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 claims 1-2, 9-12, 14-15, and 19-20 in the reply filed on 07/30/2026 is acknowledged. Claims 3-8, 13, and 16-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDS’s) submitted on 03/13/2025, 04/23/2025, and 03/03/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 1, 9-12, and 19 are objected to because of the following informalities (Examiner notes that some of the objections below refer to the spacing and/or placement of the limitations in the claim, affecting the flow/rhythm of the sentence/limitation/clause):
Claim 1 should be amended to the following, “A medical elongated body comprising:
a catheter shaft that extends in an axial direction and is provided with an outer layer and an inner layer that is disposed inward in a radial direction of the outer layer; and
a distal member that is fused to a distal side of the catheter shaft and is more flexible than the catheter shaft,
wherein in a cross-sectional view in the axial direction,
a distal portion of the inner layer intrudes in an arc outward in the radial direction from an inner surface of the distal member.”
Claim 9 should be amended to the following, “A balloon catheter comprising:
the medical elongated body according to claim 1;
a balloon that is disposed on an outer periphery of the catheter shaft; and
a distal portion of the balloon intrudes in an arc inward in the radial direction from an outer surface of the distal member.” To maintain consistency of the terms/limitations as they were initially introduced and to avoid confusion.
Claim 10 should be amended to the following, “The balloon catheter according to claim 9, wherein
the catheter shaft includes:
an outer tube shaft that is provided with a lumen, and
an inner tube shaft that is disposed in the lumen of the outer tube shaft.”
Claim 11 should be amended to the following, “The balloon catheter according to claim 10, wherein a thickness at a distal end of the balloon positioned at a portion fused to the inner tube shaft is equal to or smaller than a thickness of the inner tube shaft at a site closer to a proximal side than a portion where the balloon is bonded to the inner tube shaft, and is larger than a thickness of the inner tube shaft at a portion bonded to the balloon.”
Claim 12 should be amended to the following, “The balloon catheter according to claim 9, wherein
in the cross-sectional view in the axial direction,
the distal portion of the balloon includes:
a wedge portion that is wedge-shaped, and
the wedge portion includes a parallel portion parallel to the axial direction.”
Claim 19 should be amended to the following, “A medical elongated body comprising:
a catheter shaft that extends in an axial direction and is provided with an outer layer and an inner layer that is disposed inward in a radial direction of the outer layer; and
a distal member that is fused to a distal side of the catheter shaft,
wherein in a cross-sectional view in the axial direction,
a distal portion of the outer layer intrudes in an arc inward in the radial direction from an outer surface of the distal member, extends to be curved to a most distal end of the outer layer, is gradually tapered in a thickness, and terminates at an intermediate position in the radial direction of the catheter shaft.”
Appropriate correction is required.
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 and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suzuki (US20170224965A1).
Regarding claim 1, Suzuki discloses, a medical elongated body (Figure 1(A), medical elongated body (1); Paragraph [0021]) comprising:
a catheter shaft (Figures 1(A)-1(B) and 5(A)-5(B), elongate shaft (200) which includes catheter main body (100)/tube body (110); Paragraphs [0062], [0065], & [0070]) that extends in an axial direction (Paragraphs [0021], [0023], & [0025]) and is provided with an outer layer (Figure 1(B), outer layer (130)) and an inner layer (Figure 1(B), inner layer (120)) that is disposed inward in a radial direction of the outer layer (Paragraphs [0026] and [0031]); and
a distal member (Figures 1(A)-2, distal member (140)) that is fused to a distal side of the catheter shaft (tube body (110)) and is more flexible than the catheter shaft (Paragraphs [0025], [0029], [0033]-[0035], and [0041]),
wherein in a cross-sectional view in the axial direction (Figures 1(B)-2; Paragraphs [0012]-[0013]), a distal portion (Figure 2, distal portion (123); Paragraph [0034]) of the inner layer (inner layer (120)) intrudes in an arc outward in the radial direction from an inner surface of the distal member (Figure 2, surface of distal member (140) on the side of/forming through hole (141); Paragraph [0030]) (Paragraph [0043], discloses, “The outer surface 121 and the inner surface 122 of the inner layer 120 are inclined toward the outside (outside in a radial direction of the tube body 110). The outer surface 121 of the inner layer 120 extends in contact with and along the inner surface 132 of the outer layer 130 at the distal portion 123 of the inner layer 120.” Paragraph [0050], also discloses, “By using the operation described above, the distal portion 123 of the inner layer 120 can form, for example, a shape which is curved and inclined towards the radially outside of the medical elongated body 1 in the cross section taken along the axial direction of the distal portion of the medical elongated body 1 as illustrated in FIG. 2.” Given this and the illustration of Figures 1(B)-2, the distal portion (123) of inner layer (120) is intruding in an arc outward in the radial direction from an inner surface of the distal member (140)).
