DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
This Office Action is responsive to the amendment filed February 5, 2026. As directed by the amendment: Claims 1, 2, 9, 10, 15, 16, and 22 have been amended. Claims 13 and 14 were withdrawn. Claims 1-22 are presently pending in this application.
Examiner’s Note
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.
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) 1-6, 8, and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chuter (US 2015/0133988).
Regarding claim 1, Chuter discloses a balloon catheter traction device (figure 11) comprises a balloon catheter (212) and a balloon (210) fixed onto the balloon catheter (212) (figure 11), wherein the balloon (210) fixed onto the balloon catheter (212) is an eccentrically positioned balloon (figure 11), and when fluid is inflated into the balloon (210) (¶82), the balloon (210) bends (¶82 and figure 11) and causes the balloon catheter (212) to bend correspondingly (¶82 and figure 11), and a radial restraint (elements 254a, 254b) is applied to the balloon (210), preventing it from further expanding in a radial direction once it reaches a certain diameter (¶81 and figure 11).
Regarding claim 2, Chuter discloses wherein the balloon (210) fixed onto the balloon catheter (212) is a semi-compliant balloon (¶54).
Regarding claim 3, Chuter discloses wherein the balloon (210) fixed onto the balloon catheter (212) is provided with a fixed-length restraint (elements 254b) on an inner side of an axial intended bending direction (figure 11), without any restriction on an outer side of the axial intended bending direction (figure 11).
Regarding claim 4, Chuter discloses wherein the fixed-length restraint (elements 254b) on the inner side of the balloon's axial intended bending direction (figure 11) is a reinforcing rib (figure 11) positioned on the inner side of the balloon's axial intended bending direction (figure 11).
Regarding claim 5, Chuter discloses wherein the fixed-length restraint (elements 254b) on the inner side of the balloon's axial intended bending direction (figure 11) are lines or threads (¶81, ¶82) affixed to the inner side of the balloon's bending direction (figure 11).
Regarding claim 6, Chuter discloses wherein the fixed-length restraint (elements 254b) on the inner side of the balloon's axial intended bending direction (figure 11) are lines or threads or strands (¶81, ¶82) fixed at both ends of the balloon (210) (figure 11).
Regarding claim 8, Chuter discloses wherein the radial restraint (elements 254a, 254b) of the balloon (210) comprises specific regions of the balloon (considered as portions of element 210) modified to increase modulus and stiffness of the balloon in those specific regions (¶81 and figure 11).
Regarding claim 16, Chuter discloses wherein the radial restraint (elements 254a, 254b) of the balloon (210) is an anisotropic material (e.g. Nitinol, ¶55), with a lower elastic modulus in an axial direction and a higher elastic modulus in a radial direction (¶55).
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) 7, 9-12, 15, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chuter (US 2015/0133988) in view of Davies, Jr. et al. (US 7,914,487), herein referred to as Davies, Jr.
Regarding claim 7, Chuter’s balloon catheter traction device discloses all the features/elements as claimed but lacks wherein the radial restraint of the balloon is a mesh or a sleeve with a fixed diameter, or another balloon with a fixed diameter. Yet, Chuter teaches in alternative embodiments, the balloon includes a supporting structure such as one or more wires or other fibers provided as a braid, wrap, mesh, and the like (¶42).
In addition, Davies, Jr. teaches a restraint (e.g. sleeve) with a fixed diameter (Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chuter’s balloon catheter traction device with wherein the radial restraint of the balloon is a mesh or a sleeve with a fixed diameter as taught by Davies, Jr., since such a modification would provide an alternative supporting structure.
Regarding claim 9, Chuter’s balloon catheter traction device discloses all the features/elements as claimed but lacks wherein the radial restraint of the balloon is a woven mesh around the outer circumference of the balloon, and the woven mesh exhibits different stretching properties in a radial direction and an axial direction. Yet, Chuter teaches in alternative embodiments, the balloon includes a supporting structure such as one or more wires or other fibers provided as a braid, wrap, mesh, and the like (¶42) and wherein the fibers may be formed from Nitinol (e.g. exhibits different stretching properties in a radial direction and an axial direction) (¶55).
