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 .
Status of the Claims
Claims 6-8, 10, 13, 16, 20-23, and 25-26 are cancelled. Claim 30 is newly added. Claims 1, 9, and 11-12 are currently amended. Claims 1-5, 9, 11-12, 14-15, 17-19, 24, and 27-30 are currently pending. Claims 27-29 are withdrawn. Claims 1-5, 9, 11-12, 14-15, 17-19, 24, and 30 are currently rejected.
Response to Arguments
Applicant’s arguments, see Remarks, filed 09/17/2025, with respect to the rejection(s) of claim(s) 1 as amended, subject matter previously found in claim 8, under 35 U.S.C. 103, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
However, upon further consideration, a new ground(s) of rejection is made in view of a different interpretation of Florio and alternatively a different interpretation of Florio modified by Shelton.
Applicant argued that Florio as previously modified by Shelton would not allow independent control of Florio’s steering wires. Please see the new 103 rejection of claim 1 as amended which clarifies the combination and maintains Florio’s omnidirectional control.
In response to applicant's argument that the articulation slide of Shelton would interfere with the workings of Florio, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to applicant’s argument based upon the age of the references, contentions that the reference patents are old are not impressive absent a showing that the art tried and failed to solve the same problem notwithstanding its presumed knowledge of the references. See In re Wright, 569 F.2d 1124, 193 USPQ 332 (CCPA 1977).
Claim Rejections - 35 USC § 102 and 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 9, 14, and 30 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Florio et al (US-7056314-B1; hereafter Florio), or, in the alternative, under 35 U.S.C. 103 as obvious over Florio in view of Shelton et al (US 20080029572 A1; hereafter Shelton).
Regarding claim 1, Florio discloses a steerable introducer for a catheter device (steerable obturator 40, fig. 3, col. 5 ln. 10-22), the steerable introducer comprising:
a body portion (elongated obturator body 42, fig. 3) having a longitudinal axis (longitudinal, central axis 44, fig. 3) extending from a proximal end (proximal end 55, fig. 3) of the introducer toward a distal end (distal tip 48, fig. 3) of the introducer (fig. 3, col 5 ln. 10-22, body portion/obturator body 42 extends along a longitudinal, central axis 44 and has a distal tip 48 and proximal end 55), wherein the body portion comprises a flexible distal portion (col. 5 ln. 10-22, body portion 42 has a deflectable distal end section 46 terminating as distal tip 48) extending to the distal end (48);
a hollow (central, coaxial longitudinal lumen 56, fig. 4) within a part of the body portion (col. 5 ln. 23-40, central lumen defined by body portion/obturator body 42) for holding the catheter device during a procedure to introduce the catheter device into the body (col. 5 ln. 41-44, hollow/central lumen 56 may provide passageway for various devices such as an ultrasonic probe);
at least one steering control wire (col. 5 ln. 45-52, elongated actuation members 70 and 72 may comprise pull wires or cables, fig. 6) extending axially along the body portion (42) and along at least a part of an axial length of the flexible distal portion (col. 5 ln. 45-52, members 70 and 72 extend through outer lumens 58 and 60 in the body portion 42 from the control handle 54 to the distal tip 48 of the body portion 42);
a pair of twisting control wires (members 71 and 73, fig. 6) extending axially along the body portion and along at least a part of an axial length of the flexible distal portion (col. 5 ln. 45-52, members 71 and 73 may similarly extend through outer lumens 59 and 61 of body portion 42 from control handle 54 to distal tip 48); and
a controller (control handle 54, fig. 3, col. 5 ln. 18-22) for controlling the tension in the at least one steering control wire and in the pair of twisting control wires (col. 5 ln. 18-22, control handle 54 is used to control deflection of flexible distal end section 46; col. 6 ln. 18-34, control handle 54 controls movements of steering control wires 70 and 72 as well as twisting control wires 71 and 73),
wherein the at least one steering control wire (70, 72) has a distal end (col. 5 ln. 60-66, actuation members have distal extremities) that is fixed to the flexible distal portion at a first point in a first axial and circumferential position on the flexible distal portion (fig. 7 shows control wires 70 and 72 anchored in the distal tip 48), with the introducer being arranged to allow for tension (col. 5 ln. 45-46 actuation members may be pull wires; Examiner notes that claim language of “being arranged to” implies functional language and the prior art must only be capable of performing the recited function.) on the at least one steering control wire to cause a curvature of the flexible distal portion (col. 6 ln. 6-17, compound deflections of varying directions may be obtained); and
wherein the pair of twisting control wires each have a distal end (col. 5 ln. 60-66, actuation members have distal extremities), with the twisting control wire distal ends being fixed to the flexible distal portion (col. 5 ln. 60-66, distal extremities are anchored to the body portion at off-axis points proximally of tip 48) at second and third points at respective second and third axial (col. 6 ln. 6-17, each of the actuation members 70-73 may be anchored at a different distance from the tip 48) and circumferential positions on the flexible distal portion, with the circumferential position of the twisting control wire distal ends being different from each other as well as different from the circumferential position of the steering control wire (fig. 4 shows that each actuation member 70-73 has its own lumen and therefore its own unique circumferential position), and with the introducer being arranged to (Claim language of “being arranged to” implies functional language and the prior art must only be capable of performing the recited function.) allow for variations in relative tension between the pair of twisting control wires to cause twisting of the flexible distal portion (col. 6 ln. 6-17, compound deflections of varying directions may be obtained).
