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 .
Claim Objections
Claims 7 and 10-11 are objected to because of the following informalities: in lines 10-11 of claim 7, “the anatomical structure the prothesis at the target location to obstruct the vascular opening” should be amended to “the anatomical structure such that the prothesis at the target location obstructs the vascular opening” to make grammatical sense; in line 1 of claim 10, “it” should read “the at least one tether” for clarity; and in line 2 of claim 11, “it” should read “the at least one tether” for clarity. Appropriate correction is required.
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) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thill et al. (U.S. Patent No. 6,214,029).
Regarding claim 1, Thill et al. discloses a method (C4:L21-29), comprising:
providing a delivery system (47) having a prosthesis (20) removably attached to a distal end thereof (FIG. 10: 20 is removably attached to 47 by urging means 46);
delivering the delivery system over a guidewire (46) routed to a target location within a patient’s vasculature (FIG. 8: 47 is delivered to atrial septum S);
deploying the prosthesis at the target location to obstruct a vascular opening to be sealed (C4:L21-29: 20 is used to block S);
detaching the prosthesis from the delivery system (FIGs. 1 and 20: 20 is fully outside of 47, which is being considered detachment);
withdrawing the delivery system over the guidewire after the prosthesis has been detached therefrom (C6:L13-34: 47 is moved along 46, which includes after deployment of 46);
advancing the delivery system toward the target location over the guidewire after the withdrawing step (4 C6:L13-34: 47 must be moved back to 20 after deployment to retrieve 20);
reattaching the prosthesis to the delivery system (C6:L13-34: 20 can be reinserted into 47 for retrieval); and
performing a further step with the prosthesis (Claim 23: the occluder is repetitively redeployable, where the second deployment is a further step).
Regarding claim 2, Thill et al. further discloses partially collapsing the prosthesis after the deploying step (FIG. 11: 20 is partially collapsed after deployment and during retrieval).
Regarding claim 3, Thill et al. further discloses at least partially repositioning the prosthesis after the deploying step (FIGs. 8-10: 20 is partially repositioned after deployment as the discs expand; FIG. 11: 20 is also repositioned by retrieval and redeployment).
Regarding claim 4, Thill et al. further discloses at least partially repositioning the prosthesis after the detaching step (Claim 23: repetitively redeploying the occluder requires repositioning the occlude after first deployment, either at the same target site or a new target site).
Regarding claim 5, Thill et al. further discloses collapsing and withdrawing the prosthesis into the delivery system (FIGs. 11-12: 20 is collapsed to be retrieved by 47).
Regarding claim 6, Thill et al. further discloses withdrawing the delivery system with the prosthesis attached thereto over the guidewire (FIGs. 11-12: 47 is withdrawn over the center 46 with 20 attached).
Regarding claim 7, Thill et al. discloses a method (C4:L21-29), comprising:
providing a delivery system (47) having a prosthesis (20) removably attached to a distal end thereof (FIG. 10: 20 is removably attached to 47 by urging means 46), the prothesis being configured to radially self-expand into at least two axially spaced discs (FIGs. 8-10: 20 expands radially into occluder panels 30 and 60);
delivering the delivery system over a guidewire (46) routed to a target location within a patient’s vasculature (FIG. 8: 47 is delivered to atrial septum S);
deploying a first of said at least two discs proximate a first side of a first wall of an anatomical structure next to a vascular opening to be sealed (FIG. 9: 30 is delivered to the distal side of S);
deploying a second of said at least two discs proximate a second side of the first wall of the anatomical structure (FIG. 10: 60 is delivered to the proximal side of S) so that the prosthesis at the target location obstructs the vascular opening (C4:L21-29: 20 is used to block S);
applying tension to at least one tether routed through said at least two axially spaced discs to cause the prothesis to collapse axially (C6:L13-34: the outer 46 are used to collapse 20).
Regarding claim 8, Thill et al. further discloses tension is applied to the at least one tether until leaks through the vascular opening are stopped (C4:L21-29: 20 is deployed until the flow of blood through S is stopped; C7:L4-6: 46 are used during deployment of 20; therefore, 46 are manipulated through tension until the flow of blood through S has stopped and no leaks remain).
Regarding claim 9, Thill et al. further discloses securing the at least one tether (C7:L4-6: 46 are cooperatively engaged by 44 to secure the connection between 20 and 46).
Regarding claim 10, Thill et al. further discloses the at least one tether is secured by tying the at least one tether off (FIG. 8: 46 are threaded through 44, which is a tie).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thill et al. in view of Prom (Pub. No. 2014/0257361).
Regarding claim 11, Thill et al. discloses the invention as claimed in claim 9, as discussed above. Thill et al. is silent regarding the at least one tether is secured by applying at least one clip to the at least one tether.
Prom teaches in the same field of endeavor of delivering occlusive devices (Abstract), and discloses at least one tether (24) that is secured by applying at least one clip to the at least one tether ([0056] 24 is secured by central clamp 16) for the purpose of releasably securing the at least one tether ([0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted the securing method of Thill et al. (tying) with the securing method of Prom (clip) because both are equivalent methods of releasably securing the tether, and the substitution of one for the other would have the predictable result of releasably securing the tether.
Conclusion
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771