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 Amendment
This office action is responsive to the amendment filed on 07/22/2016. As directed by the amendment: claims 1, 3, 12, 14 have been amended. Thus, claims 1-20 are presently pending in the application.
Response to Arguments
Applicant's arguments filed 07/22/2026 have been fully considered but they are not persuasive. Applicant argues on pages 8-9, the prior art Vad discloses interconnecting wire portion 150 is formed by a single continuous wire 105, wherein the interconnecting wire portion 150 of a single continuous wire 105 extends into both self-expanding and balloon-expandable stent frames 110b, 110a. The examiner respectfully disagrees. Vad discloses the proximal portion 120 formed by balloon expandable portion 110b can be longitudinally spaced apart from and not joined to the self-expanding portion 110a (paragraph [0034]), therefore Vad discloses the coupling of the balloon expandable portion 110b and the self-expanding portion 110a is through the graft and not directly coupled to each other via a strut.
Applicant argues on pages 10-11, claim 14 was amended to recite “a self-expanding stent frame at a first portion of the hybrid stent prosthesis and a balloon-expandable stent frame at a second portion of the hybrid stent prosthesis distal to the first portion,” wherein applicant argues Vad does not disclose a balloon-expandable stent frame at a second portion of the hybrid stent prosthesis that is distal to the first portion. The examiner respectfully disagrees. Vad discloses in Figures 4A-4E, the delivery of the hybrid prothesis 100, wherein the self-expanding stent frame 410a is expanded and released first and said balloon-expandable stent frame 410b is expanded last, therefore in at least the delivery configuration of the hybrid stent 100, the self-expanding stent frame 410a is proximal to the balloon-expandable stent frame 410b (paragraphs [0061-0062]). Furthermore, claim 14 is directed to the balloon-expandable stent frame is distal to the [self-expanding] stent during the delivering [from] a deployment system. Therefore, the examiner has maintained the 102 rejection(s) of claim 14 over Vad U.S. Publication 2015/0034217 A1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 7, 9 and 12-16 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vad U.S. Publication 2015/0034217 A1.
Regarding Claim 1, Vad discloses a hybrid stent prosthesis 100 comprising: a self-expanding stent frame 110a; a balloon-expandable stent frame 110b (paragraph [0030]); and a cover 216 integrating the self-expanding stent frame 110a and the balloon-expandable stent frame 110b such that when the hybrid stent prosthesis is in a deployed configuration (as seen in Figure 2 and paragraph [0038]), a lumen 218 of the hybrid stent prosthesis passes through the self-expanding stent frame and the balloon-expandable stent frame (paragraphs [0030], [0038]). Vad further discloses wherein the cover comprises a transition zone separating adjacent ends of the self-expanding stent frame and balloon-expandable stent frame (see paragraph [0034], Vad discloses the proximal portion 120 formed by balloon expandable portion 110b can be longitudinally spaced apart from and not joined to the self-expanding portion 110a, therefore Vad discloses the coupling of the balloon expandable portion 110b and the self-expanding portion 110a is through the graft and not directly coupled to each other via a strut.
Regarding Claim 2, Vad discloses wherein a luminal surface of the cover 216 is continuous between the self-expanding stent frame and the balloon expandable stent frame (as seen in Figure 2 and paragraphs [0030], [0038]).
Regarding Claim 3, Vad discloses wherein the transition zone (where the interconnecting wire portion 150 would be located, as Vad discloses in an alternative embodiment the wire portion 150 can be removed to create longitudinal spacing and not joined self-expanding and balloon-expandable portions) comprises a portion of the cover that is not supported by the self-expanding stent frame or the balloon-expandable stent frame (paragraph [0034] and see Figure 1A).
Regarding Claim 7, Vad discloses wherein the transition zone of the cover and regions of the cover integrating the self-expanding stent frame and the balloon-expandable stent frame include a single, continuous material (paragraphs [0030], [0038]).
