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 .
Election/Restrictions
Claims 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on August 17, 2026.
Applicant’s election without traverse of Invention I, claims 1-18 in the reply filed on August 17, 2026 is acknowledged.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Wulfman (US 20040230212).
Regarding claim 1, Wulfman discloses a medical device positionable in a biological lumen, the medical device comprising: an elongated outer tubular shaft (150) configured to be positioned in the biological lumen, the elongated outer tubular shaft having an inner surface surrounding an interior of the elongated outer tubular shaft; a rotatable elongated drive shaft (154) positioned in the interior of the elongated outer tubular shaft so that a distal portion of the elongated outer tubular shaft surrounds and axially overlaps at least a distal portion of the rotatable elongated drive shaft (figure 4), the rotatable elongated drive shaft being rotatable relative to the elongated outer tubular shaft, the rotatable elongated drive shaft having an outer surface; the elongated outer tubular shaft and the rotatable elongated drive shaft being configured so that during rotation of the rotatable elongated drive shaft relative to the elongated outer tubular shaft, the distal portion of the rotatable elongated drive shaft contacts the inner surface of the elongated outer tubular shaft (figure 4), a distal end covering portion (168, 162, 164, 172) located at and covering the distal portion of the rotatable elongated drive shaft (figure 4) , the distal end covering portion having an outer surface; the distal end covering portion including a proximal end portion terminating at a proximal end of the distal end covering portion, the distal end covering portion (162) also including a distal end portion terminating at a distal end of the distal end covering portion, the rotatable elongated drive shaft extending proximally beyond the proximal end of the distal end covering (figure 4). Wulfman further teaches it was known in the art at the time of the invention to make the distal end covering portions of various embodiments out of resin (PTFE, PFA) and the outer surface of the distal end covering portion made of resin reducing friction at a time of the contact of the rotatable elongated drive shaft with the elongated outer tubular shaft during rotation of the rotatable elongated drive shaft relative to the elongated outer tubular shaft (paragraph 0037, 0050) to allow the catheter to slide easily through the body path and create a highly flexible area. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the distal end covering portion of resin such that the outer surface of the distal end covering portion is made of resin to reduce friction at a time of the contact of the rotatable elongated drive shaft with the elongated outer tubular shaft, as taught as a known material by Wulfman, in order to allow the catheter to slide easily through the body path and create a highly flexible area at the distal end of the catheter.
Regarding claim 2, Wulfman teaches all of the limitations set forth in claim 1, further comprising a cutter (152) configured to cut an object located in the biological lumen, the cutter being connected to the rotatable elongated drive shaft so that rotation of the rotatable elongated drive shaft results in rotation of the cutter (figure 4).
Regarding claim 3, Wulfman teaches all of the limitations set forth in claim 1, wherein the rotatable elongated drive shaft (154) comprises one or more wires that are spirally wound so that the rotatable elongated drive shaft includes axially adjacent windings, the resin of the distal end covering portion being positioned between the axially adjacent windings (figure 4).
Regarding claim 4, Wulfman teaches all of the limitations set forth in claim 1, wherein the distal portion of the elongated outer tubular shaft that axially overlaps the distal portion of the rotatable elongated drive shaft is a curved portion (at reference numeral 168 or 166, slight bend in or curve, figure 4) of the elongated outer tubular shaft.
Regarding claim 5, Wulfman teaches all of the limitations set forth in claim 4, wherein the proximal end (162 is proximal of 166) of the distal end covering portion is proximal of the curved portion.
Regarding claim 6, Wulfman teaches all of the limitations set forth in claim 4, wherein the curved portion of the elongated outer tubular shaft includes a first curved portion and a second curved portion that are separated from one another in an axial direction of the elongated outer tubular shaft and are curved in opposite directions to each other.
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Regarding claim 7, Wulfman teaches all of the limitations set forth in claim 1, further comprising a coil (164) wound around the outer surface of the rotatable elongated drive shaft, the coil including a distal portion terminating at a distal end of the coil and a proximal portion terminating at a proximal end of the coil, the distal end of the coil being positioned proximal of the proximal end of the distal end covering portion that is made of the resin (figure 4).
