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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 9/19/2024, 12/5/2024, and 8/7/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claim(s) 1-3 and 6-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Becton, Dickinson and Company (EP 2228092; hereafter Becton).
In regard to claim 1, Becton discloses a catheter assembly (10) comprising: a catheter member comprising: a catheter (not numbered, shown in Fig. 1A-1B) having a lumen, and a catheter hub (distal portion of 26) located at a proximal end of the catheter; a needle member comprising: an inner needle (14) located in the lumen of the catheter, and an inner needle hub (connection point for needle 14) located at a proximal end of the inner needle; a catheter operation member (proximal portion of 26) attached to the catheter member; and a safety member (28) configured to be movable with respect to the inner needle in an axial direction of the inner needle (see Figs. 1A-1C); wherein: a needle tip (point of 14) of the inner needle is exposed from the safety member in an initial state (see Fig. 1A), is located distal of the safety member, and is covered with the safety member in a state in which the inner needle is removed from the catheter member (see Figs. 1B-1C); the catheter operation member comprises a connection portion (22) that separably connects the safety member and is elastically deformable (see par. [0016]-[0030]); the connection portion comprises a first restriction portion (48); the safety member comprises a second restriction portion (38) located distal of the first restriction portion so as to face the first restriction portion in the initial state; and when the safety member is moved relative to the catheter operation member in a proximal end direction, the connection portion is pressed by the second restriction portion and is elastically deformed and the second restriction portion passes over the first restriction portion in the proximal end direction, thereby causing the catheter operation member and the safety member to be separated from each other (see Figs. 1A-1C).
In regard to claim 2, Becton discloses wherein: the connection portion (22) has a tubular shape; and a slit (34) is formed in the connection portion along an axial direction of the connection portion.
In regard to claim 3, Becton discloses wherein: the connection portion (22) comprises a first fitting portion (34); the safety member (28) comprises: a needle protection portion located in a lumen of the connection portion in the initial state (see Fig. 1A), and a second fitting portion (42) located in the needle protection portion and fitted to the first fitting portion in the initial state (see Fig. 1A); the first restriction portion (48) is located in the first fitting portion; and the second restriction portion (38) is provided in the second fitting portion (see Fig. 1A).
In regard to claim 6, Becton discloses wherein: the first fitting portion (34) is located on a groove inner surface forming the slit (see Figs. 1A-1C).
In regard to claim 7, Becton discloses, wherein: the first fitting portion (34) is located on an inner surface forming the lumen of the connection portion (see Figs. 1A-1C).
In regard to claim 8, Becton discloses wherein: the second fitting portion (42) extends annularly in a circumferential direction of the needle protection portion (see Fig. 1A).
In regard to claim 9, Becton discloses, wherein: the first fitting portion (34) is a recess or a hole; and the second fitting portion (38) is a protrusion fittable to the recess or the hole (see Fig. 1A).
In regard to claim 10, Becton discloses a method of operating a catheter assembly (10), the method comprising: providing a catheter assembly comprising: a catheter member (not numbered, shown in Fig. 1A-1B) comprising: a catheter having a lumen, and a catheter hub (distal portion of 26) located at a proximal end of the catheter, a needle member comprising: an inner needle (14) located in the lumen of the catheter, and an inner needle hub (connection point of needle 14) located at a proximal end of the inner needle, a catheter operation member (proximal portion of 26) attached to the catheter member, and a safety member (28) configured to be movable with respect to the inner needle in an axial direction of the inner needle (see Figs. 1A-1C); wherein: a needle tip (point of 14) of the inner needle (14) is exposed from the safety member and located distal of the safety member in an initial state (see Fig. 1A), and is covered with the safety member (28) in a state in which the inner needle is removed from the catheter member (see Figs. 1B-1C), the catheter operation member comprises a connection portion (22) that separably connects the safety member (28) and is elastically deformable (see par. [0016]-[0030]), the connection portion comprises a first restriction portion (48), and the safety member comprises a second restriction portion (38) located distal of the first restriction portion so as to face the first restriction portion in the initial state (see Fig. 1A); puncturing skin of a living body with the inner needle and the catheter such that the needle tip of the inner needle is located in a blood vessel of the living body; gripping the catheter operation member and moving the catheter operation member toward a distal end of the catheter such that the catheter moves in a distal end direction along the inner needle, the first restriction portion (48) pushes the second restriction portion (38) in a distal end direction, and the safety member (28) moves in the distal end direction along with the catheter operation member; separating the catheter from the catheter operation member and indwelling the catheter in the blood vessel; moving the inner needle in a proximal end direction since such that the needle tip is located in the safety member; moving the safety member relative to the catheter operation member in a proximal end direction, such that the connection portion is pressed by the second restriction portion and is elastically deformed and the second restriction portion passes over the first restriction portion in the proximal end direction, thereby causing the catheter operation member and the safety member to be separated from each other (see Figs. 1A-1C).
In regard to claim 11, please see the rejections above as the examiner believes all of the limitations are adequately addressed.
Claim(s) 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Woehr (US 2014/0276453).
