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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/06/2026 has been entered.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed 05/03/2022, 10/01/2024, and 02/14/2025 have been considered by the Examiner.
Status of the Claims
Claims 1-16 are currently pending. Claims 1-11 and 16 are currently rejected. Claims 12-15 are currently withdrawn. Claim 16 is newly added. Claim 1 is currently amended.
Response to Arguments
Applicant’s arguments, see Remarks, filed 08/06/2026, with respect to the rejection(s) of claim(s) 1 under 35 USC § 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 Therefore, the rejection has been withdrawn.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 Tran et al (US 20160158497 A1).
Claim Rejections - 35 USC § 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 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) 1-4, 6-10, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tegg et al (US 20180296801 A1; hereafter Tegg) in view of Tran et al (US 20160158497 A1; hereafter Tran).
Regarding claim 1, Tegg discloses a catheter tube for a steerable catheter (introducer assembly 100, fig. 1, [0025]), comprising a tube wall (wall of steerable sheath 106 surrounding lumen 216 shown in fig. 2, [0026]) surrounding a tube lumen (lumen 216, fig. 2, [0038]), the tube wall comprising the following:
- a guide lumen (lumen 214 for housing the pull wire 210, fig. 2, [0031]) in which a pull element (pull wire 210, fig. 2) extends from a proximal portion of the catheter tube to a distal portion of the catheter tube ([0043] “Pull wires 210 extend from a proximal end 310 of steerable sheath 106 to distal end 108.”; see figs. 1 and 3),
wherein the pull element is guided axially along the catheter tube (see section 116 in fig. 4; [0048] “first pull wire 300 and second pull wire 302 each traverse a substantially straight path from a proximal end 312 of deflectable portion 116 to distal end 108”) within the tube wall via the guide lumen (as shown in fig. 2); and
the pull element being connected in a tension-resistant manner to the tube wall in the distal portion ([0037] “Pull wires 210 are connected to at least one steering ring (not shown in FIG. 2) typically located near the distal end 108 (shown in FIG. 1) of steerable introducer assembly 100.”),
the guide lumen guiding the pull element at least partially around the tube lumen ([0005]-[0007], [0044]: " helical path around the circumference of the inner liner"; [0032]: " pull wires 210 rotate around a circumferential direction 220 of steerable sheath 106 as they extend along the non-deflectable portion 114 of steerable sheath 106"), and
wherein the guide lumen includes a section of a helical path within the tube wall in the distal portion of the catheter tube (at least at the section immediately proximal of section 116 in fig. 4) so as to guide the pull element helically around the tube lumen in the distal portion of the catheter tube (same, at least at the section immediately proximal of section 116 in fig. 4).
Tegg is silent to a mesh provided on an outer surface of the guide lumen and extending about an outer circumference of the guide lumen along a length of the guide lumen.
Tran, directed to a steerable catheter with pull wire, teaches a mesh (braided layer of pull-wire sleeve noted in [0030] “the pull-wire sleeve 28 can comprise a polymeric tube reinforced with a braided metal layer … an inner polymeric layer can be secured to the inner surface of the braided layer and/or an outer polymeric layer can be secured to the outer surface of the braided layer.”) provided on an outer surface of the guide lumen (space within pull-wire sleeve 28 described in [0030]) and extending about an outer circumference of the guide lumen along a length of the guide lumen ([0030] pull-wire sleeve 28 extends coaxially over at least a portion of the length of the pull wire 22; see fig. 3 and fig. 5, for example).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify Tegg to include the braided reinforcement layer of Tran either on the outer surface or inner surface of the polymeric tubular member 212 of Tegg (see fig. 2, [0031] “pull wires 210 are encased inside another polymeric tubular member 212 forming a lumen 214 for housing the pull wire 210”), since both references deal with pull wires disposed within polymeric tubing. One would have been motivated to make the modification because, as noted by Tegg [0030], the braided layer helps to reinforce the polymeric tube such that the combination is “sufficiently flexible yet substantially axially non-compressible” [0030], thus ensuring that the catheter is suitably flexible while still able to be advanced reliably.
