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
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/17/2026.
Claim Objections
Claims 3 and 15 are objected to because of the following informalities:
Claim 3, line 3: “the tip-end side” should be amended to recite “a tip-end side” in order to first establish an antecedent basis for the term.
Claim 15, line 4: “the inner surface” should be amended to recite “the inner surface of the one of the tapered portions” to clarify which inner surface is being discussed.
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)(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.
(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.
Claims 1-7 and 10-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nakagawa (US PGPub 2015/0320985 A1).
With respect to claim 1, Nakagawa discloses a balloon catheter (10 in Fig. 1) comprising a balloon (20) that is inflatable and deflatable (see deflated balloon 20 in Fig. 4), wherein
the balloon (20 in Fig. 1) includes an outer surface that includes a first region (90) and a second region (80) that is at a part of the balloon (20) in an axial direction of the balloon (20) and has surface roughness greater than surface roughness of the first region (PP [0031]: “A rough portion 80 that has a large surface roughness and a smooth portion 90 that has a surface roughness that is smaller than the surface roughness of the rough portion 80 are formed on the surface of the balloon 20”).
Regarding claim 2, Nakagawa further discloses wherein the balloon (20 in Fig. 1) includes:
a straight tube portion (see straight portions of 80 and 90 in annotated Fig. 1 below) that has a diameter that is to be maximum when the balloon is inflated (the annotated area has the greatest diameter on the balloon when inflated); and
two tapered portions that sandwich the straight tube portion with respect to the axial direction (see annotated Fig. 1 below), wherein the tapered portions decrease in diameter toward farther sides from the straight tube portion (the tapered portions taper away from the straight portion), wherein
the second region (80) is formed in an outer surface of one of the tapered portions (80 is on the outer surface of at least part of the tapered portions).
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Regarding claim 3, Nakagawa further discloses wherein the second region (80 in Fig. 1) is formed in the outer surface of the one of the tapered portions on the tip-end side (80 is formed in the outer surface of at least part of the distal/left/tip end side tapered portion).
Regarding claim 4, Nakagawa further discloses a catheter tube (30 in Fig. 1) that includes a tip-end portion (60) at which the balloon (20) is disposed, wherein
the balloon (20) includes a tip-end leg portion (22) that is on an opposite side of the one of the tapered portions (22 is opposite from the proximal tapered portion of balloon 20) on the tip-end side from the straight tube portion (see annotated Fig. 1 below), wherein the tip-end leg portion (22) is joined to the catheter tube (PP [0027]: “The distal end of the inner tube 50 is secured to the tip 60 and the distal end attaching portion 22 of the balloon 20”), and
the second region (80) is formed in an outer surface of the tip-end leg portion (80 extends into the outer surface of tip end portion 22 in Fig. 1).
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Regarding claim 5, Nakagawa further discloses wherein the first region (90 in Fig. 1) is formed in an outer surface of the straight tube portion (see annotated Fig. 1 above, 90 is formed in the outer surface of at least part of the straight tube portion).
Regarding claim 6, Nakagawa further discloses wherein the first region (90 in Fig. 1) is formed in an outer surface of the straight tube portion (see annotated Fig. 2 above, 90 is formed in the outer surface of at least part of the straight tube portion).
Regarding claim 7, Nakagawa further discloses wherein the first region (90 in Fig. 1) is formed in an outer surface of the straight tube portion (see annotated Fig. 2 above, 90 is formed in the outer surface of at least part of the straight tube portion).
Regarding claim 10, Nakagawa further discloses a catheter tube (30 in Fig. 1) that includes a tip-end portion (60) at which the balloon (20) is disposed, wherein
the balloon (20) includes a tip-end leg portion (22) that is on an opposite side of the one of the tapered portions (22 is opposite from the proximal tapered portion of balloon 20) on the tip-end side from the straight tube portion (see annotated Fig. 1 below), wherein the tip-end leg portion (22) is joined to the catheter tube (PP [0027]: “The distal end of the inner tube 50 is secured to the tip 60 and the distal end attaching portion 22 of the balloon 20”), and
the second region (80) is formed in an outer surface of the tip-end leg portion (80 extends into the outer surface of tip end portion 22 in Fig. 1).
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Regarding claim 11, Nakagawa further discloses wherein the second region (80 in Fig. 1) is present for an entire area of the balloon (20) with respect to a circumferential direction of the balloon (see Fig. 1, 80 is present for an entire area with respect to a circumferential direction of the balloon, the area being a radial section of the full circumference).
