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 Objections
Claim 16 objected to because of the following informalities:
In line 6, “the conduit” should read “a conduit”.
In line 7, “conduit” should read “the conduit”.
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.
Claims 16-17 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sepetka et al. (US 2005/0154417).
Regarding claim 16, an invention relating to occlusive implants, Sepetka discloses (Figs. 1-6) a method comprising: disposing an occlusive implant (28) at a treatment site (Par. 0055), the implant having a proximal hub (30) releasably coupled to a conduit engagement portion (36) via an expandable member (40) in an expanded state (Par. 0055); expanding the occlusive implant at the treatment site [i.e. radially outward displacement of elements 44] (Par. 0055); collapsing the expandable member to disengage a conduit (26) from the proximal hub; and proximally retracting the conduit and the expandable member while the occlusive implant remains at the treatment site (Par. 0055).
Regarding claim 17, Sepetka discloses the method of claim 16. Sepetka further discloses wherein the treatment site comprises an aneurysm sac (Par. 0053).
Regarding claim 20, Sepetka discloses the method of claim 16. Sepetka further discloses wherein, before collapsing the expandable member, the expandable member exerts a radially outward force on a radially inner surface of the implant proximal hub (Par. 0055).
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.
Claims 1-7, 9-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Sepetka et al. (US 2005/0154417) in view of Swain et al. (US 2006/0167482).
Regarding claim 1, an invention relating to occlusive implants, Sepetka discloses (Figs. 1-6) a treatment system (2, 4, 24) comprising: an occlusive implant (28) comprising a proximal hub (30) having a radially inner surface [i.e. inner surface of elements 44] defining a hub lumen [i.e. space occupied by element 40] (Par. 0050), the implant configured to be positioned at an intrasaccular treatment site (Par. 0040); a conduit (26) comprising an engagement portion (36), the conduit defining a conduit lumen [i.e. inner lumen] extending along its length (Par. 0042); and an expandable member (40) coupled to a radially outer surface of the conduit engagement portion (Par. 0049) and configured to transition between an engaged configuration (Fig. 5) and a disengaged configuration (Fig. 6), wherein: in the engaged configuration, the expandable member is expanded such that the expandable member exerts a radially outward force on the radially inner surface of the proximal hub to prevent axial movement of the proximal hub with respect to the conduit engagement portion; and in the disengaged configuration, the expandable member is collapsed such that the conduit engagement portion can be slidably retracted with respect to the proximal hub (Par. 0055). Also, Sepetka further discloses the expandable member has a construction similar to those used in conventional balloon catheters (Par. 0049). However, Sepetka fails to further disclose the engagement portion configured to be releasably disposed within the hub lumen, the conduit defining a conduit lumen extending along its length and configured to pass an embolic element therethrough.
In the analogous art of balloon catheters, Swain teaches (Fig. 4) a conduit (7) comprising an engagement portion [i.e. portion of surrounded by the balloon and distal to the balloon] configured to be releasably disposed within the hub lumen, the conduit defining a conduit lumen [i.e. catheter lumen] extending along its length (Par. 0027) and configured to pass an embolic element therethrough and an expandable member (8) coupled to a radially outer surface of the conduit engagement portion (Par. 0017-0018).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sepetka to have the engagement portion configured to be releasably disposed within the hub lumen, the conduit defining a conduit lumen extending along its length and configured to pass an embolic element therethrough, as taught by Swain. Sepetka further discloses the expandable member having a construction of a conventional balloon catheters is desired (Par. 0049), thus Swain’s balloon catheter would have provided Sepetka with a balloon catheter having the construction of a conventional balloon catheter.
Regarding claim 2, Sepetka, as modified by Swain, discloses the treatment system of claim 1. Sepetka further discloses wherein the expandable member comprises a balloon, and wherein expanding the expandable member comprises inflating the balloon, and wherein collapsing the expandable member comprises deflating the balloon (Par. 0055).
Regarding claim 3, Sepetka, as modified by Swain, further discloses comprising an inflation lumen running alongside the conduit lumen and in fluid communication with the balloon [i.e. inflation channel, see Swain paragraph 0018].
