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 .
Response to Amendment
As of the reply filed 3/30/2026, claims 1-20 are pending. Claims 1, 3-4, 7-10, 14, and 18-20 have been amended.
Response to Arguments
Applicant states that “Claims 1, 7, 18, and 19 are amended to address the minor informalities noted on pages two and three of the Official Action” (see page 11 of reply), however the Examiner notes that only the objections to claims 1, 7, and 19 have been obviated via amendment. The objections to claim 18 were not remedied, therefore these claim objections still apply and are included further below.
Additionally, in view of Applicant’s amendments to the claims, further claim objections now apply.
Claim 1 has been amended to include “a connection portion”, providing antecedent basis, therefore the previously filed rejection under 35 U.S.C. 112(b) is withdrawn.
However, in view of Applicant’’s amendments to the claims, a new rejection under 35 U.S.C. 112(b) applies.
Applicant’s arguments with respect to the amended claims have been considered but are largely moot because most of the new grounds of rejection do not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
With respect to Applicant’s argument that “the distal end portion 93 and the core member 100 are not actually shaft portions” (see page 12 of reply), Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. The Applicant argues that the “drawing figures in Kawai make clear that the disclosed insertion assisting tool does not include three shaft portions as claimed”, but does not specifically state why the drawings do not read on the claim language of the present application. The Examiner argues that since 93 of hypotube 91 and core member 100 are elongated structures, they are shaft portions and therefore read on the claim language.
With respect to the Applicant’s argument that “a person of ordinary skill in the art would not have been motivated to use Fugoso’s guide wire with Kawai’s insertion tool because the outer diameter of the proximal portion of the distal end portion 2 would be excessively large… so much so that the tool would not be useful for its intended purpose” (see page 15 of reply), the Examiner respectfully disagrees. The device of Kawai is intended for use through the vasculature and coronary artery (see Fig. 7), as is the guidewire of Fugoso et al. (col. 4, lines 35-36: “Applicant's invention depicts a shaft transition for an over-the-wire coronary catheter”), showing their similar mode of operation. Additionally, Kawai is silent on any required guidewire diameters or guide wire lumen diameters, stating only that “The diameter of the lumen 22 and the distal-end opening of the tapered portion 12 is slightly larger than the diameter of the guide wire G so that the guide wire G can be slidably supported” (PP [0031]). Although a range of diameters are contemplated, these recitations do not constitute statements of criticality and the Examiner argues that changing the relative sizes of the guidewire and guidewire lumen as proposed would not alter the mode of operation of the Kawai device.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 recites the limitation "the shaft portion… having a distal end side opposite the proximal end side" on page 6, line 6. There is insufficient antecedent basis for this limitation in the claim because it is unclear what proximal end side the claim is referring to. Claim 10 recites “a proximal end side of the main body portion” in lines 4-5 on page 6, however the present specification does not support a distal end side of the shaft portion being opposite the proximal end side of the main body portion, particularly when claim 10 establishes “a shaft portion… connected to a proximal end side of the main body portion at a connection portion”. Fig. 6 additionally shows the connection portion at recess 12, where the distal end of shaft portion 20 connects to a proximal portion of the main body portion 10, therefore these ends cannot be said to be opposite to one another. In light of this, examination will continue under the assumption that claim 10 refers to a proximal end side of the shaft portion, and that the limitation should read “the shaft portion… having a distal end side opposite a proximal end side of the shaft portion” instead.
Claim Objections
Claims 1 and 18 is objected to because of the following informalities:
Claim 1, last line: “the shaft portion” should be amended to recite “the first shaft portion” instead to reflect the amendments to the claim.
Claim 18, lines 13 and 15: “the main body” as recited in each line should be amended to recite “the main body portion” to match the prior naming basis.
Claim 18, line 18: “fixed to main body portion” is missing an article and should be amended to recite “fixed to the main body portion” instead.
Appropriate correction is required.
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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Aboytes et al. (US PGPub 2020/0008820 A1) in view of Kasahara et al. (US PGPub 2026/0100295 A1).
