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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/30/26 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/09/25 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendment filed 01/30/26 has been entered. Claims 1, 5, and 20 have been amended. Claims 2-4, 6-10, 12-14, 21 are in the original/ previously presented form. Claims 11 and 15-19 are cancelled. Claims 22-24 are newly presented. Thus, claims 1-10, 12-14, and 20-24 remain pending in the application. There were no objections or 112 rejections set forth in the Final Office Action mailed 10/30/25. Therefore, there are no objections or 112 rejections withstanding.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 5-6, 8, and 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Carrison et al. (U.S. PGPUB No. 2003/0060833), hereinafter Carrison, in view of Pacetti (U.S. PGPUB No. 2003/0120148).
Regarding claim 1, Carrison discloses a vascular access instrument (see FIG. 1) configured to insert through a vascular access device (such as a catheter, see [0012] & [0026]), the vascular access instrument comprising:
a single continuous wire that is monolithically formed as a single unit (see [0028-0029]: distal tip of core wire 20 is wrapped to form a coil section) having an outer surface (see ‘Modified Figure 1’ below) and a solid, uninflatable, and uniform cross-section along its length (see [0028-0029]),
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the outer surface (see ‘Modified Figure 1’ above) of the wire configured for contact with and overcoming an obstruction within a vasculature (see [0007] & [0014] and [0026-0027], [0031], and [0044]: wire guides distal end past obstruction for basket retrieval and thus the distal end/ the wire must be configured for contact with and for overcoming an obstruction), the wire comprising:
a coil portion (70, see [0041]: coil portion attached to core wire such as by wrapping core to form coil as described in [0029]), comprising a plurality of loops (see ‘Modified Figure 1’ above) wound around a central axis (see [0029]: core portion 20 wrapped to form coil section and central axis is longitudinal axis), the plurality of loops (see ‘Modified Figure 1’ above) having an inner surface (surface of coil facing radially inward towards central axis such as seen in ‘Modified Figure 1’ above) defining an open flow path (see Figure 3. See gap/spacing between each coil and the core portion & each adjacent coil portion such that an “open flow path” is formed through the coil portion that aligns with Applicant disclosure in at least [0057]) through the coil portion (70) and extending along the central axis (see ‘Modified Figure 1’ above);
a core portion (20, see [0026]: 20 referred to as both the core wire and the control wire) extending through (see Figure 3 and [0029]) the coil portion (70) and aligned with the central axis (as seen in ‘Modified Figure 1’ above), at least a portion of the core portion (20) spaced from a portion of the inner surface (see ‘Modified Figure 3’ below)
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of the plurality of loops (see ‘Modified Figure 1’ above) to maintain the open flow path (See Figure 3 with gap/spacing between each coil and the core portion & each adjacent coil portion such that an “open flow path” is formed through the coil portion that aligns with Applicant disclosure in at least [0057]) through the coil portion (70); and
a bent portion (see ‘Modified Figure 1’ above and [0029]) connecting (see [0029]) a distal end (rightward end at bent portion) of the coil portion (70) with a distal end (rightward end at bent portion) of the core portion (20), wherein the bent portion (see ‘Modified Figure 1’) is blunt and forms a distal end of the wire (as seen in Figure 1 and described in [0028-0029]), and wherein at least one of the proximal tip of the coil portion and a proximal tip of the core portion (20) are configured to be coupled to an advancement device (24, see [0032]).
Carrison is silent to “wherein a proximal end of the coil portion is joined to the core portion or the proximal end of the coil portion includes a straight portion extending parallel with a proximal end of the core portion”.
