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 Amendment
The Amendment filed 07/29/26 has been entered. Claims 1, 7, 10, 14, and 16 have been amended. Claims 1-20 are addressed in the following office action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Concerning claim 16, applicant’s original disclosure fails to detail the method step of “the implant having a proximal hub releasably coupled to a conduit engagement portion via an expandable member in a fully expanded state while being advanced to the treatment site”. Applicant’s original specification and figures do not explicitly state the expandable member is in a fully expanded state to engage the proximal hub. Hence, the limitation is considered new matter. Claims 17-20 are rejected for the same reasons as claim 16 by virtue of dependency on claim 16.
Claim Objections
Claim 1 objected to because of the following informalities: In line 8, “its length” should read “a length of the conduit”. Appropriate correction is required.
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), both cited in previous office action.
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 extending along longitudinally a length of the proximal hub [i.e. inner surface of elements 44] and 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 into apposition with the radially inner surface of the proximal hub along the length of the proximal hub 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 such that a radially outer surface of the conduit engagement portion opposes the radially inner surface of the proximal hub along the length of the proximal hub, the conduit defining a conduit lumen extending along its length and configured to pass an embolic element therethrough; and the expandable member extending along longitudinally substantially all of the conduit engagement portion.
In the analogous art of balloon catheters, Swain teaches (Fig. 4) a conduit (7) comprising an engagement portion [i.e. portion of the conduit surrounded by the balloon and distal to the balloon]; 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 and extending along longitudinally substantially all 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 such that a radially outer surface of the conduit engagement portion opposes the radially inner surface of the proximal hub along the length of the proximal hub, the conduit defining a conduit lumen extending along its length and configured to pass an embolic element therethrough; and the expandable member extending along longitudinally substantially all 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. Note given the broadest reasonable interpretation, Swain’s balloon catheter’s engagement portion provided in Sepetka’s device would obviously be configured to be releasably disposed within the hub lumen such that a radially outer surface of the conduit engagement portion opposes the radially inner surface of the proximal hub along the length of the proximal hub, since Sepetka discloses the expandable member, which surrounds the engagement portion, is expanded into apposition with the radially inner surface of the proximal hub along the length of the proximal hub.
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 configuration, 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 extending along a length of the proximal hub [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 into apposition with the radially inner surface of the proximal hub along the length of the proximal hub 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 such that a radially outer surface of the core member engagement portion opposes the radially inner surface of the proximal hub along the length of the proximal hub; the expandable member extending along longitudinally substantially all of the core member engagement portion.
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], an expandable member (8) extending along a length of the proximal hub, an expandable member coupled to a radially outer surface of the core member engagement portion and extending along longitudinally substantially all of the core member 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 such that a radially outer surface of the core member engagement portion opposes the radially inner surface of the proximal hub along the length of the proximal hub; the expandable member extending along longitudinally substantially all of the core member 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. Note given the broadest reasonable interpretation, Swain’s balloon catheter’s engagement portion provided in Sepetka’s device would obviously be configured to be releasably disposed within the hub lumen such that a radially outer surface of the core member engagement portion opposes the radially inner surface of the proximal hub along the length of the proximal hub, since Sepetka discloses the expandable member, which surrounds the engagement portion, is expanded into apposition with the radially inner surface of the proximal hub along the length of the proximal hub.
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 medial device 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.
Response to Arguments
Applicant’s arguments, see pages 6-8, filed 07/29/26, with respect to claims 16-17 and 20 have been fully considered and are persuasive. The claim objections of claim 16 and the 35 USC § 102 rejection of claims 16-17 and 20 have been withdrawn.
Applicant generally argues that previously cited prior art references fails to disclose the new limitations. However, no specific arguments in relation to the new limitations were presented. Examiner maintains that the previously cited prior art references read on the previously examined limitations and newly entered limitations. See rejection above for detailed description of how the prior art of record discloses or makes obvious the new limitations.
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 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
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
