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
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, 11, 13, 15-17, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Devgon (U.S. Patent No. 20140364766) (cited by Applicant) in view of Burkholz (U.S. Patent Pub. No. 20190022357).
Regarding claim 1, Devgon ‘766 teaches a vascular access device (Figs. 9-10, 6000), comprising: a hub (Fig. 9,) having a proximal end portion (6120), a distal end portion (6130), and a lumen (6113) extending therethrough; a proximal port (Fig. 12, 6420) coupled to the proximal end portion (6120), the proximal port (6420) including a seal (locking mechanism 6131) transitionable from a closed configuration to an open configuration; (Paragraph [0099] teaches an embodiment where seal can be opened to allow access for the catheter to advance to a second configuration); a catheter (6200) coupled to the distal end portion (6130); a side port (6420) coupled to the hub between the distal end portion (6130) and the proximal end portion (6120) and in fluid communication with the lumen (6113).
However, Devgon ‘766 does not teach “a guide structure formed internally within the hub and positioned entirely within the lumen, the guide structure configured to deflect a device inserted through the side port towards the distal end portion.”
Burkholz ‘357, in a related field of endeavor, teaches a vascular access device (Fig. 5) comprising a guide structure formed internally within the hub (internal wall 203) and positioned entirely within the lumen (See Fig. 5), the guide structure configured to deflect a device inserted through the side port (105) towards the distal end portion. (See Fig. 5)
As a result, 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 Devgon ‘766 to provide “a guide structure formed internally within the hub and positioned entirely within the lumen, the guide structure configured to deflect a device inserted through the side port towards the distal end portion” of Burkholz ‘357. Doing so helps direct a probe towards the distal part of the catheter. (Paragraph [0071]).
Regarding claim 2, Devgon ‘766 does not teach “wherein the guide structure is a circular structure”.
Burkholz ‘357 teaches wherein the guide structure (203) is a circular structure (Fig. 8; Paragraph [0074] internal wall 203 has a convex surface at the point of contact with probe 205 that resembles a circular structure).
As a result, 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 Devgon ‘766 to provide “wherein the guide structure is a circular structure” as taught by Burkholz ‘357. Doing so provides a conducive structure to direct a probe towards the distal part of the catheter. (Paragraph [0071]).
Regarding claim 3, Devgon ‘766 does not teach “wherein the guide structure is a triangular structure”.
Burkholz ‘357 illustrates (Fig. 5) wherein the guide structure (203) is a triangular structure (See Fig. 5, where the angles formed by the combination of the internal wall 203 and wedge 202 resemble a triangular structure).
As a result, 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 Devgon ‘766 to provide “wherein the guide structure is a triangular structure” as contemplated by Burkholz ‘357. Doing so provides a conducive structure to direct a probe towards the distal part of the catheter. (Paragraph [0071]).
Regarding claim 11, Devgon ‘766 teaches an extension tubing (inlet catheter 6425) coupled to the side port (6420).
Regarding claim 13, Devgon ‘766 teaches an introducer (6100) including a proximal end portion (6120) and a distal end portion (6130), wherein the distal end portion (6130) of the introducer (6100) is configured to couple to the proximal end portion of the hub (Paragraph [0108 wall of introducer 6100) and transition the seal (locking mechanism 6131) from the closed configuration to the open configuration when a lock is coupled to the hub. (Paragraph [0099] teaches an embodiment where seal can be opened to allow access for the catheter to advance to a second configuration).
Regarding claim 15, Devgon ‘766 teaches an embodiment wherein the distal end portion (7130) of the introducer (7100) includes a proboscis (7150) that defines a lumen (Fig.18, 7113), the proboscis being configured to extend through the seal (7131) to place the lumen of the proboscis (7150) in fluid communication with the lumen of the hub (7400).
