DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/22/2025 has been entered.
Response to Arguments
Applicant's arguments filed 9/22/2025 have been fully considered but they are not persuasive. Applicant argues Drews teaches the use of visual marker 44 to align two components of a prosthetic valve together, and thus it would not have been obvious to combine the teachings of Drews with Tuval. This is not persuasive; Drews teaches radiopaque markers (para. 62) placed at a location on a valve prosthesis corresponding to the valve cusp (fig. 1). The marker functions to indicate that location relative to the native anatomy and relative to the second part of the prosthesis. Examiner notes, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Here, the visual indicator marker 44 of Drews does not cease to be a visual indicator because Drews utilizes the marker to align two components of the a two-part valve together.
Examiner has added reference to Case et al. (Pub. No.: US 2004/0167619) to teach that radiopaque markers are known to be used for placement of a prosthetic within the native anatomy of an implantation site. This Office Action is Non-Final.
Applicant’s arguments regarding the evidence of secondary considerations are addressed in the Response to Amendment section below.
Response to Amendment
The Declaration under 37 CFR 1.132 filed 9/22/2025 is insufficient to overcome the rejection of claims 1-22 based upon Tuval et al. (Pub. No.: US 2008/0071369) in view of Drews et al. (Pub. No.: US 2005/0165479) under 35 U.S.C. 103, as set forth in the last Office action because: the declarant’s opinion evidence against the assertion of obviousness under Section 103 is not persuasive because the arguments at points 10-12 amount to a piecemeal analysis of the references applied under Section 103. In the Declaration, the declarant argues that one of ordinary skill would not provide the positioning structure of Tuval with a radiopaque marker because Drews is a two-component heart valve. This does not provide evidence that the statutory bar of obviousness has not been met. Examiner has asserted that Drews provides teachings for an implantable device with markers to identify the location of the valve cusps. Tuval has cusp-engaging structures 22 which would benefit from the inclusion of a marker to allow both tactile and visual indicators of the native valve sinus. Section 103 recites:
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.
Here, the opinion evidence in the Declaration does not overcome the evidence in the record suggesting non-obviousness under Section 103. The Declarant argues one of ordinary skill would not modify Tuval with Drews to place a marker on the tip of the positioning structure as the cusp marker 44 is for aligning with another prosthetic component and not with the native valve. This is not persuasive as the Drews marker can also be used to align with the native anatomy and is not limited to aligning the two components of the Drews prosthesis. Drews is teaching use of a marker on the cusp or sinus portion of the prosthesis; that is, the portion meant to align with the native valve cusp. The radiopaque marker functions as a radiopaque anatomical marker as well as a radiopaque alignment marker.
Regarding the secondary consideration of long-felt but unsolved need, Applicant’s claims make no distinction between the treatment of aortic regurgitation as opposed to aortic stenosis. Applicant’s claims, in contrast, are directed towards the structure of the prosthetic device.
Regarding the secondary consideration of the failure of others, The declaration is not sufficient to overcome obviousness under Section 103, as the Medronic engager recall is only for the 23mm Engager, whereas the 26mm Engager was not subject to the recall.
Regarding the secondary consideration of industry praise, Applicant’s claims make no identification that the claimed prosthetic is for treatment of aortic regurgitation. Applicant’s claims, in contrast, are directed towards the structure of the prosthetic device. While the claimed structure may provide a stable fit and reduce the risk of valve migration, this is not probative evidence that Tuval in Drews is insufficient to show obviousness under Section 103.
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 heart valve (abstract), 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 and comprises 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 heart 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 heart valve (e.g., fig. 6A, 6B).
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 heart valve (abstract), 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 and comprises 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).
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
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/SUBA GANESAN/Primary Examiner, Art Unit 3774