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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 21 and 22 have been considered but are moot because the new ground of rejection over Tran et al. US 2014/0207162, as discussed below.
Tran et al. US 2014/0207162 discloses a sealing element 130 which may assume a generally flattened shape when collapsed (paragraph 0042), the shape of the sealing element may be controlled and transitioned from a collapsed to expanded configuration which extends radially outwards therefrom (paragraph 0043), the sealing element may be allowed to be filled with a liquid 136 and can expand (paragraph 0041) with an embolic material 170 delivered therethrough (figure 7).
Examiner notes applicant fails to argue Eskridge et al. US 8545530 with regards to claim 1-4, as claims 1-4 do not require that the expandable toroidal member is expanded by being filled with a liquid or gel, the liquid of gel solidifies after the expandable toroidal member is filled.
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eskridge et al. US 8545530.
Regarding claim 1, Eskridge et al. discloses device to occlude an aneurysm (figures 1C-1E) comprising: a longitudinal catheter (delivery catheter 14 with sheath 15) that is configured to be inserted into a blood vessel (figures 1C-1E), wherein the blood vessel is the parent vessel from which an aneurysm has formed (figure 1C, aneurysm 17); a longitudinal flexible embolic member 18 that is configured to travel through the longitudinal catheter and be inserted into the aneurysm sac (column 10, lines 2-4, embolic coils 18 may be introduced through delivery catheter); and an expandable member (structure 10 comprising a frame 12 with patch 11) that is configured to travel through the longitudinal catheter (within sheath portion 15 which is retracted to expose expandable member, figure 1B-1D), be inserted into the aneurysm sac (figures 1C and 1D), and be expanded within the aneurysm sac (figure 1D), wherein the expandable member is configured to substantially occlude the aneurysm neck after it is expanded (column 9, lines 46-51, closure structure 10 covers opening of an aneurysm), wherein the longitudinal flexible embolic member is inserted into the aneurysm sac through a central opening 13 of the expandable member (embolic material or coils 18 may be introduced through delivery catheter 14 and the opening or slot 13 expandable member into the aneurysm, figure 1E, column 5, lines 41-46; column 9, line 17-21), and wherein the expandable member prevents the longitudinal flexible member from protruding into the parent vessel of the aneurysm (column 9, line 58-column 10, line 10; placed across the aneurysm opening and reducing or preventing the exchange of materials between the blood vessel and the aneurysm interior).
Eskridge et al. discloses the expandable closure structure size and perimeter configuration of closure structure 10 is designed to be at least slightly larger, in at least one dimension, than the neck or opening of an aneurysm desired to be closed (column 9, lines 46-51) and may have a variety of configurations such as generally round, oval, oblong, or polygonal (column 9, lines 46-51) for closing the aneurysm.
Eskridge et al. discloses the claimed invention except for the expandable closure structure being an expandable toroidal structure. It would have been an obvious matter of design choice change the shape of the expandable closure structure or framework patch to be an expandable toroidal structure to cover or close the opening in the aneurysm neck, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 2, Eskridge et al. discloses wherein the longitudinal flexible embolic member is a coil (embolic coils 18, figure 1E).
Regarding claim 3, Eskridge et al. discloses wherein the expandable toroidal member is expanded in a radial- expansion plane that is substantively parallel with the plane defined by the central circumference of the aneurysm neck (figure 1D, structure 12 with patch 11 parallel to the neck opening in the expanded configuration).
Regarding claim 4, Eskridge et al. discloses wherein a plurality of embolic members (embolic coils 18) are inserted into the aneurysm sac through the central opening (figure 1E).
Claim(s) 1, 2, 3, 4, 21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. US 2014/0207162.
Regarding claim 1, Tran et al. discloses a device to occlude an aneurysm comprising: a longitudinal catheter that is configured to be inserted into a blood vessel (figure 7), wherein the blood vessel is the parent vessel from which an aneurysm has formed (figure 7, aneurysm 190); a longitudinal flexible embolic member 170 that is configured to travel through the longitudinal catheter and be inserted into the aneurysm sac (paragraph 0047, any suitable embolic for occluding a cavity such as coils delivered over a guidewire, fibers, particles, etc); and an expandable member 130 that is configured to travel through the longitudinal catheter and be inserted into the aneurysm sac (may be deployed within and protected by a catheter sheath 160, paragraph 0045; or alternatively for example, similar embodiment shown with sheath 160 also serving as a catheter or tubular member 110, figure 20), and be expanded within the aneurysm sac (once released from the catheter or sheath), wherein the expandable member is configured to substantially occlude the aneurysm neck after it is expanded (sealing element 130 configured to seal the orifice in the neck of the aneurysm, once expanded, figure 3, paragraph 0011), wherein the longitudinal flexible embolic member is inserted into the aneurysm sac through a central opening of the expandable member (for example, figures 8, 9; through lumen 124 of tubular member), and wherein the expandable toroidal member prevents the longitudinal flexible member from protruding into the parent vessel of the aneurysm (paragraph 0011, seals the orifice once expanded radially, or the collapsed configured along the aneurysm neck orifice, figure 10).
Tran et al. discloses the claimed invention including a generally expandable disk-like shape (figure 3), the shape may be any generally disk like shape once deployed for sealing the orifice the shape may be controlled in various ways as required (paragraph 0042, 0043), and may be filled with a liquid or gel (paragraph 0041), but fails to explicitly disclose the expandable closure structure being an expandable toroidal structure. It would have been an obvious matter of design choice change the shape of the expandable closure structure or framework patch to be an expandable toroidal structure to cover or close the opening in the aneurysm neck, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 2, Tran et al. discloses wherein the longitudinal flexible embolic member is a coil (paragraph 0047, any suitable embolic for occluding a cavity such as coils, fibers, particles, etc).
Regarding claim 3, Tran et al. discloses in combination wherein the expandable toroidal member is expanded in a radial- expansion plane that is substantively parallel with the plane defined by the central circumference of the aneurysm neck (figures 3, 7, 10, sealing member 130 extends radially outward from neck of aneurysm 190).
Regarding claim 4, Tran et al. discloses in combination wherein a plurality of embolic members are inserted into the aneurysm sac through the central opening (paragraph 0046, figures 8-10; embolic members 170 through lumen 124 which extends through sealing member 130).
Regarding claim 21, Tran et al. discloses in combination wherein the expandable toroidal member is expanded by being filled with a liquid or gel (paragraph 0041).
Regarding claim 22, Tran et al. discloses in combination wherein the expandable toroidal member is expanded by being filled with a liquid or gel (paragraph 0041), but fails to explicitly disclose wherein the liquid or gel solidifies after the expandable toroidal member has been filled.
However, Tran et al. discloses wherein the sealing member is a mesh, the introduction of an embolic liquid or gel that may solidify once filled into the aneurysm and anchor the sealing element within the aneurysm (paragraphs 0046, 0047). Examiner notes the sealing member may be porous or mesh (paragraph 0041), thereby allowing for introduction of the embolic members for anchoring the sealing member within the aneurysm.
Therefore, it would have been obvious to one having ordinary skill in the art to provide a liquid or gel that may solidify once the expandable member has been filled and expanded, as taught by Tran et al., to fill and secure or anchor the sealing member within the aneurysm.
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.
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/C.C.L/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771