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 Objections
Claim 2 is objected to because of the following informalities:
Claim 1, line 2 recites “wherein strength of the inner shaft and strength of the outer shaft at longitudinal strain of” but should read “wherein a strength of the inner shaft and a strength of the outer shaft at a longitudinal strain of” due to the lack of articles.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Yagi (WO 2019156195 A1, however for convenience, the rejection will reference the corresponding US Publication 20210045806 A1, which applicant cited and provided copies of on 6/7/2024) in view of Miki et al. (US 6706010 B1).
Regarding claim 1, Yagi discloses a balloon catheter (100) comprising:
an outer shaft (1) having flexibility (Paragraph [0015]);
an inner shaft (4) inserted into the outer shaft (Fig. 1) and having flexibility (Paragraph [0018]);
an intermediate tube (5) fitted onto the inner shaft (Fig. 1), only a proximal end portion of the intermediate tube being fixed on the inner shaft (Paragraph [0078]);
a longitudinally expandable balloon (9) made of an elastic material (Paragraph 0022]) and connected to a distal end portion of the outer shaft and a distal end portion of the inner shaft (Fig. 1).
Yagi is silent regarding
a radiopaque marker located inside the balloon and fixed on the intermediate tube.
In analogous art, Miki teaches a radiopaque marker (16) located inside a balloon (3) and fixed on an intermediate tube (14, Fig. 3).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the ballon catheter of Yagi to incorporate the teachings of Miki to incorporate a radiopaque marker located inside the balloon and fixed on the intermediate tube in order to locate the balloon within the body via X-ray.
Regarding claim 3, Yagi in view in Miki disclose the balloon catheter of claim 1, wherein a tensile modulus of the intermediate tube is 1.3 to 4 GPa (Yagi discloses that the intermediate tube is made from a polyimide, see Paragraph [0079], and polyimide has a tensile modulus of 3.4 GPa, as evidenced by applicant’s disclosure, see Paragraph [0066]).
Regarding claim 4, Yagi in view in Miki disclose the balloon catheter of claim 1, wherein a clearance between an inner diameter of the intermediate tube and an outer diameter of the inner shaft is 0.01 to 0.20 mm (Paragraph [0023], Yagi).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Yagi (WO 2019156195 A1, however for convenience, the rejection will reference the corresponding US Publication 20210045806 A1) in view of Miki et al. (US 6706010 B1) further in view of Miyata et al. (US 5695467 A).
Regarding claim 2, Yagi in view of Miki disclose the balloon catheter of claim 1,
wherein strength of the outer shaft at longitudinal strain of 5% is 5.0 to 15.0 N (Examiner notes that Paragraphs [0060]-[0061] of the present application describe that the outer shaft has a certain cross-sectional area, thus having a strength of 8.5N at a longitudinal strain of 5%. Yagi teaches the outer cylinder shaft (1) being made of the same material and also having the same cross-sectional shape, see Paragraphs [0121]-[0122], therefore the strength of the outer cylinder shaft of Yagi would also be 8.5N).
Yagi in view Miki are silent regarding wherein strength of the inner shaft and strength of the outer shaft at longitudinal strain of 5% are 4.5 to 14.5 N and 5.0 to 15.0 N, respectively, and the strength of the outer shaft at the longitudinal strain of 5% with respect to the strength of the inner shaft at the longitudinal strain of 5% is 100% to 160%.
Yagi teaches that the inner shaft (4) is made of polyamide, has an outer diameter of 1.2mm, and an inner diameter of 1.0mm (Paragraph [0126]), therefore teaching a cross-sectional area of 0.11π mm2.
In analogous art, Miyata teaches an inner shaft (130) is made of polyamide, has an outer diameter of 1.4mm, and an inner diameter of 1.0mm (Col 12, lines 56-58), therefore teaching a cross-sectional area of 0.24π mm2.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the inner shaft of Yagi to incorporate the teachings of Miyata to incorporate increasing the cross-sectional area in order to allow a larger variety of guidewire sizes to be inserted through the lumen.
The modification of Yagi in view of Miki further in view of Miyata would teach a strength of the inner shaft at a longitudinal strain of 5% to be 7N (If F=0.05AE, 0.05 being 5%, A being the cross-sectional area, and E being the elastic modulus of polyamide, then the strength of the inner shaft would be (6.5)(0.24)/0.2016=7.7N). The modification of Yagi in view of Miki further in view of Miyata would further teach that the strength of the outer shaft at the longitudinal strain of 5% with respect to the strength of the inner shaft at the longitudinal strain of 5% is 100% to 160% ((8.5)(100)/7.7=110%).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Yagi (WO 2019156195 A1, however for convenience, the rejection will reference the corresponding US Publication 20210045806 A1) in view of Miki et al. (US 6706010 B1) further in view of Perreault et al. (US 20050154414 A1).
Regarding claim 5, Yagi in view in Miki disclose the balloon catheter of claim 1, but are silent regarding wherein, when a longitudinal length of the balloon in a balloon contracted state is taken as 100%, a center of the radiopaque marker is located 30 to 60% from a proximal end portion of the balloon.
In analogous art, Perreault teaches a center of a radiopaque marker (232) is located 30 to 60% from a proximal end portion of a balloon or at other desired locations (Paragraph [0024], Fig. 4).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the radiopaque marker of Miki to incorporate having a center of the radiopaque marker is located 30 to 60% from a proximal end portion of the balloon (as taught by Perreault) when a longitudinal length of the balloon in a balloon contracted state is taken as 100% since mere rearrangement of the essential working parts of a devices involves only routine skill in the art In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Conclusion
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/HONG-VAN N TRINH/Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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