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 December 23, 2025. As directed by the amendment: claims 1, 3, 9, 15 have been amended, claims 21-29 have been added, claims 2, 11, 12 have been canceled. Thus claims 1, 3-10, and 13-29 are presently pending in this application, and claims 15-20 remain withdrawn.
Response to Arguments
Applicant’s arguments, see Remarks, filed December 23, 2025, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Young fails to disclose the amended limitations of wherein the external distal end portion length is shorter than the medical instrument length of a medical instrument to be passed over the bend from the distal end toward the insertion portion and into a patient. Therefore, the rejection has been withdrawn, and the rejections of claims 3-10 and 13-14 have been withdrawn due to their dependency on claim 1. However, upon further consideration, in light of the amendments, a new ground(s) of rejection is made below.
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 25 and 28-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoshizaki et al. (US 20090105724), hereinafter Yoshizaki.
Regarding claim 25, Yoshizaki discloses a guidewire for insertion of a medical instrument having a medical instrument length, into a patient (Fig. 1-10 and [0032], guidewire for facilitating the insertion of a catheter into a patient), the guidewire comprising: an elongated wire (Figs. 1-10 and [0032], guidewires are made from an elastic linear body formed of wire) having a proximal end (Fig. 1, distal tip 6. Examiner notes: Yoshizaki defines the proximal/distal ends as opposite to the definition of the proximal/distal ends of the instant application), a distal end (Fig. 1, proximal end of proximal portion 1), an insertion portion at the proximal end (Fig. 1, distal end of wire including intermediate linear portion 3 to the distal tip 6), and an external portion at the distal end (Fig. 1, proximal portion 1); and a bend located between the proximal end and the distal end (Fig. 1, first curve 2 located between proximal portion 1 and distal tip 6), the bend configured to prevent the external portion from entering a patient, while at the same time allowing the medical instrument to be passed over the bend ([0032-0033, 0035], the guidewire is a pre-shaped and used for facilitating insertion of a catheter, therefore the guidewire is configured to allow a catheter to pass over the first curve 2 when facilitating the insertion of the catheter; while the first curve 2 also holds the catheter in place at the curve into the body cavity, thus keeping the proximal portion 1 and its handle external to the body).
Regarding claim 28, Yoshizaki discloses the guidewire of claim 25, the bend comprising a single bend in the elongated wire (Fig. 1, first curve 2 comprises a single bend in the wire).
Regarding claim 29, Yoshizaki discloses the guidewire of claim 25, wherein the medical instrument is a catheter or a needle ([0032], a medical instrument inserted over the wire may be a catheter).
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.
Claims 1, 3, 6-7, 13-14, 21-24, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshizaki (US 20090105724), in view of Keating et al. (US 20230069826), hereinafter Keating.
Regarding claim 1, Yoshizaki discloses ---a guidewire for preventing guidewire retention (guidewires of figs. 1-10 for insertion into the body from the outside and formed to match curve shape of body cavity to facilitate the insertion/retention [0033]), comprising: an elongated wire (Figs. 1-10 and [0032], guidewires are made from an elastic linear body formed of wire) comprising an insertion portion (Fig. 1, distal end of wire including intermediate linear portion 3to the distal tip 6) and an external portion (Fig. 1, proximal end of wire including the proximal portion 1 and the first curve 2), wherein the external portion has a distal end (Fig. 1, external portion has a proximal end on proximal portion 1. Examiner notes that Yoshizaki defines the proximal/distal ends as opposite to the definition of the proximal/distal ends of the instant application); and a stopping mechanism comprising a bend (Fig. 1, first curve 2, which is a bend), wherein the bend defines an external distal end portion of said elongated wire which has an external distal end portion length from the distal end of said elongated wire to the bend (Fig. 1, first curve 2 may define the external distal portion of the wire which has a length from the proximal end of the proximal portion 1 to the first curve 2).
Yoshizaki fails to disclose wherein the external distal end portion length is shorter than the medical instrument length of a medical instrument to be passed over the bend from the distal end toward the insertion portion and into a patient. However, Keating discloses wherein the external distal end portion length is shorter than the medical instrument length of a medical instrument to be passed over the bend from the distal end toward the insertion portion and into a patient (Fig. 1 and 7 and [0003, 0023, 0026, 0028, 0031], the overall length L of the catheter needs to be a few cm longer than the length of the catheter which passes over it. The distal and intermediate portions of the catheter (equivalent to insertion portions of the catheter) contribute to a significant portion of the length of the catheter as seen in Fig. 1 and disclosed in the example lengths of La (15 cm) and Lb (20cm). Since the guidewire length need only be "a few cm" longer than the catheter length, a proximal portion 106 (external portion) may have a length Lc which is shorter than the length of the catheter. Catheter is passed over the guidewire from the proximal end (see Fig. 7) to its location in the body).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yoshizaki to incorporate the disclosures of Keating and modify the external distal end portion length to be shorter than the medical instrument length of a medical instrument to be passed over the bend from the distal end toward the insertion portion and into a patient. Doing so would provide a guidewire which is sized such that the lengths of the guidewire regions are appropriate to promote the desired properties for controlling guidewire and catheter delivery to the target region (Keating [0003,0016, 0028]).