wherein the controller is arranged to (Claim language of “arranged to” implies functional language and the prior art must only be capable of performing the recited function.) control relative tension between the pair of twisting control wires (members 71 and 73, fig. 6; col. 6 ln. 18-34 longitudinal movement of twisting control members 71 and 73 are controlled by control handle 54; Examiner notes that since these members are pull wires as noted in col. 5 ln. 45-48 the tension of each wire, and thus the relative tension of those wires, is being controlled).
wherein the controller (control handle 54, fig. 3) includes a twisting control mechanism comprising: a tensioner (elements 100 and 102, fig. 8; col. 6 ln. 37-41, Frictional elements, such as the elements 100 and 102 cooperating with the knob 92, provide an appropriate level of resistance to movement of the knobs, introducing sufficient friction so that a selected knob is retained in the position in which it is placed) for applying tension (col. 3 ln. 46-48, control handle includes a plurality of manually movable control members) to both of the pair of twisting control wires (71 and 73), and a tension balancer (knobs 92-95, fig. 3) for varying the relative tension of the pair of twisting control wires (col. 6 ln. 24-32 each wire 70-73 is attached to a knob 92-95 which can be independently advanced or retracted in coordination with the other knobs to appropriately deflect the distal end section 46).
wherein the tension balancer (knobs 92-95, fig. 3) is arranged to vary the relative tension in the pair of twisting control wires (71 and 73) by adjusting a lateral force on each wire of the pair of twisting control wires (see fig. 8, note that moving knob 92 changes the angle of deflection of wire 70 and changes the overall force in the wire, thus also changing a lateral force on the fire; this mechanism is used for all wires).
Alternatively, regarding claim 1, Florio discloses a steerable introducer for a catheter device (steerable obturator 40, fig. 3, col. 5 ln. 10-22), the steerable introducer comprising:
a body portion (elongated obturator body 42, fig. 3) having a longitudinal axis (longitudinal, central axis 44, fig. 3) extending from a proximal end (proximal end 55, fig. 3) of the introducer toward a distal end (distal tip 48, fig. 3) of the introducer (fig. 3, col 5 ln. 10-22, body portion/obturator body 42 extends along a longitudinal, central axis 44 and has a distal tip 48 and proximal end 55), wherein the body portion comprises a flexible distal portion (col. 5 ln. 10-22, body portion 42 has a deflectable distal end section 46 terminating as distal tip 48) extending to the distal end (48);
a hollow (central, coaxial longitudinal lumen 56, fig. 4) within a part of the body portion (col. 5 ln. 23-40, central lumen defined by body portion/obturator body 42) for holding the catheter device during a procedure to introduce the catheter device into the body (col. 5 ln. 41-44, hollow/central lumen 56 may provide passageway for various devices such as an ultrasonic probe);
at least one steering control wire (col. 5 ln. 45-52, elongated actuation members 70 and 72 may comprise pull wires or cables, fig. 6) extending axially along the body portion (42) and along at least a part of an axial length of the flexible distal portion (col. 5 ln. 45-52, members 70 and 72 extend through outer lumens 58 and 60 in the body portion 42 from the control handle 54 to the distal tip 48 of the body portion 42);
a pair of twisting control wires (members 71 and 73, fig. 6) extending axially along the body portion and along at least a part of an axial length of the flexible distal portion (col. 5 ln. 45-52, members 71 and 73 may similarly extend through outer lumens 59 and 61 of body portion 42 from control handle 54 to distal tip 48); and
a controller (control handle 54, fig. 3, col. 5 ln. 18-22) for controlling the tension in the at least one steering control wire and in the pair of twisting control wires (col. 5 ln. 18-22, control handle 54 is used to control deflection of flexible distal end section 46; col. 6 ln. 18-34, control handle 54 controls movements of steering control wires 70 and 72 as well as twisting control wires 71 and 73),
