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 .
Election/Restrictions
Applicant’s election without traverse of Species A (claims 1- 10 and 16- 20) in the reply filed on 4/27/26 is acknowledged.
Claims 11- 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/27/26.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1- 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schoenle et al. (US Pub. No. 2015/0005791 A1). Schoenle is cited in the IDS filed 5/30/24.
Regarding claim 1, Schoenle discloses a tissue-removing catheter for removing tissue in a body lumen, the tissue-removing catheter comprising:
an elongate drive member (120) (Fig. 7) having proximal and distal ends and a length and longitudinal axis extending between the proximal and distal ends, the elongate drive member (120) being sized and shaped to be received in the body lumen and configured to be rotated about its longitudinal axis (P. [0002] - - The present application relates to devices and methods for removing tissue from body passageways, such as removal of atherosclerotic plaque from arteries, utilizing a high-speed rotational atherectomy device); and
a tissue-removing element (Described, not explicitly shown) (P. [0028] - - crown 127) operatively coupled to the distal end of the elongate drive member (120), the tissue-removing element (Described, not explicitly shown) (P. [0028] - - crown 127) being configured to be rotated by the elongate drive member (120) to remove the tissue in the body lumen (Abstract, P. [0028] - - An atherectomy device may include a handle having a rotational drive mechanism therein, a drive shaft operably coupled to the drive mechanism and having an abrasive element arranged at a distal end thereof; atherectomy crown 127 may be positioned on this latter portion 128 which may be adapted to extend out of the distal end of the sheath 130 for purposes of addressing an occlusion or other obstruction),
wherein the elongate drive member (120) includes a first (126) and second (127, 128) longitudinal portions (Fig. 7), the first longitudinal portion (126) being proximal of and stiffer than the second longitudinal portion (127, 128) (P. [0028] - - a relatively stiff proximal portion 126 may be provided followed by a central portion 127 having a relatively flexible torsional stiffness and having a spin-to-open profile 120A. Yet another portion 128 of the drive shaft may include an additional relatively flexible portion with a smaller diameter and having a spin-to-close 120B or a spin-to-open 120A profile).
Regarding claim 2, Schoenle further discloses further comprising a coupler (132) (Fig. 7) coupling together the first (126) and second (127, 128) longitudinal portions of the elongate drive member (120) (P. [0032] - - the varying diameters of the several portions 126, 127, and 128 may be accommodated by providing coupling elements 132 in the form of reducers to transition from larger diameter portions to smaller diameter portions).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 3- 6 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schoenle et al. (US Pub. No. 2015/0005791 A1) in view of Jamous et al. (US Pub. No. 2018/0317952 A1). Jamous is cited in the IDS filed 5/30/24.
Regarding claims 3- 5, Schoenle discloses the apparatus of claim 2, but Schoenle does not disclose
(claim 3) wherein the coupler comprises a bearing assembly;
(claim 4) wherein the coupler includes a coupler body, and the bearing assembly is received in the coupler body;
(claim 5) wherein the bearing assembly includes a bushing and a bearing, wherein the bearing is configured to rotate about and ride on the bushing, the inner liner being secured to the bushing, the bearing being secured to the coupler body, whereby the elongate drive member and the bearing are rotatable about the inner liner and the bushing.
