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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/15/2025, 03/06/2025, is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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(s) 1-3, 7-10, 12-16, is/are rejected under 35 U.S.C. 102 as being anticipated by Ewing (US 20090163891).
Regarding claim 1, Ewing discloses a system (FIG. 2) comprising:
a shaft (shaft 140) defining a void (core wire lumen 120; Space around the retractable core wire 170; FIG. 2; para [0135]) and having a length extending between a proximal end and a distal end; and
an elongated member (wire 170, guide wire 190; para [0033]) disposed within the void of the shaft and along at least a portion of the length of the shaft, wherein the elongated member is configured to define at least two regions (Portion containing wire would have one stiffness and other portion would have different stiffness; FIG. 2; Para [0004]), wherein the at least two regions each have a different stiffness, facilitating a variable stiffness along the length of the shaft (Retractable core wire is manipulated by the user to impart variable stiffness to the shaft as the core wire is retracted and extended within the lumen. Abstract; para [0032]).
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Regarding claim 2, Ewing discloses a wherein the void of the shaft includes one or more lumens (lumen 120; lumen 130; FIG. 5) along the length of the shaft.
Regarding claim 3, Ewing discloses a wherein the elongated member is disposed in one of the one or more lumens (Wires 170, guide wire 190; FIG. 5).
Regarding claim 7, Ewing discloses wherein the elongated member comprises a first wire and a second wire, the first wire being shorter than the second wire (wire 270, wire 290; FIGS. 15-16; para [0051]).
Regarding claim 8, Ewing discloses wherein the first wire and the second wire are disposed in a first region of the at least two regions and the second wire is disposed in a second region of the at least two regions (Wire 270, wire 290; FIGS. 15-16; lumens 230 and 220 provide two regions; para [0051]).
Regarding claim 9, Ewing discloses wherein the shaft defines a first zone, a second zone, and a third zone, and wherein the first region is disposed within the first zone, the second region is disposed within the second zone, and the third zone does not include any length of the first wire or the second wire (Lumens 220, 230 and 220; lumens 210 does not have wire; FIG. 15).
Regarding claim 10, Ewing discloses wherein the first wire has a first size cross-section and the second wire has a second size cross-section (Note the cross-sections in FIG. 16).
Regarding claim 12, Ewing discloses system comprising: a shaft defining a void and having a length extending between a proximal end and a distal end; and an elongated member disposed within the void of the shaft and along at least a portion of the length of the shaft, wherein the elongated member has a first diameter that tapers (Wire 170 tapers; FIG. 19B; ) to at least a second diameter along a length of the elongated member, facilitating a variable stiffness along the length of the shaft (Tapering wires provides two different diameters at the proximal end and distal end of the wire. FIG. 19B).
Regarding claim 13, Ewing discloses wherein the void of the shaft includes one or more lumens along the length of the shaft (Lumens 210, 220, 230; FIG. 16).
Regarding claim 14, Ewing discloses wherein the elongated member is disposed in one of the one or more lumens (FIG. 16).
Regarding claim 15, Ewing discloses wherein the elongated member comprises one or more wires (FIG. 16).
Regarding claim 16, Ewing discloses wherein the shaft defines a first zone, a second zone, and a third zone, and wherein the elongated member tapers along the length of the elongated member such that the first zone is stiffer than the second zone and the third zone (Three zones with different stiffness can be defined; FIG. 19B).
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.
Claim(s) 4-6, 11, is/are rejected under 35 U.S.C. 103 as being unpatentable over Ewing (US 20090163891) in view of Ishibe (US 5230348).
Regarding claim 4, Ewing does not expressly disclose wherein the elongated member comprises a wire that wraps back around at an end of the wire such that there are two lengths of wire within a first region of the at least two regions and one length of wire within a second region of the at least two regions.
Ishibe is directed to guide wire for a catheter (abstract) and teaches wherein the elongated member comprises a wire that wraps back around at an end of the wire (Core 2, two core wires, bends back at the distal end; FIG. 2) such that there are two lengths of wire within a first region (there are two lengths of wire within a first region) of the at least two regions and one length of wire within a second region of the at least two regions (FIG. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ewing to substitute core wire 2 of Ishibe for wires 170 of Ewing (replace wires 170 with core wire 2) so that the same wire can provide added difference in stiffness in the shaft length.
Regarding claim 5, Ewing as modified teaches wherein the shaft defines a first zone, a second zone, and a third zone, and wherein the first region of the wire is disposed within the first zone, the second region of the wire is disposed within the second zone (FIG. 2, annotated), and the third zone does not include any length of the wire (Ishibe: When core wire 2, FIG. 1, is disposed within the lumens of Ewing and by having lumen 110 empty.).
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Regarding claim 6, Ewing as modified teaches wherein the end of the wire that wraps back around is disposed at an angle from a longitudinal axis of the shaft (Ishibe: An angle is formed near the distal portion; FIGS. 1-2).
Regarding claim 11, Ewing as modified teaches wherein the first wire and the second wire each extend between a first end a second end, the first ends of the first wire and the second wire each defining an angle and the second ends of the first wire and the second wire each defining an end feature (Ishibe: When core wire 2 (two core wires) is disposed within the lumens of Ewing).
Claim(s) 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ewing (US 20090163891) in view of Ishibe (US 5230348).
Regarding claim 17, Ewing discloses a system (FIG. 2) comprising:
a shaft defining a void (lumen 210); and having a length extending between a proximal end and a distal end (FIGS. 2, 16).
Ewing does not expressly disclose a plurality of removable rods disposed within the void of the shaft, wherein a first portion of the plurality of removable rods are disposed at a length that is shorter than a second portion of the plurality of removable rods, facilitating a variable stiffness along the length of the shaft.
Ishibe is directed to a guide wire for a catheter (abstract) and teaches a plurality of removable rods (Core 2, FIG. 1, with different thickness at the distal portion and proximal portion) disposed within the void of the shaft, wherein a first portion of the plurality of removable rods are disposed at a length that is shorter than a second portion of the plurality of removable rods, facilitating a variable stiffness along the length of the shaft (When core 2 is inserted within the core wire lumen 210 of Ewing, first portion would have first stiffness and second portion would have second variable thickness. FIG. 3).
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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 Ewing to include a rod in the void in accordance with the teaching of Ishibe so that variable stiffness could be provided to the shaft by using a single rod.
Regarding claim 18, Ewing discloses wherein the void of the shaft includes one or more lumens along the length of the shaft (FIG. 5; lumens 110, 130, 120).
Regarding claim 19, Ewing as modified teaches wherein the plurality of removable rods are disposed in one of the one or more lumens (Ishibe: core wire 2; Ewing: wires 170, 190).
Regarding claim 20, Ewing as modified teaches wherein the shaft defines a first zone, a second zone, and a third zone (FIG. 2, annotated), and wherein the first portion and the second portion of the plurality of removable rods are disposed within the first zone (when the core 2 is inserted in the lumen 210), the second portion of the plurality of removable rods are disposed within the second zone (when the core 2 is inserted in the lumen 210), and the third zone of the shaft does not include any of the plurality of removable rods (As shown in FIG. 2, the third zone does not have any space for the rod to include.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO – 892. See Friedman (US 20210128877) for core wire portion 235 that extends and bends at the distal end (FIG. 3A).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANKAR R GHIMIRE whose telephone number is (571)272-0515. The examiner can normally be reached 8 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHANKAR RAJ GHIMIRE/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 6/18/26
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