Regarding claim 16, Devgon ‘766 teaches wherein an outer surface of the proboscis (7150) is configured to engage a portion of the seal (7131) to collectively form a fluid tight seal therebetween. (See Fig. 18; Paragraph [0128]).
Regarding claim 17, Devgon ‘766 teaches a method comprising providing vascular access, (Paragraph [0008]), and positioning at least a portion of a second catheter (7425) within the lumen of the hub (7400). (See Fig. 18).
Regarding claim 20, Devgon teaches transitioning the seal (6131) from the closed configuration to the open configuration. (Paragraph [0099]).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Devgon ‘766 in view of Burkholz (‘357), further in view of Burkholz (WO 2019067176).
Regarding claim 4, Devgon ‘766 does not teach “wherein the guide structure is positioned within the lumen to intersect a first axis extending between the proximal end portion and second end portion and a second axis defined by the side port”.
Burkholz ‘357 illustrates (Fig. 5, 8) wherein the guide structure (203) is positioned within the lumen (204) to intersect a first axis extending between the proximal end portion and second end portion (See Figs. 5, 8).
Burkholz ‘176, in a related field of endeavor, illustrates (Fig. 2C) an embodiment of a peripheral intravenous catheter wherein the guide structure (diverter 203) is positioned within the lumen to intersect a second axis defined by the side port (204).
As a result, 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 Devgon ‘766 to provide “wherein the guide structure is positioned within the lumen to intersect a first axis extending between the proximal end portion and second end portion” as taught by Burkholz ‘357 and “a second axis defined by the side port” as taught by Burkholz ‘176. Doing so provides a conducive structure to direct a probe towards the distal part of the catheter. (Paragraph [0071] of Burkholz ‘357).
Regarding claim 5, Devgon ‘766 does not teach “wherein the second axis is disposed at an obtuse angle relative to the first axis”.
Burkholz ‘176 illustrates wherein the second axis is disposed at an obtuse angle relative to the first axis. (See Fig. 2C, the angle between the sidewall of catheter adapter 201 and the longitudinal axis of the side port 204 is greater than 90 degrees)
As a result, 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 Devgon ‘766 to “wherein the second axis is disposed at an obtuse angle relative to the first axis” as taught by Burkholz ‘176. Doing so provides angle that enables fluid flow into catheter adapter in a distal direction towards catheter. (Paragraph [0004]).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Devgon ‘766 in view of Burkholz ‘357, further in view of Belson (WO 2008137956) (previously cited).
Regarding claim 6, Devgon ‘766 as modified does not teach “wherein the seal includes a pivotable flap”.
Belson, in a related field of endeavor, teaches a vascular access device (Fig. 28A) wherein the seal (250) includes a pivotable flap (250a).
As a result, 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 Devgon ‘766 as modified to teach “wherein the seal includes a pivotable flap” as taught by Belson. Doing so forms a suitable barrier to the passage of blood.
Regarding claim 7, Devgon ‘766 does not teach “wherein the seal includes a plurality of movable flaps”.
Belson teaches a vascular access device (Fig. 28A) wherein the seal (250) includes a plurality of movable flaps (250a, 250b).
As a result, 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 Devgon ‘766 as modified to teach “wherein the seal includes a plurality of movable flaps” as taught by Belson. Doing so forms a suitable barrier to the passage of blood.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Devgon ‘766 in view of Burkholz ‘357 and Belson, further in view of Schuster (WO 2017162574) (previously cited).
Regarding claim 8, Devgon ‘766 as modified does not teach “wherein the plurality of movable flaps are positionable to at least partially overlap each other”.
Schuster, in a related field of endeavor, teaches a fluid drawing device (Figs. 4a, 4b) wherein the plurality of movable flaps (opposing members of beak-shaped valve 19) are positionable to at least partially overlap each other. (See Fig. 4b, when open, beak-shaped valve head 19 establishes flow connection to the flow opening so that the withdrawn liquid can flow into the tube; when closed, the opposing members of beak-shaped valve 19 are shown to partially coincide/overlap).
