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 .
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claims 15-21 have been renumbered as 14-20.
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.
Claims 2, 7-10, are rejected under 35 U.S.C. 103 as being unpatentable over WO 2013/163227 to Heuser in view of US 2016/0066993 to Root et al.
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In the specification and figures, Heuser discloses the apparatus substantially as claimed by Applicant. With regard to claims 2, 6, 7, 12, 17, 18 (renumbered claims 18, 19), Heuser discloses a guidewire routing system comprising a catheter assembly comprising a shaft 70, a capture structure 80 comprising an expandable cage (which suggests a plurality of interconnected struts), and a second catheter with a needle and a guidewire that is configured to advance to the capture structure of the first catheter assembly. The first catheter assembly is configured to capture a guidewire and retract, leading the guidewire from a first vessel to a second vessel (see FIGS 12A-H and accompanying text). Heuser does not disclose a sheath. However, Root discloses a guidewire capture catheter with an expandable funnel 1218 and a sheath 1232 coupled to a hub 550 3in order to capture a guidewire 1204 that has been passed through obstruction 1206, teaching that the sheath in the Root reference functions as claimed by Applicant (see FIGs 11, 12, ¶0034).
Where a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the claim is unpatentable under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d 1509, 1518-19 (BPAI, 2007) (citing KSR v. Teleflex, 127 S.Ct. 1727, 1740, 82 USPQ2d 1385, 1396 (2007)). Applicant claims a combination that only unites old elements with no change in the respective functions of those old elements, and the combination of those elements yields predictable results; absent evidence that the modifications necessary to effect the combination of elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d at 1518-19 (BPAI, 2007) (citing KSR, 127 S.Ct. at 1740, 82 USPQ2d at1396. Accordingly, since the applicant[s] have submitted no persuasive evidence that the combination of the above elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103(a) because it is no more than the predictable use of prior art elements according to their established functions resulting in the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement.
In the instant case, it would have been obvious to a person of ordinary skill in the art to use the sheath system disclosed by Root on the catheter system disclosed by Heuser, since each embodiment is known in the art.
With regard to claims 3-5, 13-16 (renumbered claims 15-17), Heuser discloses that part of the stent graft comprises nitinol, and that the guidewire assembly may comprise a radiopaque marker (see ¶0017, 0051). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use nitinol and radiopaque markers as disclosed by Heuser in the combination suggested by the prior art, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP § 2144.07.
With regard to claims 8-10 and 19 (renumbered claim 20), Heuser discloses that the first blood vessel with the capture structure is a femoral vein, and the second blood vessel with the occlusion is a femoral artery.
With regard to claims 11 and 20 (renumbered claim 21), both references disclose a hub (Heuser ¶0052 y-shaped hub with multiple ports 72; Root ¶0034 hub with multiple ports 550), demonstrating that hubs are well-known elements in the art of vascular catheterization. The instant recitation of a hub does not patentably distinguish the claims from the cited prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 6,379,319 Garibotto et al
Snaring guidewires to bypass an occlusion.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
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/LESLIE R DEAK/ Primary Examiner, Art Unit 379
9 January 2026