Examiner notes that since the polymeric tubular member 212 of Tegg ([0031], fig. 2) is what forms the guide lumen ([0031] “polymeric tubular member 212 forming a lumen 214”), and the polymeric tubular member 212 as modified includes contact along its own entire circumference and length with the mesh/braided reinforcement layer of Tran, then the mesh provided on an outer surface of the guide lumen must extend about the entire outer circumference of the guide lumen along the entire length of the guide lumen.
Regarding claim 2, Tegg as modified discloses the catheter tube according to claim 1. Tegg further discloses wherein the section of the helical path within the tube wall (see figs. 3 and 4) is also in the proximal portion of the catheter tube (the claim puts no other restrictions on the definition of the “proximal portion” and thus reads on a portion of the helical path on the left end of fig. 4).
Regarding claim 3 Tegg as modified discloses the catheter tube according to claim 1. Tegg further discloses wherein the guide lumen extends across a circumferential angle of at least 30° in the tube wall (as shown in figs. 3 and 4 and described in [0044]).
Regarding claim 4, Tegg as modified discloses the catheter tube according to claim 1. Tegg further discloses wherein the guide lumen (lumen 214, fig. 2) is delimited by a guide lumen tube (polymeric tubular member 212, fig. 2, [0031] “polymeric tubular member 212 forming a lumen 214 for housing the pull wire 210”).
Regarding claim 6, Tegg as modified discloses the catheter tube according to claim 1. Tegg further discloses wherein the distal portion can be deformed three-dimensionally by an actuation of the pull element ([0032] steerable sheath 106 can be deflected in two opposite directions by coordinated manipulation of the pull wires 210, see fig. 3).
Regarding claim 7, Tegg as modified discloses the catheter tube according to claim 6. Tegg further discloses wherein the catheter tube can be deformed, by an actuation of the pull element, in such a way that the distal portion is bent with respect to a main extension axis of the proximal portion (see fig. 3 and [0032]).
Regarding claim 8, Tegg as modified discloses the catheter tube according to claim 6. Tegg further discloses wherein the catheter tube can be deformed, by an actuation of the pull element, in such a way that the distal portion describes at least a section of a spiral-shaped or helical path (see fig. 3 which shows a portion of a spiral-shaped or helical path, and [0032]).
Regarding claim 9, Tegg as modified discloses the catheter tube according to claim 6, wherein the catheter tube can be deformed, by an actuation of the pull element, in such a way that local extension axes of the distal portion, as seen in a projection along a main extension axis of the catheter tube, pass over an angle within a range from 0° to 30° (see [0032] and figs. 3 and 4; Examiner notes that the angles shown include angles on the claimed range, through which the device passes on its way to reaching the illustrated angles, including an angle just slightly more than zero degrees, as claimed).
Regarding claim 10, Tegg as modified discloses the catheter tube according to claim 6. Tegg further discloses wherein the catheter tube can be deformed, by an actuation of the pull element, in such a way that local extension axes of the distal portion, in a projection along a main extension axis of the catheter tube, describe at least a section of a circular arc having a radius (see figs. 3 and 4 and description in [0032] of pull wire actuation).
Tegg as modified discloses all claim limitations except that Tegg as modified is silent to wherein the circular arc having a radius in the range of 2 mm to 100 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the device of Tegg, to have a distal end radius of curvature, upon actuation of their pulling elements, in the range of 2 mm to 100 mm, since it has been held that, “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 1345 (Fed. Cir. 1984), cert. denied, 469 U.S. 830 (1984). In the instant case, the device of Tegg would not operate differently with the claimed radius of curvature, as the device would still curve as otherwise disclosed and be useful for the stated purposes. Furthermore, Applicant assigns no criticality to the claimed distal end radius of curvature, indicating simply that, “[a] resulting radius is, for example, between 2 mm and 100 mm ” (Instant Specification, pg. 10, lines 21-22) and “[f]urthermore, as is likewise illustrated in FIG. 5, the formed distal portion 1-2, in the projection along the main extension axis Z, can at least approximately describe a section of a circular arc, wherein an associated radius R is preferably in the range of 2 mm to 100 mm” (Instant Specification, pg. 15, lines 1-3).
