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 .
Acknowledgments
In the reply, filed on July 2, 2026, Applicant amended claims 1, 3, 8, 10, and 19-20.
Applicant cancelled claims 7 and 16-18.
In the non-final rejection of April 7, 2026, Examiner objected to the Abstract. Applicant amended the Abstract. Objection is withdrawn.
Examiner objected to claims 1, 3, 10, and 19-20. Applicant amended claims 1, 3, 10, and 19-20. Objection is withdrawn.
Examiner rejected claims 3-6 and 19-20 under 35 U.S.C. 112(b). Applicant amended claims 3 and 19-20. Rejection is withdrawn.
Claim Objections
Claim 19 is objected to because of the following informalities:
In regards to claim 19, lines 15-16, “the adjacent threads of the plurality of threads over the distal waist” should be changed to “adjacent threads of the plurality of threads over the distal waist”.
In regards to claim 19, line 17, “the adjacent threads of the plurality of threads over the intermediate portion” should be changed to “adjacent threads of the plurality of threads over the intermediate portion”.
In regards to claim 19, lines 18-19, “the adjacent threads of the plurality of threads over the distal transition portion” should be changed to “adjacent threads of the plurality of threads over the distal transition portion”.
Appropriate correction is required.
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.
Claims 1-6, 8, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Weng et al (US 2009/0038752), and further in view of Thielen et al (US 8,808,237).
In regards to claim 1, Weng et al teaches a balloon catheter (Figures 1-2, balloon 1)(paragraph [0026]: distal and proximal balloon neck portions (10) and (12) are bonded to a catheter shaft), comprising:
an inflatable balloon (1), wherein the inflatable balloon includes an intermediate portion (4), a distal waist (12), and a transition portion (8) between the intermediate portion and the distal waist, wherein at least a portion of the transition portion has a cone angle of at least 40 degrees (Figure 1), wherein the inflatable balloon includes an outer balloon wall (14)
a braiding (22/24/26) positioned on an exterior surface of the inflatable balloon, wherein the braiding includes a plurality of threads (22/24/26), wherein a spacing between adjacent threads of the plurality of threads over the distal waist is smaller than a spacing between adjacent threads of the plurality of threads over the intermediate portion (Figure 1), and wherein a spacing between adjacent threads of the plurality of threads over the transition portion gradually transitions over the transition portion from the spacing between the adjacent threads of the plurality of threads over the intermediate portion to the spacing between the adjacent threads of the plurality of threads over the distal waist (Figure 1)
a mandrel (catheter shaft) (paragraph [0026])
Weng et al is silent about wherein the inflatable balloon includes an inner balloon wall, and wherein the outer balloon wall is configured to be spaced away from the inner balloon wall over at least the intermediate portion and the transition portion when the inflatable balloon is inflated. Thielen et al teaches a balloon catheter (Figure 1B) wherein an inflatable balloon (10) includes an inner balloon wall (20) and an outer balloon wall (15), and wherein the outer balloon wall is configured to be spaced away from the inner balloon wall over at least an intermediate portion and a transition portion when the inflatable balloon is inflated (Figure 1B). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the inflatable balloon, of the balloon catheter of Weng et al, with an inner balloon wall, and wherein the outer balloon wall is configured to be spaced away from the inner balloon wall over at least the intermediate portion and the transition portion when the inflatable balloon is inflated, as taught by Thielen et al, as such will form an annular space that can be inflated using saline or contrast medium (column 2, lines 66-67, to column 3, lines 1-2) from a smaller diameter configuration to an expanded larger diameter configuration (column 14, lines 58-62).
Weng et al is silent about the mandrel radially inward of the inner balloon wall, wherein the inner balloon wall is coupled to the mandrel. Thielen et al teaches a mandrel (92) radially inward of the inner balloon wall (Figure 1B: 105 of 92 is radially inward of 20), wherein the inner balloon wall is coupled to the mandrel (Figure 1B). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the mandrel, of the modified balloon catheter of Weng et al and Thielen et al, to be radially inward of the inner balloon wall, wherein the inner balloon wall is coupled to the mandrel, as taught by Thielen et al, as such will provide a separate through-lumen that can be used to provide passage for a guidewire or for delivery of fluid, drug, or contrast to a position distal to the balloon (column 7, lines 49-54).
