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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 12, 2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on June 12, 2026. As directed by the amendment: no claims have been amended, claims 31-50 have been added, claims 1, 3-10, and 13-30 have been canceled. Thus claims 31-50 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see Remarks, filed June 12, 2026, with respect to the rejection(s) of prior claim(s) 1 and 25 under 35 U.S.C. 103 and 35 U.S.C. 102, respectively, have been fully considered and are persuasive. While these claims have been cancelled, applicant argues that the new independent claims 31, 43, 47, which include at least some of the limitations of the prior independent claims, have overcome the applied prior art of Yoshizaki and Keating, namely wherein the herein the bend has a bend angle of 45 degrees or greater and the bend has a bend radius of between about 0.75 inch and about 1.25 inch; and 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. However, upon further consideration, in light of the amendments, a new ground(s) of rejection is made below.
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 31-34 and 40-42 are rejected under 35 U.S.C. 103 as being unpatentable over Young (WO 2015015203), in view of Beeckler et al. (US 20200206464), hereinafter Beeckler.
Regarding claim 31, Young discloses a guidewire for preventing guidewire retention (Fig. 1 and pg. 10, ln 21-24, guidewire 100 for preventing guidewire retention) comprising: an elongated wire (Fig. 1, guidewire 100 is an elongated wire) comprising an insertion portion (Fig. 1 and 4, first portion 1) and an external portion (Fig. 1 and 4, second portion 5); and a stopping mechanism located along the external portion (Fig. 1 and 4, midsection 3, which is located on a portion of the second portion 5 that is adjacent to the first portion 1), the stopping mechanism configured to prevent the external portion from entering a blood vessel of a patient (Fig. 4 and Pg. 10, ln 5-24, midsection 3 is for preventing further insertion of the guidewire, such that the second portion 5 remains external to the body), wherein the stopping mechanism comprises a bend located entirely within the external portion (Figs. 4 and 8 and pg. 12, ln 31-pg. 13, ln 14, midsection 3 comprises a bend located entirely external to the body), wherein the bend has a bend angle of 45 degrees or greater (Figs. 4 and 8 and pg. 13, ln 1-14, bend angle of midsection 3 may be at least 90 degrees).
Young fails to disclose wherein the bend has a bend radius of between about 0.75 inch and about 1.25 inch. However, Beeckler discloses wherein the bend has a bend radius of between about 0.75 inch and about 1.25 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 Young to incorporate the disclosures of Beeckler and modify the bend to have a bend radius of between about 0.75 inch and about 1.25 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]).
Regarding claim 32, Young, in view of Beeckler, discloses the guidewire of claim 31, as explained above. As noted above, Young fails to disclose a bend radius between about 0.75 inch and about 1.25 inch, and is thus silent to wherein the bend radius is about 1 inch. However, Beeckler further 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 Young, in view of Beeckler, to further 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]).
Regarding claim 33 and Young, in view of Beeckler, Young further discloses the guidewire of claim 31, wherein the bend angle is 75 degrees or greater (Figs. 4 and 8 and pg. 13, ln 1-14, bend angle of midsection 3 may be at least 90 degrees).
Regarding claim 34 and Young, in view of Beeckler, Young further discloses the guidewire of claim 33, wherein the bend angle is 90 degrees or greater (Figs. 4 and 8 and pg. 13, ln 1-14, bend angle of midsection 3 may be at least 90 degrees).
Regarding claim 40 and Young, in view of Beeckler, Young further discloses the guidewire of claim 31, 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).
Regarding claim 41 and Young, in view of Beeckler, Young further discloses the guidewire of claim 31, wherein the elongated wire comprises stainless steel or nitinol (Pg. 9, ln 23-24, guidewire 100 has a core of Nitinol).
Regarding claim 42 and Young, in view of Beeckler, Young further discloses the guidewire of claim 31, a portion of the bend forming a part of the external portion (Fig. 1 and 4, midsection 3, which is located on a part of the second portion 5).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Young (WO 2015015203), in view of Beeckler (US 20200206464), as applied to claim 31 above, and further in view of Bown et al. (US 20080194994), hereinafter Bown.
