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 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 12-14 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 12:
The limitations “spring”, “first segment”, “second segment”, “metal ring” and “distal end” in lines 3, 4, 5, 6 and 8 respectively of the claim are unclear. The limitations are unclear because these structures have already been established in claim 1 (on which this claim depends) raising a question of if multiples of these structures are required by claim 12 or if they refer to the same structure. For the sake of examination, the office has assumed that they refer to the same structure however the applicant should amend the claim to clarify.
Claims 13-14 are rejected due to their dependence on claim 12.
Regarding claim 14:
The limitations “proximal section” and “distal section ” in line2 of the claim are unclear. The limitations are unclear because these structures have already been established in claim 1 (on which this claim depends) raising a question of if multiples of these structures are required by claim 14 or if they refer to the same structure. For the sake of examination, the office has assumed that they refer to the same structure however the applicant should amend the claim to clarify.
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 1-5, 8, 9 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 7182735 B2 to Shireman et al. (Shireman).
Shireman discloses:
Regarding claim 1:
A delivery guidewire (figure 11), comprising:
a core wire (312) comprising, arranged in sequence, a first segment (see first segment A in figure 1 below), a second segment (see second segment B in figure 1 below) and a third segment (see third segment C in figure 1 below), wherein diameters of the first (A in figure 1 below), second (B in figure 1 below) and third (C in figure 1 below) segments gradually increase from a distal end (see the distal end D in figure 1 below) to a proximal end (see the proximal end E in figure 1 below) thereof (see the how the diameters increase from D to E in figure 1 below);
a metal ring (see the soldered ring 393 in figure 1 below described as an attachment member and solder in column 19, line 23- column 20, line 10) at least partially disposed at a proximal end (see the proximal portion F in figure 1 below) of the first segment (A in figure 1 below); and
a spring (390) at least partially sleeved over an outer side of the second segment (B in figure 1 below), wherein the spring (390) has a distal end (end of the spring 390 proximal to 383) abutting against a proximal end (see the proximal end of 393 covering and connecting 390 and 380) of the metal ring (393), and wherein an outer diameter (see the outer diameter of 390 at location 383) of a distal section (see the section of the spring 390 near 393) of the spring (390) is smaller than an outer diameter (the diameter of 390 near 393 is less than the diameter of 390 near C in figure 1 below) of a proximal section (section of the spring 390 near C in figure 1 below) of the spring (390).
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Figure 1 – fig. 11 of Shireman, annotated by the examiner
Regarding claim 2:
The delivery guidewire of claim 1, wherein the distal section (see the section of the spring 390 near 393) of the spring has an inner diameter that is 0.01 -0.03 mm greater than a maximum outer diameter (the section of the spring 390 must have an inner diameter less than the maximum outer diameter of C (indicated as .015 inches in column 7, lines 10-27) but greater that the minimum diameter of section B (indicated as .005 inches in column 7, lines 10-27) and the section A can have a maximum diameter of .005 and a minimum of .001 indicating a possible range between 390 and section A as .014 to 0 inches (.3556 mm to 0 mm) which overlaps with the claimed range) of the first segment (see first segment A in figure 1 above).
Regarding claim 3:
The delivery guidewire of claim 1, wherein the metal ring (393) has a tapered proximal portion (see the tapered inner portion of 393 as shown in figure 11 that surrounds 393).
Regarding claim 4:
The delivery guidewire of claim 1, wherein the spring (390) has a varying- diameter section (see the varying diameter between D and C in figure 1 above) between the distal and proximal sections (see section near D in C in figure 1 above) thereof, wherein the varying- diameter section has a diameter gradually increasing from the distal section to the proximal section (see figure 1 above and how the diameter increases of spring 390).
Regarding claim 5:
The delivery guidewire of claim 4, wherein a proximal end (end near F in figure 1 above) of the metal ring (393) is provided with an opening (see the opening of 393 that receives 390), and wherein the distal section of the spring (390) is received in the opening (see figure 11 which shows 390 received in the opening of metal ring 393).
Regarding claim 9:
The delivery guidewire of claim 5, wherein a number of coil turns of the varying-diameter section of the spring (390) is greater than 3 (see the numbers of coils in the 393 which numbers 3+ as shown in figure 11).
Regarding claim 12:
A method of making the delivery guidewire of claim l, comprising:
providing a spring (390, see the provided spring 390 in figure 11);
inserting a first segment (A in figure 1 above) of the core wire (312) through at least part of the spring (390)(as shown in figure 1 above) and sleeving the at least part of the spring (390) over a second segment (B in figure 1 above) of the core wire (312)(also shown in figure 1 above with 390 surrounding B); and
providing a metal ring (393), and inserting (as shown in figure 1 above) the first segment (A in figure 1 above) through at least part of the metal ring (393) and sleeving the at least part of the metal ring (393) over a proximal end (see proximal portion F in figure 1 above) of the first segment (A in figure 1 above), so that a proximal end face (end of the ring 393 abuts a distal end of 390 near F as shown in figure 1 above) of the metal ring (393) abuts against a distal end (distal end of 390 near point F in figure 1 above) of the spring (390).
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) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 7182735 B2 to Shireman et al. (Shireman).
Regarding claim 10:
Shireman fails to disclose:
The delivery guidewire of claim 5, wherein a number of coil turns of the varying-diameter section of the spring is smaller than 1.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shireman to modify the varying diameter section of the spring to smaller than 1 coil turn as a matter of design choice. The number of coils in the varying diameter section is dependent on the attachment section/soldering joint and the size of the joint and the required strength of the joint. The less coils in the attachment section/varying diameter section results in a weaker bond that may be acceptable depending on how the guide wire is used. Further, it appears that applicant places no criticality on the range of coil turns as claimed, indicating simply that the number of turns “may” be within the claimed ranges.
Regarding claim 11:
Shireman fails to disclose:
The delivery guidewire of claim 10, wherein the number of coil turns of the varying-diameter section of the spring is smaller than 3/4 of a complete coil turn, wherein a detachment strength of the spring, the metal ring and the core wire ranges from 9Nto 10.4N.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shireman to modify the varying diameter section of the spring to smaller than less than 3/4 coil turn as a matter of design choice. The number of coils in the varying diameter section is dependent on the attachment section/soldering joint and the size of the joint and the required strength of the joint. The less coils in the attachment section/varying diameter section results in a weaker bond that may be acceptable depending on how the guide wire is used. Further, it appears that applicant places no criticality on the range of coil turns as claimed, indicating simply that the number of turns “may” be within the claimed ranges. The number of turns and size of attachment section/metal ring also determine the detachment strength and therefore making it a design choice as well.
Allowable Subject Matter
Claims 6-8 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 13-14 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-20030225418-A1
Esksuri
See the ring 32
US-5640970-A
Arenas
See ring 41
US-5135503-A
Abrams
See ring 23
US-5042985-A
Elliott
See ring 25
US-5762615-A
Weier
See ring 50
US-5749837-A
Palermo
See ring 128
US-5345945-A
Hodgson
See ring 44
CN-104623790-A
ZHANG
See ring 3
CN-210990521-U
PENG
See ring 105
CN-211156010-U
PENG
See ring 161
JP-2016221246-A
TERASHI
See ring 5D
WO-2017149843-A1
FUJIKI
See ring 43
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