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 .
Election/Restrictions
Applicant’s election of Group I directed toward claims 1-19 (now 1-16, 18-19, 24-28) and species A directed toward a balloon expandable anchor frame without traverse is acknowledged.
Claim Objections
Claim(s) 19 is/are objected to because of the following informalities:
In regard to claim 19, “TFE-PMVE copolymer” should be written out in full form as “copolymer of tetrafluoroethylene and perfluoromethyl vinyl ether”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 6-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Benichou (2009/0281609A1).
In regard to claim 1, Benichou discloses a prosthetic comprising:
an anchor frame (100a, 108) adapted to anchor to tissue, the anchor frame having a total length between an inflow end (at 1136) and an outflow end (at 1238) of the anchor frame, an inner diameter, and a first deployed transverse deformation resistance (every material has some resistance), the anchor frame including a first interface region defining a shoulder feature 604 (fig 6),
and a leaflet frame (100b, 100) including a leaflet assembly 204 coupled to the leaflet frame along a leaflet coupling region (fig 6),
the leaflet frame having a total length between an inflow end (toward 1136) and an outflow end (toward 1238) of the leaflet frame, an outer diameter, and a second deployed transverse deformation resistance (every material has some resistance),
the leaflet frame (100b, 100) having a second interface region extending at least along the leaflet coupling region, the second interface region defining a complementary shoulder feature (at 604, fig 6) to the shoulder feature of the anchor frame subcomponent (see fig 6, both shoulders at 604)
wherein the anchor frame(100a, 108) and the leaflet frame (100b, 100) are adapted to be transitioned from an un-nested configuration in which the leaflet frame and the anchor frame are axially separated from one another (figure 1) to a nested configuration (figure 6) in which the anchor frame and the leaflet frame engage along a combined interface corresponding to the first interface region and the second interface region via an interference fit with the shoulder feature 604 and the complementary shoulder feature at 604 engaged and such that the prosthetic valve has a combined interface transverse deformation resistance along the combined interface that exceeds each of the first and second deployed transverse deformation resistances of the anchor frame and the leaflet frame, respectively. This is a material property. Two layers of material will have a greater deformation resistance than one layer.
In regard to claim 2, Benichou discloses the prosthetic valve of claim 1, and further discloses the shoulder feature 604 and the complementary shoulder feature at 604 include complementary tapered profiles. (figure 6)
In regard to claim 6, Benichou discloses the prosthetic valve of claim 1, and further discloses in the nested configuration (fig 6), the inner diameter of the anchor frame (100a, 108) and the outer diameter of the leaflet frame (100b, 100) abut one another along the leaflet coupling region of the leaflet frame.
In regard to claim 7, Benichou discloses the prosthetic valve of claim 1, and further discloses the combined interface has a length that extends from an inflow side of the leaflet assembly to an outflow side of the leaflet assembly. (see figure 6)
In regard to claim 8, Benichou discloses the prosthetic valve of claim 1, and further teaches the anchor frame (100a, 108) is configured to retain a compacted, undeployed profile until expanded to an expanded, deployed profile by an expansion force. (fig 3E, balloon 104; [0037; 0039])
In regard to claim 9, Benichou discloses the prosthetic valve of claim 1, and further discloses the anchor frame (100a, 108) is configured to be balloon expandable. (fig 3E; [0039: balloon expandable]
In regard to claim 10, Benichou discloses the prosthetic valve of claim 1, and further discloses at least one of the leaflet frame (100b, 100) or the anchor frame (100a, 108) is configured to be self- expanding. [0039]
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.
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benichou (2009/0281609A1).
In regard to claim 3, Benichou discloses the prosthetic valve of claim 1, and further teaches in the nested configuration (fig 6) an outflow end of the prosthetic valve (toward 208).
However Benichou remains silent to the transverse deformation resistance of the outflow end of the prosthetic valve.