Regarding claim 16, Tegg as modified discloses the catheter tube according to claim 1, including wherein the mesh is provided on an entire circumferential surface of the guide lumen along the length of the guide lumen (see 103 rejection of claim 1 above).
Examiner reiterates that since the polymeric tubular member 212 of Tegg ([0031], fig. 2) is what forms the guide lumen ([0031] “polymeric tubular member 212 forming a lumen 214”), and the polymeric tubular member 212 as modified includes contact along its own entire circumference and length with the mesh/braided reinforcement layer of Tran, then the mesh provided on an outer surface of the guide lumen must extend about the entire outer circumference of the guide lumen along the entire length of the guide lumen.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tegg modified by Tran as applied to claim 4 above, and further in view of Olson et al (US 20190192820 A1; hereafter Olson ‘820).
Regarding claim 5, Tegg as modified discloses the catheter tube according to claim 4.
Tegg as modified is silent to wherein the guide lumen tube comprises a lubricious material.
Olson ‘820 relates to catheters that are steerable through the use of pull wires and is therefore from an art which is the same as, or very closely analogous to, those of Applicant' s claims. Olson ‘820 teaches that, when constructing such pull wire catheters, the tube in which the pull wire(s) pass may be lined with PTFE (a lubricious coating), to reduce sliding friction between the wire and the tube, thus making the device easier to use ([0026]).
It 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, to form Tegg’s catheter such that its guide lumen tube comprises a lubricous coating as taught by Olson ‘820 since both references deal with catheter steered using pull wires. One would have been motivated to make the modification because Olson 820’ teaches including the lubricious coating of PTFE to reduce sliding friction between the wire and the tube, thus making the device easier to use.
Claim(s) 10 is/are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Tegg modified by Tran as applied to claim 6 above, and further in view of Griffin (US 20170258614 A1; hereafter Griffin).
Regarding claim 10, Tegg as modified discloses the catheter tube according to claim 6. Tegg further discloses wherein the catheter tube can be deformed, by an actuation of the pull element, in such a way that local extension axes of the distal portion, in a projection along a main extension axis of the catheter tube, describe at least a section of a circular arc having a radius (see figs. 3 and 4 and description in [0032] of pull wire actuation).
Tegg as modified is silent to wherein the circular arc having a radius in the range of 2 mm to 100 mm.
Griffin, in the art of steerable catheters, teaches wherein a catheter tube (steerable catheter 100, fig. 2, [0031]) can be deformed, by an actuation of the pull element ([0031] “second anchor point 138 is at distal end 106 of tubular sheath 102 such that tensioning or pulling of pull wire 132 via second actuator 162 bends or curves distal steerable portion 140 to a second radius of curvature R.sub.2 as shown on FIGS. 2 and 4”), in such a way that local extension axes of the distal portion (see fig. 2 which shows deflection of distal portion 140 described in [0031]), in a projection along a main extension axis of the catheter tube, describe at least a section of a circular arc having a radius in the range of 2 mm to 100 mm (see fig. 2 and fig. 4; [0031] second radius of curvature R.sub.2 ranges between twenty (20) millimeters and sixty (60) millimeters).
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 Tegg as modified such that the radius of curvature was 20 mm to 60 mm, as taught by Griffin, since Griffin also deals with the deflection of a distal catheter portion via pull wire actuation. One would have been motivated to make the modification because, as noted by Griffin, [0031], this range of radius of curvatures is suitable for accessing some specific geometries within a patient’s body including the heart, and Tegg [0003] note that steerable introducers are often used for accessing a patient’s heart.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tegg modified by Tran as applied to claim 1 above, and further in view of Olsen (US 20190201688 A1; hereafter Olson ‘688).
Regarding claim 11, Tegg as modified discloses the catheter tube according to claim 1.
Tegg as modified is silent to wherein the catheter tube comprises a plurality of tube segments having differing rigidities.