Regarding Claim 9, Vad discloses wherein an end portion of the cover 216 corresponding to the balloon-expandable stent frame (the graft extends continuously around the first and second ends encompassing the balloon-expandable stent frame 110b, see Figure 2). The limitation, [the cover] has an elasticity that functionally corresponds to a maximum deployable diameter of the balloon-expandable stent frame is a recitation of intended use of the cover. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding Claim 12, Vad discloses a deployment system 480, comprising: an elongate tubular member 470 (as seen in Figures 4A-4B and paragraph [0059]); a hybrid stent prosthesis 100 collapsed around the elongate tubular member comprising: a self-expanding stent frame 110a; a balloon-expandable stent frame 110b (paragraph [0030]); and a cover 216 integrating the self-expanding stent frame 110a and the balloon-expandable stent frame 110b such that when the hybrid stent prosthesis is in a deployed configuration (as seen in Figure 2 and paragraph [0038]), a lumen 218 of the hybrid stent prosthesis passes through the self-expanding stent frame and the balloon- expandable stent frame (paragraphs [0030], [0038]), a balloon 476 within the balloon-expandable stent frame that is inflatable through the elongate tubular member to deploy a portion of the hybrid stent prosthesis corresponding to the balloon-expandable stent frame (as seen in Figures 4C-4D and paragraph [0062]); and a catheter sleeve 472 constraining the self-expanding stent frame of the hybrid stent prosthesis against the elongate tubular member (paragraphs [0061-0062]). Vad further discloses wherein the cover comprises a transition zone separating adjacent ends of the self-expanding stent frame and balloon-expandable stent frame (see paragraph [0034], Vad discloses the proximal portion 120 formed by balloon expandable portion 110b can be longitudinally spaced apart from and not joined to the self-expanding portion 110a, therefore Vad discloses the coupling of the balloon expandable portion 110b and the self-expanding portion 110a is through the graft and not directly coupled to each other via a strut.
Regarding Claim 13, Vad discloses wherein the catheter sleeve 472 further covers the balloon- expandable stent frame of the hybrid stent prosthesis (as seen in Figures 4A-4C and paragraphs [0060-0062]).
Regarding Claim 14, Vad discloses a method of deploying a hybrid stent prosthesis, comprising delivering a deployment system along a guide wire 474 to a deployment site, the deployment system comprising: an elongate tubular member 470; the hybrid stent prosthesis collapsed around the elongate tubular member 470 (as seen in Figures 4A-4B and paragraph [0059]), wherein the hybrid stent prosthesis comprises: a self-expanding stent frame 110a at a first portion of the hybrid stent prosthesis; a balloon-expandable stent frame 110b at a second portion of the hybrid stent prosthesis distal to the first portion (Vad discloses in Figures 4A-4E, the delivery of the hybrid prothesis 100, wherein the self-expanding stent frame 410a is expanded and released first and said balloon-expandable stent frame 410b is expanded last, therefore in at least the delivery configuration of the hybrid stent 100, the self-expanding stent frame 410a is proximal to the balloon-expandable stent frame 410b, paragraphs [0061-0062]; and a cover 216 integrating the self-expanding stent frame110a and the balloon-expandable stent frame 110b (as seen in Figure 2 and paragraph [0030] and [0038]), a first balloon 476 within the balloon-expandable stent frame (as seen in Figures 4C-4D and paragraph [0062]); and a catheter sleeve 472 constraining the self-expanding stent frame against the elongate tubular member 470 (as seen in Figures 4A-4C and paragraphs [0059-0062]); and deploying the first portion and the second portion of the hybrid stent prosthesis, wherein a lumen of the hybrid stent prosthesis passes through the self-expanding stent frame of the hybrid stent prosthesis and the balloon-expandable stent frame of the hybrid stent prosthesis when both the second portion of the hybrid stent prosthesis and the first portion of the hybrid stent prosthesis are deployed (as seen in Figures 4A-4D and paragraphs [0060-0062]).
Regarding Claim 15, Vad discloses wherein deploying the first portion and the second portion of the hybrid stent prosthesis comprises: inflating the first balloon 476 to deploy the second portion of the hybrid stent prosthesis corresponding to the balloon-expandable stent frame at the deployment site (as seen in Figures 4A-4C); and after inflating the first balloon to deploy the second portion of the hybrid stent prosthesis, retracting the catheter sleeve 472 from the self-expanding stent frame of the hybrid stent prosthesis to deploy the first portion of the hybrid stent prosthesis (as seen in Figures 4A-4D and paragraph [0060-0062]).
