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 Arguments
Applicant’s arguments, see pages 3-5 of remarks (pgs 10-12 of response), filed 11/3/25, with respect to the rejection(s) of claim(s) 1,7-14,17,30,33 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection over Ducke as combined with Lostetter has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Mathis et al. (2005/0010240). Additionally, the arguments are not persuasive for claim 40 as the only argument was the looping of a wire twice and use of a crimp which is taught by Mathis as mentioned. Thus the rejection is presented below.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1,3-14,17,30,33,34 are rejected under 35 U.S.C. 103 as being unpatentable over Ducke et al. (2012/0035714) in view of Mathis et al. (2005/0010240). With respect to claims 1,30,33 Ducke et al. show (Figs. 2a,4a) a support ring 60 for an aortic prosthesis, comprising a) a helical coil 80 having a helical coil first end and a helical coil second end, the helical coil defining a lumen and extending in an arc, wherein the helical coil first end and the helical coil second end are in an opposing relation to each other that defines a space that is between the helical coil first end and the helical coil second end and is outside the lumen; and b) a wire 71 extending through the lumen and having a wire first end and a wire second end, the wire traversing the space between the helical coil first end and the helical coil second end along at least one length of the wire between the wire first end and the wire second end. However, Ducke et al. did not explicitly disclose the wire completes two or more complete loops and the wire first end and wire second end overlap and the wire first end and the wire second end are secured to each other with a crimped connector. Mathis et al. teach (Fig. 2) a support ring 14 having a wire two complete loops and having its first end of the wire secured to the second end secured with each other and overlapping in a crimped connector 18. It would have been obvious to one of ordinary skill in the art to alternatively couple the ends of the wire of a prosthetic ring using two complete loops and securing ends in a crimp connector as taught by Mathis et al. with the prosthetic ring of Ducke et al. such that the diameter cannot change and it maintains its opening size and stable to keep the branch stent graft in place. With respect to claim 3, since the ends overlap in the device of Ducke and the incorporation of a crimp and two loops, one would place the crimped connector in the location between the ends of the two helical coil ends in the device of Ducke per the modification with Mathis. Regarding claim 4, Mathis teaches (paragraph 31) the crimped connector can be titanium. The examiner takes official notice that titanium metals used in the art include nitinol as a well- known, common material. Regarding claim 5, Ducke discloses (paragraph 48) the helical coil is radiopaque since it is metallic. Regarding claim 6, Ducke discloses (paragraph 49) the helical coil is including nitinol. Regarding claim 6, Regarding claims 7-10, Ducke et al. disclose (paragraphs 24, 56) the wire includes a shape-memory alloy, i.e. nitinol, a nickel-titanium alloy. Regarding claims 11,12 Ducke et al. disclose the wire traverses the space between the helical coil first end and the helical coil second end at a plurality of lengths between the wire first end and the wire second end and can vary distance due to turns of wire ends, see Fig. 2a and paragraph 46. Regarding claims 13,14,17,30,34 see Fig. 1 of Ducke showing a stent graft 10 with at least one fenestration 24 between the stent-graft first end 21 and the stent-graft second end 29 with the helical coil 60 fixed to the tubular graft wall at the fenestration and the fenestration within the arc of the helical coil. wall at the fenestration and the fenestration within the arc of the helical coil. Regarding claims 17,30,33 the same modification and limitations of the wire being formed with two loops and traversing the space to be joined by a crimped connector is suggested by the combination with Mathis as explained supra similar to claim 1.
Claim(s) 40 is rejected under 35 U.S.C. 103 as being unpatentable over Ducke et al. (2012/0035714) in view of Hartley et al. (9101456) and Eller (2018/0200089) and also in view of Mathis et al. (2005/0010240). Ducke et al. disclose (paragraph 11) method for implanting a branched aortic prosthesis, comprising the steps of: a) directing an aortic prosthesis to an aortic surgical site, the aortic prosthesis including, i) Fig. 1 showing a tubular graft component 10 including a tubular graft first end 21 and a tubular graft second end 29, and a tubular graft wall 30 extending between the tubular graft first end and the tubular graft second end, the tubular graft wall defining at least one fenestration 24 between the tubular graft first end and the tubular graft second end, ii) a graft sleeve 22 having a graft sleeve proximal end, a graft sleeve distal end, and a graft sleeve wall extending between the graft sleeve proximal end and the graft sleeve distal end and wherein the graft sleeve wall is fixed to the tubular wall around the fenestration. It can also be seen (Fig. 1) there is a support ring 60 fixed to the graft sleeve wall. However, Ducke et al. did not disclose the graft sleeve proximal end 26 having a base diameter and the graft sleeve distal end 8 having a diameter less than the base diameter, wherein the graft sleeve proximal end defines a plane that intersects a plane defined by the graft sleeve distal end. Hartley et al. teach (Fig. 2) an aortic stent graft with a graft sleeve proximal end having a base diameter and the graft sleeve distal end having a diameter less than the base diameter, wherein the graft sleeve proximal end defines a plane that intersects a plane defined by the graft sleeve distal end. It would have been obvious to one of ordinary skill in the art to utilize a stent graft having the proximal end with a larger diameter as taught by Hartley et al. in the stent graft of Ducke et al. such that it can be placed in the ascending aorta, see Hartley (col. 3, lines 8-21). It can also be seen that Hartley teaches placement of a support ring which is fixed to the graft sleeve wall closer to the graft sleeve proximal end than to the graft sleeve distal end and thus would have been obvious to one of ordinary skill in the art to place the support ring of Ducke closer to the proximal end per the teaching of Hartley in order to match the side branch location of the vessel when modifying to place in the aortic arch and arteries. It is noted that Ducke did disclose directing (paragraph 18) a branch stent graft distally through the graft sleeve until a branch stent graft proximal end is distal to the support ring. However, Ducke did not explicitly state the branch stent graft is secured by an interference fit between the branch stent graft distal end and the graft sleeve, thereby implanting the branched stent graft at the surgical site. Eller teaches (paragraph 55) that branch stent grafts are secured within fenestrations of a main graft sleeve via an interference fit. It would have been obvious to one of ordinary skill in the art to provide the engagement of the branch stent graft with the main body stent graft to be an interference fit as taught by Eller with the stent graft device of Ducke as modified with Hartley such that it reduces delivery or surgical operation time by not requiring any additional time and efforts to attach the two elements together often done by suturing. However, Ducke et al. did not explicitly disclose the wire completes two or more complete loops and the wire first end and wire second end overlap and the wire first end and the wire second end are secured to each other with a crimped connector. Mathis et al. teach (Fig. 2) a support ring 14 having a wire two complete loops and having its first end of the wire secured to the second end secured with each other and overlapping in a crimped connector 18. It would have been obvious to one of ordinary skill in the art to alternatively couple the ends of the wire of a prosthetic ring using two complete loops and securing ends in a crimp connector as taught by Mathis et al. with the prosthetic ring of Ducke et al. such that the diameter cannot change and it maintains its opening size and stable to keep the branch stent graft in place. Ducke discloses a helical coil, see above explanation.
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.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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