Regarding claim 2, Suzuki further discloses, wherein in the cross-sectional view in the axial direction (Figures 1(B)-2), a distal portion (Figure 2, distal portion (133); Paragraph [0043]) of the outer layer (outer layer (130)) intrudes in an arc inward in the radial direction from an outer surface of the distal member (As shown in Figure 2, distal portion (133) of outer layer (130) includes an outer surface (131) and an inner surface (132). As described in Paragraphs [0043] and [0050], the outer surface lies flat/flush/straight/parallel with the axial direction of the tube body (110), but then bends, slopes, or arcs inward toward the axial direction (i.e., in the radial direction). This inclination/arching of the outer layer is in the radial direction from the outer surface of distal member (140) as seen in Figure 2).
Regarding claim 19, Suzuki discloses, a medical elongated body (Figure 1(A), medical elongated body (1); Paragraph [0021]) comprising:
a catheter shaft (Figures 1(A)-1(B), catheter main body (100)/tube body (110)) that extends in an axial direction (Paragraphs [0021], [0023], & [0025]) and is provided with an outer layer (Figure 1(B), outer layer (130)) and an inner layer (Figure 1(B), inner layer (120)) that is disposed inward in a radial direction of the outer layer (Paragraphs [0026] and [0031]); and
a distal member (Figures 1(A)-2, distal member (140)) that is fused to a distal side of the catheter shaft (tube body (110)) (Paragraphs [0025], [0029], [0033]-[0035], and [0041]),
wherein in a cross-sectional view in the axial direction (Figures 1(B)-2; Paragraphs [0012]-[0013]), a distal portion (Figure 2, distal portion (133); Paragraph [0043]) of the outer layer (outer layer (130)) intrudes in an arc inward in the radial direction from an outer surface of the distal member (As shown in Figure 2, distal portion (133) of outer layer (130) includes an outer surface (131) and an inner surface (132). As described in Paragraphs [0043] and [0050], the outer surface lies flat/flush/straight/parallel with the axial direction of the tube body (110), but then bends, slopes, or arcs inward toward the axial direction (i.e., in the radial direction). This inclination/arching of the outer layer is in the radial direction from the outer surface of distal member (140) as seen in Figure 2), extends to be curved to a most distal end of the outer layer (Where the inclination/arching at the distal portion (133) of outer layer (130) provides the curvature which extends to the distal end of distal portion (133) of outer layer (130) as seen best in Figure 2), is gradually tapered in a thickness (As clearly seen in Figure 2 and the disclosure of Paragraphs [0043] and [0050] with regards to the inclination/arching at the distal portion (133) of outer layer (130), there is clear tapering at the distal portion (133) of outer layer (130) terminating at the distal end of the distal portion (133)), and terminates at an intermediate position in the radial direction of the catheter shaft (Figure 2; Paragraphs [0043], [0050], & [0054]; Because the inner surface (132) of the distal portion (133) of the outer layer (130) is inclined toward the outer surface (131), the distal end of the outer layer (130) ends at an intermediate radial position within the wall of the tube body (110) (between the outermost surface of the tube body and the lumen), thereby allowing the inner layer (120) to be interposed between the outer layer (130) and the distal member (140) at the joint portion (150)).
