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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/17/26 has been entered.
Response to Arguments
Applicant's arguments filed 12/17/26 have been fully considered but they are not persuasive.
On page 7 regarding prior art rejections Applicant argues anchors 34/40 do not conform to the shape of sewing ring 62, and instead “barbed ends” embed in the ring to lodge the anchors therein. Applicant concludes the anchors 36-40 do not “conform to the circular cross-section of the body member” as is required by amended claims. Applicant also concludes anchors do not have a C-shape that can secure to the body member and having a larger diameter than the body member.
The Examiner respectfully disagrees, referring to the rejection where Revuleta describes what the Examiner understands as being “conforming”, and the alternative interpretation in light of Rowe. The Examiner also is unclear why Applicant does not believe the anchors are c-shaped, as this is absolutely the shape shown by the figures of Revuelta. Further, Revuelta Figure 2c shows the anchors secure to the body member therearound. Regarding the larger diameter, see the rejection below regarding newly amended claims.
On pages 7-8 Applicant argues further that Revuelta does not teach a frame with leaflets and a D-shaped cross section, or the frame having a maximum diameter and a minimum diameter. Applicant argues instead that their frame lacks a minimum diameter, and does not teach the frame anchors being disposed between the proximal and distal end of the frame at the minimum diameter of the frame as amended claims require.
The Examiner respectfully agrees and points out that the rejection of record acknowledges Revuelta does not teach a D-shaped cross section. The Examiner disagrees that Revuelta does not teach a frame with leaflets, as these are clearly illustrated in Revuelta as element 14, and notes every structure has a maximum diameter and minimum diameter. See the rejection below regarding the newly required subject matter. Further, Revuelta Figure 1b shows how the anchors 16 (34, 40) lie between the proximal and distal ends of the frame as the claim requires.
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 1-4, 7-15 and 17, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsukashima et al. (US 20120123531 A1) hereinafter known as Tsukashima in view of Revuelta et al. (US 20060052867 A1), hereinafter known as Revuelta, and as is evidenced by Navia et al. (US 20110004299 A1) hereinafter known as Navia,
or in the alternative, over Tsukashima and Revuelta, evidenced by Navia, and further in view of Rowe (US 20080208327 A1),
or in the alternative, over Tsukashima and Revuelta, evidenced by Navia, or in the alternative, over Tsukashima and Revuelta, evidenced by Navia, and further in view of Morriss et al. (US 20150351903 A1) hereinafter known as Morriss,
or in the alternative, over Tsukashima and Revuelta, evidenced by Navia, and further in view of Rowe and Moriss.
Regarding claim 1 Tsukashima discloses an implantable valve system comprising:
an adjustable stabilizing ring (Figure 1a) comprising a body member (Figure 1a item 113) having an elongate insertion geometry and an annular operable geometry (Abstract), and a plurality of anchors (Figure 2a item 104) housed within the body member in both the elongate and annular geometry (Figure 3a-b), wherein the anchors have a deployment configuration in the annular geometry to engage an annulus of a cardiovascular valve (Figure 3b; see also Figure 14e),
wherein the body member has a circular cross-section (Figure 6a the tubular body member’s cross-section is seen to be circular),
but is silent with regards to the system including an implantable valve frame with leaflets which has a D-shaped cross-section and a minimum diameter and a maximum diameter,
where the valve frame comprises a plurality of C-shaped frame anchors disposed between a proximal and a distal end of the valve frame at the minimum diameter of the valve frame which are configured to conform to the circular cross-section of the body member so each frame anchor contacts a surface of the body member with the circular cross-section along the C-shape of each frame anchor to secure the implantable frame to the ring in the annular geometry so the valve frame is in mechanical communication with the body member, the C-shaped anchors being configured to be secured to the body member and having a larger diameter than that of the body member.