However, Jamous teaches a tissue-removing catheter in the same field of endeavor (Abstract)
(claim 3) wherein the coupler (57) (Fig. 4) comprises a bearing assembly (98, 100) (Fig. 4);
(claim 4) wherein the coupler (57) includes a coupler body (92) (Fig. 4), and the bearing assembly (98, 100) is received in the coupler body (92);
(claim 5) wherein the bearing assembly (98, 100) includes a bushing (90) and a bearing (98, 100), wherein the bearing (98, 100) is configured to rotate about and ride on the bushing (90), the inner liner (14) (Figs. 1- 2, 4- 6) being secured to the bushing (90), the bearing (98, 100) being secured to the coupler body (92), whereby the elongate drive member (12) and the bearing (98, 100) are rotatable about the inner liner (14) and the bushing (90) (Ps. [0030], [0031], [0032] - - The busing 90 comprises a center ring portion 92, a proximal ring portion 94 extending proximally from the center ring portion, and a distal ring portion 96 extending distally from the center ring portion. The ring portions of the bushing 90 define a channel 99 extending through the bushing that receives a portion of the inner liner 14; A first bearing 98 is disposed around the proximal ring portion 94 of the bearing 90, and a second bearing 100 is disposed around the distal ring portion 96 of the bearing … As such the bushing 90 and bearings 98, 100 are held within the cavity 72 of the tissue-removing element 20. Broadly, the bushing 90 and bearings 98, 100 may be considered a coupling assembly 57 for coupling the inner liner 14 to the tissue-removing element 20; an interior surface of the bushing 90 is fixedly attached to the inner liner 14 such that the inner liner is coupled to the tissue-removing element 20 through the bushing … However, the outer layer 12 is not directly attached to the bushing 90, bearings 98, 100, or inner liner 12. Thus, rotation of the outer layer 12 and tissue-removing element 20 is not transmitted to the inner liner 14 to also rotate the inner liner. Rather the tissue-removing element 20 rotates around the bushing 90 and bearings 98, 100. And because the inner liner is fixedly attached to the bushing 90, which is retained within the cavity 72 of the tissue-removing element 20 by the outer layer 12, the inner liner 14 is coupled to the outer layer through the bushing and bearing arrangement. Therefore, translational movement of the outer layer 12 is transmitted to the inner liner 14 such that the inner liner and outer layer will translate together when one of the inner layer and outer layer is advanced or retracted within the body lumen. This configuration prevents the outer layer 12 and tissue-removing element 20 from advancing past a distal end of the inner liner 14 and contacting the guidewire 26).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the coupler associated with Schoenle such that it includes bearings, bushings and an inner liner according to the teachings of Jamous because rotation of the elongate drive member and tissue-removing element would not transmitted to the inner liner to also rotate the inner liner and because the inner liner is fixedly attached to the bushing, the inner liner is coupled to the outer layer through the bushing and bearing arrangement and as such, translational movement of the outer layer 12 is transmitted to the inner liner 14 such that the inner liner and outer layer will translate together when one of the inner layer and outer layer is advanced or retracted within the body lumen (Ps. [0030], [0031], [0032]).
Regarding claim 6, Schoenle in view of Jamous discloses the apparatus of claim 5, Schoenle further disclosing the varying diameters of the several portions 126, 127, and 128 may be accommodated by providing coupling elements 132 in the form of reducers to transition from larger diameter portions to smaller diameter portion such that the outside of the reducers may be tapered as shown in Fig. 7 or such that the coupling elements 132 have a constant outside diameter with varying inside diameters (P. [0032]), but Schoenle does not explicitly disclose
(claim 6) wherein the coupler comprises a metal tube welded to a proximal end portion of the second longitudinal portion and a distal end portion of the first longitudinal portion.
However, Schoenle teaches that other approaches to coupling the varying diameters of the several portions 126, 127, and 128 may be provided as discussed with reference to the embodiment of Figs. 5, 6 (P. [0032])
(claim 6) wherein the coupler (32) (Figs. 5, 6) comprises a metal tube welded to a proximal end portion of the second longitudinal portion (26) (Figs. 5, 6) and a distal end portion of the first longitudinal portion (28) (Figs. 5, 6) (P. [0027] - - As shown in FIG. 6, the proximal and distal portions 26, 28 of the drive shaft 20 may be secured to one another with a coupling element 32. The coupling element 32 may include a sleeve type coupling element 32 such as a hypotube coupler with an inner diameter smaller than the outer diameter of the drive shaft 20 such that a portion of the drive shaft 20 may be turned down, step ground, or otherwise reduced in diameter and placed within the coupling element 32 for a friction fit. In other embodiments, in addition or in alternative to a friction fit, a welded, brazed, adhered, or other connection to the coupling element 32 may be provided. In still other embodiments, two adjoining drive shafts 26, 28 may be sleeved, one within the other, for a friction fit and/or welded, brazed, or adhered, for example).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the coupler associated with the embodiment of Fig. 7 such that it comprises a metal tube welded to a proximal end portion of the second longitudinal portion and a distal end portion of the first longitudinal portion according to the embodiment of Figs. 5, 6 because it would predictably provide an approach to coupling the different portions of the first and second longitudinal portions contemplated by the reference itself (Ps. [0027], [0032]).