In regards to claim 2, in the modified balloon catheter of Weng et al and Thielen et al, Weng et al teaches wherein the plurality of threads includes a plurality of clockwise threads (24), a plurality of counterclockwise threads (26), and a plurality of longitudinal threads (22), wherein the plurality of clockwise threads, the plurality of counterclockwise threads, and the plurality of longitudinal threads are braided together over the exterior surface of the inflatable balloon (Figure 1).
In regards to claim 3, in the modified balloon catheter of Weng et al and Thielen et al, Weng et al teaches wherein the plurality of threads includes a same number of the clockwise threads of the plurality of clockwise threads, the counterclockwise threads of the plurality of counterclockwise threads, and the longitudinal threads of the plurality of longitudinal threads over the intermediate portion, the transition portion, and the distal waist (Figure 1).
In regards to claim 4, in the modified balloon catheter of Weng et al and Thielen et al, Weng et al teaches a thermoplastic polyurethane layer (16) formed over at least a portion of the inflatable balloon between the inflatable balloon and the braiding (Figure 2)(paragraph [0040]).
In regards to claim 5, in the modified balloon catheter of Weng et al and Thielen et al, Weng et al teaches wherein the thermoplastic polyurethane layer is a first thermoplastic polyurethane layer (16), and wherein the balloon catheter further comprises a second thermoplastic polyurethane layer formed over at least a portion of the braiding (20) (Figure 2)(paragraph [0027]).
In regards to claim 6, in the modified balloon catheter of Weng et al and Thielen et al, Weng et al is silent about a silicone-based lubricious coating on an exterior of the balloon catheter. Thielen et al teaches a silicone-based lubricious coating (50) on an exterior of the balloon catheter (column 6, lines 19-29). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified balloon catheter, of Weng et al and Thielen et al, with a silicone-based lubricious coating on an exterior of the balloon catheter, as taught by Thielen et al, as such will form a fluid-tight balloon silicone surface or coating that can stretch to accommodate length and diameter changes for the balloon (column 6, lines 19-29).
In regards to claim 8, in the modified balloon catheter of Weng et al and Thielen et al, Weng et al is silent about wherein the mandrel extends along an entire length of the inflatable balloon. Thielen et al teaches wherein the mandrel extends along an entire length of the inflatable balloon (Figure 1B: 105 of 92 extends along an entire length of 10). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the mandrel, of the modified balloon catheter of Weng et al and Thielen et al, to extend along an entire length of the inflatable balloon, as taught by Thielen et al, as such will provide a separate through-lumen that can be used to provide passage for a guidewire or for delivery of fluid, drug, or contrast to a position distal to the balloon (column 7, lines 49-54).