However, regarding claim 1, Revuelta teaches a valve system which includes an annular stabilizing element (Figure 2a; Abstract), but also includes an implantable valve frame (Figure 1a item 12) with leaflets (Figure 1a item 14), the frame having a maximum diameter (the outermost extent of the diameter of the frame is realized at the radially outermost ends of the anchors 16 (34, 40)) and a minimum diameter (the outer diameter of the body of the frame realized at the outermost radial extent of the frame 12 at the locations where the anchors 16 (34, 40) join thereto),
wherein the valve frame comprises a plurality of c-shaped frame anchors (Figure 1a item 16 (34, 40)) disposed between a proximal and a distal end of the valve frame ([0034] the anchors extend inwardly relative to the inflow end 38; see also [0036] the anchors can be intermediately disposed along the length of the support structure 12), at the minimum diameter of the implantable valve frame (Figure 1a shows the anchors 16 (34, 40) joined to the body of the frame 12 at the minimum outer diameter), and configured to be secured to the [annular stabilizing element] and having a larger diameter than that of the [annular stabilizing element] (Figure 2c shows how both the annular stabilizing element (e.g. the previously implanted valve) and the proximal/distal ends of the valve frame which holds the anchors (16/34/40) are similar/in harmony in their circular cross-sections within the annulus. See also [0035] the anchors extend around the stent structure of the previously implanted valve (e.g. at a larger diameter than, to engage therewith to physically dock; [0046] the anchors wrap around the previously implanted valve),
configured to conform to the circular cross-section of the [annular stabilizing element] (“conform” is defined by Merriam-Webster as “to be similar or identical; be the in agreement or harmony”. Figure 2c shows how both the annular stabilizing element (e.g. the previously implanted valve) and the proximal/distal ends of the valve frame which holds the anchors (16/34/40) are similar/in harmony in their circular cross-sections within the annulus. See also [0035] the anchors extend around the stent structure of the previously implanted valve to engage therewith to physically dock; [0046] the anchors wrap around the previously implanted valve. Alternatively, see the rejection below regarding “conforming” to the circular cross-section in view of Rowe.)
such that each frame anchor contacts a surface of the [annular stabilizing element’s] body (again, see Figure 2c where the anchors are seen contacting proximal and distal surfaces of the previously implanted valve, and [0034] the anchors engage the previously implanted valve; [0035] the anchors extend around the stent structure of the previously implanted valve to engage therewith to physically dock; [0046] the anchors wrap around the previously implanted valve)
along the C-shape of each frame anchor (Figure 2c again shows the anchors 16/34/40 where contact occurs at at least some point along the C-shape of the anchors; [0034] the anchors engage the previously implanted valve, which indicates at their point of engagement they are in conformance with one another, and contacting the surface at a point along the C-shape of the anchor)
to secure the valve frame to [the annular stabilizing element] ([0034]-[0035], Figure 2c show and describe how the anchors are designed to “engage”, “project around”, and “engaging within” the previously implanted annular element, to “physically dock” the two elements together),
such that the valve frame is mechanical communication with the body of the [annular stabilizing element] ([0034] the anchors engage the previously implanted valve; [0035] the anchors extend around the stent structure of the previously implanted valve to engage therewith to physically dock; [0046] the anchors wrap around the previously implanted valve).
Tsukashima and Revuelta are involved in the same field of endeavor, namely repair of valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of Tsukashima to include the valve frame and leaflets as is taught by Revuelta in order to provide a mechanism to replace a damaged annular stabilizing element device without having to first remove the damaged element, which might damage the cardiac tissue. Further, see Navia, which describes how a failed annuloplasty ring device can be supplemented with a new valve ([0173]) instead of replacing a failed valve with a new valve ([0175]).
Alternatively, with regards to the frame anchors being configured to conform to the cross-section of the body member, Revuelta teaches that the anchors do not necessarily pierce through the previously implanted valve ([0048]). If the anchors of Revuelta are going to anchor around the ring-shaped stabilizing ring of Tsukashima without piercing the ring, then it would be obvious for either the ring body or the anchors to conform to the other to achieve such anchoring. Rowe teaches that it is desirable for a new, replacement valve to conform to the geometry of the previously implanted valve in order to adequately anchor and form an effective seal ([0003]). Tsukashima and Rowe are involved in the same field of endeavor, namely valve repair. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of the Tsukashima Revuelta Combination to have the anchors (of Revuelta) to conform to the body member of Tsukashima as is taught by Rowe in order to ensure adequate anchoring and effective sealing (Rowe [0003]).
Further, regarding claim 1 Tsukashima teaches that valve repair devices could desirably have a D-shaped geometry ([0050]) in order to mimic the native anatomical geometry of a healthy human mitral valve annulus. Thus, the person of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the shape of the valve frame of the Combination to be D-shaped in order to mimic the native natural shape of a human mitral valve.
Alternatively, regarding claim 1 Morriss teaches that valves can take on a D-shaped cross-sectional profile ([0123]). Tsukashima and Morriss are involved in the same field of endeavor, namely valve repair. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of the Tsukashima Revuelta (Rowe) Combination to have the valve comprise a D-shaped cross-section as is taught by Morriss in order to provide a valve that mimics the shape of a mitral valve, thus closely following the natural and healthy valve shape of a non-diseased valve.