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 transverse deformation resistance is a result effective variable with a lower resistance allowing a greater ease of collapsing or expanding. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was file to have an outflow end of the valve have a transverse deformation resistance that is less than the combined interface transverse deformation resistance in order to allow the outflow end of the valve to expand and collapse first compared to the body of the valve during implantation and removal. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.05IIB
In regard to claim 4, Benichou meets the claim limitations as discussed in the rejection of claim 1, and further teaches the prosthetic valve includes an inflow region (toward bottom of the valve in fig 6), an outflow region (toward 204 in fig 6), and an intermediate region between the inflow and outflow regions (middle of valve, fig 6).
However, Benichou remains silent to the transverse deformation resistance of the inflow, outflow and intermediate regions.
It has been held that the mere optimization of a result effective variable, yielding a predictable result, requires no more than routine skill in the art. The transverse deformation resistance is a result effective variable with a greater resistance needing more force to be expanded or collapsed and a lower resistance requiring less force to be expanded or collapse. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have lower transverse deformation resistance at the inflow and outflow regions than the combined intermediate transverse deformation resistance in order to allow the ends of the stent to collapse and expand first during implantation or removal. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.05IIA
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benichou (2009/0281609A1) in view of House (WO2009/108615A1).
In regard to claim 5, Benichou meets the claim limitations as discussed in the rejection of claim 1 and further teaches the prosthetic valve includes:
an inflow region (bottom of the valve in figure 6)
an outflow region (toward 204, fig 6),
the intermediate region between the inflow region and outflow region (mid valve) having a constant diameter that defines an un-tapered form. (A portion of the middle region is untapered for example at 108 in figure 6. The claim does not require the entire intermediate region to be un-tapered).
However, Benichou does not teach an inflow and outflow taper.
House teaches having a varying diameter to define an inflow taper;
an outflow region having a varying diameter that defines an outflow tapered region; (see ends 130).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to taper the inflow and outflow ends of the stent of Benichou as taught by House because the inflow and outflow tapers assist the stent in holding the valve in place [0042; fig 2].
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benichou (2009/0281609A1) in view of Dooley (2010/0331946A1).
In regard to claim 11, Benichou meets the claim limitations as discussed in the rejection of claim 1, and further teaches the leaflet frame can be self-expanding. [0056; 0039]
However, Benichou remains silent to the leaflet frame material.
Dooley teaches a self expanding frame (see for example claim 9) is formed of shape memory material. (shape memory alloy, nitinol, abstract)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the shape memory alloy of Dooley for the leaflet frame of Benichou because the prestrained alloy results in increase in fatigue life and overall improvement in fatigue performance (abstract).
Claim(s) 12, 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benichou (2009/0281609A1) in view of Gainor (2013/0204360A1).
In regard to claim 12, Benichou meets the claim limitations as discussed in the rejection of claim 1, but does not teach an interstage tube.
Gainor teaches an interstage tube 110 coupling the outflow end of the anchor frame to the inflow end of the leaflet frame (see fig 8B, opposite ends are connected).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the interstage tube of Gainor between the frames of Benichou because the interstage tube prevents perivalvular leakage [0059].
In regard to claim 13, Benichou meets the claim limitations as discussed in the rejection of claim 12, but does not teach the interstage tube.
Gainor further teaches in the nested configuration, the interstage tube assumes an everted configuration. (fig 7B-C; while [0059] states inverted, the sleeve in fig 7C is folded outwards and therefore actually meets the definition of everted).
In regard to claim 14, Benichou meets the claim limitations as discussed in the rejection of claim 12, but does not teach the interstage tube.
Gainor further teaches the interstage tube 110 is operable to permit blood flow therethrough when the leaflet frame is not nested in the anchor frame (see fig 8B), and is operable to restrict flow therethrough when the leaflet frame is nested within the anchor frame [0059].
In regard to claim 15, Benichou meets the claim limitations as discussed in the rejection of claim 12, but does not teach the interstage tube as claimed.
