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 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, 4-10, 12-13, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent App. Pub. No. 2008/0255655 (Kusleika et al.) in view of US Patent 8,475,515 (Dorn et al.), and further in view of US Patent App. Pub. No. 2019/0117938 (Norman et al.).
Kusleika discloses a medical tubular body delivering device (see Figure 10A) for delivering a medical tubular body (stent 114) into a living body, the medical tubular body delivering device comprising an outer tube (113) extending from a proximal side to a distal side and having a lumen through which the medical tubular body is disposed;
a guidewire insertion member (117a) provided in the lumen of the outer tube (113) and proximal to the medical tubular body (114);
an inner insertion member (117c) provided in the lumen of the outer tube (113);
a guidewire tube (117s) having a lumen through which a guidewire is to be passed [0086];
wherein the guidewire insertion member (117a) has a penetration passage,
the guidewire tube and the guidewire insertion member are configured so that the guidewire tube (117s) is disposed in the penetration passage of the guidewire insertion member (117a) and the guidewire tube (117s) protrudes from a proximal opening of the penetration passage toward the proximal side, the inner insertion member (117c) is partially fixed to the guidewire insertion member (117a) at a fixing portion (see inner insertion member 117c extending into the insertion member 117a in Fig. 10A).
Kusleika fails to disclose a first protection member and a second protection member covering portions of the inner insertion member (117c). Dorn discloses another catheter with an elongate inner insertion member (16) attached to a proximal end of a guidewire insertion member (8) (see Figure 2A; column 9, lines 38-50). Dorn teaches the concept of a tubular protection member (18) surrounding a portion of the length of the inner insertion member (16) (Fig. 2B), wherein the protection member (18) serves as a lumen through which the insertion member (16) moves to retract the sheath (4) and for maintaining the desired position of the insertion member (16) relative to the other components in the delivery device, such as a guidewire tube (200)(column 9, lines 27-50; column 10, lines 60-65). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to include a protection member covering the inner insertion member of the Kusleika device, as taught by Dorn, as the modification merely involves a combination of known catheter components that achieves a predictable result of maintaining a desired arrangement of moveable components within a catheter and to provide a lumen through which an elongate member slides for actuation.
Kusleika, as modified by Dorn, fails to include two such protection members spaced from one another in a longitudinal direction. Norman discloses another catheter with an elongate inner insertion member (“manipulation shaft” 16) in the form of a shaft attached to a proximal end of a tubular member (14) at a junction (see Figure 3A; [0119]. Norman teaches the concept of including at least one protection member (sheath segment 34) over a portion of the length of the inner insertion member (“manipulation shaft” 16) (Fig. 3A; [0122]). As shown in Figures 6D-F, Norman teaches that the number and configuration of the sheath segments (88A-B; 92A-D; 96A-B) surrounding the inner insertion member can be varied to influence the torsional compliance and torque transmission characteristics of the device [0140]. This relates to the disclosure in Kusleika wherein the catheter desirably has torque transmission capabilities [0058]. One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to further modify Kusleika to include two longitudinally separated protection members covering the inner insertion member, as taught by Norman, as the modification merely involves a combination of known catheter components that achieves a predictable result of optimizing the desired torque transmission and compliance characteristics of the catheter for a particular application.
Dorn discloses the protection member is positioned proximal to the fixing portion (the location at which the insertion member 16 is connected to the guidewire insertion member 8). Norman teaches that the two protection members are positioned about the insertion member (16) proximal to a fixing portion (location of attachment of shaft 16 to tubular member 14). Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to arrange the guidewire insertion member, the inner insertion member, the first protection member, and the second protection member are configured so that a proximal portion of the inner insertion member is covered by the first protection member and a distal portion of the inner insertion member is covered by the second protection member, and the second protection member is disposed between the fixing portion and the first protection member in a longitudinal direction from the proximal side to the distal side.
In regards to claim 2, Dorn discloses the concept of the inner insertion member (16) being moveable disposed within the protection member (18). Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to arrange the second protection member to be moveable relative to the inner insertion member.
In regards to claim 4, Kusleika discloses the working length of the catheter is in the range of 60- 200 cm and the stent (54) has a length in the range of 20 -400 mm [0057]. Since the guidewire insertion member (117a) is connected to the inner insertion member (117c), and Norman teaches varying a position of a protection member to optimize torque transmission [0140], one of ordinary skill in the art would have found it obvious to arrange the distance between the proximal end of the guidewire insertion member (117a) and a distal end of the first protection member (covering the inner insertion member 117c) to be 30 mm or shorter.
In regards to claim 5, Norman teaches the protection members being fixed to the inner insertion member [0140]. Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to fix the second protection member of modified Kusleika to the inner insertion member at a location proximal to the fixing portion where the inner insertion member and guidewire insertion member are joined.
In regards to claim 6, Norman illustrates that the protection member (34) may be spaced from the tubular member (14) to which the insertion member (16) is attached (see Fig. 3A). Norman also teaches various arrangements of spacing between the protection members (Fig. 6D-F). Norman teaches that the distance between components can be selected to obtain desired torsional compliance and torque transmission characteristics of the device [0140]. Therefore, it would have been further obvious to arrange the first and second protection members of modified Kusleika such that a proximal end of the guidewire insertion member (117a) and a distal end of the second protection member are located apart from each other in a longitudinal axis direction, and a proximal end of the second protection member and a distal end of the first protection member are located apart from each other in the longitudinal axis direction, in order to obtain desired torque transmission and/or compliance characteristics.
