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 .
Response to Amendments and Arguments
Applicant's amendments and arguments filed 27 April 2026 have been fully considered but they are not persuasive.
Applicant argues that neither Heuser nor Avitall1 disclose or suggest a capture structure comprising a plurality of interconnected struts (see Remarks p 9, 11). Turning to the specification, Applicant correctly identifies a definition of “struts” to include parts of a tube that are left after a cutting procedure. However, the Specification also discloses that the disclosed struts may comprise wires or filaments “not cut from a hypotube or sheet” (see Specification, 0275). Accordingly, Heuser’s woven or braided cage suggests the ”interconnected struts” as claimed by Applicant.
Applicant further argues that Root fails to disclose a sheath that is movable to capture the guidewire within one of the cells of the capture structure (see Remarks, p 9-10). However, the Examiner notes that the wherein clause argued by Applicant does not involve the sheath at all. Heuser discloses a pair of catheters with a capture catheter comprising an expandable cage 80 that is collapsed to capture a penetration guidewire PGW (see Heuser FIG 12C, ¶0060). The Examiner relies on Root only to teach the presence of a movable sheath that may compress a capture structure, not the actual capturing, which is disclosed by Heuer.
Upon further consideration drawn to the manner in which a guidewire from a first catheter is ensnared by a second catheter, the Examiner presents an additional rejection addressing the amendments to the claims that shows how a sheath of Hauser assists in capture of a guidewire.
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 2-21 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2013/163227 to Heuser.
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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, 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 cage 80 of the first catheter assembly is configured to capture a guidewire PGW within the cells of the cage 80 and retract, leading the guidewire from a first vessel to a second vessel (see FIGS 12A-H and accompanying text). Heuser further discloses a sheath that may cover the cage in a contracted state for deployment, retracted to expand the cages, then advanced to cover the cage for catheter withdrawal, further securing the PGW within the cage 80 (see ¶0052, 0048, 0020).
With regard to claims 3-5, 13-16, 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, 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, Heuser disclose a hub (Heuser ¶0052 y-shaped hub with multiple ports 72; Root ¶0034 hub with multiple ports 50), 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.
In the alternative, claims 2-21 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, 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 cage 80 of the first catheter assembly is configured to capture a guidewire PGW within the cells of the cage 80 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 that is moveable to expand or contract the funnel. The assembly is coupled to a hub 550 and functions 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, moving to contract or expand the expandable member of a capture structure (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, 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, 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, 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 3799
11 May 2026
1 There is no Avitall referenced in the Non-final Rejection. The Examiner assumes Applicant is referring to Root as the secondary reference.
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