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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 14 recites the limitation “wherein the actuator is configured to movably receive a second catheter therein, the introducer comprising an actuator at least partially disposed in the introducer and coupled to the second catheter to move the second catheter between a first position, in which the second catheter is disposed within the introducer, and a second position, in which the second catheter extends through the seal of the hub”. However, the Specification does not clearly identify proper written description or drawings of support describing this limitation. Paragraph [0073] of Applicant’s Specification discusses wherein the actuator is configured to movably receive a second catheter therein, the introducer comprising an actuator at least partially disposed in the introducer coupled to the second catheter, but there is no clear disclosure related to “to move the second catheter between a first position, in which the second catheter is disposed within the introducer, and a second position, in which the second catheter extends through the seal of the hub”.
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.
Claims 13-14 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 13 recites the limitation “the lock” in line 4. There is insufficient antecedent basis for this limitation in the claim. Clarification requested. For examination purposes, the “lock” with be interpreted as the “seal”
Claim 14 recites the limitation “the actuator” in line 1. There is insufficient antecedent basis for this limitation in the claim. Clarification requested.
Claim 14 recites the limitations “an actuator” in line 2. Is this actuator the same or different from the “the actuator” recited in line 1. Clarification requested.
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 1-5, 11, 13-17, 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 Lee (U.S. Patent Pub. No. 20080221550).
Regarding claim 1, Devgon 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 does not teach “a guide structure positioned within the lumen and configured to deflect a device inserted through the side port towards the distal end portion.”
Lee, in a related field of endeavor, teaches (Figure 1) an infusion catheter comprising a guide structure (second inner tubular structure 41) positioned within the lumen (13) and configured to deflect a device inserted through the side port (17) towards the distal end portion (15). (Paragraph [0020]).
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 to provide “a guide structure positioned within the lumen and configured to deflect a device inserted through the side port towards the distal end portion” of Lee. Doing so provides for highly maneuverable guiding of the catheter as it is moved into the central lumen. (Paragraph [0022]).
Regarding claim 2, Devgon does not teach “wherein the guide structure is a circular structure”.
Lee teaches wherein the guide structure (second inner tubular structure 41) is a circular structure (crescent-shaped passage creates a circular guide structure). (Paragraph [0008]).
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 to provide “wherein the guide structure is a circular structure” as taught by Lee. Doing so provides for highly maneuverable guiding of the catheter as it is moved into the central lumen, (Paragraph [0022]), wherein the crescent-shaped guidewire lumen
serves the same function and purpose as the circular guide, so as to obtain predictable results of safely directing the catheter.
Regarding claim 3, Devgon does not teach “wherein the guide structure is a triangular structure”.
Lee contemplates wherein the guide structure (second inner tubular structure 41) is a triangular structure (Paragraph [0008] passage can have a variety of suitable shapes, for example, it may assume a shape configured for a triangular guide 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 to provide “wherein the guide structure is a triangular structure” as contemplated by Lee. Doing so provides for highly maneuverable guiding of the catheter as it is moved into the central lumen, (Paragraph [0022]), wherein the crescent-shaped guidewire lumen serves the same function and purpose as the triangular guide, so as to obtain predictable results of safely directing the catheter.
Regarding claim 4, Devgon 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”.
Lee illustrates (Fig. 1) wherein the guide structure (second inner tubular structure 41) is positioned within the lumen (13) to intersect a first axis extending between the proximal end portion (14) and second end portion (proximal end of shaft) and a second axis defined by the side port (17). (Paragraph [0008], [0015]).
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 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 and a second axis defined by the side port” as taught by Lee. Doing so provides for highly maneuverable guiding of the catheter as it is moved into the central lumen. (Paragraph [0022]).
Regarding claim 5, Devgon does not teach “wherein the second axis is disposed at an obtuse angle relative to the first axis”.
Lee illustrates (Fig. 1) wherein the second axis is disposed at an obtuse angle relative to the first axis.
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 to “wherein the second axis is disposed at an obtuse angle relative to the first axis” as taught by Lee. Doing so provides for highly maneuverable guiding of the catheter as it is moved into the central lumen. (Paragraph [0022]).
Regarding claim 11, Devgon teaches an extension tubing (inlet catheter 6425) coupled to the side port (6420).
Regarding claim 13, Devgon 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 the 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 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 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 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 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Devgon in view of Lee, further in view of Belson (WO 2008137956).
Regarding claim 6, Devgon 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 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 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 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 in view of Lee, further in view of Schuster (WO 2017162574).
Regarding claim 8, Devgon 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 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 in view of Lee, further in view of Tanabe (WO 2010029806).
Regarding claim 9, Devgon 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 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 in view of Lee, further in view of Hoch (US 4412548).
Regarding claim 10, Devgon 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 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 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Devgon in view of Lee, further in view of Uchigaki (US 4512348).
Regarding claim 18, Devgon as modified does not teach “drawing a fluid into the second catheter”.
Uchigaki, in a related field of endeavor, teaches drawing a fluid into the second catheter (82). (See Fig. 11; Col. 14, lines 53-54).
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 as modified to teach “drawing a fluid into the second catheter” as taught by Uchigaki. Doing so a provides a mean for sucking and taking-out a mixed liquid of the blood and anticoagulant out of the cannula. (Claim 3, Col. 19, lines 1-3).
Regarding claim 19, Devgon does not teach “placing a transfer device in fluid communication with the second catheter; and collecting the fluid in the transfer device”.
Uchigaki teaches placing a transfer device (sample liquid cup 15) in fluid communication with the second catheter (82) (See Fig. 11); and collecting the fluid in the transfer device. (See Fig. 11).
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 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 Uchigaki. Doing so a provides a mean for collecting the mixed liquid of the blood and anticoagulant.
Allowable Subject Matter
Claim 12 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.
Regarding claim 12, Devgon 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 does not teach “a piercing member attached to the shell and configured to pierce the extension tubing”.
/OM PATEL/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791