Regarding Claim 16, Vad discloses wherein deploying the first portion and the second portion of the hybrid stent prosthesis comprises: retracting the catheter sleeve 472 from the self-expanding stent frame of the hybrid stent prosthesis to deploy the first portion of the hybrid stent prosthesis; and after retracting the catheter sleeve from the self-expanding stent frame of the hybrid stent prosthesis, inflating the first balloon 476 to deploy the second portion of the hybrid stent prosthesis corresponding to the balloon-expandable stent frame at the deployment site (as seen in Figures 4A-4D and paragraphs [0060-0063]).
Regarding Claim 20, Vad discloses wherein the first portion of the hybrid stent prosthesis is deployed proximally and the second portion of the hybrid stent prosthesis is deployed distally (as seen in Figures 4A-4D).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vad U.S. Publication 2015/0034217 A1 in view of Casanova et al. WO 2007/056762 A2.
Regarding Claim 4, Vad does not expressly disclose wherein the transition zone comprises a longitudinal beading extending from the self-expanding stent frame to the balloon-expandable stent frame. Casanova et al. teaches a graft device 100 in the same field of endeavor comprising beading 104 helically wound about the stent graft 100 for the purpose of providing additional structural rigidity to the stent graft 100 and allowing visual location and orientation of the different segments of the stent graft (paragraph [0011-0012] and [0056]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Vad’s transition zone to further include a longitudinal beading as taught by Casanova et al. for the purpose of providing additional structural rigidity to the stent graft and allowing visual location and orientation of the different segments of the stent graft.
Regarding Claim 5, Vad does not expressly disclose wherein the transition zone comprises a helical beading extending from the self-expanding stent frame to the balloon-expandable stent frame. Casanova et al. teaches a graft device 100 in the same field of endeavor comprising beading 104 helically wound about the stent graft 100 for the purpose of providing additional structural rigidity to the stent graft 100 and allowing visual location and orientation of the different segments of the stent graft (paragraph [0011-0012] and [0056]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Vad’s transition zone to further include a longitudinal beading as taught by Casanova et al. for the purpose of providing additional structural rigidity to the stent graft and allowing visual location and orientation of the different segments of the stent graft.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vad U.S. Publication 2015/0034217 A1 in view of Quigley et al. U.S. Publication 2009/0163994 A1.
Regarding Claim 6, Vad does not expressly disclose wherein a first layering of the cover in the transition zone is different than a second layering of the cover at an end of one of the self-expanding stent frame and the balloon-expandable stent frame that is adjacent to the transition zone. Quigley et al. teaches a stent graft in the same field of endeavor comprising a hybrid stent having self-expanding and balloon expandable extents (paragraph [0033] and as seen in Figure 2) and further includes graft with different graft regions 120, 122, 124 forming a first region that is doubled graft layers while another is an unfolded singular graft wall (paragraph [0040]) for the purpose of guiding the different bending flexibility of the stent wall (paragraphs [0035] and [0040]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Vad’s stent graft to further include grafts that include a first layering that is singular and a second region having a doubled graft layers as taught by Quigley et al. for the purpose of aiding in the different bending flexibilities of the stent wall.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vad U.S. Publication 2015/0034217 A1 in view of Banks et al. U.S. Publication EP2916883B1.
Regarding Claim 8, Vad does not expressly disclose wherein a first nominal diameter of an end portion of the cover that corresponds to the balloon-expandable stent frame is larger than a second nominal diameter of the balloon-expandable stent frame. Banks et al. teaches a stent graft prothesis 100B as seen in Figure 1B in the same field of endeavor comprising a first end 112B and a second 110B, wherein the first end 112B has a greater diameter (flared) than the second end to anchor the stent into the wall of the vessel and allow for the stent graft to be held in place by mechanical engagement (paragraph [0002] and [0012]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Vad’s stent to further include a first diameter and a second diameter, wherein the first diameter is larger than a second diameter as taught by Banks et al. for the purpose of allowing the stent graft to be held in place by mechanical engagement.
