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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the:
“first functional member”
“second functional member”
“a first functional member spaced apart from the recess by the cross sectional dimension”
must be shown in the elected embodiments or the feature(s) canceled from the claim(s). No new matter should be entered. It appears functional members are supported in the instant disclosure but may be labeled using different language. Please use consistent antecedent basis with the claims in the figure descriptions for clarity. Further, while cross-sectional dimensions are labeled (D1—D4),it appears that the first functional member cannot be both positioned inward of and spaced apart from the recess by the cross-sectional dimension of the inner shaft. Please label the figures and explain.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12364614B2 in view of Stinson (2002/0099435A1).
It has been held that a species anticipates a genus and the prior filed patent anticipates each and every aspect of the claim except “a first functional member inward of the recess and extending through the implant region”. Further, while the prior filed patent states “the functional member comprises a fiber that does not entirely surround the recess”, surrounding the recess meets the limitation of “a second functional member outward of the recess” since the fiber cannot surround the recess without being outward of the recess.
Stinson teaches a first functional member 21 that extends inward of the recess (as shown in fig 9, inward of the recess where stent 31 fits) and through the implant region (fig 8-9).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the first functional member of Stinson in order to prevent the stent from sliding relative to the catheter during deployment [0054].
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) 1-3, 6-7, 10-14, 18, 20, 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stinson (2002/0099435A1) in view of Longo (2020/0155332) and further in view of Katsurada (2012/0271232A1).
In regard to claim 1, Stinson teaches a delivery device configured to deliver an implant to a target vessel of a patient (stent delivery system, abstract; 11), the delivery device 11 comprising:
an inner shaft 13 defining a lumen 19 extending along a length of the delivery device 11, wherein the inner shaft 13 comprises
an implant region including a surface (surface of 13 which abuts 21) defining a recess (see recess stent 31 fits within as shown in figure 9) configured to receive a self-expandable implant 31, and
an outer shaft 51 surrounding the inner shaft 13 along at least a first portion (proximal portion, fig 1-2) of the length of the delivery device 11, wherein the outer shaft 13 comprises
a second functional member 41 outward of the recess (space within which 31 fits, fig 8-9) and extending along at least a second portion (middle section between tip and proximal end; fig 9) of the length of the delivery device 11, and
and wherein the outer shaft 51 is retractable in a proximal direction relative to the inner shaft 13 (see fig 8-9, 51 is retracted for the stent 31 to open);
and a tip portion 17 distal to the outer shaft 51 and/or the recess (fig 8-9), wherein the tip portion 17 extends to a distal terminus of the delivery device 11 and includes a cross-sectional dimension that tapers in a distal direction (see fig 8-9).
However, Stinson does not teach a coil or the first functional member.
Longo teaches a coil [0012, 0083: within outer sheath 12, 0090] extending along at least a third portion of the length of the delivery device. Since a third portion of the length is not describe, this could be any portion of the length of the delivery device.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the coil of Longo in the outer sheath of Longo because this makes the sheath radioopaque and visible during implantation and postoperatively [0012, 0083, 0090].
Katsurada teaches a first functional member (braid 56) inward of the recess (part of inner layer therefore will be inward of the recess when combined with the invention of Stinson) and extending through the implant region (abstract: a braid arranged on the inner layer); wherein the recess is spaced apart from the first functional member (braid 56) by the surface [0070: covered in resin, therefore spaced apart from the recess by the surface of resin].
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the first functional member of Katsurada on the inner shaft of Stinson because the braid acts as a reinforcing member [0066].
In regard to claim 2, Stinson meets the claim limitations as discussed in the rejection of claim 1, and further teaches the self-expandable implant 31 is configured to expand from a constrained state to an unconstrained state. (see fig 8-9; expands when the outer shaft 51 is retracted)
In regard to claim 3, Stinson meets the claim limitations as discussed in the rejection of claim 1, but does not teach the first functional member as claimed.
Katsurada further teaches the first functional member 56 provides increased longitudinal stiffness to the inner shaft along at least a portion of the implant region. [0064: braid as a reinforcing member] Further, the braid is extra material which will therefore add increased stiffness.
In regard to claim 6, Stinson meets the claim limitations as discussed in the rejection of claim 1, but does not teach the first functional member.
Katsurada further teaches the use of stainless steel and/or nitinol in a delivery device [0069: stainless steel or other metals; 56 is part of the braid 0070].
In regard to claim 7, Stinson meets the claim limitations as discussed in the rejection of claim 1, but does not teach the first functional member.
