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 Arguments
Applicant’s arguments, see pages 2-4, filed 06/30/2026, with respect to the rejection(s) of claim(s) 1, 18, and 19 under the 103 rejection over Jorgenson in view of Miki have been fully considered and are persuasive. The examiner agrees that Miki fails to teach “a base end of the X-ray opaque marker is located distally relative to a base end of the balloon joint, and a distal end of the X-ray opaque marker is located proximally relative to the base end of the taper part”. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Jorgensen (US 20030105426) in view of Muller et al. (US 20120095517).
Claim Objections
Claim 7 is objected to because of the following informalities:
Claim 7, lines 2-3: “a joint portion between the inner shaft and the outer shaft”. It appears that joint portion is the same as the joint portion of the distal end of the reduced diameter area of the outer shaft and the inner shaft, as recited in claim 1. Therefore, the limitation should recite “the joint portion between the inner shaft and the outer shaft”. 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.
Claim(s) 1-2, 7, 12-14, and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Jorgensen (US 20030105426) in view of Muller et al. (US 20120095517) [hereinafter Muller].
Regarding claims 1, 18, and 19, Jorgensen discloses a balloon catheter 40 (Fig. 2A, para. 0026), comprising:
an inner shaft 44 having a tubular shape (Fig. 2A, para. 0026);
a balloon 46 covering a portion of the inner shaft 44 and including a distal end joined to the inner shaft 44 (Fig. 2A, para. 0028);
an X-ray opaque marker 48 on an outer peripheral surface side of the inner shaft 44 and within the balloon 46 (Fig. 2A, para. 0028); and
an outer shaft 42 having a tubular shape (Fig. 2A, para. 0027) and accommodating a part of the inner shaft 44 (Fig. 2A, para. 0027),
wherein the outer shaft 42 includes a balloon joint 47 joined to a base end of the balloon 46 (Fig. 2A, para. 0028) and a reduced diameter area in the balloon (see annotated Fig. 2A below, para. 0029) and having an outer diameter smaller than an outer diameter of the balloon joint 47 (Fig. 2A, para. 0029), the outer shaft 42 being joined to the inner shaft 44 in the balloon (Fig. 2A, para. 0027, 0030),
the reduced diameter area includes a taper part 49 in which a diameter of an outer peripheral surface of the taper part decreases from a base end of the taper part to a distal end of the taper part (see annotated Fig. 2A [1] of Jorgenson below, para. 0029: “Outer tube 42 preferably comprises taper 49 that reduces the diameter of outer tube 42 within balloon segment 55 to reduce the overall distal profile”),
the X-ray opaque marker 48 is disposed, in an axial direction of the inner shaft 44 (Fig. 2A, para. 0028) between a joint portion (interpreted as the portion of the reduced diameter where the inner shaft 44 contacts the outer shaft 42) of a distal end of the reduced diameter area of the outer shaft 42 and the inner shaft 44, and a proximal end of a portion corresponding to the balloon joint 47 (annotated Fig. 2A [2] of Jorgenson below, para. 0027-0028, 0030),
the joint portion being within the balloon 46 (see annotated Fig. 2A [2] of Jorgensen below),
the balloon catheter 40 includes a communication hole 52 that provides a flow path between an inside of the balloon 46 with an expansion lumen 43 formed between an inner peripheral surface of the outer shaft 42 and an outer peripheral surface of the inner shaft (Fig. 2A, para. 0031), and
in the balloon 46, and an outer diameter on an outermost periphery of a structure formed by the inner shaft 44, the X-ray opaque marker 48, and the outer shaft 42 decreases continuously from the base end of the balloon toward the distal end of the balloon (see annotated Fig. 2A [3] of Jorgenson below).
However, Jorgensen fails to disclose that the X-ray opaque marker is covered by and spaced apart from the outer shaft such that the X-ray opaque marker is nearer a base end (interpreted as a proximal end) of the balloon catheter than is the joint portion between the inner shaft and the outer shaft, a base end of the X-ray opaque marker is located distally relative to a base end of the balloon joint, and a distal end of the X-ray opaque marker is located proximally relative to the base end of the taper part.
Muller in the same field of endeavor of balloon catheter devices (Fig. 3) teaches that it is known in the art to position an X-ray opaque marker 134 such that it is covered by an outer shaft 108 (see Fig. 3), a base end of the X-ray opaque marker 134 is located distally relative to a base end of a balloon joint (see annotated Fig. 3 of Muller below), and a distal end of the X-ray opaque marker 134 is located proximally relative to a taper part of balloon 166 (see annotated Fig. 3 of Muller below, para. 0030 of Muller: “A marker 134 may be provided that is fixed to a portion of the inner catheter body 110 that extends within the balloon structure 106”).
Since Muller teaches that it is known in the art for an X-ray opaque marker to be positioned at the area of the balloon joint as claimed, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the location of the X-ray opaque marker of Jorgenson to the location as taught by Miki, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 (CCPA 1950).
The combination of Jorgensen in view of Muller would result in a product wherein the X-ray opaque marker of Jorgensen is spaced apart from the outer shaft, is nearer the base end (interpreted as a proximal end) of the balloon catheter than is the joint portion between the inner shaft and the outer shaft, and the distal end of the X-ray opaque marker is located proximally relative to the base end of the tapered part of the reduced diameter area since Muller teaches that distal end of the X-ray opaque marker would be positioned proximally of the tapered part of the balloon and the base end of tapered part of the reduced diameter area in Jorgensen is positioned proximally of the tapered part of the balloon (see annotated Fig. 3 of Muller and Fig. 2A [4] of Jorgensen below).
