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 .
Election/Restrictions
Applicant’s election without traverse of species A in the reply filed on 11/17/25 is acknowledged. Claims 10 and 27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/17/25.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 6, 17, 20, 21, 23, 24, and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3 and 5 of U.S. Patent No. 12,508,031. Although the claims at issue are not identical, they are not patentably distinct from each other because they disclose overlapping subject matter as discussed below. Examiner notes it would be obvious to have a method of delivering a flow diverter or system for delivering a flow diverter as known in the art.
Claims of Application 18236663
Claims of U.S. Patent No. 12,508,031
Overlapping Subject matter
1
1
System or method comprising a microcatheter or tubular member, a core wire or deployment wire, a flow diverter and at least one deployment feature
6
1
Pusher extending along the distal portion of the core or deployment wire engaged with the proximal end of the flow diverter, at least one friction pump extending distally beyond the pusher
17
1
System or method comprising a tubular member, a core wire or deployment wire, a flow diverter and at least one deployment feature
20
1
Pusher extending along the distal portion of the core or deployment wire engaged with the proximal end of the flow diverter, at least one friction pump extending distally beyond the pusher, support coil along the distal portion of the core wire
21
2
Friction bumps equally spaced
23
4
Friction bump comprises radiopaque element
24
5
Radiopaque element comprising a coil of wire
25
1
Support coil extends at least partially through the pusher and distally beyond the friction bump
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.
Claim(s) 17, 18 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nishigishi US 2016/0151183.
Regarding claim 17, Nishigishi discloses a system for delivering a flow diverter into a neurovascular blood vessel to treat an aneurysm (paragraph 0003), the system comprising: an elongate tubular member 50 having a proximal end and a distal end, the tubular member comprising an interior wall defining a lumen (paragraph 0003, 0028, figure 1A); a core wire 30 through the tubular member and into the flow channel of the flow diverter 10 (figures 1A-1C), the core wire comprising a proximal end, a distal end, and distal portion having a taper (figure 1A, core tapered from proximal portion toward distal end having joining portion 36 and holding coil 34), the distal end of the core wire terminating in a flow channel of a flow diverter (figure 1A, channel of flow diverter 10); at least one deployment feature coupled to the distal portion of the core wire (coil 34 or protrusion 40, figure 1A-1C, coupled at portion 20 of flow diverter); and deploying the flow diverter from the catheter and into the neurovascular blood vessel to treat an aneurysm by advancing the at least one deployment feature via advancement of the core wire (figure 1B, paragraph 0028, core shaft is pushed in the distal direction to release the stent 10 to the target site).
Regarding claim 18, Nishigishi discloses wherein the distal end of the core wire terminates between the proximal end and the distal end of the flow diverter (figure 1A).
Regarding claim 19, Nishigishi discloses wherein the distal end of the core wire does not extend distally beyond the distal end of the flow diverter when the flow diverter is contained in the constrained configuration (figure 1A, distal end against 36 within flow diverter 10).
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, 2, 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nishigishi US 2016/0151183 in view of Nageswaran et al. US 2019/0314179.
Regarding claim 1, Nishigishi discloses a method for delivering a flow diverter into a neurovascular blood vessel to treat an aneurysm (paragraph 0003), the method comprising: advancing a catheter 50 proximate to a treatment location within a neurovascular blood vessel (paragraph 0003, 0028); advancing a core wire 30 through the catheter (figures 1A-1C), the core wire comprising a proximal end, a distal end, and distal portion having a taper (figure 1A, core tapered from proximal portion toward distal end having joining portion 36 and holding coil 34), the distal end of the core wire terminating in a flow channel of a flow diverter (figure 1A, channel of flow diverter 10), the flow diverter 10 contained in a constrained configuration within the catheter (figure 1A), the core wire coupled to the flow diverter via at least one deployment feature (coil 34 or protrusion 40, figure 1A-1C, coupled at portion 20 of flow diverter); and deploying the flow diverter from the catheter and into the neurovascular blood vessel to treat an aneurysm by advancing the at least one deployment feature via advancement of the core wire (figure 1B, paragraph 0028, core shaft is pushed in the distal direction to release the stent 10 to the target site).
Nishigishi discloses any catheter 50 may be used (paragraph 0027), but fails to disclose the catheter is a microcatheter.
