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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/17/2026 has been entered.
Response to Amendment
Claims 1, 3-7, 10, and 12-13 remain pending.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over O’Donnell et al. (US 20130184642, henceforth O’Donnell) in view of Tegg (US 20120203169, henceforth Tegg), Sullivan et al. (US 20060069311, henceforth Sullivan), Davies et al. (US 20150231366, henceforth Davies), and Schultz (US 20120143088, henceforth Schultz).
Regarding claim 1, O’Donnell discloses a bi-directional steerable catheter (introducer sheath assembly 10, fig. 1A) comprising: a handle (handle assembly 20, fig. 1A); and an elongate sheath (sheath member 15, fig. 1A) extending distally from the handle (see fig. 1A, the distal direction is the direction from handle assembly 20 towards distal tip 28; the proximal direction is opposite the distal direction); wherein the handle includes an axial translation mechanism (control knob 50, drive shaft 55, shuttle assembly 60, fig. 3A); wherein the axial translation mechanism includes a threaded member (shuttle assembly 60 includes mating internal threads 80, [0039]) slidably disposed within the handle (“shuttle assembly 60 can translate axially”, [0039]); wherein a first steering wire (right side pull wire 75, fig. 3B) extends through the elongate sheath from the handle to a distal end portion ([0036], [0041]); wherein a second steering wire (left side pull wire 70, fig. 3A) extends through the elongate sheath from the handle to the distal end portion ([0036], [0041]), the second steering wire being disposed on an opposite side of the elongate sheath from the first steering wire relative to a central longitudinal axis of the elongate sheath (see fig. 2, and since the pull wires are for right and left sides, respectively, it is further understood that they are opposite); wherein the first steering wire is configured to engage with the axial translation mechanism (see [0042], “crimp tube 108 operates to engage the shuttle assembly 60 and thereby couples the pull wire 75 to the shuttle assembly 60”) to bend a distal portion of the elongate sheath (“causes the pull wire 75 to be placed in tension … to cause deflection of the distal end portion 27 of the sheath member 15”, [0046]) in a first direction (it is understood that tension on the right side pull wire, which causes a deflection as disclosed, would cause a deflection in the rightward direction when the device is held in the orientation of fig. 1); wherein the second steering wire is configured to engage with the axial translation mechanism (“crimp tube 106 is selectively positioned and secured to the pull wire 70 so as to permit a desired amount of translation of the shuttle assembly 60 in the proximal direction before the crimp tube 106 will engage the left shuttle portion 60a”, [0045], pull wire 70 is engaged to shuttle assembly 60 via crimp tube 106) to bend the distal portion of the elongate sheath (“proximal translation of the shuttle assembly 60 causes the pull wire 70 to be placed in tension to cause deflection of the distal end portion 27 of the sheath member 15”, [0045]) in a second direction (it is understood that tension on the left side pull wire, which causes a deflection as disclosed, would cause a deflection in the leftward direction when the device is held in the orientation of fig. 1) opposite the first direction (a rightward direction and a leftward direction are opposite directions); wherein a pulley wheel (right pulley wheel 144, fig. 3B) is disposed within the handle (see fig. 3B, right pulley wheel 144 is disposed inside of outer housing assembly 40 of handle assembly 20), the first steering wire engaged with the pulley wheel (see fig. 3B and see [0046], right pull wire 75 is engaged with right pulley wheel 144 where it is supported by it and wraps around it); wherein a tensioning member (spring member 98, fig. 3B), which is a coil spring (see fig. 4B, spring 98 is shown as a coil spring), couples a proximal end of the first steering wire to the handle ([0042]) at a coupling location distal of a proximal end of the first steering wire (see fig. 2; spring 98 connects to pull wire 75 at end 104 of spring 98, and this end of pull wire 75 is its proximal end; see also fig. 3B where spring 98 is coupled to either inner housing 45 or outer housing 40 at end 102 at a location distal to end 104, and see [0042]); wherein the first steering wire extends from the distal end portion (see [0036] and [0041], right pull wire 75 extends proximally towards the handle from the distal end portion), around the pulley wheel (see fig. 4b, right pull wire 75 loops around right pulley wheel 144 as shown), and to the coupling location (see fig, 4b and see [0042], this is where the other end of pull wire 75 is located); wherein the tensioning member maintains engagement between the first steering wire and the pulley wheel when the first steering wire is not under tension from the axial translation mechanism (see [0046], the maintaining of a desired amount of tension to