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 .
Status of Claims
Claims 1-20 are pending and examined below
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) 1, 4, 7-9, 12, 15, 18, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0177594 (Patel)
Regarding claim 1, Patel discloses a docking device for securing a prosthetic valve at a native valve (Figs. 3 and 6), the docking device comprising:
a coil (Fig. 3, ¶0094, “coil with a plurality of turns”) comprising a plurality of helical turns when deployed at the native valve (Fig. 7, wherein 1 is deployed at mitral valve);
an expandable member (Fig. 19, 1180) extending radially outwardly from the coil (see Fig. 19, wherein 1180 extends outward from coil), the expandable member being movable between a radially-compressed/axially-elongated state and a radially-expanded/axially-foreshortened state (¶0142, wherein “braided” corresponds to movable between a radially-compressed/axially-elongated state and a radially-expanded/axially-foreshortened state); and
a cover member (Fig. 15, 420) surrounding an outer surface of the expandable member (¶0144, wherein “covering 420 can be added to 1100” corresponds to surrounding an outer surface of the expandable member), wherein both a distal end portion of the cover member and a distal end portion of the expandable member are fixedly coupled to the coil via a distal suture (¶0122, “suturing holes for attaching a cover layer over the coil of the docking device”), wherein the distal suture comprises a plurality of knots and a plurality of wraps (¶0122, wherein “suture” corresponds to a plurality of knots and wraps),
proximal end portion of the expandable member (¶0142, wherein the expandable member is “braided” and therefore is configured to move axially as it is compressed/retracted) and the proximal end portion of the cover member are axially movable relative to the coil (¶0016, wherein “lower friction cover layer” corresponds to movable relative to the coil).
Patel doesn't explicitly teach or disclose a wherein both a distal end portion of the cover member and a distal end portion of the expandable member are fixedly coupled to the coil via a distal suture or wherein a proximal end portion of the expandable member is fixedly coupled to a proximal end portion of the cover member. However, Patel offers suggestion that the securing holes 1164 in Fig. 19 can be used to secure the cover layers to the wire core (¶0164)
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the distal end portion and proximal end portion with sutures securing the cover member and the expandable member, in order to prevent slipping or movement between the expandable member and the cover member (¶0164)
Regarding claim 4, Patel discloses wherein the coil comprises a shape memory material (¶0100, wherein docking device 1 is made of “shape memory material”).
Regarding claim 7, Patel further discloses wherein the proximal end portion of the cover member comprises a fold wrapping at a proximal end of the expandable member (Fig. 29, wherein 1300 corresponds to a fold wrapping, see also ¶0204), wherein the proximal end of the expandable member is a terminal end (see Fig. 29A, wherein 1300 is a terminal end)
Regarding claim 8, Patel further discloses a retention element (Fig. 15, 420, see also ¶0102) disposed radially between the coil and the expandable member (¶0103, wherein 420 is disposed radially between 410 and the expandable heart valve”), wherein the retention element is configured for retaining the position of the proximal end portion of the expandable member relative to the coil member.
Regarding claim 9, Patel discloses a docking device for securing a prosthetic valve at a native valve (Fig. 3), the docking device comprising:
a coil (Fig. 3) comprising a proximal end (Fig. 3, 31) and a distal end (Fig. 3, 21);
a first cover (Fig. 21, ePTFE cover layer 1170, ¶0157) surrounding at least a portion of the coil (see Fig. 21, wherein 1170 surrounds a portion of the coil); and
a guard member surrounding at least a portion of the first cover (see below), wherein the guard member comprises an expandable member (Fig. 19, 1180) a second cover (¶0144, 420) surrounding an outer surface of the expandable member (¶0144, wherein “420 can be added to any of the docking devices described herein” corresponds to surrounding an outer surface of the expandable member), wherein a distal end portion of the guard member is fixedly attached to the first cover (see Fig. 19, wherein guard member is attached to 1170), wherein a proximal end portion of the guard member is movable relative to the first cover and the coil (¶0156, wherein the 1180 is slidably moveable because 1170 is a low friction material), wherein the guard member is movable between a radially compressed state and a radially expanded state (¶0157, wherein “braided” corresponds to changeable between a radially expanded state and a radially compressed state),
Patel doesn't explicitly teach or disclose wherein the proximal end portion of the guard member is disposed closer to the proximal end of the coil when the guard member is in the radially compressed state than in the radially expanded state.
However, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the guard member to be closer to the proximal end of the coil when radially compressed, in order to slide distally towards the native valve once it is radially expanded.
Regarding claim 12, Patel further discloses wherein a proximal end portion of the second cover is fixedly coupled to a proximal end of the expandable member (¶0144, wherein “420 can be added to any of the docking devices described herein” corresponds to fixedly coupled to a proximal end of the expandable member because it is fixedly coupled to the entire expandable member 1180)
Regarding claim 15, Patel discloses a cover assembly for a docking device configured to receive a prosthetic valve (Figs. 3), the cover assembly comprising:
a first cover (Fig. 21, ePTFE cover layer 1170, ¶0157) configured to cover at least a portion of a helical coil of the docking device (see Fig. 21, wherein 1170 covers at least a portion of the helical coil);
an expandable member (Fig. 19, 1180) surrounding at least a portion of the first cover (¶0157, wherein “on top of the ePTFE layer 1170) corresponds to surrounding at least a portion of the first cover), the expandable member being changeable between a radially expanded state and a radially compressed state (¶0157, wherein “braided” corresponds to changeable between a radially expanded state and a radially compressed state); and
a second cover (¶0144, 420) surrounding an outer surface of the expandable member (¶0144, wherein “420 can be added to any of the docking devices described herein” corresponds to surrounding an outer surface of the expandable member), wherein a proximal end portion of second cover comprises a fold covering a proximal end of the expandable member (Fig. 29, wherein the proximal portion is folded onto itself), wherein the proximal end of the expandable member is slidably movable relative to the first cover and the helical coil of the docking device (¶0156, wherein the 1180 is slidably moveable because 1170 is a low friction material)
Patel doesn't explicitly teach or disclose wherein a distal end portion of the second cover is fixedly coupled to a distal end portion of the expandable member and the first cover
However, Patel offers a suggestion that the securing holes 1164 in Fig. 19 can be used to secure the cover layers to the wire core (¶0164)
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify distal end portion of the second cover is fixedly coupled to a distal end portion of the expandable member and the first cover using the securing holes 1164 with a suture, in order to prevent slipping or movement between the expandable member and the cover member (¶0164)
Regarding claim 18, Patel further discloses wherein the second cover (see rejection of claim 15 above) comprises ePTFE (¶0103, wherein 420 comprises ePTFE)
Regarding claim 19, Patel further discloses wherein the second cover (see rejection of claim 15 above) comprises PET (¶0104, “PET braid” over the ePTFE tube)
Claim(s) 2 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0177594 (Patel) in view of US 2017/0100246 (Rust)
Regarding claim 2, Patel discloses a cover member and an expandable member (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the proximal end portion of the expandable member and the proximal end portion of the cover member moves distally when the expandable member changes from the radially-compressed/axially-elongated state to the radially-expanded/axially-foreshortened state.
Rust discloses wherein the proximal end portion of the expandable member and the proximal end portion of the cover member moves distally when the expandable member changes from the radially-compressed/axially-elongated state to the radially-expanded/axially-foreshortened state (¶0029, wherein an expandable member expands beyond a threshold amount and moves distally which corresponds to moves distally when the expandable member changes from the radially-compressed/axially-elongated state to the radially-expanded/axially-foreshortened state)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the expandable member and the cover to move distally upon expansion, as taught by Rust, in order to move the expandable member into position within the native valve.