Katsurada further teaches the first functional member 56 comprises a braid that forms a perimeter inward of the recess. Since the first functional member 56 is within the inner shaft, when combined into the inner shaft of Stinson, the first functional member will be inward of the recess.
In regard to claim 10, Stinson meets the claim limitations as discussed in the rejection of claim 1, and further teaches the second functional member 41 provides increased tensile strength to the outer shaft 51. By adding additional material, the strength of the outer shaft will be increased compared to not having the additional material of the second functional member.
In regard to claim 11, Stinson meets the claim limitations as discussed in the rejection of claim 1, but does not teach the coil.
Longo further teaches the coil is outward and/or over the second functional member. [0083]
In regard to claim 13, Stinson meets the claim limitations as discussed in the rejection of claim 1, wherein the second functional member 41 comprises a braid [0041] that forms a perimeter outward of the recess (see fig 9).
In regard to claim 14, Stinson meets the claim limitations as discussed in the rejection of claim 1, and further teaches the second functional member 41 comprises a fiber [0015: flexible, filamentary material; polyester], and wherein the fiber is a string [0015: filament] and/or does not entirely surround the recess.
In regard to claim 18, Stinson meets the claim limitations as discussed in the rejection of claim 1, and further teaches the outer shaft 51 includes the second functional member 41 (see figure 9) and the coil, such that the second functional member 41 and the outer shaft 51 are retractable relative to the inner shaft 13 (see fig 9).
However, Stinson does not teach the coil as claimed.
Since Longo teaches a coil [0012, 0083: within outer sheath 12, 0090] as which is in the outer sheath, when combined as discussed in the rejection of claim 1, when the outer sheath of Stinson is retracted, the coil as combined will be as well.
In regard to claim 20, Stinson meets the claim limitations as discussed in the rejection of claim 1.
While Stinson remains silent to the amount of force the outer shaft can withstand because it was not measured.
It has been held that a mere optimization of the working parts of an invention, yielding a predictable result, requires no more than routine skill in the art. A stronger device will withstand more force but may be less flexible while a device that withstands less force will be more flexible but have less strength. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to optimize the strength of the outer shaft to withstand a radial outward force between 0.1 N/mm and 10 N/mm for the particular application. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.05IIA,B
In regard to claim 23, Stinson meets the claim limitations as discussed in the rejection of claim 1, but remains silent to the length of the tip portion.
It has been held that a mere change in the size of the working parts of the invention, yielding a predictable result, requires no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have the tip portion have a tip length of at least 1.5 centimeters, a proximal region having a cross-sectional dimension of 1.0-2.5 millimeters, and a distal region having a cross-sectional dimension of 0.5-1.5 millimeters in order to optimize the device for the particular application and stent being delivered. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04IVA
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stinson (2002/0099435A1) in view of Longo (2020/0155332) in view of Katsurada (2012/0271232A1) and further in view of Dorn (2011/0137402A1).
In regard to claim 4, Stinson meets the claim limitations as discussed in the rejection of claim 1, but does not teach the first functional member.
Katsurada further teaches the first functional member 56 extends through the implant region (figs 8-9) and at least a portion of the tip portion. (extends into the tip 22 as shown in figure 8)
In regard to claim 5, Stinson meets the claim limitations as discussed in the rejection of claim 1, but does not teach the first functional member.
Katsurada further teaches the first functional member 56 extends through the implant region and at least a portion of the tip portion. (extends into the tip 22 as shown in figure 8)
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stinson (2002/0099435A1) in view of Longo (2020/0155332) in view of Katsurada (2012/0271232A1) and further in view of Parker (2010/0268243).
In regard to claim 15, Stinson meets the claim limitations as discussed in the rejection of claim 1, but does not teach the second functional member 41 comprises an aramid or liquid crystal polymer fiber.
Parker teaches the second functional member comprises an aramid and/or liquid crystal polymer fiber. [0024]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the second functional member out of aramid fibers because of the high strength properties.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stinson (2002/0099435A1) in view of Longo (2020/0155332) in view of Katsurada (2012/0271232A1) and further in view of Tieu (AU2008/345596A1) and further in view of Harris (2017/0281381A1).
In regard to claim 17, Stinson meets the claim limitations as discussed in the rejection of claim 1, and further teaches the second functional member 41 is a braid [0015: stent restraining member may be a braided tube] comprising metal [0015: metal].
However, Stinson does not teach the coil as claimed or that the second functional member’s metal material is stainless steel.
Harris teaches that any components of the stent deployment system may be made of stainless steel [0060].