In regard to claim 1, Woehr discloses a catheter assembly (100) comprising: a catheter member comprising: a catheter (104) having a lumen, and a catheter hub (distal portion of 102) located at a proximal end of the catheter; a needle member comprising: an inner needle (108) located in the lumen of the catheter, and an inner needle hub (106) located at a proximal end of the inner needle; a catheter operation member (proximal portion of 102) attached to the catheter member; and a safety member (156) configured to be movable with respect to the inner needle in an axial direction of the inner needle; wherein: a needle tip (92) of the inner needle is exposed from the safety member in an initial state (see Fig. 1), is located distal of the safety member, and is covered with the safety member in a state in which the inner needle is removed from the catheter member (not shown but 156 is configured to cover needle point); the catheter operation member comprises a connection portion (124) that separably connects the safety member and is elastically deformable (see par. [0050]-[0055]); the connection portion comprises a first restriction portion (proximal reduced diameter portion of 124); the safety member comprises a second restriction portion (distal bends of 90, 90b) located distal of the first restriction portion so as to face the first restriction portion in the initial state; and when the safety member (156) is moved relative to the catheter operation member in a proximal end direction, the connection portion is pressed by the second restriction portion and is elastically deformed and the second restriction portion passes over the first restriction portion in the proximal end direction, thereby causing the catheter operation member and the safety member to be separated from each other (see Figs. 4 and 8).
In regard to claim 2, Woehr discloses wherein: the connection portion (124) has a tubular shape (see Fig. 1); and a slit (148) is formed in the connection portion along an axial direction of the connection portion.
In regard to claim 3, Woehr discloses wherein: the connection portion (124) comprises a first fitting portion (middle portion of 124); the safety member (156) comprises: a needle protection portion (154) located in a lumen of the connection portion in the initial state (see Fig. 1), and a second fitting portion (90a, 90b) located in the needle protection portion and fitted to the first fitting portion in the initial state (see Fig. 1); the first restriction portion is located in the first fitting portion; and the second restriction portion is provided in the second fitting portion (see Fig. 1).
In regard to claim 4, Woehr discloses wherein: the first fitting portion (middle portion of 124) is located in a middle of the connection portion in the axial direction (see Figure 1).
In regard to claim 5, Woehr discloses wherein: the first fitting portion (middle portion of 124) is located distal of a center of the connection portion in the axial direction (the first fitting portion can be considered as extending past the center of the connection portion).
In regard to claim 6, Woehr discloses wherein: the first fitting portion (middle portion of 124) is located on a groove inner surface forming the slit (see Fig. 1).
In regard to claim 7, Woehr discloses, wherein: the first fitting portion (middle portion of 124) is located on an inner surface forming the lumen of the connection portion (see Fig. 1).
In regard to claim 8, Woehr discloses wherein: the second fitting portion (90a, 90b) extends annularly in a circumferential direction of the needle protection portion (see Fig. 1).
In regard to claim 9, Woehr discloses, wherein: the first fitting portion (middle portion of 124) is a recess or a hole; and the second fitting portion (90a, 90b) is a protrusion fittable to the recess or the hole (see Fig. 1).
In regard to claim 10, Woehr discloses a method of operating a catheter assembly (100), the method comprising: providing a catheter assembly comprising: a catheter member comprising: a catheter (104) having a lumen, and a catheter hub (distal portion of 102) located at a proximal end of the catheter, a needle member comprising: an inner needle (108) located in the lumen of the catheter, and an inner needle hub (106) located at a proximal end of the inner needle, a catheter operation member (proximal portion of 102) attached to the catheter member, and a safety member (156) configured to be movable with respect to the inner needle in an axial direction of the inner needle (see Fig. 1); wherein: a needle tip (92) of the inner needle (108) is exposed from the safety member and located distal of the safety member in an initial state (see Fig. 1), and is covered with the safety member (156) in a state in which the inner needle is removed from the catheter member (not shown but 156 is configured to cover needle point), the catheter operation member comprises a connection portion (124) that separably connects the safety member (156) and is elastically deformable (see par. [0050]-[0055]), the connection portion comprises a first restriction portion (proximal reduced diameter portion of 124), and the safety member comprises a second restriction portion (90a,90b) located distal of the first restriction portion so as to face the first restriction portion in the initial state (see Fig. 1); puncturing skin of a living body with the inner needle and the catheter such that the needle tip of the inner needle is located in a blood vessel of the living body; gripping the catheter operation member and moving the catheter operation member toward a distal end of the catheter such that the catheter moves in a distal end direction along the inner needle, the first restriction portion pushes the second restriction portion in a distal end direction, and the safety member (1568) moves in the distal end direction along with the catheter operation member; separating the catheter from the catheter operation member and indwelling the catheter in the blood vessel; moving the inner needle in a proximal end direction since such that the needle tip is located in the safety member; moving the safety member relative to the catheter operation member in a proximal end direction, such that the connection portion is pressed by the second restriction portion and is elastically deformed and the second restriction portion passes over the first restriction portion in the proximal end direction, thereby causing the catheter operation member and the safety member to be separated from each other (see Figs. 4 and 8).
In regard to claim 11, please see the rejections above as the examiner believes all of the limitations are adequately addressed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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