Regarding claim 19, Schoenle discloses the apparatus of claim 1, but Schoenle does not disclose
(claim 19) further comprising an inner liner received in and extending along the length of the elongate drive member, wherein the inner liner defines a longitudinal passage configured to receive a guidewire therein, the elongate member being rotatable about the inner liner.
However, Jamous teaches a tissue-removing catheter in the same field of endeavor (Abstract)
(claim 19) further comprising an inner liner (14) (Figs. 1- 2, 4- 6) received in and extending along the length of the elongate drive member (12) (Figs. 1- 2, 4- 6), wherein the inner liner (14) defines a longitudinal passage configured to receive a guidewire (26) (Figs. 1- 2, 4- 6) therein, the elongate member (12) being rotatable about the inner liner (14) (Ps. [0020], [0021] - - Referring to FIGS. 1 and 2, the catheter 10 comprises an elongate outer layer 12 disposed around an elongate inner liner 14 … The inner liner 14 defines a guidewire lumen 24 (FIG. 5) for slidably receiving a guidewire 26 therein so that the catheter 10 can be advanced through the body lumen by traveling along the guidewire. The guidewire can be a standard 0.014 inch outer diameter, 300 cm length guidewire. In certain embodiments, the inner liner 14 may have a lubricious inner surface for sliding over the guidewire 26 (e.g., a lubricious surface may be provided by a lubricious polymer layer or a lubricious coating). In the illustrated embodiment, the guidewire lumen 24 extends from the proximal end portion 16 through the distal end portion 18 of the catheter 10 such that the guidewire 26 is extendable along an entire working length of the catheter 10; The catheter 10 further comprises a handle 40 secured at the proximal end portion 16 of the catheter. The handle 40 supports an actuator 42 (e.g., a lever, a button, a dial, a switch, or other device) configured for selectively actuating a motor 43 disposed in the handle to drive rotation of the outer layer 12, and tissue-removing element 20 mounted at the distal end of the outer layer).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the elongate drive member associated with Schoenle in order to include an inner liner according to the teachings of Jamous because it would allow for a lubriciously coated inner surface of a guidewire lumen for slidably receiving a guidewire so that the catheter can be advanced through the body lumen by traveling along the guidewire (Jamous - - Ps. [0020], [0021]).
Claim(s) 7- 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schoenle et al. (US Pub. No. 2015/0005791 A1) in view of Jamous et al. (US Pub. No. 2018/0317952 A1) as applied to claim 6 above, and further in view of McKenzie (US Pat. No. 5,108,411).
Regarding claim 7, Schoenle in view of Jamous discloses the apparatus of claim 6, but Schoenle in view of Jamous does not explicitly disclose
(claim 7) wherein the first longitudinal portion of the elongate drive member extends along a majority of the length of the elongate drive member.