In regards to claim 19, Weng et al teaches a balloon catheter (Figures 1-2, balloon 1)(paragraph [0026]: distal and proximal balloon neck portions (10) and (12) are bonded to a catheter shaft), comprising:
an inflatable balloon (1), wherein the inflatable balloon includes an intermediate portion (4), a proximal waist (10), a proximal transition portion (6) between the proximal waist and the intermediate portion, a distal waist (12), and a distal transition portion (8) between the intermediate portion and the distal waist, wherein at least a portion of the distal transition portion includes a cone angle of at least 50 degrees (Figure 1), wherein the inflatable balloon includes an outer balloon wall (14)
a braiding (22/24/26) positioned on an exterior surface of the inflatable balloon, wherein the braiding includes a plurality of clockwise threads (24), a plurality of counterclockwise threads (26), and a plurality of longitudinal threads (22), wherein the plurality of clockwise threads, the plurality of counterclockwise threads, and the plurality of longitudinal threads collectively form a plurality of threads (22/24/26), wherein a spacing between the adjacent threads of the plurality of threads over the distal waist is smaller than a spacing between the adjacent threads of the plurality of threads over the intermediate portion (Figure 1), and wherein a spacing between the adjacent threads of the plurality of threads over the distal transition portion gradually transitions over the distal transition portion from the spacing between the adjacent threads over the intermediate portion to the spacing between the adjacent threads over the distal waist (Figure 1)
a mandrel (catheter shaft) (paragraph [0026])
Weng et al is silent about wherein the inflatable balloon includes an inner balloon wall, and wherein the outer balloon wall is configured to be spaced away from the inner balloon wall over at least the intermediate portion and the distal transition portion when the inflatable balloon is inflated. Thielen et al teaches a balloon catheter (Figure 1B) wherein an inflatable balloon (10) includes an inner balloon wall (20) and an outer balloon wall (15), and wherein the outer balloon wall is configured to be spaced away from the inner balloon wall over at least an intermediate portion and a distal transition portion when the inflatable balloon is inflated (Figure 1B). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the inflatable balloon, of the balloon catheter of Weng et al, with an inner balloon wall, and wherein the outer balloon wall is configured to be spaced away from the inner balloon wall over at least the intermediate portion and the distal transition portion when the inflatable balloon is inflated, as taught by Thielen et al, as such will form an annular space that can be inflated using saline or contrast medium (column 2, lines 66-67, to column 3, lines 1-2) from a smaller diameter configuration to an expanded larger diameter configuration (column 14, lines 58-62).
Weng et al is silent about the mandrel coupled to the inner balloon wall and extending along an entire length of the inflatable balloon from the proximal waist to the distal waist. Thielen et al teaches a mandrel (92) coupled to the inner balloon wall and extending along an entire length of the inflatable balloon from a proximal waist to a distal waist (Figure 1B: 105 of 92 extends along an entire length of 10 from a proximal waist to a distal waist). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the mandrel, of the modified balloon catheter of Weng et al and Thielen et al, to be coupled to the inner balloon wall and extending along an entire length of the inflatable balloon from the proximal waist to the distal waist, as taught by Thielen et al, as such will provide a separate through-lumen that can be used to provide passage for a guidewire or for delivery of fluid, drug, or contrast to a position distal to the balloon (column 7, lines 49-54).
In regards to claim 20, in the modified balloon catheter of Weng et al and Thielen et al, Weng et al teaches wherein the plurality of threads includes a same number of the clockwise threads of the plurality of clockwise threads, the counterclockwise threads of the plurality of counterclockwise threads, and the longitudinal threads of the plurality of longitudinal threads over the proximal waist, the proximal transition portion, the intermediate portion, the distal transition portion, and the distal waist (Figure 1).
Claims 9-11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Weng et al and Thielen et al, as applied to claim 1 above, and further in view of Tilson et al (US 9,592,119).
In regards to claim 9, in the modified balloon catheter of Weng et al and Thielen et al, Weng et al does not teach wherein the inflatable balloon includes a diameter of 10 mm, as Weng et al instead teaches wherein the inflatable balloon includes a diameter of 8 mm (paragraph [0062]), and Weng et al does not teach wherein the transition portion includes a length of 8.5 mm, as Weng et al instead teaches wherein the transition portion includes a length of 10 mm (paragraph [0062]). Tilson et al teaches a balloon catheter (Figures 1A-1B) wherein an inflatable balloon (20) includes a diameter (50) of 10 mm (column 9, lines 66-67, to column 10, line 1), and wherein a transition portion (42) includes a length (44) of 8.5 mm (column 10, lines 56-57). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the inflatable balloon, of the modified balloon catheter of Weng et al and Thielen et al, to include a diameter of 10 mm and the transition portion to include a length of 8.5 mm, as taught by Tilson et al, as such will provide for medical invasive balloons, such as those used for transcutaneous heart valve implantation, such as balloons used for transcatheter aortic-valve implantation (Abstract).
In regards to claim 10, in the modified balloon catheter of Weng et al, Thielen et al, and Tilson et al, Weng et al teaches wherein at least a portion of the transition portion extends at an angle of 25 degrees from a distal end of the intermediate portion (Figure 1).