Nageswaran et al. teaches a stent delivery system 200 comprising a catheter, the catheter may comprise various catheter such as a microcatheter for percutaneous access a desired target location (paragraph 0337).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Nishigishi with a microcatheter, as taught by Nageswaran et al. as known in the art to provide a catheter or microcatheter as necessary to deliver a stent to the desired target location.
Regarding claim 2, Nishigishi discloses wherein the flow diverter 10 comprising a diverter proximal end (figure 1A, proximal end with anchor 20) and a diverter distal end (figure 1A, opposite end from anchor 20), wherein the distal end of the core wire terminates between the diverter proximal end and the diverter distal end (figure 1A).
Regarding claim 4, Nishigishi discloses wherein the distal end of the core wire does not extend distally beyond the distal end of the flow diverter when the flow diverter is contained in the constrained configuration (figure 1A, distal end against 36 within flow diverter 10).
Regarding claim 5, Nishigishi in combination discloses retracting the flow diverter into the microcatheter (figure 1C); adjusting positioning of the microcatheter with respect to the treatment location (paragraphs 0029, stent pulled back into the catheter to reposition); and advancing the core wire through the microcatheter to fully deploy the flow diverter from the microcatheter (paragraph 0029, operation begins again in the better positioned catheter for deployment).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nishigishi US 2016/0151183 in view of Nageswaran et al. US 2019/0314179.
Regarding claim 12, Nishigishi discloses a method of delivering a flow diverter, the flow diverted expands at the target site of the blood vessel (paragraph 0024, figure 1B), but fails to explicitly disclose the flow diverter comprising a deployed diameter of at least approximately 4.25mm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the device of the Nishigishi to provide a flow diverter comprising a deployed diameter of at least approximately 4.25mm to expand within a blood vessel, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
Claim(s) 1, 2, 3, 4, 6, and 13-16, is/are rejected under 35 U.S.C. 103 as being unpatentable over Sepetka US 5234437 in view of Nageswaran et al. US 2019/0314179.
Regarding claim 1, Sepetka discloses a method for delivering a flow diverter into a neurovascular blood vessel to treat an aneurysm (column 1, lines 6-10), the method comprising: advancing a catheter 24 proximate to a treatment location within a neurovascular blood vessel (column 1, lines 6-10); advancing a core wire 16 through the catheter (figure 2, column 3, lines 19-22), the core wire comprising a proximal end 15, a distal end 16, and distal portion having a taper (figure 2, tapered between portions 15 and 16), the distal end of the core wire terminating in a flow channel of a flow diverter 13 (within channel of coil 13, figure 2), the flow diverter contained in a constrained configuration within the catheter (figure 2, within catheter 24), the core wire coupled to the flow diverter via at least one deployment feature (deployment features tip 17 including portions 18, 19 or 20, figure 4); and deploying the flow diverter from the catheter and into the neurovascular blood vessel to treat an aneurysm by advancing the at least one deployment feature via advancement of the core wire (column 4, lines 39-56; assembly including core wire 15/16 and deployment features of tip 17 is advanced through the catheter prior to releasing at the site), but fails to disclose the catheter being a microcatheter.
Nageswaran et al. teaches a delivery system 200 comprising a catheter, the catheter may comprise various catheter such as a microcatheter for percutaneous access a desired target location (paragraph 0337).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Nishigishi with a microcatheter, as taught by Nageswaran et al. as known in the art to provide a catheter or microcatheter as necessary to deliver a stent to the desired target location.
Regarding claim 2, Sepetka discloses wherein the flow diverter 13 comprising a diverter proximal end and a diverter distal end (proximal end and distal end of coil 13), wherein the distal end of the core wire terminates between the diverter proximal end and the diverter distal end (figure 2).
Regarding claim 3, Sepetka discloses wherein the distal end of the core wire does not extend distally beyond the distal end of the flow diverter during the deploying of the flow diverter (figures 1-3; does not extend distal of distal end of coil 13).
Regarding claim 4, Sepetka discloses wherein the distal end of the core wire does not extend distally beyond the distal end of the flow diverter when the flow diverter is contained in the constrained configuration (figure 2, distal end within coil 13).
