DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 “lower surface”, “first stent cell pattern”, and “second stent cell pattern” of claim 1 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 § 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 31 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.
The term “substantially” in claim 31 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what qualifies as “substantially co-planar” and what does not.
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.
Claims 28-34 are rejected under 35 U.S.C. 103 as being unpatentable over Benson et al. (US Pat. No. 9532887 B2), “Benson” in view of Garde et al. (US Pat. No. 8986375 B2), “Garge”.
Regarding claim 28, Benson teaches a collapsible and expandable stent adapted to treat blood flow regurgitation in a native heart valve by allowing downstream blood flow and preventing upstream blood flow, the stent (Fig. 4, stent 100) comprising: an outer section defining a lower surface (Fig. 4, annulus section 108); an inner valve support section extending radially upward into the outer section (Figs. 4 and 6A, foldable section 110 is inverted or folded under the annulus section 108 (col. 5, lines 57-58)) and comprising a first stent cell pattern or a second stent cell pattern (Fig. 5, foldable section 110 comprises bendable struts 138 which form a pattern), the inner valve support section supporting prosthetic valve leaflets attached therein (Fig. 6A, valve assembly 200 attached to foldable section 110 comprises leaflets 202); a transition section that is configured to collapse between the outer section and the inner valve support section (Fig. 6A, radial space between outer layer of stent 100 and valve assembly 200 is collapsible (col. 6, par. 3)), but fails to teach a boss section integrated with, or attached to, the outer section and extending downstream from the lower surface, wherein the boss section is adapted to expand radially within an annular throat of the native heart valve.
Garde teaches a heart valve prosthesis comprising a boss section integrated with, or attached to, the outer section and extending downstream from the lower surface (Fig. 3, anti-paravalvular leakage component 330), wherein the boss section is adapted to expand radially within an annular throat of the native heart valve (Fig. 3, component 330 is positioned in situ at the native valve annulus (col. 7, par. 2)). Garde discloses that the anti-paravalvular leakage component is in direct apposition with the native valve annulus and blocks blood flow around the perimeter of the prosthesis, minimizing leakage at the implantation site (col. 7, par. 2). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Benson with the boss section taught by Garde in order to minimize blood leakage at the implantation site.
Regarding claim 29, Benson fails to teach the limitations of claim 29. Garde teaches a heart valve prosthesis wherein the boss section comprises at least one expanded shape selected from the group consisting of: circular, D-shaped, oval, elliptical, and complementary and/or adaptable to an upper annular shape (Fig. 3B, component 330 is circular in shape and fits to the native valve annulus). Garde discloses that the anti-paravalvular leakage component is in direct apposition with the native valve annulus and blocks blood flow around the perimeter of the prosthesis, minimizing leakage at the implantation site (col. 7, par. 2). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Benson with the boss section taught by Garde in order to minimize blood leakage at the implantation site.
Regarding claim 30, Benson fails to teach the limitations of claim 30. Garde teaches a heart valve prosthesis wherein the boss section is contoured to complement a shape of the native heart valve (Fig. 3, component 330 is positioned in situ at the native valve annulus (col. 7, par. 2)). Garde discloses that the anti-paravalvular leakage component is in direct apposition with the native valve annulus and blocks blood flow around the perimeter of the prosthesis, minimizing leakage at the implantation site (col. 7, par. 2). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Benson with the boss section taught by Garde in order to minimize blood leakage at the implantation site.
Regarding claim 31, Benson fails to teach the limitations of claim 31. Garde teaches a heart valve prosthesis further comprising the boss section extending downstream to a position that is selected from the group consisting of: above an annular plane, substantially co-planar with the annular plane, and slightly below the annular plane within an annulus (Fig. 3, component 330 may be positioned in situ at the annulus, slightly above the annulus, slightly below the annulus, or some combination thereof (col. 7, par. 2)). Garde discloses that the anti-paravalvular leakage component is in direct apposition with the native valve annulus and blocks blood flow around the perimeter of the prosthesis, minimizing leakage at the implantation site (col. 7, par. 2). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Benson with the boss section taught by Garde in order to minimize blood leakage at the implantation site.
Regarding claim 33, Benson teaches the prosthetic leaflets aligned with the native valve leaflets (Fig. 6, valve 200 and stent 100 are implanted at a native valve annulus (col. 6, par. 3) (i.e., leaflets are positioned to function as native valve leaflets)), but fails to teach wherein the boss section is adapted to align the stent within the native heart valve.
Garde teaches a heart valve prosthesis wherein the boss section is adapted to align the stent within the native heart valve (Fig. 3, component 330 is positioned in situ at the native valve annulus (col. 7, par. 2)). Garde discloses that the anti-paravalvular leakage component is in direct apposition with the native valve annulus and blocks blood flow around the perimeter of the prosthesis, minimizing leakage at the implantation site (col. 7, par. 2). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Benson with the boss section taught by Garde in order to minimize blood leakage at the implantation site.
Regarding claim 34, Benson teaches wherein the boss section is adapted to mitigate perivalvular leakage within the native heart valve (Fig. 3, anti-paravalvular leakage component 330 minimizes and/or eliminates paravalvular leakage (col. 7, par. 2)). Garde discloses that the anti-paravalvular leakage component is in direct apposition with the native valve annulus and blocks blood flow around the perimeter of the prosthesis, minimizing leakage at the implantation site (col. 7, par. 2). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Benson with the boss section taught by Garde in order to minimize blood leakage at the implantation site.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA GISELLE B RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 7:30-6:00 EST.
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/G.G.R./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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