Regarding claim 3 and Yoshizaki, in view of Keating, Yoshizaki further discloses ---the guidewire of claim 1, wherein the bend has a bend angle (Fig. 1, first curve 2 is bent to be at an angle, thus having a bend angle).
Regarding claim 6 and Yoshizaki, in view of Keating, Yoshizaki further discloses ---the guidewire of claim 3, wherein the bend has a bend radius of greater than about 0.75 inches (Fig. 6 and [0041], first curve has radius R1 which may be 50.7-56.0 mm (~2-2.2 in).
Regarding claim 7 and Yoshizaki, in view of Keating, Yoshizaki further discloses ---the guidewire of claim 6, wherein the bend radius is less than about 2.50 inches (Fig. 6 and [0041], first curve has radius R1 which may be 50.7-56.0 mm (~2-2.2 in).
Regarding claim 13 and Yoshizaki, in view of Keating, Yoshizaki further discloses ---the guidewire of claim 1, wherein the elongated wire comprises stainless steel ([0032], guidewire may be a stainless steel wire).
Regarding claim 14 and Yoshizaki, in view of Keating, Yoshizaki further discloses ---the guidewire of claim 1, wherein the elongated wire comprises nitinol ([0037], guidewire may comprise shape memory material such as nickel-titanium based alloys (nitinol)).
Regarding claim 21 and Yoshizaki, in view of Keating, Yoshizaki further discloses ---the guidewire of claim 1, wherein the medical instrument comprises a catheter ([0032], guidewire can be loaded with a catheter to help facilitate the insertion of the catheter).
Regarding claim 22 and Yoshizaki, in view of Keating, Yoshizaki further discloses ---the guidewire of claim 1, the bend comprising a single bend in the elongated wire (Fig. 1, first curve 2 comprises a single bend in the wire).
Regarding claim 23 and Yoshizaki, in view of Keating, Yoshizaki further discloses ---the guidewire of claim 1, wherein the medical instrument can be passed over the bend, while at the same time the bend prevents the external portion from entering the patient ([0032-0033, 0035], the guidewire is a pre-shaped stylet that used for facilitating insertion of a catheter, therefore the guidewire is configured to allow a catheter to pass over the first curve 2 while the first curve 2 holds the catheter in place at the curve into the body cavity, thus keeping the proximal portion 1 and its handle external to the body).
Regarding claim 24 and Yoshizaki, in view of Keating, Yoshizaki further discloses ---the guidewire of claim 1, wherein the medical instrument is a catheter or a needle ([0032], guidewire can be loaded with a catheter to help facilitate the insertion of the catheter).
Regarding claim 26, Yoshizaki discloses the guidewire of claim 25, wherein the medical instrument is passed over the bend ([0032-0033, 0035], the guidewire is a pre-shaped stylet that used for facilitating insertion of a catheter, therefore the guidewire is configured to allow a catheter to pass over the first curve 2).
Yoshizaki fails to disclose wherein the medical instrument is passed over from the distal end toward the proximal end for insertion into the patient. However, Keating discloses wherein the medical instrument is passed over from the distal end toward the proximal end for insertion into the patient (Fig. 7 and [0003, 0023], catheter 300 is passed over the guidewire 100 from the proximal end 106 (see Fig. 7) to distal end 102 at the target location in the body).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yoshizaki to incorporate the disclosures of Keating and modify the guidewire device to be configured to have the medical instrument is passed over from the distal end toward the proximal end for insertion into the patient. Doing so would allow the guidewire to hold and guide the catheter to its target location in the body (Keating [0002-0003]).
Regarding claim 27, Yoshizaki discloses the guidewire of claim 25, wherein the bend defines an external distal end portion of said elongated wire which has an external distal end portion length from the distal end of said elongated wire to the bend (Fig. 1, first curve 2 may define the external distal portion of the wire which has a length from the proximal end of the proximal portion 1 to the first curve 2).
