DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant has amended claim 1 and claim 12 to recite the tip of the positioning structure comprises a radiopaque marker, and the leaflet are configured to open to permit blood flow through the prosthetic valve and to close during a cardiac cycle, thereby treating a patient’s aortic valve insufficiency. Examiner has maintained the rejection under Section 103 in view of Tuval et al. (Pub. No.: US 2008/0071369) in view of Drews et al. (Pub. No.: US 2005/0165479) and Case et al. (Pub. No.: US 2004/0167619).
Applicant argues neither Tuval, Drews, nor case teach or suggest “a stent comprising at least one positioning structure comprising at least one end coupled to the stent and a tip that is freestanding, the tip of the at least one positioning structure comprising a radiopaque marker.” Applicant argues that the Office is combining three different references teaching significantly different stent structures and prosthetic valve designs, without providing motivation to combine the references. Examiner disagrees, motivation to modify Tuval to include radiopaque markers is to provide a visual indication of the relative orientation of the prosthetic valve.
Applicant argues Tuval teaches away from the proposed combination by stating the prosthesis self-aligns without using any imaging techniques. This is not persuasive because “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discredit the solution claimed” (MPEP 2141.02 VI, quoting In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004)). Here, Tuval’s disclosure highlights tactile positioning and alignment and recognizes that tactile positioning may be sufficient on its own to place the heart valve. However, Tuval does not teach away from imaging-based positioning as an additive positioning indicator. Additionally, radiopaque markers have utility beyond the positioning phase of implantation, as radiopaque markers may be imaged throughout the life of the implant to provide real-time positioning information without surgical intervention.
Regarding Applicant’s evidence of secondary considerations, Applicant argues that Medtronic entirely discontinued use of the Engager product line, providing evidence of failure of others. Examiner disagrees because Medtronic’s internal business decisions to continue or discontinue a product line is not commensurate in scope with the claims at issue, nor is any nexus between the claims and the failure of others provided. Applicant’s declaration is insufficient to overcome the rejection under Section 103. Applicant’s declaration does not show that the objective evidence of non-obviousness is commensurate in scope with the claims, in particular the evidence of long-felt need is not commensurate with the claim scope.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 12/285544, and Application No. 12/071814, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior filed applications fail to provide adequate support or enablement for an annular collar at an end of the stent or a supporting structure comprising a plurality of struts.
Claims 1-7 have an effective filing date of 2/26/2008.
Claims 8-11 have an effective filing date of 2/25/2009.
Claims 12-22 have an effective filing date of 2/25/2010.
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.
Claims 1-22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tuval et al. (Pub. No.: US 2008/0071369) in view of Drews et al. (Pub. No.: US 2005/0165479) and Case et al. (Pub. No.: US 2004/0167619).
Tuval et al. (hereinafter, Tuval) discloses a stent-valve prosthesis for implantation at a patient's native aortic valve (abstract) to treat aortic valve insufficiency, the stent-valve prosthesis comprising: a stent 10 comprising at least one positioning structure 22 comprising a first end 20 coupled to the stent (e.g., fig. 1) and a second end 26 that is freestanding, the tip of the at least one positioning structure comprising a radio opaque marker (not disclosed); and a prosthetic valve 104 coupled to the stent and comprising a plurality of leaflets (e.g., fig. 1); wherein the second end of the at least one positioning structure is configured to at least partially expand to engage a pocket defined by a native leaflet of the native aortic valve such that the radiopaque marker (not disclosed) positioning structure is positioned within the pocket defined by the native leaflet and is configured to facilitate positioning during implantation of the stent-valve prosthesis, thereby aligning the prosthetic valve with patient's native aortic valve (e.g., fig. 6A, 6B), wherein the plurality of leaflets are configured to open to permit blood to flow through the prosthetic valve and to close during a cardiac cycle, thereby treating the patient’s aortic valve insufficiency (Tuval functions as a prosthetic valve).
As provided in italicized text above, Tuval lacks a radiopaque marker on the second end of the positioning structure. Drews et al. (hereinafter, Drews) teaches radiopaque markers on a prosthetic valve cusp (e.g., marker 44, para. 62) for the purpose of visualizing the orientation of the lobed prosthetic valve component. Case further teaches the use of a radiopaque marker 39 at the tip (fig. 1, 1A) of a prosthetic device for the purpose of orienting the prosthetic device within the native anatomy (abstract). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the positioning structure 22 of Tuval with a radiopaque marker as taught by Drews and Case for the purpose of providing a visual indication of the relative orientation of the prosthetic valve. This modification would have occurred using known methods and would have yielded predictable results.
For claim 2, Tuval teaches the stent-valve prosthesis of claim 1, wherein the stent comprises at least two positioning structures 22 (e.g., fig. 1, 2A).
For claim 3, Tuval discloses the stent-valve prosthesis of claim 1, wherein the stent further comprises at least one retaining arch 33 (e.g., fig. 3F, 3G).
For claim 4, Tuval discloses the stent-valve prosthesis of claim 3, wherein the second end of the at least one positioning structure 22 is configured to engage an outflow side of the native leaflet of the native heart valve and the retaining arch 33 is configured to engage an inflow side of the native leaflet (e.g., fig. 7E).
For claim 5, Tuval discloses the stent-valve prosthesis of claim 3, wherein the positioning structure 22 is a positioning arch having a first apex 20 and the retaining arch 33 has a second apex 35 (e.g., fig. 3F, 3G).