Regarding claim 12, Nakagawa further discloses wherein the second region (80 in Fig. 1) is present for an entire area of the balloon (20) with respect to a circumferential direction of the balloon (see Fig. 1, 80 is present for an entire area with respect to a circumferential direction of the balloon, the area being a radial section of the full circumference).
Regarding claim 13, Nakagawa further discloses wherein the second region (80 in Fig. 1) is present for an entire area of the balloon (20) with respect to a circumferential direction of the balloon (see Fig. 1, 80 is present for an entire area with respect to a circumferential direction of the balloon, the area being a radial section of the full circumference).
Regarding claim 14, Nakagawa further discloses wherein the second region (80 in Fig. 1) is present for an entire area of the balloon (20) with respect to a circumferential direction of the balloon (see Fig. 1, 80 is present for an entire area with respect to a circumferential direction of the balloon, the area being a radial section of the full circumference).
Claims 1-2, 3, 5-6, and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticiapted by Kitsch et al. (US PGPub 2006/0182873 A1).
With respect to claim 1, Kitsch et al. discloses a balloon catheter (PP [0002]: “Medical devices that include balloons, such as balloon catheters”) comprising a balloon (200 in Fig. 3) that is inflatable and deflatable (PP [0005]: “The hollow interior of the balloon is in fluid communication with the hollow interior of the shaft. The shaft may be used to provide a fluid supply for inflating the balloon or a vacuum for deflating the balloon”), wherein
the balloon (200) includes an outer surface that includes a first region (middle portion, see annotated Fig. 3) and a second region (204 and 204’) that is at a part of the balloon (200) in an axial direction of the balloon (200) and has surface roughness greater than surface roughness of the first region (204 and 204’ have a greater surface roughness due to channels 208 and 208’).
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Regarding claim 2, Kitsch et al. further discloses wherein the balloon (200 in Fig. 3) includes:
a straight tube portion (see straight portions in annotated Fig. 3 below) that has a diameter that is to be maximum when the balloon is inflated (the annotated area has the greatest diameter on the balloon when inflated); and
two tapered portions (204 and 204’) that sandwich the straight tube portion with respect to the axial direction (see annotated Fig. 3 below), wherein the tapered portions (204 and 204’) decrease in diameter toward farther sides from the straight tube portion (the tapered portions taper away from the straight portion), wherein
the second region (204 and 204’) is formed in an outer surface of one of the tapered portions (see both annotated Fig. 3 below, and the annotated Fig. 3 associated with claim 1, the second region is on the tapered portions).
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Regarding claim 3, Kitsch et al. further discloses wherein the second region (204 and 204’) is formed in the outer surface of the one of the tapered portions on the tip-end side (204 is the tip end side tapered region).
Regarding claim 5, Kitsch et al. further discloses wherein the first region (straight middle portion of balloon 200 in Fig. 3, see annotated Fig. 3 above for claim 1) is formed in an outer surface of the straight tube portion (see annotated Fig. 3 above, the first region is formed in the outer surface of the straight tube portion).
Regarding claim 6, Kitsch et al. further discloses wherein the first region (straight middle portion of balloon 200 in Fig. 3, see annotated Fig. 3 above for claim 1) is formed in an outer surface of the straight tube portion (see annotated Fig. 3 above, the first region is formed in the outer surface of the straight tube portion).
Regarding claim 8, Kitsch et al. wherein the second region of one of the tapered portions (204 and 204’ in Fig. 3, see annotation above) has surface roughness that decreases toward the straight tube portion (since channels 208 and 208’ narrow towards the straight tube portion, the surface roughness decreases as the surface area of the channels decreases).
Regarding claim 9, Kitsch et al. wherein the second region of one of the tapered portions (204 and 204’ in Fig. 3, see annotation above) has surface roughness that decreases toward the straight tube portion (since channels 208 and 208’ narrow towards the straight tube portion, the surface roughness decreases as the surface area of the channels decreases).
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.
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 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Nakagawa (US PGPub 2015/0320985 A1), as applied above to claims 1-2, and further in view of Okamoto et al. (US PGPub 2021/0113821 A1).
Regarding claim 15, Nakagawa fails to disclose an internal protrusion that protrudes from an inner surface of the one of the tapered portions and extends in an axial direction along the inner surface, wherein
the one of the tapered portions on which the internal protrusion is disposed includes an outer surface that includes an overlapping region that overlaps the internal protrusion with respect to a thickness direction of the one of the tapered portions.
