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 statements (IDS) submitted on 8/30/2024, 7/16/2025, and 5/29/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities:
On line 10 of claim 1, “to an inner surface the” should read “to an inner surface of the” to correct a minor typographical error.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7 and 29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regard to claims 7 and 29, the specification indicates that the locking mechanism includes the latching mechanism (see par. [0012]) and there are no other examples of the locking mechanism. It is unclear if the applicant is claiming two separate structures in these claims or if the locking mechanism is more narrowly claimed as a latching mechanism. The latter interpretation is being used in this action. Amendments are encouraged.
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) 1-11 and 23-30 are rejected under 35 U.S.C. 103 as being unpatentable over Tolkoff et al. (US 5,637,102; hereafter Tolkoff) in view of Stankowski et al. (US 2020/0108242; hereafter Stankowski).
In regard to claim 1, Tolkoff discloses a cathlock system, comprising: a catheter (58) defining a lumen (104); a stem (34) configured to engage the lumen of the catheter (see Fig. 9); and a cathlock (see Fig. 7-10) configured to engage an outer surface of the catheter and secure the catheter to the stem, the cathlock (82) comprising: a body (182, 184) having a first portion (182) coupled to a second portion (184) and transitionable between an open position and a first closed position (“First slot 186 and a second slot 188 enable C-shaped clamps 182 and 184 to pivot away from each other, expanding first slot 186 and second slot 188 therebetween, when an outwardly directed radial force is imposed on either of C-shaped clamps 182, 184.”); a locking mechanism (the resiliency of the clamps is the locking mechanism that keeps the clamps in the locked position) configured to releasably engage the first portion and the second portion in the first closed position; and a sleeve (94) coupled to an inner surface the first portion or an inner surface of the second portion and configured to secure the cathlock to the catheter in both the open position and the first closed position (see at least Figs. 9-10 which show an open position in Fig. 9 and a closed position in Fig. 10- the sleeve 94 is coupled to the first and second portions in both position).
Tolkhoff fails to expressly disclose the first portion (182) is hingedly coupled to a second portion (184) as is recited in claim 1.
In a similar art, Stankowski discloses a connection clamping device (21; 61; 81; 131; 151) arranged for securing a flexible tube (1) to a barbed end (5b) of a tube connector (5), whereby the barbed end (5b) comprises a barb (9) and the tube connector during connection is arranged to protrude into an end of the flexible tube (1), characterized in that said connection clamping device comprises two sections (23a, 23b) connected via hinge (31) which, during connection when the tube connector protrudes into an end of the flexible tube, are arranged to be connected and locked to each other by a locking mechanism (33a,33b,34a,34b; 63a, 63b, 64a, 64b) around the tube connector (5) and the flexible tube (1), such that the flexible tube (1) is compressed against the tube connector (5) by a rib (41a, 41b) provided on the inner circumference of the connection clamping device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the C-shaped clamps and locking sleeve (82) of Tolkhoff to include the hinged clamp of Stankowski in order to provide an easy-to-connect clamping mechanism that maintains a reliable, leak-proof and steady connection as expressly taught by Stankowski (see par. [0006]). The substitution merely replaces one known clamping mechanism with another known clamping mechanism performing the same function of securing a tube to a barbed connector, yielding the predictable result of coupling the components. The modified device would incorporate the locking mechanism (33a, 33b, 34a, 34b) of Stankowski as well since this locking mechanism is configured to keep the hinged embodiment in the closed position.
In regard to claim 2, both references teach wherein the body in the first closed position defines a channel having a diameter that is less than an outer diameter of the catheter (the body has to have a smaller diameter in the closed position to secure the catheter).
In regard to claim 3, Tolkhoff discloses wherein the sleeve (94) defines a lumen (171) having a first inner diameter that is equal to the outer diameter of the catheter (see Figs. 9-10) and is elastically deformable to a second inner diameter that is less than the first inner diameter (sleeve 94 is made of silicone; see col. 11, lines 38-40).
In regard to claim 4, Tolkhoff discloses wherein the sleeve (94) is elastically deformable to a third inner diameter that is larger than the first inner diameter (sleeve 94 is made of silicone; see col. 11, lines 38-40).
In regard to claim 5, Tolkhoff discloses wherein the sleeve (94) is formed of a plastic, polymer, elastomer, rubber, or silicone rubber (sleeve 94 is made of silicone; see col. 11, lines 38-40).
In regard to claim 6, the combination teaches wherein the body further includes a second closed position, a diameter of the channel in the second closed position being larger than the outer diameter of the catheter (the modified device moves through N number of closed positions between extending between the max open and max closed positions).
In regard to claim 7, Stankowski teaches, further including a latching mechanism (33a, 33b, 34a, 34b) configured to provide mechanical advantage to transition from the second closed position to the first closed position.
In regard to claim 8, the combination teaches wherein one or both of the first portion and the second portion are formed of a rigid or resilient material (both references teach each of these materials).
In regard to claim 9, Tolkhoff discloses wherein the sleeve (94) is slidably engaged with the catheter in the open position (see col. 12, lines 47-53).
In regard to claim 10, Tolkhoff discloses wherein the sleeve (94) engages the catheter (58) in the open position in an interference fit and is configured to be positioned on the catheter at a first longitudinal position and remain at the first longitudinal position until repositioned to a second longitudinal position, different from the first longitudinal position (see col. 12, lines 47-53).
In regard to claim 11, Tolkhoff discloses wherein the stem (34) is in fluid communication with a port (16).
In regard to claims 23-30, 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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