DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-15 and 17-20 have been considered but are moot because the new ground of rejection over Bridgeman et al. US 2011/0054515 in view of Kreidler US 2007/0066993 in view of Quinn et al. US 2007/0162048 and in view of Mazzocchi US 2001/0000797, as further discussed below.
Claim Objections
Claim 17 is objected to because of the following informalities: claim 17 should be dependent upon claim 15, as claim 16 has been cancelled. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1-15 and 17- 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bridgeman et al. US 2011/0054515 in view of Kreidler US 2007/0066993 in view of Quinn et al. US 2007/0162048 and in view of Mazzocchi US 2001/0000797.
Regarding claims 1 and 8, Bridgeman et al. discloses an occlusion device for an atrial appendage, the device comprising:
a proximal collar 35 having a proximal collar thickness in an axial direction (figure 1a, thickness of 35 along the axial axis or longitudinal direction);
a distal collar having a distal end region and a proximal end region (proximal and distal surfaces of collar 50) and a distal thickness in the axial direction (figure 1a; thickness of 50 along the axial axis or longitudinal direction); and
a support frame 10 including a plurality of struts extending between the proximal collar and the distal collar and defining an interior volume of the occlusion device (figure 1a), the plurality of struts each having a proximal end fixed to the proximal collar (paragraph 0044, portions of struts joined at the collar 35) and a distal end fixed to the distal end region of the distal collar (paragraph 0048, strut ends 58 are connected with hub 50, the ends are fixed to both the proximal or distal end regions, as the hub is integral and fixedly connected to the ends regardless of where the ends extends therefrom);
a membrane 19 extending over at least a portion of the support frame (figure 1b) wherein the membrane comprises a filter membrane (paragraph 0041, membrane of a desired permeability for the desired use),
a first row of anchors integrally formed with the support frame (figure 1a, anchors 47 extending in a first row circumferentially around frame),
wherein the support frame defines an interior volume (within frame 10, figure 1A),
wherein when in an expanded configuration, the distal collar is positioned proximal of a distalmost extent of the support frame (figure 1A, portion 50 is at the proximal most edge extending proximally into the frame connecting ends 58, while the curved portion 60 is the distal most extend of frame);
wherein the proximal end region of the distal collar is positioned within the interior volume of the occlusive device (figure 1a, collar 50 proximal end is at the proximal most position within the interior volume, as the struts extend distally therefrom and then back around proximally to the proximal collar 35 to enclose the collar 50 within the interior)
wherein the support frame 10 has a proximal section defining a first maximum diameter, a distal section defining a second maximum diameter less than the first maximum diameter, and an intermediate section between the proximal section and the distal section, the intermediate section tapering from the first maximum diameter to the second maximum diameter (see annotated figure 1a below).
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Bridgeman et al. discloses a membrane around the proximal end of the frame (figure 1b), but fails to disclose the first row of anchors extending through the membrane, a second row of anchors integrally formed with the support frame, each of the second row of anchors positioned distal of the membrane.
Kreidler teaches a closure implant comprising a frame (for example, cage 300 with frame 402; figures 2, 4) comprising a first row of anchors at the proximal portion of the frame (see annotated figure 4 below), and a second row of anchors distal to the first row (see annotated figure 4 below, paragraph 0071, one or more barbs 318 may be placed in a row on the proximal end 302, distal end 304 and the center portion 313, paragraph 0074). Additionally, Kreidler discloses a filter membrane paragraph 0025) which may be positioned at either the proximal or distal end (figure 2, paragraph 0060, 0061, membrane 500A for example at the proximal end, 500B at the distal end of frame; membrane placed on both sides of the frame), the second row of anchors would result in being distal to the first row and the first membrane 500A.
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Kreidler discloses placing both an anchor row and a membrane surrounding the proximal portion of the frame, the membrane may be placed on the exterior or interior of the frame (figures 5, 6), but fails to explicitly show wherein the anchor extends through the membrane.
However, Quinn et al. teaches a similar closure implant comprising a membrane 48 extending over the entire frame 26 and comprising a first and second row of anchors 64 (figure 4, anchors in a proximal row position, central row position, and distal row position), the anchors extending through the membrane covering (paragraph 0055).
