DETAILED ACTION
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/08/26 has been entered.
Response to Arguments
Applicant's arguments filed 06/08/26 have been fully considered but they are not persuasive.
On page 6 regarding drawing objections, Applicant argues figure 7 shows leaf guards 200’ and the valve support 104. Applicant argues the point where these two elements connect is the “connection point” and this is accordingly shown.
The Examiner respectfully notes that item 200’ and 104 are not clearly showing a connection in figure 7, either due to scale or density of lines. The figure also does not show any of the other requirements in the drawing objections, including it being located above the left ventricle of the heart, or in the atrium. This argument is accordingly unpersuasive.
On pages 6-7 regarding claim objections Applicant argues amendments overcome the objections of record.
The Examiner respectfully agrees and withdraws claim objections.
On page 7 Applicant argues the prior art fails to teach or show there being two leaf guards that oppose each other and together define an hourglass shaped cross section.
The Examiner respectfully refers to the rejection below.
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 “connection point” between the leaf guards and valve support, and the connection point being located “above the left ventricle of the heart” and “in the left atrium” 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 14, and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over McLean et al. (US 20130304200 A1) hereinafter known as McLean in view of Aklog et al. (US 20050004668 A1) hereinafter known as Aklog.
Regarding claim 1 McLean discloses a collapsible and expandable stent ([0162]) for implanting into a left atrium of a heart (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the patented structure of McLean was considered capable of performing the cited intended use. See, for example [0141] mitral valve replacement) the stent comprising:
an expanded outer section (Figure 10a item 110) comprising an outer surface, inner surface, and defining an interior;
an inner valve support extending radially upward into the interior of the outer section (Figure 10a item 120) and comprising an inflow end (Figure 10a item 121) superior to an outflow end when implanted in the heart (Figure 10a item 123; [0198], Figure 10b),
wherein the inner valve support includes an inner surface defining a flow channel between the inflow and outflow ends (Figure 10a along axis 101), and
wherein the inner valve support is positioned entirely within the interior of the outer section (Figure 10a-d);
a plurality of prosthetic valve leaflets disposed within the flow channel (Figure 10a item 130), wherein the leaflets are configured to allow flow from the inflow to the outflow end and prevent flow from the outflow to the inflow end (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of McLean discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See, for example [0202]);
a transition section comprising a plurality of cells extending between the outer section and the inner valve support (see Figures 24a-c; [0250] the inner 120 and outer 110 sections are integrally connected in what can be called a “transition section”. Since these are integrally connected at their ribs 114 and posts 122, and each inner 120 and outer 110 sections include transverse struts as well, the integral connection at the transition section end inherently includes cells formed between the various struts/posts/ribs of the inner and outer sections),
wherein the transition section comprises an outer surface and an inner edge that faces the interior defined by the outer section (Figures 24a-c),
wherein the outer section, transition section, and inner valve support are a single unitary stent structure formed of a continuous series of cells ([0250]. Please also refer to the explanation above regarding the transition section and its formation of cells), and the prosthetic leaflets are disposed within the flow channel,
and two leaf guards (Figure 80g, item 1728), each having an upstream end connected with the inner surface of the valve support at an outflow end of the valve support (where the guards 1728 connects to the stent) and a downstream end,
wherein the two leaf guards oppose each other (Figure 80g),
and when the stent is implanted in the heart, the prosthetic leaflets are disposed within the flow channel such that they are spaced away, in an upstream direction, from the two leaf guards (Figure 80g shows leaflets 130 positioned upstream and within the flow channel from the guards 1728), wherein the guards are positioned at least in part over the native leaflets (this does not appear to materially affect the structure of the claimed leaf guards and depends instead upon a method and location of implantation (see the explanation of “intended use” statements above).), and are configured to extend inwardly during systole and during diastole extend away from the valve support in a downstream direction and allow blood flow therealong (see Figure 80g which shows the guards extending inwardly and away from the support),
but is silent with regards to the leaf guards towards defining an hourglass shape,
and the lower portion of each guard being flexible and responsive to pressure and fluid flow .