However, McKenzie teaches an elongate drive member (14) (Figs. 1- 3) having proximal (40) (Figs. 1- 3) and distal (42) (Figs. 1- 3) ends and a length and longitudinal axis extending between the proximal and distal ends, the elongate drive member (14) being sized and shaped to be received in the body lumen and configured to be rotated about its longitudinal axis in the same field of endeavor (Col. 1, l. 16- 22)
(claim 7) wherein the first longitudinal portion (40) of the elongate drive member (14) extends along a majority of the length of the elongate drive member (14) (Col. 4, l. 10- 28 - - In order to efficiently drive the work element, it is necessary that the more flexible distal section and the less flexible proximal section both have relatively high torsional stiffness (i.e., torsional modulus of elasticity) but that the flexural stiffness (flexural modulus of elasticity) of the proximal section be substantially greater than that of the distal section. In this way, both the proximal and distal sections will be able to efficiently transmit torque without substantial wind up and springiness. The distal section of the cable, however, will be much more flexible and be able to bend around tight twists and curves in the catheter lumen caused by placement of the catheter in a tortuous path, e.g., certain portions of the vascular system. The proximal section, in contrast, will remain relatively stiff compared to the distal section. Such flexural stiffness is desirable over most of the length of the torque cable since it will minimize bending of the cable within the lumen reducing the chance for seizing and binding of the cable).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the elongate driver associated with Schoenle in view of Jamous such that the first longitudinal portion of the elongate drive member extends along a majority of the length of the elongate drive member according to the teachings of McKenzie because it would minimize bending of the elongate drive member within the vasculature, thereby reducing the chance for seizing and binding of the elongate member (McKenzie - - Col. 4, l. 10- 28)
Regarding claim 8, Schoenle in view of Jamous and McKenzie discloses the apparatus of claim 7, modified Schoenle does not disclose
(claim 8) wherein the first longitudinal portion of the elongate drive member extends along at least 90% of the length of the elongate drive member.
However, McKenzie teaches an elongate drive member (14) (Figs. 1- 3) having proximal (40) (Figs. 1- 3) and distal (42) (Figs. 1- 3) ends and a length and longitudinal axis extending between the proximal and distal ends, the elongate drive member (14) being sized and shaped to be received in the body lumen and configured to be rotated about its longitudinal axis in the same field of endeavor (Col. 1, l. 16- 22)
(claim 8) wherein the first longitudinal portion of the elongate drive member extends along at least 90% of the length of the elongate drive member (See Table 1 in Col. 4 - - 90% of the length of the elongate drive member falls within the disclosed range of a proximal first longitudinal portion 10- 200 cm and a distal second longitudinal portion 1- 50 cm).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the elongate driver associated with modified Schoenle such that the first longitudinal portion of the elongate drive member extends along at least 90% of the length of the elongate drive member according to the teachings of McKenzie because it will minimize bending of the elongate drive member within the vasculature, thereby reducing the chance for seizing and binding of the elongate member (McKenzie - - Col. 4, l. 10- 28).
Regarding claim 9, Schoenle in view of Jamous and McKenzie discloses the apparatus of claim 8, but modified Schoenle does not disclose
(claim 9) further comprising an inner liner received in and extending along the length of the elongate drive member, wherein the inner liner defines a longitudinal passage configured to receive a guidewire therein, the elongate member being rotatable about the inner liner.