Olson ‘688, directed to a catheter steered by pull wires disposed in lumens, teaches wherein the catheter tube comprises a plurality of tube segments having differing rigidities ([0042]: “. . . the catheter shaft may include one or more layers of a polyether block amide material that transition from harder to softer along that catheter shaft from the proximal end portion to the distal end portion.”).
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 catheter of Tegg to include the plurality of segments having differing rigidities as taught by Olson ‘688, since both references deal with steerable catheters. One would have been motivated to make the modification because, as noted by Olson ‘688 [0042] may better facilitate the desired deformation of the distal end of the steerable catheter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, and particularly to the well-known option in the art of pullwire steerable catheters of reinforcing the pullwire tube, including:
Campbell (US-9884170 B2) – fig. 4d, fig. 21, mesh/braided tube for a guidewire fixed in a slot
“FIG. 4D describes an alternative embodiment whereby a braided tube 37 is procured, this tube having an outside diameter corresponding to the inside diameter of slot 104 of catheter shaft 15. The braided tube 37 is made to have a suitable inside diameter to provide adequate clearance for passage therethrough of an intended guidewire. Braided tube is fitted into slot 104 by interference, or by joining with an adhesive.”
Martin (US-20040044350 A1) – fig. 11a, pull wire lumen liners of braided polyimide extend through a pullwire lumen
[0079] In addition, pullwire lumen liners 106 may extend through the pullwire lumens 102 and encapsulate the pullwires 80. Such pullwire lumen liners 106 may be comprised of a braided polyimide or any suitable material to provide strength, flexibility, and protection of the pullwires 80.
Alvarez (US-20100280449 A1) – fig. 3b, pull wire tubes may be braided and include a slidable surface
[0058] The operational tubes (304) may be made of any suitable polymer material, bio-compatible polymer material or metallic material (e.g., polyimide, stainless steel or spiral cut stainless steel, Nitinol, etc.). The separate operational tubes (304) may be melted and/or braided into the wall of the minor, secondary, or peripheral lumens of the outer tube (302) or inner tube (312). The operational tubes (304) may provide a substantially slidable surface and interface for the flex tubes (306), such that the flex tubes (306) may slide substantially freely about the interior of the operational tubes (304) in a substantially decoupled configuration.
Yamaguchi (US-20160001040 A1) – fig. 1, multiple braided/mesh layers are used to reinforce multiple catheter lumens
[0063] The retaining wire 70 is a member that winds together the sub-tube 40 and the wire reinforcing layer 30 and is characteristic in the present embodiment. The retaining wire 70 is coiled or braided in the shape of a mesh around the sub-tube 40. Among these, the retaining wire 70 of the present embodiment is a coil, more specifically, a coil (multi-strand coil) in which a plurality of the retaining wires 70 are wound in multiple strands.
[0074] The tubular body 10 includes the second reinforcing layer 80 formed by winding the second reinforcing wire 82 in a circular sectional shape, outside the retaining wire 70. The second reinforcing layer 80 of the present embodiment is a braided layer in which a metallic thin wire is braided in the shape of a mesh. That is, the tubular body 10 of the present embodiment includes a metal layer of three layers referred to as the wire reinforcing layer 30, the retaining wire 70, and the second reinforcing layer 80.
Gardeski (US 20040116848 A1) – fig. 12, braided lumen liner for both main and guide wire lumens
[0046] The tubular wire braid 28 may be of a variety of different materials and configurations designed to impart the desired stiffness to the catheter shaft section and in particular ensure that the cross-sectional shape of the delivery and deflection lumen liners 44 and 46 to remain substantially undistorted as the catheter body 12 undergoes high flexure encountered traversing sharp bends in the vascular pathway. The wire braid 28 constructions include metallic and non-metallic fibers or wires or ribbons that may be configured in a single or multiple spirals, braids or knits as is known in the art. Wire braid 28 can be formed of a metallic material, such as a super-elastic alloy or stainless steel, or non-metallic materials such as those made of polyaramids, carbon fibers, Dacron, Nylon, or liquid crystal polymer and can even be made using natural fibers such as silk and cotton.
Please additionally note all references cited in previous Office Actions.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 09/17/2026
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