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 Amendment
This action is entered in response to Applicant’s amendment and reply of July 30, 2026. Claims 8, 11, 15 are amended. Claims 1-20 are pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed July 30, 2026, with respect to the rejection of claims 11, 15-20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph have been fully considered and are persuasive in light of the amendments to the claims. Therefore, the rejection has been withdrawn.
Applicant’s arguments, see Remarks, filed July 30, 2026, with respect to the rejection of claims 8-20 under 35 U.S.C. 102(a)(1) as being anticipated by White et al, US 6,231,563 have been fully considered and are persuasive in light of the amendments to the claims. However, upon further consideration, a new ground(s) of rejection is made over White in view of Lualdi, US 2012/0089220 A1.
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 8-20 are rejected under 35 U.S.C. 103 as being unpatentable over White US 6,231,563 in view of Lualdi, US 2012/0089220 A1.
Regarding claims 8, 15, 16, White discloses a system (see all Figs. 2i, 3-4, 9-10, col. 5, lines 20-65) for use with a branching stent prosthesis and/or comprising: a branching stent prosthesis (bifurcated graft 17, Fig. 2i) having a first branching portion (19), a second branching portion (19a), and trunk portion (17c); a dilator (52, Figs. 3-4, 10) comprising a port (50) disposed on a sidewall of the dilator (Figs. 3-4); and a first guidewire (26) configured to be advanced through the first branching portion and out the trunk portion of the branching stent prosthesis via the port of the dilator (col. 5, lines 45-55); and a second guidewire (23), wherein a portion of the second guidewire is disposed within a guide sheath (24), the guide sheath (24) configured to transport the first guidewire and the dilator along the second guidewire from the first branching portion of the branching stent prosthesis towards the intersection, wherein the first guidewire, the second guidewire, and the dilator are disposed within the guide sheath (col. 5, lines 20-60).
White does not expressly teach a radiopaque marker disposed on one or more edges of the port.
However, Lualdi, in the same field of art, namely a system for delivering branching stent prosthesis to a bifurcation (para [0144]), teaches a branching stent prosthesis device (1001, Figs. 17-20 and Figs. 27-38, para [0145]) having an elongated body or catheter/dilator (1002, Figs. 17-18, para [0145]) with a port (distal ports 1014 or 1015, Fig. 18, par [0149]) disposed on a sidewall of the body/catheter/dilator, and a radiopaque marker (radio-opaque markers located at 1014 or 1015, Fig. 18, paras [0169]-[0170]) disposed on one or more edges of the port, and a guidewire (1024, 1025, para [0152]) that is configured to be inserted through a lumen of the catheter/dilator and out of the port (para [0152]-[0153]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the port of White with a radiopaque marker around the edge of the port as taught by Lualdi in order to provide the stated benefit of providing the identification of the position along the body of the ports and/or other features of the elongated body to ensure proper placement of the guidewires (Lualdi, para [1070]).
Regarding claims 9 and 20, White as modified discloses the system of claim 8, and White further teaches wherein the port (50) is disposed at a distal end of the dilator (Figs. 3-4).
Regarding claims 10 and 17, White as modified discloses the system of claim 8, and White further teaches further comprising: a second guidewire (23) extending between the first branching portion and the second branching portion of the branching stent prosthesis; and a guide sheath (24) housing the dilator, the first guidewire, and a portion of the second guidewire, the guide sheath to advance the dilator and the first guidewire along the second guidewire within the first branching portion of the branching stent prosthesis (Figs. 3-4, col. 5, lines 20-60).
Regarding claim 11, White as modified discloses the system of claim 10, and White further teaches wherein the dilator (52) and the first guidewire (26) are advanced along the second guidewire (23) towards an intersection between the first branching portion, the second branching portion, and the trunk portion of the branching stent prosthesis to direct the dilator toward the second branching portion of the branching stent prosthesis and to direct the first guidewire along the trunk portion of the branching stent prosthesis (col. 5, lines 20-60; system of White is capable of performing the steps in claim 11 since claim 11 is directed towards the device and not the method, see 112b rejection above).
Regarding claim 12, White as modified discloses the system of claim 8, and White further teaches wherein the dilator (52) is configured to be retracted through the first branching portion of the branching stent prosthesis (col. 5, lines 20-60).
Regarding claim 13, White as modified discloses the system of claim 8, and White further teaches further comprising a balloon (20) disposed within the branching stent prosthesis to expand the branching stent prosthesis (col. 5, lines 35-45).
Regarding claim 14, White as modified discloses the system of claim 8, and White further teaches wherein the branching stent prosthesis (17) is disposed at a branching implant site within a vascular system of a body (Fig. 2i, col. 5, lines 20-30, Fig. 9).
Regarding claim 18, White as modified discloses the system of claim 15, and White further teaches wherein at the intersection, the first guidewire (26) is configured to exit the dilator through the port and be advanced within the trunk portion of the branching stent prosthesis and the dilator is directed toward to second branching portion of the branching stent prosthesis (col. 5, lines 30-60).
Regarding claim 19, White as modified discloses the system of claim 15, and White further teaches wherein the dilator (52) is configured to be retracted through the first branching portion of the branching stent prosthesis independently of the first guidewire (26) (col. 5, lines 20-30; guidewire 26 can be moved independently of 52 since disposed within a supplementary sheath).
Allowable Subject Matter
Claims 1-7 are allowed. The following is a statement of reasons for the indication of allowable subject matter: The prior art of record White, Kipperman, and the other prior art references cited (see PTO-892) does not teach or render obvious the combination of method steps as recited in claim 1, and in particular directing the dilator system towards an intersection between the first branching portion, the second branching portion, and the trunk portion of the branching stent prosthesis; advancing a distal end of the dilator toward the second branching portion of the branching stent prosthesis; advancing, at the intersection, a distal end of the first guidewire along the trunk portion of the branching stent prosthesis through a port disposed on a sidewall of the dilator.
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 KATRINA M STRANSKY whose telephone number is (571)270-3843. The examiner can normally be reached Monday-Friday 8:30 am-5:00 pm EST.
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/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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