inhibit the formation of undesired slack is a maintaining of engagement between right pull wire 75 and right pulley wheel 144 as claimed); wherein the second steering wire includes a second stop element (crimp tube 106, fig. 2) configured to engage with the axial translation mechanism (“crimp tube 106 will engage the left shuttle portion 60a”, [0045]) proximate a distal end of the threaded member (see fig. 3A, internal threads 80 exist within the insides of the shuttle assembly 60; thus, the distal end of the threaded member as claimed is the semicircular rounded ends of shuttle portions 60a and 60b as shown in fig. 2; the engagement between assembly 60 and crimp tube 106 occurs proximate to the distal end of assembly 60 where the elements are located close to each other relative to the distance from either of the elements to hemostasis valve assembly 25 or distal tip 28 of sheath member 15, see also fig. 1A, especially where assembly 60 and crimp tube 106 are found roughly in the middle to distal half of handle assembly 20 as shown in fig. 3A) when the threaded member slides in a proximal direction within the handle (“Once the shuttle assembly 60 contacts the crimp tube 106, as shown, further proximal translation of the shuttle assembly 60 causes the pull wire 70 to be placed in tension … to cause deflection of the distal end portion 27 of the sheath member 15”, [0045]); wherein the second stop element disengages from the axial translation mechanism when the threaded member slides in a distal direction within the handle (“translation of the shuttle assembly 60 in the distal direction will tend to release this tension in the pull wire 70, to the point at which the crimp tube 106 no longer abuts the shuttle portion 60a”, [0045], where the lack of abutment is a disengagement). Additionally, O’Donnell discloses that the distal end portion can have a member which the pull wires can attach to (“an anchor member” can be incorporated into the distal end portion 27 of sheath member 15 in [0036]) and discloses that the presence of slack in the pull wires is undesirable ([0045]).
{Examiner notes that O’Donnell is understood to have a typographical error in [0042] where it refers to “the end 102 of the spring 98 is connected, either directly or indirectly, to the inner housing 45 or the inner housing 40”, which should read outer housing 40 to keep in line with the rest of the reference. Examiner has underlined the changes to the reference to call them out for clarity.}
O’Donnell does not explicitly disclose that its distal end portion where the first steering wire and the second steering wire terminate is a distal pull ring. Tegg teaches a steerable catheter (elongate medical device 10, fig. 1) using a plurality of pull wires (pull wires 78, fig. 11 and [0108]) which extend from a handle (“catheter handle at the proximal end of the finished shaft”, [0100]) through an elongate sheath (shaft 62, see [0100]) to a distal pull ring (pull ring 90, fig. 13 and [0113]) which is a member added to the elongate sheath (see fig. 13 and see [0115], pull ring 90 is added to the shaft of the catheter device as desired). Tegg additionally teaches that it is well known in the art to use pull rings as a means of attaching pull wires to the distal ends of steerable catheters ([0006]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the pull ring of Tegg for the anchoring member of O’Donnell as it would enable a physician to advance the catheter to an intended destination as desired ([0072]), especially since such a modification is well known to those of ordinary skill in the art as taught by Tegg ([0006]), and where such a substitution would have yielded the same, predictable result of a catheter being steerable within the body by adding tension to pull wires at a distal end portion of an elongate sheath such as to cause a deflection of said elongate sheath.
O’Donnell as modified discloses the catheter wherein the second steering wire extends distally from the second stop element to the distal pull ring (the second pull wire extends from the handle, in a proximal position, to the added pull ring anchoring member of Tegg, in a distal position, and thus it extends distally from the handle which comprises the second stop element to the pull ring).
O’Donnell as modified does not disclose that the tensioning member is an elastic polymer. Sullivan teaches that an elastic polymer and a coil spring are equivalents which can both be used as tensioning members to absorb slack when it is present as it is not desired ([0035], note that rubber is a well-known elastic polymer and is disclosed as a possible alternative to a spring to act as a biasing member).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the spring of O’Donnell with a piece of rubber as Sullivan teaches that rubber can be substituted for a spring as an art effective means of absorbing slack, and further as such a substitution would have yielded the same, predictable result of the pull wires of O’Donnell being connected to the handle of O’Donnell in a manner where slack would be absorbed if needed.