In regards to claim 11, in the modified balloon catheter of Weng et al, Thielen et al, and Tilson et al, Weng et al teaches wherein the transition portion is a distal transition portion (8), and wherein the inflatable balloon further includes a proximal waist (10) and a proximal transition portion (6) between the intermediate portion and the proximal waist.
In regards to claim 15, in the modified balloon catheter of Weng et al and Thielen et al, Weng et al is silent about wherein the balloon catheter has a rated burst pressure of at least 30 atmospheres. Tilson et al teaches a balloon catheter (Figures 1A-1B) wherein the balloon catheter has a rated burst pressure of at least 30 atmospheres (column 10, line 20: about 500 psi (3,448 kPa)). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified balloon catheter, of Weng et al and Thielen et al, to have a rated burst pressure of about 500 psi (3,448 kPa), as taught by Tilson et al, which is at least 30 atmospheres, as such will provide for medical invasive balloons, such as those used for transcutaneous heart valve implantation, such as balloons used for transcatheter aortic-valve implantation (Abstract).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Weng et al and Thielen et al, as applied to claim 1 above, and further in view of Shohat et al (US 2011/0245841).
In regards to claim 12, in the modified balloon catheter of Weng et al and Thielen et al, Weng et al does not teach wherein the balloon catheter is configured to be used for a percutaneous nephrolithotomy or nephrolithotripsy procedure such that the distal waist is positioned adjacent to a stone, as Weng et al instead teaches wherein the balloon catheter is configured to be used for percutaneous transluminal angioplasty (paragraph [0002]). Shohat et al teaches a balloon catheter (Figure 18), wherein the balloon catheter is configured to be used for a percutaneous nephrolithotomy or nephrolithotripsy procedure such that a distal waist (of 71) is positioned adjacent to a stone (paragraph [0092]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified balloon catheter, of Weng et al and Thielen et al, to be configured to be used for a percutaneous nephrolithotripsy procedure such that the distal waist is positioned adjacent to a stone, as taught by Shohat et al, as such may be desirable in order to, for example, prevent stone migration to cavities such as calyxes of the kidney during ureteroscopy and/or percutaneous nephrolithotripsy (paragraph [0092]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Weng et al and Thielen et al, as applied to claim 1 above, and further in view of Holman et al (US 8,672,990).
In regards to claim 13, in the modified balloon catheter of Weng et al and Thielen et al, Weng et al is silent about wherein the plurality of threads are fused together over at least a portion of the distal waist. Holman et al teaches a balloon catheter (Figure 16) wherein a plurality of threads (112) are fused together over at least a portion of a distal waist (16). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of threads, of the modified balloon catheter of Weng et al and Thielen et al, to be fused together over at least a portion of the distal waist, as taught by Holman et al, as such will remain fixed relative to one another at the point of the bond such that one may control and create a specific expansion shape of the balloon and will facilitate proper alignment of the threads over the balloon during inflation and will allow a highly efficient collapse of the threads and balloon to a reduced profile after inflation (column 2, lines 40-53).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Weng et al and Thielen et al, as applied to claim 1 above, and further in view of Moffarah (WO 2020/040790).
In regards to claim 14, in the modified balloon catheter of Weng et al and Thielen et al, Weng et al does not teach wherein the plurality of threads are VectranTM fibers, as Weng et al instead teaches wherein the plurality of threads are high-tenacity para-aramid, thermotropic liquid crystal polyester-polyarylate, ultra-high molecular weight polyethylene, or extended chain polyethylene, poly-p-phenylene-2,6-benzobisoxazole and poly-paraphenylene terephthalamide (paragraph [0042]). Moffarah teaches a balloon catheter (Figure 3) wherein a plurality of threads (134) are VectranTM fibers (paragraph [00035]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of threads, of the modified balloon catheter of Weng et al and Thielen et al, to be VectranTM fibers, as taught by Moffarah, as such are inelastic fibers for reinforcing the balloon (paragraph [00035]) that can be manufactured quickly and easily, with a low profile and enhanced trackability, while still maintaining its ability to withstand high pressures, provide precise shape control, and have highly controlled tear properties (paragraph [00010]).