In addition, Davies, Jr. teaches a braided fabric sleeve (woven mesh) (Abstract) around an outer circumference of a balloon (Abstract), and the woven mesh (Abstract) exhibits different stretching properties in a radial direction (figures 4a-4c) and an axial direction (figures 4a-4c).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chuter’s balloon catheter traction device with wherein the radial restraint of the balloon is a woven mesh around the outer circumference of the balloon, and the woven mesh exhibits different stretching properties in a radial direction and an axial direction as taught by Davies, Jr., since such a modification would provide an alternative supporting structure.
Regarding claim 10, the modified Chuter’s balloon catheter traction device has wherein longitudinal threads of the woven mesh (the modified Chuter’s balloon catheter traction device having the woven mesh) possess a strong elastic modulus, resisting stretching and maintaining a fixed diameter (figure 11 of Chuter), and latitudinal threads of the woven mesh (the modified Chuter’s balloon catheter traction device having the woven mesh) possess good elasticity, enabling the woven mesh to have stretching characteristics in the axial direction (figure 11 of Chuter).
Regarding claim 11, the modified Chuter’s balloon catheter traction device has wherein a weaving method or pattern of the woven mesh (the modified Chuter’s balloon catheter traction device having the woven mesh) provides denser longitudinal threads and sparser latitudinal threads (¶57 of Chuter).
Regarding claim 12, the modified Chuter’s balloon catheter traction device has wherein ends of the woven mesh (the modified Chuter’s balloon catheter traction device having the woven mesh) are fixed at both ends of the balloon (210 of Chuter), and the woven mesh (the modified Chuter’s balloon catheter traction device having the woven mesh) and balloon (210 of Chuter) are initially in a folded and rolled configuration (¶49 of Chuter), and during use, as the balloon inside the balloon catheter (212 of Chuter) inflates and bends (figure 11 of Chuter), the woven mesh follows the bending (figure 11 of Chuter), and once a diameter of the balloon (210 of Chuter) reaches a preset diameter of the woven mesh (the modified Chuter’s balloon catheter traction device having the woven mesh), even if the balloon is further inflated, its diameter no longer changes (¶81, ¶82 of Chuter).
Regarding claim 15, the modified Chuter’s balloon catheter traction device has wherein in an axial intended bending direction of the balloon (210 of Chuter), one or a nearby number of latitudinal threads of the woven mesh (the modified Chuter’s balloon catheter traction device having the woven mesh) are of the same material as the longitudinal threads (¶55 of Chuter).
Regarding claims 17, 18, Chuter’s balloon catheter traction device discloses all the features/elements as claimed but lacks wherein the radial restraint of the balloon is a series of radial reinforcement ribs or a reinforcement mesh applied externally to the balloon after it is formed, wherein the radial reinforcement rib or reinforcement mesh is externally coated with a polymer film or membrane for fixing the reinforcement or reinforcement mesh. Yet, Chuter teaches in alternative embodiments, the balloon includes a supporting structure such as one or more wires or other fibers provided as a braid, wrap, mesh, and the like (¶42).
In addition, Davies, Jr. teaches a reinforcement mesh (510) applied externally to a balloon (500) after it is formed (col. 11, ll. 25-30), wherein the reinforcement mesh (510) is externally coated with a polymer film (514) or membrane for fixing the reinforcement mesh (510).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chuter’s balloon catheter traction device with a reinforcement mesh applied externally to a balloon after it is formed, wherein the reinforcement mesh is externally coated with a polymer film or membrane for fixing the reinforcement mesh as taught by Davies, Jr., since such a modification would provide an alternative supporting structure and wherein the polymer film would further secure the parts in place.