With respect to claim 1, Aboytes et al. discloses an elongated medical body (see Fig. 3A, the elongate body comprises 34 and 42) usable in combination with a catheter (33, see 33 of tubular body 16 in Figs. 1-2) provided with a lumen so that a distal end of the elongated medical body is positionable in the lumen of the catheter (see 34 within 33 in Fig. 3A) to assist insertion of the catheter into a living body (see device of Fig. 2A usable with catheter 31 in Fig. 2B), the elongated medical body (34 and 42) comprising:
a main body portion (34) extending in an axial direction between a proximal end of the main body portion (left end of 34) and a distal end of the main body portion (right end of 34), the main body portion (34) including a proximal portion that terminates at the proximal end of the main body portion (left portion of 34 which terminates at the proximal end), the proximal portion of the main body portion (34) including a recess (36);
the main body portion (34) including a guide wire lumen (40) extending axially throughout the main body portion (34) from the proximal end of the main body portion to the distal end of the main body portion (see 40 extend along the length of 34), the guide wire lumen (40) being open to outside the main body portion (34) at both the proximal end of the main body portion and the distal end of the main body so that a guide wire is positionable in the guide wire lumen (a guide wire may be inserted through manifold 18 in Fig. 1 and through lumen 40 in Fig. 3A) and extends distally beyond the distal end of the main body and proximally beyond the proximal end of the main body portion (a guide wire may extend through 33 along locations proximal to 34, and also distally beyond distal end 38 of 34), the guide wire lumen (40) possessing an inner diameter (see diameter of lumen 40 in Fig. 3A);
a first shaft portion (42) extending in the axial direction, the first shaft portion (42) including a distal portion positioned in the recess (see unmarked recess of 34 which 42 enters for a fixed connection, PP [0055]: “the portion of the pull wire 42 distal of the proximal end of the distal section 34”) in the main body portion (34) and fixed to the main body portion (34) at a connection portion (proximal portion 44 where 42 attaches, PP [0055]: “the portion of the pull wire 42 distal of the proximal end of the distal section 34”) so that the first shaft portion (42) extends away from the main body portion (34, 42 extends away from 34 in a proximal direction), the first shaft portion (42) possessing an outer diameter (outer diameter of 42);
the first shaft portion (42) extending such that i) at least a part of first shaft portion (42) is positioned on a proximal side of the proximal end of the main body portion (42 extends proximally from 34); and ii) an outer surface of the part of first shaft portion (42) is exposed outside the main body portion (42 extends proximally from 34 outside of 34 such that it is exposed, PP [0050]: “the proximal end of pull wire 42 may exit through a port on manifold 18, such that it may be manually grasped and pulled or pushed by the clinician to extend or retract the distal section 34”);
a guide wire port (opening of 36) through which the guide wire enters and exits the guide wire lumen (a guide wire may enter 36 of 34 to enter lumen 40), the guide wire port (36) being provided at the connection portion (44) between the main body portion (34) and the shaft portion (42); and
the inner diameter of the guide wire lumen (40) being equal to or larger than the outer diameter of the shaft portion (4, see Fig. 4, D1 is larger than D2).
However, Aboytes et al. fails to disclose a second shaft portion and a third shaft portion that each extend away from the main body portion in the axial direction so that: i) at least a part of the second shaft portion and at least a part of the third shaft portion are positioned on a proximal side of the proximal end of the main body portion; and ii) an outer surface of the part of the second shaft portion and an outer surface of the part of the third shaft portion are exposed outside the main body portion.
In the field of stranded wires (abstract), which is relevant due to their particular relation to catheter core wires (PP [0028]: “stranded wire 1 is used in applications that demand thinness, such as a catheter (catheter guide wire), a fishing leader, or a motion transmission line of a robot”), Kasahara et al. teaches a core wire (10 in Fig. 3) which includes a first shaft portion, a second shaft portion, and a third shaft portion (each strand 11 is a shaft portion and there are seven strands, providing at least three shaft portions, see annotated Fig. 3 below).