O’Donnell as modified by Tegg and Sullivan does not disclose the catheter wherein the second steering wire does not extend proximally from the second stop element. Davies teaches a bi-directional steerable catheter (the combination of handle 100 and sheath 90, fig. 1) comprising: a handle (handle 100, fig. 1), an elongate sheath (sheath 90, fig. 1) extending distally from the handle (see fig. 1, the distal direction runs from housing 20 towards sheath 90), a first steering wire (control wire 42, fig. 2B) extending through the elongate sheath (see [0055]) to a mounting location (distal portion of sheath 90, [0055]), a second steering wire (control wire 40, fig. 2B) extending through the elongate sheath (see [0055]) to the mounting location (distal portion of sheath 90, [0055]), the second steering wire being configured to engage with an axial translation mechanism (slide assembly 30, see [0055]-[0047]) including a threaded member (bolt 32, fig. 2B and fig. 2C) slidably disposed within the handle (see [0081], bolt 32 causes rotating and sliding movements), wherein the second steering wire includes a second stop element (crimp 41, fig. 3A) wherein the second steering wire does not extend proximally from the second stop element to any other structures (see figs. 3A and 3C, control wire 40 extends from sheath 90 in the proximal direction, through carriage 34, and to crimp 41 where it no longer extends proximally to any other structures).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the arrangement of O’Donnell to have had the second steering wire not extend proximally from the second stop element to any other structures as in Davies as Davies teaches this to be an art effective equivalent arrangement for a pull wire where the pull wire only extends in a single direction between the pull ring and the stop element and does not require extension past the stop element to any further structures, and further because such a modification would have yielded the same, predictable result of a pull wire being tensionable to cause a deflection in the sheath as a result of a movement in the axial translation mechanism causing a translation of the second pull wire.
O’Donnell as modified by Tegg, Sullivan, and Davies thus discloses that the second steering wire does not extend proximally from the second stop element to any further proximal structures.
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O’Donnell fig. 3 calling out a small portion of the second steering wire which only extends for a short distance distally from the second stop element for mounting purposes
O’Donnell as modified by Tegg, Sullivan, and Davies does not explicitly disclose that the second steering wire does not extend proximally from the second stop element. Schultz teaches an arrangement where a pull wire (puller member 42, fig. 9) extends to a stop element for mounting the pull wire at the stop (stop 96, fig. 9) where the pull wire does not extend through and beyond the stop element (see fig. 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mounting of the pull wire of the modified arrangement of O’Donnell as modified by Davies so that the pull wire does not extend proximally from the stop element as in Schultz as Schultz teaches a mounting of a pull wire to not extend beyond the stop element which it is mounted to as an art effective equivalent means of mounting a pull wire to a stop element, and further because such a modification would have yielded the same, predictable result of the pull wire being securely mounted to the stop element and not extending distally from the stop element to any further structures which the pull wire needs to interact with.
Regarding claim 3, O’Donnell as modified by Tegg, Sullivan, Davies, and Schultz (henceforth O’Donnell as modified) discloses the catheter wherein the axial translation mechanism includes a rotatable knob (control knob 50, fig. 2) configured to rotate about at least a portion of the handle (control knob 50 is axially rotatable relative to the sheath member 15 and the housing assemblies 40, 45, [0038]).
Regarding claim 4, O’Donnell as modified discloses the catheter wherein the rotatable knob is configured to engage the threaded member ([0040]) such that rotation of the rotatable knob relative to the handle causes axial translation of the threaded member within the handle (“rotation of the control knob 50 and the drive shaft 55 relative to shuttle assembly 60 … causes axial translation of the shuttle assembly relative to the drive shaft 55 within the outer housing assembly 40 and the inner housing assembly 45”, [0040]).
Regarding claim 5, O’Donnell as modified discloses the catheter wherein the first steering wire includes a first stop element (crimp tube 108, fig. 2) configured to engage with the axial translation mechanism (“crimp tube 108 engages the right shuttle portion 60b”, [0046]) when the threaded member slides in a distal direction within the handle (“distal translation of the shuttle assembly 60 causes the pull wire 75 to be placed in tension”, [0046]) to apply tension to the first steering wire ([0046]).
