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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/28/2026 has been entered.
Status of Claims
Applicant's arguments, filed 08/28/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 08/28/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claim 1.
Applicants have left claims 2-4 as originally filed/previously presented.
Claims 1-4 are the current claims hereby under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/12/2026 is being considered by the examiner.
Claim Objections - Withdrawn
Response to Arguments
Applicant’s arguments, see pages 4-5 of Remarks, filed 08/28/2026, with respect to the objections of claim 3 regarding “a distal end” have been fully considered and are persuasive. The objections of claim 3 have been withdrawn.
Claim Rejections - 35 USC § 103 - Withdrawn and Newly Applied Necessitated by Applicant’s Amendments
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Lupton et al. (US 20160331943 A1) (previously cited), hereinafter referred to as Lupton, in view of Terashi et al. (US 20180036515 A1), hereinafter referred to as Terashi.
The claims are generally directed towards guide wire comprising: a core shaft coinciding with a central axis of the guide wire, and including a distal end portion that is curved in a predetermined direction; a tubular body covering an outer periphery of the core shaft; and a distal tip joining the distal end portion of the core shaft and a distal end portion of the tubular body, wherein the distal tip has a convex shape oriented toward a distal end side of the guide wire, in a cross section of the core shaft cut along a plane extending along the central axis, the distal tip includes: a curve inner portion located on an inside of a curve of the distal end portion relative to the central axis, and a curve outer portion located on an outside of the curve of the distal end portion relative to the central axis, a cross-sectional area of the curve inner portion is smaller than a cross-sectional area of the curve outer portion, and the distal tip has a hemispherical shape that has been shaved on one side to form the curve inner portion.
Regarding claim 1, Lupton discloses a guide wire (Abstract, Fig. 6, para. [0116], “guide wire”) comprising:
a core shaft coinciding with a central axis of the guide wire (Fig. 6, element 5, “core wire”, para. [0116]), and including a distal end portion that is curved in a predetermined direction (Fig. 10, para. [0123], “core wire may be curved …”);
a tubular body covering an outer periphery of the core shaft (Fig. 6, element 10, para. [0116], “sleeve … over the core wire …”); and
a distal tip joining the distal end portion of the core shaft and a distal end portion of the tubular body (Fig. 6, element 7, para. [0116], “terminal member … secured to the core wire at its distal end …”), wherein
the distal tip has a convex shape oriented toward a distal end side of the guide wire (Fig. 6, para. [0117], “leading edge portion is radiused … radius r of the convex surface of the leading edge portion …”),
in a cross section of the core shaft cut along a plane extending along the central axis, the distal tip includes:
a curve inner portion located on an inside of a curve of the distal end portion relative to the central axis (see annotated Fig. 6 below - “a curve inner portion” being the indicated portion of the distal tip in relation to the predetermined curve of Fig. 10), and
a curve outer portion located on an outside of the curve of the distal end portion relative to the central axis (see annotated Fig. 6 below - “a curve outer portion” being the indicated portion of the distal tip in relation to the predetermined curve of Fig. 10).
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Lupton teaches the distal tip can have numerous different shapes and dimensions, including an inner portion and an outer portion having different shapes and dimensions (Fig. 6-36) to penetrate an occlusion in a vessel of the vascular system (para. [0116]).
However, Lupton does not explicitly disclose a cross-sectional area of the curve inner portion is smaller than a cross-sectional area of the curve outer portion, and the distal tip has a hemispherical shape that has been shaved on one side to form the curve inner portion.
Terashi teaches an analogous guide wire (Abstract, Fig. 3) comprising: a core shaft coinciding with a central axis of the guide wire (para. [0050-0051]), a tubular body covering an outer periphery of the core shaft (para. [0050-0051]); and a distal tip joining the distal end portion of the core shaft and a distal end portion of the tubular body (Fig. 3, element 4A, para. [0051]). Terashi further teaches the distal tip includes a curve inner portion and a curve outer portion and a cross-sectional area of the curve inner portion is smaller than a cross-sectional area of the curve outer portion (See annotated Fig. 3 below. A cross-sectional area of the inner portion of element 4a is smaller than a cross-sectional area of the outer portion of element 4a). Terashi further teaches the distal tip has a hemispherical shape that has been shaved on one side to form the curve inner portion (See annotated Fig. 3 below. The distal tip (element 4a) has a hemispherical shape, with “shaved” flat side on the top of the curve inner portion).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal tip and curve inner portion and curve outer portion disclosed by Lupton to explicitly include a distal tip such that a cross-sectional area of the curve inner portion is smaller than a cross-sectional area of the curve outer portion, and the distal tip has a hemispherical shape that has been shaved on one side to form the curve inner portion, as taught by Terashi. This is because Terashi teaches a distal tip with different cross-sectional areas of the curve inner and curve outer portions, in combination with a shaved side, improves the distal tip for treating a completely occluded lesion and improves patient safety (para. [0066], para. [0085]).
Regarding claim 2, modified Lupton discloses the guide wire according to claim 1.
