal section for supporting the valve opener, and an intermediate section between the distal section and proximal section, wherein the intermediate section is flexible and deformable so the valve opener can move from the initial non-venting condition to the venting condition when the intermediate section is deformed (col. 5, l. 52- col. 6, l. 39).
Regarding dependent claim 10, Mansour in view of Christensen teaches the invention as claimed and discussed above. Christensen further teaches wherein the engagement body is movable along the connector in a distal direction as the valve opener moves from the initial non-venting condition to the venting condition (col. 6, l. 25-40).
Regarding dependent claim 11, Mansour in view of Christensen teaches the invention as claimed and discussed above. Christensen further teaches wherein the engagement body comprises an engagement section having a distal region and a proximal region, the distal region having a structure that is deformable as the valve opener moves from the initial non-venting condition to the venting condition (col. 6, l. 20-40).
Regarding dependent claim 12, Mansour in view of Christensen teaches the invention as claimed and discussed above. Christensen further teaches wherein the engagement body comprises at least one arm 105 having a distal tip adapted to engage behind a narrowing in an outer surface of the connector to maintain the valve opener in the venting condition (fig. 7).
Regarding dependent claim 13, Mansour in view of Christensen teaches the invention as claimed and discussed above. Christensen further teaches wherein the at least one arm comprises a plurality of resilient arms 105 adapted to engage behind the narrowing in the outer surface of the connector, in space relation (fig. 5)
Regarding dependent claim 14, Mansour in view of Christensen teaches the invention as claimed and discussed above. Christensen further teaches wherein the plurality of resilient arms 101 comprises two arms adapted to engage behind the narrowing in the outer surface of the connector on opposite sides of the connector (fig. 5).
Regarding dependent claim 15, Mansour in view of Christensen teaches the invention as claimed and discussed above. Christensen further teaches wherein a distal end of the valve opener is slotted (col. 6, l.10-20).
Regarding dependent claim 16, Mansour in view of Christensen teaches the invention as claimed and discussed above. Christensen further teaches wherein the engagement body rotates onto the connector to engage the connector, the engagement body comprising one or more finger grip members 410 on an outer surface of the engagement body.
Regarding dependent claim 17, Mansour in view of Christensen teaches the invention as claimed and discussed above. Christensen further teaches a port assembly for a vascular access assembly, comprising:an adapter 18 comprising at least two connectors; and a vent device according to claim 1 attached to a first connector of said at least two connectors (col. 3, ll. 25-40).
Regarding dependent claim 18, Mansour in view of Christensen teaches the invention as claimed and discussed above. Christensen further teaches wherein the adapter 18 is a Y-site (fig, 1).
Regarding dependent claim 19, Mansour in view of Christensen teaches the invention as claimed and discussed above. Christensen further teaches wherein the vent device and the first connector define a sterile volume containing a distal end of the valve opener and a proximal end of the valve (col. 4, ll.9-21).
Regarding dependent claim 20, Mansour in view of Christensen teaches the invention as claimed and discussed above. Christensen further teaches a vascular access assembly comprising: a port assembly according to claim 17; a catheter assembly 14; and an extension tube 16 connecting the port assembly to the catheter assembly.
Regarding dependent claim 21, Mansour in view of Christensen teaches the invention as claimed and discussed above. Christensen further teaches further comprising a clamp 20 on the extension tube 16.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG SANG KIM whose telephone number is (571)270-1418. The examiner can normally be reached 7:00 AM - 3:00 PM.
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/CRAIG KIM/
Primary Examiner
Art Unit 3741