However, Pacetti teaches a vascular access instrument (see [0022]: a guidewire) comprising a coil portion (16, see FIG. 1 and [0022]) and a core portion (12), wherein a proximal end of the coil portion (16) is joined to (by adhesive 19, see [0022]: coil 16 joined at proximal end by mass 19 to core portion 12. Adhesive aligns with Applicant’s disclosure of joined in at least [0063] of the elected embodiment) the core portion (12) or the proximal end of the coil portion includes a straight portion extending parallel with a proximal end of the core portion.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal end of the coil portion disclosed in Carrison to be joined to the core portion as taught by Pacetti for the purpose of joining the core and coil portion (see [0022]) such that a desired mechanical property of the wire is achieved (see [0008-0010]), thus achieving “wherein a proximal end of the coil portion is joined to the core portion or the proximal end of the coil portion includes a straight portion extending parallel with a proximal end of the core portion”.
Regarding claim 5, Carrison discloses a vascular access instrument (see FIG. 1) configured to insert through a vascular access device (such as a catheter, see [0012] & [0026]), the vascular access instrument comprising:
a single continuous wire that is monolithically formed as a single unit (see [0028-0029]: distal tip of core wire 20 is wrapped to form a coil section), the wire comprising:
a coil portion (70, see [0041]: coil portion attached to core wire such as by wrapping core to form coil as described in [0029]), comprising a plurality of loops (see ‘Modified Figure 1’ below)
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wound around a central axis (see [0029]: core portion 20 wrapped to form coil section and central axis is longitudinal axis), the plurality of loops (see ‘Modified Figure 1’ above) having an inner surface (surface of coil facing radially inward towards central axis such as seen in ‘Modified Figure 1’ above) defining an open flow path (see Figure 3. See gap/spacing between each coil and the core portion & each adjacent coil portion such that an “open flow path” is formed through the coil portion that aligns with Applicant disclosure in at least [0057]) through the coil portion (70) and extending along the central axis (see ‘Modified Figure 1’ above);
a core portion (20, see [0026]: 20 referred to as both the core wire and the control wire) extending through (see Figure 3 and [0029]) the coil portion (70) and aligned with the central axis (as seen in ‘Modified Figure 1’ above), at least a portion of the core portion (20) spaced from a portion of the inner surface (see ‘Modified Figure 3’ below)
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of the plurality of loops (see ‘Modified Figure 1’ above) to maintain the open flow path (See Figure 3 with gap/spacing between each coil and the core portion & each adjacent coil portion such that an “open flow path” is formed through the coil portion that aligns with Applicant disclosure in at least [0057]) through the coil portion (70); and
a bent portion (see ‘Modified Figure 1’ above and [0029]) connecting (see [0029]) a distal end (rightward end at bent portion) of the coil portion (70) with a distal end (rightward end at bent portion) of the core portion (20), wherein the bent portion (see ‘Modified Figure 1’) is blunt and forms a distal end of the wire (as seen in Figure 1 and described in [0028-0029]), and wherein at least one of the proximal tip of the coil portion and a proximal tip of the core portion (20) are configured to be coupled to an advancement device (24, see [0032]), wherein the coil portion (70, see Figure 1) is formed by a flat portion of the wire (see [0027]: cross section of wire 20 can be square==flat portion) wound around the central axis (see [0029]: wire 20 wrapped to form coil 70) into the plurality of loops (see ‘Modified Figure 1’ above), wherein the flat portion of the wire (see [0027]) comprises a portion of the wire that includes a first side (outside surface/ surface facing radially outward relative the central axis) and a second side (inside surface/ surface facing radially inward relative the central axis) opposite the first side (outside surface/ surface facing radially outward relative the central axis), and wherein the first side (outside surface/ surface facing radially outward relative the central axis) and/or the second side (inside surface/ surface facing radially inward relative the central axis) is planar prior to the wire being wound around the central axis into loops (see [0027]: cross-section is square/planar).
Carrison is silent to “wherein a proximal end of the coil portion is joined to the core portion or the proximal end of the coil portion includes a straight portion extending parallel with a proximal end of the core portion”.