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It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Aboytes et al. device according to the teachings of Kasahara et al. to replace the push wire 42 of Aboytes et al. with the multi-stranded wire of Kasahara et al. such that there is a second and third shaft portion and that: i) at least a part of the second shaft portion and at least a part of the third shaft portion are positioned on a proximal side of the proximal end of the main body portion; and ii) an outer surface of the part of the second shaft portion and an outer surface of the part of the third shaft portion are exposed outside the main body portion, as is the case with core wire 42 of the Aboytes et al. device. One of ordinary skill in the art would have been motivated to perform this modification in order to “suppress kinking” and to increase overall strength of the push wire (PP [0032]: “with metal stranded wire 10 alone, kinking tends to occur more, as compared with a stranded wire using stainless steel, nylon, or polyethylene strands. In contrast, in stranded wire 1, metal stranded wire 10 is covered by resin film 20 having a predetermined thickness, so that stranded wire 1 can suppress kinking while also being increased in strength”). Furthermore, the modification as proposed would not alter the main operating principle of the Aboytes et al. reference since the Kasahara et al. stranded wire is contemplated for use as a catheter guidewire (see PP [0028]).
Regarding claim 2, Aboytes et al. as modified by Kasahara et al. further discloses wherein the main body portion (34 in Fig. 3A of Aboytes et al.) includes a curved inner surface surrounding the guide wire lumen (40, PP [0042]: “the tubular body 16 is divided into at least a fixed proximal section 33 and an axially extendable and retractable distal section 34”, 34 is tubular and has a curved inner surface) and having a 360 degree circumferential extent (the lumen 40 extends around the inner circumference of the device and therefore has a 360 degree circumferential extent), the main body portion (34) at the guide wire port (36) including a continuation of the curved inner surface having a circumferential extent less than 360 degrees (the slanted face of 36 gives the main body portion 34 a circumferential extent less than 360 degrees).
Regarding claim 3, Aboytes et al. as modified by Kasahara et al. further discloses wherein the main body portion (34 in Fig. 3A of Aboytes et al.) is made of resin (PP [0141]: “The catheters of the present invention may be composed of any of a variety of biologically compatible polymeric resins having suitable characteristics when formed into the tubular catheter body segments”) and the shaft portion (42) is made of metal (PP [0055]: “the pull wire 42 may comprise metal”, see also PP [0031] of Kasahara et al. which supports a “metal stranded wire 10 is constituted of a plurality of metal wires 11”).
Regarding claim 4, Aboytes et al. as modified by Kasahara et al. further discloses wherein the outer surface of the part of the second shaft portion and the outer surface of the part of the third shaft portion are in direct contact with an outer surface of the first shaft portion (see strands 11 in Fig. 3 of Kasahara et al., these strands are twisted together such that they are in direct contact with an outer surface of the central first shaft portion, see annotated Fig. 3 below).
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Regarding claim 5, Aboytes et al. as modified by Kasahara et al. further discloses wherein a total cross-sectional area of the first shaft portion (42 in Fig. 3A of Aboytes et al., see also central strand 11 in Fig. 3 of Kasahara et al.), the second shaft portion and the third shaft portion (see other strands 11 in Fig. 3 of Kasahara et al.) is equal to or larger than a cross-sectional area of the guide wire lumen (40 in Fig. 3A of Aboytes et al., see also Fig. 3 of Kasahara et al., the claim does not specify the plane/orientation of the cross-section, each of these sections have a transverse lengthwise cross-sectional area which when combined would be larger than the cross-sectional area of guidewire lumen 40 as seen in Fig. 3A of Aboytes et al.).
Regarding claim 6, Aboytes et al. as modified by Kasahara et al. further discloses wherein portions of the second shaft portion and the third shaft portion (see strands 11 in Fig. 3 of Kasahara et al. modified to replace 42 in Fig. 3A of Aboytes et al.) diverge away from each other and terminate at distal ends (the second and third shaft portions continuously diverge as they twist along the length of the core wire 10, see annotated Fig. 3 of Kasahara et al. below), the distal end of the second shaft portion and the distal end of the third shaft portion being positioned in respective recesses in the main body portion (34 in Fig. 3A of Aboytes et al., the combination as proposed would modify the recess of 34 to securely match the geometry of stranded wire 10 of Kasahara et al. such that the recess has corresponding recessed grooves for receiving the second and third shaft portions) and being fixed to the main body portion (34 in Fig. 3A of Aboytes et al.).