Regarding claim 19, Chuter’s balloon catheter traction device discloses all the features/elements as claimed but lacks wherein the radial restraint of the balloon is a woven mesh embedded within the balloon, and both the inner and outer sides of the balloon consist of thermoplastic elastomeric material and encase the woven mesh. Yet, Chuter teaches in alternative embodiments, the balloon includes a supporting structure such as one or more wires or other fibers provided as a braid, wrap, mesh, and the like (¶42).
In addition, Davies, Jr. teaches a radial restraint (e.g. braided fabric sleeve) of a balloon (500) is a woven mesh (510) embedded within a balloon (500), and both the inner and outer sides of the balloon (500) consist of thermoplastic elastomeric material (514) (col. 10, ll. 49-57) and encase the woven mesh (col. 11, ll. 25-30).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chuter’s balloon catheter traction device with wherein the radial restraint of the balloon is a woven mesh embedded within the balloon, and both the inner and outer sides of the balloon consist of thermoplastic elastomeric material and encase the woven mesh as taught by Davies, Jr., since such a modification would provide an alternative supporting structure and wherein a polymer film would further secure the parts in place.
Claim(s) 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chuter (US 2015/0133988).
Regarding claim 20, Chuter’s balloon catheter traction device discloses all the features/elements as claimed but lacks wherein the radial restraint of the balloon is a memory metal mesh incorporated into outer sheathing of the balloon, with the memory metal mesh having a memory of a contracted or original shape.
However, Chuter teaches in alternative embodiments, the balloon includes a supporting structure (e.g. radial restraint) such as one or more wires or other fibers provided as a braid, wrap, mesh, and the like (¶42) and the fiber(s) may be formed from a Nitinol material (¶55) (memory metal having a memory of a contracted or original shape).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chuter’s balloon catheter traction device with wherein the radial restraint of the balloon is a memory metal mesh incorporated into outer sheathing of the balloon, with the memory metal mesh having a memory of a contracted or original shape as taught by Chuter, since such a modification would provide an alternative supporting structure.
Regarding claim 21, the modified Chuter’s balloon catheter traction device has wherein the memory metal mesh (¶55) has a diameter contracted to an original state (¶55).
Regarding claim 22, the modified Chuter’s balloon catheter traction device has wherein the memory metal mesh (¶55) of the balloon catheter traction device maintains at least one fixed-length memory metal wire on an inner side of the balloon's anticipated or intended axial bending direction (figure 11).
Response to Arguments
Applicant's arguments filed February 5, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 6-7, under 35 U.S.C. 102(a)(1) and 35 U.S.C. 103, of the Remarks are directed to amended claim 1 and the reference Chuter. Applicant argues that “As amended, Claim 1 recites a balloon catheter and a balloon fixed onto the balloon catheter, wherein the balloon fixed onto the balloon catheter is an eccentrically positioned balloon. Nothing in Chuter provides or suggests that there is a fixed balloon is eccentrically positioned. The inflated Chuter embodiments are clearly shown and described as defined by their "supporting structure," and not by an eccentrically positioned fixed balloon on the balloon catheter.” However, the Examiner respectfully disagrees because as generally claimed, Chuter discloses wherein the balloon (210) fixed (defined as “attached” by The Free Dictionary) onto the balloon catheter (212) is an eccentrically (defined as “not situated in the center” or “not precisely circular” by The Free Dictionary) positioned balloon (figure 11).
Applicant further argues that “would not need or look to Davies to provide an inelastic braided sleeve for this same, albeit even more rigid, purpose”. Yet, Chuter teaches in alternative embodiments, the balloon includes a supporting structure such as one or more wires or other fibers provided as a braid, wrap, mesh, and the like (¶42). In addition, Davies, Jr. teaches a restraint (e.g. sleeve) with a fixed diameter (Abstract). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chuter’s balloon catheter traction device with wherein the radial restraint of the balloon is a mesh or a sleeve with a fixed diameter as taught by Davies, Jr., since such a modification would provide an alternative supporting structure.
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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/SI MING KU/Primary Examiner, Art Unit 3775