Response to Arguments
Applicant's arguments filed July 2, 2026, have been fully considered but they are not persuasive:
In regards to claim 1, Applicant argued: Independent claim 1, as amended, recites a balloon catheter comprising, among other things, an inflatable balloon, "wherein the inflatable balloon includes an inner balloon wall and an outer balloon wall, and wherein the outer balloon wall is configured to be spaced away from the inner balloon wall over at least the intermediate portion and the transition portion when the inflatable balloon is inflated," and "a mandrel radially inward of the inner balloon wall, wherein the inner balloon wall is coupled to the mandrel." Each claim that depends from claim 1 includes the same limitations. Neither Weng alone nor in combination with the other cited references teaches or suggests a balloon catheter as claimed… Thielen's catheter shaft 92 is not radially inward of the inner tubing 20. As shown in at least Thielen's FIG. 3A, "[a]n inflation lumen (90) provides inflation fluid through the catheter shaft (92) from a manifold (95) located at the perfusion balloon catheter proximal end (100) and delivered to the annular space (45)" between the outer tubing or outer balloon (15) and the inner tubing (20). Thielen at col. 6, II. 9-11 and col. 7, II. 43- 46. The other cited references do not cure the deficiencies of Weng and Thielen (Remarks, pages 9-10). Examiner disagrees. In the combination of Weng et al and Thielen et al, Weng et al teaches wherein the inflatable balloon (1) includes an outer balloon wall (14), and a mandrel (catheter shaft) (paragraph [0026]), and Thielen et al renders obvious wherein an inflatable balloon (10) includes an inner balloon wall (20) and an outer balloon wall (15), and wherein the outer balloon wall is configured to be spaced away from the inner balloon wall over at least an intermediate portion and a transition portion when the inflatable balloon is inflated (Figure 1B), and a mandrel (92) radially inward of the inner balloon wall (Figure 1B: 105 of 92 is radially inward of 20), wherein the inner balloon wall is coupled to the mandrel (Figure 1B).
In regards to claim 19, Applicant argued: Independent claim 19, as amended, recites a balloon catheter comprising, among other things, an inflatable balloon including "an inner balloon wall and an outer balloon wall, and wherein the outer balloon wall is configured to be spaced away from the inner balloon wall" and "a mandrel coupled to the inner balloon wall and extending along an entire length of the inflatable balloon from the proximal waist to the distal waist." Claim 20 depends from claim 19 and includes the same features. Neither Weng alone nor in combination with the other cited references teaches or suggests a balloon catheter as claimed.
As discussed above with respect to claim 1, the Office Action acknowledges that Weng does not disclose an inner balloon wall and an outer balloon wall, or a mandrel. Office Action at pp. 8-9. Thielen does not cure the deficiencies of Weng. For example, Thielen's catheter shaft 92 does not extend an entire length of Thielen's balloon catheter. Nor would one have attempted to extend the catheter shaft 92 when the purpose of the catheter shaft 92 is to deliver inflation fluid inside the balloon catheter (Remarks, page 10). Examiner disagrees. In the combination of Weng et al and Thielen et al, Weng et al teaches wherein the inflatable balloon (1) includes an outer balloon wall (14), and a mandrel (catheter shaft) (paragraph [0026]), and Thielen et al renders obvious wherein an inflatable balloon (10) includes an inner balloon wall (20) and an outer balloon wall (15), and wherein the outer balloon wall is configured to be spaced away from the inner balloon wall over at least an intermediate portion and a distal transition portion when the inflatable balloon is inflated (Figure 1B), and a mandrel (92) coupled to the inner balloon wall and extending along an entire length of the inflatable balloon from a proximal waist to a distal waist (Figure 1B: 105 of 92 extends along an entire length of 10 from a proximal waist to a distal waist).
Conclusion
THIS ACTION IS MADE FINAL. 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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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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