Yoshizaki fails to disclose wherein the external distal end portion length is shorter than the medical instrument length of the medical instrument to be passed over the bend from the distal end to the proximal end into the patient. However, Keating discloses wherein the external distal end portion length is shorter than the medical instrument length of a medical instrument to be passed over the bend from the distal end to the proximal end into the patient (Fig. 1 and 7 and [0003, 0023, 0026, 0028, 0031], the overall length L of the catheter needs to be a few cm longer than the length of the catheter which passes over it. The distal and intermediate portions of the catheter (equivalent to insertion portions of the catheter) contribute to a significant portion of the length of the catheter as seen in Fig. 1 and disclosed in the example lengths of La (15 cm) and Lb (20cm). Since the guidewire length need only be "a few cm" longer than the catheter length, a proximal portion 106 (external portion) may have a length Lc which is shorter than the length of the catheter. Catheter is passed over the guidewire from the proximal end (see Fig. 7) to its location in the body).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yoshizaki to incorporate the disclosures of Keating and modify the external distal end portion length to be shorter than the medical instrument length of a medical instrument to be passed over the bend from the distal end to the proximal end into the patient. Doing so would provide a guidewire which is sized such that the lengths of the guidewire regions are appropriate to promote the desired properties for controlling guidewire and catheter delivery to the target region (Keating [0003,0016, 0028]).
Claims 4-5 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshizaki (US 20090105724), in view of Keating (US 20230069826), as applied to claims 1 and 3 above, and further in view of Young (WO 2015015203).
Regarding claim 4, Yoshizaki, in view of Keating, discloses the guidewire of claim 3.
Yoshizaki, in view of Keating, fails to disclose wherein the bend angle is at least 45 degrees. However, Young discloses wherein the bend angle is at least 45 degrees (Figs. 4 and 8 and pg. 13, ln 1-14, bend angle of midsection 3 may be at least 90 degrees).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yoshizaki, in view of Keating, to incorporate the disclosures of Young and modify the bend to have a bend angle of at least 45 degrees. Doing so would provide the bend at an angle which inhibits further insertion of the guidewire into the patient due to contact with a portion of the patient, such as their skin (Young. Pg. 12, ln 16-22).
Regarding claim 5, Yoshizaki, in view of Keating, discloses the guidewire of claim 3.
Yoshizaki, in view of Keating, fails to disclose wherein the bend angle is at least 90 degrees. However, Young discloses wherein the bend angle is at least 90 degrees (Figs. 4 and 8 and pg. 13, ln 1-14, bend angle of midsection 3 may be at least 90 degrees).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yoshizaki, in view of Keating, to incorporate the disclosures of Young and modify the bend to have a bend angle of at least 90 degrees. Doing so would provide the bend at an angle which inhibits further insertion of the guidewire into the patient due to contact with a portion of the patient, such as their skin (Young. Pg. 12, ln 16-22).
Regarding claim 9, Yoshizaki, in view of Keating, discloses the guidewire of claim 1.
Yoshizaki, in view of Keating, fails to disclose wherein the bend is heat treated. However, Young discloses wherein the bend is heat treated (Pg. 16, ln 31-Pg. 17, ln 3, the midsection 3 may be formed into its bent shape by heating the midsection, then shaping it).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yoshizaki, in view of Keating, to incorporate the disclosures of Young and modify the bend to be heat treated. Doing so would allow the guidewire bend portion to have shape memory for forming the desired bend shape (Young, Pg. 12, ln 15-25; Pg. 16, ln 31-Pg. 17, ln 3).
Regarding claim 10, Yoshizaki, in view of Keating, discloses the guidewire of claim 1.
Yoshizaki, in view of Keating, fails to disclose wherein the stopping mechanism comprises a coiled section of the elongated wire. However, Young discloses wherein the stopping mechanism comprises a coiled section of the elongated wire (Fig. 8C and Pg. 12, ln 30-32, midsection 3 may formed into a coil).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yoshizaki, in view of Keating, to incorporate the disclosures of Young and modify the stopping mechanism to comprise a coiled section of the elongated wire. Doing so would provide the bend/stopping mechanism as a shape/morphology which inhibits further insertion of the guidewire into the patient due to contact with a portion of the patient, such as their skin (Young. Pg. 12, ln 16-22).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Yoshizaki (US 20090105724), in view of Keating (US 20230069826), as applied to claim 6 above, and further in view of Beeckler et al. (US 20200206464), hereinafter Beeckler.
Regarding claim 8, Yoshizaki, in view of Keating, discloses the guidewire of claim 6.
Yoshizaki, in view of Keating, fails to disclose wherein the bend radius is about 1 inch. However, Beeckler discloses wherein the bend radius is about 1 inch (Fig. 2-3 and [0043], the bend of proximal segment 60 may have a tight bend radius of approximately 1 inch).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yoshizaki, in view of Keating, to incorporate the disclosures of Beeckler and modify the bend radius to be about 1 inch. Doing so would provide the proximal segment a bend radius that is appropriate for the gentler traversal pathway it must navigate relative to the distal portion, while also aiding in allowing the distal portion to navigate to the target region with minimal whipping during operation (Beeckler, [0041-0043]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH D GRASMEDER whose telephone number is (571)272-0258. The examiner can normally be reached M-F 8 am-5 pm EST.
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783