Update 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/18/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 06/18/2026. As directed by the amendment: claims 1, 8, 13 have been amended; claims 6-7, 9-12, 16-19 have been canceled; and no new claims have been added. Thus, claims 1-5, 8, 13-15 are presently pending in this application.
Response to Arguments
Applicant’s argument pages 5-6 of the remarks filed 06/18/2026 that Alsheikh fails to disclose the amended limitation of claims 1 and 8. Applicant’s argument has been fully considered and are not persuasive. Alsheikh discloses a core wire (90, figs. 8-9) comprising a semi-cylindrical surface (see annotated fig. 8 below) wherein the semi-cylindrical surface has a radius smaller than or equal to an inner radius of the helical coil (Examiner notes: see annotated fig. 8 below for the radius of the semi-cylindrical surface as well as the radius of the core wire 90 is smaller than the inner radius of the helical coil 92. See fig. 8 and par. 0051 for the core wire 90 is positioned within the helical coil 92, and the diameter of the core wire 90 tapers from the handle region, to the mid portion, to the end portion so that the very distal end of the core wire is flattened), the semi-cylindrical surface engaging a portion of the helical coil (Examiner notes: see fig. 8, since the outer surface of the proximal portion of 90 is in contact with the inner surface of the proximal portion of 92, and the flattened distal end of 90 is in contact with the tip 100 and the tip 100 is in contact with the distal end of 92, 90 engages with 92 and the semi-cylindrical surface of 90 engages with a portion of 92), and wherein the planar surface extends along a chord of the central passage (see annotated fig. 8 for the planar surface of 90 positioned within the central passage of 92; therefore, the planar surface of 90 extends along a chord of the central passage of 92)
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Applicant’s argument pages 6-8 of the remarks filed 06/18/2026 that Alsheikh fails to disclose the amended limitation of claim 13. Applicant’s argument has been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection has been made, as seen below.
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) 1-5, 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alsheikh (US 2021/0052860).
Regarding claim 1, Alsheikh discloses
An instrument (instrument shown in figs. 8-9 and pars. 0143-0148) configured to be inserted through a vascular access device (see par. 0005), the instrument (14, figs. 8-9) comprising:
a helical coil (92, figs. 8-9) formed by a wire (see figs. 8-9 and pars. 0048-0049), the helical coil (92) defining a central passage (central passage of 92 for 90 positioned within, figs. 8-9); and
a core wire (90) extending along a longitudinal axis of the helical coil (longitudinal axis of 92) through at least a portion of the central passage of the helical coil (see figs. 8-9), wherein at least a portion of the core wire (90) comprises a planar surface (see annotated fig. 8 below) extending in a direction along the longitudinal axis (see fig. 8) and a semi- cylindrical surface (see annotated fig. 8 below) extending in a direction along the longitudinal axis (see fig. 8) (Examiner notes: see figs. 7-8 and par. 0051 for the core wire comprising a tapered portion 106 and this end portion of the core wire is then flattened to form flattened portion),
wherein the semi-cylindrical surface has a radius smaller than or equal to an inner radius of the helical coil (Examiner notes: see annotated fig. 8 below for the radius of the semi-cylindrical surface as well as the radius of the core wire 90 is smaller than the inner radius of the helical coil 92. See fig. 8 and par. 0051 for the core wire 90 is positioned within the helical coil 92, and the diameter of the core wire 90 tapers from the handle region, to the mid portion, to the end portion so that the very distal end of the core wire is flattened), the semi-cylindrical surface engaging a portion of the helical coil (Examiner notes: see fig. 8, since the outer surface of the proximal portion of 90 is in contact with the inner surface of the proximal portion of 92, and the flattened distal end of 90 is in contact with the tip 100 and the tip 100 is in contact with the distal end of 92, 90 engages with 92 and the semi-cylindrical surface of 90 engages with a portion of 92), and wherein the planar surface extends along a chord of the central passage (see annotated fig. 8 for the planar surface of 90 positioned within the central passage of 92; therefore, the planar surface of 90 extends along a chord of the central passage of 92).
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Assuming arguendo that Alsheikh does not explicitly disclose in the specification that a portion of the core wire comprising a semi-cylindrical surface.
There is no evidence of record that establishes that changing the shape of the tapered portion would result in a difference in function of Alsheikh device. Further, a person having ordinary skill in the art, being faced with modifying the tapered portion of Alsheikh, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed surfaces.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the tapered portion of Alsheikh to have a semi-cylindrical surface as an obvious matter of design choice within the skill of the art.
Regarding claim 2, Alsheikh discloses
The instrument of claim 1, wherein the core wire (90) comprises a first transverse cross-sectional shape (see figs. 7-8 and par. 0051 for the tapered portion 106), the first transverse cross-sectional shape having a linear section and a semi- circular section (see fig. 8 for the linear section and semi-circular section of 106/108).
Regarding claim 3, Alsheikh discloses
The instrument of claim 2, wherein the core wire (90) comprises a second transverse cross-sectional shape (see figs, 7-8 for the proximal portion to the left of the tapered portion 106), and wherein the second transverse cross-sectional shape is circular (see figs. 7-8).
Regarding claim 4, Alsheikh discloses
The instrument of claim 2, wherein the first transverse cross-sectional shape (see figs. 7-8 and par. 0051 for the tapered portion 106) is less than 33% of a transverse cross-sectional area of the central passage (see par. 0051 for the tapered portion 106 with the diameter tapers through the tapered portion and the end portion of the core wire is then flattened to form flattened portion).
Regarding claim 5, Alsheikh discloses
The instrument of claim 3, wherein the core wire tapers in size from the second transverse cross-sectional shape to the first transverse cross-sectional shape (see par. 0051 for the tapered portion 106 with the diameter tapers through the tapered portion).