Regarding claim 10, Patel discloses a guard member, an expandable member, and a cover member (see rejection of claim 9) but doesn't explicitly teach or disclose wherein the proximal end portion of the guard member slides axially over the first cover and toward the distal end of the coil when the guard member moves from the radially compressed state to the radially expanded state
Rust discloses wherein the proximal end portion of the expandable member and the proximal end portion of the cover member moves distally when the expandable member changes from the radially-compressed/axially-elongated state to the radially-expanded/axially-foreshortened state (¶0029, wherein the valve expands beyond a threshold amount and moves distally which corresponds to moves distally when the expandable member changes from the radially-compressed/axially-elongated state to the radially-expanded/axially-foreshortened state)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the guard member of Patel to move distally when expanded, as taught by Rust, in order to deploy the device into the native valve.
Claim(s) 3 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0177594 (Patel) in view of US 2016/0120646 (Dwork)
Regarding claim 3, Patel discloses a cover member and a radial expanded expandable member (see rejection of claim 1 above) but doesn't explicitly teach or disclose engaging with the prosthetic valve deployed within the docking device so as to reduce paravalvular leakage between the docking device and the cover member when the expandable member is in the radially-expanded/axially-foreshortened state.
Dwork discloses an expandable member deployed within the docking device so as to reduce paravalvular leakage (¶0032, wherein 402 prevents paravalvular leakage in the expanded configuration shown in Fig. 4) between the docking device and the cover member when the expandable member is in the radially-expanded/axially-foreshortened state (¶0032, wherein the expandable member is expanded during deployment of the valve)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to engage the cover member of Patel engage with the prosthetic valve, as taught by Dwork, in order to prevent paravalvular leakage (¶0032).
Regarding claim 16, Patel discloses an expandable member that can radially expand and second cover (see rejection of claim 15) but doesn't explicitly teach or disclose wherein the second cover is configured to engage with the prosthetic valve deployed within the docking device so as to reduce paravalvular leakage between the prosthetic valve and the second cover
Dwork discloses a prosthetic valve deployed within the docking device so as to reduce paravalvular leakage between the prosthetic valve and the second cover (¶0032, wherein 402 prevents paravalvular leakage in the expanded configuration shown in Fig. 4)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the expandable member and cover member of Patel to engage with the prosthetic valve, as taught by Dwork, in order to prevent paravalvular leakage (¶0032).
Claim(s) 5 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0177594 (Patel) in view of US 2016/0228247 (Maimon)
Regarding claim 5, Patel discloses an expandable member that is braided (see rejection of claim 1) but doesn't explicitly teach or disclose a braided wire frame.
Maimon discloses an expandable member comprising a braided wire frame (¶0040, wherein 34 can be formed of wire and braided)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the expandable member of Patel to have a braided wire frame, as taught by Maimon, in order to easily expand and contact the expandable member.
Regarding claim 17, Patel discloses a braided expandable member (see rejection of claim 15) but doesn't explicitly teach or disclose a Nitinol material
Maimon discloses a device to secure a prosthetic heart valve within a native valve (Fig. 4a-4m) comprising a braided Nitinol frame (¶0045, wherein 34 can be formed from Nitinol and can be braided for flexibility)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the expandable member of Patel to have a braided Nitinol frame, as taught by Maimon, in order to easily expand and contract in the body.
Claim(s) 6 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0177594 (Patel) in view of US 2004/0138743 (Myers)
Regarding claim 6, Patel discloses an expandable member (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the proximal end portion of the expandable member tapers radially inwardly from a first diameter at a first location to a second diameter at the second location when the expandable member is in the radially-expanded/axially-foreshortened state, wherein the first location is distal to the second location.
Myers discloses an expandable member (Fig. 16) wherein the proximal end portion of the expandable member tapers radially inwardly from a first diameter at a first location to a second diameter at the second location when the expandable member is in the radially-expanded/axially-foreshortened state, wherein the first location is distal to the second location (¶0103, wherein “the diameter of the out-flow annulus is less than the diameter of the in-flow annulus corresponds to tapering radially inward from a first location to a second location)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the expandable member of Patel to taper radially inwardly, as taught by Myers, in order to form a better interface with the valve.