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the stainless steel of Harris in place of the metal of Stinson through functional equivalents since stainless steel is a metal and it appears either material would work equally well. MPEP 2144.06II
Longo further teaches the coil is positioned over the second functional member. [0083: coil; can be positioned on top of outer sheath]
However, the combination of Stinson in view of Longo remains silent to the material of the coil.
Tieu teaches a radiopaque that contains nitinol (“Another material that may be advantageous for forming the coil is a bimetallic wire comprising a highly elastic metal with a highly radiopaque metal.”) (invention section)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to substitute the coil material of Tieu in place of the coil material of Stinson in view of Longo because the material is “resistance to deformation” and also performs the same function of being radiopaque. (invention section)
Claim(s) 21, 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stinson (2002/0099435A1) in view of Longo (2020/0155332) in view of Katsurada (2012/0271232A1) and further in view of Gibbons (2014/0257460A1).
In regard to claim 21, Stinson meets the claim limitations as discussed in the rejection of claim 1, and further teaches the inner shaft 13 or the tip portion 17 includes a ledge distal to and extending from the recess (see fig 9, the proximal edge of 17 forms a ledge next to the recess), when the implant 31 is in a constrained state, and an outermost region of the outer shaft 51 is longitudinally aligned with an outermost region of the tip portion 17 (fig 8).
However, Stinson does not teach a distal end of the outer shaft is over the ledge.
Gibbons teaches a distal edge of the outer shaft 18 is over the ledge (of 22; see fig 3).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the tip of Stinson so that the outer shaft fits over a ledge in the distal tip as taught by Gibbons because this makes the catheter insertion atraumatic [0026] and for a more secure fit between pieces.
In regard to claim 25, Stinson meets the claim limitations as discussed in the rejection of claim 1, but does not teach the tip portion includes a ledge which is overlapped by the outer shaft.
Gibson teaches the tip portion 22 includes a ledge distal to and extending from the recess (fig 3) and wherein when the implant is in a constrained state, a distal end of the outer shaft overlaps the ledge.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the tip of Stinson so that the outer shaft fits over a ledge in the distal tip as taught by Gibbons because this makes the catheter insertion atraumatic [0026] and for a more secure fit between pieces.
While the combination of Stinson in view of Gibson does not teach the overlap of the outer shaft over the ledge is at least 1mm, it has been held that a mere change in size or proportion of the working parts of an invention, yielding a predictable result, requires no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have an overlap of at least 1mm. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04IVA
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stinson (2002/0099435A1) in view of Longo (2020/0155332) in view of Katsurada (2012/0271232A1) and further in view of Hartigan (5681322).
In regard to claim 22, Stinson meets the claim limitations as discussed in the rejection of claim 1, but does not teach a vent.
Hartigan teaches a vent extending outward from an annulus between the inner shaft and the outer shaft, through at least a portion of the inner shaft and/or the outer shaft, wherein the vent is within and/or distal to the recess of the inner shaft (Col 2, lines 54-60; Col 4, lines 40-49).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to place the vent holes of Hartigan in the shafts of Dorn so that sterilization gas can be vented (Col 2, lines 54-60; Col 4, lines 40-49).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stinson (2002/0099435A1) in view of Longo (2020/0155332) in view of Katsurada (2012/0271232A1) and further in view of Lui (2012/0239142A1).
In regard to claim 26, Stinson meets the claim limitations as discussed in the rejection of claim 1, but does not teach a minimum bend radius.
Lui teaches the delivery device includes a minimum bend radius of at least 7 millimeters. [0167: minimum bend radius of 1”]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the bend radius of at least 7mm as taught by Lui in order to allow the device to be delivered through a tortuous body lumen and to prevent kinking for the particularly anatomy needed.
Claim(s) 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stinson (2002/0099435A1) and in view of Katsurada (2012/0271232A1).
In regard to claim 27, Stinson discloses a delivery device 11 configured to deliver an implant 31 to a target vessel of a patient, the delivery device 11 comprising:
an inner shaft 13 defining a lumen 19 extending along a length of the delivery device 11 (fig 8-9), wherein the inner shaft 13 comprises an implant region (region within which 31 fits) including a cross-sectional dimension (interpreted as best understood to refer to the surface wall of the recess) defining a recess (see space within which 31 fits in fig 9) configured to receive a self-expandable implant 31;
an outer shaft 51 surrounding the inner shaft 13 along at least a first portion of the length of the delivery device,
wherein the outer shaft 51 is retractable relative to the inner shaft 13 (see retraction fig 8-9);
a tip portion 17 distal to the outer shaft 51 and the recess (see fig 8-9),
wherein the tip portion 17 includes a proximal region having a first cross-sectional tip dimension and a distal region having a second cross-sectional tip dimension less than the first cross-sectional tip dimension (tip is tapered as shown in fig 8-9);
and a second functional member positioned 41 outward of the recess (see fig 9) and configured to provide increased tensile strength to the outer shaft 51 (will provide increased tensile strength compared to no additional added material).
