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 .
Election/Restrictions
Claims 6, 9, and 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected specie, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/27/2025.
Applicant’s election without traverse of 1-5, 7-8 and 10-16 in the reply filed on 10/27/2025 is acknowledged.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-3, 7-8, 11-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Zadini et al (US 5415177 A).
Regarding claim 1, Zadini embodiment of Fig 18, hereinafter Zadini-18, discloses a catheter placement system (Fig 18), comprising: a needle (Hollow needle 130, Fig 18) supported by a needle hub (hub 136, Fig 18) and defining a needle lumen (lumen 1000, Annotated Fig 1); a guidewire (guide wire 190, Fig 18) having a distal tip (1001, Annotated Fig 1) disposed within the needle lumen (1000, Annotated Fig 1); a catheter disposed on a proximal portion of the guidewire (Col 11, lines 59-69); and a guidewire locking system (1003, Annotated Fig 1), comprising: a housing (210) defining a needle channel (conduits 214+215, Fig 18 ) and a guidewire channel (conduit 216, Fig 18) communicating with the needle channel (214+215) and extending at an angle thereto (angle between conduits 214+215 and 216, Fig 18), and a portion of the guidewire (190) extending through the guidewire channel (216); and a locking mechanism (lock 220+224 and seal 165+157+158, Fig 18) having a lock (Tooth 224 of lever 220, Fig 18) and a seal ("O" ring 165 , anterior piston segment 157 and resilient posterior segment 158, Fig 18) and transitionable between an unlocked position (position when 224 is removed from recess 230 of anterior piston segment 157; hereinafter “UP”) and a locked position (position when 224 is inserted in recess 230 of anterior piston segment 157, Fig 18; hereinafter “LP”) (Col 12, lines 1-21), the locking mechanism (220+224) in the locked position (LP)configured to inhibit axial movement of the guidewire (190) through the guidewire channel (216) (Col 12, lines 1-21).
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Zadini-18 is silent wherein a portion of the needle extending through the needle channel.
Zadini embodiment of Fig 10, hereinafter Zadini-10, teaches a portion of the needle (needle 100, Fig 10) extending through a needle channel (Col 8, lines 60-63).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Zadini-18 with of a needle extending into the needle channel as taught by Zadini-10 for the purpose of directly guide the guidewire (Col 3, line 67- Col 4, line 1).
Regarding claim 2, Zadini-18/Zadini-10 discloses the catheter placement system according to claim 1. Zadini-18 discloses wherein the seal (165+157+158) is formed of a compliant material (Col 10, line 66- Col 11, line 12) and defines a seal guidewire lumen (1004, Annotated Fig 1) configured to receive a portion of the guidewire (190) therethrough (Fig 18), the lock (224+220) in the locked position (LP) configured to compress the seal radially inwards to impinge on the guidewire and inhibit axial movement thereof (When tooth 224 is in the lock position LP, it prevents movements of anterior piston segment 157, and maintains seal 157+158+165 in a position of radial compression as seen in Fig 18, which prevents axial movement of the guidewire).
Regarding claim 3, Zadini-18/Zadini-10 discloses the catheter placement system according to claim 2, wherein a diameter of the seal guidewire lumen (1004) is equal to or less than an outer diameter of the guidewire (190) and engages the guidewire (190) in an interference fit in both of the locked position (LP) and the unlocked position (UP) (Col 12, lines 1-21; Both LP and UP there is an interference fit between the lumen 1004 and guidewire 190 which is moved distally with the seal by action of spring 164 upon release of the tooth 224).
Regarding claim 7, Zadini-18/Zadini-10 discloses the catheter placement system according to claim 1. Zadini-18 discloses further including a peel pin (tubular guide 204, Fig 18) extending through the seal (157+165+158) and disposed at a junction (Annotated Fig 5) between the guidewire channel ( 216) and the needle channel (214+215) and configured to support the guidewire (190) as the needle is withdrawn proximally from the needle channel (214+215).
Regarding claim 8, Zadini-18/Zadini-10 discloses the catheter placement system according to claim 7. Zadini-18 discloses wherein the peel pin (24) is formed integrally with the housing (210) (Fig 18).
Regarding claim 11, Zadini-18/Zadini-10 discloses the catheter placement system according to claim 1, further including a handle (handle 175, Fig 18) extending from the housing (210) and configured to facilitate grasping and manipulating the housing (210) relative to the needle hub (136) (Fig 18; manipulation of handle 175 would require grasping and manipulation of housing 210 relative to the needle hub 136).
Regarding claim 12, Zadini-18/Zadini-10 discloses the catheter placement system according to claim 1, wherein the housing (210) includes a housing slot (posterior segment 193, Fig 18) extending longitudinally and communicating with one or both of the needle channel (214+215) and the guidewire channel (216), the housing slot (193) configured to allow the guidewire (190)to pass therethrough when the locking mechanism (lock 220+224 and seal 165+158+157, Fig 18) is in the unlocked position (UP) (Col 12, lines 1-21).