Claim(s) 10-11 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vad U.S. Publication 2015/0034217 A1 in view of Hartley et al WO 2005/034807 A1.
Regarding Claim 10, Vad does not expressly disclose an additional self-expanding stent frame, wherein the cover integrates the additional self-expanding stent frame with the balloon-expandable stent frame positioned between the self-expanding stent frame and the additional self-expanding stent frame. Hartley et al. teaches a stent graft in the same field of endeavor comprising a balloon expandable stent portion 3 and a self-expanding stent portion 15 and a transition region 13 and a covering 1 extending continuously to form a lumen therein (page 9, lines 20-31), wherein the covering 1 further includes self-expanding stent 5 in the transition region 13 for the purpose of providing a good seal against the wall of the vessel when deployed (page 3, lines 15-27). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Vad’s transition region having the covering to include a plurality of self-expanding stents as taught by Hartley et al. for the purpose of providing a good seal against the wall of the vessel when deployed.
Regarding Claim 11, Vad does not expressly disclose an additional balloon-expandable stent frame, wherein the cover integrates the additional balloon-expandable stent frame with the self-expanding stent frame positioned between the balloon-expandable stent frame and the additional balloon-expandable stent frame. Hartley et al. teaches a stent graft in the same field of endeavor comprising a balloon expandable stent portion 3 and a self-expanding stent portion 15 and a transition region 13 and a covering 1 extending continuously to form a lumen therein, wherein the covering 1 further includes a plurality of balloon expandable stent (page 4, lines 9-13) for the purpose of separately expanding a first and second portion of the stent to expand the first portion into a fenestration and a later balloon expand a second portion to retain the position into a side branch (page 4, lines 27-31). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Vad’s transition region having the covering to include additional plurality of balloon-expandable stent frame as taught by Vad for the purpose of separately expanding the first end and the intermediate portion, such that the first portion can be deployed into a fenestration and the intermediate portion can be expanded to a side branch, enabling separate expansion regions.
Regarding Claim 17, 19, Vad does not expressly disclose delivering a second balloon to the deployment site along the guide wire; and using the second balloon to adjust the second portion of the hybrid stent prosthesis corresponding to the balloon-expandable stent frame and wherein the second portion of the hybrid stent prosthesis is deployed in a renal artery at the deployment site, and wherein the first portion of the hybrid stent prosthesis is deployed within a lumen of a parent prosthesis at the deployment site. Hartley et al. teaches a stent graft in the same field of endeavor comprising a balloon expandable stent portion 3 and a self-expanding stent portion 15 and a transition region 13 and a covering 1 extending continuously to form a lumen therein, wherein a second balloon 64 is used along the guide wire 47 distal to the first balloon 62 so as to ensure the proper expansion of the balloon expandable region 3 of the stent to firmly secure the region to the fenestration (page 12, lines 14-30). In addition, Hartley discloses wherein the first portion is deployed within a parent prosthesis 33 and a second portion is deployed in a renal artery (as seen in Figures 3-5) for the purpose of assisting in the blood flow through a bifurcation (abstract). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Vad’s stent to further include deploying a second balloon along the guidewire and having a first portion deployed within a lumen of a parent and a second portion deployed in a renal artery as taught by Hartley et al. for the purpose of ensuring the proper expansion of the balloon expandable region of the stent to firmly secure the region into a fenestration.
Regarding Claims 17, 18, Vad does not expressly disclose wherein the deployment system is delivered along the guide wire to the deployment site through a parent prosthesis and Hartley et al. teaches a stent graft in the same field of endeavor comprising a balloon expandable stent portion 3 and a self-expanding stent portion 15 and a transition region 13 and a covering 1 extending continuously to form a lumen therein, wherein a deployment system is delivered along a guide wire 47 to a deployment site through a parent prosthesis 33 (as seen in Figures 3-5) for the purpose of assisting in the blood flow through a bifurcation (abstract). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Vad’s stent to further include a system deploying through a parent prosthesis as taught by Hartley for the purpose of assisting in the blood flow through a bifurcation.
Conclusion
THIS ACTION IS MADE FINAL. 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 SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