Therefore, it would have been an obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Bridgeman et al. with a membrane extending over the proximal portion of the cage or frame and comprising a first set of anchors extending through the membrane, and a second row of anchors extending around the frame and positioned distal to the membrane, as taught by Kreidler and Quinn et al., as it is known to position various rows of anchors and membranes along various portions of the cage, such as the proximal and central and distal end, or as desired for the particular use. In combination, the membrane and anchors may result in the claimed structure.
Bridgeman et al. fails to disclose each of the plurality of struts having a width orthogonal to the axial direction that is less than the proximal collar thickness and less than the distal collar thickness.
Mazzocchi teaches a closure apparatus, comprising a proximal collar 15 having a proximal collar thickness in an axial direction (figure 5A, thickness of 15 along the longitudinal direction, at the proximal end adjacent 70), and a distal collar 15 having a distal end region and a proximal end region (figure 5A, proximal end of 15, closer to the proximal end 70, distal end of 15, closer to distal end 84) and a distal collar thickness in the axial direction (figure 5A, 5B thickness of 15 along the longitudinal direction, at the distal end adjacent 84), each of the plurality of struts having a width orthogonal to the axial direction that is less than the proximal collar thickness and less than the distal collar thickness (figures 5A, 5B; longitudinal thickness or length of 15 is larger than the individual orthogonal widths of the struts or wires of 60, as they are connected within the collar 15, providing a proximal or distal collar 15 having a greater axial thickness). Mazzocchi further discloses it may be understood the clamp or collar may be an attachment of various ways or with various materials or any other suitable fashion (paragraph 0078).
Therefore, it would have been an obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Bridgeman et al. to have each of the plurality of struts having a width orthogonal to the axial direction that is less than the proximal collar thickness and less than the distal collar thickness, as taught by Mazzocchi as a simple substitution of one known element for another to obtain predicable results, such as substituting the collar type to connect or attach the struts at a proximal or distal end of the device.
Regarding claim 2, Bridgeman et al. discloses wherein the proximal collar, distal collar, and the support frame together form a monolithic structure cut from a single tubular member (paragraphs 0044, 0064, device may be formed by laser cutting a single mesh tube, and frame with the cap may alternatively be formed of a double or single-piece device). Additionally, it is noted that “[E]ven though product‑by‑process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product‑by‑process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Furthermore, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.2.
Regarding claim 3, Bridgeman et al. discloses wherein each of the plurality of anchors includes a hook portion extending radially outward from the support frame figure 1a,14a; anchor 47 shaped as a hook extending outward from frame).
Regarding claim 4, Bridgeman et al. discloses wherein the plurality of anchors each extends radially outward from a junction of at least two struts (figure 1a).
Regarding claim 5, Bridgeman et al. discloses wherein the support frame is self-expanding (biased into the expanded configuration by the super-elastic nature of the frame and processing, paragraph 0005).
Regarding claim 6, Bridgeman et al. discloses wherein the distal end of each of the plurality of struts extends proximally to the distal collar (figure 1a, extends proximally from bumper 125 portion to collar 50).
Regarding claim 7, Bridgeman et al. discloses wherein the proximal end of each of the plurality of struts extends proximally to the proximal collar (figure 1a, extends within the end of the s-shaped curve proximally to the collar 35).
Regarding claim 9, Bridgeman et al. discloses wherein when in the expanded configuration, the proximal collar is positioned at or distal of a proximal most extent of the support frame (figure 1a).
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Regarding claim 10, Bridgeman et al. discloses wherein in the expanded configuration, each strut extends radially outward from the proximal collar in a complex curve including a first bend and a second bend, wherein at the second bend, each strut turns distally and radially inward (see annotated figure 1a below).