Regarding claim 20, Suzuki further discloses, wherein a distal portion (Figure 2, distal portion (123); Paragraph [0034]) of the inner layer (inner layer (120)) intrudes in an arc outward in the radial direction from an inner surface of the distal member (Figure 2, surface of distal member (140) on the side of/forming through hole (141); Paragraph [0030]) (Paragraph [0043], discloses, “The outer surface 121 and the inner surface 122 of the inner layer 120 are inclined toward the outside (outside in a radial direction of the tube body 110). The outer surface 121 of the inner layer 120 extends in contact with and along the inner surface 132 of the outer layer 130 at the distal portion 123 of the inner layer 120.” Paragraph [0050], also discloses, “By using the operation described above, the distal portion 123 of the inner layer 120 can form, for example, a shape which is curved and inclined towards the radially outside of the medical elongated body 1 in the cross section taken along the axial direction of the distal portion of the medical elongated body 1 as illustrated in FIG. 2.” Given this and the illustration of Figures 1(B)-2, the distal portion (123) of inner layer (120) is intruding in an arc outward in the radial direction from an inner surface of the distal member (140)).
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) 9-12 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki, in view of Katsurada (US 2017/0071613 A1).
Regarding claim 9, Suzuki teaches, a balloon catheter (Figure 5, balloon catheter (2); Paragraph [0065]) comprising: the medical elongated body according to claim 1 (See above rejection of claim 1; Figure 5(B); Paragraph [0070]); a balloon (Figure 5(B), balloon (20)) that is disposed on an outer periphery of the catheter shaft (Figure 5(B); Paragraph [0076]); and a distal portion of the balloon (Figure 5(B), distal portion (23); Paragraph [0076]).
Suzuki fails to teach, the distal portion of the balloon intrudes in an arc inward in the radial direction from an outer surface of the distal member.
Katsurada discloses, a balloon catheter. Katsurada teaches, a balloon catheter (10) in which the distal end (22A) of the balloon (20A) is sandwiched between the inner shaft (50A) and the tip (60; distal member), with the outer periphery (24) of the distal end of the balloon covered by the tip proximal end portion (64) such that the distal portion of the balloon is positioned inward of (and under) the outer surface of the tip/distal member and in contact with the unevenness (arcs) (Figures 1-2; Paragraph [0035], “…the outer periphery 24 of the distal end 22A of the balloon 20A is covered with the tip proximal end portion 64 of the tip 60…”; the tip covers the balloon distal end so the balloon distal portion lies radially inward relative to the outer surface of the tip).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the distal balloon-tip junction of Suzuki so that the arched distal portion of the balloon intrudes under/inward from the outer surface of the distal member (tip), as taught by Katsurada, as both references and the claimed invention are directed to balloon catheters having a shaft with a distal tip/member and a balloon whose distal end is joined near the tip to improve joint integrity and prevent detachment or damage. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make this modification, as such a modification would have been predictable, namely, to increase the joining/contact area, obtain an anchoring or covering effect that prevents detachment of the balloon distal end from the shaft/tip under inflation stress or insertion forces, reduce the risk of balloon damage or rupture at a stenosis, and minimize the number of components while maintain a smooth tapered outer profile (Paragraphs [0031] and [0035]-[0039] of Katsurada).
Regarding claim 10, Suzuki further teaches, wherein the catheter shaft (elongate shaft (200)) includes an outer tube shaft (Figure 5(B), outer tube shaft (210)) that is provided with a lumen (Figure 5(B), lumen (211); Paragraph [0065]), and an inner tube shaft (Figure 5(B), inner tube shaft (220)) that is disposed in the lumen of the outer tube shaft (Paragraph [0065]).
Regarding claim 11, Suzuki teaches, the distal portion (distal portion (23)) of the balloon (balloon (20)) is fused/joined to the distal portion of inner tube shaft (tube body (110)/ inner tube shaft (220)) (Figure 5(B); Paragraphs [0076]-[0077]), and that the wall thickness of the layers of the inner tube shaft vary in the axial direction at and near the joint (joint portion (150)) (e.g., the inner-layer wall thickness is smaller than the outer-layer wall thickness proximal to the joint portion; Paragraphs [0045]-[0046] and [0073]).
Thus, Suzuki teaches the claimed invention except for the precise numerical relationship that, “a thickness at a distal end of the balloon positioned at a portion fused to the inner tube shaft is equal to or smaller than a thickness of the inner tube shaft at a site closer to a proximal side than a portion where the balloon is bonded to the inner tube shaft, and is larger than a thickness of the inner tube shaft at a portion bonded to the balloon.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select the relative thickness of the balloon distal end and the inner-tube-shaft wall (proximal to the bond and at the bond itself) exactly as claimed, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art. No unexpected results flow from the claimed thickness relationship; it is merely the application of ordinary skill to achieve the same flexibility and bond-strength objectives already pursued by Suzuki. In re Aller.