Regarding claim 8, Wulfman teaches all of the limitations set forth in claim 1, wherein Wulfman teaches the rotatable elongated drive shaft comprises one or more wires that are spirally wound so that the rotatable elongated drive shaft includes axially adjacent windings; and placing the resin of the distal end covering portion between the axially adjacent windings; the resin of the distal end covering portion extends radially inwardly towards a central axis of the rotatable elongated drive shaft; and the resin of the proximal end portion of the distal end covering portion extending further radially inwardly towards the central axis of the rotatable elongated drive shaft than the resin of the distal end portion of the distal end covering portion (paragraph 0039, resin between gaps).
Regarding claim 9, Wulfman discloses a device comprising: an elongated drive shaft (154) having a longitudinally extending central axis and being rotatable around the central axis, the drive shaft having an outer surface and including a distal end portion; an elongated outer tubular shaft (182, 164, 166, 172) disposed outside the drive shaft; and the outer surface of the distal end of the elongated drive shaft being covered with a distal end covering portion made of resin. Wulfman further teaches it was known in the art at the time of the invention to make the distal end covering portions of various embodiments out of resin (PTFE, PFA) and the outer surface of the distal end covering portion made of resin reducing friction at a time of the contact of the rotatable elongated drive shaft with the elongated outer tubular shaft during rotation of the rotatable elongated drive shaft relative to the elongated outer tubular shaft (paragraph 0037, 0050) to allow the catheter to slide easily through the body path and create a highly flexible area. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the distal end covering portion of resin such that the outer surface of the distal end covering portion is made of resin to reduce friction at a time of the contact of the rotatable elongated drive shaft with the elongated outer tubular shaft, as taught as a known material by Wulfman, in order to allow the catheter to slide easily through the body path and create a highly flexible area at the distal end of the catheter.
Regarding claim 10, Wulfman teaches all of the limitations set forth in claim 9, wherein the drive shaft is a tubular body comprised of plural wires that are spirally wound around the central axis (154, loops, figure 4) so the drive shaft includes axially adjacent windings of the wires, and at least a part of the distal end covering portion being positioned between the axially adjacent windings of the wires (figure 4).
Regarding claim 11, Wulfman teaches all of the limitations set forth in claim 10, wherein the distal end covering portion (166) includes a proximal end and a distal end, and the proximal end of the distal end covering portion enters more deeply toward the central axis of the shaft than the distal end portion of the distal end covering portion (figure 4, proximal end curves inward).
Regarding claim 12, Wulfman teaches all of the limitations set forth in claim 11, wherein the distal end portion of the outer tubular shaft is a curved portion of the outer tubular shaft, and the proximal end of the distal end covering portion is located on a proximal end side from the curved portion (curved portion at 168, figure 4).
Regarding claim 13, Wulfman teaches all of the limitations set forth in claim 12, wherein the curved portion of the outer tubular shaft includes a first curved portion and a second curved portion that are separated from one another in an axial direction of the outer tubular shaft and are curved in opposite directions to each other (see image above).
Regarding claim 14, Wulfman teaches all of the limitations set forth in claim 12, wherein the distal end covering portion continuously enters the inside of the drive shaft from a position on a distal end side from the curved portion to a position on the proximal end side from the curved portion (resin fills in gaps between loops, paragraph 0039).
Regarding claim 15, Wulfman teaches all of the limitations set forth in claim 10, wherein Wulfman teaches the distal end covering portion extends radially inwardly towards the central axis of the drive shaft by a depth of more than 0 μm and 100 μm or less from an imaginary plane connecting surfaces farthest from the axis of the wires (thickness 0.002inch).
Regarding claim 1, Wulfman teaches all of the limitations set forth in claim 9, further comprising a coil wound spirally on an outer peripheral surface of the drive shaft so that axially adjacent windings are axially spaced apart from one another, and the proximal end of the distal end covering portion is distal of a distal end of the coil (154, loops, coil, figure 4).
Regarding claim 17, Wulfman teaches all of the limitations set forth in claim 9, wherein a protection tube (lumen of 154) into which a guide wire is inserted is disposed in the drive shaft (paragraph 0006, 0029, 0048).
Regarding claim 18, Wulfman teaches all of the limitations set forth in claim 17, wherein the protection tube is disposed so as not to rotate together with the drive shaft (paragraph 0058, multiple sheaths).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANH T DANG/ Primary Examiner, Art Unit 3771
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