wherein the at least one steering control wire (70, 72) has a distal end (col. 5 ln. 60-66, actuation members have distal extremities) that is fixed to the flexible distal portion at a first point in a first axial and circumferential position on the flexible distal portion (fig. 7 shows control wires 70 and 72 anchored in the distal tip 48), with the introducer being arranged to allow for tension (col. 5 ln. 45-46 actuation members may be pull wires; Examiner notes that claim language of “being arranged to” implies functional language and the prior art must only be capable of performing the recited function.) on the at least one steering control wire to cause a curvature of the flexible distal portion (col. 6 ln. 6-17, compound deflections of varying directions may be obtained); and
wherein the pair of twisting control wires each have a distal end (col. 5 ln. 60-66, actuation members have distal extremities), with the twisting control wire distal ends being fixed to the flexible distal portion (col. 5 ln. 60-66, distal extremities are anchored to the body portion at off-axis points proximally of tip 48) at second and third points at respective second and third axial (col. 6 ln. 6-17, each of the actuation members 70-73 may be anchored at a different distance from the tip 48) and circumferential positions on the flexible distal portion, with the circumferential position of the twisting control wire distal ends being different from each other as well as different from the circumferential position of the steering control wire (fig. 4 shows that each actuation member 70-73 has its own lumen and therefore its own unique circumferential position), and with the introducer being arranged to (Claim language of “being arranged to” implies functional language and the prior art must only be capable of performing the recited function.) allow for variations in relative tension between the pair of twisting control wires to cause twisting of the flexible distal portion (col. 6 ln. 6-17, compound deflections of varying directions may be obtained).
wherein the controller is arranged to (Claim language of “arranged to” implies functional language and the prior art must only be capable of performing the recited function.) control relative tension between the pair of twisting control wires (members 71 and 73, fig. 6; col. 6 ln. 18-34 longitudinal movement of twisting control members 71 and 73 are controlled by control handle 54; Examiner notes that since these members are pull wires as noted in col. 5 ln. 45-48 the tension of each wire, and thus the relative tension of those wires, is being controlled).
wherein the controller (control handle 54, fig. 3) includes a twisting control mechanism comprising: a tensioner (knobs 92-95, fig. 3) for applying tension (col. 3 ln. 46-48, control handle includes a plurality of manually movable control members) to both of the pair of twisting control wires (col. 6 ln. 24-32 each wire 70-73 is attached to a knob 92-95 which can be independently advanced or retracted in coordination with the other knobs to appropriately deflect the distal end section 46),
Florio is silent to a separate tension balancer.
Shelton, in the art of surgical tools and also employing wires to articulate a distal part of the surgical device, teaches wherein the controller (articulation control 200, fig. 5, [0142]) includes a twisting control mechanism (frame 204, articulation slide 202, and slot 208 fig. 5) comprising: a tensioner (frame 204, fig. 5) for applying tension (see fig. 5, note [0143] band portions 150 and 160 are anchored to tensioner / frame 204 at connection points 210 and 212) to both of the pair of twisting control wires (band portions 150 and 160, fig. 5, [0144] force of bent bands 150 and 160 causes deflection of end effector 12 shown in fig. 1), and a tension balancer (articulation slide 202 and slot 208, fig. 5, [0142]) for varying the relative tension of the pair of twisting control wires ([0144] moving tension balancer 202/208 to the side exerts a lateral force on bands 150 and 160 which in turn exert a force on the boss 122 to different effect depending on the position of the tension balancer 202/208; see fig. 6 which shows band 150 exerting a force on boss 122 which causes the boss 122 to pivot).