Gainor further teaches the interstage tube 110 comprises one or more reinforcement elements 106 operable to maintain the leaflet frame and the anchor frame in the nested configuration. [0060]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the interstage tube with the reinforcement element of Gainor between the frames of Benichou because the interstage tube prevents perivalvular leakage [0059].
In regard to claim 16, Benichou meets the claim limitations as discussed in the rejection of claim 12, but does not teach an interstage tube.
Gainor further teaches the interstage tube 110 comprises a continuous sinuous reinforcement element 106 (continuous circle) formed separate and distinct from any frame element of the anchor frame and the leaflet frame. This is a product-by-process limitation, patentable only based on the resulting structure. However, the element is a separate piece as shown in figure 8B and therefore the limitations have been met.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the interstage tube with the reinforcement element of Gainor between the frames of Benichou because the interstage tube prevents perivalvular leakage [0059].
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benichou (2009/0281609A1) in view of Yang (2002/0138138A1).
In regard to claim 18, Benichou meets the claim limitations as discussed in the rejection of claim 1, and further discloses the anchor frame (100a, 108) includes a plurality of tissue anchoring barbs operable to engage tissue. (claim 19: the first stent includes barbs; 0033; 0028)
However, Benichou does not teach the barbs are radially projecting.
Yang teaches a plurality of radially projecting anchoring barbs 272 (fig 11E) operable to engage tissue.
It would have been obvious to one of ordinary skill in the art at the time the invention was field to use the barbs of Yang in place of the barbs of Benichou through functional equivalents since both barbs anchor a stent to the valve annulus. MPEP 2144.06II
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benichou (2009/0281609A1) in view of Chang (7462675B2).
In regard to claim 19, Benichou meets the claim limitations as discussed in the rejection of claim 1, wherein the leaflet assembly 208 further comprises a plurality (defined as two or more) of leaflets 208 (see fig 6);
And further teaches the valvular structure can be made of any biocompatible material [0027].
However, Benichou does not teach the leaflets are made of porous synthetic fluoropolymer membrane with a filter of TFE-PMVE copolymer.
Chang teaches medical applications such as vascular devices (Col 3, lines 45-60) comprise a composite material including a matrix material and a filler material;
the matrix material includes a porous synthetic fluoropolymer membrane defining pores (see fig 14B-C);
and the filler material includes a fluoropolymer material
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the material of Chang to fabricate the leaflets of Benichou because the material has high tensile strength, excellent biocompatibility and high abrasion resistance (Col 3, lines 15-20).
Claim(s) 24-25, 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benichou (2009/0281609A1) in view of Gainor (2013/0204360A1) and in view of House (WO2009/108615A1).
In regard to claim 24, Benichou teaches a prosthetic valve comprising:
an anchor frame (100a, 108) including:
and an intermediate region (portions of 108) that has a constant diameter;
a leaflet frame (100b, 100)
a leaflet assembly 208 coupled to the leaflet frame (100b, 100; see fig 6);
wherein, in a nested configuration of the prosthetic valve:
the anchor frame and leaflet frame engage in an interference fit (fig 6, complimentary shapes, therefore interference fit.
However, Benichou does not teach an outwardly tapered shoulder feature at a first end or a second end that is outwardly tapered or an interstage component.
Gainor teaches an interstage subcomponent 110 coupling an outflow end of the anchor frame to an inflow end of the leaflet frame (see fig 8B, opposite ends of the stent and leaflet frame are coupled together by 110)
and in the nested configuration at least a part of the interstage subcomponent 110 is disposed between the shoulder feature and complimentary shoulder feature (between inner and outer frame as shown in figure 8C) As shown in figure 8C at least a part of the interstage component is connected between an end and mid portion of the frame (fig 8c) by the ring 84.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the interstage tube of Gainor between the frames of Benichou because the interstage tube prevents perivalvular leakage [0059].
