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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-3, 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGuckin (US 20070270891 A1).
Regarding 1, McGuckin discloses a vascular occluder forming system (paras. [0011]-[0062]) comprising: a vascular occlusion coil 30 (Fig. 7; para. [0044]); a container 20 comprising a fluid permeable side wall (para. [0047] discloses the bag is made of a tissue-like substance which could permit endothelization and incorporation) enclosing a container space configured for implantation within a tubular lumen section of a target blood vessel (paras. [0044]), wherein the container space is configured to accommodate the vascular occlusion coil (para. [0045]); a coil dispenser configured to release the vascular occlusion coil into the container space (catheter or delivery tube 50 delivers wire 30; Fig. 10 para. [0045]); wherein the coil dispenser, the container, and the vascular occlusion coil are configured such that when the vascular occlusion coil is released from the coil dispenser into the container, arced segments of the vascular occlusion coil are sequentially positioned and pushed against different portions of the side wall (20 is expanded by the coiled shaped wire 30; Fig. 10, para. [0047]).
Regarding 2, McGuckin discloses the vascular occluder forming system of claim 1. McGuckin also discloses wherein at least some different arced segments extend along distinct planes having different spatial orientation relative to planes along which other arced segments extend (Fig. 10), thereby collectively forming a structure in the container space configured to resist compressive forces extending along multiple spatial directions (Fig. 10 as shown through the coiled configuration along 20).
Regarding 3, McGuckin discloses the vascular occluder forming system of claim 2. McGuckin also discloses wherein the vascular occlusion coil comprises a cylindrical spiral body enclosing an elongated coil passage (i.e., as shown in Fig. 10 such that the interior space is within 30).
Regarding 9, McGuckin discloses the vascular occluder forming system of claim 1. McGuckin also discloses wherein the vascular occlusion coil has an elastically relaxed configuration comprising series of arced segments arranged in two or more different orientations (para. [0049]), wherein the vascular occlusion coil is configured to be elastically deformed into a linear configuration for placement in the coil dispenser (para. [0049] i.e., elongated substantially straight), and wherein the vascular occlusion coil is configured to sequentially form the series of arced segments of the elastically relaxed configuration as it is pushed out from a distal end of the coil dispenser (para. [0049]).
Claims 23-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wilson et al. (US 2003/0070682 A1).
Regarding 23, Wilson discloses a vascular occlusion coil comprising: a cylindrical spiral body enclosing an elongated coil passage (para. [0245]); and a core member positioned within the elongated coil passage (paras. [0245]-[0247]).
Regarding 24, Wilson discloses the vascular occlusion coil of claim 23. Wilson also discloses wherein the core member is configured to force the vascular occlusion coil into a secondary structure in which the cylindrical spiral body is bent, rotated and/or twisted into a three-dimensional form (i.e., at least since para. [0245] discloses that the coil is wrapped around the core thereby deforming the coil from a straight configuration into a wrapped configuration around core).
Regarding 25, McGuckin discloses the vascular occlusion coil of claim 24. McGuckin also discloses wherein the secondary structure comprises a series of arced segments arranged in two or more different orientations (i.e., at least each wind has a different arc when transitioning from the one arc to the second arc along the core; i.e., see para. [0245] also which discloses adding a “modified j” tip which is a different orientation).
Claims 26, 28-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dias et al. (US 20190015107 A1).
Regarding 26, Dias discloses a vascular occlusion coil 100 having an elastically relaxed configuration comprising a series of arced segments arranged in two or more different orientations (i.e., see Fig. 1 which shoes arced segments each with different orientations), wherein the vascular occlusion coil is configured to be elastically deformed into a linear configuration for placement in a coil dispensing catheter 10 (para. [0023]), and wherein the vascular occlusion coil is configured to sequentially form the series of arced segments of the elastically relaxed configuration as it is pushed out from a distal end of the coil dispensing catheter (para. [0023]).
Regarding 28, Dias discloses the vascular occlusion coil of claim 26. Dias also discloses wherein the vascular occlusion coil forms a plurality of helical segments (i.e., 110C and 110F) interlinked with a corresponding curved linking portion (i.e., 110E, 110B, etc).