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Annotated Fig. 2A of Jorgensen
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Annotated Fig. 2A [1] of Jorgensen
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Annotated Fig. 2A [2] of Jorgensen
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Annotated Fig. 2A [3] of Jorgensen
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Annotated Fig. 3 of Muller Annotated Fig. 2A [4] of Jorgensen
Regarding claim 2, modified Jorgensen discloses wherein the distal end of the reduced diameter area 49 in the outer shaft 42 is joined to the inner shaft 44 (Fig. 2A, 0027, 0029 of Jorgensen).
Regarding claim 7, modified Jorgensen discloses wherein the X-ray opaque marker (positioned on the inner shaft and at the balloon joint, as taught by Miki; see Fig. 2 of Miki) is nearer a base end (interpreted as a proximal end) of the balloon catheter 10 than is a joint portion (interpreted as portion of the reduced diameter area where the inner shaft 44 contacts the outer shaft 42, see annotated Fig. 2A of Jorgensen above) between the inner shaft and the outer shaft (see annotated Fig. 2A [4] of Jorgensen above).
Regarding claim 12, modified Jorgensen discloses wherein the reduced diameter area (see annotated Fig. 2A of Jorgensen above) includes a separated portion (interpreted as portion comprising taper 49, see Fig. 2A, para. 0029 of Jorgensen) separated from the outer peripheral surface of the inner shaft 44 in a radially outward direction of the inner shaft 44 (Fig. 2A, para. 0029 of Jorgensen), and the communication hole 52 is in the separated portion (Fig. 2A, para. 0031 of Jorgensen).
Regarding claim 13, modified Jorgensen discloses wherein the distal end of the reduced diameter area of the outer shaft 42 (see annotated Fig. 2A of Jorgensen above) is at a position separated from a joint 53 between the inner shaft 42 and the balloon 46 in the axial direction of the inner shaft 42 (Fig. 2A, para. 0028 of Jorgensen).
Regarding claim 14, modified Jorgensen discloses wherein the reduced diameter area of the outer shaft 42 (see annotated Fig. 2A of Jorgensen above) is integrally formed with a portion of the outer shaft 42 adjacent to the reduced diameter area (see annotated Fig. 2A of Jorgensen above, para. 0029 of Jorgensen).
Regarding claim 20, modified Jorgensen discloses wherein the communication hole 52 (Fig. 2A of Jorgensen) is located closer to the distal end of the balloon 46 (Fig. 2A of Jorgensen) than the X-ray opaque marker (see annotated Fig. 2A [4] of Jorgensen above).
Regarding claim 21, modified Jorgensen discloses wherein a distal end of the outer shaft 42 is closer to the base end (i.e. proximal end) of the balloon 46 than to the distal end of the balloon 46 in the axial direction of the inner shaft 44 (see Fig. 2A of Jorgensen).
Claim(s) 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Jorgensen (US 20030105426) in view of Muller et al. (US 20120095517) [hereinafter Muller] as applied to claim 1 above, and further in view of Burns et al. (US 5221260) [hereinafter Burns].
Regarding claim 9, modified Jorgensen discloses all of the limitations set forth above in claim 1. However, modified Jorgensen fails to disclose wherein the outer diameter of the balloon joint of the outer shaft is smaller than an outer diameter of a portion of the outer shaft nearer a base end than is the balloon joint.
Burns in the same field of endeavor teaches a balloon catheter C comprising a balloon joint 17 of an outer shaft 10 (Fig. 1, col. 3 lines 5-8), wherein an outer diameter of the balloon joint 17 of the outer shaft 10 is smaller than an outer diameter of a portion of the outer shaft nearer a base end of a balloon 11 than is the balloon joint (Fig. 1, col. 3 lines 30-41).
The substitution of one known element (balloon joint of the outer shaft having a stepped configuration as shown in Burns) for another (balloon joint of the outer shaft having a continuous configuration as shown in modified Jorgensen) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the stepped balloon joint shown in Burns would have yielded predictable results, namely, an alternative way to construct the balloon joint of the outer shaft (Fig. 1, col. 3 lines 30-41 of Burns); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
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Annotated Fig. 1 of Burns
Regarding claim 11, modified Jorgensen discloses all of the limitations set forth above in claim 1. However, modified Jorgensen fails to disclose wherein the outer peripheral surface of the reduced diameter area of the outer shaft decreases in diameter in a plurality of steps from the balloon joint toward the distal end of the outer shaft.
Burns in the same field of endeavor teaches a balloon catheter C comprising a reduced diameter area 18 of an outer shaft 10 (Fig. 1, col. 3 lines 22-28), wherein an outer peripheral surface of the reduced diameter area 18 of the outer shaft 10 decreases in diameter in a plurality of steps from a balloon joint 17 toward a distal end of the outer shaft 10 (see annotated Fig. 1 [a] of Burns below).
The substitution of one known element (the balloon joint and reduce diameter area of the outer shaft having a stepped configuration as shown in Burns) for another (the balloon joint and reduce diameter area of the outer shaft having a continuous configuration as shown in modified Jorgensen) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the stepped balloon joint shown in Burns would have yielded predictable results, namely, an alternative way to construct the balloon joint of the outer shaft (Fig. 1, col. 3 lines 30-41 of Burns); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
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Annotated Fig. 1 [a] of Burns
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 LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 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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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
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