Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claims 2 and 24 are 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.
In regard to claims 2 and 24, the claims recite “the outer skirt terminates at or upstream of a midpoint of an axial height of each cell” and then recites that “at least half an outflow half of each cell remains uncovered by the outer skirt”. If the outer skirt terminates upstream of a midpoint of an axial height of each cell, it is not possible that at least half an outflow half of each cell will be uncovered. The two limitations conflict with one another. The instant disclosure does not provide further clarification.
Since claims 2 and 24 are rejected under 112, claims 4-8, 10-11, 14-16, 18-23, 25-26 are also rejected under 112b.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 4-6, 8, 10-11, 14-16, and 18-22, 24-26 are rejected under 35 US.C. 103 as being unpatentable over Essinger et al. (WO 2009/053497 A1) in view of Nguyen et al. (US Pub. No 2005/0075720 A1) and in view of Spenser (2003/0114913A1) and in view of Tabor (WO2009/094188A1).
Regarding claim 2, Essinger disclose a valve replacement device for transcatheter implantation (Figs. 1A-B), comprising:
a stent component (102, 104, 108) including a lattice structure defining a plurality of circumferentially adjacent closed cells (see stent at 102, 104, 108 are made up of closed cells), the stent component having an inflow, upstream section (102) with an inflow extremity, an intermediate section (106), and an outflow, downstream section (108) defining an outflow extremity of the stent component (fig 1A-B);
wherein a first row of circumferentially adjacent closed cells (at 102) defines the inflow extremity (see blood flow arrow, the bottom of figure 1A is the inflow extremity) and a second row of circumferentially adjacent closed cells defines the outflow extremity (at 104);
wherein the second row of circumferentially adjacent closed cells (at 108) extends downstream (downstream of 102, see arrow in figure 1A) and curves first radially outward from the plurality of commissural posts (see fig 1A, is outward radially compared to posts at 108)
wherein the stent component 100 is radially compressible to a compressed state for delivery to a site of implantation and radially expandable to a functional state (Paragraph 0046); valve leaflets mounted at least partly within the stent component (Paragraph 0046 – valve component 124 includes leaflets);
and an inner skirt (122) and an outer skirt (126),
the inner skirt extending at least partly within the stent component towards the inflow extremity (Fig. 1B depicts the inner skirt 122 located inside of the stent and at the inflow end; Paragraph 0071),
and the outer skirt 126 extends axially from the inflow extremity (interpreted as along the long axis of the stent, see fig 1B) along an inflow portion of each cell in the row of circumferentially adjacent cells (fig 1B) (Fig. 1B depicts the outer skirt 126 located outside of the stent and located at the inflow extremity; Paragraph 0071);
wherein at least a portion of the stent component extends upstream of the outer skirt (See Fig. 1B) Wherein the outer skirt extends along an outside of the stent component (fig 1B).
In the embodiment of figures 1A-B, Essinger does not disclose the stent component comprises a plurality of commissural posts or that the second row of circumferentially closed cells curves radially inward at the tips of the closed cells or that the outer skirt terminates at or upstream of a midpoint of an axial height of each cell.
Tabor teaches the second row of circumferentially closed cells and then curves radially inward at the tips of the closed cells that define the outflow extremity and a terminal end of an entirety of the stent component (see annotated figure 32)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outflow cells of the stent of Essinger to flare inwardly after flaring outwardly as taught by Tabor because the inward flaring ensures atraumatic implantation while still maintaining contact with the patient’s anatomy [00059; 00078].
Nguyen teaches wherein the stent component comprises a plurality of commissural posts 22, the valve leaflets being secured to the plurality of commissural posts (see fig 6A, using tabs 35) [0088]; and teaches the commissural posts comprises an elongate hole formed therein (21) and a plurality of small holes formed therein (41).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the commissural posts of Nguyen in the stent valve of Essinger because the small holes facilitate the placement of additional sutures to secure the valve [0092] and the posts stabilize the valve [0086].
Spenser teaches an outer skirt 21 that terminates at or upstream of a midpoint of an axial height of each cell, such that at least an outflow half of each cell remains uncovered by the outer skirt (see figure 1; in as much as the claim allows for and the instant invention).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the outer skirt height of the heart valve of Spenser in the outer skirt and heart valve of Essinger because the cuff enhances stability [0171] and to avoid interfering native anatomy, reducing the risk of complications during deployment and preserving access for future interventions.
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Regarding claim 4, Essinger in view of Nguyen discloses the valve replacement device of claim 2. Essinger further teaches wherein the stent is self-expandable (Paragraph 0061).