House teaches an outwardly tapered shoulder feature associated with a first end of the anchor frame; a second end that is outwardly tapered. (see ends 130) When combined with the stent of Benichou the leaflet frame will also have a complementary outwardly tapered shoulder feature due to the interference fit of the anchor and leaflet frames (fig 6), in order for the assembly to continue to function as intended.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to taper the inflow and outflow ends of the stent of Benichou as taught by House because the inflow and outflow tapers assist the stent in holding the valve in place [0042; fig 2].
In regard to claim 25, Benichou meets the claim limitations as discussed in the rejection of claim 24, but does not teach the interstage component.
Gainor further teaches the interstage subcomponent 110 comprises a film (defined as thin, flexible strip; 110 meetsin the definition of a thin, flexible strip).
In regard to claim 27, Benichou meets the claim limitations as discussed in the rejection of claim 24, but does not teach the interstage component.
Gainor further teaches the interstage subcomponent 110 comprises a film (110 meets the definition of a film which is a thin, flexible strip) having one or more reinforcement elements 84 associated therewith. (see fig 8B)
In regard to claim 28, Benichou teaches a prosthetic valve comprising:
an anchor frame (100a, 108) configured to anchor to tissue of a target valve annulus, the anchor frame including:
and an intermediate region (portion of 108 that is straight, fig 6) between ends of the frame (fig 6), the intermediate region having a constant diameter defining an un-tapered tubular form (at least a portion of 108 as a constant diameter and is not tapered in figure 6);
a leaflet frame (100b, 100) configured to nest at least partially within anchor frame (100a, 108) in a nested configuration (see fig 6),
the leaflet frame (100a, 108) including:
and an un-tapered second end (inflow end; figure 6);
a leaflet assembly 208 coupled to the leaflet frame (100a, 108; see fig 6);
wherein: the anchor frame (100a, 108) and the leaflet frame (100b, 100) are configured to be transitioned from an un-nested configuration in which the leaflet frame and the anchor frame are separated from one another to the nested configuration (fig 6 is the nested configuration; fig 3A-D is unnested)
in which the anchor frame (100a, 108) and the leaflet frame (100b, 100) are nested via an interference fit (fig 6).
However, Benichou does not teach a first flared should or a second flared shoulder of the anchor frame or a flared complementary shoulder of the leaftlet frame or an interstage component.
House teaches a first flared shoulder associated with a first end of the anchor frame; (see end 130)
a second flared shoulder associated with a second end of the anchor frame; (see opposite end 130). When combined with the stent of Benichou the leaflet frame will also have a complementary and fully overlapped outwardly tapered shoulder feature due to the interference fit of the anchor and leaflet frames (fig 6), in order for the assembly to continue to function as intended.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to taper the inflow and outflow ends of the stent of Benichou as taught by House because the inflow and outflow tapers assist the stent in holding the valve in place [0042; fig 2].
Gainor teaches an interstage subcomponent 110 coupling the first end of the anchor frame to the un-tapered second end of the leaflet frame;
and in the nested configuration at least a part of the interstage subcomponent 110 is disposed between the first flared shoulder of the anchor frame and the flared complementary shoulder of the leaflet frame (between inner and outer frame as shown in figure 8C) As shown in figure 8C at least a part of the interstage component is connected between an end and mid portion of the frame (fig 8c) by the ring 84.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the interstage tube of Gainor between the frames of Benichou because the interstage tube prevents perivalvular leakage [0059].
Allowable Subject Matter
Claim 26 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regard to claim 26, the closest prior art over Benichou (2009/0281609A1) in view of Gainor (2013/0204360A1) and in view of House (WO2009/108615A1) and further in view of Steinseifer (CZ20004531A3) teaches all of the claim limitations except “the inner film layer includes a first set of apertures; and the outer film layer includes a second set of apertures that are non-overlapping with the first set of apertures” in combination with the other claim limitations.
Conclusion
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774