DETAILED ACTION
Claims 1-4 are hereby under examination.
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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/11/2023, 10/30/2024, 05/27/2025, and 08/21/2025 are being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: R1 and R2 as referenced in para. [0025] and para. [0030] are not included in the drawings. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As to claim 2, it is not clear whether the “a distal end side” in lines 2 and 4 of the claim refers to the same distal end side referred to in claim 1 or if this is a different distal end side. Are there multiple distal end sides?
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller et al. (US 4917102 A) (cited in the IDS filed 05/27/2025), hereinafter referred to as Miller.
The claims are generally directed towards a guide wire comprising: a core shaft extending along a central axis, 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, in a cross section of the core shaft cut along a plane including 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, and a cross-sectional area of the curve inner portion is smaller than a cross-sectional area of the curve outer portion.
Regarding claim 1, Miller discloses a guide wire (Abstract, “guidewire assembly”, Fig. 3) comprising:
a core shaft extending along a central axis (Figs. 2-4, element 33, “fixed core”, - element 33 extends along a central axis as shown in Figs. 2-4), and including a distal end portion that is curved in a predetermined direction (Fig. 3, Fig. 4, element 42, “most distal curved section”, col. 4, lines 4-10, “moveable core is extended axially in the proximal direction, the fixed core assumes its preshaped state …”);
a tubular body covering an outer periphery of the core shaft (Figs. 2-4, element 30, “outer tubular member”, col. 3, lines 17-30, “inner core member 33 which is fixed within the interior of the outer tubular member 30”); and
a distal tip joining the distal end portion of the core shaft and a distal end portion of the tubular body (Figs. 2-4, element 35, “plug”, col. 3, lines 31-55, “outer tubular member … comprises a helical coil extending proximally from plug 35 at the distal tip … fixed core is secured by its distal tip to plug 35 …”), wherein
the distal tip has a convex shape oriented toward a distal end side (Figs. 2-4, element 35 - element 35 is convex),
in a cross section of the core shaft cut along a plane including the central axis (See Annotated Fig. 3 below - the cross section cut along a plane including the central axis of the core shaft being the dashed line through the tip of element 33 connected to element 35), 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. 3 below - Element A being a curve inner portion), 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. 3 below - Element B being 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 - the cross-sectional area of Element A is smaller than the cross-sectional area of Element B).
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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.
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 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (US 4917102 A) (cited in the IDS filed 05/27/2025), hereinafter referred to as Miller as applied to claim 1 above, and further in view of Lupton et al. (US 20160331943 A1) (cited in the IDS filed 12/11/2023), hereinafter referred to as Lupton.
Regarding claim 2, Miller discloses the guide wire according to claim 1, wherein: an outer shape of the curve inner portion on a distal end side includes a first arcuate portion having a first curvature (See Annotated Fig. 3 above - Element A has a first arcuate portion with a first curvature); and an outer shape of the curve outer portion on a distal end side includes a second arcuate portion having a second curvature (See Annotated Fig. 3 above - Element B has a second arcuate portion with a second curvature).
However, Miller does not explicitly disclose the first curvature being smaller than the second curvature.
Lupton teaches an analogous guide ware (Abstract). Lupton further teaches the distal tip of the guide wire includes an inner portion with a first curvature being smaller than an outer portion with a second curvature (Fig. 22, Fig. 23, elements 18 and 21, para. [0142]). 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 curvatures of the first curvature and the second curvature to explicitly have the first curvature be smaller than the second curvature, as taught by Lupton. This is because Lupton teaches different shapes of the distal tip allows for ease of penetration of a vascular occlusion (para. [0072]).
Additionally, Lupton clearly teaches that variability of the dimensions and dimensional relationships of the components, which suggests that the dimensions can be optimized based on manufacturing, design, and use applications. As such, the dimensions and dimensional relationships of the components are results-effective variables that would have been optimized through routine experimentation based on the manufacturing, design, and use applications. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to select the dimensions and dimensional relationships of the components, using the teachings of Lupton as a starting point, so as to obtain the desired manufacturing, design, and use applications.
Regarding claim 3, Miller discloses the guide wire according to claim 1.
However, Miller 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.
Lupton teaches an analogous guide ware (Abstract). Lupton further teaches a distal tip of a guide wire includes a distal portion provided in a curve outer portion and being a longest distance from a distal end of the tubular body relative to a remainer of the distal tip so as to have a longest projection length relative to the remainder of the distal tip (Fig. 22, element 21, para. [0140]); 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 (Fig. 22, element 18, para. [0140]), and a projection length of the distal tip becomes shorter from the distal portion toward the proximal portion (Fig. 22, elements 18 and 21, para. [0140]). 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 portion to explicitly have two projection lengths such that the distal tip becomes shorter from the distal portion toward the proximal portion, as taught by Lupton. This is because This is because Lupton teaches different shapes of the distal tip allows for ease of penetration of a vascular occlusion (para. [0072]).
Additionally, Lupton clearly teaches that variability of the dimensions and dimensional relationships of the components, which suggests that the dimensions can be optimized based on manufacturing, design, and use applications. As such, the dimensions and dimensional relationships of the components are results-effective variables that would have been optimized through routine experimentation based on the manufacturing, design, and use applications. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to select the dimensions and dimensional relationships of the components, using the teachings of Lupton as a starting point, so as to obtain the desired manufacturing, design, and use applications.
Regarding claim 4, modified Miller discloses the guide wire according to claim 3.
However, modified Miller 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.
Lupton 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 (Fig. 22, element 8, para. [0140]). 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 to additionally include 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, as taught by Lupton. This is because Lupton teaches different shapes of the distal tip allows for ease of penetration of a vascular occlusion (para. [0072]).
Additionally, Lupton clearly teaches that variability of the dimensions and dimensional relationships of the components, which suggests that the dimensions can be optimized based on manufacturing, design, and use applications. As such, the dimensions and dimensional relationships of the components are results-effective variables that would have been optimized through routine experimentation based on the manufacturing, design, and use applications. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to select the dimensions and dimensional relationships of the components, using the teachings of Lupton as a starting point, so as to obtain the desired manufacturing, design, and use applications.
Conclusion
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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/K.W.K./Examiner, Art Unit 3791
/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791