Regarding claim 35, Young, in view of Beeckler, discloses the guidewire of claim 34.
Young, in view of Beeckler, fails to disclose wherein the bend angle is about 90 degrees. However, Bown discloses wherein the bend angle is about 90 degrees (Fig. 2 and 4 and [0031], proximal portion 3 may have a bend angle which is a right angle (90 degs.)).
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 Young, in view of Yoshizaki and Keating, to incorporate the disclosures of Bown and modify the bend angle to be about 90 degrees. Doing so would provide a bend angle which aids in preventing unintended advancement of the guidewire into the vasculature during use (Bown, [0022, 0031]). The examiner additionally notes that this bending angle is included in the preferred bending angle range (0-150 degrees) disclosed for the midsection 3 in Young (Young, Pg. 8, ln. 4-8).
Claims 36-39 are rejected under 35 U.S.C. 103 as being unpatentable over Young (WO 2015015203), in view of Beeckler (US 20200206464), as applied to claim 31 above, and further in view of Matsukuma et al. (CA 2757198), hereinafter Matsukuma.
Regarding claim 36, Young, in view of Beeckler, discloses the guidewire of claim 31.
Young, in view of Beeckler, fails to disclose wherein the bend angle is between one of the following ranges: about 45 degrees and about 60 degrees, about 60 degrees and about 75 degrees, about 75 degrees and about 90 degrees, about 90 degrees and about 105 degrees, and about 105 degrees and about 120 degrees. However, Matsukuma discloses wherein the bend angle is between one of the following ranges: about 45 degrees and about 60 degrees, about 60 degrees and about 75 degrees, about 75 degrees and about 90 degrees, about 90 degrees and about 105 degrees, and about 105 degrees and about 120 degrees (Fig. 1 and Table 1, guidewire curving angle 3 may be 45 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 Young, in view of Beeckler, to incorporate the disclosures of Matsukuma and modify the bend angle to be between one of the following ranges: about 45 degrees and about 60 degrees, about 60 degrees and about 75 degrees, about 75 degrees and about 90 degrees, about 90 degrees and about 105 degrees, and about 105 degrees and about 120 degrees. Doing so would provide the guidewire with an optimal bending angle for delivery of a catheter into a target region, such as the heart (Matsukuma, [0097-0098]). The examiner additionally notes that this bending angle is included in the preferred bending angle range (0-150 degrees) disclosed for the midsection 3 in Young (Young, Pg. 8, ln. 4-8).
Regarding claim 37, Young, in view of Beeckler and Matsukuma, discloses the guidewire of claim 36, as explained above. As noted above, Young and Beeckler do not disclose the bend angle between one of the above ranges, and are thus silent to wherein the bend angle is between one of the following ranges: about 45 degrees and about 60 degrees, and about 60 degrees and about 75 degrees. However, Matsukuma further discloses wherein the bend angle is between one of the following ranges: about 45 degrees and about 60 degrees, and about 60 degrees and about 75 degrees (Fig. 1 and Table 1, guidewire curving angle 3 may be 45 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 Young, in view of Beeckler and Matsukuma, to further incorporate the disclosures of Matsukuma and modify the bend angle to be between one of the following ranges: about 45 degrees and about 60 degrees, and about 60 degrees and about 75 degrees. Doing so would provide the guidewire with an optimal bending angle for delivery of a catheter into a target region, such as the heart (Matsukuma, [0097-0098]). The examiner additionally notes that this bending angle is included in the preferred bending angle range (0-150 degrees) disclosed for the midsection 3 in Young (Young, Pg. 8, ln. 4-8).
Regarding claim 38, Young, in view of Beeckler and Matsukuma, discloses the guidewire of claim 37, as explained above. As noted above, Young does not disclose the bend radius and is thus silent to 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 Young, in view of Beeckler and Matsukuma, to further incorporate the disclosures of Beeckler and modify the bend to have a bend radius of between about 0.75 inch and about 1.25 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]).