Regarding claim 4, Sepetka, as modified by Swain, further discloses wherein the expandable member circumferentially surrounds the conduit engagement portion [see Swain paragraph 0017].
Regarding claim 5, Sepetka, as modified by Swain, discloses the treatment system of claim 1. Sepetka further discloses wherein the conduit engagement portion has a smaller outermost cross-sectional dimension than a proximal portion of the conduit (see annotated figure below).
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Regarding claim 6, Sepetka, as modified by Swain, discloses further wherein the conduit comprises a distal end portion extending distal to the conduit engagement portion [i.e. distal end of catheter, see Swain annotated figure below].
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Regarding claim 7, Sepetka, as modified by Swain, discloses further wherein the implant defines an implant lumen in fluid communication with the conduit lumen when in the engaged state, the implant lumen configured to pass an embolic material therethrough to a position distal to at least a portion of a distal face of the implant [i.e. Swain’s catheter lumen would be in fluid communication with the implant lumen detailed in Sepetka when the expandable member is in the engaged state].
Regarding claim 9, Sepetka, as modified by Swain, discloses the treatment system of claim 1. Sepetka further discloses wherein in the engaged configuration, a radially outer surface of the expandable member mechanically interlocks with the radially inner surface of the proximal hub (Par. 0055).
Regarding claim 10, an invention relating to occlusive implants, Sepetka discloses (Figs. 1-6) a treatment system (2, 4, 24) comprising: a detachable medical device (28) comprising a proximal hub (30) having a radially inner surface [i.e. inner surface of elements 44] defining a hub lumen [i.e. space occupied by element 40] (Par. 0050); a core member (26) comprising an engagement portion (36); and an expandable member (40) coupled to a radially outer surface of the core member engagement portion (Par. 0049) and configured to transition between an engaged configuration (Fig. 5) and a disengaged configuration (Fig. 6), wherein: in the engaged configuration, the expandable member is expanded such that the expandable member exerts a radially outward force on the radially inner surface of the proximal hub to prevent axial movement of the proximal hub with respect to the core member engagement portion; and in the disengaged configuration, the expandable member is collapsed such that the core member engagement portion can be slidably retracted with respect to the proximal hub (Par. 0049). Also, Sepetka further discloses the expandable member has a construction similar to those used in conventional balloon catheters (Par. 0049). However, Sepetka fails to further disclose the engagement portion configured to be releasably disposed within the hub lumen.
In the analogous art of balloon catheters, Swain teaches (Fig. 4) a core member (7) comprising an engagement portion [i.e. portion of surrounded by the balloon and distal to the balloon] configured to be releasably disposed within the hub lumen, an expandable member (8) coupled to a radially outer surface of the conduit engagement portion (Par. 0017-0018).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sepetka to have the engagement portion configured to be releasably disposed within the hub lumen, as taught by Swain. Sepetka further discloses the expandable member having a construction of a conventional balloon catheters is desired (Par. 0049), thus Swain’s balloon catheter would have provided Sepetka with a balloon catheter having the construction of a conventional balloon catheter.
Regarding claim 11, Sepetka, as modified by Swain, discloses he treatment system of claim 10. Sepetka further discloses wherein the expandable member comprises a balloon, and wherein expanding the expandable member comprises inflating the balloon, and wherein collapsing the expandable member comprises deflating the balloon (Par. 0055).
Regarding claim 12, Sepetka, as modified by Swain, discloses further comprising an inflation lumen running along the core member and in fluid communication with the balloon [i.e. inflation channel, see Swain paragraph 0018].
Regarding claim 13, Sepetka, as modified by Swain, discloses further wherein the core member comprises a conduit defining a conduit lumen configured to pass an embolic element therethrough [i.e. catheter lumen is structurally capable of introducing an embolic element, see Swain paragraphs 0017-0018].
Regarding claim 15, Sepetka, as modified by Swain, discloses the treatment system of claim 10. wherein in the engaged configuration, a radially outer surface of the expandable member mechanically interlocks with the radially inner surface of the proximal hub (Par. 0055).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Sepetka et al. (US 2005/0154417), in view of Swain et al. (US 2006/0167482), as applied to claim 1 above, and further in view of Tran et al. (US 2005/0283183).