Regarding claim 2 the Tsukashima Revuelta (Rowe) (Moriss) Combination teaches the system of claim 1 substantially as is claimed,
wherein Tsukashima further discloses the adjustable ring is coated with a pliable polymer material ([0056]).
Regarding claim 3 the Tsukashima Revuelta (Rowe) (Moriss) Combination teaches the system of claim 1 substantially as is claimed,
wherein Revuelta further teaches the valve frame extends radially inward toward a central axis (Figure 4a).
Regarding claim 4 the Tsukashima Revuelta (Rowe) (Moriss) Combination teaches the system of claim 1 substantially as is claimed,
wherein Revuelta further teaches the frame comprises a first support element, second support element and a bridging element extending from the first to second element (see Annotated Figure 4a, below).
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Regarding claim 7 the Tsukashima Revuelta (Rowe) (Moriss) Combination teaches the system of claim 4 substantially as is claimed,
wherein Revuelta further teaches the leaflets are at least partially secured to the first/second/bridging element ([0037]).
Regarding claim 8 the Tsukashima Revuelta (Rowe) (Moriss) Combination teaches the system of claim 4 substantially as is claimed,
wherein Revuelta further teaches the bridging element comprises a continuous surface having a first end and second end, wherein the first end is in physical contact with an entirety of the first support element and the second end is in physical contact with an entirety of the second support element (Annotated Figure 4a).
Regarding claim 9 the Tsukashima Revuelta (Rowe) (Moriss) Combination teaches the system of claim 4 substantially as is claimed,
wherein Revuelta further teaches the bridging element comprises a collapsible material (Figure 2b, [0042]).
Regarding claim 10 the Tsukashima Revuelta (Rowe) (Moriss) Combination teaches the system of claim 4 substantially as is claimed,
wherein Revuelta further teaches the bridging element extends radially inward towards a central axis of the frame (Annotated Figure 4a).
Regarding claim 11 the Tsukashima Revuelta (Rowe) (Moriss) Combination teaches the system of claim 4 substantially as is claimed,
wherein Revuelta further teaches at least a portion of an exterior surface of the bridging element is in mechanical communication with the adjustable stabilizing [element] (Figures 2b-c).
Regarding claim 12 the Tsukashima Revuelta (Rowe) (Moriss) Combination teaches the system of claim 1 substantially as is claimed,
wherein Revuelta further teaches the valve frame is at least partially collapsible ([0045]; Figure 2b, [0042]).
Regarding claim 13 the Tsukashima Revuelta (Rowe) (Moriss) Combination teaches the system of claim 1 substantially as is claimed,
wherein Revuelta further teaches the valve frame is configured to be delivered via a catheter ([0041]; Figure 2b) in an at least partially collapsed state (Figure 2b; [0042]).
Regarding claim 14 the Tsukashima Revuelta (Rowe) (Moriss) Combination teaches the system of claim 13 substantially as is claimed,
wherein Revuelta further teaches the valve frame is expandable from the partially collapsed state ([0045]).
Regarding claim 15 the Tsukashima Revuelta (Rowe) (Moriss) Combination teaches the system of claim 1 substantially as is claimed,
wherein Revuelta further teaches the valve frame comprises a shape memory or stainless steel material ([0030]).
Regarding claim 17 the Tsukashima Revuelta (Rowe) (Moriss) Combination teaches the system of claim 1 substantially as is claimed,
wherein Revuelta further teaches the plurality of frame anchors are configured to partially encompass the adjustable stabilizing [element] (Figure 2c; [0046]).
Regarding claim 19 the Tsukashima Revuelta (Rowe) (Moriss) Combination teaches the system of claim 1 substantially as is claimed,
wherein Tsukashima further discloses the annular operable geometry has a closed state (Figure 1d) to conform to the annulus of the cardiovascular valve ([0128]).
Regarding claim 20 the Tsukashima Revuelta (Rowe) (Moriss) Combination teaches the system of claim 1 substantially as is claimed,
wherein Revuelta further teaches there is at least one gap between the valve frame and stabilizing [element] ([0031] areas where the wall of the stent 12 is cut away will be gapped from the stabilizing element; see also/alternatively Figures 3, 6b, 10b etc. which all show gaps possible).
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 02/13/26
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