DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application repeats a substantial portion of prior Application No. 12/569,856, filed 9/29/2009 (now Patent 8,403,983), and adds disclosure not presented in the prior application (see for example “…The leaflet supports taper in width in a direction extending from the upstream end portion of the frame toward the downstream end portion of the frame…” and “…wherein each leaflet support is generally triangular in shape…”). Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “the leaflet supports taper in width in a direction extending from the upstream end portion of the frame toward the downstream end portion of the frame must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
5. Claim 9-10, 12-14, 16-17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Braido et al. 2010/0168839 in view of Ionescu et al. 4,388,735.
Regarding claims 9 and 10 and noting figures 14, 27-33, Braido et al. discloses a prosthetic heart valve, comprising: a radially expandable and compressible stent frame (10200) comprising a plurality of struts arranged in a zig-zag pattern (see section 10100) to define a plurality of cells; a valve body (fig.30) having an inner layer and an outer layer (see fig. 33), the inner layer (8300c) comprising a plurality of leaflets (500a, b, c) each having a downstream edge and a cusp edge (see fig. 31) and the outer layer (8300 b) configured as a skirt portion comprising a plurality of leaflet supports (8264a-c) spaced apart around a circumference of the skirt portion.
Braido et al does not specify that “each leaflet of the plurality of leaflets is coupled to two adjacent leaflet supports along the cusp edge of the leaflet”. Ionescu et al. teaches that heart valve leaflets may be triangular in shape and may be attached along the edges (this is interpreted to be all of the edges, See 6:1-25) and coupled to two adjacent leaflet supports (formed by 102) along the cusp edge of the leaflet (via stitch 210). It would have been obvious to one having ordinary skill in the art to modify the invention of Braido et al. to provide each leaflet of the plurality of leaflets coupled to two adjacent leaflet supports along the cusp edge of the leaflet as taught by Ionescu in order to provide stability to the leaflets as blood flow from the inflow end to the outflow end of the valve and to reduce stresses in the areas of the cusp (See 8: 28-48).
Regarding claims 12 and 13, Braido et al. does not specifically state that “the outer layer is disposed between the stent frame and the inner layer” or “the outer layer is disposed on an outer surface of the stent frame”. It would have been obvious to one having ordinary skill in the art to modify the invention of Braido et al. and to provide the claimed layers upon different areas of the stent frame because Braido contemplates the use of various combinations of different layers attached to the insider and/or outside of the stent (see [0011]).
Regarding claims 16-17, Braido discloses plurality of apices (e.g. 236) spaced apart from one another about a circumference of the stent frame at an upstream end (outflow region) of the stent frame, and wherein an upstream edge portion of the cusp edge of each leaflet of the plurality of leaflets extends between adjacent apices (see figure 8 where cusp/edges extend between).
Allowable Subject Matter
Claims 1-8 and 18-20 are allowed.
Claims 11 and 15 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 closest prior art is considered to be Braido et al. 2010/0168839 and Bergheim et al. 2006/0025857 which disclose a prosthetic heart valve, with a radially expandable and compressible stent frame comprising a plurality of struts arranged in a zig-zag pattern to define a plurality of cells, the stent frame comprising an upstream end portion and a downstream end portion; a plurality of leaflets disposed inside the frame and configured to regulate a flow of blood through the frame in one direction, each leaflet having a downstream edge and a cusp edge comprising opposing leaflet side edges; and an inner skirt disposed inside the frame and comprising a plurality of leaflet supports.
Regarding claims 1-8, 15, and 18-20, the prior art fails to disclose or suggest that each of the leaflet supports tapers in width in a direction extending from the upstream end portion of the frame to the downstream end portion of the frame.
Regarding claim 11, the prior art fails to disclose or suggest that each leaflet support has a first and a second window side edge, the first window side edge being stitched to a first leaflet side edge of a first leaflet of the plurality of leaflets and the second window side edge being stitched to the second leaflet side edge of a second leaflet of the plurality of leaflets.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 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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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 February 20, 2026