As a result, 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 Devgon ‘766 as modified to teach “wherein the plurality of movable flaps are positionable to at least partially overlap each other” as taught by Schuster. Doing so regulates blood and other fluids from passing through. (Page 5, lines 17-20; Fig. 4b).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Devgon ‘766 in view of Burkholz ‘357, further in view of Tanabe (WO 2010029806) (previously cited).
Regarding claim 9, Devgon ‘766 as modified does not teach “wherein the seal includes a pre-formed slit”.
Tanabe, in a related field of endeavor, teaches a vascular access device (Fig. 2) wherein the seal (8) includes a pre-formed slit (81). (Page 10, lines 19-21 of Machine Translation).
As a result, 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 Devgon ‘766 as modified to teach “wherein the seal includes a pre-formed slit” as taught by Tanabe. Doing so allows the needle to smoothly pass through the seal member when the needle is advanced. (Page 10, line 25 of Machine Translation).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Devgon ‘766 in view of Burkholz ‘357, further in view of Hoch (US 4412548) (previously cited).
Regarding claim 10, Devgon ‘766 as modified does not teach “wherein the seal includes one or more biasing members configured to bias the seal towards the closed configuration”.
Hoch, in a related field of endeavor, teaches a vascular access device (Fig. 3, sample needle device) wherein the seal includes one or more biasing members (spring 26) configured to bias the seal towards the closed configuration. (See Fig. 3; Col. 5, lines 30-36, 49-54).
As a result, 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 Devgon ‘766 as modified to teach “wherein the seal includes one or more biasing members configured to bias the seal towards the closed configuration” as taught by Hoch. Doing so prevents blood and other fluids from passing through the chamber. (Col. 5, lines 53-54).
Claims 12 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Devgon ‘766 in view of Burkholz ‘357, further in view of Bonnal (US 20120130305).
Regarding claim 12, Devgon ’766 teaches a port placement device (adapter 6400) coupled to the extension tubing (6425), the port placement device including: a shell positionable on an exterior of the extension tubing (housing of 6400); and a port (6420) positionable in fluid communication with the extension tubing, but Devgon ’766 does not teach “a piercing member attached to the shell and configured to pierce the extension tubing”.
Bonnal, in a related field of endeavor, teaches an apparatus for selectively establishing a needleless injection port on an IV tubing (Figs. 1B) comprising a piercing member (Fig. 1B, 750) attached to the shell (housing 732) and configured to pierce the extension tubing (34). (Paragraph [0052]).
As a result, 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 Devgon ‘766 as modified to teach “a piercing member attached to the shell and configured to pierce the extension tubing” as taught by Bonnal. Doing so establishes fluid communication between the IV tubing and a sealing member on the apparatus, thus enables an operator to inject liquid from a syringe into the IV tubing. (Abstract; Paragraph [0076]).
Regarding claim 21, Devgon ’766 teaches a vascular access device (Figs. 9-10, 6000), comprising: a hub (Fig. 9) having a proximal end portion (6120), a distal end portion (6130), and a lumen (6113) extending therethrough; a proximal port (Fig. 12, 6420) coupled to the proximal end portion (6120), the proximal port (6420) including a seal (locking mechanism 6131) transitionable from a closed configuration to an open configuration (Paragraph [0099] teaches an embodiment where seal can be opened to allow access for the catheter to advance to a second configuration); a catheter (6200) coupled to the distal end portion (6130); a side port (6420) coupled to the hub between the distal end portion (6130) and the proximal end portion (6120) and in fluid communication with the lumen (6113); an extension tubing (inlet catheter 6425) coupled to the side port (6420); a port placement device (adapter 6400) coupled to the extension tubing (6425), the port placement device including: a shell positionable on an exterior of the extension tubing (housing of 6400); and a port (6420) positionable in fluid communication with the extension tubing.
