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
This action is entered in response to Applicant's amendment and reply of 5/4/26. The claims 1-4, 6-14, 16-20 are pending. The claims 1, 11, and 16 are amended. Claims 5 and 15 are cancelled.
Response to Arguments
Applicant’s amendments have overcome the objection to the specification.
Applicant’s amendments have overcome the previous 35 U.S.C. 112(b) rejection.
Applicant’s arguments, filed 5/4/26 with respect to the rejections of claims 1-4, 6-9 under 35 U.S.C. 102(a)(1) as being anticipated by Amplatz (US2007/0118207) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Applicant’s arguments, filed 5/4/26 with respect to the rejections of claims 1-20 under 35 U.S.C. 103 as being unpatentable over Murray (US2008/0262590) in view of Amplatz (US2007/0118207) have been fully considered and the amendment overcomes the previous rejection. The amendment to claims 1 and 11 to recite “removing the mesh and guidewire from the vessel after removing the tube” further limit the claim. Applicant argues, the claimed mesh does not amount to a mere switching of order of the claimed process steps, and that it adds a method step not contemplated by Murray or Amplatz, since the prior art references are for stents and stent grafts and not intended to be removed. A new grounds of rejection has been made in view of Murray (US2008/0262590) in view of Amplatz (US2007/0118207) and Folan (US2019/0183666). Where Folan teaches stents being removable after implantation.
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 of this title, 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 1-4, 6-14, 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over by Murray (US2008/0262590) in view of Amplatz (US2007/0118207) and Folan (US2019/0183666).
Regarding claim 1, Murray discloses a method of lining a vessel, the method comprising the steps of:
inserting a guidewire ([0055]);
sliding a deployment device (204) along the guidewire ([0055], see Fig. 2);
actuating at least one of a tube (106) and an implant (stent graft 202) positioned along the tube to cause a lock (112) to release the implant from the distal end of the deployment device such that the implant expands inside the vessel ([0063]); and
Murray is silent regarding the implant being a mesh.
Amplatz teaches a delivery mechanism for routing a prosthesis through the vascular system (see Abstract). The delivery mechanism is for delivering a mesh (mesh of prosthesis 12, prosthesis can be made of braided metal strands, [0025]).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to have substituted the mesh of Amplatz for the implant of Murray, since the substitution would have yielded the same predictable result of placement of an implant for treating an aneurysm.
Murray is silent regarding the steps of: inserting the guidewire into the vessel through a puncture in a vessel wall; sliding the deployment device along the guidewire until a distal end of the tube is inside the vessel; while maintaining the mesh in the vessel, removing the tube from within the mesh.
Amplatz teaches a delivery mechanism for routing a prosthesis through the vascular system (see Abstract). The delivery mechanism including the steps of inserting a guidewire into the vessel through a puncture in a vessel wall (gain access by Seldiner technique, guidewire placed in artery by the access or puncture site, [0060]); sliding an deployment device (14, [0060]) along a guidewire until a distal end of the elongated tube is inside the vessel, and then removing the guidewire ([0060]); actuating at least one of a tube (26, [0066]) and a mesh (mesh of prosthesis 12, prosthesis can be made of braided metal strands, [0025]) positioned along the tube to cause a lock to release the mesh from the distal end of the elongated tube such that the mesh expands inside the vessel ([0063]); while maintaining the mesh in the vessel, removing the tube from within the mesh ([0064]).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to have the method of lining a vessel of Murray include the steps of: inserting a guidewire into the vessel through a puncture in a vessel wall; sliding the deployment device along the guidewire until a distal end of the tube is inside the vessel; while maintaining the mesh in the vessel, removing the guidewire, removing the tube from within the mesh, since the steps recited are common technique used to gain access to a vessel and would have been known to one having ordinary skill in art as to gain access to an artery, and also removing the tube from within the mesh is common medical practice in order to complete a procedure for patient discharge.
Murray does not explicitly disclose removing the mesh. Folan teaches a stent implanted within the body, where Folan teaches steps to remove the implant from a body lumen ([0051]). 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 mesh of Murray/Amplatz be removable as taught by Folan in order to reposition and/or remove the stent from the body lumen post deployment for a reason such as stent migration ([0004]).
The modified invention of Murray/Amplatz/Folan teaches removing the mesh (Folan, [0051]) and removing the guidewire (Amplatz, [0060]). Murray/Amplatz/Folan does not explicitly disclose removing the mesh and the guidewire from the vessel after removing the tube. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to switch the order of performing process steps, i.e. the order the removal of the guidewire and the mesh after release of the mesh, would be obvious absent any clear and convincing evidence and/or arguments to the contrary, because both methods would produce an expanded implant and a delivery apparatus to be withdrawn from the body (MPEP 2144.04 [R-1]). “Selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results”.
