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 January 21, 2026. As directed by the amendment: claims 1 and 7 have been amended, no claims have been added, claim 2 has been canceled. Thus claims 1 and 4-10 are presently pending in this application, and claims 4-6 and 8-10 remain withdrawn.
Response to Arguments
Applicant’s arguments, see Remarks, filed January 21, 2026, with respect to the rejection(s) of claim(s) 1 and 7 under 35 U.S.C. 103 have been fully considered and are persuasive. None of Avellanet, Sakaguchi, Ginster, or Burkholz disclose all the amended limitations of claims 1 and 7, namely a puncture needle provided on a side of the hub, and an extension tube connected to a directly opposite side of the hub. Therefore, the rejections of claims 1 and 7 have been withdrawn. However, upon further consideration in light of the amendments, a new ground(s) of rejection is made below.
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.
Claim 1 is 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.
Claim 1 recites the limitation "the guide wire" in line 6. There is insufficient antecedent basis for this limitation in the claim. For examining purposes, the guide wire is interpreted as a new claim limitation.
Claim Rejections - 35 USC § 103
Claims 1 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Avellanet et al. (US 5487729), hereinafter Avellanet, in view of Sakaguchi et al. (US 20180214120), hereinafter Sakaguchi, Gross (US 4349023), and Ginster (US 20210077787).
Regarding claim 1, Avellanet discloses a catheter capable of preventing guide wire retention (catheter system of Fig. 1), comprising: a catheter body (Fig. 1, guide catheter 10), comprising an extension tubing (Fig. 1, guide catheter 10 comprises an extended tubing 10), wherein the extension tube comprises an adapter (Fig. 1, proximal end of the tubing 10 comprises the connector/adapter with luer fitting 24); wherein the guide wire is made of a magnetic material or provided with a magnetic element (Fig. 2 and C.6:15-18, catheter 12 defines a magnetic section M at its proximal end); wherein the catheter body is provided with at least one detachable magnetic attraction mechanism (Fig. 1, holding attachment 20, comprising annular magnet 22, which can detachably connect to the guide catheter 10) for attracting the guide wire and holding the guide wire in position relative to the catheter body after the guide wire is inserted through the catheter body (C. 6:15-18; 42-54, magnet 22 of holding attachment 20 attracts the magnetic portion M of the guidewire 12 and holds the position of the magnetically stabilized guidewire within guide catheter 10); wherein the detachable magnetic attraction mechanism comprises a magnetic positioning member (Fig. 1, holding attachment 20), wherein the magnetic positioning member comprises: a base (Fig. 1, attachment 20 body), wherein the base is provided with a through hole (Fig. 1, bore of attachment 20), and the base is further provided with a locking portion corresponding to an end of the through hole (Fig. 1 and C.5:55-59, distal end of attachment 20 body has a connector end, wherein bore of attachment 20 ends at the connector end), and the locking portion is configured to be locked to the adapter (Fig. 1 and C.5:55-59, distal end of attachment 20 has connector end which is configured to be connected/lock to the luer fitting 24 via conventional luer connection); and a magnetically attractive element (Fig. 1, annular magnet 22) provided at the base (Fig. 1, annular magnet 22 is provided within the attachment body 20) and configured to attract the guide wire after the guide wire is inserted through the catheter to hold the guide wire in position relative to the catheter body (C. 6:15-18; 42-54, magnet 22 of holding attachment 20 attracts the magnetic portion M of the guidewire 12 and holds the position of the magnetically stabilized guidewire within guide catheter 10), wherein the guide wire is exposed from the detachable magnetic attraction mechanism (Fig. 1, an end of the guidewire 12 is exposed from holding attachment 20, as the guidewire extends through the opening at fitting 24 to be exposed from the device at the guidewire proximal end 12a).
Avellanet discloses all the above limitations, but is silent to wherein the locking portion comprises a screw thread structure, a position-limiting rib, an elastic clip or an elastic gripper, the locking portion is provided on an inner wall of the through hole. However, Sakaguchi discloses wherein the locking portion (Fig. 13-14, connection section 250, comprising connector main body portion 251 which connects the connector to a catheter sheath 220) comprises a screw thread structure, a position-limiting rib, an elastic clip or an elastic gripper (Fig. 13, female screw portion 252), the locking portion is provided on an inner wall of the through hole (Fig. 13, female screw portion 252 on the internal wall of main body portion 251, wherein through hole extends). The female screw portion of Sakaguchi interacts with a male screw portion 221 on a proximal end of a catheter sheath 220 to connect the connector main body to the catheter sheath 220 such that the lumens of the connector main body 251 and catheter sheath 220 are in communication. A simple substitution is being made of one known element (a female screw connection portion which interacts with a male screw connection portion) for another (a luer lock connector which interacts with a corresponding luer lock connector) to obtain predictable results, namely, the ability to connect/lock the component to a proximal end opening of a catheter sheath (See Sakaguchi, Fig. 13 and [0104-0105] and Avellanet, Fig. 1 and C.5:55-59).