However, regarding claim 1 Aklog teaches mechanisms for positioning under valves to prevent valve prolapse ([0013]), can be flexible ([0039]),
and the Combination further teaches the leaf guards being capable of being responsive to pressure and fluid flow changes (This is stated as a functional limitation (see the explanation above). A flexible leaf guard will inherently be capable of flexing in response to pressure or fluid flow changes), and the Combination also teaches the guards would obviously be prevented from flexing upwardly past a point where coaptation of native leaflets would normally occur (McLean Figure 2 shows where coaptation of leaflets normally occurs ([0166]) at FE, with Figure 10b showing how the replacement leaflets 130 are positioned at the location of normal coaptation, and the end of the stents 120/110 extending downstream therefrom. With the leaf guards connecting as the McLean Figure 80g details above, at the downstream end of the stents 120/110, the lower portion of the leaf guards would actually have to be angled upward in order to achieve a location upward past the point of normal native coaptation. If allowed to flex upwardly past this location, the leaf guards would interfere with the replacement leaflets of McLean. Accordingly, while not disclosed, the person of ordinary skill in the art at the time the invention was filed would have found it obvious for the leaf guards to not flex upwardly past a point where the native coaptation of leaflets would occur in order to ensure they do not interfere unnecessarily with the replacement leaflets 130 of McLean.). McLean and Aklog are involved in the same field of endeavor, namely heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of McLean so that the leaf guard was flexible as is taught by Aklog since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, Aklog teaches the use of leaf guards that are rigid, semi-rigid, or flexible as all being obvious to try.
Further, regarding claim 1 it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the shape of the leaf guards of the Combination to be any shape, including an hourglass shape, since it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See MPEP 2144.04 (IV)(B). It appears that the disclosed device would perform equally well shaped as disclosed by McLean, since there is no discussion in the disclosure regarding this shape of the guards and what benefits or functions it might provide.
Regarding claim 14 the McLean Aklog Combination teaches the stent of claim 1 substantially as is claimed,
wherein McLean further discloses the outflow end of the inner valve support does not extend outwardly past the transition section (Figures 24a-c).
Regarding claim 21 the McLean Aklog Combination teaches the stent of claim 1 substantially as is claimed,
wherein the McLean Aklog Combination further teaches when the stent is implanted in the heart, the leaf guards are configured to pin the native leaflets (this is stated as an intended location of implantation of the stent (which does not materially or structurally affect the stent of the claim). The native leaflets being configured to be pinned by the leaf guards is a functional limitation of the guards (see the explanation regarding both “intended use” and “functional limitations” in the rejection to claim 1 above. The leaf guards are understood to be capable of pinning back native leaflets if implanted in a particular manner, into a heart shaped particularly, that would allow this to occur. See for example McLean Figure 10b which shows the native leaflet location and 80g which shows the leaf guards, indicating the guards could secure the leaflets outside the blood flow channel if implanted in a manner that allowed this in a heart dimensioned to accommodate this).
Regarding claim 22 the McLean Aklog Combination teaches the stent of claim 1 substantially as is claimed,
wherein the McLean Aklog Combination further teaches when the stent is implanted in the heart, a connection point between the leaf guards and the valve support is located above a left ventricle of the heart (this is stated as an intended location of implantation of the stent (which does not materially or structurally affect the stent of the claim). There being a “connection point” that is located in a specific position of the heart also does not appear to materially affect the structure of the claimed invention, but rather appears to depend upon the geometry of the heart into which it is implanted, and the manner of implanting, both of which are understood to be adjustable in a manner that meet this claim limitation. Based on McLean Figures 10b, 80g it appears the connection point of the guards 1728 occurs in the vicinity of the annulus AN, which indicates it is capable of being positioned precisely location above the ventricle if desired).
Regarding claim 23 the McLean Aklog Combination teaches the stent of claim 22 substantially as is claimed,
wherein the McLean Aklog Combination further teaches when the stent is implanted in the heart, the connection point is located in the left atrium (this is stated as an intended location of implantation of the stent (which does not materially or structurally affect the stent of the claim). There being a “connection point” that is located in a specific position of the heart also does not appear to materially affect the structure of the claimed invention, but rather appears to depend upon the geometry of the heart into which it is implanted, and the manner of implanting, both of which are understood to be adjustable in a manner that meet this claim limitation.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 07/14/26