wherein the tension balancer (articulation slide 202 and slot 208, fig. 5 and 6) is arranged to vary the relative tension in the pair of twisting control wires (bands 150 and 160, fig. 5 and 6) by adjusting a lateral force on each wire of the pair of twisting control wires ([0144] pushing the articulation slide 202 to the side of the shaft assembly 100 may exert a laterally directed force on bands 150, 160).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the controller of Florio to include the separate tension balancer as taught by Shelton since both deal with using the relative tension of steering control wires to articulate a surgical device. One would have been motivated to make the modification because the tension balancer of Shelton is simple to use and provides an intuitive adjustment system as seen in fig. 6, where the position of the tension balancer 202 is clearly visible to a user of the device as a constant reminder of the articulation effect of tension balancer 202 on the device tip. This modification would thus beneficially provide an intuitive secondary control option for achieving twisting.
Regarding claim 2, Florio, or alternatively Florio modified by Shelton, discloses the steerable introducer (steerable obturator 40, fig. 3) as claimed in claim 1, as described above. Florio further discloses wherein the distal end of the introducer (distal tip 48, fig. 3) can be (Examiner notes that claim language of “can be” implies functional language and the prior art must only be capable of performing the recited function.) moved via a twisting movement simultaneously with a steering movement (col. 5 ln. 13-16 The obturator body includes a flexible, omnidirectionally deflectable distal end section 46 terminating at a distal tip 48 having a curved or rounded outer tip surface 50), so that the distal end (48) may shift out-of-plane from the plane of the curvature and result in tension on the at least one steering control wire alone (col. 3 ln. 46-56 each actuating member is controlled by a control member, and one or more selected control members can be used to cause deflection of the distal tip).
Regarding claim 3, Florio, or alternatively Florio modified by Shelton, discloses the steerable introducer as claimed in claim 1, as described above. Florio further discloses wherein the axial position of the twisting control wire (members 71 and 73, fig. 6) distal ends is about the same (col. 5 ln. 66-col. 6 ln. 17 members 70-73 may be anchored along or near the same plane 77, see fig. 6).
Regarding claim 9, Florio discloses the steerable introducer as claimed in claim 1, as described above. Florio further discloses wherein: the twisting control mechanism includes lateral restraints (see shoulder labeled “LR” in annotated fig. 8 below) spaced apart from the tension balancer (knobs 92-95, fig. 3) in a longitudinal direction (see fig. 8 below) of the pair of twisting control wires (71 and 73, fig. 4) and fixed either side of the tension balancer (see fig. 8 below, tension balancer includes both opposite knobs which, and the shoulder against which the wires deflect is on both sides as well, so the lateral restraints are present on either side of the tension balancer); and
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wherein the lateral restraints (see fig. 8 above) are provided to restrict lateral movement of the pair of twisting control wires (71 and 73) in a direction of the lateral force applied by the tension balancer (see 102 rejection of claim 1 above over Florio), such that variation in a lateral displacement of each twisting control wire changes a longitudinal tension in said twisting control wire (Examiner notes that moving tension balancer /knobs 92-95 would change tension in both a longitudinal and lateral direction since the angle of deflection against the lateral restraint would change).
Alternatively, regarding claim 9, Florio modified by Shelton discloses the steerable introducer as claimed in claim 1, as described above, including wherein: the twisting control mechanism (Shelton: frame 204, articulation slide 202, and slot 208, fig. 5) includes lateral restraints (Shelton: connection points 210 and 212, fig. 5, [0143] band portions 150 and 160 are anchored to tensioner / frame 204 at connection points 210 and 212) spaced apart from the tension balancer (Shelton: 202/208, fig. 5) in a longitudinal direction (Shelton: as shown in fig. 5, the tension balancer 202 and the lateral restraints 210 and 212 are spaced apart longitudinally) of the pair of twisting control wires (Shelton: bands 150 and 160, fig. 5) and fixed either side of the tension balancer (Shelton: see fig. 5, connection points are on either side of tension balancer slot 208 which is in the middle of tension balancer 202/208); and
wherein the lateral restraints (Shelton: connection points 210 and 212, fig. 5) are provided to restrict lateral movement of the pair of twisting control wires (Shelton: 150, 160) in a direction of the lateral force applied by the tension balancer (Shelton: 202/208) (Shelton: see fig. 6 which shows that when the tension balancer 202/208 is moved the twisting control wires are bent from a point proximal of the tension balancer 202/208; [0143] band portions 150 and 160 may be anchored anywhere in the instrument 10 located proximally from the slot 208 of tension balancer 202), such that variation in a lateral displacement of each twisting control wire changes a longitudinal tension in said twisting control wire (Examiner notes that pushing the control wires of Florio modified by Shelton laterally would increase the tension in the entire wire including in the longitudinally extending portion).
