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 .
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.
Claim 5 is 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.
Regarding claim 5, the recitation “wherein blood flow in the bypass tube is formed opposite to an entry direction of the balloon” renders the claim indefinite because the claim is unclear if the claim is positively reciting “blood flow” as a part of the claimed invention or if the balloon dilatation catheter is configured to have blood flow in the pass tube formed opposite to an entry direction of the balloon. For examination purposes, examiner construes that the balloon dilatation catheter is configured to have blood flow in the bypass tube formed opposite to an entry direction of the balloon.
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 4-6 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).
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 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 bypass tube 128 is formed opposite to an entry direction of the balloon 102.
Regarding claim 6, Ramanath teaches wherein the balloon 102 contracts around the bypass tube 128 when the balloon is contracted, and is supported in contact with the bypass tube 128.
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).
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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