Regarding claim 39, Young, in view of Beeckler and Matsukuma, discloses the guidewire of claim 38, as explained above. As noted above, Young and Beeckler do not disclose the bend angle between one of the above ranges, and are thus silent to wherein the bend angle is between about 45 degrees and about 60 degrees. However, Matsukuma further discloses wherein the bend angle is between about 45 degrees and about 60 degrees (Fig. 1 and Table 1, guidewire curving angle 3 may be 45 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 Young, in view of Beeckler and Matsukuma, to further incorporate the disclosures of Matsukuma and modify the bend angle to be between about 45 degrees and about 60 degrees. Doing so would provide the guidewire with an optimal bending angle for delivery of a catheter into a target region, such as the heart (Matsukuma, [0097-0098]). The examiner additionally notes that this bending angle is included in the preferred bending angle range (0-150 degrees) disclosed for the midsection 3 in Young (Young, Pg. 8, ln. 4-8).
Claims 43-45 are rejected under 35 U.S.C. 103 as being unpatentable over Young (WO 2015015203), in view of Beeckler (US 20200206464), Yoshizaki et al. (US 20090105724), hereinafter Yoshizaki, and Keating et al. (US 20230069826), hereinafter Keating.
Regarding claim 43, Young discloses a guidewire for preventing guidewire retention (Fig. 1 and pg. 10, ln 21-24, guidewire 100 for preventing guidewire retention) comprising: an elongated wire (Fig. 1, guidewire 100 is an elongated wire) comprising an insertion portion (Fig. 1 and 4, first portion 1) and an external portion (Fig. 1 and 4 and Pg. 10, ln 5-24, second portion 5), wherein the external portion has a distal end (Fig. 4, distal end of second portion 5, which includes midsection 3; and a stopping mechanism comprising a bend (Fig. 1 and 4, midsection 3, which comprises at least one bend), wherein the bend defines an external distal end portion of said elongated wire (Fig. 4, midsection 3 defines the proximal end of an external distal end portion of guidewire 100) which has an external distal end portion length from the distal end of said elongated wire to the bend (Fig. 1-2 and Pg. 9, ln 16-32, midsection 3 has a length which extends from the distal end of second portion 2 to the proximal end of the bend in midsection 3), wherein the bend has a bend angle of 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).
Young fails to disclose wherein the bend has a bend radius of between about 0.75 inch and about 1.25 inch. However, Beeckler discloses wherein the bend has a bend radius of between about 0.75 inch and about 1.25 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 Young to incorporate the disclosures of Beeckler and modify the bend to have a bend radius of between about 0.75 inch and about 1.25 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]).
Young, in view of Beeckler, fails to disclose wherein the bend is configured such that a medical instrument to be passed over the bend from the distal end toward the insertion portion and into a patient. However, Yoshizaki discloses wherein the bend is configured such that a medical instrument to be passed over the bend from the distal end toward the insertion portion and into a patient (Fig. 1 and 3, [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).
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 Young, in view of Beeckler, to incorporate the disclosures of Yoshizaki and modify the bend to be configured such that a medical instrument to be passed over the bend from the distal end toward the insertion portion and into a patient. Doing so would allow the guidewire to function as a pre-shaped stylet for facilitating the insertion of the catheter (Yoshizaki, [0032]).
Young, in view of Beeckler and 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 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 the 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 Young, in view of Beeckler and Yoshizaki, to incorporate the disclosures of Keating and modify the guidewire such that 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 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 44, Young, in view of Beeckler, Yoshizaki, and Keating, discloses the guidewire of claim 43, as explained above. As noted above, Young fails to disclose a bend radius between about 0.75 inch and about 1.25 inch, and is thus silent to wherein the bend radius is about 1 inch. However, Beeckler further 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 Young, in view of Beeckler, Yoshizaki, and Keating, to further 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]).