However, Pacetti teaches a vascular access instrument (see [0022]: a guidewire) comprising a coil portion (16, see FIG. 1 and [0022]) and a core portion (12), wherein a proximal end of the coil portion (16) is joined to (by adhesive 19, see [0022]: coil 16 joined at proximal end by mass 19 to core portion 12. Adhesive aligns with Applicant’s disclosure of joined in at least [0063] of the elected embodiment) the core portion (12) or the proximal end of the coil portion includes a straight portion extending parallel with a proximal end of the core portion.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal end of the coil portion disclosed in Carrison to be joined to the core portion as taught by Pacetti for the purpose of joining the core and coil portion (see [0022]) such that a desired mechanical property of the wire is achieved (see [0008-0010]), thus achieving “wherein a proximal end of the coil portion is joined to the core portion or the proximal end of the coil portion includes a straight portion extending parallel with a proximal end of the core portion”.
Regarding claim 6, the modified system of Carrison teaches the vascular access instrument of claim 1, and Carrison further discloses wherein each (see ‘Modified Figure 3i’ below) of the plurality of loops (see ‘Modified Figure 1’ above) of the coil portion (70) is spaced apart from a next adjacent loop of the plurality of loops (see ‘Modified Figure 3i’ below).
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Regarding claim 8, the modified system of Carrison teaches the vascular access instrument of claim 1, and Carrison further discloses wherein the coil portion (70, see circular cross-section in Figure 3. Thus, the coil portion is cylindrical in 3D) and the core portion (20, see [0028-0029]: wire 20 has diameter and is thus cylindrical) are cylindrical (see [0029]: core wire 20 has diameter and is wrapped to form coil portion and thus both are cylindrical).
Regarding claim 20, Carrison discloses a vascular access system (see Figure 5 and [0020]: figure 5 same as fig.1 with included actuator mechanisms), comprising:
a catheter assembly (see Figure 5 which includes catheter assembly as shown in Figure 1) configured for collecting a fluid (see [0043]), comprising a catheter adapter (24) and a catheter (5) extending distally (rightward in Figure 5) from the catheter adapter (24);
an instrument advancement device (28) coupled to (see [0042-0043]) the catheter assembly (as shown in Figure 5), wherein the instrument advancement device comprises a vascular access instrument (see wire of Figure 1), wherein the instrument advancement device (28) is configured to advance the vascular access instrument from a retracted position to an advanced position beyond a distal end of the catheter (see [0042-0043]: 28 controls wire and thus is “configured to advance” the wire from a retracted to advanced position), wherein the vascular access instrument (wire in Figure 1) comprises:
a single continuous wire that is monolithically formed as a single unit (see [0028-0029]: distal tip of core wire 20 is wrapped to form a coil section) having an outer surface (see ‘Modified Figure 1’ below) and a solid, uninflatable, and uniform cross-section along its length (see [0028-0029]),
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the outer surface (see ‘Modified Figure 1 above) of the wire configured for contact with and overcoming an obstruction within a vasculature (see [0007] & [0014] and [0026-0027], [0031], and [0044]: wire guides distal end past obstruction for basket retrieval and thus the distal end/ the wire must be configured for contact with and for overcoming an obstruction), the wire comprising:
a coil portion (70, see [0041]: coil portion attached to core wire such as by wrapping core to form coil as described in [0029]), comprising a plurality of loops (see ‘Modified Figure 1’ above) wound around a central axis (see [0029]: core portion 20 wrapped to form coil section and central axis is longitudinal axis), the plurality of loops (see ‘Modified Figure 1’ above) having an inner surface (surface of coil facing radially inward towards central axis such as seen in ‘Modified Figure 1’ above) defining an open flow path (see Figure 3. See gap/spacing between each coil and the core portion & each adjacent coil portion such that an “open flow path” is formed through the coil portion that aligns with Applicant disclosure in at least [0057]) through the coil portion (70) and extending along the central axis (see ‘Modified Figure 1’ above);