Regarding claim 7, Aboytes et al. as modified by Kasahara et al. further discloses wherein an entirety of the second shaft portion and an entirety of the third shaft portion (see strands 11 in annotated Fig. 3 of Kasahara et al. below, modified to replace 42 in Fig. 3A of Aboytes et al.) are exposed outside the main body portion and are positioned on a proximal side of the proximal end of the main body portion (34 in Fig. 3A of Aboytes et al., 42 extends proximally from 34 outside of 34 such that it is exposed, PP [0050]: “the proximal end of pull wire 42 may exit through a port on manifold 18, such that it may be manually grasped and pulled or pushed by the clinician to extend or retract the distal section 34”, in the modification as proposed 42 would have multiple strand shaft portions such that they are also exposed outside the main body portion 34).
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Regarding claim 8, Aboytes et al. as modified by Kasahara et al. further discloses wherein the inner diameter of the guide wire lumen (40 in Fig. 3A of Aboytes et al.) is equal to or greater than 0.9 mm (PP [0046]: “the untapered internal diameter at the proximal end of the distal section 34 may be about 0.071 inches”).
However, Aboytes et al. as modified by Kasahara et al. fails to disclose wherein the outer diameter of the first shaft portion is equal to or greater than 0.4 mm.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Aboytes et al. and Kasahara et al. combination to incorporate the outer diameter of the first shaft portion as claimed 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, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)). In the instant case, the device of Aboytes et al. would not operate differently with the claimed diameters since the Aboytes et al. device is also a catheter extension device configured for use in the body. Furthermore, the Applicant places no criticality on the ranges claimed, indicating that “An outer diameter D1 (see FIG. 9) of the shaft portion 20 is not particularly limited as long as it is smaller than an inner diameter of the guide wire lumen” (PP [0055]).
Regarding claim 9, Aboytes et al. as modified by Kasahara et al. further discloses wherein a cross-sectional area of the first shaft portion (42 in Fig. 3A of Aboytes et al.) is smaller than a cross-sectional area of the guide wire lumen (40).
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Aboytes et al. (US PGPub 2020/0008820 A1) in view of Wainwright et al. (US PGPub 2023/0248377 A1).
With respect to claim 10, Aboytes et al. discloses an elongated medical body (see Fig. 3A, the elongate body comprises 34 and 42) usable in combination with a catheter provided with a lumen (see 34 within catheter 33 in Fig. 3A) so that a distal end of the elongated medical body (34 and 42) protrudes into the lumen of the catheter and assists insertion of the catheter into a living body (PP [0053]: “distal section 34 and pull wire 42 may be configured as a stand-alone catheter extension device as is discussed in greater detail below. The catheter extension device may be introduced into the proximal end of proximal section 33 after placement of proximal section 33 and advanced distally there through as illustrated in FIG. 3A”), the elongated medical body (34 and 42) comprising
a main body portion (34) extending in an axial direction and including a guide wire lumen (40) through which is passable a guide wire (a guide wire may be inserted through manifold 18 in Fig. 1 and through lumen 40 in Fig. 3A), the guide wire lumen (40) possessing an inner diameter (see diameter of 40 in Fig. 3A);
a shaft portion (42) extending in the axial direction and connected to a proximal end side of the main body portion (34) at a connection portion (44), the shaft portion (42) possessing an outer diameter (see outer diameter of 42) and having a distal end side (end of 42 terminating within 34) opposite the proximal end side (the distal end of 42 is opposite a proximal end of 42, PP [0050]: “the proximal end of pull wire 42 may exit through a port on manifold 18, such that it may be manually grasped and pulled or pushed by the clinician to extend or retract the distal section 34”);
a guide wire port (opening of 36) through which the guide wire enters and exits the guide wire lumen (a guide wire may enter 36 of 34 to enter lumen 40), the guide wire port (36) being provided at the connection portion (44) between the main body portion (34) and the shaft portion (42); and
the main body portion (34) having an outer diameter, the main body portion including a tapered part (38) in which the outer diameter of the main body portion (34) tapers so that the outer diameter of the tapered part of the main body portion decreases toward the distal end side (PP [0045]: “the distal section 34 may be tapered near its distal end”); and
the inner diameter of the guide wire lumen (40) being equal to or larger than the outer diameter of the shaft portion (42).
However, Aboytes et al. fails to explicitly disclose the inner diameter of the guide wire lumen being constant throughout the tapered part of the main body portion.