Regarding 29, Dias discloses the vascular occlusion coil of claim 28. Dias also discloses wherein the helical segments are substantially coinciding and spaced apart with each other, such that they form a tubular-like frame configured with a substantially constant helix diameter and/or pitch (Fig. 3 shows 110C and 110F forming the tubular-like frame with a substantially constant helix diameter).
Regarding 30, Dias discloses the vascular occlusion coil of claim 28. Dias also discloses wherein each one of the helical segments is configured to form one of the arced segments (Fig. 3).
Regarding 31, Dias discloses the vascular occlusion coil of claim 28. Dias also discloses wherein at least one of the helical segments includes a single winding (Fig. 3) or a partial winding between each sequential pair of the corresponding curved linking portion.
Regarding 32, Dias discloses the vascular occlusion coil of claim 28. Dias also discloses wherein at least one of the curved linking portions is formed as an arc having an arc central angle within a range of about 45° to about 225° (Fig. 3), optionally particularly greater than about 90°,optionally particularly about 180°.
Regarding 33, Dias discloses the vascular occlusion coil of claim 28. Dias also discloses wherein at least one of the curved linking portions is formed as an arc having an arc central angle greater than 90° (Fig. 3).
Regarding 34, Dias discloses the vascular occlusion coil of claim 28. Dias also discloses wherein at least one of the curved linking portions is formed as an arc having an arc central angle of about 180° (Fig. 3).
Regarding 35, Dias discloses the vascular occlusion coil of claim 28. McGuckin also discloses wherein the helical segments in at least one sequential pair of the helical segments are oppositely winded relative to each other (Fig. 3; i.e., 110F, 110C).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over McGuckin in view of Wilson et al. (US 2003/0070682 A1).
Regarding 4, McGuckin discloses the vascular occluder forming system of claim 3. McGuckin doesn’t directly disclose wherein the vascular occlusion coil comprises a core member within the cylindrical spiral body.
In the same field of endeavor, namely bronchial flow control devices, Wilson discloses a similar device to McGuckin and discloses a core member wrapped with coil (para. [0245]).
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 device of McGuckin to have a core member within the spiral body for purposes of imparting stiffness (para. [0245]).
Regarding 5, McGuckin and Wilson disclose the vascular occluder forming system of claim 4. McGuckin also discloses wherein the core member comprises an elastic wire (i.e., at least by way of expanding as disclosed in para. [0049] which also discloses nitinol).
Regarding 6, McGuckin discloses the vascular occluder forming system of claim 5. Wilson discloses wherein the core member is formed of metal (i.e., para. [0245] discloses stainless steel).
Regarding 7, McGuckin discloses the vascular occluder forming system of claim 4. McGuckin also discloses wherein the core member is configured to force the vascular occlusion coil into a secondary structure in which the cylindrical spiral body is bent, rotated and/or twisted into a three- dimensional form (para. [0049]; Figs. 5-7).
Regarding 8, McGuckin discloses the vascular occluder forming system of claim 7. McGuckin also discloses wherein the container is configured to receive into the container space the vascular occlusion coil in the secondary structure and to force the vascular occlusion coil into a tertiary structure derivable from a shape of the side wall when the cylindrical spiral body is axially compacted and/or radially expanded from the secondary structure when released into the container space from the coil dispenser (i.e., at least during transition from its straight elongated shape to a coiled shape; para. [0049]; Figs 5-7).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Dias in view of Wilson et al. (US 2003/0070682 A1).
Regarding 27, Dias discloses the vascular occlusion coil of claim 26. Dias also discloses wherein the vascular occlusion coil comprises: a cylindrical spiral body enclosing an elongated coil passage (i.e., in the space to which 100 expands; i.e., see Figs. 1-3). Dias doesn’t directly disclose a core member positioned within the elongated coil passage.
In the same field of endeavor, namely bronchial flow control devices, Wilson discloses a similar device to McGuckin and discloses a core member wrapped with coil (para. [0245]).
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 device of Dias to have a core member within the spiral body for purposes of imparting stiffness (para. [0245]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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