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 .
Response to Amendment
This office action is responsive to the amendment filed on 01/16/2026. As directed by the amendment: no claims have been amended; claims 9-12, 16-19 have been canceled; and no new claims have been added. Thus, claims 1-8, 13-15 are presently pending in this application.
Response to Arguments
Applicant’s argument pages 5-6 of the remarks filed 01/16/2026 that Alsheikh fails to disclose that the flattened portion 108 would not necessarily include a planar surface and a semi-cylindrical surface as Alsheikh does not disclose how the flattened portion 108 is formed and the tapered portion 106 could be flattened on both sides such that there is no semi-spherical surface. Applicant’s argument has been fully considered and are not persuasive. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., semi-spherical surface) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In addition, Alsheikh fig. 8 shows the tapered portion and the flattened portion with a planar surface and semi-cylindrical surface at a section along those portions.
Applicant’s argument page 7 of the remarks filed 01/16/2026 that modifying Alsheikh to reach the claimed invention as an obvious matter of design choice failed to establish a prima facie case of obviousness with respect to independent claims 1 and 8. The Examiner has provided no reasoning or explanation as to why one of ordinary skill in the art would modify Alsheikh, absent hindsight reconstruction of the claimed invention. Applicant’s argument has been fully considered and are not persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In addition, Alsheikh discloses one end of the cylindrical portion of the core wire being tapered through a tapered portion to reduce the diameter of the core wire and then being flattened to form flattened portion. Therefore, within the level of ordinary skill at the time the claimed invention was made and not including knowledge gleaned only from the applicant's disclosure, it is proper to modify the tapered portion to have a semi-cylindrical surface as an obvious matter of design choice.
Applicant’s argument pages 7-8 of the remarks filed 01/16/2026 that the modified device would not function as intended because increasing the cross-sectional area to provide a semi-cylindrical surface would appear to impact the function of the flattened portion 108 to freely bend. Applicant’s argument has been fully considered and are not persuasive. As stated in the office action, the tapered portion is modified to have a semi-cylindrical surface, not the flattened portion. Also, the semi-cylindrical surface on a section along the tapered portion still provides a reduced/tapered diameter as Alsheikh discloses in par. 0051 (the core wire diameter tapers from the handle region to the mid portion, then tapers again through tapered portion to an ultimate diameter near the tip. The end portion of the core wire is then flattened to form flattened portion). Therefore, changing a section of the tapered portion to have a semi-cylindrical surface would not result in a difference in function of Alsheikh device. A person having ordinary skill in the art, being face 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 give the claimed surfaces.
Applicant’s argument pages 8-9 of the remarks filed 01/16/2026 that Alsheikh does not explicitly disclose a C-shaped transverse cross-section and Examiner has failed to establish a prima facie case of obviousness with respect to claim 13. Applicant’s argument has been fully considered and are not persuasive. Alsheikh fig. 8 shows the tapered portion and the flattened portion with a C-shaped transverse cross section at a section along those portions. In addition, Alsheikh discloses one end of the cylindrical portion of the core wire being tapered through a tapered portion to reduce the diameter of the core wire and then being flattened to form flattened portion. Therefore, within the level of ordinary skill at the time the claimed invention was made and not including knowledge gleaned only from the applicant's disclosure, it is proper to modify the tapered portion to have a C-shaped transverse cross section as an obvious matter of design choice. As stated in the office action, the tapered portion is modified to have a C-shaped transverse cross section, not the flattened portion. Also, the C-shaped transverse cross section along the tapered portion still provides a reduced/tapered diameter as Alsheikh discloses in par. 0051 (the core wire diameter tapers from the handle region to the mid portion, then tapers again through tapered portion to an ultimate diameter near the tip. The end portion of the core wire is then flattened to form flattened portion). Therefore, changing a section of the tapered portion to be C-shaped transverse cross section would not result in a difference in function of Alsheikh device. A person having ordinary skill in the art, being face 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 give the claimed cross-section.
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) 1-8, 13-15 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).
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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 6, Alsheikh discloses
The instrument of claim 1, wherein the semi-cylindrical surface has a radius smaller than or equal to an inner radius of the helical coil (see figs. 7-8 and par. 0051).
Regarding claim 7, Alsheikh discloses
The instrument of claim 6, wherein the planar surface extends along a chord of the central passage (see figs. 7-8 and par. 0051).
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).
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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 13, 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 a length of the core wire has a C-shaped transverse cross-section (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).
Assuming arguendo that Alsheikh does not explicitly disclose in the specification that a portion of the core wire has a C-shaped transverse cross-section.
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 cross-section.
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 C-shaped transverse cross-section as an obvious matter of design choice within the skill of the art.
Regarding claim 14, Alsheikh discloses
The instrument of claim 13, wherein an outer surface of the core wire (90) has a radius smaller or equal to an inner radius of the helical coil (92) (see fig. 8).
Regarding claim 15, Alsheikh discloses
The instrument of claim 13, wherein the core wire (90) comprises a first portion (tapered portion 106) including the length of the core wire with the C-shaped transverse cross-section (see figs. 7-8) and a second portion (non-tapered portion 106) having a circular transverse cross-section (see figs. 7-8).
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 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/Primary Examiner, Art Unit 3783