However, modified Lupton does not explicitly disclose an outer shape of the curve inner portion on the distal end side includes a first arcuate portion having a first curvature; and an outer shape of the curve outer portion on the distal end side includes a second arcuate portion having a second curvature, the first curvature being smaller than the second curvature.
Terashi further teaches an outer shape of the curve inner portion on the distal end side includes a first arcuate portion having a first curvature; and an outer shape of the curve outer portion on the distal end side includes a second arcuate portion having a second curvature, the first curvature being smaller than the second curvature (See annotated Fig. 3 below. The curve inner portion is curved and has a first arcuate portion having a first curvature. The curve outer portion is curved and has a second arcuate portion having a second curvature. The first curvature is smaller than the second curvature. A larger radiused circle (e.g., the curve inner portion) has a lower (smaller) curvature in comparison to a smaller radiused circle (e.g., the curve outer portion) which has a higher (larger) curvature).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal tip taught by modified Lupton to additionally include an outer shape of the curve inner portion on the distal end side includes a first arcuate portion having a first curvature; and an outer shape of the curve outer portion on the distal end side includes a second arcuate portion having a second curvature, the first curvature being smaller than the second curvature, as taught by Terashi. This is because Terashi teaches a distal tip with different curvatures improves the distal tip for treating a completely occluded lesion and improves patient safety by easily capturing the entrance of a blood vessel (para. [0066], para. [0085]).
Regarding claim 3, modified Lupton discloses the guide wire according to claim 1.
However, modified Lupton does not explicitly disclose wherein: the distal tip includes: a distal portion provided in the curve outer portion and being a longest distance from a distal end of the tubular body relative to a remainder of the distal tip so as to have a longest projection length relative to the remainder of the distal tip; and a proximal portion provided in the curve inner portion and being a shorter distance from the distal end of the tubular body than the distal portion so as to have a shorter projection length than that of the distal portion, and a projection length of the distal tip becomes shorter from the distal portion toward the proximal portion.
Terashi further teaches the distal tip includes: a distal portion provided in the curve outer portion and being a longest distance from a distal end of the tubular body relative to a remainder of the distal tip so as to have a longest projection length relative to the remainder of the distal tip; and a proximal portion provided in the curve inner portion and being a shorter distance from the distal end of the tubular body than the distal portion so as to have a shorter projection length than that of the distal portion, and a projection length of the distal tip becomes shorter from the distal portion toward the proximal portion (See annotated Fig. 3 below. The curve outer portion includes a distal portion, being the longest distance from where element 4A starts, and the curve inner portion includes a proximal portion, being the shortest distance from where element 4A starts. The distal tip (Fig. 4A) is slanted, such that the distal tip becomes shorter from the distal portion to the proximal portion).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal tip taught by modified Lupton to explicitly include a distal portion provided in the curve outer portion and being a longest distance from a distal end of the tubular body relative to a remainder of the distal tip so as to have a longest projection length relative to the remainder of the distal tip; and a proximal portion provided in the curve inner portion and being a shorter distance from the distal end of the tubular body than the distal portion so as to have a shorter projection length than that of the distal portion, and a projection length of the distal tip becomes shorter from the distal portion toward the proximal portion, as taught by Terashi. This is because Terashi teaches a distal tip with different curvatures and with different lengths of inner and outer portions improves the distal tip for treating a completely occluded lesion and improves patient safety by easily capturing the entrance of a blood vessel (para. [0066], para. [0085]).
Regarding claim 4, modified Lupton discloses the guide wire according to claim 3.
However, modified Lupton does not explicitly disclose wherein: the distal tip includes a flat portion, and the flat portion extends from the curve inner portion to the curve outer portion so as to be inclined in a direction away from the tubular body.
Terashi further teaches the distal tip includes a flat portion, and the flat portion extends from the curve inner portion to the curve outer portion so as to be inclined in a direction away from the tubular body (See annotated Fig. 3 below. The distal tip element 4A includes a flat portion, for example, a tangent line on element 4a where the center axis of the guide wire is. The flat portion extends from the curve inner portion and the curve outer portion, and is inclined away from the tubular body).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal tip taught by modified Lupton to additionally include a flat portion, and have the flat portion extend from the curve inner portion to the curve outer portion so as to be inclined in a direction away from the tubular body, as taught by Terashi. This is because Terashi teaches a distal tip with an incline improves the distal tip for treating a completely occluded lesion and improves patient safety by easily capturing the entrance of a blood vessel (para. [0066], para. [0085])
Response to Arguments
Applicant’s arguments, see pages 5-7 of Remarks, filed 08/28/2026, with respect to the rejections of claims 1-4 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. Specifically, Applicants amendments and arguments regarding “the distal tip has a hemispherical shape that has been shaved on one side to form the curve inner portion” is considered persuasive. However, upon further consideration, a new ground of rejection is made in view of a different interpretation of Lupton and in view of Terashi et al. (US 20180036515 A1), hereinafter referred to as Terashi.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Maruyama Akihiro (JP 2020151068 A) - discloses a guide wire with a distal tip with a curve inner portion and a curve outer portion with different cross-sectional areas (Fig. 2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE W. KRETZER/Examiner, Art Unit 3791
