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 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 18-22 are 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 18 recites the limitation “wherein a portion of the helical coil is received within the flow tube and bonded to the helical coil.” It is unclear what is bonded to the helical coil, whether it’s the flow tube, or a portion of the helical coil. Examiner interprets that a portion of the helical coil is bonded to the flow tube.
Claim 22 recites the limitation "the instrument" in "wherein the instrument advancement device is configured to advance the instrument from a retracted position to an advanced position beyond a distal end of the catheter". There is insufficient antecedent basis for this limitation in the claim. Examiner interprets “the instrument” to be the tubular member.
All remaining claims are rejected as they depend from rejected independent claim 18.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1,2, 5, 7-9, 11, 13-15, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burkholz et al. (Pub. No. US 20200316346 A1, herein Burkholz).
Regarding Claim 1, Burkholz discloses an instrument (guidewire 48 which may include a fluid permeable structure 64, Paragraph [0085], Fig. 7A) configured to be inserted through a vascular access device (Paragraph [0082]), the instrument comprising:
a tubular member (118, Fig 7E) having a first end (122), a second end positioned opposite the first end (123), and a sidewall extending between the first end and the second end (sidewall extending between ends in Fig. 7E), the tubular member defining a central passage (66 runs through tube 118), wherein the first end of the tubular member comprises a closed end positioned perpendicularly to the sidewall (Paragraph [0116], Fig 7E).
Regarding Claim 2, Burkholz discloses the instrument of claim 1, wherein the first end of the tubular member is integral and continuous with the sidewall of the tubular member (“the elongated core 66 may extend…completely through the tube 118” – Paragraph [0117], Fig. 7G).
Regarding Claim 5, Burkholz discloses the instrument of claim 1, wherein the tubular member (118) defines a plurality of sidewall openings (120) in fluid communication with the central passage (“the tube 118 may be porous. As illustrated in FIG. 7E, in some embodiments, the tube 118 may include multiple holes 120, which may be arranged in various patterns and numbers and may include various sizes” – Paragraph [0115]).
Regarding Claim 7, Burkholz discloses an instrument configured to be inserted through a vascular access device (abstract), the instrument comprising: a helical coil (68, Figs. 2A-2G) formed by a wire (“the coil 68 may include a metal wire disposed in a helix about the elongated core 66” – Paragraph [0089]), the helical coil defining a central passage (Figs. 2A-2G); a core wire (48, where “the distal end 60 of the guidewire 48 may include a fluid permeable structure 64. In some embodiments, the fluid permeable structure 64 may include an elongated core 66 and a coil 68 extending around the elongated core 66” – Paragraph [0085]) extending along a longitudinal axis of the helical coil through at least a portion of the central passage of the helical coil (“the elongated core 66 may extend along a central axis of the coil 68.” – Paragraph [0096]); a flow tube (102) having a distal end (106) and a proximal end (104);
and a hub (107, See annotated Fig. 6B Below) having a first end (Annotated Fig. 6B) and a second end positioned opposite the first end (Annotated Fig. 6B), the hub defining an opening extending between the first end and the second end (Annotated Fig. 6B), wherein the flow tube is attached to the first end of the hub (102 connected to first end at 52) and the core wire is attached to the second end of the hub (48 connected to second end in annotated Fig. 6B).
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Regarding Claim 8, Burkholz discloses the instrument of claim 7, wherein the core wire (48) extends through the flow tube (102) from the distal end to the proximal end (Paragraph [0107]).
Regarding Claim 9, Burkholz discloses the instrument of claim 8, wherein the opening of the hub at the first end of the hub is larger in diameter than the opening of the hub at the second end of the hub (Annotated Fig. 6B where the first end opening is larger than the second end opening).