a core portion (20, see [0026]: 20 referred to as both the core wire and the control wire) extending through (see Figure 3 and [0029]) the coil portion (70) and aligned with the central axis (as seen in ‘Modified Figure 1’ above), at least a portion of the core portion (20) spaced from a portion of the inner surface (see ‘Modified Figure 3’ below)
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of the plurality of loops (see ‘Modified Figure 1’ above) to maintain the open flow path (See Figure 3 with gap/spacing between each coil and the core portion & each adjacent coil portion such that an “open flow path” is formed through the coil portion that aligns with Applicant disclosure in at least [0057]) through the coil portion (70) and facilitate a flow of fluid through the vascular access instrument and the catheter assembly (gaps create pathway for fluid flow and therefore the structure will “facilitate a flow of fluid” therethrough); and
a bent portion (see ‘Modified Figure 1’ above and [0029]) connecting (see [0029]) a distal end (rightward end at bent portion) of the coil portion (70) with a distal end (rightward end at bent portion) of the core portion (20), wherein the bent portion (see ‘Modified Figure 1’) is blunt and forms a distal end of the wire (as seen in Figure 1 and described in [0028-0029]), and wherein at least one of the proximal tip of the coil portion and a proximal tip of the core portion 920) are coupled to the advancement device (28, see [0032] & [0042]).
Carrison is silent to “wherein a proximal end of the coil portion is joined to the core portion or the proximal end of the coil portion includes a straight portion extending parallel with a proximal end of the core portion”.
However, Pacetti teaches a vascular access instrument (see [0022]: a guidewire) comprising a coil portion (16, see FIG. 1 and [0022]) and a core portion (12), wherein a proximal end of the coil portion (16) is joined to (by adhesive 19, see [0022]: coil 16 joined at proximal end by mass 19 to core portion 12. Adhesive aligns with Applicant’s disclosure of joined in at least [0063] of the elected embodiment) the core portion (12) or the proximal end of the coil portion includes a straight portion extending parallel with a proximal end of the core portion.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal end of the coil portion disclosed in Carrison to be joined to the core portion as taught by Pacetti for the purpose of joining the core and coil portion (see [0022]) such that a desired mechanical property of the wire is achieved (see [0008-0010]), thus achieving “wherein a proximal end of the coil portion is joined to the core portion or the proximal end of the coil portion includes a straight portion extending parallel with a proximal end of the core portion”.
Regarding claim 21, the modified system of Carrison teaches the vascular access system of claim 20, and Carrison further discloses wherein the coil portion (70, see Figure 1) is formed by a flat portion of the wire (see [0027]: cross section of wire 20 can be square==flat portion) wound around the central axis (see [0029]: wire 20 wrapped to form coil 70) into the plurality of loops (see ‘Modified Figure 1’ above), wherein the flat portion of the wire (see [0027]) comprises a portion of the wire that includes a first side (outside surface/ surface facing radially outward relative the central axis) and a second side (inside surface/ surface facing radially inward relative the central axis) opposite the first side (outside surface/ surface facing radially outward relative the central axis), and wherein the first side (outside surface/ surface facing radially outward relative the central axis) and/or the second side (inside surface/ surface facing radially inward relative the central axis) is planar prior to the wire being wound around the central axis into loops (see [0027]: cross-section is square/planar) to facilitate a flow of fluid through the vascular access instrument and the catheter assembly (gaps create pathway for fluid flow and therefore the structure will “facilitate a flow of fluid” therethrough).
Regarding claim 22, the modified system of Carrison teaches the vascular access instrument of claim 1, and Carrison further discloses wherein the wire comprises one of nitinol, stainless steel (see [0028]), carbon steel, steel, and chrome.
Regarding claim 23, the modified system of Carrison teaches the vascular access instrument of claim 5, and Carrison further discloses wherein the wire comprises one of nitinol, stainless steel (see [0028]), carbon steel, steel, and chrome.