Regarding claim 11, Patel discloses a guard member that can radially expand (see rejection of claim 9) but doesn't explicitly teach or disclose that it tapers radially outwardly from a first diameter at a first location to a second diameter at a second location, the second location being disposed distal to the first location.
Myers discloses an expandable member which tapers radially outwardly from a first diameter at a first location to a second diameter at a second location, the second location being disposed distal to the first location (¶0103, wherein “the diameter of the out-flow annulus is less than the diameter of the in-flow annulus corresponds to tapering radially inward from a first location to a second location)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the guard member of Patel with a tapered diameter towards the distal end, as taught by Myers, in order to form a secure fit with the valve.
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0177594 (Patel in view of US 2015/0320552 (Letac)
Regarding claim 13, Patel discloses a first cover, a second cover, and an expandable member (see rejection of claim 9) but doesn't explicitly teach or disclose wherein a distal end portion of the second cover is fixedly coupled to a distal end portion of the expandable member and the first cover
Letac discloses wherein a distal end portion of the second cover is fixedly coupled to a distal end portion of the expandable member and the first cover (see Fig. 6d, wherein exterior cover 19’’ is fixed couple to distal portion of expandable member 10)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the distal portion of the expandable member of Patel to be fixed to the distal end portion of the expandable member and the first cover, as taught by Letac, in order to prevent paravalvular leakage
Regarding claim 14, Patel discloses a first cover (see rejection of claim 9) but doesn't explicitly teach or disclose wherein the first cover extends through the distal end portion of the expandable member
Letac discloses wherein the first cover extends through the distal end portion of the expandable member (see Fig. 6d, wherein first cover 19’ extends distally through the distal end portion of 10)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the first cover of Patel to extend through the distal end portion of the expandable member, as taught by Letac, in order to prevent paravalvular leakage
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0177594 (Patel) in view of US 2018/0289476 (Vyas)
Regarding claim 20, Patel discloses a docking device for securing a prosthetic valve at a native valve (Fig. 3), the docking device comprising:
a coil (Fig. 3, ¶0094, “coil with a plurality of turns”) configured to surround native tissue when deployed at the native valve (see Fig. 7);
a tubular member (Fig. 15, 420) surrounding at least a portion of the coil (¶0144, wherein 420 covers the coil)
a retention element surrounding at least a portion of the tubular member (Fig. 16, 520); and
a guard member (Fig. 19, 1180) surrounding at least a portion of the retention element (see Fig. 19, wherein 1180 goes over retention element) and configured to reduce paravalvular leakage (¶0157, wherein “create a more secure locking mechanism” corresponds to reduce paravalvular leakage”), wherein a proximal end of the guard member is axially movable relative to the coil (¶0156, wherein the 1180 is slidably moveable because 420 is a low friction ePTFE), and wherein when deployed at the native valve, the proximal end of the guard member is positioned between the first seating marker and the second seating marker (See Fig. 19, wherein 1180 is positioned between radiopaque markers of paragraph 0142)
Patel discloses a tubular member (Fig. 15, 420 with radiopaque markers (¶01442) but doesn't explicitly teach or disclose at least a first seating marker and a second seating marker, wherein the first seating marker is positioned proximal relative to the second seating marker
Vyas discloses a tubular member (Fig. 3) comprising at least a first seating marker (Fig. 3, 312) and a second seating marker (Fig. 3, 306), wherein the first seating marker is positioned proximal relative to the second seating marker (Fig. 3, wherein 312 is positioned proximal relative to 306)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tubular member of Patel with at least a first seating marker and a second seating marker, as taught by Vyas, in order to better understand the position of the coil under fluoroscopy during implantation (¶0063)
Conclusion
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774