Regarding claim 7, Kusleika discloses the inner insertion member (117c) is fixed to a proximal end of the guidewire insertion member (117a). Since the second protection member taught by Dorn and Norman surrounds a distal portion of the inner insertion member (117c), it would have been further obvious to fix the distal end of the second protection member to the proximal end of the guidewire insertion member (117a).
In regards to claim 8, Kusleika generally discloses the length of the catheter is 60-200 cm and the stent (54) length is 20-400 mm [0057]. Since the catheter components have lengths on the order of millimeters, one of ordinary skill in the art would have found it obvious to configure the distance between a proximal end of the second protection member and a distal end of the first protection member to be 5 mm or shorter, since Norman teaches that the spacing between protection members can be selected to obtain desired torque transmission and compliance characteristics [0140].
Regarding claim 9, Kusleika discloses that a distalmost portion of the inner insertion member (117c) overlaps in length with a part of the guidewire tube (117s) protruding from the proximal opening of the penetration passage of the guidewire insertion member (117s). Therefore, it would have been further obvious to arrange the second protection member of modified Kusleika so that it covers a part of the guidewire tube (117s) protruding from the proximal opening of the penetration passage of the guidewire insertion member (117s), in order to obtain desired torque characteristics, as taught by Norman [0140].
Regarding claim 10, Kusleika discloses the device is of a rapid exchange type in which the outer tube (113) has a guidewire port (113s), wherein the guidewire port is located at a side distal to a proximal end of the outer tube (see Fig. 10A; [0086]).
In regards to claims 12 and 13, Kusleika fails to further disclose an inner tube having a lumen through which the guidewire is to be passed. Dorn teaches the concept of an additional inner tube (200) disposed in the lumen of the outer tube (204), wherein the proximal end of the inner tube (200) is fixed to a guidewire port (226) (see especially Figure 2B). Additionally, the inner tube (200) has a portion within a guidewire tube (210) (column 9, lines 27-37). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to further modify Kusleika to include an inner tube component partially within the guidewire tube and fixed to the guidewire port, as taught by Dorn, as the modification merely involves a combination of known guidewire exchange catheters according to known methods that achieves a predictable result of tubular components that function to form a continuous passage for a guidewire from a distal end of the catheter to a proximal guidewire port (Dorn column 9, lines 55-65).
In regards to claim 15, the term “colored” is given its broadest reasonable interpretation to encompass any hue of the guidewire insertion member, including white, semi-transparent, silver/metallic, etc. Dorn teaches that the guidewire insertion tube (8) can include a radiopaque marker band (col 9, lines 40-50) and that marker bands are made of metallic material (col 11, line 58). Additionally, Norman teaches the use of visual markers [0139]. One of ordinary skill in the art would recognize the well-known benefit of including markers on the guidewire insertion member of modified Kusleika having at least one color.
Regarding claim 16, Kusleika discloses the medical tubular body is a self-expanding stent [0042].
Claim(s) 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kusleika et al. in view of Dorn et al. and Norman et al., as applied to claim 1 above, and further in view of US Patent No. 8,758,421 (Gerdts et al.).
Regarding claim 11, Kusleika discloses the guidewire tube (117s) is disposed in the penetration passage of the guidewire insertion member (117a). Another section of the guidewire tube (117b) protrudes from a distal opening of the penetration passage (inner lumen of 117a) toward the distal side (see Fig. 10A).
Kusleika fails to configure a single guidewire tube to protrude from both a proximal opening (claim 1) and a distal opening of the penetration passage of the guidewire insertion member (117a).
Gerdts discloses a guidewire tube (134) formed as a continuous member that extends from a distal tip (116) of the catheter to a proximal port (144) in order to direct the guidewire in a manner that reduces friction and prevents damage to the guidewire (Fig 7B; col 7, lines 25-50). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to substitute the guidewire tube sections (117b and 117s) with a single tubular member that extends through the guidewire insertion member (117a) and protrudes from both proximal and distal ends, as the modification merely involves a combination of known guidewire tubes according to known methods that achieves a predictable result of reducing friction and/or damage to the catheter components and guidewire.
In regards to claim 14, Gerdts additionally teaches that a guidewire tube (134) defines a shape that tapers from the distal end towards the proximal end at the proximal guidewire port (144) (see Fig. 7A). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to further modify Kusleika such that guidewire tube has a tapered shape, as taught by Gerdts, as the modification merely involves a change in shape of a tubular component to provide a smooth passage for a guidewire to a proximal guidewire port.
Allowable Subject Matter
Claim 3 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.
The following is a statement of reasons for the indication of allowable subject matter: none of the cited art above discloses protection members that are capable of changing length.
USPAP 2012/0143088 (Schultz) discloses the concept of helically coiled protection members (44) disposed on elongate members (42) in order to provide flexibility/ bending (Fig. 2B; [0046]), but the coils are fixed at both ends [0047] and therefore unable to shorten.
USPAP 2013/0297012 (Willard) discloses a compressible spring supporting an inner member (180), but is for the purpose of selectively engaging the member (180) for rotational alignment [0034], which is not relevant to the cited art above.
Conclusion
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774