Regarding claim 5, Essinger in view of Nguyen discloses the valve replacement device of claim 2. Essinger further discloses wherein the inner skirt and the outer skirt partly overlap in an axial direction (Fig. 1B below depicts the inner and outer skirt overlap in the axial direction). When the inner skirt of Spenser is applied to the ends of the stent, there will still be axial overlap since the inner skirt is almost the entire length of the stent.
Regarding claim 6, Essinger in view of Nguyen discloses the valve replacement device of claim 5. Essinger further discloses the inner skirt in the axial direction is at least 8 mm (Paragraph 0085 – Fig. 5 is used to illustrate dimensions of the stent; Paragraph 0086 – length of H2 can be between 3-15mm; Fig. 1B depicts the outer skirt cover the distance of H2 (Fig. 5).
However, Essinger in view of Spenser does not teach the degree of overlap of the inner and outer skirt in the axial direction is at least 8mm.
It has been held that a mere optimization of the working parts of the invention, yielding a predictable result, requires no more than routine skill in the art. The length of the outer skirt is a result effective variable with a longer skirt resulting in a greater seal and a shorter skirt resulting in more ingrowth to prevent the stent from dislodging. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to optimize the length of the outer skirt of Essinger in view of Sepnser to be 8mm long. Since the inner skirt of Essinger is the full length of the stent, this results in an overlap of 8mm. Absent a teaching of criticality (new or unexpected result), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.05IIB
Regarding 8, Essinger in view of Nguyen discloses the valve replacement device of claim 2. Essinger further discloses wherein the inner skirt extends further towards the outflow extremity of the stent component than does the outer skirt (Fig. 1B below depicts the inner skirt 122 extends further towards the outflow end than the outer skirt 126). When the outer skirt of Spenser is applied, the skirt is only around the end of the stent while the inner skirt of Essinger is almost the entire length of the stent. Therefore, the inner skirt of Essinger extends further toward the outflow extremity of the stent when the references are combined.
Regarding claim 10, Essinger in view of Nguyen discloses the valve replacement device of claim 2. Essinger further discloses wherein the valve leaflets are attached to an interior portion of the inner skirt (Paragraph 0070 – the inner skirt is sutured to at least the inflow tract of the valve component (leaflets)).
Regarding claim 11, Essinger in view of Nguyen discloses the valve replacement device of claim 2. Essinger further discloses wherein the inner and outer skirts are made of the same material (Paragraph 0070 – both skirts are made of PET).
Regarding claim 14, Essinger in view of Nguyen discloses the valve replacement device of claim 2. Essinger further discloses wherein the lower edges of the leaflets are attached to the inner skirt by suturing (Paragraph 0070 – inner skirt is sutured to at least the inflow tract of the valve component (leaflets). One of ordinary skill in the art would understand that the inflow tract of the valve component is equivalent to the lower edges of the valve component (leaflets)).
Regarding claim 15, Essinger in view of Nguyen discloses the valve replacement device of claim 2. Essinger further discloses wherein the valve leaflets are made of porcine pericardial tissue (Paragraph 0048 – the preferred material for the valve component is mammal pericardium tissue; Paragraph 0049 – valve can be made of porcine tissue).
Regarding claim 16, Essinger in view of Nguyen discloses a combination of a valve replacement device according to claim 2. Essinger further discloses a delivery device (Fig. 14A ; 550) for inserting the valve replacement device at the heart, the delivery device comprising a distal portion (See Fig. 14A below) with an accommodation region (554) for accommodating the valve replacement device in its compressed state (Paragraph 00113), the delivery device further comprising a stent holder provided at the accommodation region (560) for mating engagement with the stent component for restraining the valve replacement device against axial movement (Paragraph 00103 – the stent is coupled to the stent holder 560 by fixation elements. One of ordinary skill in the art would understand that if the stent is attached to the stent holder, the stent would resist axial movement).
Regarding claim 18, Essinger in view of Nguyen discloses the valve replacement device of claim 2, but does not teach the commissural posts as claimed.
Nguyen further teaches wherein the elongate hole is oriented axially (Nguyen: Fig. 6C depicts the long hole 21 is oriented axially)).
Regarding claim 19, Essinger in view of Nguyen discloses the valve replacement device of claim 2.
Essinger does not teach the commissural posts.
Nguyen further teaches the plurality of small holes comprises two columns of small holes, each comprising more than one hole. (Nguyen: Fig. 6C depicts there are two columns of small holes 41 with 2 holes in each column)).
Regarding claim 20, Essinger in view of Nguyen discloses the valve replacement device of claim 19 but does not teach the holes as claimed.