Regarding Claim 11, Burkholz discloses an instrument configured to be inserted through a vascular access device (Abstract), the instrument comprising: a helical coil (68) formed by a wire (“the coil 68 may include a metal wire disposed in a helix about the elongated core 66” – Paragraph [0089]), the helical coil defining a central passage (Figs. 2A-2G); a core wire (48 where “the distal end 60 of the guidewire 48 may include a fluid permeable structure 64. In some embodiments, the fluid permeable structure 64 may include an elongated core 66 and a coil 68 extending around the elongated core 66” – Paragraph [0085]) extending along a longitudinal axis of the helical coil through at least a portion of the central passage of the helical coil (“the elongated core 66 may extend along a central axis of the coil 68.” – Paragraph [0096]); and a flow tube (102) having a distal end (106) and a proximal end (104), wherein a portion of the core wire is encapsulated in a material forming the flow tube (tubing 102 encapsulates guidewire 48 in Fig. 7B).
Regarding Claim 13, Burkholz discloses the instrument of claim 11, wherein the flow tube is co-extruded with the core wire (“the guidewire 48 may be disposed within the tubing 102 and/or may extend distally through the tubing 102 when the guidewire 48 is advanced. In some embodiments, the guidewire 48 may be fully retracted when the tubing 102 is advanced, as illustrated, for example, in FIGS. 6A-6B. In some embodiments, the guidewire 48 and the tubing 102 may be advanced and/or retracted simultaneously.” – Paragraph [0107]).
Regarding Claim 14, Burkholz discloses wherein the distal end of the flow tube is tapered (distal end 106 is tapered in Figs. 7C-7D) and configured to form a seal with an inner diameter of a catheter (Paragraph [0114])).
Regarding Claim 15, Burkholz discloses an instrument configured to be inserted through a vascular access device (Abstract), the instrument comprising: a helical coil (68) formed by a wire (“the coil 68 may include a metal wire disposed in a helix about the elongated core 66” – Paragraph [0089]), the helical coil defining a central passage (Figs. 2A-2G); and a flow tube (102) having a distal end (106) and a proximal end (104), wherein a portion of the helical coil is encapsulated in a material forming the flow tube (Fig. 7C-7C showing helical coil 68 within tubing 102).
Regarding Claim 17, Burkholz discloses the instrument of claim 15, wherein the flow tube is co-extruded with the helical coil (Paragraph [0114]).
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.
Claim(s) 10, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz.
Regarding Claim 10, Burkholz discloses the instrument of claim 9, wherein the flow tube is attached to the first end of the hub (Annotated Fig. 6B, “the tubing 102 may be secured to the tubing hub 107” – Paragraph [0109]) and wherein the core wire is attached to the second end of the hub (Annotated Fig. 6B).
Burkholz does not expressly disclose wherein the flow tube is attached to the first end of the hub via an adhesive, and wherein the core wire is attached to the second end of the hub via an adhesive.
Burkholz teaches where different elements of the device are bonded via an adhesive (Paragraphs [0095], [0096], [0097])
Therefore, it would have been obvious to one of ordinary skill within the art at the time of the invention to modify the instrument disclosed by Burkholz wherein the flow tube is attached to the first end of the hub via an adhesive, and wherein the core wire is attached to the second end of the hub via an adhesive as taught by Burkholz so that the flow tube and core wire are properly secured within the hub.
Regarding Claim 22, Burkholz discloses a vascular access system (Abstract) comprising:
a catheter adapter (16) comprising a catheter (14) configured to be inserted into a patient's vasculature (Paragraph [0076]);
an instrument advancement device (62) coupled to the catheter adapter (Fig. 1D-1E), wherein the instrument advancement device comprises a tubular member (118) having a first end (122), a second end positioned opposite the first end (123), and a sidewall extending between the first end and the second end (sidewall extending between ends in Fig. 7E), the tubular member defining a central passage (66 runs through tube 118 in Fig. 7E),
wherein the first end of the tubular member comprises a closed end positioned perpendicularly to the sidewall (Paragraph [0116], Fig 7E).
Burkholz does not expressly disclose wherein the instrument advancement device is configured to advance the instrument from a retracted position to an advanced position beyond a distal end of the catheter.