However, Devgon ’766 does not teach “a guide structure formed internally within the hub and positioned entirely within the lumen, the guide structure configured to deflect a device inserted through the side port towards the distal end portion; a piercing member attached to the shell and configured to pierce the extension tubing”.
Burkholz ‘357, as previously discussed, teaches a vascular access device (Fig. 5) comprising a guide structure formed internally within the hub (internal wall 203) and positioned entirely within the lumen (See Fig. 5), the guide structure configured to deflect a device inserted through the side port (105) towards the distal end portion. (See Fig. 5).
As a result, 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 Devgon ‘766 to provide “a guide structure formed internally within the hub and positioned entirely within the lumen, the guide structure configured to deflect a device inserted through the side port towards the distal end portion” of Burkholz ‘357. Doing so helps direct a probe towards the distal part of the catheter. (Paragraph [0071]).
Bonnal, as previously discussed, teaches an apparatus for selectively establishing a needleless injection port on an IV tubing (Figs. 1B) comprising a piercing member (Fig. 1B, 750) attached to the shell (housing 732) and configured to pierce the extension tubing (34). (Paragraph [0052]).
As a result, 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 Devgon ‘766 as modified to teach “a piercing member attached to the shell and configured to pierce the extension tubing” as taught by Bonnal. Doing so establishes fluid communication between the IV tubing and a sealing member on the apparatus, thus enables an operator to inject liquid from a syringe into the IV tubing. (Abstract; Paragraph [0076]).
Claims 14, 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Devgon in view of Burkholz ‘357, further in view of Devgon (WO 2017136630).
Regarding claim 14, Devgon ‘766 as modified does not teach “wherein the introducer is configured to movably receive secondary catheter therein, the introducer comprising an actuator at least partially disposed in the introducer and coupled to the secondary catheter”.
Devgon ‘630 teaches wherein the introducer (210) is configured to movably receive secondary catheter (265) therein, the introducer comprising an actuator (270) at least partially disposed in the introducer and coupled to the secondary catheter. (Paragraph [1085]).
As a result, 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 Devgon ‘766 as modified to teach “wherein the introducer is configured to movably receive secondary catheter therein, the introducer comprising an actuator at least partially disposed in the introducer and coupled to the secondary catheter” as taught by Devgon ‘630. Doing so may reduce and/or substantially prevent leaks associated with fluid flowing between the catheter and the secondary catheter and can also limit, reduce, and/or substantially prevent hemolysis of a volume of blood as the volume of blood flows through the catheter and the secondary catheter. (Paragraph [1085]).
Regarding claim 18, Devgon ‘766 as modified does not teach “drawing a fluid into the second catheter”.
Devgon ‘630, in a related field of endeavor, teaches drawing a fluid into the second catheter (82). (Paragraph [1085]).
As a result, 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 Devgon ‘766 as modified to teach “drawing a fluid into the second catheter” as taught by Devgon ‘630. Doing so a provides a means for evacuating a portion of the blood.
Regarding claim 19, Devgon ‘766 does not teach “placing a transfer device in fluid communication with the second catheter; and collecting the fluid in the transfer device”.
Devgon ‘630 teaches placing a transfer device (i.e., evacuated container holder) in fluid communication with the second catheter (265); and collecting the fluid in the transfer device. (Paragraph [1085] coupler 269 is coupled to a fluid reservoir, evacuated container).
As a result, 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 Devgon ‘766 as modified to teach “placing a transfer device in fluid communication with the second catheter; and collecting the fluid in the transfer device” as taught by Devgon ‘630. Doing so enables a means of collection of the evacuated a portion of the blood.
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 3/30/2026, with respect to the rejections of claims 1-20 have been fully considered. However, upon further consideration, a new ground of rejection is made under 103. In the new ground of rejection, Burkholz ‘357 is relied upon for the amended feature.
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 Om A. Patel whose telephone number is (571)272-6331. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m..
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/OM PATEL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
