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 .
Status of Claims
This office action is responsive to the filing dated 8 January 2026.
Claims 11-24 are withdrawn.
Claims 25 and 26 are added.
Claims 1-10 are presently pending in this application.
Claim Rejections - 35 USC § 102
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.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mathews et al. (US Patent No. 11400261 B2), hereinafter Mathews.
Regarding claim 1, Mathews teaches a guidewire (Mathews: Fig. 1, guidewire 11), comprising: a proximal portion (Fig. 2, transition region 21) and a distal portion (Fig. 2, barrel portion 27-1) extending from the proximal portion (Fig. 2, region 21) to a distal end (Fig. 1, comprising barrel portions 27-2 and 27-3, tapered portions 29-1 and 29-2, and atraumatic tip 32) of the guidewire (Fig. 1, guidewire 11); a solid core wire (Fig. 1, inner core wire 13) including a proximal section (Fig. 2, comprising proximal region 17 and transition region 21) and a distal section (Fig. 2, barrel portion 27-1), the distal section (Fig. 2, barrel portion 27-1) extending from the proximal portion (Fig. 2, comprising regions 17 and 21) to the distal end (Fig. 1, comprising barrel portions 27-2 and 27-3, tapered portions 29-1 and 29-2, and atraumatic tip 32), and the distal section (Fig. 2, barrel portion 27-1) having a constant diameter (Fig. 2, potion 27-1 is shown to have a constant diameter from the region 21 to the portion 29-1; col 5, ln 30-39); a coil (Fig. 2, outer casing 15) wound around the distal section (Fig. 2, barrel portion 27-1) of the solid core wire (Fig. 1, inner core wire 13), wherein the proximal section (Fig. 2, comprising proximal region 17 and transition region 21) has a flexural stiffness that is greater than a flexural stiffness of the distal section (proximal region 17 is relatively stiff compared to the relatively flexible distal region 19, which comprises portion 27-1; col 4, ln 51-57); and a preformed curved distal tip (Fig. 1, distal segment 39 is preformed and curved; col 7, ln 9-17).
Regarding claim 2, Mathews teaches the guidewire above, wherein a diameter (Fig. 2, outer diameter D1) of the proximal section (Fig. 2, comprising proximal region 17 and transition region 21) is greater than the diameter (Fig. 2, outer diameter D2) of the distal section (Fig. 2, diameter D1 is 0.035 inches, which is larger than diameter D2, which is 0.025 inches).
Regarding claim 3, Mathews teaches the guidewire above, wherein the distal section (Fig. 2, barrel portion 27-1) is configured for insertion into a patient vasculature (Fig. 5a-d, distal region 19, which comprises portion 27-1, is inserted into a patient aorta; col 5, ln 15-29).
Regarding claim 4, Mathews teaches the guidewire above, wherein the distal section (Fig. 2, barrel portion 27-1) is configured to guide a catheter along a patient vasculature (distal region 19, which comprises portion 27-1, guides a catheter into vasculature; col 7, ln 27-42).
Regarding claim 5, Mathews teaches the guidewire above, wherein the proximal section (Fig. 2, comprising proximal region 17 and transition region 21) is configured to be inserted through a catheter (the guidewire 11 as a whole is inserted into a catheter; col 8, ln 30-35), and wherein the proximal section (Fig. 2, comprising proximal region 17 and transition region 21) provides a column strength to the catheter (guidewire 11 provides a support structure for catheter implantation. Therefore, because the proximal region 17 provides stiffness for insertion, it would reasonably provide column strength to the catheter; col 5, ln 15-29 and col 8, ln 30-35).
Regarding claim 6, Mathews teaches the guidewire above, wherein the guidewire is configured so that, during insertion, the proximal section (Fig. 2, comprising proximal region 17 and transition region 21) provides a column strength to a proximal portion of a catheter (guidewire 11 provides a support structure for catheter implantation. Therefore, because the proximal region 17 provides stiffness for insertion, it would reasonably provide column strength to the proximal portion of the catheter; col 5, ln 15-29 and col 8, ln 30-35) while the distal section (Fig. 2, barrel portion 27-1) simultaneously provides guidance to a distal portion of the catheter along a patient vasculature (distal region 19 guides a catheter into vasculature; col 7, ln 27-42). Examiner interprets that since both the column strengthening and guiding occur during catheter insertion, it can be assumed that they occur simultaneously during catheter insertion.
Regarding claim 7, Mathews teaches the guidewire above, wherein the flexural stiffness of the proximal section (Fig. 2, comprising proximal region 17 and transition region 21) is configured to enable manual displacement of the proximal section into a catheter without kinking or breaking (the transition from the proximal to the distal regions, from stiffer to more flexible respectively, allows the guidewire to be resistant to kinging upon manual displacement; col 1, ln 64 – col 2, ln 17).
Regarding claim 8, Mathews teaches the guidewire above, wherein the proximal section (Fig. 2, comprising proximal region 17 and transition region 21) of the solid core wire (Fig. 1, inner core wire 13) defines an outer diameter (Fig. 2, outer diameter D1) of a portion of the guidewire (outer diameter D1 defines an outer diameter of the proximal region 17 of the guidewire 11).
Regarding claim 10, Mathews teaches the guidewire above, further comprising an atraumatic distal tip (Fig. 3, atraumatic tip 32).
Regarding claim 26, Mathews teaches the guidewire above, wherein: a diameter of the proximal section (Fig. 2, comprising region 17 and 21) is equal to the diameter of the distal section (Fig. 2, at the distal end of the transition region 21, the diameter of the region 21 becomes the same as the diameter of the barrel portion 27-1), and the guidewire (Fig. 1, guidewire 11) further comprises a cannula (Fig. 5a, guide catheter 41) disposed around and attached to the proximal section (Fig. 5a, catheter 41 is shown disposed around proximal region 17).
Claim Rejections - 35 USC § 103
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Mathews in view of Shireman et al. (US Patent Publication No. 20040167443 A1), hereinafter Shireman.
Regarding claim 9, Mathews teaches the guidewire above.
Mathews does not expressly disclose the proximal section is longer than the distal section.
Shireman teaches a guidewire (Shireman: Fig. 1, guidewire 10), wherein a proximal section (Fig. 1, proximal portion 14) is longer than (Shireman: para. 0055) a distal section (Fig. 1, distal portion 16).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guidewire of Mathews such that the proximal section is longer than the distal section as taught by Shireman in order to increase torquability and pushability of the guidewire (Shireman: para. 0055).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Mathews in view of Mitchell et al. (US Patent Publication No. 20160220786 A1), hereinafter Mitchell.
Regarding claim 25, Mathews teaches the guidewire above.
Mathews does not expressly disclose the proximal section includes indicia indicating a distance to the distal end of the proximal section.
Mitchell teaches a proximal section (Mitchell: proximal end of the guidewire 15; para. 0034) includes indicia (Fig. 10, visible marks; para. 0034) indicating a distance to a distal end of the proximal section (indicate depth of the wire; para. 0034).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guidewire of Mathews such that the proximal section includes indicia indicating a distance to the distal end of the proximal section as taught by Mitchell in order to avoid placement too deep within a vasculature (Mitchell: para. 0034).
Response to Arguments
Applicant’s arguments, see pages 7-8, filed 8 January 2026, with respect to the rejections of claims 1-10 under 35 USC 102 and 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of an alternative interpretation of Mathews cited above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
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