Regarding claim 2, Murray/Amplatz/Folan makes obvious the method of claim 1, Amplatz further teaches wherein the sliding step further comprises placing the tube on a proximal end of the guidewire and advancing the tube in a distal direction along the guidewire and into the vessel ([0060]).
Regarding claim 3, Murray/Amplatz/Folan makes obvious the method of claim 2, the modified invention further discloses wherein the sliding step further comprises advancing the tube along the guidewire into the vessel until a hub of the tube is in contact with a skin surface near the puncture (Amplatz teaches the tube would be advanced to a location of the deployment site within the vessel, [0060], where the hub portion of tube is interpreted as the portion of the hub that would in contact with a skin surface near the puncture).
Regarding claim 4, Murray/Amplatz/Folan makes obvious the method of claim 3, the modified invention further discloses wherein the actuating step occurs when the hub is in contact with the skin surface near the puncture (the hub portion is interpreted as the portion of the hub that would contact the skin surface near the puncture when the actuating step occurs).
Regarding claim 6, Murray/Amplatz/Folan makes obvious the method of claim 1, Murray further discloses wherein the actuating step further comprises engaging an actuator (1810, [0107]) to actuate the tube when the distal end of the deployment device abuts the puncture (at least some portion of the deployment device 118 would abut the puncture of the vessel wall since its passes through it)
Regarding claim 7, Murray/Amplatz/Folan makes obvious the method of claim 1, the modified invention discloses wherein the actuating step further comprises engaging an actuator to actuate the tube when the mesh is completely inside the vessel (the implant of Murry is intended to be released when fully inside of the vessel, [0071]).
Regarding claim 8, Murray/Amplatz/Folan makes obvious the method of claim 1, Murray further discloses wherein the actuating step further comprises moving the lock from a locked position, where the mesh is fixed to the tube, to an unlocked position, where the mesh is not fixed to the tube ([0071]).
Regarding claim 9, Murray/Amplatz/Folan makes obvious the method of claim 8, Murray further discloses wherein the actuating step further comprises extending the tube (106) from a first position where the lock is in the locked position to a second position where the lock is in the unlocked position ([0071]).
Regarding claim 10, Murray/Amplatz/Folan makes obvious the method of claim 9, Murray further discloses wherein the actuating step further comprises moving the lock from the locked position where the lock (112) is disposed on a protrusion (124) positioned between a proximal surface and a distal stop surface (proximal and distal surfaces of the protrusion 124) that is spaced from the proximal surface along a longitudinal axis in a distal direction, to an unlocked position where the lock is not disposed on the protrusion, to release the mesh in the unlocked position ([0071]).
Regarding claim 11, Murray discloses a method of lining a vessel, the method comprising the steps of:
inserting a guidewire ([0055]);
sliding an elongated tube (106) along the guidewire ([0055], see Fig. 2), the tube having a proximal end, a distal end spaced from the proximal end of the tube (see Fig. 2), a protrusion (124), and a distal groove (groove defined by the annular space 128) between the protrusion and the distal end of the tube (see Fig. 1);
actuating at least one of the tube and an implant (stent graft 202) positioned along the protrusion ([0064], see Fig. 2) of the tube to cause a lock (112) to release the implant from between the proximal end of the tube and the distal groove such that the implant expands inside the vessel ([0071]).
Murray is silent regarding the implant being a mesh.
Amplatz teaches a delivery mechanism for routing a prosthesis through the vascular system (see Abstract). The delivery mechanism is for delivering a mesh (mesh of prosthesis 12, prosthesis can be made of braided metal strands, [0025]).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to have substituted the mesh of Amplatz for the implant of Murray, since the substitution would have yielded the same predictable result of placement of an implant for treating an aneurysm.
Murray is silent regarding the steps of: inserting the guidewire into the vessel through a puncture in a vessel wall; sliding the tube along the guidewire until a distal end of the tube is inside the vessel; while maintaining the mesh in the vessel, removing the tube from within the mesh.