However, Jamous teaches a tissue-removing catheter in the same field of endeavor (Abstract)
(claim 9) further comprising an inner liner (14) (Figs. 1- 2, 4- 6) received in and extending along the length of the elongate drive member (12) (Figs. 1- 2, 4- 6), wherein the inner liner (14) defines a longitudinal passage configured to receive a guidewire (26) (Figs. 1- 2, 4- 6) therein, the elongate member (12) being rotatable about the inner liner (14) (Ps. [0020], [0021] - - Referring to FIGS. 1 and 2, the catheter 10 comprises an elongate outer layer 12 disposed around an elongate inner liner 14 … The inner liner 14 defines a guidewire lumen 24 (FIG. 5) for slidably receiving a guidewire 26 therein so that the catheter 10 can be advanced through the body lumen by traveling along the guidewire. The guidewire can be a standard 0.014 inch outer diameter, 300 cm length guidewire. In certain embodiments, the inner liner 14 may have a lubricious inner surface for sliding over the guidewire 26 (e.g., a lubricious surface may be provided by a lubricious polymer layer or a lubricious coating). In the illustrated embodiment, the guidewire lumen 24 extends from the proximal end portion 16 through the distal end portion 18 of the catheter 10 such that the guidewire 26 is extendable along an entire working length of the catheter 10; The catheter 10 further comprises a handle 40 secured at the proximal end portion 16 of the catheter. The handle 40 supports an actuator 42 (e.g., a lever, a button, a dial, a switch, or other device) configured for selectively actuating a motor 43 disposed in the handle to drive rotation of the outer layer 12, and tissue-removing element 20 mounted at the distal end of the outer layer).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the elongate drive member associated with modified Schoenle in order to include an inner liner according to the teachings of Jamous because it would allow for a lubriciously coated inner surface of a guidewire lumen for slidably receiving a guidewire so that the catheter can be advanced through the body lumen by traveling along the guidewire (Jamous - - Ps. [0020], [0021]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schoenle et al. (US Pub. No. 2015/0005791 A1) in view of Jamous et al. (US Pub. No. 2018/0317952 A1) and McKenzie (US Pat. No. 5,108,411) as applied to claim 9 above and in further view of Yang et al. (US Pub. No. 2019/0336727 A1).
Regarding claim 10, Schoenle in view of Jamous and McKenzie discloses the apparatus of claim 9, but Schoenle in view of Jamous and McKenzie does not disclose
(claim 10) wherein the inner liner includes first and second longitudinal portions, the first longitudinal portion being proximal of and stiffer than the second longitudinal portion.
However, Yang teaches a tissue-removing catheter in the same field of endeavor (P. [0074])
(claim 10) wherein the inner liner includes first (3118) and second (3114) longitudinal portions, the first longitudinal portion (3118) being proximal of and stiffer than the second longitudinal portion (3114) (Ps. [0239], [0245], [0246] - - Referring to FIG. 31D, distal catheter tip 3110 comprises a tubular body 3112 which includes an advance segment 3114, a marker band 3116 and a proximal segment 3118. An inner tubular liner 3120 may extend throughout the length of the distal catheter tip 3110, and may comprise dip coated PTFE ; The high crush strength may provide radial support to the adjacent advance segment 3114 and particularly to the leading side wall portion 3128, to facilitate the functioning of distal tip 3132 as an atraumatic bumper during transluminal advance and to resist collapse under vacuum. The proximal segment 3118 preferably has a lower bending stiffness than the marker band zone, and the advance segment 3114 preferably has even a lower bending stiffness and crush strength than the proximal segment 3118; The advance segment 3114 may comprise a distal extension of the outer jacket 3124 and optionally the inner liner 3120 … The advance segment 3114 may have a bending stiffness and radial crush stiffness that is no more than about 50%, and in some implementations no more than about 25% or 15% or 5% or less than the corresponding value for the proximal segment 3118; It is noted since the inner liner 3120 extends throughout the length of the distal catheter tip 3110, the liner 3120 is included in the second longitudinal portion (3114) and is included in the first longitudinal portion 3118. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the thickness of the dip coated liner 3120 such that it is correspondingly lower in thickness within the second longitudinal portion (3114) having a lower bending stiffness).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the inner liner associated with modified Schoenle such that the inner liner includes first and second longitudinal portions, the first longitudinal portion being proximal of and stiffer than the second longitudinal portion according to the teachings of Yang because it would facilitate transluminal advancement of the catheter and help avoid collapse under vacuum (Yang - - Ps. [0239], [0245], [0246]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schoenle et al. (US Pub. No. 2015/0005791 A1).