Regarding claim 14, Florio, or alternatively Florio modified by Shelton, discloses the steerable introducer as claimed in claim 1, as described above. Florio further discloses comprising at least one of (Examiner notes that the reference need only have one of the following limitations.):
one or more constant tension device for maintaining a minimum tension on one or more wires of the pair of twisting control wires; and
more than one steering control wire (70 and 72, as noted in the rejection of claim 1 Florio discloses two steering control wires, see fig. 4) to allow for (Claim language of “to allow for” implies functional language and the prior art must only be capable of performing the recited function.) a greater control of a degree of curvature (Examiner notes that the second steering control wire attaching at a separate circumferential and axial position would allow for a greater control of a degree of curvature).
Regarding claim 30, Florio discloses the steerable introducer as claimed in claim 9, as described above, including wherein: the lateral restraints include fixed restraints (see fig. 8, the lateral restraints are fixed as part of the controller body) for preventing movement of the at least one twisting control wire at corresponding points in the direction of the lateral force applied by the tension balancer (knobs 92-95, fig. 3), such that the lateral force from the tension balancer distorts a respective twisting control wire of the pair of twisting control wires into a V-shape (see fig. 8 above which shows that each twisting control wire forms a V-shape due to the fixed restraints).
Alternatively, regarding claim 30, Florio modified by Shelton discloses the steerable introducer as claimed in claim 9, as described above, including wherein: the lateral restraints include fixed restraints (Shelton: Examiner notes that the only detailed structure provided for the lateral restraints is fixed restraints, which is shown in fig. 5 at the connection points 210 and 212 between the control wires / bands 150 and 160 and the frame 204) for preventing movement of the at least one twisting control wire at corresponding points in the direction of the lateral force applied by the tension balancer (Shelton: 202/208, fig. 5), such that the lateral force from the tension balancer (Shelton: 202/208) distorts a respective twisting control wire of the pair of twisting control wires (Shelton: 150 and 160) into a V-shape (Shelton: see fig. 6 which shows control wire / band 150 distorted into a V-shape).
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Florio in view of Shelton.
Regarding claim 11, Florio modified by Shelton discloses the steerable introducer as claimed in claim 1, as described above, including wherein the tension in the pair of twisting control wires (Shelton: bands 150 and 160, fig. 5 and 6) is controlled by the tension balancer (Shelton: articulation slide 202 and slot 208, fig. 5 and 6) through a sledge (Shelton: articulation slide 202 may be one piece) in contact with both wires of the pair of twisting control wires (Shelton: see fig. 5 and 6 which show contact of wires 150, 160 with the sledge 202), where a sliding motion of the sledge (Shelton: 202) in a first direction will increase a lateral displacement of a first twisting control wire (Shelton: 150, see fig. 6) of the pair of twisting control wires whilst decreasing the lateral displacement of a second twisting control wire (Shelton: 160, see fig. 6) of the pair of twisting control wires, and where a sliding motion of the sledge in a second direction will increase a lateral displacement of the second twisting control wire whilst decreasing the lateral displacement of the first twisting control wire (Shelton: see fig. 6 which shows a decrease in the lateral displacement of control wire 160 and a simultaneous increase in the lateral displacement of the control wire 150, Examiner notes that [0144] describes that the opposite movement of articulation slide 202 would have the opposite effect).