Regarding claim 24, the modified system of Carrison teaches the vascular access system of claim 20, and Carrison further discloses wherein the wire comprises one of nitinol, stainless steel (see [0028]), carbon steel, steel, and chrome.
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Carrison in view of Pacetti as applied to claim 1 above, and further in view of Radman et al. (U.S. PGPUB No. 2017/0055908), hereinafter Radman.
Regarding claim 2, the modified system of Carrison teaches the vascular access instrument of claim 1, but Modified Carrison is silent to “wherein the bent portion is disposed distal to the coil portion.”
However, Radman teaches a vascular access instrument (see [0126]: guidewire) with a core portion (454, see FIG. 14) and a coil portion (456) connected by a bent portion (see [0126]: “the core 454 extends back over itself and is wound to form a coil 456 that extends over the core 454”. The portion of coil that is “wound” back is the bent portion, see ‘Modified FIG. 14’ below),
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wherein the bent portion (see ‘Modified FIG. 14’ above) is disposed distal (leftward) to the coil portion (456).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the core portion wound about the central axis to form the coil portion at the bent portion as disclosed in Carrison to be wound such that the bent portion is disposed distal to the core portion as taught by Radman for the purpose of ensuring that the bent portion formed when winding the core portion into the coil portion takes the shape of an atraumatic tip (see [0051] and [0126]), thus achieving “wherein the bent portion is disposed distal to the coil portion.”
Regarding claim 3, the modified system of Carrison teaches the vascular access instrument of claim 2, but Carrison is silent to “wherein the bent portion comprises a U-shape.”
However, Radman teaches a vascular access instrument (see [0126]: guidewire) with a core portion (454, see FIG. 14) and a coil portion (456) connected by a bent portion (see [0126]: “the core 454 extends back over itself and is wound to form a coil 456 that extends over the core 454”. The portion of coil that is “wound” back is the bent portion, see ‘Modified FIG. 14’ below), wherein the bent portion (see ‘Modified FIG. 14’ above) is disposed distal (leftward) to the coil portion (456) and wherein the bent portion (see ‘Modified FIG. 14’ above) comprises a U-shape (see ‘Modified FIG. 14’ above).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the core portion wound about the central axis to form the coil portion at the bent portion as disclosed in Carrison to be wound such that the bent portion is disposed distal to the core portion and comprises a U-shape as taught by Radman for the purpose of ensuring that the bent portion formed when winding the core portion into the coil portion takes the shape of an atraumatic tip (see [0051] and [0126]), thus achieving “wherein the bent portion comprises a U-shape.”
Regarding claim 4, the modified system of Carrison teaches the vascular access instrument of claim 3, but Carrison is silent to “wherein the bent portion comprises a loop.”
However, Radman teaches a vascular access instrument (see [0126]: guidewire) with a core portion (454, see FIG. 14) and a coil portion (456) connected by a bent portion (see [0126]: “the core 454 extends back over itself and is wound to form a coil 456 that extends over the core 454”. The portion of coil that is “wound” back is the bent portion, see ‘Modified FIG. 14’ below), wherein the bent portion (see ‘Modified FIG. 14’ above) is disposed distal (leftward) to the coil portion (456), wherein the bent portion (see ‘Modified FIG. 14’ above) comprises a U-shape (see ‘Modified FIG. 14’ above), and wherein the bent portion (see ‘Modified FIG. 14’ above) comprises a loop (see ‘Modified FIG. 14’ above and [0126]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the core portion wound about the central axis to form the coil portion at the bent portion as disclosed in Carrison to be wound such that the bent portion is disposed distal to the core portion and comprises a U-shape and a loop as taught by Radman for the purpose of ensuring that the bent portion formed when winding the core portion into the coil portion takes the shape of an atraumatic tip (see [0051] and [0126]), thus achieving “wherein the bent portion comprises a loop.”
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Carrison in view of Pacetti as applied to claim 1 above, and further in view of Richter et al. (U.S. PGPUB No. 2016/0183963), hereinafter Richter.
