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
Claims 2 and 4 are objected to because of the following informalities:
Claims 2 and 4 recite “the aneurism” should be changed to recite “the aneurysm”.
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 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Vale (US2014/0371779) in view Jordan (US2006/0100688).
Regarding claim 1, Vale discloses a flow diverter delivery system, comprising:
a catheter (302) sized for insertion and movement through a blood vessel, the catheter having a delivery lumen (lumen of microcatheter, [0221]);
a pusher wire (shaft 151) slidably disposed within the delivery lumen ([0221]);
a distal guide (collar 152, [0214], [0217]) linearly coupled to a distal end of the pusher wire ([0214], see Fig. 5a);
a flow diverter (153/154/155/156, [0214]) having an undeployed configuration and a deployed configuration ([0214], see Fig. 7a-7d), the flow diverter, in the deployed configuration, including; a low-porosity distal cap (155, [0023]) structurally configured to be longitudinally positionable adjacent a luminal wall of a blood vessel bifurcation at an aneurysm (the clot retrieval device is configured for being placed within a obstructed vessel and would therefore be capable of being positioned at a blood vessel bifurcation at an aneurysm);
a transverse flow section (section of 154 excluding 155/156, [0214], see Fig. 5a) coupled to a proximal end of the distal cap ([0214], see Fig. 5a); and
a linear support body (153) coupled to a proximal end of the transverse flow section (153 is coupled at 160 to proximal end of section of 154, see Fig. 5a, [0214]) and having a proximal transverse opening (one of the openings at the proximal end of 153 near collar 152, see Fig. 5a, [0215]) with a distal facing region (region of the opening that extends distally), wherein the low-porosity distal cap is structurally configured to divert at least a portion of blood received from the linear support body through the transverse flow section (the distal cap 155 would be capable of diverting blood received from the linear support body through the transverse flow section, since the members are intended to create a flow channel, [0215]);
Vale according to the embodiment of clot retrieval device 150 does not explicitly disclose the distal cap having a convex shape. Vale according to other embodiments teaches the fragment protection structure (distal cap) struts arrangement in a volumetric pattern such as a spherical shape (spherical shape is interpreted as convex, [0040]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the distal cap shape of Vale for the distal cap to having a convex shape as taught by the spherical embodiment of Vale, since the substitution would have the same predictable result of acting as a fragment protection structure.
Vale according to the embodiment of clot retrieval device 150 does not explicitly disclose a flow diverter anchor coupled to the distal guide and having a proximal transverse edge, the proximal transverse edge mechanically engaged to the distal-facing region of the proximal transverse opening of the flow diverter in the undeployed configuration, wherein the proximal transverse edge is further structurally configured such that radial movement of the proximal transverse opening away from the transverse edge disengages the flow diverter from the flow diverter anchor. Vale according to other embodiments teaches a proximal joint 657 at the proximal end of the clot retrieval device, and the proximal joint can be detached for release of the implant ([0235]). Jordan teaches a system for delivering and deploying a stent 24, the stent 24 is contained within an outer catheter that is retracted for deployment ([0062]). Further, the stent 24 has loops 46 (proximal transverse opening) at a proximal end ([0061]). The loops 46 are anchored by anchoring device 40 (flow diverter anchor) with fins 58 on the anchoring device 40 extending through the loops 46 ([0066], see Fig. 6). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have substituted the detachment mechanism at the end of pusher wire to release of the implant of Vale for the release mechanism including an anchoring block on an pusher wire with fins extending through loops at the proximal end of the implant as taught by Jordan, since the substitution would have yielded the same predictable result of holding and releasing the implant for delivery at the desired site. Where the modified invention of Vale/Jordan discloses the proximal transverse edge (see annotated Fig. 6) mechanically engaged to the distal-facing region of the proximal transverse opening (engaged by the fin 58 being within the loop 46, see Fig. 6) of the flow diverter in the undeployed configuration, wherein the proximal transverse edge is further structurally configured such that radial movement of the proximal transverse opening away from the transverse edge disengages the flow diverter from the flow diverter anchor (when the implant and pusher wire with the anchoring member is released from an outer catheter, the loops 46 would be allowed to move radially when the implant is expanded, [0076] of Jordan).