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 Avellanet to incorporate the disclosures of Sakaguchi and modify the locking portion to comprise a screw thread structure, a position-limiting rib, an elastic clip or an elastic gripper, the locking portion is provided on an inner wall of the through hole. Doing so would be a simple substitution of the female/male screw connection for the male/female luer lock connection to obtain the predictable result of connecting/locking the locking portion to a proximal end opening of a catheter sheath.
Avellanet, in view of Sakaguchi, fails to disclose the catheter body comprising a hub, a puncture needle provided on a side of the hub, and the extension tube connected to a directly opposite side of the hub, the catheter body further comprises a guide channel extending through the extension tube, the hub, and the puncture needle, wherein the guide wire is configured to be inserted into the puncture needle and passed through the extension tube via the guide channel. However, Gross discloses the catheter body comprising a hub (Fig. 3-4, catheter system comprises a hub 20), a puncture needle (Fig. 1-4, needle 11) provided on a side of the hub (Fig. 1 and 4, needle extends from distal end of hub 20), and the extension tube connected to a directly opposite side of the hub (Fig. 3-4, extension catheter tubing 30 connects to the directly opposite proximal side of hub 20), the catheter body further comprises a guide channel extending through the extension tube, the hub, and the puncture needle (Fig. 4-5, a guide channel is formed and extends through the internal passages of the needle 11, the hub 20, and the catheter tubing 30), wherein the guide wire is configured to be inserted into the puncture needle and passed through the extension tube via the guide channel (Fig. 4-5, the guide channel extends through the internal passages of the needle 11, the hub 20, and the catheter tubing 30, therefore a guidewire which extends through the catheter tubing (as seen in Fig. 1 of Avellanet, wherein the catheter tubing 10 is equivalent to catheter tubing 30 of Gross) would then also be inserted into/extend through needle 11, as the guide channel connects these internal passages).
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 Avellanet, in view of Sakaguchi, to incorporate the disclosures of Gross and modify the catheter body to comprise a hub, a puncture needle provided on a side of the hub, and the extension tube connected to a directly opposite side of the hub, wherein the extension tube comprises an adapter the venous catheter body further comprises a guide channel extending through the extension tube, the hub, and the puncture needle, wherein the guide wire is configured to be inserted into the puncture needle and passed through the extension tube via the guide channel. Doing so would provide a low cost and disposable catheter system comprising a hub and needle structure which facilitates a smooth passageway for the catheter tubing therethrough, which thus affords the introduction of the catheter into the patient in a quick and efficient manner (Gross, Col. 1:49-54).
Avellanet, in view of Sakaguchi and Gross, fails to disclose wherein the catheter body is a venous catheter body. However, Ginster discloses wherein the catheter body is a venous catheter body ([0015], catheter used with guidewire may be any vascular instrument including a venous catheter).
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 Avellanet, in view of Sakaguchi and Gross, to incorporate the disclosures of Ginster and modify the catheter body to be a venous catheter body. Doing so would allow for prevention of guidewire loss/accidental release in vascular procedures including central venous catheterization (Ginster, Abstract and [0015, 0038]). Additionally, Avellanet also discusses the use of magnetic guidewire coupling for catheterization procedures within the cardiovascular system (Avellanet, Abstract and Col. 3:61-65), therefore also using magnetic guidewire coupling to a vascular instrument, like the device of Ginster.