{Examiner notes that O’Donnell is understood to have a pair of typographical errors in [0046], the first where it refers to “crimp tube 108 abutting the end of the right shuttle portion 60a”, which should read right shuttle portion 60b to keep in line with the rest of the reference, and the second where it refers to “The crimp tube 107 engages the right shuttle portion 60b, such that distal translation of the shuttle assembly 60 causes the pull wire 75 to be placed in tension”, which should read the crimp tube 108 to keep in line with the rest of the reference. Examiner has underlined the changes to the reference to call them out for clarity.}
Regarding claim 6, O’Donnell as modified discloses the catheter wherein the first stop element disengages from the axial translation mechanism to release tension on the first steering wire when the threaded member slides in a proximal direction within the handle (while not explicitly disclosed, this is understood to be true since it is disclosed that “The crimp tube 108 engages the right shuttle portion 60b, such that distal translation of the shuttle assembly 60 causes the pull wire 75 to be placed in tension … to cause deflection of the distal end portion 27 of the sheath member 15”, [0046], and that the tension can be released in an opposite manner, crimp tube 108 would disengage from right shuttle portion 60b when the tension in pull wire 75 is released; further, the action between the crimp tubes for pull wire 75 are disclosed as being equivalent to the action of crimp tubes for pull wire 70 in [0042], and it is disclosed for the crimp tubes for pull wire 70, “translation of the shuttle assembly 60 in the distal direction will tend to release this tension in the pull wire 70, to the point at which the crimp tube 106 no longer abuts the shuttle portion 60a”, [0045], which is considered to be an equivalent disengagement as crimp tubes 106 and 108 are considered to be equivalents in light of [0042]).
Regarding claim 7, O’Donnell as modified discloses the catheter wherein the first stop element is configured to float relative to the axial translation mechanism (see equivalency between crimp tubes for pull wire 75 and for pull wire 70 in [0042] as discussed in claim 6 above and see “crimp tube 106 no longer abuts the shuttle portion 60a” in [0045]; since crimp tube 106 contacts the left shuttle portion 60a and crimp tube 108 contacts the right shuttle portion 60b, they are considered to be equivalents with equivalent actions, and since and since crimp tube 106 floats relative to shuttle assembly 60 where it is no longer in abutment with it as in [0045], it is understood that crimp tube 108 floats relative to shuttle assembly 60 where it is no longer in abutment with it as well; Examiner notes that, in keeping in line with Applicant’s specification at pg. 14, line 17, the term “float” is considered to mean that the stop element is not directly fixed to the shuttle assembly, which is true if the crimp tube is no longer in abutment with the shuttle assembly) when the threaded member slides in a proximal direction within the handle (see [0046], proximal movement of shuttle assembly 60 causes the release of tension in pull wire 75).
Regarding claim 10, O’Donnell as modified discloses the catheter wherein the second stop element is configured to float relative to the axial translation mechanism (“crimp tube 106 no longer abuts the shuttle portion 60a”, [0045], and see Examiner’s interpretation of the term “floats” in claim 7 above) when the threaded member slides in a distal direction within the handle (“translation of the shuttle assembly 60 in the distal direction will tend to release this tension in the pull wire 70”, [0045]).