Regarding claim 6, Sepetka discloses wherein the at least one deployment feature comprises: a pusher 14 extending along and around the distal portion of the core wire (pusher sleeve 14 around the distal end of core wire 16 (figures 1-3), the pusher having a distal end configured to engage with a proximal end of the flow diverter (figures 1-3; column 4, lines 56-60, pusher sleeve abuts proximal end of coil 13); and at least one friction bump (may consider bumps 19 or coil bumps 20, figure 4) along a portion of the core wire extending distally beyond the pusher (figure 2, bump 19 and at least a portion of coil bumps 20 are distal of sleeve pusher 14), wherein the at least one friction bump is inside the flow channel of the flow diverter and engaged with a portion of the flow diverter (figure 2).
Regarding claims 13, Sepetka discloses wherein an expanded diameter of greater than approximately 4mm or wherein the flow diverter having a length between approximately 5mm and approximately 60mm (coil has linear configuration within catheter length of .5 to 60cm; column 3, lines 11-18). It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a length of at least 20mm when in the constrained configuration, 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 claims 14 and 15, Sepetka discloses wherein the distal end diameter of the core wire is between .25 mm to .90 mm (column 3, lines 33-35; portion 16 will typically be in the range of between approximately .013 inches and .025 inches; but fails to explicitly disclose the proximal thickness of between approximately .013 and .025 inches and the distal end of the core wire comprises a tip thickness of between approximately .0001 inches and approximately .008 inches. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the proximal thickness of between approximately .013 and .025 inches and the distal end of the core wire comprises a tip thickness of between approximately .0001 inches and approximately .008 inches, 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 16, Sepetka discloses wherein the entire core wire length is between about 100 to 200 cm, or more usually 160 to 180 cm in length (column 3, lines 30-33), but fails to explicitly disclose wherein the distal portion of the core wire having the taper comprises a length between approximately 30 cm and approximately 50 cm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the distal portion of the core wire having the taper comprises a length between approximately 30 cm and approximately 50 cm, 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.
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sepetka US 5234437 in view of Nageswaran et al. US 2019/0314179 and further in view of Garcia et al. US 8636760.
Regarding claim 7, Sepetka in combination discloses wherein the at least one friction bump comprises a plurality of friction bumps distributed along the portion of the core wire (bumps may be considered each winding of coil 20, figure 4), wherein the plurality of friction bumps are equally spaced (bumps equally spaced along coil 20 to interlock to move with coil 13) wherein each of the plurality of friction bumps is configured to facilitate retraction of the flow diverter into the microcatheter when the flow diverter is partially deployed from the microcatheter and to facilitate deployment of the flow diverter from the microcatheter (interlock with coil, pusher sleeve 14 holds coil in place when advanced, thereby also configured to facilitate movement within catheter for retraction if moved proximally, figure 2), but fails to discloses wherein at least one of the plurality of friction bumps comprises a radiopaque element.
Garcia et al. teaches radiopaque marker bands being placed along the guidewire core assembly as required for visualization of the guidewire and occluding device during placement within the vasculature, the radiopaque markers may be on the coils along the guidewire (column 11, lines 4-15, may be on coils 60 or 35, for example).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify Sepetka with a marker band on the first friction bump, as taught by Garcia et al. as it is known in the art to provide marker bands on various elements of a system, and may be placed around a guidewire or core in the form of a coil, as required to allow for visualization during placement within the vasculature.
Regarding claim 8, Sepetka discloses wherein the core wire terminates in a proximal third of the flow diverter when the flow diverter is contained in the constrained configuration (figure 2).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sepetka US 5234437 in view of Nageswaran et al. US 2019/0314179 and further in view of Garcia et al. US 8636760 in view of Nishigishi US 2016/0151183.
Regarding claim 11, Sepetka discloses the method essentially disclosed as discussed above, but fails to disclose wherein at least one of the pusher and the at least one friction bump is radiopaque; the method further comprising imaging the radiopaque at least one of the pusher and the at least one friction bump to determine a position of the flow diverter in the neurovascular blood vessel and a position of the at least one friction bump with respect to the microcatheter, wherein the flow diverter is retracted into the microcatheter when at least one of the at least one friction bump has not exited the microcatheter, and wherein the positioning of the microcatheter is adjusted with respect to the treatment location based on the imaging.