PNG
media_image1.png
287
468
media_image1.png
Greyscale
Regarding claim 2, Vale/Jordan makes obvious the flow diverter delivery system of claim 1, Vale further discloses wherein the transverse flow section is comprised of a plurality of support members (struts 158) coupled between the distal cap and the linear support body (see Fig. 5a), the plurality of support members structurally configured to support the distal cap at the aneurysm ([0214]).
Regarding claim 3, Vale/Jordan makes obvious the flow diverter delivery system of claim 1, Vale further discloses wherein the linear support body has a lower porosity than the transverse flow section (inner member has a denser scaffold than the outer member, [0215]); yet, does not explicitly disclose the linear support body has a higher porosity than the distal cap. Vale according to other embodiments teaches the distal scaffolding (distal cap) having fine wires to provide added scaffolding. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the linear support body have a higher porosity than the distal cap, since it is desirable to have the distal cap to incorporate fine wires to further decrease the porosity relative to the linear support body to provide added scaffolding and tensile strength to the distal cap ([0192])
Regarding claim 4, Vale/Jordan makes obvious the flow diverter delivery system of claim 1, Vale further discloses wherein the distal cap has a porosity that allows sufficient blood flow through into the aneurysm to inhibit thrombosis from forming on the distal cap and that restricts sufficient blood flow into the aneurism to facilitate endothelization on the distal cap (distal scaffolding is intended to allow blood flow while preventing clot fragments from flowing through it, [0022]; therefore would prevent thrombosis from forming on the distal cap in the same manner as the claimed invention, while restricting blood flow by the scaffolding structure being a wire net, [0216] and would therefore facilitate endothelization on the distal cap in the same manner as the claimed invention).
Regarding claim 5, Vale/Jordan makes obvious the flow diverter delivery system of claim 1; yet, does not explicitly disclose wherein the distal cap has a porosity of from about 15% to about 55%. Vale sets forth that the porosity of the distal cap a result effective variable, dependent on the density of the wires of the distal cap to reduce the pore size of its openings for desired characteristics such as prevention of emboli from exiting the cap ([0215]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected a porosity of the distal cap from about 15% to 55%, for the purpose of selecting a desired density for capturing emboli, 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 claim 6, Vale/Jordan makes obvious the flow diverter delivery system of claim 1; yet, does not explicitly disclose wherein the distal cap has a porosity of from about 30% to about 40%. Vale sets forth that the porosity of the distal cap a result effective variable, dependent on the density of the wires of the distal cap to reduce the pore size of its openings for desired characteristics such as prevention of emboli from exiting the cap ([0215]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected a porosity of the distal cap from about 30% to 40%, for the purpose of selecting a desired density for capturing emboli, 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 claim 7, Vale/Jordan makes obvious the flow diverter delivery system of claim 1; yet, does not explicitly disclose wherein the distal cap, the transverse flow section, and the linear support body are comprised of braided wires. Vale according to other embodiments teaches the inner and outer members that includes the distal scaffolding are comprised of a braided material ([0021], [0192]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the distal cap, the transverse flow section, and the linear support body for a braided material as taught by another embodiment of Vale, since the substitution would have the same predictable result of an expansion device that allows blood flow while capturing emboli ([0022]).
Regarding claim 8, Vale/Jordan makes obvious the flow diverter delivery system of claim 7, Jordan further teaches wherein the proximal transverse opening is an opening in a braiding pattern of the braided wires (loop 46 is an extension of a braided structure, [0056], [0061]).
Regarding claim 9, Vale/Jordan makes obvious the flow diverter delivery system of claim 1, Vale further discloses wherein the delivery lumen is sized to maintain the flow diverter in the undeployed configuration (see Fig. 7b, [0221]).
Regarding claim 10, Vale/Jordan makes obvious the flow diverter delivery system of claim 9, the modified invention discloses wherein the distal-facing region of the proximal transverse opening is held mechanically engaged with the proximal transverse edge by the delivery lumen (where the loops 46 would be mechanically engaged with the fins 58 within the microcatheter of Vale, see Fig. 7b, [0221] of Vale).
Regarding claim 11, Vale/Jordan makes obvious the flow diverter delivery system of claim 10, the modified invention teaches wherein the proximal transverse edge of the flow diverter anchor is structurally configured to mechanically disengage from the proximal transverse opening when the delivery lumen is withdrawn to fully expose a proximal end of the linear support body (when the microcatheter of Vale is withdrawn to expose the implant; the edge of the anchor 40 of Jordan as shown in annotated Fig. 6 from the rejection of claim 1, would disengage from the loop 46 of the implant by expansion of the implant).