Regarding claim 12, O’Donnell discloses a bi-directional steerable catheter (introducer sheath assembly 10, fig. 1A) comprising: a handle (handle assembly 20, fig. 1A); and an elongate sheath (sheath member 15, fig. 1A) extending distally from the handle (see fig. 1A, the distal direction is the direction from handle assembly 20 towards distal tip 28; the proximal direction is opposite the distal direction); wherein the handle includes an axial translation mechanism (control knob 50, drive shaft 55, shuttle assembly 60, fig. 3A) that includes a threaded member (shuttle assembly 60 includes mating internal threads 80, [0039]) slidably disposed within the handle (“shuttle assembly 60 can translate axially”, [0039]); wherein a first steering wire (right side pull wire 75, fig. 3B) extends through the elongate sheath from the handle to a distal end portion ([0036], [0041]); wherein a second steering wire (left side pull wire 70, fig. 3A) extends through the elongate sheath from the handle to the distal end portion ([0036], [0041]), the second steering wire being disposed on an opposite side of the elongate sheath from the first steering wire relative to a central longitudinal axis of the elongate sheath (see fig. 2, and since the pull wires are for right and left sides, respectively, it is further understood that they are opposite); wherein the first steering wire is configured to engage with the axial translation mechanism (see [0042], “crimp tube 108 operates to engage the shuttle assembly 60 and thereby couples the pull wire 75 to the shuttle assembly 60”) to bend a distal portion of the elongate sheath (“causes the pull wire 75 to be placed in tension … to cause deflection of the distal end portion 27 of the sheath member 15”, [0046]) in a first direction (it is understood that tension on the right side pull wire, which causes a deflection as disclosed, would cause a deflection in the rightward direction when the device is held in the orientation of fig. 1); wherein the second steering wire is configured to engage with the axial translation mechanism (“crimp tube 106 is selectively positioned and secured to the pull wire 70 so as to permit a desired amount of translation of the shuttle assembly 60 in the proximal direction before the crimp tube 106 will engage the left shuttle portion 60a”, [0045], pull wire 70 is engaged to shuttle assembly 60 via crimp tube 106) to bend the distal portion of the elongate sheath (“proximal translation of the shuttle assembly 60 causes the pull wire 70 to be placed in tension to cause deflection of the distal end portion 27 of the sheath member 15”, [0045]) in a second direction (it is understood that tension on the left side pull wire, which causes a deflection as disclosed, would cause a deflection in the leftward direction when the device is held in the orientation of fig. 1) opposite the first direction (a rightward direction and a leftward direction are opposite directions); wherein a tensioning member (spring member 98, fig. 3B), which is a coil spring (see fig. 4B, spring 98 is shown as a coil spring), couples a proximal end of the first steering wire to the handle ([0042]) at a coupling location distal of a proximal end of the first steering wire (see fig. 2; spring 98 connects to pull wire 75 at end 104 of spring 98, and this end of pull wire 75 is its proximal end; see also fig. 3B where spring 98 is coupled to either inner housing 45 or outer housing 40 at end 102 at a location distal to end 104, and see [0042]); wherein a pulley wheel is disposed within the handle (right pulley wheel 144, fig. 3B), the pulley wheel being engaged with the first steering wire (see [0046] and see fig. 3B); wherein the first steering wire extends from the distal pull ring (see [0036] and [0041], right pull wire 75 extends proximally towards the handle from the distal end portion), around the pulley wheel (see fig. 4b, right pull wire 75 loops around right pulley wheel 144 as shown), and to the coupling location (see fig, 4b and see [0042], this is where the other end of pull wire 75 is located); wherein the tensioning member maintains engagement between the first steering wire and the pulley wheel when the first steering wire is not under tension from the axial translation mechanism (see [0046], the maintaining of a desired amount of tension to inhibit the formation of undesired slack is a maintaining of engagement between right pull wire 75 and right pulley wheel 144 as claimed); wherein the second steering wire includes a second stop element (crimp tube 106, fig. 2) configured to engage with the axial translation mechanism (“crimp tube 106 will engage the left shuttle portion 60a”, [0045]) when the threaded member slides in a proximal direction within the handle (“Once the shuttle assembly 60 contacts the crimp tube 106, as shown, further proximal translation of the shuttle assembly 60 causes the pull wire 70 to be placed in tension … to cause deflection of the distal end portion 27 of the sheath member 15”, [0045]); wherein the second stop element disengages from the axial translation mechanism when the threaded member slides in a distal direction within the handle (“translation of the shuttle assembly 60 in the distal direction will tend to release this tension in the pull wire 70, to the point at which the crimp tube 106 no longer abuts the shuttle portion 60a”, [0045], where the lack of abutment is a disengagement). Additionally, O’Donnell discloses that the distal end portion can have a member which the pull wires can attach to (“an anchor member” can be incorporated into the distal end portion 27 of sheath member 15 in [0036]) and that the presence of slack in the pull wires is undesirable ([0045]).
