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 .
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.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims are addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 1-4, 7-14, and 16-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fujiki (US 20180369542 A1).
For claim(s) 1, 8, and 14-15, Fujiki teaches
A guidewire, comprising:
a wire [2] that includes an outer surface that defines a diameter;
wherein the wire defines a recess [grooves / ridges of 71-72] extending into and helically around the wire
and a winding [5] that extends around a proximal region of the wire wherein the wire and the winding cooperate to define an undulating surface that extends along a length of the wire; [Fig(s). 1-6]
the winding configured to fit within the recess and extend helically around the wire at least four times to create at least three valleys where the outer surface of the wire is not covered by the winding [Fig(s). 3-4]
wherein peaks of the undulating surface are defined by the winding and valleys of the undulating surface are defined by the outer surface of the wire [Fig(s). 3-6]
wherein a middle portion and ends of the winding are within the helical recess of the wire. [Fig(s). 3-6]
For claim(s) 2 and 9, Fujiki teaches
a wrap [52] that covers outer peripheries of at least the winding and a portion of the wire not covered by the winding. [Fig(s). 2 with layer 52 in ¶55 covering at least some of 72 where some of 72 is also not directly overlaid by winding 5]
For claim(s) 3, 10, 11, and 17-18, Fujiki teaches
wherein the winding extends radially beyond the outer surface by at least 0.01 and 0.07 millimeters and a remainder is 0.05 mm in length. [¶30, ¶45]
For claim(s) 4, Fujiki teaches
wherein the wire includes a first wire and a second wire; [any two of 21-23]
wherein the first wire includes the outer surface that defines the diameter and the second wire includes an additional outer surface that defines an additional diameter that is smaller than the diameter; [tapering of 21-23 in Fig. 2]
and wherein the winding extends around the second wire and the peak of the undulating surface extends radially from the outer surface. [Figs. 3-4 in view of Fig. 2]
For claim(s) 7, 12, and 20, Fujiki teaches
wherein the winding has a cross-sectional shape including one or more of a circle, an ellipse, a square, a pentagon, a hexagon, and an octagon. [Figs. 3-4]
For claim(s) 13, Fujiki teaches
the winding includes a first coil and a second coil [4 and 5] , and a distance between the first coil and the second coil is sized to accommodate a finger of a user so that the finger of the user can feel the outer surface of the wire when the user is manipulating the guidewire. [e.g., a user could feel for member 43 when using the guidewire]
For claim(s) 21, Fujiki teaches
wherein the at least three valleys are each sized to accommodate a finger of a user so that the finger of the user can feel the outer surface of the wire when the user is manipulating the guidewire. [at features 42, 43, and 72]
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(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fujiki in view of Burkett (US 20160058382 A1).
For claim(s) 5 and 6 Fujiki fails to teach adjacent windings being between 0.5 and 20 mm apart.
Burkett teaches a guidewire [abstract] where adjacent coil windings are >1 mm apart. [¶61]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the coil(s) of Fukiji to incorporate the spacing of Burkett in order to improve handling of the guidewire. As motivated by Burkett ¶¶3-16.
Response to Arguments
Applicant's 11/21/25 arguments with respect to the cited art have been fully considered but they are not persuasive.
Applicant argues in remarks p. 8 that Fujiki fails to teach a winding held by the operator while the guidewire is inserted into a patient. However, such a feature encompasses an intended use which does not distinguish from the structural teachings of Fujiki. See MPEP § 2114.
Applicant argues in remarks p. 8-9 that Fujiki fails to teach amended claim(s) 2. Examiner respectfully disagrees. Consider at least element 72 in Fujiki Fig(s). 1-2 which has portions both covered and uncovered by coil 5.
Applicant’s arguments with respect to claim(s) 5 have been considered but are moot because the arguments do not apply to the new combination of references being used in the current rejection.
Applicant argues in remarks p. 9 that Fujiki fails to teach the winding extending around the wire four times to create at least three valleys. Examiner respectfully disagrees. Fujiki Fig(s). 3-4 clearly depict at least five windings forming at leas four valleys. Whether or not a portion of the grooves of Fujiki are at a distal end does not correspond to contradistinctive limitations in the claim.
Applicant argues in remarks p. 10 that Fujiki fails to teach a middle portion of the windings in a recess of the wire. Examiner respectfully disagrees. At least some turns of coil 5 in grooves 712 in Fujiki Fig(s). 3-4 can constitute, under BRI, a relative form of a ‘middle’ portion of the winding in a recess.
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).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN S MELHUS whose telephone number is (571)272-5342. The examiner can normally be reached Monday - Friday | 9:00 AM - 5:00 PM.
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/BENJAMIN S MELHUS/ Primary Examiner, Art Unit 3791
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