Garcia et al. teaches radiopaque marker bands being placed along the guidewire core assembly as required for visualization of the guidewire and occluding device during placement within the vasculature, the radiopaque markers may be on the coils along the guidewire (column 11, lines 4-15, may be on coils 60 or 35, for example).
Nishigishi teaches retracting the flow diverter into the microcatheter (figure 1C); adjusting positioning of the microcatheter with respect to the treatment location (paragraphs 0029, stent pulled back into the catheter to reposition); and advancing the core wire through the microcatheter to fully deploy the flow diverter from the microcatheter (paragraph 0029, operation begins again in the better positioned catheter for deployment).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify Sepetka with a marker band on the first friction bump, as taught by Garcia et al. as it is known in the art to provide marker bands on various elements of a system, and may be placed around a guidewire or core in the form of a coil, as required to allow for visualization during placement within the vasculature, and by retracting the flow diverter when only partially deployed, as taught by Nishigishi, to allow for adjusting and allow for the operation to begin again once repositioned as desired for deployment.
Claim(s) 17-22, 28 and 30-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sepetka US 5234437 in view of Bashiri et al. US 2009/0143786.
Regarding claim 17, Sepetka discloses a system for delivering a flow diverter into a neurovascular blood vessel to treat an aneurysm (column 1, lines 6-10), the system comprising: an elongate tubular member 24 proximate to a treatment location within a neurovascular blood vessel (column 1, lines 6-10) having a proximal end and a distal end, the tubular member comprising an interior wall defining a lumen (proximal and distal end of catheter 24, catheter having an internal lumen, figure 2); a flow diverter 13 having a proximal end and a distal end (proximal and distal end of coil 13), the flow diverter defining a flow channel extending therethrough (lumen though coil 13), the flow diverter contained in a constrained configuration within the catheter (figure 2, within catheter 24), a core wire 16 extending through the lumen of the tubular member and into the flow channel of the flow diverter (figure 2, column 3, lines 19-22), the core wire comprising a proximal end 15, a distal end 16, and distal portion having a taper (figure 2, tapered between portions 15 and 16), the distal end of the core wire terminating in a flow channel of a flow diverter 13 (within channel of coil 13, figure 2), at least one deployment feature coupled to the distal portion of the core wire (deployment features tip 17 over core wire 16 including portions 18, 19 or 20, figure 4); the at least one deployment feature coupled to the flow diverter (coil portions 17 interlock with coil 13, figure 2, column 3, lines 45-50, coupled in a threaded relationship) such that movement of the core wire relative to the tubular member moves the flow diverter relative to the tubular member and into a neurovascular blood vessel (such that the flow diverter from the catheter and into the neurovascular blood vessel to treat an aneurysm by advancing the at least one deployment feature via advancement of the core wire (column 4, lines 39-56; assembly including core wire 15/16 and deployment features of tip 17 is advanced through the catheter prior to releasing at the site), but fails to explicitly disclose the flow diverter being self-expanding member.
Bashiri et al. teaches a system for delivering a flow diverter into a neurovascular blood vessel to treat an aneurysm (paragraph 0003), the flow diverter may be a coil 1520, or a stent such as a self-expanding stent for delivery into and treatment for an aneurysm (paragraph 0064).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Sepetka, with a self-expandable member, as taught by Bashiri et al. as known in the art to provide a self-expanding member delivered for treatment of an aneurysm.
Regarding claim 18, Sepetka discloses wherein the distal end of the core wire terminates between the proximal end and the distal end of the flow diverter (figures 1-3; does not extend distal of distal end of coil 13).
Regarding claim 19, Sepetka discloses wherein the distal end of the core wire does not extend distally beyond the distal end of the flow diverter when the flow diverter is contained in the constrained configuration (figure 2, distal end within coil 13).
Regarding claim 20, Sepetka discloses wherein the at least one deployment feature comprises: a pusher 14 extending along and around the distal portion of the core wire (pusher sleeve 14 around the distal end of core wire 16 (figures 1-3), the pusher having a distal end configured to engage with a proximal end of the flow diverter (figures 1-3; column 4, lines 56-60, pusher sleeve abuts proximal end of coil 13); and at least one friction bump (bump 19, figure 4) along a portion of the core wire extending distally beyond the pusher (figure 2, bump 19 distal of sleeve pusher 14), wherein the at least one friction bump is inside the flow channel of the flow diverter and engaged with a portion of the flow diverter (figure 2), and a support coil 17 extending along and around the distal portion of the core wire (figure 2, around distal portion 16 of core wire).