Amplatz teaches a delivery mechanism for routing a prosthesis through the vascular system (see Abstract). The delivery mechanism including the steps of inserting a guidewire into the vessel through a puncture in a vessel wall (gain access by Seldiner technique, guidewire placed in artery by the access or puncture site, [0060]); sliding an elongated tube (14, [0060]) along a guidewire until a distal end of the elongated tube is inside the vessel and removing the guidewire ([0060]); actuating at least one of a tube (26, [0066]) and a mesh (mesh of prosthesis 12, prosthesis can be made of braided metal strands, [0025]) positioned along the tube to cause a lock to release the mesh from the distal end of the elongated tube such that the mesh expands inside the vessel ([0063]); while maintaining the mesh in the vessel, removing the tube from within the mesh ([0064]).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to have the method of lining a vessel of Murray include the steps of: inserting a guidewire into the vessel through a puncture in a vessel wall; sliding an elongated tube along the guidewire until a distal end of the tube is inside the vessel; sliding an elongated tube along the guidewire until a distal end of the tube is inside the vessel; while maintaining the mesh in the vessel, removing the guidewire, removing the tube from within the mesh, since the steps recited are common technique used to gain access to a vessel and would have been known to one having ordinary skill in art as to gain access to an artery, and also removing the tube from within the mesh is common medical practice in order to complete a procedure for patient discharge.
Murray does not explicitly disclose removing the mesh. Folan teaches a stent implanted within the body, where Folan teaches steps to remove the implant from a body lumen ([0051]). 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 mesh of Murray/Amplatz be removable as taught by Folan in order to reposition and/or remove the stent from the body lumen post deployment for a reason such as stent migration ([0004]).
The modified invention of Murray/Amplatz/Folan teaches removing the mesh (Folan, [0051]) and removing the guidewire (Amplatz, [0060]). Murray/Amplatz/Folan does not explicitly disclose removing the mesh and the guidewire from the vessel after removing the tube. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to switch the order of performing process steps, i.e. the order the removal of the guidewire and the mesh after release of the mesh, would be obvious absent any clear and convincing evidence and/or arguments to the contrary, because both methods would produce an expanded implant and a delivery apparatus to be withdrawn from the body (MPEP 2144.04 [R-1]). “Selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results”.
Regarding claim 12, Murray/Amplatz/Folan makes obvious the method of claim 11, Amplatz further teaches wherein the sliding step further comprises placing the tube on a proximal end of the guidewire and advancing the tube in a distal direction along the guidewire and into the vessel ([0060]).
Regarding claim 13, Murray/Amplatz/Folan makes obvious the method of claim 12, the modified invention further discloses wherein the sliding step further comprises advancing the tube along the guidewire into the vessel until a hub of the tube is in contact with a skin surface near the puncture (Amplatz teaches the tube would be advanced to a location of the deployment site within the vessel, [0060], where the hub portion of tube is interpreted as the portion of the hub that would in contact with a skin surface near the puncture).
Regarding claim 14, Murray/Amplatz/Folan makes obvious the method of claim 13, the modified invention further discloses wherein the actuating step occurs when the hub is in contact with the skin surface near the puncture (the hub portion is interpreted as the portion of the hub that would contact the skin surface near the puncture when the actuating step occurs).
Regarding claim 16, Murray/Amplatz/Folan makes obvious the method of claim 11, Murray further discloses wherein the actuating step further comprises engaging an actuator (1810, [0107]) to actuate the tube.
Regarding claim 17, Murray/Amplatz/Folan makes obvious the method of claim 11, the modified invention discloses wherein the actuating step further comprises engaging an actuator (1810, [0107]) to actuate the tube when the mesh is completely inside the vessel (the implant of Murry is intended to be released when fully inside of the vessel, [0071]).
Regarding claim 18, Murray/Amplatz/Folan makes obvious the method of claim 11, Murray further discloses wherein the actuating step further comprises moving the lock from a locked position, where the mesh is fixed to the tube, to an unlocked position, where the mesh is not fixed to the tube ([0071]).
Regarding claim 19, Murray/Amplatz/Folan makes obvious the method of claim 18, Murray further discloses wherein the actuating step further comprises extending the tube (106) from a first position where the lock is in the locked position to a second position where the lock is in the unlocked position ([0071]).
Regarding claim 20, Murray/Amplatz/Folan makes obvious the method of claim 19, Murray further discloses invention further discloses wherein the actuating step further comprises moving the lock from the locked position where the lock is disposed on the protrusion positioned between a proximal surface and a distal stop surface (proximal and distal surfaces of the protrusion 124) that is spaced from the proximal surface along a longitudinal axis in a distal direction, to an unlocked position where the lock is not disposed on the protrusion, to release the mesh in the unlocked position ([0071]).
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 MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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