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Regarding claims 11-14, Bridgeman et al. discloses wherein at the second bend as each strut turns distally and radially inward, a cross-sectional profile of a first segment of the strut extends distally at a first angle relative to a line parallel to a central longitudinal axis of the support frame (frame shown similar to the first angle between 5 to 25 degrees (see annotated figure 1a below) and due to the flexibility and deformability of the frame, the dimensions and shape adjust somewhat to suit the deployed environment (paragraph 0042), wherein the first segment of the strut extends distally and radially inward from the second bend to a third bend where the cross-sectional profile turns radially inward at a sharper angle while still extending distally (see annotated figure 1a below), wherein a second segment of the strut extends distally from the third bend forms a second angle with the first segment (see annotated figure 1a below), wherein the second segment extends distally and radially inward from the third bend to a fourth bend (see annotated figure 1a below), and at the fourth bend provides an angle between about 0 and 90 degrees (paragraph 0049), the cross-sectional profile turns proximally and a third segment of the strut extends proximally from the fourth bend to the distal collar 50 (figure 1a, disposed at an angle between about 0 and 45 degrees, paragraph 0048).
Bridgeman et al. fails to explicitly disclose cross-sectional profile of a first segment of the strut extends distally at a first angle between 5 degrees to 25 degrees relative to a line parallel to a central longitudinal axis of the support frame or wherein a second segment of the strut extends distally from the third bend forms a second angle with the first segment of between 20 degrees to 65 degrees.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide an angle within the range of 5 degrees to 25 degrees relative to a line parallel to a central longitudinal axis of the support frame, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claims 15 and 19, Bridgeman et al. discloses an occlusion device for an atrial appendage, the device comprising:
a proximal collar 35 having a proximal collar thickness (figure 1a, thickness of 35 along the axial axis or longitudinal direction);
a distal collar having a distal end region and a proximal end region (proximal and distal surfaces of collar 50) and a distal collar thickness (figure 1a; thickness of 50 along the longitudinal direction of the device);
a self-expanding support frame 10 (biased into the expanded configuration by the super-elastic nature of the frame and processing, paragraph 0005) including a plurality of struts extending between the proximal collar and the distal collar and defining an interior volume of the occlusion device (figure 1a), the plurality of struts each having a proximal strut end fixed to the proximal collar (paragraph 0044, portions of struts joined at collar 35) and a distal strut end fixed to the distal end region of the distal collar (paragraph 0048, strut ends 58 are connected with hub 50, the ends are fixed to both the proximal or distal end regions, as the hub is integral and fixedly connected to the ends regardless of where the ends extends therefrom);
a membrane 19 extending over at least a portion of the support frame (figure 1b),
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wherein a support frame defines an interior volume (within frame 10, figure 1A) and a plurality of anchors 47 comprising a first row of anchors integrally formed with the support frame (figure 1b), the plurality of anchors including hook portions 47 extending radially outward from the support frame (figure 1a); wherein when in an expanded configuration, the proximal end region of the distal collar is positioned within the interior volume of the occlusion device (figure 1a, collar 50 proximal end is recessed proximally and collar 50 is at the proximal most position within the interior volume, as the struts extend distally therefrom and then back around proximally to the proximal collar 35 to enclose the collar 50 within the interior) and the proximal collar is positioned at or distal of a proximal-most extent of the support frame (figure 1a); wherein when in the expanded configuration, each strut extends radially outward from the proximal collar in a complex curve including a first bend and a second bend (see annotated figure 1a below), wherein at the second bend, each strut turns distally and radially inward forming a tapered surface extending from a first outer diameter at a proximal section of the support frame to a second outer diameter at a distal section of the support frame, where the first outer diameter is larger than the second outer diameter (see annotated figure 1a below).
Bridgeman et al. discloses a membrane around the proximal end of the frame (figure 1b), but fails to disclose the first row of anchors extending through the membrane, a second row of anchors integrally formed with the support frame, each of the second row of anchors positioned distal of the membrane.
Kreidler teaches a closure implant comprising a frame (for example, cage 300 with frame 402; figures 2, 4) comprising a first row of anchors at the proximal portion of the frame (see annotated figure 4 below), and a second row of anchors distal to the first row (see annotated figure 4 below, paragraph 0071, one or more barbs 318 may be placed in a row on the proximal end 302, distal end 304 and the center portion 313, paragraph 0074). Additionally, Kreidler discloses a filter membrane paragraph 0025) which may be positioned at either the proximal or distal end (figure 2, paragraph 0060, 0061, membrane 500A for example at the proximal end, 500B at the distal end of frame; membrane placed on both sides of the frame), the second row of anchors would result in being distal to the first row and the first membrane 500A.