Regarding claim 16, Schoenle discloses the apparatus of claim 2, Schoenle further disclosing the varying diameters of the several portions 126, 127, and 128 may be accommodated by providing coupling elements 132 in the form of reducers to transition from larger diameter portions to smaller diameter portion such that the outside of the reducers may be tapered as shown in Fig. 7 or such that the coupling elements 132 have a constant outside diameter with varying inside diameters (P. [0032]), but Schoenle does not explicitly disclose
(claim 16) wherein the coupler comprises a metal tube welded to a proximal end portion of the second longitudinal portion and a distal end portion of the first longitudinal portion.
However, Schoenle teaches that other approaches to coupling the varying diameters of the several portions 126, 127, and 128 may be provided as discussed with reference to the embodiment of Figs. 5, 6 (P. [0032])
(claim 16) wherein the coupler (32) (Figs. 5, 6) comprises a metal tube welded to a proximal end portion of the second longitudinal portion (26) (Figs. 5, 6) and a distal end portion of the first longitudinal portion (28) (Figs. 5, 6) (P. [0027] - - As shown in FIG. 6, the proximal and distal portions 26, 28 of the drive shaft 20 may be secured to one another with a coupling element 32. The coupling element 32 may include a sleeve type coupling element 32 such as a hypotube coupler with an inner diameter smaller than the outer diameter of the drive shaft 20 such that a portion of the drive shaft 20 may be turned down, step ground, or otherwise reduced in diameter and placed within the coupling element 32 for a friction fit. In other embodiments, in addition or in alternative to a friction fit, a welded, brazed, adhered, or other connection to the coupling element 32 may be provided. In still other embodiments, two adjoining drive shafts 26, 28 may be sleeved, one within the other, for a friction fit and/or welded, brazed, or adhered, for example).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the coupler associated with the embodiment of Fig. 7 such that it comprises a metal tube welded to a proximal end portion of the second longitudinal portion and a distal end portion of the first longitudinal portion according to the embodiment of Figs. 5, 6 because it would predictably provide an approach to coupling the different portions of the first and second longitudinal portions contemplated by the reference itself (Ps. [0027], [0032]).
Claim(s) 17- 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schoenle et al. (US Pub. No. 2015/0005791 A1) in view of McKenzie (US Pat. No. 5,108,411).
Regarding claim 17, Schoenle discloses the apparatus of claim 1, but Schoenle does not explicitly disclose
(claim 17) wherein the first longitudinal portion of the elongate drive member extends along a majority of the length of the elongate drive member.
However, McKenzie teaches an elongate drive member (14) having proximal (40) and distal (42) ends and a length and longitudinal axis extending between the proximal and distal ends, the elongate drive member (14) being sized and shaped to be received in the body lumen and configured to be rotated about its longitudinal axis in the same field of endeavor (Col. 1, l. 16- 22)
(claim 17) wherein the first longitudinal portion (40) of the elongate drive member (14) extends along a majority of the length of the elongate drive member (14) (Col. 4, l. 10- 28 - - In order to efficiently drive the work element, it is necessary that the more flexible distal section and the less flexible proximal section both have relatively high torsional stiffness (i.e., torsional modulus of elasticity) but that the flexural stiffness (flexural modulus of elasticity) of the proximal section be substantially greater than that of the distal section. In this way, both the proximal and distal sections will be able to efficiently transmit torque without substantial wind up and springiness. The distal section of the cable, however, will be much more flexible and be able to bend around tight twists and curves in the catheter lumen caused by placement of the catheter in a tortuous path, e.g., certain portions of the vascular system. The proximal section, in contrast, will remain relatively stiff compared to the distal section. Such flexural stiffness is desirable over most of the length of the torque cable since it will minimize bending of the cable within the lumen reducing the chance for seizing and binding of the cable).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the elongate driver associated with Schoenle such that the first longitudinal portion of the elongate drive member extends along a majority of the length of the elongate drive member according to the teachings of McKenzie because it will minimize bending of the elongate drive member within the vasculature, thereby reducing the chance for seizing and binding of the elongate member (McKenzie - - Col. 4, l. 10- 28)
Regarding claim 18, Schoenle in view of McKenzie discloses the apparatus of claim 17, Schoenle does not disclose
(claim 18) wherein the first longitudinal portion of the elongate drive member extends along at least 90% of the length of the elongate drive member.