Regarding claim 12, Florio modified by Shelton discloses the steerable introducer as claimed in claim 1, as described above, including wherein the controller (Florio: control handle 54, fig. 3) includes control inputs (Shelton: extending exterior portions of articulation control 200, fig. 5) for manual control (Shelton: see assembled device in fig. 1, note articulation control 200 is accessible to a user’s hands) of the tension in the wires (Shelton: band portions 150 and 160, fig. 5, [0144] force of bent bands 150 and 160 causes deflection of end effector 12 shown in fig. 1), wherein the control inputs include an input to control relative tension between the pair of twisting control wires via manual user input (Shelton: [0144] moving tension balancer 202/208 to the side exerts a lateral force on bands 150 and 160 which in turn exert a force on the boss 122 to different effect depending on the position of the tension balancer 202/208; see fig. 6 which shows band 150 exerting a force on boss 122 which causes the boss 122 to pivot).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Florio, or alternatively Florio modified by Shelton, as applied to claim 1 above, and further in view of Macnamara et al (US 8894610 B2; hereafter Macnamara).
Regarding claim 4, Florio, or alternatively Florio modified by Shelton, discloses the steerable introducer as claimed in claim 1, as described above.
Florio and Shelton are silent to the distal ends of the control wires being separated in their circumferential position by between 5-40% of a circumference of the flexible distal portion.
Macnamara, directed to a catheter with pull wires, teaches wherein the distal ends of the pair of twisting control wires (pullwires 408, fig. 19-19C) are separated in their circumferential position by between 5-40% of a circumference (col. 27 ln. 37-56, pull wires may be 90 degrees apart or 120 degrees apart, Examiner notes that these scenarios would space a pair of twisting control wires 25% or 33.3% of a circumference apart, thus falling within the claimed range.) of the flexible distal portion (distal articulation section 414, col. 27 ln. 58).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Florio or Florio modified by Shelton to have the different relative spacings as taught by Macnamara since both deal with pull wires. Instead of having two steering wires and two twisting control wires, Florio could have three equidistant twisting wires as taught by Macnamara and one steering control wire. One would have been motivated to make the modification because having a third twisting control wire would let the interplay of the three wires determine the deflection instead of balancing two separate pairs of wires to determine a deflection, which could be more cumbersome than balancing the three wires to get the appropriate deflection.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Florio, or alternatively Florio modified by Shelton, as applied to claim 1 above, and further in view of Wallace et al (US 20120004668 A1; hereafter Wallace).
Regarding claim 5, Florio, or alternatively Florio modified by Shelton, discloses the steerable introducer as claimed in claim 1, as described above. Florio further discloses wherein a distal segment of the flexible distal portion (deflectable distal end section 46, fig. 3; col. 5 ln. 10-22, body portion 42 has a deflectable distal end section 46) comprises a reinforced backbone (braided stainless steel wire, col. 5 ln. 23-28) surrounded with an elastic polymer material (thermoplastic resin, col. 5 ln. 23-28) (col. 5 ln. 23-28, body 42 may comprise a braided stainless steel wire embedded in a thermoplastic resin such as a polyether-block co-polyamide polymer).
Florio and Shelton are silent to the reinforced backbone being a reinforced polymer backbone.
Wallace, directed to a robotic catheter system, teaches a reinforced polymer backbone (polymeric spine 124, fig. 31 and 32, [0179] distal reinforcing structure may also comprise a polymeric spine 124).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the reinforced backbone of Florio to be the reinforced polymer backbone taught by Wallace since both deal with reinforcement members for surgical tubes. One would have been motivated to make the modification because, as noted in Wallace [0179], the polymeric spine 24 is a high-precision structure and may be formed by injection molding and/or other techniques less inexpensive than laser cutting and etching.
Claim(s) 15, 17, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Florio, or alternatively Florio modified by Shelton, as applied to claim 1 above, and further in view of Corcoran et al (US 20060241564 A1; hereafter Corcoran).
Regarding claim 15, Florio, or alternatively Florio modified by Shelton, discloses the steerable introducer as claimed in claim 1, as described above. Florio further discloses wherein the flexible distal portion is arranged to have a curve and a twist in its resting position (col. 1 ln. 63-67, distal end may be pre-shaped in a curve) and the use of at least one steering control wire (col. 5 ln. 45-52, elongated actuation members 70 and 72 may comprise pull wires or cables, fig. 6) or the pair of twisting control wires (members 71 and 73, fig. 6) to apply tension (col. 5 ln. 45-46 actuation members may be pull wires) and deflect the flexible distal portion (col. 6 ln. 6-17, compound deflections of varying directions may be obtained).
Florio and Shelton are silent to the flexible distal portion elastically returning to a rest position when under no tension.