Nguyen further teaches the two columns of holes are disposed on opposing sides of the elongate hole. The modification of the commissural posts of Essinger to include a plurality of small holes and an elongate hole as taught by Nguyen would yield the columns of small holes are located on opposing sides of the long hole (Nguyen: Fig. 6C depicts the two columns of small holes 41 located on opposing sides of the long hole 21)).
Regarding claim 21, Essinger in view of Nguyen discloses the valve replacement device of claim 2, but does not teach the commissural posts as claimed.
Nguyen further teaches the elongate hole is configured to receive tabs extending laterally from the valve leaflets. (Nguyen: Paragraph 0088)).
Regarding claim 22, Essinger in view of Nguyen discloses the valve replacement device of claim 2.
In another embodiment (Fig. 9), Essinger further teaches wherein the stent component further comprises at least one attachment element extending axially from the inflow end (Fig. 9 depicts the stent having multiple fixation elements (attachment elements) extending axially from the inflow end (bottom)) for mating engagement with a delivery device (Paragraph 0033).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stent of Figs. 1A-B of Essinger in view of Nguyen to include at least one attachment element as taught by Fig. 9 of Essinger for the purpose of attaching the stent to the catheter (Essinger: Paragraph 00103).
In regard to claim 24, Essinger teaches a valve replacement device for transcatheter implantation, comprising:
a stent component 100 having an inflow, upstream section (see arrow in fig 1A) with an inflow extremity (102), an intermediate section 104, and an outflow, downstream section defining an outflow extremity 108 of the stent component,
wherein a first row of circumferentially adjacent closed cells defines the inflow extremity (see blood flow arrow, the bottom of figure 1A is the inflow extremity) and a second row of circumferentially adjacent closed cells defines the outflow extremity (at 108);
valve leaflets mounted at least partly within the stent component; [0046: valved-stent; 0050: sewing leaflets to a stent; 0051: valve attached to the inner channel of the stent; 0047: heart valve comprises moveable leaflets]
an inner skirt 122 extending at least partly within the stent component 100 towards the inflow extremity (fig 1B, a part of the skirt is at the inflow portion near 102);
and an outer skirt 126 extending axially from the inflow extremity (see fig 1B) along an inflow portion of each cell in the row of circumferentially adjacent cells (fig 1B),
wherein the second row of circumferentially adjacent closed cells (at 108) extends downstream (downstream of 102, see arrow in figure 1A) and curves first radially outward from the plurality of commissural posts (see fig 1A, is outward radially at 108).
However, Essinger does not teach a lower anchoring crown at the inflow extremity, commissural posts as claimed or the second row of circumferentially closed cells curves radially inward at the tips of the closed cells or that the outer skirt terminates at or upstream from a midpoint of each cell.
Nguyen teaches wherein the stent component comprises a plurality of commissural posts 22, the valve leaflets being secured to the plurality of commissural posts (see fig 6A, using tabs 35) [0088];
wherein each commissural post 22 comprises a long hole 21 (any hole can be considered long because there is no comparison) formed therein and a plurality (defined as two or more) of small holes 41 formed therein. (see fig 6C).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the commissural posts of Nguyen in the stent valve of Essinger because the small holes facilitate the placement of additional sutures to secure the valve [0092] and the posts stabilize the valve [0086].
The embodiment of figure 2B of Essinger teaches the stent component defining a lower anchoring crown 202 at the inflow extremity, the lower anchoring crown formed by a lattice structure (see lattice) defining a row of circumferentially adjacent cells (fig 2B). [0053]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed use the anchoring crown of Essinger in the embodiment of figure 2B in the embodiment of figures 1A-B because the anchoring crown to reduce migration of the valve [0055].
Tabor teaches the second row of circumferentially closed cells curves radially outwardly and then curves radially inward at the tips of the closed cells that define the outflow extremity and a terminal end of an entirety of the stent component (see annotated figure 32)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outflow cells of the stent of Essinger to flare inwardly after flaring outwardly as taught by Tabor because the inward flaring ensures atraumatic implantation while still maintaining contact with the patient’s anatomy [00059; 00078].
Spenser teaches an outer skirt 21 that terminates at or upstream of a midpoint of an axial height of each cell, such that at least an outflow half of each cell remains uncovered by the outer skirt (see figure 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the outer skirt height of the heart valve of Spenser in the outer skirt and heart valve of Essinger because the cuff enhances stability [0171] and to avoid interfering native anatomy, reducing the risk of complications during deployment and preserving access for future interventions.