{Examiner notes that O’Donnell is understood to have a typographical error in [0042] where it refers to “the end 102 of the spring 98 is connected, either directly or indirectly, to the inner housing 45 or the inner housing 40”, which should read outer housing 40 to keep in line with the rest of the reference. Examiner has underlined the changes to the reference to call them out for clarity.}
O’Donnell does not explicitly disclose that its distal end portion where the first steering wire and the second steering wire terminate is a distal pull ring. Tegg teaches a steerable catheter (elongate medical device 10, fig. 1) using a plurality of pull wires (pull wires 78, fig. 11 and [0108]) which extend from a handle (“catheter handle at the proximal end of the finished shaft”, [0100]) through an elongate sheath (shaft 62, see [0100]) to a distal pull ring (pull ring 90, fig. 13 and [0113]) which is a member added to the elongate sheath (see fig. 13 and see [0115], pull ring 90 is added to the shaft of the catheter device as desired). Tegg additionally teaches that it is well known in the art to use pull rings as a means of attaching pull wires to the distal ends of steerable catheters ([0006]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the pull ring of Tegg for the anchoring member of O’Donnell as it would enable a physician to advance the catheter to an intended destination as desired ([0072]), especially since such a modification is well known to those of ordinary skill in the art as taught by Tegg ([0006]), and where such a substitution would have yielded the same, predictable result of a catheter being steerable within the body by adding tension to pull wires at a distal end portion of an elongate sheath such as to cause a deflection of said elongate sheath.
O’Donnell as modified discloses the catheter wherein the second steering wire extends distally from the second stop element to the distal pull ring (the second pull wire extends from the handle, in a proximal position, to the added pull ring anchoring member of Tegg, in a distal position, and thus it extends distally from the handle which comprises the second stop element to the pull ring).
O’Donnell as modified does not disclose that the tensioning member is an elastic polymer. Sullivan teaches that an elastic polymer and a coil spring are equivalents which can both be used as tensioning members to absorb slack when it is present as it is not desired ([0035], note that rubber is a well-known elastic polymer and is disclosed as a possible alternative to a spring to act as a biasing member).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the spring of O’Donnell with a piece of rubber as Sullivan teaches that rubber can be substituted for a spring as an art effective means of absorbing slack, and further as such a substitution would have yielded the same, predictable result of the pull wires of O’Donnell being connected to the handle of O’Donnell in a manner where slack would be absorbed if needed.
O’Donnell as modified does not explicitly disclose that the first steering wire extends into a wall of the elongate sheath proximate a distal end of the handle at a first angle relative to the central longitudinal axis of the elongate sheath, and the second steering wire extends into the wall of the elongate sheath proximate the distal end of the handle at a second angle relative to the central longitudinal axis of the elongate sheath different from the first angle. Davies teaches a bi-directional steerable catheter (the combination of handle 100 and sheath 90, fig. 1) comprising: a handle (handle 100, fig. 1), an elongate sheath (sheath 90, fig. 1) extending distally from the handle (see fig. 1, the distal direction runs from housing 20 towards sheath 90) along a central longitudinal axis thereof (this is the dashed line extending through sheath 90 shown in fig. 2 extending along the distal direction D and the proximal direction P as shown), a first steering wire (control wire 42, fig. 2B) extending through the elongate sheath (see [0055]) to a mounting location (distal portion of sheath 90, [0055]), a second steering wire (control wire 40, fig. 2B) extending through the elongate sheath (see [0055]) to the mounting location (distal portion of sheath 90, [0055]), wherein the first steering wire extends into a wall of the elongate sheath (see [0055] the wires extend into sheath 90; this is also shown in detail in fig. 3C) proximate a distal end of the handle (see fig. 3C. the first steering control wire 42 enters the exterior wall of sheath 90 very near to the distal most edge of intermediate housing 38 of handle 100 which is a distal end of the handle as claimed; see annotated fig. 3C below calling out the distal most edge of intermediate housing 38 which is a part of handle 100) at a first angle relative to the central longitudinal axis of the elongate sheath (see fig. 3C, the first angle is pictured as being closer to the far side of intermediate housing 38 from the point of view of fig. 3C; see also annotated fig. 3C), and the second steering wire extends into the wall of the elongate sheath (see [0055] the wires extend into sheath 90; this is also shown in detail in fig. 3C) proximate the distal end of the handle (see fig. 3C. the second steering control wire 40 enters the exterior wall of sheath 90 very near to the distal most edge of intermediate housing 38 of handle 100 which is a distal end of the handle as claimed; see annotated fig. 3C below calling out the distal most edge of intermediate housing 38 which is a part of handle 100) at a second angle relative to the central longitudinal axis of the elongate sheath (see fig. 3C, the second angle is pictured as being further from the far side of intermediate housing 38 from the point of view of fig. 3C; see also annotated fig. 3C) different from the first angle (see annotated fig. 3C below, the angles are different due to the different directions which the control wires 40 and 42 enter the sheath 90 from).
