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 .
Claims 1 and 22 are amended.
Claims 4-6 and 18-21 are cancelled.
Claims 1-3, 7-17, and 22 are being examined in this Office Action.
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) 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 7, Burkholz discloses an instrument configured to be inserted through a vascular access device (Fig. 1F), 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 (“the guidewire 48 and the tubing 102 may be advanced and/or retracted simultaneously.” – Paragraph [0107], Examiner interprets when guidewire 48 and tubing 102 are advanced simultaneously, at that point, the guidewire 48 is indirectly attached to tubing hub 107).
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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. I 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 circumferentially 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 the instrument of claim 11, 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 (tubing 102 encapsulates guidewire 48 circumferentially in Fig. 7C).
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) 1, 2, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz et al. (Pub. No. US 20200316346 A1, herein Burkholz) in view of Bates et al. (Pub. No. US 20050038455 A1, herein Bates).
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), and wherein the tubular member defines a plurality of sidewall openings (120) in fluid communication with the central passage (Paragraph [0115], Fig. 7E).
Burkholz does not expressly disclose wherein the closed end is formed by a plurality of leaves extending from the sidewall of the tubular member.
Bates teaches wherein the closed end (Fig. 4B, petals in a closed configuration) is formed by a plurality of leaves (21-24) extending from the sidewall of the tubular member (15, Fig. 4B).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the instrument disclosed by Burkholz wherein the closed end is formed by 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]).
Regarding Claim 2, modified Burkholz in view of Bates 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 (Burkholz, sidewall continuous between distal and proximal end in Fig. 7G).
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),
wherein the tubular member defines a plurality of sidewall openings in fluid communication with the central passage.
Burkholz does not expressly disclose wherein the instrument advancement device is configured to advance the tubular member 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 tubular member 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 tubular member 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]).
Burkholz does not expressly disclose wherein the closed end is formed by a plurality of leaves extending from the sidewall of the tubular member.
Bates teaches wherein the closed end (Fig. 4B, petals in a closed configuration) is formed by a plurality of leaves (21-24) extending from the sidewall of the tubular member (15, Fig. 4B).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vascular access system disclosed by Burkholz wherein the closed end is formed by 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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Bates further in view of Walker et al. (US 6027461, herein Walker).
Regarding Claim 3, modified Burkholz in view of Bates discloses the instrument of claim 1.
Modified Burkholz in view of Bates 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 modified Burkholz in view of Bates 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).
Claim(s) 10 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 before the effective filing date of the claimed 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.
Claim(s) 12, 14, 16, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Matlock et al. (Pub. No. US 20190184142 A1, herein Matlock).
Regarding Claim 12, Burkholz discloses the instrument of claim 11.
Burkholz wherein the flow tube is overmolded onto the core wire (Matlock, “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 be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the instrument disclosed by Burkholz wherein a portion of the core wire is encapsulated in a material forming the flow tube as taught by Matlock so that there may be proper securement and provide a desired stiffness of the coil axis (Paragraph [0082]).
Regarding Claim 14, modified Burkholz in view of Matlock discloses the instrument of claim 11, wherein the distal end of the flow tube is tapered (Burkholz, distal end 106 is tapered in Figs. 7C-7D) and configured to form a seal with an inner diameter of a catheter (Burkholz, Paragraph [0114]).
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 (“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 or techniques as will be apparent to those of ordinary skill in the art in view of the teachings herein.” – Paragraph [0080], Fig. 13).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the instrument disclosed by Burkholz wherein the flow tube is overmolded onto the helical coil as taught by Matlock so that the helical coil is properly secured to the flow tube (Matlock, Paragraph [0080]).
Regarding Claim 17, modified Burkholz in view of Matlock discloses the instrument of claim 15, wherein the flow tube is co-extruded with the helical coil (Burkholz, Paragraph [0107]).
Response to Arguments
Applicant’s arguments filed 6/18/2026 have been fully considered.
In regards to Applicant’s argument that
“Claims 18-22 have been rejected under 35 U.S.C. § 112(b) for indefiniteness for the reasons identified at page 2 of the Office Action. In view of the above amendments, reconsideration and withdrawal of this rejection are respectfully requested.”
This argument is persuasive and the 35 U.S.C. § 112(b) rejection for claim 22 has been withdrawn.
In regards to Applicant’s argument that
“Burkholz fails to disclose "wherein the closed end is formed by a plurality of leaves extending from the sidewall of the tubular member" as recited in amended independent claim 1.”
This argument is persuasive and the 35 U.S.C. § 102(a)(1) rejection for claim 1 has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Bates. Bates discloses a stent with a tube comprising a plurality of petals extending from the sidewall which are folded into a closed end, Fig. 4B. Bates is used to teach a plurality of leaves extending from the sidewall of the tubular member as Burkholz previously discloses a closed end positioned perpendicularly to the sidewall.
In regards to Applicant’s argument that
“Burkholz fails to disclose "wherein the flow tube is attached to the first end of the hub and the core wire is attached to the second end of the hub" as recited in independent claim 7.”
This argument is not persuasive for the following reasons:
Burkholz discloses “the guidewire 48 and the tubing 102 may be advanced and/or retracted simultaneously.” – Paragraph [0107]. Examiner is interpreting that when guidewire 48 and tubing 102 are advanced simultaneously, at that point, guidewire 48 is indirectly attached to tubing hub 107.
The rejection is maintained as recited above.
In regards to Applicant’s argument that
“Burkholz fails to disclose "wherein a portion of the core wire is encapsulated in a material forming the flow tube" as recited in independent claim 11.”
This argument is not persuasive for the following reasons:
As seen in Fig. 7B of Burkholz, the guidewire 48 is encapsulated circumferentially by tubing 102.
The rejection is maintained as recited above.
In regards to Applicant’s argument that
“Burkholz fails to disclose "wherein a portion of the helical coil is encapsulated in a material forming the flow tube" as recited in independent claim 15.”
This argument is not persuasive for the following reasons:
As seen in Fig. 7C of Burkholz, the guidewire 48 is encapsulated circumferentially by tubing 102.
The rejection is maintained as recited above.
In regards to Applicant’s argument that
“Burkholz fails to disclose "wherein the first end of the tubular member comprises a plurality of leaves extending from the sidewall of the tubular member" as recited in amended independent claim 22.”
This argument is persuasive and the 35 U.S.C. § 102(a)(1) rejection for claim 22 has been withdrawn. However, after further consideration, a new ground of rejection is in view of Bates.
Bates discloses a stent with a tube comprising a plurality of petals extending from the sidewall which are folded into a closed end, Fig. 4B. Bates is used to teach a plurality of leaves extending from the sidewall of the tubular member as Burkholz previously discloses a closed end positioned perpendicularly to the sidewall.
Conclusion
THIS ACTION IS MADE FINAL. 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 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
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