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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 76, 78 and 80-82 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Gross et al. (2016/0324633) “Gross”.
Regarding claim 76, Gross discloses an apparatus for use with a heart of a subject (abstract and Figs. 23A-23B), the apparatus comprising: an inner stent frame 42 that: defines a tubular portion (par. 0165 discloses the inner stent 42 is cylindrical) and a plurality of inner-frame coupling elements 422, and has a relaxed expanded state in which the tubular portion defines an inner-stent-frame relaxed expanded diameter (inner-stent 42 when expanded would inherently have a relaxed expanded diameter); and an outer stent frame 40 (Fig. 1H), that: defines a ring (outer edge 69 of outer stent 40; Fig. 1H and par. 0161) and a plurality of outer-frame coupling elements (at least one pocket 640 (Fig. 23B and par. 0278 discloses at least one pocket which is interpreted to mean one or more), and has a relaxed expanded state in which the ring defines an outer-stent-frame relaxed expanded diameter (when expanded the outer stent frame inherently has a relaxed expanded diameter; Fig. 1H) that is smaller than the inner-stent-frame relaxed expanded diameter (par. 0169 discloses the expansion of the inner stent 42 within outer stent 40 exerts radial force on the outer stent 40 allowing for a friction force lock between the stent frames, the diameter of the inner stent frame would have to be larger than the outer stent frame in order to provide a friction radial force to couple and seal the outer and inner stents together),
wherein: together, the inner stent frame and the outer stent frame define at least part of a frame assembly in which the outer-frame coupling elements are fixed to the inner-frame coupling elements (Fig. 23B and par. 0280 disclose the coupling elements 422 are coupled with at least one pocket 640) and the ring circumscribes the tubular portion (as shown in Fig. 23B, the outer edge of the outer stent circumscribes the cylindrical body of inner stent 42), and the frame assembly: further comprises a plurality of prosthetic leaflets secured to, and disposed within, the tubular portion (par. 0165 discloses the valve leaflets are placed within the lumen of inner stent 42), has a compressed state in which the frame assembly is transluminally advanceable to the heart (the inner and outer stent frames are transluminally implanted in the heart vias tube 44; Fig. 1B), and is expandable into an expanded state in which the tubular portion defines an inner-stent-frame constrained expanded diameter that is smaller than the inner-stent- frame relaxed expanded diameter (par. 0169 discloses the expansion of the inner stent 42 within outer stent 40 exerts radial force on the outer stent 40 allowing for a friction force lock between the stent frames, the diameter of the inner stent frame would inherently decrease from its expanded relaxed diameter to a constrained expanded diameter in order to exert radial forces on the outer frame allowing for a coupling and sealing between the inner and outer stent frames).
Regarding claim 78, Gross discloses wherein the outer-frame coupling elements
are welded to the inner-frame coupling elements (Fig. 23B and par. 0280 disclose the coupling elements 422 are coupled with at least one pocket 640).
Furthermore, the claimed phrase “are welded” is being treated as a product-by-process limitation and a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. MPEP 2113.
Regarding claim 81, Gross discloses the inner stent frame 42 defines an annular upstream support portion (top annular edge of the stent frame 42; Fig. 23B), extending from the tubular portion (Fig. 23B), and dimensioned to be placed against an upstream surface of a heart valve of the heart of the subject (as shown in a similar embodiment in Fig. 8B), and the outer stent frame further defines a plurality of flanges 62/66 (Fig. 8B) that extend from the ring, and are dimensioned to be placed against a downstream surface of the heart valve (as shown in Fig. 8B).
Regarding claim 82, Gross discloses wherein the frame assembly defines a
toroidal space between the flanges 62/66, and the tubular portion (as shown in Fig. 8b, the gap between flanges 62/66 and the outer surface of tubular inner frame 42).
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 80 is rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. (2016/0324633) “Gross”.
Gross discloses the claimed invention except for the tubular portion is barrel-shaped. It would have been an obvious matter of design choice to modify the shape of the tubular portion to be barrel-shaped since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. MPEP 2144.04.
Allowable Subject Matter
Claims 77, 79 and 83-87 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the subject matter is allowable since the closest prior art of record fails to disclose “wherein the outer frame is coupled to the inner frame such that: in the compressed state of the frame assembly, the outer frame is in circumferential contact with the tubular portion, and throughout expansion of the frame assembly into its expanded state, circumferential contact is maintained between the outer frame and the tubular portion (claim 77); wherein: the apparatus defines a plurality of commissures at which the leaflets are secured to the frame assembly, and the outer frame is secured to the inner frame by both (i) the fixation of the outer-frame coupling elements to the inner-frame coupling elements, and (ii) stitching of the outer frame to the inner frame at the commissures (claim 79); wherein the upstream support portion comprises a plurality of arms that, in the expanded state of the frame assembly, protrude radially outward from the tubular portion (claim 83); wherein the plurality of arms and the plurality of flanges extend in an upstream direction from the tubular portion (claim 84); wherein: the tubular portion has an upstream end and a downstream end and a lumen therethrough, the prosthetic leaflets are configured to provide one-way blood flow through the lumen from the upstream end to the downstream end, each arm of the plurality of arms is attached to the tubular portion at a site that is downstream of the upstream end,
progressively lateral portions of each arm define, respectively: an ascending portion that extends in an upstream direction past the upstream end of the tubular portion,
an arch portion that curves in a downstream direction to form an arch, and a lateral portion that curves in an upstream direction (claim 85); wherein the frame assembly defines a
toroidal space between the flanges, the tubular portion, and the arch portions of the arms of
the upstream support portion (claim 86) and wherein each flange extends radially
outward from the tubular portion and toward a tip of the flange, and the arch portion of the
arms curves in the downstream direction past the tips of the flanges (claim 87)” which has not been found anticipated by or obvious over prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached 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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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774