Regarding claim 7, Avellanet discloses a detachable magnetic attraction mechanism for holding a guide wire in position relative to a catheter body (Fig. 1 and C. 6:15-18; 42-54, holding attachment 20 for stabilizing a guidewire relative to a catheter), configured to be provided in relation to the catheter body (Fig. 1, holding attachment is provided in relation to guide catheter 10), wherein the catheter body comprises an extension tubing (Fig. 1, guide catheter 10 comprises an extended tubing 10), wherein the extension tube comprises an adapter (Fig. 1, proximal end of the tubing 10 comprises the connector/adapter with luer fitting 24); the detachable magnetic attraction mechanism comprising a magnetic positioning member (Fig. 1, holding attachment 20), the magnetic positioning member comprising: a base (Fig. 1, attachment 20 body), wherein the base is provided with a through hole (Fig. 1, bore of attachment 20) and the base is further provided with a locking portion corresponding to an end of the through hole (Fig. 1 and C.5:55-59, distal end of attachment 20 body has a connector end, wherein bore of attachment 20 ends at the connector end), and the locking portion is configured to be locked to the adapter of the extension tubing (Fig. 1 and C.5:55-59, distal end of attachment 20 has connector end which is configured to be connected/lock to the luer fitting 24 via conventional luer connection); and a magnetically attractive element (Fig. 1, annular magnet 22) provided at the base (Fig. 1, annular magnet 22 is provided within the attachment body 20) and configured to attract the guide wire after the guide wire is inserted through the catheter body to hold the guide wire in position relative to the catheter body (C. 6:15-18; 42-54, magnet 22 of holding attachment 20 attracts the magnetic portion M of the guidewire 12 and holds the position of the magnetically stabilized guidewire within guide catheter 10), wherein the guide wire is exposed from the detachable magnetic attraction mechanism (Fig. 1, an end of the guidewire 12 is exposed from holding attachment 20, as the guidewire extends through the opening at fitting 24 to be exposed from the device at the guidewire proximal end 12a).
Avellanet discloses all the above limitations, but is silent to wherein the locking portion comprises a screw thread structure, a position-limiting rib, an elastic clip or an elastic gripper, the locking portion is provided on an inner wall of the through hole. However, Sakaguchi discloses wherein the locking portion (Fig. 13-14, connection section 250, comprising connector main body portion 251 which connects the connector to a catheter sheath 220) comprises a screw thread structure, a position-limiting rib, an elastic clip or an elastic gripper (Fig. 13, female screw portion 252), the locking portion is provided on an inner wall of the through hole (Fig. 13, female screw portion 252 on the internal wall of main body portion 251, wherein through hole extends). The female screw portion of Sakaguchi interacts with a male screw portion 221 on a proximal end of a catheter sheath 220 to connect the connector main body to the catheter sheath 220 such that the lumens of the connector main body 251 and catheter sheath 220 are in communication. A simple substitution is being made of one known element (a female screw connection portion which interacts with a male screw connection portion) for another (a luer lock connector which interacts with a corresponding luer lock connector) to obtain predictable results, namely, the ability to connect/lock the component to a proximal end opening of a catheter sheath (See Sakaguchi, Fig. 13 and [0104-0105] and Avellanet, Fig. 1 and C.5:55-59)
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 Avellanet to incorporate the disclosures of Sakaguchi and modify the locking portion to comprise a screw thread structure, a position-limiting rib, an elastic clip or an elastic gripper, the locking portion is provided on an inner wall of the through hole. Doing so would be a simple substitution of the female/male screw connection for the male/female luer lock connection to obtain the predictable result of connecting/locking the locking portion to a proximal end opening of a catheter sheath.
Avellanet, in view of Sakaguchi, fails to disclose wherein the catheter body comprises a hub, a puncture needle provided on a side of the hub, and the extension tube connected to a directly opposite side of the hub. However, Gross discloses the catheter body comprising a hub (Fig. 3-4, catheter system comprises a hub 20), a puncture needle (Fig. 1-4, needle 11) provided on a side of the hub (Fig. 1 and 4, needle extends from distal end of hub 20), and the extension tube connected to a directly opposite side of the hub (Fig. 3-4, extension catheter tubing 30 connects to the directly opposite proximal side of hub 20).
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 Avellanet, in view of Sakaguchi, to incorporate the disclosures of Gross and modify the catheter body to comprise a hub, a puncture needle provided on a side of the hub, and the extension tube connected to a directly opposite side of the hub. Doing so would provide a low cost and disposable catheter system comprising a hub and needle structure which facilitates a smooth passageway for the catheter tubing therethrough, which thus affords the introduction of the catheter into the patient in a quick and efficient manner (Gross, Col. 1:49-54).
Avellanet, in view of Sakaguchi and Gross, fails to disclose wherein the catheter body is a venous catheter body. However, Ginster discloses wherein the catheter body is a venous catheter body ([0015], catheter used with guidewire may be any vascular instrument including a venous catheter).
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 Avellanet, in view of Sakaguchi and Gross, to incorporate the disclosures of Ginster and modify the catheter body to be a venous catheter body. Doing so would allow for prevention of guidewire loss/accidental release in vascular procedures including central venous catheterization (Ginster, Abstract and [0015, 0038]). Additionally, Avellanet also discusses the use of magnetic guidewire coupling for catheterization procedures within the cardiovascular system (Avellanet, Abstract and Col. 3:61-65), therefore also using magnetic guidewire coupling to a vascular instrument, like the device of Ginster.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH D GRASMEDER whose telephone number is (571)272-0258. The examiner can normally be reached M-F 8 am-5 pm EST.
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783