Corcoran, directed to a steerable catheter assembly, teaches wherein the flexible distal portion is elastically flexible ([0058] distal portion of the outer shaft is formed from a shape memory material) and returns elastically to a resting position when no tension is applied ([0054] in an `at rest` or unstressed position, the outer shaft distal end 4 will be disposed at an angle of approximately 90 degrees to the proximal end 5 of the shaft. The bend or curvature is such that if the outer shaft is manually straightened, the shaft will automatically return to its unstressed position on release); and
wherein the flexible distal portion is arranged to have a curve and a twist in its resting position such that a tension must be applied to one or more wires of the at least one steering control wire in order to move the flexible distal portion into a straight configuration ([0054] if tip is manually straightened it will return to its unstressed curved position on release), wherein the flexible distal portion has a resting position that has 20-60% of a curve and twist required for deployment of the catheter device.
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the steerable introducer of Florio or Florio modified by Shelton to have the pre-shaped tip which returns to its rest position as taught by Corcoran since both deal with steerable medical tubes. One would have been motivated to make the modification because having the pre-shaped tip allows for a complex, consistent shape to be easily formed at the end of the tube after insertion while still allowing for the flexible, detailed control provided by the pull wires of Florio for fine tuning and easy maneuvering to the treatment site.
Florio modified by Corcoran, or Florio modified by Shelton and Corcoran, discloses the claimed invention except for the flexible distal portion having a twist as well as a curve and the resting position having 20-60% of a curve and twist required for deployment of the catheter device. This limitation represents only a change in shape (MPEP 2144.04(IV)(B)). Altering the resting position of the flexible distal portion to incorporate a twist or to have a certain percentage of curve required for deployment would not adversely affect the function of the device of Florio modified by Corcoran or Florio modified by Shelton and Corcoran, and would be possible with the present device due to the shape memory material which may be heat treated as noted in Corcoran [0060] to achieve a particular shape. Since the resting position of the flexible distal portion may influence the ease of insertion of the device into the vessel and eventual ease of final placement and positioning of the device, it would be obvious to one of ordinary skill in the art to adjust the resting position. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation.
Regarding claim 17, Florio, or alternatively Florio modified by Shelton, discloses the steerable introducer as claimed in claim 1, as described above.
Florio and Shelton silent to the flexible distal portion having different elasticity at different axial positions and/or with respect to bending in different directions.
Corcoran teaches wherein the flexible distal portion has a different elasticity at different axial positions (note fig. 13 and 13A, [0064] outer shaft may be moved longitudinally relative to the inner shaft) and/or different elasticity with respect to bending in different directions (fig. 15A/B inner and outer tube slots can be rotated to achieve different alignments and flexibility) (Examiner notes that the elastic elements 2/3 comprise different geometries of slots 10 along the length of the tube, since the inner tube may project past the end of the outer tube to form a more flexible section while the outer tube overlaps with a different section of the inner tube to form a portion with lower flexibility.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the steerable introducer of Florio or Florio modified by Shelton to have the slotted tubes taught by Corcoran since both references deal with steerable devices. One would have been motivated to make the modification because having the heat set curved tubes allows for variations in flexibility at will which can make steering easier and more predictable.
Regarding claim 24, Florio, or alternatively Florio modified by Shelton, discloses the steerable introducer as claimed in claim 1, as described above.
Florio and Shelton are silent to an elastic element comprising a heat set metal tube with cuts.
Corcoran teaches wherein the flexible distal portion comprises elastic elements (inner shaft 3 and outer shaft 2, fig. 15A/B, [0075]) including one or more elements having the form of a tube (see fig. 15A/B, both inner shaft 3 and outer shaft 2 are in the form of a tube with cuts/slots 10) with cuts (slots 10, fig. 15A/B) permitting bending of the tube ([0075] cuts/slots 10 permit in-plane bending of the tubes), and wherein the elastic element(s) (inner shaft 3 and outer shaft 2) comprise differing geometries of cuts (slots 10) at different points along the length of the flexible distal portion (note fig. 13 and 13A, [0064] outer shaft may be moved longitudinally relative to the inner shaft; fig. 15A/B inner and outer tube slots can be rotated to achieve different alignments and flexibility; Examiner notes that the elastic elements 2/3 comprise different geometries of slots 10 along the length of the tube, since the inner tube may project past the end of the outer tube to form a more flexible section while the outer tube overlaps with a different section of the inner tube to form a portion with lower flexibility.); and
wherein the tube is a tube that has been formed by heat setting a metal ([0058] inner shaft 3 comprises a shape memory material such as nitinol. Nickel-based, copper-based, iron-based, platinum-based or polymer shape memory materials may also be used.), with the heat setting being used in order that the tube has a resting position that incorporates some curve and twist ([0060] curvature may be formed by heat treatment of the shaft 3 or by use of shape memory material).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the steerable introducer of Florio or Florio modified by Shelton to have the slotted tubes taught by Corcoran since the references deal with steerable devices. One would have been motivated to make the modification because having the heat set curved tubes allows for variations in flexibility at will which can make steering easier.