In a differing embodiment, Burkholz teaches wherein the instrument advancement device is configured to advance the instrument from a retracted position to an advanced position beyond a distal end of the catheter (“the guidewire hub 62 may be configured to move along the slot 56 to advance the guidewire 48 in a distal direction and distal to the distal end 52 of the housing 50.” – Paragraph [0083], Fig. 1D-1E, wherein Fig. 7E shows the embodiment in which the tube 118 is coupled with the guidewire 48 extending past the distal end of the catheter).
Therefore, it would have been obvious to one of ordinary skill within the art at the time of the invention to modify the vascular access system as disclosed by Burkholz wherein the instrument advancement device is configured to advance the instrument from a retracted position to an advanced position beyond a distal end of the catheter so that the distal end may move anything that might obstruct the catheter away preventing occlusions (Paragraph [0086]).
Claim(s) 3 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Walker et al. (US 6027461, herein Walker).
Regarding Claim 3, Burkholz discloses the instrument of claim 1.
Burkholz does not expressly disclose wherein the first end of the tubular member comprises a radiused edge.
Walker teaches wherein the first end (18) of the tubular member (50) comprises a radiused edge (end at 18 in Fig. 5 shows a radiused edge).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the instrument as disclosed by Burkholz wherein the first end of the tubular member comprises a radiused edge as taught by Walker so that steerability of the guidewire is improved (Walker, Col. 7 Lines 14-16).
Regarding Claim 21, Burkholz discloses the instrument of claim 19.
Burkholz does not expressly disclose wherein the flow tube comprises heat shrink film.
Walker teaches wherein the flow tube comprises heat shrink film (Fig. 5, Col. 5 Line 66 through Col. 6 Line 2).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the instrument as disclosed by Burkholz wherein the flow tube comprises heat shrink film as taught by Walker so that the outer surface of the flow tube may be smooth (Walker, Col. 6 Lines 2-3).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Bates et al. (Pub. No. US 20050038455 A1, herein Bates).
Regarding Claim 4, Burkholz discloses the instrument of claim 1.
Burkholz does not expressly disclose wherein the first end of the tubular member comprises a plurality of leaves extending from the sidewall of the tubular member.
Bates teaches wherein the first end (47) of the tubular member (15) comprises a plurality of leaves (21, 22, 23, 24) extending from the sidewall of the tubular member (Fig. 4A-4C).
Therefore, it would have been obvious to one of ordinary skill within the art at the time of the invention to modify the instrument as disclosed by Burkholz wherein the first end of the tubular member comprises a plurality of leaves extending from the sidewall of the tubular member as taught by Bates so that the tubular member can engage with a vessel wall (Bates, Paragraph [0038]).
Claim(s) 6, 12, 16, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz '152 in view of Matlock et al. (Pub. No. US 20190184142 A1, herein Matlock).
Regarding Claim 6, Burkholz discloses an instrument configured to be inserted through a vascular access device (abstract), the instrument comprising: a helical coil (68) formed by a wire (“the coil 68 may include a metal wire disposed in a helix about the elongated core 66” – Paragraph [0089]), the helical coil defining a central passage (Figs. 2A-2G); a core wire (48 where “the distal end 60 of the guidewire 48 may include a fluid permeable structure 64. In some embodiments, the fluid permeable structure 64 may include an elongated core 66 and a coil 68 extending around the elongated core 66” – Paragraph [0085]) extending along a longitudinal axis of the helical coil through at least a portion of the central passage of the helical coil (“the elongated core 66 may extend along a central axis of the coil 68.” – Paragraph [0096]); and a flow tube (102) having a distal end (106).
Burkholz does not expressly disclose where the core wire is attached to the flow tube via an adhesive.
Matlock teaches where the core wire (282) is attached to the flow tube (152) via an adhesive (Fig. 13, “Proximal ends of core wires (282, 284, 286) are secured within proximal end (202) of coil body (152) by a proximal end securement (not shown), which may be an overmolding, a soldering, a welding, an adhesive, an epoxy, or any other suitable means or techniques” – Paragraph [0079]).
Therefore, it would have been obvious to one of ordinary skill within the art at the time of the invention to modify the instrument as disclosed by Burkholz where the core wire is attached to the flow tube via an adhesive as taught by Matlock so that the core wire is properly secured within the flow tube (Matlock, Paragraph [0079]).
