DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Claim Objections
Claim 18 is objected to because of the following informalities:
line 1 should be amended to - A method of manufacturing [[a]] the guidewire of claim 1, the method comprising-.
line 4 should be amended to - inserting [[a]] the distal end of the core wire through the inner lumen of the elongated-. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: line 1 should be amended to - wherein when the one or more [[surface]] surfaces of the locking-. Appropriate correction is required.
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.
Claims 5-13 and 19-20 are 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.
Regarding claim 5:
The claim is unclear because of the limitations “the reference plane”, “the second width” and “the first width” in lines 8 and 10. These limitations are unclear because multiples of each limitations have been established in claims 1-5 and its unclear which one these limitations refer to. For the sake of examination, the office has assumed that these limitations refer to the same limitation established in claim 5. However, the applicant should amend the claims to clarify.
Claims 6-12 are rejected due to their dependence on claim 5.
Regarding claim 8:
The claim recites the limitation "the locking recess" in line 2. There is insufficient antecedent basis for this limitation in the claim. First and second locking recesses have been established in the claims but not “the locking recess”.
Claims 9-12 are rejected due to their dependence on claim 8.
Regarding claim 10:
The claim is unclear because of the limitation “the reference plane” in line 6. This limitation is unclear because multiples this limitation have been established in claims 1-10 and it’s unclear which one this limitation refers to. For the sake of examination, the office has assumed that this limitations refers to the same limitation established in claim 5. However, the applicant should amend the claims to clarify.
Claims 11-12 are rejected due to their dependence on claim 9.
Regarding claim 13:
The claim recites the limitation "the locking recess" in line 2. There is insufficient antecedent basis for this limitation in the claim. First and second locking recesses have been established in the claims but not “the locking recess”. The applicant should consider the other limitations of “the locking recess” in the claim when amending the claim.
Regarding claim 19:
The claim recites the limitation "the one or more surfaces" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 is rejected due to its dependence on claim 19.
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.
Claims 1-3 and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20060271202 A1 to Ward.
Ward discloses:
Regarding claim 1:
A guidewire (figures 5 and 6b-6e) comprising:
a core wire (140a) defining a longitudinal axis (along 140a as shown in figure 6b);
an elongated member (110a) extending along the longitudinal axis (as shown in figure 6b), the elongated member (110a) defining:
an inner surface (see the inner surface A in figure 1 below) defining an inner lumen (see the inner lumen as shown in figure 6b for receiving 120a), wherein a distal section (see end of 140a) of the core wire (140a) is positioned within the inner lumen (as shown in figure 6b),
a plurality of openings (111a) disposed along a portion of the elongated member (110a), each opening of the plurality of openings (111a) extending from an outer surface (outer surface of 110a) of the elongated member (110a) towards the inner surface (A in figure 1 below) of the elongated member (110a) (as shown in figure 5),
a first locking recess (see recess B in figure 1 below of 134a) distal to the plurality of openings (111a) (as shown in figure 5), the first locking recess (B in figure 1 below) extending through the elongated member (110a) from a first location on the outer surface of the elongated member (110a) to the inner lumen (see figure 6b which shows recesses A and B in figure 1 below (of 134) extending form the outer surface to the inner surface of the elongated member 110a),
a second locking recess (see recess C in figure 1 below of 134a) distal to the plurality of openings (111a) (as shown in figure 5), the second locking recess (C in figure 1 below) extending from the inner surface (A in figure 1 below) of the elongated member (110a) towards a second location on the outer surface of the elongated member (110a) (as shown in figure 1 below where it extends form the outer surface of 110a to a different location on the inner surface of 110a), wherein the second location is different from the first location (as shown in figure 1 below), and wherein the first locking recess (B in figure 1 below) and the second locking recess (C in figure 1 below) defines a locking channel (as shown in figure 1 below a straight lines is formed between B and C for the locking element 126a to engage with) extending from the first location (as shown in figure 1 below); and
a locking element (126a) disposed within the locking channel and the inner lumen (as shown in figure 6b) and affixed to the elongated member (110a) (held in place after assembly as shown in figures 6c-6e), the locking element (126a) defining an aperture (129a), wherein a distal end (end of 140a) of the core wire (140a) extends through the aperture (129a) (as shown in figure 6b),
wherein the locking element (126a) is configured to inhibit unintended proximal movement of the core wire (140a) along the longitudinal axis relative to the elongated member (110a) (¶0039 the 110 and 126 can only be moved along the guide wire 140a when forced and otherwise doesn’t move in an unintended fashion).