Regarding claim 14, Zadini-18/Zadini-10 discloses the catheter placement system according to claim 1. Zadini-18 discloses wherein the seal (165+158+157) includes a seal slot (tunnel 169, Fig 18) extending longitudinally and communicating with one or both of the seal guidewire lumen (216) and a seal needle lumen (214+215), the seal slot (169) configured to allow the guidewire to pass therethrough when the locking mechanism (lock 220+224 and seal 165+158+157, Fig 18) is in the unlocked position(UP) (Col 12, lines 1-21).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Zadini et al (US 5415177 A) in view of Kraus et al. (US 5273052 A).
Regarding claim 4, Zadini-18/Zadini-10 discloses the catheter placement system according to claim 1. Zadini-18/Zadini-10 is silent wherein the lock includes a tapered recess at a distal end and configured to receive a portion of the seal therein and compress the seal radially inwards as the locking mechanism is transitioned to the locked position.
Kraus teaches catheter placement system (Fig 6) comprising a lock (rotator 81, Fig 6) includes a tapered recess (2000, Annotated Fig 2) at a distal end and configured to receive a portion of a seal (pin-vise 83, Fig 6) therein and compress the seal (83) radially inwards as the locking mechanism (rotator 81, + pin-vise 83, Fig 6) is transitioned to the locked position (Col 15, lines 34-39).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the lock of device of Zadini-18/Zadini-10 with similar locking and seal at the proximal end as taught by Kraus for the purpose of clamping the rod against either rotational or axial movement before and prevent unintended movement of the guidewire by using a threading mechanism (Col 15, lines 34-39).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Zadini et al (US 5415177 A) in view of Chu et al. (US 5397310 A).
Regarding claim 5, Zadini-18/Zadini-10 discloses the catheter placement system according to claim 1. Zadini-18/Zadini-10 is silent wherein the lock includes a collar threadably engaged with the housing and configured to urge the lock axially through the guidewire channel as the lock is rotated about the axis of the guidewire.
Chu teaches a catheter placement system (Fig. 7D) wherein the lock includes a collar (3000, Annotated Fig 3) threadably engaged with the housing (3001, Annotated Fig 3) and configured to urge the lock (3002, Annotated Fig 3) axially through the guidewire channel (3003, Annotated Fig 3) as the lock (3002, Annotated Fig 3) is rotated about the axis (A, Annotated Fig 3) of the guidewire (Col 9, line 65 – Col 10, line 5).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the lock device of Zadini-18/Zadini-10 with similar lock as taught by Chu for the purpose of having a threaded lock to lock the guidewire in place preventing unwanted movement (Col 9, line 65 – Col 10, line 5).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Zadini et al (US 5415177 A) in view of Asai (US 20110071502 A1).
Regarding claim 10, Zadini-18/Zadini-10 discloses the catheter placement system according to claim 1. Zadini-18/Zadini-10 are silent wherein a proximal end of the housing is releasably engaged with the needle hub in one of an interference fit, press fit, or snap fit engagement.
Asai teaches a catheter placement system (catheter indwelling device 10a, Fig 3) comprising proximal end of the housing (proximally extending portion of distal side main port 40, Fig 3) is releasably engaged with the needle hub (needle hub 56, Fig 3) in one of an interference fit, press fit, or snap fit engagement ([0047]: interference fit).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Zadini-18/Zadini-10 with similar taper fitment connection as taught by Asai for the purpose of reduce assembly effort and time ([0047]).
Claims 1, 12, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kurth et al. (US 20090187147 A1) in view of Khanicheh et al. (US 20190022354 A1).
Regarding claim 1, Kurth discloses a catheter placement system (Fig 11), comprising: a needle (needle 16, Fig 7) supported by a needle hub (needle hub 24, Fig 7) and defining a needle lumen (lumen 5003 of needle 16, Annotated Fig 5); a guidewire (guidewire 8; [0057]) having a distal tip disposed within the needle lumen (tip of guidewire 8, not shown is disposed in the needle lumen before it is being inserted into the target area); a catheter (not shown) disposed on a proximal portion of the guidewire (8) ([0046]: “catheter (not shown) from Zeus Industrial Products Inc. in Orangeburg, S.C. can be bonded or heat shrunk to the proximal portion 12 of the guidewire 8”); a housing (housing defined by needle hub 24, Fig 11) defining a needle channel (4000, Annotated Fig 4) and a guidewire channel (4001, Annotated Fig 4) communicating with the needle channel (4000, Annotated Fig 4) and extending at an angle thereto (angle between 4000 and 4001, Annotated Fig 4), a portion of the needle (16) extending through the needle channel (4000, Annotated Fig 4) (portion of needle 16 needs to be inserted in distal portion of hub for support) and a portion of the guidewire (8) extending through the guidewire channel (4001, Annotated Fig 4; [0057]); Kurth further comprises a seal (hemostatic valve membrane 36, Fig 12).