Regarding claim 7, the modified system of Carrison teaches the vascular access instrument of claim 1, but Carrison is silent to “wherein each of the plurality of loops of the coil portion contacts a next adjacent loop of the plurality of loops around a circumference of the next adjacent loop.”
However, Richter teaches a vascular access instrument including a wire with a coil portion (130, see Figure 2 and [0081]: “tightly coiled” component 130), wherein each of the plurality of loops (see each loop forming 130 in FIGURE 2) of the coil portion contacts a next adjacent loop of the plurality of loops around a circumference (see [0083] and FIGURE 3A for reference—"tightly coiled” section 230, similar to 130 in FIGURE 2, are shown in contact around the circumference in the cross-section view provided) of the next adjacent loop (see Figure 2).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of loops disclosed in Carrison to contact each adjacent loop around a circumference as taught in Richter for the purpose of improving maneuverability of the device (see Richter [0058]), thus achieving “wherein each of the plurality of loops of the coil portion contacts a next adjacent loop of the plurality of loops around a circumference of the next adjacent loop”.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Carrison in view of Pacetti and Radman as applied to claim 2 above, and further in view of Babkin et al. (U.S. PGPUB No. 2021/0059737), hereinafter Babkin.
Regarding claim 9, the modified system of Carrison teaches the vascular access instrument of claim 2, but Modified Carrison is silent to “wherein the core portion is offset from the central axis.”
However, Babkin teaches a vascular access instrument (see FIG. 22A) wherein a core portion (836) is offset from a central axis (central axis is horizontal axis extending through center of coil 832 as shown in FIG. 22A).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the core portion of Modified Carrison to be offset from the central axis as taught by Babkin for the purpose of maintaining the elongate device in a straightened position unless otherwise articulated (see [0194]), thus achieving “wherein the core portion is offset from the central axis.”
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Carrison in view of Pacetti as applied to claim 1 above, and further in view of Peralta et al. (U.S. PGPUB No. 2017/0087340), hereinafter Peralta.
Regarding claim 10, the modified system of Carrison teaches the vascular access instrument of claim 1, and Carrison further discloses wherein the coil portion (70, see Figure 1) comprises a flat portion (see [0027]: cross section of wire 20 can be square==flat portion and [0029]: wire 20 forms coil 70) having a first side (outside surface/ surface facing radially outward relative the central axis) and a second side (inside surface/ surface facing radially inward relative the central axis) opposite the first side (outside surface/ surface facing radially outward relative the central axis), wherein the first side (outside surface/ surface facing radially outward relative the central axis) forms an outer surface (such as shown in ‘Modified Figure 1’ above) of the coil portion (70), wherein the second side (inside surface/ surface facing radially inward relative the central axis) forms the inner surface (such as shown in ‘Modified Figure 1’ above) of the coil portion (70).
Carrison is silent to “wherein the core portion contacts the inner surface of the coil portion.”
However, Peralta teaches a vascular access instrument (see [0002-0003]) with a core portion (132C, see Figure 9) and a coil portion (136), wherein the core portion (132C) contacts the inner surface (see [0025]: 136 has small diameter such that inside surface of coils partially or fully contact shaft 132C) of the coil portion (136).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the core portion disclosed in Carrison to be in contact with the inner surface of the coil portion as taught by Peralta for the purpose of increasing the stiffness of the vascular access instrument (see [0025]), thus achieving “wherein the core portion contacts the inner surface of the coil portion.”
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Carrison in view of Pacetti as applied to claim 1 above, and further in view of Matlock et al. (U.S. PGPUB No. 2019/0076629), hereinafter Matlock.
Regarding claim 12, the modified system of Carrison teaches the vascular access instrument of claim 1, but Modified Carrison is silent to “wherein the wire further comprises a straight portion connected to a proximal end of the coil portion, wherein the straight portion is parallel to a proximal end of the core portion.”