Kreidler discloses placing both an anchor row and a membrane surrounding the proximal portion of the frame, the membrane may be placed on the exterior or interior of the frame (figures 5, 6), but fails to explicitly show wherein the anchor extends through the membrane.
However, Quinn et al. teaches a similar closure implant comprising a membrane 48 extending over the entire frame 26 and comprising a first and second row of anchors 64 (figure 4, anchors in a proximal row position, central row position, and distal row position), the anchors extending through the membrane covering (paragraph 0055).
Therefore, it would have been an obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Bridgeman et al. with a membrane extending over the proximal portion of the cage or frame and comprising a first set of anchors extending through the membrane, and a second row of anchors extending around the frame and positioned distal to the membrane, as taught by Kreidler and Quinn et al., as it is known to position various rows of anchors and membranes along various portions of the cage, such as the proximal and central and distal end, or as desired for the particular use. In combination, the membrane and anchors may result in the claimed structure.
Bridgeman et al. fails to explicitly disclose each of the plurality of struts having a width that is less than the proximal collar thickness and less than the distal collar thickness.
Mazzocchi discloses a closure apparatus, comprising a proximal collar 15 having a proximal collar thickness in an axial direction (figure 5A, thickness of 15 along the longitudinal direction, at the proximal end adjacent 70), and a distal collar 15 having a distal end region and a proximal end region (figure 5A, proximal end of 15, closer to the proximal end 70, distal end of 15, closer to distal end 84) and a distal collar thickness in the axial direction (figure 5A, 5B thickness of 15 along the longitudinal direction, at the distal end adjacent 84), each of the plurality of struts having a width orthogonal to the axial direction that is less than the proximal collar thickness and less than the distal collar thickness (figures 5A, 5B; longitudinal thickness or length of 15 is larger than the individual orthogonal widths of the struts or wires of 60, as they are connected within the collar 15, providing a proximal or distal collar 15 having a greater axial thickness). Mazzocchi further discloses it may be understood the clamp or collar may be an attachment of various ways or with various materials or any other suitable fashion (paragraph 0078).
Therefore, it would have been an obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Bridgeman et al. to have each of the plurality of struts having a width orthogonal to the axial direction that is less than the proximal collar thickness and less than the distal collar thickness, as taught by Mazzocchi as a simple substitution of one known element for another to obtain predicable results, such as substituting the collar type to connect or attach the struts at a proximal or distal end of the device.
Regarding claim 17, Bridgeman et al. discloses an occlusion device essentially as claimed, wherein the plurality of anchors 47 extend radially outward from a junction of at least two struts (figure 1a).
Regarding claim 18, Bridgeman et al. further comprising a filter membrane 19 affixed to at least the proximal section of the support frame (figure 1b).
Regarding claim 20, Bridgeman et al. discloses an occlusion device for an atrial appendage, the device comprising:
a proximal collar 35 having a proximal collar thickness (figure 1a, thickness of 35 along the axial axis or longitudinal direction);
a distal collar having a distal end region and a proximal end region (proximal and distal surfaces of collar 50) and the distal collar having a distal collar thickness in (figure 1a; thickness of 50 in the longitudinal direction); and
a support frame 10 including a plurality of struts extending between the proximal collar and the distal collar, the plurality of struts each having a proximal end fixed to the proximal collar (paragraph 0044, portions of struts joined at the collar 35) and a distal end fixed to the distal end region of the distal collar (paragraph 0048, strut ends 58 are connected with hub 50, the ends are fixed to both the proximal or distal end regions, as the hub is integral and fixedly connected to the ends regardless of where the ends extends therefrom);
a membrane 19 extending over at least a portion of the support frame (figure 1b);
a first row of anchors integrally formed with the support frame (row along anchors 47, figure 1a),
wherein the support frame defines an interior volume (within struts 10, figure 1a) wherein when in an expanded configuration, the distal collar is positioned proximal of a distalmost extent of the support frame (figure 1a, collar 50 is proximal to the distal most curves 60 of struts of frame); wherein when in an expanded configuration, the proximal end region of the distal collar is positioned within the interior volume of the occlusion device (figure 1a, collar 50 proximal end is recessed proximally and collar 50 is at the proximal most position within the interior volume, as the struts extend distally therefrom and then back around proximally to the proximal collar 35 to enclose the collar 50 within the interior), wherein the distal end of each of the plurality of struts extends proximally to the distal collar (figure 1a, extends proximally from bumper 125 portion to collar 50), wherein the proximal end of each of the plurality of struts extends proximally to the proximal collar (figure 1a, extends within the end of the s-shaped curve proximally to the collar 35), wherein when in the expanded configuration, each strut extends radially outward from the proximal collar to a bend (see annotated figure 1a below), wherein at the bend, each strut turns and forms a first tapered surface extending distally and radially inward, each strut forming additional bends extending further radially inward to the distal collar (see annotated figure 1a below).
