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
Claims 1 and 3 are objected to because of the following informalities: in lines 4-5 of claim 1, “an end forming portion formed at a height same as a height of an end of the cutting blade” should read “an end forming portion formed at a height equal to a height of an end of the cutting blade” for clarity; and in lines 1-2 of claim 3, “wherein the end forming portion has a height gradually decreasing toward a distal end” should read “wherein the height of the end forming portion gradually decreases toward a distal end” for consistency. Appropriate correction is required.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5 and 7-11 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kojima et al. (Pub. No. 2026/0158246).
Regarding claim 1, Kojima et al. discloses a balloon (2; FIG. 10) for use in a balloon catheter (1), wherein one or a plurality of cutting blades (41; [0057] 41 can cut straight through stenosis) is provided on an outer peripheral face of the balloon (FIG. 10: 41 are on the outer surface of 2) in parallel with a longitudinal direction of the balloon (FIG. 10: 41 are in the x-axis direction), and wherein an end forming portion (43) formed at a height equal to a height of an end of the cutting blade is provided at either end of the cutting blade in the longitudinal direction ([0095] 43 have the height of 41 at the point where they meet 41, and are on either side of each 41; FIG. 10).
Regarding claim 2, Kojima et al. further discloses the end forming portion is formed so as to cover part of an end of a blade tip of the cutting blade (FIG. 10: each 43 covers the lateral ends of 41).
Regarding claim 3, Kojima et al. further discloses the height of the end forming portion gradually decreases toward a distal end (FIG. 10: 43 taper from 41 to 42 in both proximal and distal directions).
Regarding claim 4, Kojima et al. further discloses the cutting blade is attached to a base portion made of resin ([0099] the body 20, which includes 41, 42, and 43, is made of resin), and the end forming portion is molded integrally with the base portion ([0066] 43 is made by melting the resin between regions of 41 to make the low regions 42 and the transitions 43).
Regarding claim 5, Kojima et al. further discloses the cutting blade is divided into a plurality of parts in the longitudinal direction (FIG. 10: multiple 41 are lined up in the x-axis direction).
Regarding claim 7, Kojima et al. further discloses a balloon catheter (1) comprising the balloon according to claim 1 (2; see rejection above).
Regarding claim 8, Kojima et al. further discloses a balloon catheter (1) comprising the balloon according to claim 2 (2; see rejection above).
Regarding claim 9, Kojima et al. further discloses a balloon catheter (1) comprising the balloon according to claim 3 (2; see rejection above).
Regarding claim 10, Kojima et al. further discloses a balloon catheter (1) comprising the balloon according to claim 4 (2; see rejection above).
Regarding claim 11, Kojima et al. further discloses a balloon catheter (1) comprising the balloon according to claim 5 (2; see rejection above).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kojima et al. in view of Ikoma (Pub. No. 2025/0269152).
Regarding claim 6, Kojima et al. discloses the invention as claimed in claim 1, as discussed above. Kojima et al. is silent regarding the cutting blade includes metal blades and resin blades that are alternately disposed.
Ikoma teaches in the same field of endeavor of balloon catheters (Abstract), and discloses a cutting blade (17), where the cutting blade can include metal blades and resin blades that are alternately disposed ([0075] convex strip 17 may be made of metal or resin or a combination of both, and can vary between material designs) for the purpose of making the cracking or cutting open of a stenosis site easier while the balloon is inflated ([0075]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the cutting blade of Kojima et al. to have alternating metal and resin blades, as taught by Ikoma, for the purpose of making the cracking or cutting open of a stenosis site easier while the balloon is inflated.
Regarding claim 12, Kojima et al. further discloses a balloon catheter (1) comprising the balloon according to claim 5 (2; see rejection above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kojima et al. (Pub. No. 2026/0047861) discloses a similar balloon catheter with a cutting blade (FIGs. 1-2); and Okamoto et al. (U.S. Patent No. 12,337,128) discloses a similar ballon catheter with a cutting blade (FIGs. 2A-2B).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES R MCGINNITY/Examiner, Art Unit 3771
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