Regarding claim 12, Vale/Jordan makes obvious the flow diverter delivery system of claim 10, the modified invention discloses wherein the proximal transverse edge of the flow diverter anchor is structurally configured to mechanically disengage from the proximal transverse opening when the delivery lumen is withdrawn to expose a proximal end of the flow diverter sufficiently to allow the proximal transverse opening to lift off of the proximal transverse edge between the flow diverter anchor and the delivery lumen (when the microcatheter of Vale is withdrawn to expose the implant; the edge of the anchor 40 of Jordan as shown in annotated Fig. 6 from the rejection of claim 1, would disengage from the loop 46 of the implant by expansion of the implant, furthermore the loops 46 would lift off the edge during the expansion of the implant by it being self-expanding, see [0198] of Vale which discloses a self-expanding implant).
Regarding claim 13, Vale/Jordan makes obvious the flow diverter delivery system of claim 10, the modified invention discloses wherein the proximal transverse edge of the flow diverter anchor and the delivery lumen are structurally configured to maintain the capacity to withdraw the flow diverter into the delivery lumen when the flow diverter is at least 70% deployed (the prior art is not required to disclose the capability to withdraw the flow diverter back into the lumen when deployed at least 70% but merely have the capability of being manipulated in the recited manner, therefore the operator is capable of withdrawing the flow diverter when it is at least 70% deployed).
Regarding claim 14, Vale/Jordan makes obvious the flow diverter delivery system of claim 10, the modified invention further discloses wherein the proximal transverse edge of the flow diverter anchor and the delivery lumen are structurally configured to maintain the capacity to withdraw the flow diverter into the delivery lumen when the flow diverter is at least 80% deployed (the prior art is not required to disclose the capability to withdraw the flow diverter back into the lumen when deployed at least 80% but merely have the capability of being manipulated in the recited manner, therefore the operator is capable of withdrawing the flow diverter when it is at least 80% deployed).
Regarding claim 15, Vale/Jordan makes obvious the flow diverter delivery system of claim 10, the modified invention discloses wherein the proximal transverse edge of the flow diverter anchor and the delivery lumen are structurally configured to maintain the capacity to withdraw the flow diverter into the delivery lumen when the flow diverter is at least 90% deployed (the prior art is not required to disclose the capability to withdraw the flow diverter back into the lumen when deployed at least 90% but merely have the capability of being manipulated in the recited manner, therefore the operator is capable of withdrawing the flow diverter when it is at least 90% deployed).
Regarding claim 16, Vale/Jordan makes obvious the flow diverter delivery system of claim 7, Vale further discloses the modified invention further discloses wherein the braided wires are braided wire bundles (braided structure is formed from one or more wires, where a braided structure of more than one wire is interpreted as a wire bundle, [0226]).
Regarding claim 17, Vale/Jordan makes obvious the flow diverter delivery system of claim 16, Vale further discloses further comprising a plurality of wire bundle slack adjusters (connecting elements 157) coupled between the proximal end of the distal cap and a distal end of the transverse flow section (see Fig. 5a), wherein each of the plurality of wire bundle slack adjusters is structurally configured to provide sufficient slack to allow each associated wire bundle to stretch out along a central axis of the flow diverter in the undeployed configuration (the connecting elements 157 go from a collapsed state in which they allow the wires of the outer member 154 to extend/stretch out longitudinally, [0215], see Figs. 7a-7d) and to then take up sufficient slack to allow the flow diverter to deploy into its original shape in the deployed configuration (the connecting elements 157 expand to an expanded state and the slack is taken by the form of the implant being radially expanded, [0215], see Figs. 7a-7d).
Regarding claim 18, Vale/Jordan makes obvious the flow diverter delivery system of claim 17, the modified invention discloses wherein each of the plurality of wire bundle slack adjusters transitions at its proximal end to a primary wire bundle of a plurality of wire bundles (the bundle of wires of Vale at the proximal end of 153, see Fig. 5a) to form the transverse flow section (the modified invention includes the loops 46 as taught by Jordan, which would be incorporated into the implant).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached on 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.A.M/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774