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Kurth is silent regarding a guidewire locking system, comprising a locking mechanism having a lock and transitionable between an unlocked position and a locked position, the locking mechanism in the locked position configured to inhibit axial movement of the guidewire through the guidewire channel.
Khanicheh teaches a guidewire locking system (locking device 530, Fig 2-3), comprising a locking mechanism having a lock (zigzag locking features, Fig 2-3) and transitionable between an unlocked position (guidewire 200 not engaged in zigzag locking feature) and a locked position ([0079], Fig 3 having the guidewire 200 in a desired position by frictionally maintaining guidewire 200 in place), the locking mechanism (530) in the locked position (Fig 3)configured to inhibit axial movement of the guidewire (200) through the guidewire channel (channel, Fig 7 where guidewire 200 is disposed).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the housing of device of Kurth with similar locking mechanism as taught by Khanicheh for the purpose of eliminating the need to manually holding the guidewire by a physician to maintain a previously obtained access to the desired treatment site ([0063]).
Regarding claim 12, Kurth/Khanicheh discloses the catheter placement system according to claim 1. Kurth discloses wherein the housing (housing defined by needle hub 24, Fig 11) includes a housing slot (slot 23, Fig 10) extending longitudinally and communicating with one or both of the needle channel (4000, Annotated Fig 4) and the guidewire channel (4001, Annotated Fig 4), the housing slot (23) configured to allow the guidewire (8) to pass therethrough.
Kurth is silent regarding when the locking mechanism is in the unlocked position allow the guidewire to pass therethrough.
Khanicheh teaches a guidewire locking system (locking device 530, Fig 2-3), comprising a locking mechanism having a lock (zigzag locking features, Fig 2-3) and transitionable between an unlocked position (guidewire 200 not engaged in zigzag locking feature) and a locked position ([0079], Fig 3 having the guidewire 200 in a desired position by frictionally maintaining guidewire 200 in place), the locking mechanism (530) in the locked position (Fig 3)configured to inhibit axial movement of the guidewire (200) through the guidewire channel (channel, Fig 7 where guidewire 200 is disposed).
Khanicheh further teaches when the locking mechanism is in the unlocked position (guidewire 200 not engaged in zigzag locking feature) allow the guidewire to pass therethrough ([0079]) .
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the housing of device of Kurth with similar locking mechanism as taught by Khanicheh for the purpose of having displacement of guidewire when not in the locking position and eliminating the need to manually holding the guidewire by a physician to maintain a previously obtained access to the desired treatment site ([0063]).
Regarding claim 15, Kurth/Khanicheh discloses the catheter placement system according to claim 1. Kurth discloses wherein the needle (16) includes a guidewire aperture (proximal portion 5000 of slot 30, Annotated Fig 5) disposed in a side wall of the needle (side wall of needle 16, Fig 7) and configured to receive a portion of the guidewire (8) therethrough ([0060]), the needle also including a needle slot (remaining needle portion 5001 of slot 30, Annotated Fig 5) extending longitudinally between the guidewire aperture (5000, Annotated Fig 5) and a distal tip (beveled distal end 28, Fig 7) of the needle (16) and communicating with a needle lumen (5003, Annotated Fig 5), the needle slot (5001, Annotated Fig 5) configured to receive a portion of the guidewire (8) therethrough as the needle is withdrawn proximally ([0060]).
Regarding claim 16, Kurth/Khanicheh discloses the catheter placement system according to claim 1. Kurth discloses further including a sheath (ultra-thin walled sleeve 22, Fig 7) encircling a portion of the needle (13) ([0060]) and including a tear line (line along slot 30 of sleeve 22 teared by guidewire 8, Fig 7) extending longitudinally between a proximal end (5004, Annotated Fig 5) and a distal end (5005, Annotated Fig 5)of the sheath (22).
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kurth et al. (US 20090187147 A1) in view of Khanicheh et al. (US 20190022354 A1) in further view of Nelson et al (US 5219332 A).
Regarding claim 13, Kurth/Khanicheh discloses the catheter placement system according to claim 12. Kurth is silent wherein the lock includes a lock slot extending longitudinally and communicating with a lock lumen, the lock slot configured to align with the housing slot in the unlocked position and allow the guidewire to pass therethrough to disengage the guidewire locking system.
Nelson teaches wherein the lock (tubular plug member 11, Fig 1) includes a lock slot (slot 26, Fig 2) extending longitudinally and communicating with a lock lumen (passageway 23, Fig 3), the lock slot (26)configured to align with the housing (member 12) slot (radial slot 52, Fig 1) in the unlocked position (Fig 16) and allow the guidewire to pass therethrough to disengage the guidewire locking system (Position shown in Fig 16 is an initial position that permits movement and removal of the guidewire 14; Col 6, lines 37-40).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the guidewire housing end and lock of device of Kurth/Khanicheh with similar housing and lock mechanism as taught by Nelson for the purpose of securing the guidewire by a simple rotational or twisting motion (abstract)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/Primary Examiner, Art Unit 3783