However, Stinson does not teach the first functional member as claimed.
Katsurada teaches a first functional member (braid 56) positioned inward of the recess (part of inner layer therefore will be inward of the recess when combined with the invention of Stinson) and spaced apart from the recess by the cross sectional dimension (interpreted as best understood to mean that the first functional member is within the recess wall and does not extend into the recess; see figure 9) and extending through the implant region (abstract: a braid arranged on the inner layer); and configured to provide increased longitudinal stiffness to the inner shaft along at least a portion of the implant region. [0066: braid is reinforcing member] Since the braid is additional material, additional stiffness will be imparted.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the first functional member of Katsurada on the inner shaft of Stinson because the braid acts as a reinforcing member [0066].
In regard to claim 28, Stinson discloses the claim limitations as discussed in the rejection of claim 27, wherein the outer shaft 51 includes the second functional member 41 and the inner shaft 13 includes the first functional member 21,
such that (i) the second functional member 41 is retractable relative to the inner shaft 13 (see fig 8-9).
However, Stinson does not teach the first functional member.
Katsurada further teaches the first functional member 56 is fixed relative to the inner shaft (see fig 9). [0070: 56 is covered with the outer layer made of resin]
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stinson (2002/0099435A1) in view of Katsurada (2012/0271232A1) and further
in view of Dorn (2011/0137402A1).
In regard to claim 29, Stinson meets the claim limitations as discussed in the rejection of claim 27, but does not teach the first functional member as claimed.
Katsurada further teaches the first functional member 56 extends through the implant region (fig 8-9) and a tip portion 22 such that a distal end of the first functional 56 member is within the tip portion 22 (see fig 9).
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stinson (2002/0099435A1) in view of Katsurada (2012/0271232A1) and further
in view of Longo (2020/0155332).
In regard to claim 30, Stinson meets the claim limitations as discussed in the rejection of claim 27, but does not teach a coil.
Longo teaches a coil positioned over the second functional member, wherein the coil is radially outward of the first functional member and extends over the recess. [0083: coil is within the outer sheath]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the coil of Longo within the outer sheath of Stinson because the coil is radiopaque and will therefore allow the device to be visualized during implantation. [0083]
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stinson (2002/0099435A1) in view of Longo (2020/0155332).
In regard to claim 31, Stinson teaches a delivery device (catheter) configured to deliver an implant to a target vessel of a patient, the delivery device comprising:
an inner shaft 13 defining a lumen 19 extending along a length of the delivery device (fig 2),
wherein the inner shaft 13 comprises (i) an implant region including a recess (space within which 21 fits, fig 2) having a proximal surface and a distal surface configured to longitudinally constrain a self-expandable implant within the recess (see figure 2, implant 31 fits within the recess therefore being constrained by the recess), and (ii) a first functional member 21 inward of the recess (inward of a portion of the recess as shown in figure 2) and extending through the implant region (fig 2);
an outer shaft 51 surrounding the inner shaft 13 along at least a first portion of the length of the delivery device (fig 2-3), wherein the outer shaft 51 comprises
(i) a second functional member 41 outward of the recess and extending along at least a second portion of the length of the delivery device (fig 2),
and wherein the outer shaft 51 is retractable in a proximal direction relative to the inner shaft 13 (see fig 9);
and a tip portion 17 distal to the outer shaft and/or the recess (see fig 2), wherein the tip portion 17 extends to a distal terminus of the delivery device (fig 2) and includes a cross-sectional dimension that tapers in a distal direction. (fig 2)
However, Stinson does not teach a coil
Longo teaches a coil [0012, 0083: within outer sheath 12, 0090] extending along at least a third portion of the length of the delivery device. Since a third portion of the length is not describe, this could be any portion of the length of the delivery device.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the coil of Longo in the outer sheath of Longo because this makes the sheath radioopaque and visible during implantation and postoperatively [0012, 0083, 0090].
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stinson (2002/0099435A1) in view of Longo (2020/0155332) and in view of Katsurada (2012/0271232A1).