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Bridgeman et al. discloses a membrane around the proximal end of the frame (figure 1b), but fails to disclose the first row of anchors extending through the membrane, a second row of anchors integrally formed with the support frame, each of the second row of anchors positioned distal of the membrane.
Kreidler teaches a closure implant comprising a frame (for example, cage 300 with frame 402; figures 2, 4) comprising a first row of anchors at the proximal portion of the frame (see annotated figure 4 below), and a second row of anchors distal to the first row (see annotated figure 4 below, paragraph 0071, one or more barbs 318 may be placed in a row on the proximal end 302, distal end 304 and the center portion 313, paragraph 0074). Additionally, Kreidler discloses a filter membrane paragraph 0025) which may be positioned at either the proximal or distal end (figure 2, paragraph 0060, 0061, membrane 500A for example at the proximal end, 500B at the distal end of frame; membrane placed on both sides of the frame), the second row of anchors would result in being distal to the first row and the first membrane 500A.
Kreidler discloses placing both an anchor row and a membrane surrounding the proximal portion of the frame, the membrane may be placed on the exterior or interior of the frame (figures 5, 6), but fails to explicitly show wherein the anchor extends through the membrane.
However, Quinn et al. teaches a similar closure implant comprising a membrane 48 extending over the entire frame 26 and comprising a first and second row of anchors 64 (figure 4, anchors in a proximal row position, central row position, and distal row position), the anchors extending through the membrane covering (paragraph 0055).
Therefore, it would have been an obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Bridgeman et al. with a membrane extending over the proximal portion of the cage or frame and comprising a first set of anchors extending through the membrane, and a second row of anchors extending around the frame and positioned distal to the membrane, as taught by Kreidler and Quinn et al., as it is known to position various rows of anchors and membranes along various portions of the cage, such as the proximal and central and distal end, or as desired for the particular use. In combination, the membrane and anchors may result in the claimed structure.
Bridgeman et al. fails to explicitly disclose each of the plurality of struts having a width orthogonal to the axial direction that is less than the proximal collar thickness and less than the distal collar thickness.
Mazzocchi discloses a closure apparatus, comprising a proximal collar 15 having a proximal collar thickness in an axial direction (figure 5A, thickness of 15 along the longitudinal direction, at the proximal end adjacent 70), and a distal collar 15 having a distal end region and a proximal end region (figure 5A, proximal end of 15, closer to the proximal end 70, distal end of 15, closer to distal end 84) and a distal collar thickness in the axial direction (figure 5A, 5B thickness of 15 along the longitudinal direction, at the distal end adjacent 84), each of the plurality of struts having a width orthogonal to the axial direction that is less than the proximal collar thickness and less than the distal collar thickness (figures 5A, 5B; longitudinal thickness or length of 15 is larger than the individual orthogonal widths of the struts or wires of 60, as they are connected within the collar 15, providing a proximal or distal collar 15 having a greater axial thickness). Mazzocchi further discloses it may be understood the clamp or collar may be an attachment of various ways or with various materials or any other suitable fashion (paragraph 0078).
Therefore, it would have been an obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Bridgeman et al. to have each of the plurality of struts having a width orthogonal to the axial direction that is less than the proximal collar thickness and less than the distal collar thickness, as taught by Mazzocchi as a simple substitution of one known element for another to obtain predicable results, such as substituting the collar type to connect or attach the struts at a proximal or distal end of the device.
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 CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.C.L/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771