In the same field of balloon catheters for percutaneous transluminal angioplasty (PP [0003]), Okamoto et al. teaches a balloon catheter (see Fig. 1) comprising a balloon (13 in Fig. 2) including tapered portions (13b and 13d) and a straight portion (13c), and further teaches:
an internal protrusion (32 and 33) that protrudes from an inner surface of the one of the tapered portions (13b and 13d) and extends in an axial direction along the inner surface (see 32 and 33 extend along an inner surface of the balloon), wherein
the one of the tapered portions (13b and 13d) on which the internal protrusion (32 and 33) is disposed includes an outer surface that includes an overlapping region that overlaps the internal protrusion (32 and 33) with respect to a thickness direction of the one of the tapered portions (13b and 13d).
It would have been prima facie obvious for one of ordinary skill in the art to have modified the Nakagawa device to incorporate the teachings of Okamoto et al. and include the protrusions such that the second region is in an area of the outer surface of the one of the tapered portions on which internal protrusion is disposed, and the area includes the overlapping region. One of ordinary skill in the art would have been motivated to perform this modification in order to favorably reduce “an increase in an outer diameter of the tapered portion”, increase “the pressure resistance of the balloon”, and increase “the passability of the balloon” (PP [0012]). Incorporating the internal protrusions of Okamoto et al. in the Nakagawa device would have yielded an overlapping with the second region as claimed (see where protrusions 32 and 33 in Fig. 2 of Okamoto et al. would overlap with the tapered portions and second region 80 in Fig. 1 of Nakagawa), and furthermore would not have altered the main operating principle of the Nakagawa device as both devices are intended for angioplasty procedures (PP [0003] of Okamoto et al. and Nakagawa PP [0002]: “the disclosed embodiments relate to a balloon catheter to be inserted into a stenosis site or an occlusion site formed in a tubular organ such as a blood vessel, a bile duct, a pancreatic duct, or the like, and that dilates the stenosis site or the occlusion site to secure the flow of blood, bile (biliary fluid), pancreatic juice, or the like”), but would have predictably and favorably affected the characteristics of the device as described in PP [0012] of the Okamoto et al. reference.
Regarding claim 17, Nakagawa as modified by Okamoto et al. fails to disclose an external protrusion that protrudes from an outer surface of the straight tube portion and extends in the axial direction, wherein the internal protrusion and the external protrusion are disposed at the same position with respect to a circumferential direction of the balloon.
However, Okamoto et al. further teaches an external protrusion (31 in Fig. 2) that protrudes from an outer surface of the straight tube portion (upper portion of 13c) and extends in the axial direction (31 extends axially along a length of balloon 13), wherein the internal protrusion (32 and 33) and the external protrusion (31) are disposed at the same position with respect to a circumferential direction of the balloon (PP [0019]: “the projection of the straight tube portion and the projection of each of the tapered portions are provided at a same position in a circumferential direction of the balloon”).
It would have been prima facie obvious for one of ordinary skill in the art to have modified the Nakagawa device to further incorporate the teachings of Okamoto et al. and include the external protrusion as claimed. One of ordinary skill in the art would have been motivated to perform this modification in order to ensure “that the balloon length can be easily kept constant during the inflation of the balloon 13” (PP [0078]) and improve the pressure resistance and strength of the balloon (PP [0005]). The modification as proposed would not have altered the main operating principle of the Nakagawa device as both devices are intended for angioplasty procedures (PP [0003] of Okamoto et al. and Nakagawa PP [0002]: “the disclosed embodiments relate to a balloon catheter to be inserted into a stenosis site or an occlusion site formed in a tubular organ such as a blood vessel, a bile duct, a pancreatic duct, or the like, and that dilates the stenosis site or the occlusion site to secure the flow of blood, bile (biliary fluid), pancreatic juice, or the like”), but would have predictably and favorably improved the strength while maintaining the balloon’s axial length during inflation and deflation, which would increase the efficiency and predictability of the placement procedure.
Allowable Subject Matter
Claim 16 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
With respect to claim 16, the prior art does not disclose or render obvious at the effective filing date of the invention: the feature of the predetermined area in the overlapping region having a surface roughness greater than surface roughness of any other area of the second region, in combination with the other limitations of the independent claim.
The closest prior art is Nakagawa and Okamoto et al., which discloses each of the limitations as described above.
However, this combination fails to disclose the predetermined area in the overlapping region having a surface roughness greater than surface roughness of any other area of the second region. Furthermore, the prior art of record does not suggest any motivation to modify these disclosures to arrive at this feature.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