Regarding claim 45, Young, in view of Beeckler, Yoshizaki, and Keating, discloses the guidewire of claim 43, as explained above. Young is silent to wherein the bend angle is between one of the following ranges: about 45 degrees and about 60 degrees, about 60 degrees and about 75 degrees, about 75 degrees and about 90 degrees, about 90 degrees and about 105 degrees, and about 105 degrees and about 120 degrees. However, Yoshizaki further discloses wherein the bend angle is between one of the following ranges: about 45 degrees and about 60 degrees, about 60 degrees and about 75 degrees, about 75 degrees and about 90 degrees, about 90 degrees and about 105 degrees (Fig. 1 and 3 and [0047], first curved portion 2 can be present at an angle of 100 degrees), and about 105 degrees and about 120 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 Young, in view of Beeckler, Yoshizaki, and Keating, to further incorporate the disclosures of Yoshizaki and modify the bend angle to be between one of the following ranges: about 45 degrees and about 60 degrees, about 60 degrees and about 75 degrees, about 75 degrees and about 90 degrees, about 90 degrees and about 105 degrees, and about 105 degrees and about 120 degrees. Doing so would allow the guidewire to function as a pre-shaped stylet for facilitating the insertion of the catheter and provide the guidewire bend to be at an angle that help aids the insertion of the internal portion of the guidewire into body without adding any torque of rotation at the proximal portion of the guidewire to deliver the distal tip accurately to the target location (Yoshizaki, [0032-0033]). The examiner additionally notes that this bending angle is included in the preferred bending angle range (0-150 degrees) disclosed for the midsection 3 in Young (Young, Pg. 8, ln. 4-8).
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Young (WO 2015015203), in view of Beeckler (US 20200206464), Yoshizaki (US 20090105724), and Keating (US 20230069826), as applied to claim 45 above, and further in view of Matsukuma (CA 2757198).
Regarding claim 46, Young, in view of Beeckler, Yoshizaki, and Keating, discloses the guidewire of claim 45.
Young, in view of Beeckler, Yoshizaki, and Keating, fails to disclose wherein the bend angle is between one of the following ranges: about 45 degrees and about 60 degrees, and about 60 degrees and about 75 degrees. However, Matsukuma discloses wherein the bend angle is between one of the following ranges: about 45 degrees and about 60 degrees, and about 60 degrees and about 75 degrees (Fig. 1 and Table 1, guidewire curving angle 3 may be 45 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 Young, in view of Beeckler, Yoshizaki, and Keating, to incorporate the disclosures of Matsukuma and modify the bend angle to be between one of the following ranges: about 45 degrees and about 60 degrees, and about 60 degrees and about 75 degrees. Doing so would provide the guidewire with an optimal bending angle for delivery of a catheter into a target region, such as the heart (Matsukuma, [0097-0098]). The examiner additionally notes that this bending angle is included in the preferred bending angle range (0-150 degrees) disclosed for the midsection 3 in Young (Young, Pg. 8, ln. 4-8).
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Young (WO 2015015203), in view of Yoshizaki (US 20090105724), and Keating (US 20230069826).
Regarding claim 47, Young discloses a guidewire for insertion of a medical instrument having a medical instrument length, into a patient (Fig. 1 and pg. 10, ln 21-24, guidewire 100 for preventing guidewire retention) comprising: an elongated wire (Fig. 1, guidewire 100 is an elongated wire) comprising a proximal end (Fig. 1, proximal end located at tip 7), a distal end (Fig. 1, distal end of second portion 5), an insertion portion at the proximal end (Fig. 1 and 4, first portion 1 at the proximal end) and an external portion at the distal end (Fig. 1 and 4, second portion 5 at distal end); and a bend located between the proximal end and the distal end, (Fig. 1 and 4, midsection 3 comprising a bend, which is located between the proximal and distal end), the bend configured to prevent the external portion from entering a patient (Fig. 4 and Pg. 10, ln 5-24, midsection 3 bend shape is for preventing further insertion of the guidewire, such that the second portion 5 remains external to the body), wherein the bend defines an external distal end portion of said elongated wire (Fig. 4, midsection 3 defines the external distal end portion of guidewire 100) which has an external distal end portion length from the distal end of said elongated wire to the bend (Fig. 1-2 and Pg. 9, ln 16-32, midsection 3 and second portion 5 provide a length which extends from the distal end of second portion 5 to the proximal end of the bend in midsection 3).