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Florio, or alternatively Florio modified by Shelton, as applied to claim 1 above, and further in view of Carley et al (US 20080140101 A1; hereafter Carley).
Regarding claim 18, Florio, or alternatively Florio modified by Shelton, discloses the steerable introducer as claimed in claim 1, as described above. Florio further discloses wherein the flexible distal portion (col. 5 ln. 10-22, body portion 42 has a deflectable distal end section 46 terminating as distal tip 48) has a first flexible section at the distal end of the introducer (steerable obturator 40, fig. 3) and (col. 5 ln. 16-18 distal end section 46 of the obturator body 42 may comprise a short section that is more flexible than the remainder of the obturator body).
Florio and Shelton are silent to a second flexible section between the first flexible section and the main body.
Carley, directed to a torqueable hollow device (see Abstract), teaches a second flexible section (intermediate portion 62, fig. 2, [0056] hollow guidewire 14 is formed from a unitary construction formed from a single hypotube 60 including the proximal portion 16, the distal portion 20, and an intermediate portion 62 disposed therebetween) between the first flexible section (distal portion 20, fig. 2) and the main body (proximal portion 16, fig. 2), with each flexible section having a different elasticity ([0059] The pitch between helical windings 64 may decrease in the distal direction so as to provide the hollow guidewire 14 with increasing flexibility in the distal direction.)
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Florio or Florio modified by Shelton to have the varying flexibility along the shaft as taught by Carley since both references deal with flexible medical tubing. One would have been motivated to make the modification because the more flexible distal tip would be less likely to damage a vessel wall while the stiffer proximal portion would allow for better advancement of the distal end since the stiffness would better facilitate pushing the tubing into the patient.
Regarding claim 19, Florio modified by Carley, or Florio modified by Shelton and Carley, discloses the steerable introducer as claimed in claim 18, as described above, including wherein at least one of (Examiner notes that the reference need only have one of the following limitations since they are presented as options and/or alternatives.):
the first flexible section (Carley: distal portion 20, fig. 2) is more flexible ([0059] The pitch between helical windings 64 may decrease in the distal direction so as to provide the hollow guidewire 14 with increasing flexibility in the distal direction.) than the second flexible section (intermediate portion 62, fig. 2);
the first flexible section and the second flexible section comprise elastic materials of differing stiffness and/or thickness, with the differences in the elastic materials contributing to the different elasticity of the first flexible section and the second flexible section;
the first flexible section comprises a polymer material and the second flexible section comprises an elastic metal material; or
the first flexible section is arranged for a greater ease of twisting, whilst the second flexible section is stiffer when twisted, wherein the second flexible section has a first stiffness with respect to bending forces applied in a first direction and a second, different, stiffness with respect to bending forces applied in a second direction such that the second flexible section is relatively more flexible in a side to side direction and relatively more rigid in a front to back direction, whereas the first flexible section is able to bend relatively easily in all directions.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US-20050288627-A1 - figs. 8-9, steering mechanism changing relative tension in two wires
US-20110098531-A1 - fig. 8, lateral restraints 191 control path of wires 192
US-20160051796-A1 - fig. 14, lateral restraints 134 control path of wires 30a/b
WO-9410897-A1 - fig. 6e-g, lateral deflection of wires
WO-2013008490-A1 - fig. 3a/b, arced guide rails (231, 232, 233, 241, 242, 243) for delineating the path of the operation wires (31, 32)
Wallace (US-20120004668-A1) - fig. 55, lateral restraints 196 control path of wires 192 (Examiner notes that although Wallace is cited in the rejection of claim 5 above, fig. 55 is not used in that rejection)
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 11/25/2025