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Figure 1 – figure 6b of Ward, annotated by the examiner
Regarding claim 2:
The guidewire of claim 1, wherein the second locking recess (C in figure 1 above) extends through the elongated member (110a) from the inner surface (A in figure 1 above) of the elongated member (110a) to the second location (as shown in figure 1 above).
Regarding claim 3:
The guidewire of claim 2, wherein the first locking recess (see recess B in figure 1 above) is defined by a plurality of sidewalls (the side wall that defines 134a and the inner and outer walls of 110), wherein one or more sidewalls of the plurality of sidewalls (the cylindrical side wall of 134 interfaces with the side wall of 132 as shown in figure 6b) is configured to interface with a corresponding surface of the locking element (126a).
Regarding claim 16:
The guidewire of claim 1, further comprising a distal tip (117a) affixed to a distal end of the elongated member (110a)(as shown in figure 6b) and to the distal end of the core wire (140a)(as shown in figure 6b), wherein the distal tip is configured to inhibit unintended movement of the elongated member (110a) relative to the core wire (140a)(aids in holding the elongated member 110a).
Regarding claim 17:
The guidewire of claim 16, wherein the distal tip (117a) is affixed to the locking element (126a)(as shown in figure 6b), wherein the distal tip is configured to inhibit unintended movement between the elongated member (110a), the core wire (140a), and the locking element (126a) (¶0039 the 110 and 126 can only be moved along the guide wire 140a when forced and otherwise doesn’t move in an unintended fashion).
Regarding claim 18:
A method of manufacturing a guidewire of claim 1, the method comprising:
inserting the locking element (126a) into the locking channel on the elongated member (110a) via the first locking recess (B in figure 1 above)(as shown in figure 6b; also as indicated in ¶0083) ;
inserting a distal end of the core wire (140a) through the inner lumen of the elongated member (110a) and the aperture (129a) of the locking element (126a)(as mentioned in ¶0083 where the wire 140a is inserted into 120a);
affixing the distal end of the core wire (140a) to the locking element (126a) (as shown in figure 6b), wherein when the distal end of the core wire (140a) is affixed to the locking element (126a)(as shown in figure 6b), the locking element (126a) inhibits unintended proximal movement of the distal end of the core wire (140a) along the longitudinal axis relative to the elongated member (110a) (¶0039 the 110 and 126 can only be moved along the guide wire 140a when forced and otherwise doesn’t move in an unintended fashion); and
forming a distal tip (117a) of the guidewire around the distal end of the core wire (140a) and a distal end of the elongated member (110a), wherein the distal tip of the guidewire is configured to inhibit unintended movement of the core wire (140a) relative to the elongated member (110a)(aid in holding the elongated member 110a to the guide member 140a and only moves when the user pushes it along 140a as indicated in ¶0039).
Regarding claim 19:
The method of claim 18, wherein inserting the locking element (126a) into the locking channel comprises:
inserting the locking element (126a) into the locking channel until the one or more surfaces of the locking element (126a) interface with one or more sidewalls (as shown in figure 6b where the side walls and 132a and 134 interface) of the elongated member (110a) defining the first locking recess (B in figure 1 above) to inhibit unintended movement of the locking element (126a) along through the locking channel and towards the second locking recess (C in figure 1 above)(as shown in figure 6b).
Regarding claim 20:
The method of claim 19, wherein when the one or more surface of the locking element (126a) interfaces with the one or more sidewalls of the elongated member (110a)(as shown in figure 6b), the aperture (129a) of the locking element (126a) is positioned within the inner lumen (see the inner lumen as shown in figure 6b for receiving 120a) of the elongated member (110a) such that the longitudinal axis of the elongated member (110a) extends through the aperture (129a)(as shown in figure 6b).
Allowable Subject Matter
Claims 4 and 14-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 5-13 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
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