In the same field of catheter extensions (abstract), Wainwright et al. teaches an elongated medical body (see Fig. 8) comprising a main body portion (236) and a shaft portion (232), wherein the main body portion (236) comprises a distal taper (see the taper of OD in Figs. 9-10) and a guide wire lumen (lumen through 236) comprising an inner diameter (ID in Figs. 9-10), wherein the inner diameter of the guide wire lumen is constant throughout the tapered part of the main body portion (see Figs. 9-10 where ID does not change as OD tapers and decreases).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Aboytes et al. device according to the teachings of Wainwright et al. such that the inner diameter of the guide wire lumen is constant throughout the tapered part of the main body portion. One of ordinary skill in the art would have been motivated to perform this modification as doing so constitutes applying a known technique (a constant inner diameter in an outer taper of a catheter extension body) to the known device of Aboytes et al. in order to yield predictable results, as Aboytes et al. contemplates that “A larger lumen (internal diameter) may increase the applied aspiration force through the distal end of the distal section 34” (PP [0045]). Additionally, the modification as proposed would not alter the main operating principle of Aboytes et al. since this disclosure does not offer any statements of criticality regarding the inner diameter, stating merely that “The inner diameter and the outer diameter of the distal section 34 may be constant or substantially constant along its longitudinal length” (PP [0045-0046]).
Regarding claim 11, Aboytes et al. as modified by Wainwright et al. further discloses wherein the inner diameter of the guide wire lumen (40 in Fig. 3A of Aboytes et al.) is equal to or greater than 0.9 mm (PP [0046]: “the untapered internal diameter at the proximal end of the distal section 34 may be about 0.071 inches”).
However, Aboytes et al. as modified by Wainwright et al. fails to disclose wherein the outer diameter of the first shaft portion is equal to or greater than 0.4 mm.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Aboytes et al. and Kasahara et al. combination to incorporate the outer diameter of the first shaft portion as claimed 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, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)). In the instant case, the device of Aboytes et al. would not operate differently with the claimed diameters since the Aboytes et al. device is also a catheter extension device configured for use in the body. Furthermore, the Applicant places no criticality on the ranges claimed, indicating that “An outer diameter D1 (see FIG. 9) of the shaft portion 20 is not particularly limited as long as it is smaller than an inner diameter of the guide wire lumen” (PP [0055]).
Regarding claim 12, Kawai fails to disclose wherein the outer diameter of the shaft portion is equal to or greater than 0.6 mm.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Kawai device such that the outer diameter of the shaft portion is equal to or greater than 0.6 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, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)). In the instant case, the device of Kawai would not operate differently with the claimed shaft portion diameter since the Kawai device is also a rapid exchange device configured for use in the body. Furthermore, the Applicant places no criticality on the range claimed, indicating that “An outer diameter D1 (see FIG. 9) of the shaft portion 20 is not particularly limited as long as it is smaller than an inner diameter of the guide wire lumen” (PP [0055]).
Regarding claim 13, Aboytes et al. as modified by Wainwright et al. further discloses wherein a cross-sectional area of the shaft portion (42 in Fig. 3A of Aboytes et al.) is equal to or smaller than a cross-sectional area of the guide wire lumen (40).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Aboytes et al. (US PGPub 2020/0008820 A1) in view of Wainwright et al. (US PGPub 2023/0248377 A1), as applied to claim 10 above, and further in view of Kasahara et al. (US PGPub 2026/0100295 A1).
Regarding claim 14, Aboytes et al. as modified by Wainwright et al. further discloses wherein the shaft portion (42 in Fig. 3A of Aboytes et al.) is a first shaft portion.
However, Aboytes et al. as modified by Wainwright et al. fails to disclose a second shaft portion and a third shaft portion that each extend away from the main body portion in the axial direction, the first shaft portion, the second shaft portion and the third shaft portion each having an outer surface, the outer surface of the second shaft portion being in contact with the outer surface of the first shaft portion.
In the field of stranded wires (abstract), which is relevant due to their particular relation to catheter core wires (PP [0028]: “stranded wire 1 is used in applications that demand thinness, such as a catheter (catheter guide wire), a fishing leader, or a motion transmission line of a robot”), Kasahara et al. teaches a core wire (10 in Fig. 3) which includes a first shaft portion, a second shaft portion, and a third shaft portion (each strand 11 is a shaft portion and there are seven strands, providing at least three shaft portions, see annotated Fig. 3 below), first shaft portion, the second shaft portion and the third shaft portion each having an outer surface, the outer surface of the second shaft portion being in contact with the outer surface of the first shaft portion (see annotation below).
