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 .
Information Disclosure Statement
The information disclosure statements (IDS’) submitted are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 11-14, 16 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,904,117 in view of US 5345945 A to Hodgson et al. (cited in IDS and hereinafter, Hodgson).
Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,904,117. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims read identically with the exception of where Claim 11 recites that the radiopaque inner coil has “a length from 0.5 cm to 15.0 cm extending from the distal end to the proximal end.” U.S. Patent No. 11,904,117 already encompasses radiopaque inner coils of such lengths, and the length of the distal radiopaque coil is a result-effective carriable that is routinely selected by one of ordinary skill in the art to provide a desired visible length under fluoroscopy while maintaining desired flexibility. Varying the length of the inner radiopaque coil within the claimed range would have been an obvious matter of deign choice and does not render the claimed subject matter patentably distinct from Claim 1 of U.S. Patent No. 11,904,117.
Furthermore, while U.S. Patent No. 11,904,117 does not expressly disclose a length from 0.5 cm to 15.0 cm extending from the distal end to the proximal end, Hodgson teaches a same dual-coil architecture (inner radiopaque coil inside an outer coil, on a tapered core, FIG. 1) and teaches that the inner radiopaque coil has a length for 2-4 cm (col. 4, lines 59-65). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify U.S. Patent No. 11,904,117 with the inner coil length of 2-5 cm of Hodgson, as Hodgson teaches that controlled and/or greater flexibility (col. 4, lines 49-58).
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 11,904,117 as the claims are identical.
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11,904,117 as the claims are identical.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 11,904,117 as the claims are identical.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 11,904,117 as the claims are identical.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 11,904,117 as the claims are identical.
Claims 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,904,117 in view of US 5345945 A to Hodgson, in view of US 5984877 A to Fleischhacker, Jr. (hereinafter, Fleischhacker).
U.S. Patent No. 11,904,117 in view of Hodgson teach the claimed invention except for expressly disclosing where the inner coil is formed from a multifilar coil of wire wherein spacing between each filar is 25% of a diameter of each filar. However, Fleischhacker teaches a miltifilar coil guidewire where at least one strand is radiopaque and the remaining strands are non-radiopaque, and further teaches that the pitch/closeness of the windings is varied to control both radiopacity and flexibility of the distal portion, including using more open pitch to enhance flexibility (col. 2, lines 24-30). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the pitch of the inner coil to be 25% of a diameter of each filar as Fleischhacker teaches at col. 8, lines 26-39 that this would have improved or enhanced radiographic visualization so guidewire tip position can be readily determined.
Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance:
Clams 11-17 are not rejected over the prior art of record. The closest prior art of record includes US 20120029476 A1 to Kanazawa. The prior art of record fails to disclose, teach or fairly suggest, singly and in combination the guidewire structure as set forth in Claim 11, including where the uniform sized gap extends from the distal end to the proximal end of the radiopaque inner. The modification of Kanazawa would not have been obvious, as any modification to provide a uniform sized gap would have resulted in the destruction of the reference, as Kanazawa provides a gap that is not uniform for the purpose of preventing accidental removal of the distal end portion. Therefore, Claims 11-17 are allowable over the prior art of record and are allowable if the double patenting rejection is overcome.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791