Regarding claim 8, Sepetka, as modified by Swain, discloses the treatment system of claim 1. Sepetka fails to further disclose wherein the occlusive implant comprises a self-expandable braided implant.
In the same field of endeavor, which is occlusive implants, Tran teaches wherein the occlusive implant comprises a self-expandable braided implant (20, 30, 40; Par. 0030-00032 & 0045).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sepetka to have wherein the occlusive implant comprises a self-expandable braided implant. Doing so would reduce friction against the walls of the delivery catheter and eases delivery (Par. 0066), as taught by Tran.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Sepetka et al. (US 2005/0154417), in view of Swain et al. (US 2006/0167482), as applied to claim 10 above, and further in view of Tran et al. (US 2005/0283183).
Regarding claim 14, Sepetka, as modified by Swain, discloses the treatment system of claim 10. Sepetka fails to further disclose wherein the occlusive implant comprises a self-expandable braided implant.
In the same field of endeavor, which is occlusive implants, Tran teaches wherein the occlusive implant comprises a self-expandable braided implant (20, 30, 40; Par. 0030-00032 & 0045).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sepetka to have wherein the occlusive implant comprises a self-expandable braided implant. Doing so would reduce friction against the walls of the delivery catheter and eases delivery (Par. 0066), as taught by Tran.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Sepetka et al. (US 2005/0154417) as applied to claim 16 above, and further in view of O’Gara et al. (US 2009/0125051).
ALTERNATE REJECTION – different interpretation of the “conduit”
Regarding claim 16, an invention relating to occlusive implants, Sepetka discloses (Figs. 1-6) a method comprising: disposing an occlusive implant (28) at a treatment site (Par. 0055), the implant having a proximal hub (30) releasably coupled to a conduit engagement portion (36) via an expandable member (40) in an expanded state (Par. 0055); expanding the occlusive implant at the treatment site [i.e. radially outward displacement of elements 44] (Par. 0055); collapsing the expandable member to disengage a conduit (4 & 26) from the proximal hub; and proximally retracting the conduit and the expandable member while the occlusive implant remains at the treatment site (Par. 0055).
Regarding claim 18, Sepetka discloses the method of claim 16. However, Sepetka fails to disclose further comprising, after expanding the occlusive implant and before collapsing the expandable member, delivering an embolic element through the conduit to the treatment site.
In the same field of endeavor, which is occlusive device, O’Gara teaches (Fig. 6) the method step: after expanding an occlusive implant (20) and before collapsing the expandable member [i.e. before release of the occlusive implant. Note, Sepetka divulges the collapsing of the expandable member], delivering an embolic element (30) through a conduit (80) to the treatment site (100; Par. 0022).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sepetka to have the method step: after expanding the occlusive implant and before collapsing the expandable member, delivering an embolic element through the conduit to the treatment site. Doing so would improve the occlusion of the target site (Par. 0019), as taught by O’Gara.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Sepetka et al. (US 2005/0154417) as applied to claim 16 above, and further in view of Swain et al. (US 2006/0167482).
Regarding claim 19, Sepetka discloses the method of claim 16. Sepetka further discloses wherein collapsing the expandable member comprises deflating the balloon (Par. 0055). Also, Sepetka further discloses the expandable member has a construction similar to those used in conventional balloon catheters (Par. 0049). However, Sepetka fails to further disclose wherein the expandable member comprises a balloon disposed over an exterior surface of the conduit engagement portion.
In the analogous art of balloon catheters, Swain teaches (Fig. 4) an expandable member (8) coupled to a radially outer surface of a conduit engagement portion (7; Par. 0017-0018).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sepetka to have wherein the expandable member comprises a balloon disposed over an exterior surface of the conduit engagement portion, as taught by Swain. Sepetka further discloses the expandable member having a construction of a conventional balloon catheters is desired (Par. 0049), thus Swain’s balloon catheter would have provided Sepetka with a balloon catheter having the construction of a conventional balloon catheter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 May 2, 2026
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