However, Matlock teaches a vascular access instrument comprising a wire (see FIG. 9), wherein the wire (see FIG. 9) further comprises a straight portion (242) connected to a proximal end (see [0069], [0073]: 242 extends from proximal to distal portion of spiral coil as seen in FIG. 9) of a coil portion (245, see [0071]: helical wire coil), wherein the straight portion (242) is parallel to (see [0069]: 242 extends generally parallel with coil axis) a proximal end of a core portion (238, proximal end of core wire assembly 238 in Fig. 9).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coil portion disclosed in Carrison to have a straight portion connected to a proximal end of the coil portion, wherein the straight portion is parallel to the core portion as taught by Matlock for the purpose of providing a mechanical ground inhibiting relative movement between the coils (see [0069]), thus achieving “wherein the wire further comprises a straight portion connected to a proximal end of the coil portion, wherein the straight portion is parallel to a proximal end of the core portion.”
Regarding claim 14, the modified system of Carrison teaches the vascular access instrument of claim 1, but Modified Carrison is silent to “wherein an inner portion of the straight portion and an inner portion of the proximal end of the core portion are not joined together.”
However, Matlock teaches a vascular access instrument comprising a wire (see FIG. 9), wherein the wire (see FIG. 9) further comprises a straight portion (242) connected to a proximal end (see [0069], [0073]: 242 extends from proximal to distal portion of spiral coil as seen in FIG. 9) of a coil portion (245, see [0071]: helical wire coil), wherein the straight portion (242) is parallel to (see [0069]: 242 extends generally parallel with coil axis) a proximal end of a core portion (238, proximal end of core wire assembly 238 in Fig. 9) and wherein an inner portion of the straight portion (242) and an inner portion of the proximal end of the core portion (238) are not joined together (see [0069]: 242 is offset the coil axis and is secured proximally to tubular member of guidewire--therefore remains spaced apart from proximal end of 238 as seen in FIG. 9. See also [0070] assembly 238 NOT fixed within guidewire 200).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the straight portion connected to the proximal end of the coil portion taught by Carrison in view of Matlock to not be joined with the core portion as taught by Matlock for the purpose of inhibiting relative movement between the coils (see [0069]) while allowing lateral flexibility of the coils (see [0070]), thus achieving “wherein an inner portion of the straight portion and an inner portion of the proximal end of the core portion are not joined together.”
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Carrison in view of Pacetti and Matlock as applied to claim 12 above, and further in view of Minar et al. (U.S. PGPUB No. 2018/0256860), hereinafter Minar.
Regarding claim 13, the modified system of Carrison teaches the vascular access instrument of claim 12, but Modified Carrison is silent to “wherein an inner portion of the straight portion and an inner portion of the proximal end of the core portion are joined together.”
However, Minar teaches a vascular access instrument comprising a wire (see FIG. 1a and [0005-0006]) with a core portion (10) and a coil portion (12, see [0025]), wherein the wire further comprises a straight portion (4, see [0025]) and wherein an inner portion (surface facing radially inward, see ‘Modified FIG. 1A’ below) of the straight portion (4)
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and an inner portion (see ‘Modified FIG. 1A’ above) of a proximal end (leftward end of core not at the distal end as shown in ‘Modified FIG. 1A’ above) of the core portion (10) are joined together (see [0033]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the straight portion and core portion taught by Modified Carrison to be joined at an inner portion as taught by Minar for the purpose of providing kink resistance such that bend and kink is reduced (see [0005]), to achieve other desired mechanical properties at the joint (see [0012]), or to impart finger formability to the guidewire (see [0033]), thus achieving “wherein an inner portion of the straight portion and an inner portion of the proximal end of the core portion are joined together”.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-10, 12-14, and 20-24 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.
A new rejection under Carrison in view of Pacetti has been applied to best meet the newly amended claims, rendering the arguments against Dobak and DiCarlo moot.
Conclusion
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783