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
The Amendment filed 5/22/2026 has been entered. Claims 1-5 and 7 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every 112(b) rejections previously set forth in the Non-Final Office Action mailed 2/3/2026.
Claim Rejections - 35 USC § 102
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 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, 2 and 4-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ramanath et al. (US 2019/0099588 A1).
Regarding claim 1, Ramanath teaches a balloon dilatation catheter 100 (figure 1), comprising:
a catheter tube 104 provided to be disposed in a blood vessel;
a balloon 102 connected to the catheter tube 104 and dilatated by fluid injection;
a guide tube 106 disposed along the catheter tube 104 in the balloon 102; and
one or more bypass tubes 128 disposed through the balloon 102,
wherein balloon 102 flow is maintained through the bypass tubes 128 between both sides of the blood vessel blocked by the balloon 102 in a state where the balloon 102 is dilatated and the blood vessel is blocked (paragraph 0065, lines 19-23), and
wherein the balloon 102 is configured to contract around the at least one bypass tube 128 and tube supported in contact with an outer circumferential surface (outer circumferential surface of element 130) of the at least one bypass tube 128 during contraction (paragraph 0068, lines 1-10, since the element 130 is made of stiffer material than element 142, when deflating, the collapsing of element 142 would be faster and be able to be supported on element 130 before reaching to complete deflated state) to prevent flat contraction of the balloon 102.
Regarding claim 2, Ramanath teaches wherein the bypass tube 128 is supported on both sides of the balloon 102 and is made of an elastic material (paragraph 0065, lines 19-23, paragraph 0068, lines 1-6) that restores a dilatated shape of the balloon 102, and includes one or more of a spiral shape, a wave shape, and a curved shape (see shapes in figures 4-6 and 8, the shape includes curved shape).
Regarding claim 4, Ramanath teaches wherein the bypass tube 128 is connected to a front part (part of element 102 near element 108) of the balloon and a rear part (part of element 102 further away from element 108) of the balloon, an inlet (opening in element 128 near element 108) is located in the front part of the balloon and an outlet (opening in element 128 furthest away from element 108) is located in the rear part of the balloon 102.
Regarding claim 5, Ramanath teaches wherein the balloon dilatation catheter is configured to direct the blood flow (element 128 does not contain any structure that would prevent the blood from flowing in opposite direction to an entry direction of the balloon) in the at least one bypass tube 128 opposite to an entry direction of the balloon 102.
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ramanath et al. (US 2019/0099588 A1) in view of Fagan et al. (US 5,545,132).
Regarding claim 3, Ramanath discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 2. Ramanath further discloses the bypass tube 128 is arranged surrounding the guide tube 106 but is silent regarding the bypass tube is spirally arranged.
However, Fagan teaches a design of a perfusion balloon 10 comprising a bypass tube 16 wherein the bypass tube 16 is spirally arranged (see figure 1) for the purpose of using a well-known alternative shape allowing the perfusion of the blood past the balloon and/or maintaining balloon flexibility in the longitudinal direction to conform to blood vessel curves (column 2, lines 8-17).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the shape of the bypass tube to incorporate the bypass tube is spirally arranged for the purpose of using for the purpose of using a well-known alternative shape allowing the perfusion of the blood past the balloon and/or maintaining balloon flexibility in the longitudinal direction to conform to blood vessel curves (column 2, lines 8-17).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ramanath et al. (US 2019/0099588 A1) in view of Ham et al. (US 5,456,667).
Regarding claim 7, Ramanath discloses the claimed invention substantially as claimed, as set forth above in claim 1. Ramanath further discloses a balloon dilatation angioplasty using the balloon dilatation catheter 100, and liquid (paragraph 0066, lines 11-14, paragraph 0064, lines 21-26) is injected into the balloon through the catheter tube 104 to dilate the balloon 102, and the blood flow is maintained between the both sides of the blood vessel blocked by the balloon 102 through the bypass tube 128. Ramanath further discloses inclusion of the guidewire lumen 106 but is silent regarding wherein a guide wire pre-disposed in the blood vessel is moved through the guide tube so that the balloon is located at a procedure site of the blood vessel.
However, Ham teaches a method of inserting the balloon catheter into the patient’s body comprising wherein a guide wire 24 (figure 3, column 7, lines 39-54) pre-disposed in the blood vessel is moved through the guide tube so that the balloon is located at a procedure site of the blood vessel for the purpose of guiding the catheter insertion into the desired blood vessel location to perform a medical procedure (column 7, lines 39-54).
Therefore, it would have been prima facie obvious to one of modify the method of Ramanath to incorporate further discloses a guide wire pre-disposed in the blood vessel is moved through the guide tube so that the balloon is located at a procedure site of the blood vessel as taught by Ham for the purpose of guiding the catheter insertion into the desired blood vessel location to perform a medical procedure (column 7, lines 39-54).
Response to Arguments
Applicant's arguments filed 5/22/2026 have been fully considered but they are not persuasive.
Applicant argues on page 6, line 1-page 9, line 21 that Ramanath is only directed to a non-occluding drug-coated balloon and one or more bypass passages are provided through the balloon allowing blood to flow downstream through the passage(s) when the balloon is inflated and pressed against the vessel wall. Applicant further presents paragraph 0065 of Ramanath to indicate that outer envelope is folded around the catheter shaft and fails to disclose the claimed invention. Therefore, applicant argues that claimed invention is distinct from Ramanath. Examiner respectfully disagrees. While Ramanath is silent regarding the balloon configuration/shape when the balloon is completely deflated, Ramanath does disclose in paragraph 0068 that the lumen wall 130 is made stiffer than element 142 therefore, when the balloon is started to deflate, the stiffer material will take a longer time to reduce in structure and therefore, element 142 will collapse before element 130. Since the balloon is still getting contracted and not completely contracted, the balloon will be prevented flat contraction during the contraction process. Thus, during the deflation process, the balloon is configured to contract around the at least one bypass tube and to be supported in contact with an outer circumferential surface of the at least one bypass tube during contraction to prevent flat contraction of the balloon. Claim needs to be further amended to clarify if the claimed function is happened when the balloon is completely contracted/deflated in order to overcome the prior art of record.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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