Regarding claim 8, Alsheikh discloses
A vascular access system (see figs. 1-9 and pars. 0005-0148) comprising:
a catheter adapter (18, fig. 2) comprising a catheter (18) configured to be inserted into a patient's vasculature (see fig. 2);
an instrument advancement device (instrument shown in figs. 8-9 and pars. 0143-0148) coupled to the catheter adapter (see fig. 2), wherein the instrument advancement device (14, figs. 8-9) comprises a helical coil (92, figs. 8-9) formed by a wire (see figs. 8-9 and pars. 0048-0049), the helical coil (92) defining a central passage (central passage of 92 for 90 positioned within, figs. 8-9), and a core wire (90) extending along a longitudinal axis of the helical coil (longitudinal axis of 92) through at least a portion of the central passage of the helical coil (see figs. 8-9), wherein at least a portion of the core wire (90) comprises a planar surface (see annotated fig. 8 below) extending in a direction along the longitudinal axis (see fig. 8) and a semi- cylindrical surface (see annotated fig. 8 below) extending in a direction along the longitudinal axis (see fig. 9) (Examiner notes: see figs. 7-8 and par. 0051 for the core wire comprising a tapered portion 106 and this end portion of the core wire is then flattened to form flattened portion); and
wherein the instrument advancement device (14) is configured to advance the instrument from a retracted position (14 is positioned within 18) to an advanced position (distal end of 14 is positioned out of 18) beyond a distal end of the catheter (Examiner notes: the limitation “configured to advance the instrument from a retracted position to an advanced position beyond a distal end of the catheter” is interpreted as functional limitation. As shown in fig. 2, diameter of 14 is smaller than diameter of 18 such that 14 is positioned within 18. Therefore, 14 is capable of being placed within 18 in its retracted position and being placed out of 18 in its advanced position), the helical coil (92) of the instrument is configured to extend beyond the distal end of the catheter when the instrument is in the advanced position (Examiner notes: the limitation “configured to extend beyond the distal end of the catheter when the instrument is in the advanced position” is interpreted as functional limitation. As shown in figs. 6-8, 92 is positioned along 14 and at the distal end portion of 14. Therefore, when 14 is in the advanced position, distal end of 14 with 92 extends beyond distal end of 18),
wherein the semi-cylindrical surface has a radius smaller than or equal to an inner radius of the helical coil (Examiner notes: see annotated fig. 8 below for the radius of the semi-cylindrical surface as well as the radius of the core wire 90 is smaller than the inner radius of the helical coil 92. See fig. 8 and par. 0051 for the core wire 90 is positioned within the helical coil 92, and the diameter of the core wire 90 tapers from the handle region, to the mid portion, to the end portion so that the very distal end of the core wire is flattened), the semi-cylindrical surface engaging a portion of the helical coil (Examiner notes: see fig. 8, since the outer surface of the proximal portion of 90 is in contact with the inner surface of the proximal portion of 92, and the flattened distal end of 90 is in contact with the tip 100 and the tip 100 is in contact with the distal end of 92, 90 engages with 92 and the semi-cylindrical surface of 90 engages with a portion of 92), and wherein the planar surface extends along a chord of the central passage (see annotated fig. 8 for the planar surface of 90 positioned within the central passage of 92; therefore, the planar surface of 90 extends along a chord of the central passage of 92).
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Assuming arguendo that Alsheikh does not explicitly disclose in the specification that a portion of the core wire comprising a semi-cylindrical surface.
There is no evidence of record that establishes that changing the shape of the tapered portion would result in a difference in function of Alsheikh device. Further, a person having ordinary skill in the art, being faced with modifying the tapered portion of Alsheikh, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed surfaces.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the tapered portion of Alsheikh to have a semi-cylindrical surface as an obvious matter of design choice within the skill of the art.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wong (US 6,761,696).
Regarding claim 13, Wong discloses
An instrument (fig. 1) configured to be inserted through a vascular access device (col. 2 line 24 to col. 7 line 33), the instrument comprising:
a helical coil (15) formed by a wire (see fig. 1 and col. 4 line 13), the helical coil (15) defining a central passage (central passage of 15, see fig. 1); and
a core wire (14, fig. 1) extending along a longitudinal axis of the helical coil (see fig. 1) through at least a portion of the central passage of the helical coil (see fig. 1), wherein at least a portion of a length of the core wire (14) has a C-shaped transverse cross-section (see fig. 5) defining a concave surface and a convex surface (see fig. 5).
Assuming arguendo that Wong does not explicitly disclose in the specification that a portion of the core wire having a C-shaped transverse cross-section.
There is no evidence of record that establishes that changing the shape of the core wire would result in a difference in function of Wong device (see col. 2 lines 47-51). Further, a person having ordinary skill in the art, being faced with modifying the tapered portion of Wong, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed surfaces.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the core wire of Wong to have a C-shaped transverse cross-section as an obvious matter of design choice within the skill of the art.
Regarding claim 14, Wong discloses
The instrument of claim 13, wherein an outer surface of the core wire (14) has a radius smaller or equal to an inner radius of the helical coil (15, see fig. 1).
Regarding claim 15, Wong discloses
The instrument of claim 13, wherein the core wire (14) comprises a first portion (distal portion) including the length of the core wire with the C-shaped transverse cross-section (see fig. 5) and a second portion (proximal portion) having a circular transverse cross-section (see fig. 5).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DUNG T ULSH whose telephone number is (571)272-9894. The examiner can normally be reached Monday-Friday 9am-6pm.
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/DUNG T ULSH/Examiner, Art Unit 3783
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