Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 11 and 12 are objected to because of the following informalities: the word “balloon” is misspelled in the first line of each of claims 11 and 12. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 21 reads “wherein 20 first release wire and second release wire” which is unclear. As best understood, it appears that claim 21 is meant to read “The method of claim 20, wherein the first release wire and the second release wire…”, and claim 21 has been thus treated for purposes of claim interpretation.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 8-10 and 13-25 is/are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by Chobotov et al. (US 2002/0151953). Regarding claim 8, Chobotov ‘153 discloses a method of deploying a prosthesis comprising: placing a prosthesis in a patient's vessel (fig. 1), said prosthesis comprising an anchor member (formed of self-expanding members 32, 33) in a constrained configuration; releasing a first belt (21) constraining a first portion (32) of the anchor member while a second belt (22) is still constraining a second portion (33) of the anchor member ([0131]-[0133]).
Regarding claim 9, Chobotov ‘153 discloses releasing the second belt (22) constraining the second portion (33) of the anchor member ([0133])).
Regarding claim 10, Chobotov ‘153 discloses releasing a third belt (23) constraining a third portion of the anchor member (wherein the anchor member is considered entire prosthesis 11 for claim 10; [0134]).
Regarding claim 13, Chobotov ‘153 discloses repositioning the prosthesis within the patient vessel before releasing the second belt ([0131]-[0133]).
Regarding claim 14, the prosthesis comprises a graft body (205) attached to the anchor member (32,33).
Regarding claim 15, the method comprises radially expanding the graft body (figs. 9-11).
Regarding claims 16 and 17, the graft body (205) is expanded with an inflatable material (e.g., material 204 includes inflatable cuffs 28, 30), wherein the graft body includes one or more inflatable channels (284).
Regarding claim 18, Chobotov ‘153 discloses a method of deploying a prosthesis comprising: placing a prosthesis in a patient's vessel (fig. 1), said prosthesis comprising an anchor member (32,33) in a constrained configuration; releasing a first belt (21) constraining a first portion (32) of the anchor member while a second belt (22) is still constraining a second portion of the anchor member ([0131]-[0133]); and expanding a balloon (e.g., inflatable cuff 30) inside the prosthesis (i.e., inside wall of portion 205).
Regarding claim 19, Chobotov ‘153 discloses retracting a first release wire (24) to release the first belt (fig. 10).
Regarding claim 22, Chobotov ‘153 further discloses releasing a third belt (23) constraining a third portion (31) of the anchor member after releasing the first and second belts (see embodiment shown in figs. 9, 10, 11).
Regarding claim 23, Chobotov ‘153 discloses repositioning the prosthesis after releasing the first belt ([0131]-[0132]).
Regarding claim 24, Chobotov ‘153 discloses expanding a graft portion (205) of the prosthesis (see figures 9-11).
Regarding claim 25, Chobotov ‘153 discloses inflating an inflatable cuff portion (28) of the prosthesis.
Regarding claims 20 and 21, consider the embodiment shown in fig. 16. Chobotov ‘153 discloses releasing a first belt (22) constraining a first portion (33) of the anchor member by retracting a first release wire (312) while a second belt (21) is still constraining a second portion (32) of the anchor member ([0146], [0148]), and retracting a second release wire (316) to release the second belt (21) ([0150]). The first release wire (312) and second release wire (316) extend from the prosthesis to a handle portion of a delivery system (best shown in fig. 17).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 11 and 12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chobotov ‘153 in view of Peckham (US 2005/0278011). Chobotov ‘153 discloses the invention substantially as stated above except for the steps of expanding a balloon at least partially inside the anchor member to expand the first portion of the anchor member against the patient vessel, and expanding a balloon at least partially inside the anchor member to expand the second portion of the anchor member against the patient vessel.
Peckham discloses another stent graft ([0009]) that is self-expandable. Peckham discloses that, after self-expansion of the stent graft, a balloon may be placed and inflated inside the self-expandable stent in order to partially embed or seat the stent into the vessel wall in order to properly secure the stent in place ([0011], [0017], [0037]-[0038]). As illustrated in fig. 4, the balloon extends along the entire length of the stent graft while it is expanded in order to seat the entire length of the stent against the vessel. It would have been obvious to one of ordinary skill in the art to have modified the prior art method of Chobotov ‘153 to include expanding a balloon inside the anchor member to expand the first and second portions of the anchor member against the patient vessel in view of Peckham in order to properly secure the anchor member in place by partially embedding or seating the entire length of the self-expandable anchor member of Chobotov ‘153 into the vessel wall.
Claims 26 and 27 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chobotov ‘153 in view of Chobotov (US 2006/0224232; “Chobotov ‘232”). Chobotov ‘153 discloses the invention substantially as stated above except for the steps of placing at least a portion of a first graft extension and a second graft extension in a lumen of the prosthesis.
Chobotov ‘232 discloses another stent graft prosthesis which, like Chobotov‘153 (see fig. 19), is designed to be delivered to a bifurcation. Chobotov ‘232 discloses placing at least a portion of a first graft extension (14 that is inserted into ipsilateral leg 20 of prosthesis 12) in a lumen of the prosthesis (12) and a second graft extension (14 that is inserted into contralateral leg 26 of prosthesis 12; [0033]-[0034]; see also fig. 6, 6a of Chobotov ‘232) in a lumen of the prosthesis (12). According to Chobotov ‘232, using such extension grafts allow a main prosthesis to have a nominal axial length which is configured to allow the use of the main prosthesis in a wide variety of vascular morphologies with supplementation by the graft extensions ([0030], [0033]). It would have been obvious to have modified the prior art of Chobotov to include placing at least a portion of a first graft extension in a lumen of the prosthesis and a second graft extension in a lumen of the prosthesis (e.g., ipsilateral and contralateral legs of bifurcated main prosthesis) as taught by Chobotov ‘232 in order to allow use of the main prosthesis of Chobotov ‘153 in a wide variety of vascular morphologies with supplementation by the first and second graft extensions to form a protected fluid flow path from the aorta into the contralateral and ipsilateral iliac arteries.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2001/0037142 to Stelter discloses a prosthesis (12/14) having a self-expandable anchor member (50), and further discloses inflating a balloon within the stent to assuredly press the struts of the stent against the vessel all and seat the barbs of the stent ([0055]). Stelter also discloses inserting extension grafts (16, 22) into a lumen of the prosthesis (see figs. 5-7).
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KSH 7/28/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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