Regarding claim 21, Sepetka discloses wherein the at least one friction bump comprises a plurality of friction bumps (bumps 18 and 20, figure 4), and wherein the plurality of friction bumps are equally spaced (figure 4, two bumps spaced from each other may be considered equally spaced).
Regarding claim 22, Sepetka discloses wherein the core wire terminates in a proximal third of the flow diverter when the flow diverter is contained in the constrained configuration (figure 2).
Regarding claims 28 and 30, Sepetka discloses wherein an expanded diameter of greater than approximately 4mm or wherein the flow diverter having a length of at least 20mm when in the constrained configuration, or between approximately 5mm and approximately 60mm (coil has linear configuration within catheter length of .5 to 60cm; column 3, lines 11-18). It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a length of at least 20mm when in the constrained configuration, 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 claims 31 and 32, Sepetka discloses wherein the distal end diameter of the core wire is between .25 mm to .90 mm (column 3, lines 33-35; portion 16 will typically be in the range of between approximately .013 inches and .025 inches; but fails to explicitly disclose the proximal thickness of between approximately .013 and .025 inches and the distal end of the core wire comprises a tip thickness of between approximately .0001 inches and approximately .008 inches. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the proximal thickness of between approximately .013 and .025 inches and the distal end of the core wire comprises a tip thickness of between approximately .0001 inches and approximately .008 inches, 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 33, Sepetka discloses wherein the entire core wire length is between about 100 to 200 cm, or more usually 160 to 180 cm in length (column 3, lines 30-33), but fails to explicitly disclose wherein the distal portion of the core wire having the taper comprises a length between approximately 30 cm and approximately 50 cm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the distal portion of the core wire having the taper comprises a length between approximately 30 cm and approximately 50 cm, 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.
Claim(s) 23 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sepetka US 5234437 in view of Bashiri et al. US 2009/143786 in view of Garcia et al. US 8636760.
Regarding claim 23 and 24, Sepetka discloses the system essentially as claimed, but fails to disclose the at least one friction bump comprising a radiopaque element, the radiopaque element comprising a coil of sire.
Garcia et al. teaches radiopaque marker bands being placed along the guidewire core assembly as required for visualization of the guidewire and occluding device during placement within the vasculature, the radiopaque markers may be on the coils along the guidewire (column 11, lines 4-15, may be on coils 60 or 35, for example).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify Sepetka with a marker band on the first friction bump, as taught by Garcia et al. as it is known in the art to provide marker bands on various elements of a system, and may be placed around a guidewire or core in the form of a coil, as required to allow for visualization during placement within the vasculature.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nishigishi US 2016/0151183.
Regarding claim 29, Nishigishi discloses a method of delivering a flow diverter, the flow diverted expands at the target site of the blood vessel (paragraph 0024, figure 1B), but fails to explicitly disclose the flow diverter comprising a deployed diameter of at least approximately 4.25mm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the device of the Nishigishi to provide a flow diverter comprising a deployed diameter of at least approximately 4.25mm to expand within a typically sized blood vessel, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
Allowable Subject Matter
Claim 9 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12,508,031 as discussed above in more detail, but would be allowable if a proper terminal disclaimer is filed and the claims are rewritten to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Nishigishi US 2016/0100965 discloses a system for delivering a flow diverter comprising a first, second, and third friction bump (figures 2A-2C), a support coil 14 along the distal portion of a deployment wire 12. However, Nishigishi fails to disclose wherein the support coil extends at least partially through the pusher and distally beyond the friction bump.
Jones et al. US 2004/0158307 discloses a system for delivering a flow diverter (figure 5), a support coil 22 along the distal portion of a deployment wire 26. However, Jones et al. fails to disclose wherein the support coil extends at least partially through a pusher and distally beyond a friction bump.
Conclusion
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/CHRISTINA C LAUER/ Examiner, Art Unit 3771