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 Invention I (claims 1-15 and 19-20) in the reply filed on March 19, 2026, is acknowledged.
Claims 16-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 19, 2026.
Currently, claims 1-15 and 19-20 are under examination as encompassing elected Invention I.
Specification
The abstract of the disclosure is objected to because:
In line 10, “the spacing between adjacent threads” should be changed to “the spacing between the adjacent threads of the plurality of threads”
In line 11, “the spacing between adjacent threads” should be changed to “the spacing between the adjacent threads of the plurality of threads”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 3, 10, and 19-20 are objected to because of the following informalities:
In regards to claim 1, line 11, “the spacing between adjacent threads” should be changed to “the spacing between the adjacent threads of the plurality of threads”.
In regards to claim 1, line 12, “the spacing between adjacent threads” should be changed to “the spacing between the adjacent threads of the plurality of threads”.
In regards to claim 3, line 2, “the same number” should be changed to “a same number”.
In regards to claim 10, line 2, “the distal end” should be changed to “a distal end”.
In regards to claim 19, lines 13-14, “the spacing between adjacent threads” should be changed to “the spacing between the adjacent threads of the plurality of threads” (Note that there is insufficient antecedent basis for “the plurality of threads”).
In regards to claim 19, line 14, “the spacing between adjacent threads” should be changed to “the spacing between the adjacent threads of the plurality of threads” (Note that there is insufficient antecedent basis for “the plurality of threads”).
In regards to claim 20, line 2, “the same number” should be changed to “a same number”.
Appropriate correction is required.
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.
Claims 3-6 and 19-20 are 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.
In regards to claim 3, line 2 recites “clockwise threads”. Claim 3 depends upon claim 2. Claim 2, lines 1-2 recite “a plurality of clockwise threads”. It is unclear whether the two recitations are the same components or different components. Claims 4-6 are rejected by virtue of being dependent upon claim 3.
In regards to claim 3, line 2 recites “counterclockwise threads”. Claim 3 depends upon claim 2. Claim 2, line 2 recites “a plurality of counterclockwise threads”. It is unclear whether the two recitations are the same components or different components. Claims 4-6 are rejected by virtue of being dependent upon claim 3.
In regards to claim 3, lines 2-3 recite “longitudinal threads”. Claim 3 depends upon claim 2. Claim 2, lines 2-3 recite “a plurality of longitudinal threads”. It is unclear whether the two recitations are the same components or different components. Claims 4-6 are rejected by virtue of being dependent upon claim 3.
In regards to claim 19, lines 10-12 recite “the plurality of threads” in three recitations. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 19, lines 8-9 previously recite “a plurality of clockwise threads, a plurality of counterclockwise threads, and a plurality of longitudinal threads”. It is unclear whether “the plurality of threads” refers to one of “a plurality of clockwise threads, a plurality of counterclockwise threads, and a plurality of longitudinal threads”. Claim 20 is rejected by virtue of being dependent upon claim 19. Claim 20, line 1 also recites “the plurality of threads” for which there is insufficient antecedent basis.
In regards to claim 19, lines 12-13 recite “the transition portion” in two recitations. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 19, lines 3-4 previously recite “a proximal transition portion… and a distal transition portion”. It is unclear whether “the transition portion” refers to one of “a proximal transition portion… and a distal transition portion”. Claim 20 is rejected by virtue of being dependent upon claim 19.
In regards to claim 20, line 2 recites “clockwise threads”. Claim 20 depends upon claim 19. Claim 19, line 8 recites “a plurality of clockwise threads”. It is unclear whether the two recitations are the same components or different components.
In regards to claim 20, line 2 recites “counterclockwise threads”. Claim 20 depends upon claim 19. Claim 19, lines 8-9 recite “a plurality of counterclockwise threads”. It is unclear whether the two recitations are the same components or different components.
In regards to claim 20, lines 2-3 recite “longitudinal threads”. Claim 20 depends upon claim 19. Claim 19, line 9 recites “a plurality of longitudinal threads”. It is unclear whether the two recitations are the same components or different components.
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.
Claims 1-5 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weng et al (US 2009/0038752).
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)
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 adjacent threads over the intermediate portion to the spacing between adjacent threads over the distal waist (Figure 1)
In regards to claim 2, 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, Weng et al teaches wherein the plurality of threads includes the same number of clockwise threads, counterclockwise threads, and longitudinal threads over the intermediate portion, the transition portion, and the distal waist (Figure 1).
In regards to claim 4, 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, 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 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)
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 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 adjacent threads over the intermediate portion to the spacing between adjacent threads over the distal waist (Figure 1)
In regards to claim 20, Weng et al teaches wherein the plurality of threads includes the same number of clockwise threads, counterclockwise threads, and longitudinal threads over the proximal waist, the proximal transition portion, the intermediate portion, the distal transition portion, and the distal waist (Figure 1).
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 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Weng et al, as applied to claims 1 and 5 above, and further in view of Thielen et al (US 8,808,237).
In regards to claim 6, Weng et al is silent about a silicone-based lubricious coating on an exterior of the balloon catheter. Thielen et al teaches a balloon catheter (Figure 1A) comprising 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 balloon catheter, of Weng 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 7, Weng et al teaches wherein the inflatable balloon includes an outer balloon wall (14); however, 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).
In regards to claim 8, in the modified balloon catheter of Weng et al and Thielen et al, Weng et al teaches a mandrel (catheter shaft) (paragraph [0026]); however, Weng et al is silent about wherein the inner balloon wall is coupled to the mandrel. Thielen et al teaches wherein the inner balloon wall is coupled to a mandrel (92) (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 inner balloon wall, of the modified balloon catheter of Weng et al and Thielen et al, to be 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).
Claims 9-11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Weng 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, 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 balloon catheter of Weng 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 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 the distal end of the intermediate portion (Figure 1).
In regards to claim 11, in the modified balloon catheter of Weng 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, 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 balloon catheter, of Weng 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, as applied to claim 1 above, and further in view of Shohat et al (US 2011/0245841).
In regards to claim 12, 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 balloon catheter, of Weng 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, as applied to claim 1 above, and further in view of Holman et al (US 8,672,990).
In regards to claim 13, 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 balloon catheter of Weng 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, as applied to claim 1 above, and further in view of Moffarah (WO 2020/040790).
In regards to claim 14, 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 balloon catheter of Weng 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]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEFALI D PATEL whose telephone number is (571)270-3645. The examiner can normally be reached Monday-Friday 8:30am-4:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin C Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHEFALI D PATEL/Primary Examiner, Art Unit 3783