Young fails to disclose wherein the guidewire is configured to allow the medical instrument to be passed over the bend from the distal end toward the proximal end for insertion into the patient, 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. However, Yoshizaki discloses wherein the guidewire is configured to allow the medical instrument to be passed over the bend from the distal end toward the proximal end for insertion into the patient (Fig. 1 and 3, [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), 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 (Fig. 1 and 3, [0032-0033, 0035, 0047], Examiner notes that bend of first curve 2 may be similar to the bend of the midsection 3 of Young ([0047] first curve 2 may be at an angle of 100 degs., which is within the desired angle range of midsection 3 bend in Young Pg. 8, ln. 4-8), therefore the first curve 2 may provide a bend which both prevents an external portion from entering the body while also allowing the catheter to pass over the bend for facilitating insertion).
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 Young to incorporate the disclosures of Yoshizaki and modify the bend to be configured to allow the medical instrument to be passed over the bend from the distal end toward the proximal end for insertion into the patient, 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. Doing so would allow the guidewire to function as a pre-shaped stylet for facilitating the insertion of the catheter (Yoshizaki, [0032]).
Young, in view of 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 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 the 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 Young, in view of Yoshizaki, to incorporate the disclosures of Keating and modify the guidewire such that 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 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]).
Claims 48 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Young (WO 2015015203), in view of Yoshizaki (US 20090105724), and Keating (US 20230069826), as applied to claim 47 above, and further in view of Stack et al. (US 20220040471), hereinafter Stack.
Regarding claim 48 and Young, in view of Yoshizaki and Keating, Young further discloses the guidewire of claim 47, the bend comprising a single bend in the elongated wire (Pg. 13, ln 5-7, bend of midsection 3 may be u-shaped or v-shaped, thus being a single bend).
Young, in view of Yoshizaki and Keating, fails to disclose the bend having a bend radius of between about 0.75 inches and about 1.25 inches. However, Stack discloses wherein the bend has a bend radius of between about 0.75 inch and about 1.25 inch (Fig. 1B and [0054], proximal curve 214 has a curve radius within the range of 20-30 mm (~0.79-1.18 in)).
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 Young, in view of Yoshizaki and Keating, to incorporate the disclosures of Stack and modify the bend to have a bend radius of between about 0.75 inch and about 1.25 inch. Doing so would allow the proximal curve/bend to help position the distal portion of the device within the further portions of the body/vasculature to help position the distal tip of the device within close proximity to the target location (Stack, [0054]).
Regarding claim 50 and Young, in view of Yoshizaki and Keating, Young further discloses the guidewire of claim 48, a portion of the bend forming a part of the external portion (Fig. 1 and 4, midsection 3 is formed on a part of the second portion 5).
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Young (WO 2015015203), in view of Yoshizaki (US 20090105724), and Keating (US 20230069826), as applied to claim 47 above, and further in view of Bown (US 20080194994).
Regarding claim 49 and Young, in view of Yoshizaki and Keating, Young further discloses the guidewire of claim 47, the bend comprising a single bend in the elongated wire (Pg. 13, ln 5-7, bend of midsection 3 may be u-shaped or v-shaped, thus being a single bend).
Young, in view of Yoshizaki and Keating, fails to disclose the bend having a bend angle of between about 60 degrees and about 90 degrees. However, Bown discloses the bend having a bend angle of between about 60 degrees and about 90 degrees (Fig. 2 and 4 and [0031], proximal portion 3 may have a bend angle which is a right angle (90 degs.)).
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 Young, in view of Yoshizaki and Keating, to incorporate the disclosures of Bown and modify the bend angle to be between about 60 degrees and about 90 degrees. Doing so would provide a bend angle which aids in preventing unintended advancement of the guidewire into the vasculature during use (Bown, [0022, 0031]).
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BHISMA MEHTA can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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