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Annotated fig. 3C from Davies zoomed in to region if interest
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arranged the steering wires of O’Donnell as in Davies as Davies teaches this arrangement to be functional for pull wires which provide for steering in a sheath ([0063]) similar to that in O’Donnell as modified, and further because arranging the pull wires in the sheath in the device of O’Donnell as modified as in Davies would have yielded the predictable result of having tensionable pull wires which can be tightened to provide for steering in opposite directions between a first and a second direction (see Davies [0008]).
O’Donnell as modified by Tegg, Sullivan, and Davies does not disclose the catheter wherein the second steering wire does not extend proximally from the second stop element. Davies further teaches a bi-directional steerable catheter (the combination of handle 100 and sheath 90, fig. 1) comprising: a handle (handle 100, fig. 1), an elongate sheath (sheath 90, fig. 1) extending distally from the handle (see fig. 1, the distal direction runs from housing 20 towards sheath 90), a first steering wire (control wire 42, fig. 2B) extending through the elongate sheath (see [0055]) to a mounting location (distal portion of sheath 90, [0055]), a second steering wire (control wire 40, fig. 2B) extending through the elongate sheath (see [0055]) to the mounting location (distal portion of sheath 90, [0055]), the second steering wire being configured to engage with an axial translation mechanism (slide assembly 30, see [0055]-[0047]) including a threaded member (bolt 32, fig. 2B and fig. 2C) slidably disposed within the handle (see [0081], bolt 32 causes rotating and sliding movements), wherein the second steering wire includes a second stop element (crimp 41, fig. 3A) wherein the second steering wire does not extend proximally from the second stop element to any other structures (see figs. 3A and 3C, control wire 40 extends from sheath 90 in the proximal direction, through carriage 34, and to crimp 41 where it no longer extends proximally to any other structures).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the arrangement of O’Donnell to have had the second steering wire not extend proximally from the second stop element to any other structures as in Davies as Davies teaches this to be an art effective equivalent arrangement for a pull wire where the pull wire only extends in a single direction between the pull ring and the stop element and does not require extension past the stop element to any further structures, and further because such a modification would have yielded the same, predictable result of a pull wire being tensionable to cause a deflection in the sheath as a result of a movement in the axial translation mechanism causing a translation of the second pull wire.
O’Donnell as modified by Tegg, Sullivan, and Davies thus discloses that the second steering wire does not extend proximally from the second stop element to any further proximal structures.
O’Donnell as modified by Tegg, Sullivan, and Davies does not explicitly disclose that the second steering wire does not extend proximally from the second stop element. Schultz teaches an arrangement where a pull wire (puller member 42, fig. 9) extends to a stop element for mounting the pull wire at the stop (stop 96, fig. 9) where the pull wire does not extend through and beyond the stop element (see fig. 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mounting of the pull wire of the modified arrangement of O’Donnell as modified by Davies so that the pull wire does not extend proximally from the stop element as in Schultz as Schultz teaches a mounting of a pull wire to not extend beyond the stop element which it is mounted to as an art effective equivalent means of mounting a pull wire to a stop element, and further because such a modification would have yielded the same, predictable result of the pull wire being securely mounted to the stop element and not extending distally from the stop element to any further structures which the pull wire needs to interact with.
Regarding claim 13, O’Donnell as modified by Tegg, Sullivan, Davies, and Schultz discloses the catheter wherein the pulley wheel engages the first steering wire at a position proximal of the tensioning member (see fig. 3B, pulley wheel 144 is proximal to spring 98).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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