Regarding Claim 12, Burkholz discloses the instrument of claim 11.
Burkholz does not expressly disclose wherein the flow tube is overmolded onto the core wire.
Matlock teaches wherein the flow tube is overmolded onto the core wire (“Distal end (289) of core wire (282) is secured within distal end (204′) of coil body (152) by a distal end securement (296), which may be an overmolding, a soldering, a welding, an adhesive, an epoxy, or any other suitable means” – Paragraph [0080], Fig. 13).
Therefore, it would have been obvious to one of ordinary skill within the art at the time of the invention to modify the instrument as disclosed by Burkholz wherein the flow tube is overmolded onto the core wire as taught by Matlock so that the core wire is properly secured (Matlock, Paragraph [0079]).
Regarding Claim 16, Burkholz discloses the instrument of claim 15.
Burkholz does not expressly disclose wherein the flow tube is overmolded onto the helical coil.
Matlock teaches wherein the flow tube is overmolded onto the helical coil (“Proximal ends of core wires (282, 284, 286) are secured within proximal end (202) of coil body (152) by a proximal end securement (not shown), which may be an overmolding, a soldering, a welding, an adhesive, an epoxy, or any other suitable means or techniques” – Paragraph [0079]).
Therefore, it would have been obvious to one of ordinary skill within the art at the time of the invention to modify the instrument as disclosed by Burkholz wherein the flow tube is overmolded onto the helical coil as taught by Matlock so that the flow tube is properly secured (Matlock, Paragraph [0080]).
Regarding Claim 18, Burkholz discloses an instrument configured to be inserted through a vascular access device (abstract), the instrument comprising: a helical coil (68) formed by a wire (“the coil 68 may include a metal wire disposed in a helix about the elongated core 66” – Paragraph [0089]), the helical coil defining a central passage (Figs. 2A-2G); and a flow tube (102) having a distal end (106) and a proximal end (104), wherein a portion of the helical coil is received within the flow tube (Fig. 7C-7C showing helical coil 68 within tubing 102).
Burkholz does not expressly disclose wherein the flow tube is bonded to the helical coil.
Matlock discloses wherein flow tube is bonded to the helical coil (“Proximal ends of core wires (282, 284, 286) are secured within proximal end (202) of coil body (152) by a proximal end securement (not shown), which may be an overmolding, a soldering, a welding, an adhesive, an epoxy, or any other suitable means or techniques” – Paragraph [0079]).
Therefore, it would have been obvious to one of ordinary skill within the art at the time of the invention to modify the instrument as disclosed by Burkholz wherein flow tube is bonded to the helical coil as taught by Matlock so that the flow tube is properly secured to the helical coil (Matlock, Paragraph [0080]).
Regarding Claim 19, modified Burkholz in view of Matlock discloses the instrument of claim 18, wherein the helical coil (Burkholz, 68) has a distal portion (Burkholz, end nearest distal tip 70 in Fig. 7D) and a proximal portion (Burkholz, end within distal end 104 of tube 102 in Fig. 7D), the proximal portion of the helical coil is received by the flow tube (Burkholz, 68 is within 102 in Fig. 7D), the distal portion of the helical coil is smaller in diameter than the proximal portion of the helical coil (Burkholz, “an outer diameter of the coil 68 and/or the elongated core 66 may be variable, tapered, or straight. In some embodiments, the outer diameter of the coil 68 may be greater than a diameter of the distal opening 90 of the catheter 24 and the coil 68 may be compressible.” – Paragraph [0100], examiner interprets that the coil may be compressed when outside of the flow tube to where the distal portion of the helical coil is smaller in diameter than the proximal portion of the helical coil).
Regarding Claim 20, modified Burkholz in view of Matlock discloses the instrument of claim 19, wherein the distal end of the flow tube is tapered (Burkholz, distal end 106 of tubing 102 in Fig. 7C-7D shows a taper).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm Alt. Fri. Off
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/MARK GOLOVAN/ Patent Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783