Regarding claim 12, Suzuki teaches, aspects of the balloon catheter according to claim 9 (See above rejection of claim 9).
Suzuki fails to teach, wherein in the cross-sectional view in the axial direction, the distal portion of the balloon includes a wedge portion that is wedge-shaped, and the wedge portion includes a parallel portion parallel to the axial direction.
Katsurada teaches, wherein in the cross-sectional view in the axial direction (Figure 2), the distal portion (distal end (22A)) of the balloon (balloon (20A)) includes a wedge portion that is wedge-shaped, and the wedge portion includes a parallel portion parallel to the axial direction (Given Figure 2 and Paragraphs [0031] and [0035]-[0036], which describes the distal end of the balloon is sandwiched between the inner shaft and the tip and is covered by a tapered tip proximal-end portion. In the cross-section seen in Figure 2, the balloon distal end is forced into a narrowing, wedge profile under the covering tip, and a longitudinal segment of that profile runs parallel to the axial direction of the shaft before the final taper (Figure 1)).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to form the distal balloon portion of the Suzuki balloon catheter with the wedge-shaped geometry (including a parallel axial segment), as taught by Katsurada, as both references and the claimed invention are directed to balloon catheters having a shaft with a distal tip/member and a balloon whose distal end is joined near the tip to improve joint integrity and prevent detachment or damage. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make this modification, as such a modification would have been predictable, namely, provides gradual rigidity transition, smoother bending at the fusion site, and reduced risk of abrupt stress concentrations or detachment (Paragraphs [0031] and [0035]-[0039] of Katsurada).
Regarding claim 14, Suzuki teaches, aspects of the balloon catheter according to claim 9 (See above rejection of claim 9).
Suzuki fails to teach, wherein in the cross-sectional view in the axial direction, the distal member is disposed to wrap around a distal end of the distal portion of the balloon.
Katsurada teaches, wherein in the cross-sectional view in the axial direction (Figure 2), the distal member (tip (60)) is disposed to wrap around a distal end of the distal portion (distal end (22A)) of the balloon (balloon (20A)) (Figures 1-2; Paragraph [0035], “…the outer periphery 24 of the distal end 22A of the balloon 20A is covered with the tip proximal end portion 64 of the tip 60…”; the tip proximal-end portion (64) covers the outer periphery of the balloon distal end (22A) so that the balloon distal end is sandwiched and enveloped by the tip).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the distal balloon-tip junction of Suzuki so that the distal member wraps around the distal end of the balloon, as taught by Katsurada, as both references and the claimed invention are directed to balloon catheters having a shaft with a distal tip/member and a balloon whose distal end is joined near the tip to improve joint integrity and prevent detachment or damage. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make this modification, as such a modification would have been predictable, namely, prevents curling or detachment of the balloon distal end under inflation or insertion forces, reduces risk of balloon damage or rupture, and a smooth continuous outer profile (Paragraphs [0031] and [0035]-[0039] of Katsurada).
Regarding claim 15, Suzuki further teaches, wherein the balloon (balloon (20)) contains a polyamide elastomer (Paragraphs [0080], discloses, “The balloon 20… may be formed out of a polyamide resin.” Further, Paragraph [0099], discloses, “…the balloon can be formed of a well-known nylon elastomer or the like.” Where, “Nylon elastomer” is a common term for polyamide elastomer, combined with the explicit “polyamide resin” teaching, the balloon (20) does indeed contain a polyamide elastomer).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to also have the distal member (distal member (140)) contain a polyamide elastomer, since it has been held to within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. This’s further reinforced through Suzuki’s disclosure in paragraph [0099], which states, “The material constituting each portion of the medical elongated body and the balloon catheter is not particularly limited as long as the material forming the inner layer of the tube body is formed of at least a material having better fusing properties with respect to the material forming the distal member than the fusing properties of the material forming the outer layer of the tube body. It is possible to use a material other than the materials described in the specification. The combination of the materials of each of the constituent members is not limited to the examples discussed above. Appropriate changes can be made” In re Leshin.
Conclusion
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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