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 .
Response to Amendment
This office action is responsive to the amendment filed on 21 May 2025. As directed by the amendment: claims 1-3, 5-7, and 13-14 have been amended; claims 4, 8-12, 15, and 22-23 have been canceled; and no claims have been added. Thus, claims 1-3, 5-7, 13-14, and 21 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 21 May 2025, with respect to the rejection(s) of claim(s) 1 under 35 USC §103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Bierman (US 2004/0102736).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 5, 7, 13-14, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Giuliani et al (US 4954129) in view of Bierman (US 2004/0102736).
Regarding claim 1, Giuliani discloses:
A catheter system (Fig. 1), comprising: a catheter adapter (hub attached to catheter tube 62) having a distal end (end closer to tube 62), a proximal end (end closer to connector 68) axially aligned with the distal end, and a lumen (18) extending between the distal end and the proximal end; a catheter (62) extending distally from the distal end of the catheter adapter; an extension tube (24) having a distal end (end closer to connector 68) and a proximal end (22), wherein the distal end of the extension tube (24) is coupled to the proximal end of the catheter adapter (Col. 4:34-37 – the distal end of extension tube 24 connects to the proximal end of the catheter 14 using connector 68); a first connector (20) coupled to the proximal end (22) of the extension tube (24); a second connector (68) coupled to the distal end of the extension tube (24), wherein the first connector (20), the second connector (68), the extension tube (24), the lumen (18), and the catheter (62) form a straight pathway (pathway from fiber optic strands 32 to end of probe 16 is a straight path) for delivery of an instrument (16) to the catheter system (Col. 4:37-38).
Giuliani teaches all of the elements of the claim but is silent regarding “a stabilization feature disposed on the extension tube in between the first connector and the second connector, wherein the stabilization feature comprises opposing platforms, wherein each of the opposing platforms comprises an adhesive layer configured to contact skin of a patient.” However, Bierman teaches an accessory for a catheter connected to a patient (Abstract), thus being in the same field of endeavor, with a stabilization feature in the form of a retainer (120; Fig. 22) that can be proximal to a connector (330) of a catheter (360), which as applied to Giuliani would be between the first connector and the second connector. Bierman further teaches the retainer (120) comprising opposing platforms (110a, 110b), wherein each of the opposing platforms (110a, 110b) comprises an adhesive layer (¶0076) configured to contact skin of a patient (¶0069). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the catheter system of Giuliani to incorporate a stabilization feature as taught by Bierman in order to hold a medical device to a patient and inhibit movement of the device (Bierman, Abstract).
Regarding claim 5, Giuliani in view of Bierman discloses:
The catheter system of claim 1, wherein the extension tube (24) is a first extension tube (Fig. 1), wherein the catheter system further comprises a second extension tube (30) coupled to the first extension tube (24), wherein the second extension tube (30) extends from the first connector (20) and is disposed at an angle with respect to the first extension tube (24) (Fig. 1).
Regarding claim 7, Giuliani in view of Bierman discloses:
The catheter system of claim 5, wherein the first connector (20) comprises a Y-adapter (Fig. 1) having a first port (port connected to assembly 28) and a second port (port connected to tube 30), wherein the first port is configured to couple with an instrument delivery device (28), wherein the second extension tube (30) extends from a second port of the Y-adapter (20).
Regarding claim 13, Giuliani in view of Bierman discloses:
The catheter system of claim 1, wherein the first connector (20) comprises septum (27; the septum 27 is fully capable of controlling blood and is therefore a blood control septum).
Regarding claim 14, Giuliani in view of Bierman discloses:
The catheter system of claim 1, wherein the first connector (20) is removably coupled to the proximal end (22) of the extension tube (24).
Regarding claim 21, Giuliani in view of Bierman discloses:
The catheter system of claim 1, wherein the straight pathway comprises a uniform diameter (diameter of extension tube 24) along an entirety of a length (length of extension tube 24) of the straight pathway.
Claim 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Giuliani in view of Bierman further in view of Leinsing et al (US 2004/0127854).
Regarding claim 2, Giuliani in view of Bierman discloses the catheter system of claim 1 and further discloses wherein the distal end of the extension tube (24) is integrated with the second connector (68), wherein the proximal end of the extension tube (24) is integrated with the first connector (20), and wherein the distal end of the extension tube (24) and the proximal end of the extension tube (24) are rigid or semi-rigid (tube fittings are known in the art to be rigid structures). Giuliani is silent regarding the ends of the extension tube being “fixedly integrated” with the connectors or “wherein the second connector comprises a luer adapter threaded to the proximal end of the catheter adapter.”
Regarding the “fixedly integrated” connectors, it has been held that “the use of a one-piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice” (In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965)) (MPEP 2144.04 V. B.). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Giuliani to teach wherein the distal end of the extension tube is fixedly integrated with the second connector and the proximal end of the extension tube is fixedly integrated with the first connector.
Regarding the “luer adapter,” Leinsing teaches a catheter system (Fig. 3), thus being in the same field of endeavor, with an adapter (46), a catheter (40), an extension tube (48), and a connector (38), where the connector (38) connects to the catheter (40) and the extension tube (48) using Luer fittings (¶0043). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the connector of Giuliani to incorporate the luer fittings as taught by Leinsing to form a luer adapter in order to provide sufficient structure to connect the different tubes of the system.
Regarding claim 3, Giuliani in view of Bierman discloses the catheter system of claim 1 and further teaches the second connector (68) selectively coupling to the proximal end of the catheter adapter but is silent regarding the connections being “a luer adapter” and “a corresponding luer adapter.” However, Leinsing teaches a catheter system (Fig. 3), thus being in the same field of endeavor, with an adapter (46), a catheter (40), an extension tube (48), and a connector (38), where the connector (38) connects to the catheter (40) and the extension tube (48) using Luer fittings (¶0043). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the connector of Giuliani to incorporate the luer fittings as taught by Leinsing to form a luer adapter in order to provide sufficient structure to connect the different tubes of the system.
Allowable Subject Matter
Claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783