In regard to claim 32, Stinson teaches a delivery device (catheter) configured to deliver an implant to a target vessel of a patient, the delivery device comprising:
an inner shaft 13 defining a lumen 19 extending along a length of the delivery device (fig 2), wherein the inner shaft 13 comprises (i) an implant region including a recess (recess within which 21 fits, fig 2) configured to receive a self-expandable implant 31, and
an outer shaft 51 surrounding the inner shaft 13 along at least a first portion of the length of the delivery device, wherein the outer shaft 51 comprises
(i) a second functional member 41 outward of the recess and extending along at least a second portion of the length of the delivery device (fig 2), and
and wherein the outer shaft 51 is retractable in a proximal direction relative to the inner shaft 13 (see fig 9);
and a tip portion 17 distal to the outer shaft and/or the recess (see fig 2), wherein the tip portion 17 extends to a distal terminus of the delivery device (fig 2) and includes a cross-sectional dimension that tapers in a distal direction, (fig 2)
However, Stinson does not teach a coil or a first functional member that terminates distal to the recess.
Longo teaches a coil [0012, 0083: within outer sheath 12, 0090] extending along at least a third portion of the length of the delivery device. Since a third portion of the length is not describe, this could be any portion of the length of the delivery device.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the coil of Longo in the outer sheath of Longo because this makes the sheath radioopaque and visible during implantation and postoperatively [0012, 0083, 0090].
Katsurada teaches a first functional member 56 inward of the recess (within the inner shaft, therefore will be within the recess when applied to Stinson) and extending through the implant region wherein the first functional member 56 terminates distal to the recess and/or the second functional member (figure 9, terminates into the tip; will therefore terminate distal to the recess when applied to Stinson).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the first functional member of Katsurada on the inner shaft of Stinson because the braid acts as a reinforcing member [0066].
Allowable Subject Matter
Claim(s) 9 is/are 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(s) 8, 16, 19 is/are allowed.
In regard to claims 8-9, Stinson (2002/0099435A1) in view of Longo (2020/0155332) meets all of the claim limitations except “the first functional member includes a varying amount of slots or fenestrations along the length of the delivery device such that a flexibility of the first functional member increases in the distal direction” in combination with the other claim limitations.
In regard to claims 16 and 19, Stinson (2002/0099435A1) in view of Longo (2020/0155332) meets all of the claim limitations except “the second functional member comprises a fiber that does not entirely surround the recess” in combination with the other claim limitations.
Response to Arguments
In regard to the double patenting rejection, the applicant has decided not to file a terminal disclaimer. Accordingly, any double patenting rejections remaining are noted in this office action.
In regard to the 103(a) rejection of claims 1-3, 6-7, 10-14, 18, 20 and 23 as unpatentable over Stinson (2002/0099435A1) in view of Longo (2020/0155332), the applicant’s arguments have been fully considered but are directed towards new claim limitations which have been addressed above.
In regard to the 103(a) rejection of claim(s) 4-5 as being unpatentable over Stinson (2002/0099435A1) in view of Longo (2020/0155332) and further in view of Dorn (2011/0137402A1), no further arguments have been presented.
In regard to the 103(a) rejection of claim(s) 15 as being unpatentable over Stinson (2002/0099435A1) in view of Longo (2020/0155332) and further in view of Parker (2010/0268243), no further arguments have been presented.
In regard to the 103(a) rejection of claim(s) 17 as being unpatentable over Stinson (2002/0099435A1) in view of Longo (2020/0155332) and further in view of Tieu (AU2008/345596A1) and further in view of Harris (2017/0281381A1), no further arguments have been presented.
In regard to the 103(a) rejection of claim(s) 21, 25 as being unpatentable over Stinson (2002/0099435A1) in view of Longo (2020/0155332) and further in view of Gibbons (2014/0257460A1), no further arguments have been presented.
In regard to the 103(a) rejection of claim(s) 22 as being unpatentable over Stinson (2002/0099435A1) in view of Longo (2020/0155332) and further in view of Hartigan (5681322), no further arguments have been presented.
In regard to the 103(a) rejection of claim(s) 26 as being unpatentable over Stinson (2002/0099435A1) in view of Longo (2020/0155332) and further in view of Lui (2012/0239142A1), no further arguments have been presented.
In regard to the 102(a)(1) rejection of claims 27-28 as anticipated by Stinson (2002/0099435A1), the applicant’s arguments are all directed towards new claim limitations which have been addressed above.
In regard to the 103(a) rejection of claim(s) 29 as being unpatentable over Stinson (2002/0099435A1) in view of Dorn (2011/0137402A1), no further arguments have been presented.
In regard to the 103(a) rejection of claim(s) 30 as being unpatentable over Stinson (2002/0099435A1) in view of Longo (2020/0155332), no further arguments have been presented.
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.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774