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 .
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) 8 -20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kawasumi Chemical Industry Co., LTD. (JP H04-27936), hereinafter Kawasumi, supplied in the August 6, 2024 filed IDS.
Regarding claim 8, Kawasumi discloses a sealing member 2, 3 for a medical tube 8, the sealing member comprising: a base 3 extending along an axis of the sealing member from a proximal end of the base to a distal end of the base (see Figs. 1-4), wherein the base comprises a base flow path lumen 7 extending from the proximal end of the base to the distal end of the base (see Fig. 1); a plug 2 interconnected to the base at the distal end of the base (see Fig. 1), wherein the plug completely covers and blocks the base flow path lumen at the distal end of the base (see Fig. 1); and a joint 4 disposed between the base and the plug (see Fig. 1), the joint comprising at least one stress concentration groove extending into the sealing member in a direction toward the axis of the sealing member (see Fig. 1), the at least one stress concentration groove extending around a periphery of the joint (see Fig. 1); wherein the plug comprises a noncircular cross-sectional shape (see Figs. 2-3(c), wings part 6 and fluid channel 15 in valleys creates a non-circular shape), the noncircular cross-sectional shape surrounding the axis of the sealing member (see Figs. 2-3(c), and wherein the noncircular cross-sectional shape undulates between concave and convex portions following an outer peripheral surface of the plug (see Figs. 2-3(c), winds 6 and fluid channels in valleys create alternating concave and convex portions).
Regarding claim 9, Kawasumi discloses the noncircular cross-sectional shape undulates longitudinally as well as circumferentially as the noncircular cross-sectional shape follows the outer peripheral surface of the plug see Figs. 1-2, the noncircular cross-sectional shape follows along on a longitudinal distance of the plug).
Regarding claim 10, Kawasumi discloses the sealing member is movable between a closed state (see Figs. 1-2) and a fluid communication state (see Fig. 4), wherein in the closed state the at least one stress concentration groove is entirely unbroken along the periphery of the joint (see Fig. 1), and wherein in the fluid communication state the at least one stress concentration groove is broken along at least a portion of the periphery of the joint (see Fig. 4).
Regarding claim 11, Kawasumi discloses the noncircular cross-sectional shape of the plug comprises at least two recessed face portions 15 and at least two ridges 6 (see Figs. 3(a)-3(c)), wherein a first recessed face portion of the at least two recessed face portions is disposed between adjacent ridges of the at least two ridges (see Figs. 3(a)-3(c)).
Regarding claim 12, Kawasumi discloses the at least two ridges comprise convex surfaces of the outer peripheral surface of the plug, wherein the at least two recessed face portions comprise concave surfaces of the outer peripheral surface of the plug (see Figs. 3(a)-3(c)).
Regarding claim 13, Kawasumi discloses a first radial distance from the axis to the outer peripheral surface of the plug at each of the at least two ridges is greater than a second radial distance from the axis to the outer peripheral surface of the plug at each of the at least two recessed face portions (see Figs. 2-3(c)).
Regarding claim 14, Kawasumi discloses a circle inscribed within the noncircular cross-sectional shape contacts a portion of the joint adjacent each of the at least two recessed face portions (see Fig. 2), and wherein a radially extending space is disposed between the circle inscribed within the noncircular cross-sectional shape and a portion of the joint adjacent each of the at least two ridges the joint (see Fig. 2).
Regarding claim 15, Kawasumi discloses the at least one stress concentration groove extending around the periphery of the joint comprises a thinnest section of material of the sealing member (see Fig. 1).
Regarding claim 16, Kawasumi discloses the base comprises an outer circumferential face arranged adjacent the proximal end of the base, and wherein the outer circumferential face is sized to seal against an inner face of a medical tube in a liquid-tight contact arrangement (see Figs. 1, 4).
Regarding claim 17, Kawasumi discloses wherein, in the closed state, the sealing member prevents fluid flow past the sealing member through the medical tube (see Fig. 1), and wherein, in the fluid communication state, the sealing member allows fluid flow past the sealing member through the medical tube via the base flow path lumen (see Fig. 4).
Regarding claim 18, Kawasumi discloses the distal end of the base tapers from a first outer circumferential face diameter to a second outer circumferential face diameter, wherein the first outer circumferential face diameter is greater than the second outer circumferential face diameter (see Figs. 1, 4).
Regarding claim 19, Kawasumi discloses the noncircular cross-sectional shape of the plug comprises three recessed face portions and three ridges, wherein a first recessed face portion of the three recessed face portions is disposed between a first set of two adjacent ridges of the three ridges, wherein a second recessed face portion of the three recessed face portions is disposed between a second set of two adjacent ridges of the three ridges, and wherein a third recessed face portion of the three recessed face portions is disposed between a third set of two adjacent ridges of the three ridges (see Fig. 3(b)).
Regarding claim 20, Kawasumi discloses each ridge of the three ridges is separated from one another by 120 degrees (see Fig. 3(b)).
Allowable Subject Matter
Claims 1-7 are allowable.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art found is Kawasumi, which does not disclose the required breakable portion being a non-circular shape as claimed. In applicant’s claimed invention, the breakable portion “is non-circular in shape, the breakable portion including a plurality of tops and a plurality of connections between the plurality of tops” and a separate part from the plug that is connected to the base through the neck, and such a shape of the breakable portion not only helps in breaking the breakable portion smoothly, but also helps prevent/reduce the risk of hemolysis because the breakable portion is large in flow-path cross-sectional area (see paragraphs 9, 44, and 46 of the Specification filed August 5, 2024).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hall et al. (US 2018/0099135), disclosing a medical fluid line connector with a plug and base connected via a joint, the plug having a non-circular cross section; Nisipeanu et al. (US 2015/0238746), disclosing a medical fluid line connector with a plug and base connected via a joint, the plug having a non-circular cross section.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA ZIMBOUSKI whose telephone number is (303)297-4665. The examiner can normally be reached 8:30 - 5:00 PST M-F.
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/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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