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In regard to claim 25, Essinger meets the claim limitations as discussed in the rejection of claim 24, but doesn’t teach the outer skirt configuration as claimed.
Spenser further teaches the outer skirt 21 covers only a lower, inflow portion of the row of circumferentially adjacent cells. (figure 1)
In regard to claim 26, Essinger meets the claim limitations as discussed in the rejection of claim 24, but does not teach the stent component includes a plurality of attachment elements at the inflow extremity in the embodiment of figures 1A-B).
In the embodiment of figures 2A-B, Essinger teaches the stent component includes a plurality of attachment elements 216 at the inflow extremity [0073 one or more], wherein the plurality of attachment elements are not covered by the outer skirt. (fig 2B)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the attachment elements of the embodiment of figure 2B in the stent embodiment of figures 1A-B (outside of the skirt so they function as intended) because they are able to attach a removable element such as a catheter to the stent during delivery and allow for recapture of the stent upon a partial release [0073].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Essinger in view of Nguyen and in view of Spenser (2003/0114913A1) and in view of Tabor (WO2009/094188A1) and in further view of Hariton et al. (US Pub. No 2010/0036484 A1).
Regarding claim 7, Essinger in view of Nguyen discloses the valve replacement device of claim 2, but does not disclose wherein the outer skirt extends further towards the inflow extremity of the stent component than does the inner skirt.
Hariton discloses a prosthetic valve (Fig. 25) and teaches the inner skirt does not extend to the inflow extremity (Paragraph 0079 – skirt 340 can be mounted on the inside of the frame; Fig. 25 depicts the inner skirt 340 does not extend all the way towards the inflow extremity).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to change the length of the inner skirt of Essinger in view of Nguyen to not extend to the inflow extremity as taught by Hariton as this is a known and suitable arrangement for the inner skirt in the art. Further, it is a matter of engineering design to arrange the inner skirt in different ways, where the change in form or shape, without any new or unexpected result, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04). Finally, one would have a reasonable expectation of success by changing the arrangement of the inner skirt to the claimed limitation as Hariton teaches this arrangement is a known and suitable arrangement in the art.
The modification of the inner skirt of Essinger in view of Nguyen to not extend to the inflow extremity would yield the outer skirt of Essinger (126) extending further towards the inflow extremity than the inner skirt (340) of Hariton as the outer skirt of Essinger ends at the inflow extremity.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Essinger in view of Nguyen and further in view of Spenser (2003/0114913A1) and in view of Tabor (WO2009/094188A1) and in further view of Nguyen et al. (US Pub. No 2006/0259136 A1), hereinafter Nguyen (2006).
Regarding claim 23, Essinger in view of Nguyen discloses the valve replacement device of claim 2, but does not disclose wherein the inflow portion of the stent component has a maximal diameter in the functional state that is less than a maximal diameter of the outflow portion of the stent component in the functional state.
Nguyen (2006) discloses a prosthetic valve (Fig. 1A) and teaches wherein the inflow portion of the stent component has a maximal diameter (DI) in the functional state that is less than a maximal diameter of the outflow portion of the stent component (Do) in the functional state (Fig. 1A depicts the maximal diameter of the inflow portion is smaller than the maximal diameter of the outflow portion Do).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the stent of Essinger in view of Nguyen to have a smaller inflow diameter than the outflow diameter as taught by Nguyen (2006) for the purpose of directing blood flow through the valve body with little or no turbulence (Nguyen (2006): Paragraph 0042).
Response to Arguments
In regard to the 103(a) rejection of claims 2, 4-6, 8, 10-11, 14-16, and 18-22, 24-26 are rejected under 35 US.C. 103 as being unpatentable over Essinger et al. (WO 2009/053497 A1) in view of Nguyen et al. (US Pub. No 2005/0075720 A1) and further in view of Gabbay (2002/0032481A1) and in view of Tabor (WO2009/094188A1), the applicant’s arguments have been fully considered but are directed towards newly added claim limitations which have been addressed above.
In regard to the 103(a) rejection of claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Essinger in view of Nguyen and in view of Gabbay (2002/0032481A1) and in view of Tabor (WO2009/094188A1) and in further view of Hariton et al. (US Pub. No 2010/0036484 A1), no further arguments have been submitted.
In regard to the 103(a) rejection of claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Essinger in view of Nguyen and further in view of Gabbay (2002/0032481A1) and in view of Tabor (WO2009/094188A1) and in further view of Nguyen et al. (US Pub. No 2006/0259136 A1), hereinafter Nguyen (2006), no further arguments have been submitted.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
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