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It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Aboytes et al. device according to the teachings of Kasahara et al. to replace the push wire 42 of Aboytes et al. with the multi-stranded wire of Kasahara et al. such that the second shaft portion and the third shaft portion each extend away from the main body portion in the axial direction, as is the case with core wire 42 of the Aboytes et al. device. One of ordinary skill in the art would have been motivated to perform this modification in order to “suppress kinking” and to increase overall strength of the push wire (PP [0032]: “with metal stranded wire 10 alone, kinking tends to occur more, as compared with a stranded wire using stainless steel, nylon, or polyethylene strands. In contrast, in stranded wire 1, metal stranded wire 10 is covered by resin film 20 having a predetermined thickness, so that stranded wire 1 can suppress kinking while also being increased in strength”). Furthermore, the modification as proposed would not alter the main operating principle of the Aboytes et al. reference since the Kasahara et al. stranded wire is contemplated for use as a catheter guidewire (see PP [0028]).
Regarding claim 15, Aboytes et al. as modified by Wainwright et al. and Kasahara et al. further discloses wherein a total-cross sectional area of the first shaft portion (42 in Fig. 3A of Aboytes et al., see also annotated Fig. 3 of Kasahara et al. above), the second shaft portion, and the third shaft portion (see annotated Fig. 3 of Kasahara et al. above) is equal to or larger than a cross-sectional area of the guide wire lumen (see Fig. 3A of Aboytes et al., the claim does not specify the plane/orientation of the cross-section, each of these sections have a transverse lengthwise cross-sectional area which when combined would be larger than the cross-sectional area of 40 as seen in Fig. 3A).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Aboytes et al. (US PGPub 2020/0008820 A1) in view of Wainwright et al. (US PGPub 2023/0248377 A1), as applied to claim 10 above, and further in view of Tran et al. (US PGPub 2019/0365395 A1).
Regarding claim 16, Aboytes et al. as modified by Wainwright et al. further discloses wherein a distal portion of the shaft portion (42 in Fig. 3A of Aboytes et al.) is connected to the proximal end side of the main body portion (34) at the connection portion (44), but fails to explicitly disclose the distal portion of the shaft portion having a tapering shape.
In the field of filtering devices (abstract) for use with a catheter (see PP [0008]), which is related due to the shared concern with delivering core wires configured for insertion into a lumen of a patient, Tran et al. teaches a device (see Figs. 8A-C) comprising a shaft portion (110) attached to a main body portion (102), and contemplates the distal portion of the shaft portion (110) having a tapering shape (PP [0056]: “Decreasing or tapering the diameter of the inner wire 110 enhances flexibility for bending or pivoting of the inner wire 110 at the distal portion of the inner wire 110 while providing sufficient stiffness at the proximal portion of the inner wire 110. The proximal portion of the inner wire 110 requires sufficient stiffness to allow application of a push-pull force upon the inner wire 110 to expand the basket 102 or for retrieval of the basket 102. Tapering from a larger diameter to a smaller diameter along a length of the inner wire 110 allows the inner wire 110 to have a larger diameter along a proximal end or portion of the inner wire 110 relative to the distal end or portion”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified Aboytes et al. as modified by Wainwright et al. to further incorporate the teachings of Tran et al. and include a shaft portion having a tapering distal shape. One of ordinary skill in the art would have been motivated to perform this modification, as doing so constitutes the application of a known technique (a tapering diameter to decrease stiffness) to a known device (the Aboytes et al. catheter guide, and more particularly the push wire 42 in Fig. 3A) to yield predictable results, since Aboytes et al. discloses that “the portion of the pull wire 42, with or without a central lumen 45, which extends beyond the proximal end of the distal section 34 (e.g., into lumen 40) may decrease in stiffness (durometer) in a distal direction” (PP [0055]). Modifying the Aboytes et al. reference to achieve this decreased distal stiffness by including a taper, taught by Tran et al. to decrease stiffness, would have predictably yielded this desired distal stiffness decrease and would not have altered the main operating principle of the Aboytes et al. device.
