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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/18/2025 has been entered.
Drawings
The amendments to the drawings filed on 11/18/2025 are accepted.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 7-17 have been considered, but are moot in view of the new grounds of rejection.
Claim Rejections - 35 USC § 102
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tuval et al. (Pub. No.: US 2010/0262231 A1; hereinafter “Tuval”).
Tuval discloses the following regarding claim 1: a heart valve prosthesis for transcatheter implantation at a native heart valve, the heart valve prosthesis comprising: a frame (12) having a distal end portion (Figs. 1, 2B) and a proximal end portion (Figs. 1, 2B), the frame further comprising an exterior surface (outer surface) (Figs. 1, 2B) and an interior surface (inner surface) (Figs. 1, 2B) defining a lumen (central opening of element 12), the frame expandable from an unexpanded state to an expanded state (paras. 0011, 0060-0061), wherein the frame further comprises: an expandable region near the distal end portion of the frame (para. 0041); and a cusp region (upper portions of element 12) near the proximal end portion of the frame (Figs. 1, 2B) and comprising a plurality of commissural posts (20, 30); and a valve construct (104) comprising: (i) a plurality of leaflets (Fig. 1; para. 0581-0582) and (ii) a plurality of commissural regions (130) that are monolithic with adjacent leaflets of the plurality of leaflets (para. 0582), the plurality of commissural regions defining a plurality of slits (open slits near element 130) through the valve construct (Fig. 4A), wherein each commissural post extends into the valve construct through a slit of one of the commissural regions so that portions of the valve construct are attached to the exterior surface of the frame at least at the plurality of commissural posts (Fig. 4A; paras. 0596-0597), and wherein one or more sutures (132) extend, in a commissure suture pattern (Fig. 4A), over each of the portions of the valve construct that are attached to the exterior surface of the frame (Fig. 4A) to attach the valve construct to the proximal end portion of the frame (Fig. 4A; paras. 0596-0597).
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.
Claim(s) 7-10 and 12-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuval in view of Peterson et al. (Pub. No.: US 2021/0275298 A1; hereinafter “Peterson”).
Tuval discloses the limitations of the claimed invention, as described above. Tuval does not disclose the use and position of radiopaque markers to allow for the use of the fluoroscopy techniques. Peterson teaches that it is well known in the art that radiopaque markers are applied to a frame having struts (Figs. 31-38E; paras. 0196-0201, 0222-0237, 0254-0267), for the purpose of aiding the user in the proper placement of the valve prosthesis and providing additional structural support to the prosthetic valve. The one or more radiopaque markers are located on one or more struts of the frame (Figs. 31-38E). The one or more radiopaque markers are located on at least one node of the frame where struts of adjacent cells of the frame are connected to each other (Figs. 38A-38E). The one or more radiopaque markers are also located on one or more struts of the frame (Figs. 31-38E). The one or more radiopaque markers are located on a distal row of struts of the distal end portion of the frame (Figs. 38D-38E). The one or more radiopaque markers (e.g., 3870) located on at least one commissural post (e.g., 3826) of the plurality of commissural posts (Figs. 38A-38B). The one or more radiopaque markers are located on a strut or node of the cusp region (Figs. 30-38E). The one or more radiopaque markers are located at or near a node of a distal-most row of cells of the frame (Figs. 38A-38E) to assist a practitioner in visualizing a position of a distal end of the distal end portion of the frame during delivery. The one or more radiopaque markers are located at or near a node of a proximal-most row of cells of the distal end portion of the frame (Figs. 38B-38C) to assist a practitioner in visualizing positions of the plurality of leaflets during delivery. The one or more radiopaque markers are located on a strut or node of the cusp region (Figs. 30-38E) to assist a practitioner in visualizing positions of the plurality of leaflets during delivery. It would have obvious to one having ordinary skill in the art to modify the device of Tuval to comprise a frame with struts having radiopaque markers, as taught by Peterson, in order to aid the user in the proper placement of the valve prosthesis and to provide additional structural support to the prosthetic valve. Such a modification would be made with a reasonable expectation of success. Please note that 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.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuval in view of Dave et al. (Pub. No.: US 2008/0102098 A1; hereinafter “Dave”).
Tuval discloses the limitations of the claimed invention, as described above. Tuval does not explicitly describe using a coating for the radiopaque markers on the frame. Dave teaches that it is well known in the art that radiopaque markers comprise a coating applied to the frame (paras. 0068-0069), for the purpose of aiding the user in the proper placement of the valve prosthesis. It would have obvious to one having ordinary skill in the art to modify the device of Tuval to comprise a radiopaque marker coating on its frame, as taught by Dave, in order to aid the user in the proper placement of the valve prosthesis. Such a modification would be made with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774