However, McKenzie teaches an elongate drive member (14) having proximal (40) and distal (42) ends and a length and longitudinal axis extending between the proximal and distal ends, the elongate drive member (14) being sized and shaped to be received in the body lumen and configured to be rotated about its longitudinal axis in the same field of endeavor (Col. 1, l. 16- 22)
(claim 18) wherein the first longitudinal portion of the elongate drive member extends along at least 90% of the length of the elongate drive member (See Table 1 in Col. 4 - - 90% of the length of the elongate drive member falls within the disclosed range of a proximal first longitudinal portion 10- 200 cm and a distal second longitudinal portion 1- 50 cm).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the elongate driver associated with Schoenle such that the first longitudinal portion of the elongate drive member extends along at least 90% of the length of the elongate drive member according to the teachings of McKenzie because it will minimize bending of the elongate drive member within the vasculature, thereby reducing the chance for seizing and binding of the elongate member (McKenzie - - Col. 4, l. 10- 28).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schoenle et al. (US Pub. No. 2015/0005791 A1) in view of Jamous et al. (US Pub. No. 2018/0317952 A1) as applied to claim 19 above, and further in view of Yang et al. (US Pub. No. 2019/0336727 A1).
Regarding claim 20, Schoenle in view of Jamous discloses the apparatus of claim 19, but Schoenle in view of Jamous does not disclose
(claim 20) wherein the inner liner includes first and second longitudinal portions, the first longitudinal portion being proximal of and stiffer than the second longitudinal portion.
However, Yang teaches a tissue-removing catheter in the same field of endeavor (P. [0074])
(claim 20) wherein the inner liner includes first (3118) and second (3114) longitudinal portions, the first longitudinal portion (3118) being proximal of and stiffer than the second longitudinal portion (3114) (Ps. [0239], [0245], [0246] - - Referring to FIG. 31D, distal catheter tip 3110 comprises a tubular body 3112 which includes an advance segment 3114, a marker band 3116 and a proximal segment 3118. An inner tubular liner 3120 may extend throughout the length of the distal catheter tip 3110, and may comprise dip coated PTFE ; The high crush strength may provide radial support to the adjacent advance segment 3114 and particularly to the leading side wall portion 3128, to facilitate the functioning of distal tip 3132 as an atraumatic bumper during transluminal advance and to resist collapse under vacuum. The proximal segment 3118 preferably has a lower bending stiffness than the marker band zone, and the advance segment 3114 preferably has even a lower bending stiffness and crush strength than the proximal segment 3118; The advance segment 3114 may comprise a distal extension of the outer jacket 3124 and optionally the inner liner 3120 … The advance segment 3114 may have a bending stiffness and radial crush stiffness that is no more than about 50%, and in some implementations no more than about 25% or 15% or 5% or less than the corresponding value for the proximal segment 3118; It is noted since the inner liner 3120 extends throughout the length of the distal catheter tip 3110, the liner 3120 is included in the second longitudinal portion (3114) and is included in the first longitudinal portion 3118. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the thickness of the dip coated liner 3120 such that it is correspondingly lower in thickness within the second longitudinal portion (3114) having a lower bending stiffness).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the inner liner associated with Schoenle in view of McKenzie such that the inner liner includes first and second longitudinal portions, the first longitudinal portion being proximal of and stiffer than the second longitudinal portion according to the teachings of Yang because it would facilitate transluminal advancement of the catheter and help avoid collapse under vacuum (Yang - - Ps. [0239], [0245], [0246]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KANKINDI RWEGO whose telephone number is (303)297-4759. The examiner can normally be reached Monday- Friday: 10:00- 5:00 MT.
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/KANKINDI RWEGO/Primary Examiner, Art Unit 3771
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