Regarding claim 17, Aboytes et al. as modified by Wainwright et al. further discloses wherein the shaft portion (42 in Fig. 3A of Aboytes et al.) is a first shaft portion, but fails to disclose a second shaft portion positioned adjacent to and extending along the first shaft portion, the second shaft portion having a distal end that is spaced proximally from the proximal end side of the main body portion and the connection portion.
In the field of filtering devices (abstract) for use with a catheter (see PP [0008]), which is related due to the shared concern with delivering core wires configured for insertion into a lumen of a patient, Tran et al. teaches a device (see Figs. 8A-C) comprising a first shaft portion (110) attached to a main body portion (102), and further teaches a second shaft portion (820) positioned adjacent to and extending along the first shaft portion (110, see Fig. 8C where 110 and 820 overlap and 820 extends along the proximal end of 110), the second shaft portion (820) having a distal end that is spaced proximally from the proximal end side of the main body portion (102 in Fig. 8A) and a connection portion (proximal end of 102 where 110 enters 102).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified Aboytes et al. as modified by Wainwright et al. to further incorporate the teachings of Tran et al. to include a second shaft portion hypotube having a distal end spaced proximally from the proximal end side of the main body portion and the connection portion. One of ordinary skill in the art would have been motivated to perform this modification because doing so involves the use of a known technique (the use of extender hypotubes for extending a core wire’s length) on a known device (the Aboytes et al. catheter guide, and more particularly the push wire 42 in Fig. 3A) ready for improvement to yield predictable results. The combination as proposed would not alter the main operating principle of the Aboytes et al. device, but would simply predictably extend the length of the push wire 42 via the extender hypotube arrangement as taught by the Tran et al. reference, particularly since Aboytes et al. contemplates that “distal section 34 and pull wire 42 may be configured as a stand-alone catheter extension device” (PP [0053]).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kawai (US PGPub 2009/0264865 A1) in view of Wainwright et al. (US PGPub 2026/0100295 A1) and Fugoso et al. (US Patent No. 5,961,510).
With respect to claim 18, Kawai discloses an elongated medical body (2 in Fig. 2A) in combination with a guide wire (G), the elongated medical body (2) being usable together with a catheter having a lumen so that a distal end of the elongated medical body (2) is positionable in the lumen of the catheter to assist insertion of the catheter into a living body (see MPEP 2112.01, 2 can be considered to be usable with a catheter in this way),
the guide wire (G) being an elongated guide wire (see Fig. 2A);
the elongated medical body (2) comprising:
a main body portion (body of 2) extending in an axial direction between a proximal end of the main body portion and a distal end of the main body portion (see Fig. 2A), the main body portion (body of 2) including a guide wire lumen (10) extending axially throughout the main body portion (body of 2) from the proximal end of the main body portion to the distal end of the main body portion, the guide wire lumen (10) being open to outside the main body portion at both the proximal end of the main body portion and the distal end of the main body [portion] (10 is open at 24 and 22) so that the guide wire (G) is positionable in the guide wire lumen (10) while also extending distally beyond the distal end of the main body [portion] and proximally beyond the proximal end of the main body portion (see Fig. 2A, G extends beyond 20 and before 24), the guide wire lumen (10) possessing an inner diameter (D1 in Fig. 4);
a shaft portion (4) extending in the axial direction, the shaft portion (4) having a distal portion fixed to [the] main body portion (body of 2) at a connection portion (proximal portion of 2 where 4 enters 2) while an adjacent part of the shaft portion (4) extends away from the main body portion (2, see portion of 4 which extends proximally), the shaft portion (4) possessing an outer diameter;
a guide wire port (opening of 24) through which the guide wire (G) enters and exits the guide wire lumen (10) in the main body portion (body of 2), the guide wire port (opening of 24) being provided at the connection portion (proximal portion of 2 where 4 enters 2) between the main body portion (body of 2) and the shaft portion (4); and
the inner diameter of the guide wire lumen (10) being equal to or larger than the outer diameter of the shaft portion (4, see Fig. 4, D1 is larger than D2 including 4).
However, Kawai fails to disclose the inner diameter of the guide wire lumen being constant along an entirety of the guide wire lumen or wherein the guide wire has an outer diameter equal to or greater than 0.035 in.
