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 .
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) in view of Blanchard et al. (US 20150231364 A1) in further view of Kurth et al. (US 20090187147 A1).
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 to the needle including a guidewire aperture disposed in a side wall of the needle, and a needle slot extending longitudinally between the guidewire aperture and a distal tip of the needle and communicating with the needle lumen, wherein the guidewire aperture is configured to receive a portion of the guidewire therethrough, and the needle slot is configured to receive a portion of the guidewire therethrough as the needle is withdrawn proximally; a sheath disposed on an outer surface of the needle over the needle slot, the sheath including a tear line extending longitudinally between a proximal end and a distal end of the sheath, and a sheath guidewire aperture aligned with the needle guidewire aperture
Blanchard teaches a catheter placement system (Fig 15A),comprising is the needle (needle 216, Fig 15A) including a guidewire aperture (wider aperture Fig 17B, [0110]) disposed in a side wall of the needle (Fig 17b) and a needle slot (226) extending longitudinally between the guidewire aperture (wider portion, Fig 17B) and a distal tip (distal tip of needle 216, Fig 17A) of the needle (216) and communicating with the needle lumen (lumen of needle 216, Fig 17A), wherein the guidewire aperture (wider aperture Fig 17B, [0110]) is configured to receive a portion of the guidewire (guidewire/dilator 220, Fig 18) therethrough, and the needle slot (226) is configured to receive a portion of the guidewire (220) therethrough as the needle (216) is withdrawn proximally; a portion of the needle (216) extending through the needle channel (channel of support structure 270 where the needle extends, Fig 18).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Zadini-18 with similar needle aperture and slot as taught by Blanchard for the purpose of enabling the guidewire to be inserted into, slid relative to, and removed from the needle ([0110]).
Zadini-18/Blanchard are silent regarding a sheath disposed on an outer surface of the needle over the needle slot, the sheath including a tear line extending longitudinally between a proximal end and a distal end of the sheath, and a sheath guidewire aperture aligned with the needle guidewire aperture.
Kurth teaches a sheath (heat shrink sleeve 22, Fig 4-5) disposed on an outer surface of the needle (needle 16, Fig 4-5) over the needle slot (Fig 4), the sheath including a tear line (tear line of sleeve 22 defined by the needle slot;[0053]) extending longitudinally between a proximal end and a distal end of the sheath (Fig 5), and a sheath guidewire aperture (slit, [0053]) aligned with the needle guidewire aperture (aperture of needle corresponding to area of sleeve slit; sleeve slit needs to be aligned at least longitudinally to the needle guidewire aperture; [0053]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Zadini-18/Blanchard with similar sheath including a guidewire aperture and tear line as taught by Kurth for the purpose of sealing the needle slot and ease the start of the tear when needed ([0053]; [0060]).
Regarding claim 2, Zadini-18/Blanchard/Kurth 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/Blanchard/Kurth discloses the catheter placement system according to claim 2. Zadini-18 discloses wherein a diameter of the seal guidewire lumen (1004, Annotated Fig 1) 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/Blanchard/Kurth 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 (1005, Annotated Fig 1) 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/Blanchard/Kurth 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/Blanchard/Kurth discloses the catheter placement system according to claim 1. Zadini-18 discloses 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/Blanchard/Kurth discloses the catheter placement system according to claim 1. Zadini-18 discloses 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/Blanchard/Kurth 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 Blanchard et al. (US 20150231364 A1) in further view of Kurth et al. (US 20090187147 A1) in view of Kraus et al. (US 5273052 A).
Regarding claim 4, Zadini-18/Blanchard/Kurth discloses the catheter placement system according to claim 1. Zadini-18 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/Blanchard/Kurth 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 Blanchard et al. (US 20150231364 A1) in furter view of Kurth et al. (US 20090187147 A1) in view of Chu et al. (US 5397310 A).
Regarding claim 5, Zadini-18/Blanchard/Kurth discloses the catheter placement system according to claim 1. Zadini-18 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/Blanchard/Kurth 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 Blanchard et al. (US 20150231364 A1) in further view of Kurth et al. (US 20090187147 A1) in view of Asai (US 20110071502 A1).
Regarding claim 10, Zadini-18/Blanchard/Kurth discloses the catheter placement system according to claim 1. Zadini-18 is 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/Blanchard/Kurth with similar taper fitment connection as taught by Asai for the purpose of reduce assembly effort and time ([0047]).
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Zadini et al (US 5415177 A) in view of Blanchard et al. (US 20150231364 A1) in further view of 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, Zadini-18/Blanchard/Kurth discloses the catheter placement system according to claim 12. Zadini-18 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 Zadini-18/Blanchard/Kurth 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).
Response to Arguments
Applicant’s arguments with respect to claims 1-14, and 17-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 date of this final action.
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
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