For claim 6, Tuval discloses the stent-valve prosthesis of claim 5, wherein the first apex 20 is oriented towards a first end of the stent and the second apex 35 is oriented towards a second end of the stent opposite the first end of the stent (e.g., fig. 3F)
For claim 7, Tuval discloses the stent-valve prosthesis of claim 1, wherein the at least one positioning structure 22 is three positioning structures 22 equally spaced around the stent (e.g., fig. 1, 2A).
For claim 8, Tuval discloses the stent-valve prosthesis of claim 1, wherein the stent further comprises a row of cells forming an annular collar 12 at an end of the stent (see inner support structure, fig. 1 and 2B).
For claim 9, Tuval discloses the stent-valve prosthesis of claim 8, wherein the row of cells comprises an annular cross-sectional shape and is configured to form a seal between the stent-valve prosthesis and a vascular wall of the native heart valve (e.g., fig. 7A).
For claim 10, Tuval discloses the stent valve prosthesis of claim 8, wherein the row of cells anchors the stent-valve prosthesis to the native heart valve (e.g., fig. 7A).
For claim 11, Tuval discloses the stent valve prosthesis of claim 8, wherein the annular collar comprises a plurality of eyelets 218 (e.g., fig. 1, 2B).
For claim 12, Tuval discloses a stent-valve prosthesis for implantation at a patient's native aortic valve (abstract) to treat aortic valve insufficiency, the stent-valve prosthesis comprising: a stent 10 comprising at least one positioning structure 22 comprising a first end 20 coupled to the stent (e.g., fig. 1) and a tip 26 that is freestanding, the tip of the at least one positioning structure comprising a radio opaque marker (not disclosed), the stent further comprising a supporting structure 12 comprising a plurality of struts (e.g., fig. 2B); and a prosthetic valve 104 coupled to the stent and comprising a plurality of leaflets (e.g., fig. 1); wherein the tip 26 of the at least one positioning structure is configured to at least partially expand from a collapsed state to engage an outflow side of a native leaflet of the native heart valve such that the radiopaque marker (not disclosed) positioning structure is positioned on an outflow side of a native leaflet of the native heart valve and the supporting structure is configured to fully expand to engage an inflow side of the native leaflet (e.g., fig. 7A), and wherein the plurality of leaflets are configured to open to permit blood to flow through the prosthetic valve and to close during a cardiac cycle, thereby treating the patient’s aortic valve insufficiency (Tuval functions as a prosthetic valve).
As provided in italicized text above, Tuval lacks a radiopaque marker on the second end of the positioning structure. Drews et al. (hereinafter, Drews) teaches radiopaque markers on a prosthetic valve cusp (e.g., marker 44, para. 62) for the purpose of visualizing the orientation of the lobed prosthetic valve component. Case further teaches the use of a radiopaque marker 39 at the tip (fig. 1, 1A) of a prosthetic device for the purpose of orienting the prosthetic device within the native anatomy (abstract). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the positioning structure 22 of Tuval with a radiopaque marker as taught by Drews and Case for the purpose of providing a visual indication of the relative orientation of the prosthetic valve. This modification would have occurred using known methods and would have yielded predictable results.
For claim 13, Tuval discloses the stent-valve prosthesis of claim 12, wherein the stent comprises at least two positioning structures 22 (e.g., fig. 1, 2A).
For claim 14, Tuval discloses the stent-valve prosthesis of claim 12, wherein the at least one positioning structure is a positioning arch (e.g., fig. 1, 2A).
For claim 15, Tuval discloses the stent-valve prosthesis of claim 12, wherein the stent further comprises at least one retaining arch 33 (e.g., fig. 3F, 3G).
For claim 16, Tuval discloses the stent-valve prosthesis of claim 12, wherein the second end 26 of the at least one positioning structure 22 is configured to at least partially expand to engage a pocket defined by a native leaflet of the native heart valve thereby aligning the prosthetic valve with patient's native heart valve (e.g., fig. 7E).
For claim 17, Tuval discloses the stent-valve prosthesis of claim 12, wherein the at least one positioning structure 22 is three positioning structures equally spaced around the stent (e.g., fig. 1, 2A).
For claim 18, Tuval discloses the stent-valve prosthesis of claim 12, wherein the stent further comprises a row of cells forming an annular collar at an end of the stent (distal most row of cells on inner support structure 12).
For claim 19, Tuval discloses the stent-valve prosthesis of claim 18, wherein the row of cells comprises an annular cross-sectional shape and is configured to form a seal between the stent-valve prosthesis and a vascular wall of the native heart valve (e.g., fig. 7A).
For claim 20, Tuval discloses the stent valve prosthesis of claim 18, wherein the row of cells anchors the stent- valve prosthesis to the native heart valve (e.g., fig. 7A).
For claim 21, Tuval discloses the stent valve prosthesis of claim 18, wherein the annular collar comprises a plurality of eyelets 218 (e.g., fig. 1, 2B).
For claim 22, Tuval discloses the stent valve prosthesis of claim 18, wherein the end of the stent is flared outwards (e.g., fig. 1).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUBA GANESAN whose telephone number is (571)272-3243. The examiner can normally be reached Monday-Friday, 8 AM - 5 PM Mountain Time.
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/SUBA GANESAN/Primary Examiner, Art Unit 3774
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