In the same field of catheter extensions (abstract), Wainwright et al. teaches an elongated medical body (see Fig. 8) comprising a main body portion (236) and a shaft portion (232), wherein the main body portion (236) comprises a distal taper (see the taper of OD in Figs. 9-10) and a guide wire lumen (lumen through 236) comprising an inner diameter (ID in Figs. 9-10), wherein the inner diameter of the guide wire lumen is constant throughout the tapered part of the main body portion (see Figs. 9-10 where ID does not change as OD tapers and decreases).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Aboytes et al. device according to the teachings of Wainwright et al. such that the inner diameter of the guide wire lumen is constant throughout the tapered part of the main body portion. One of ordinary skill in the art would have been motivated to perform this modification as doing so constitutes applying a known technique (a constant inner diameter in an outer taper of a catheter extension body) to the known device of Kawai in order to yield predictable results, producing a tapered distal end portion where the wall thickness gradually decreases to enable a constant guide wire lumen and a softer distal end which is already contemplated by Kawai (PP [0031]: “A tubular-shaped soft tip 20 is made of a material which is softer than the distal end portion 2, and connected at the distal-side of the tapered portion 12. The connection is made by fusing the soft tip 20 to the distal end portion 2”). Additionally, the modification as proposed would not alter the main operating principle of the Kawai device since this disclosure does not offer any statements of criticality regarding the inner diameter, stating merely that “The diameter of the lumen 22 is the same as that of the lumen 10 at the distal end of the tapered portion 12. The lumen 22 is longitudinally coaxial and in communication with the lumen 10” (PP [0031]).
However, Kawai as modified by Wainwright et al. further fails to disclose wherein the guide wire has an outer diameter equal to or greater than 0.035 in.
In the same field of catheters with guidewires (abstract, col. 4, lines 34-39: “Whereas Applicant's invention depicts a shaft transition for an over-the-wire coronary catheter those skilled in the art would recognize that such a transition could be used for any catheter including rapid exchange or fixed wire catheters and other applications such as peripheral etc.”) Fugoso et al. discloses a guide wire comprising an outer diameter equal to or greater than 0.035 inches (col. 1, lines 14-16: “Typically a first guidewire of about 0.038 inches in diameter is steered-through the vascular system to the site of therapy”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Kawai and Wainwright et al. combination to incorporate the teachings of Fugoso et al. and include wherein the guide wire has an outer diameter equal to or greater than 0.035 in. One of ordinary skill in the art would have been motivated to perform this modification because it is a simple substitution of guidewires that would have yielded predictable results since Kawai discloses generally that “The diameter of the lumen 22 and the distal-end opening of the tapered portion 12 is slightly larger than the diameter of the guide wire G so that the guide wire G can be slidably supported” (PP [0031]). Modifying both the guide wire’s diameter and the diameter of the internal lumen to accommodate the guidewire of Fugoso et al. therefore would have been obvious, since Kawai does not teach away from alternate guidewire and lumen sizes and would be able to operate as intended with the claimed diameter.
Regarding claim 19, Kawai as modified by Wainwright et al. and Fugoso et al. further discloses wherein the shaft portion (4 in Fig. 2A of Kawai, including 91) is a first shaft portion, and further comprising at least one additional shaft portion (100 in Fig. 3B) extending along the first shaft portion (4) in the axial direction, the first shaft portion (4) and the at least one additional shaft portion (100) constituting all of the shaft portions of the elongated medical device (2), a total cross-sectional area of all of the shaft portions being equal to or larger than a cross-sectional area of the guide wire lumen (see Figs. 3B and 4, the claim does not specify the plane/orientation of the cross-section, each of these sections have a transverse lengthwise cross-sectional area which when combined would be larger than the cross-sectional area of 10 as seen in Fig. 4).
Regarding claim 20, Kawai as modified by Wainwright et al. and Fugoso et al. further discloses wherein the main body portion (body of 2 in Fig. 2A of Kawai) is made of resin (PP [0033]: “The soft tip 20 is made of PEBAX.RTM”, Pebax is a resin) and the shaft portion (4) is made of metal (PP [0036]: “the shaft 4 is arranged at the proximal-side of the distal end portion 2, and configured to include a stainless steel hypotube 91”).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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