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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/15/2026 has been entered.
Response to Amendment
Regarding the previous claim objections, the amendments to claims 1 and 18-19 are acknowledged and the claim objections are withdrawn.
Regarding the previous 112(b) rejections, the amendments to claims 2, 8, and 13 are acknowledged and the 112(b) rejections are withdrawn.
Response to Arguments
Applicant’s arguments, see pages 1-2, filed 07/01/2025, with respect to the rejection(s) of claim(s) under the 102 rejection over Onishi et al. (US 5503631) have been fully considered and are persuasive. The examiner agrees that Onishi fails to disclose “the X-ray opaque marker is disposed, in an axial direction of the inner shaft, between a joint portion of a distal end of the reduced diameter area of the outer shaft and the inner shaft, and a proximal end of a portion corresponding to the balloon joint”. Therefore, the rejection has been withdrawn.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).
Applicant’s arguments with respect to claim(s) 1 and 18-19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Upon further consideration, a new ground(s) of rejection is made in view of Jorgensen (US 20030105426) in view of Miki et al. (WO 2019180928) [see attached English translation attached].
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, 7-8, 12-14, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jorgensen (US 20030105426) in view of Miki et al. (WO 2019180928) [see attached English translation attached] [hereinafter Miki].
Regarding claim 1, 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 at 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 and the inner shaft (Fig. 2A, para. 0027, 0030), a proximal end of a portion corresponding to the balloon joint 47 (Fig. 2A, para. 0028)
the X-ray opaque marker 48 is disposed, in an axial direction of the inner shaft 44 (Fig. 2A, para. 0028), and
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).
However, Jorgensen fails to disclose that the X-ray opaque marker is covered by and spaced apart from the outer shaft and disposed between the joint portion of a distal end of the reduced diameter area of the outer shaft and the inner shaft, and the proximal end of the portion corresponding to the balloon joint, and in the balloon, and an outer diameter on an outermost periphery of a structure formed by the inner shaft, the X-ray opaque marker, and the outer shaft decreases continuously from the base end toward the distal end of the balloon.
Miki in the same field of endeavor of balloon catheters teaches that it is known in the art to position an X-ray opaque marker 7b such that is covered by and spaced apart from an outer shaft 3 and disposed at a joint portion j2d between an inner shaft 9 and a proximal end of a portion corresponding to a balloon joint j2p (see Fig. 2, page 4, eight paragraph: “Therefore, both ends of the proximal marker 7b are disposed across the proximal joint position j2p of the joint j2 between the balloon 5 and the outer shaft 3 in the longitudinal direction of the inner shaft”).
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 such that its covered by and spaced apart from the outer shaft and disposed at a joint portion between the inner shaft and the balloon joint 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 Miki would result in a product wherein the X-ray opaque marker (taught to be positioned between the inner shaft and the balloon joint, see Fig. 2 of Miki) is disposed between the joint portion of a distal end of the reduced diameter area of the outer shaft 43 and the inner shaft 44 of Jorgensen, and the proximal end of the portion corresponding to the balloon joint 47; and would result in a product wherein in the balloon 46 (see Fig. 2A of Jorgensen), an outer diameter on an outermost periphery of a structure formed by the inner shaft 44 of Jorgensen (Fig. 2A of Jorgensen), the X-ray opaque marker (positioned on the inner shaft 44 and covered by the balloon joint/reduced diameter area of the outer shaft 42) as taught by Miki (see Fig. 2 of Miki), and the outer shaft 42 of Jorgensen (Fig. 2A) decreases continuously from the base end of the balloon 46 toward the distal end of the balloon 46 (see Fig. 2A of Jorgensen).
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Annotated Fig. 2A 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 of Jorgensen above).
Regarding claim 8, modified Jorgensen discloses wherein the X-ray opaque marker is at a position corresponding to the balloon joint j2d of the outer shaft 3 (see Fig. 2 of Miko).
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 (positioned on the inner shaft 44 at the balloon joint 47, as taught by Miki; see Fig. 2 of Miki).
Regarding claim 18, 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 [1] 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 X-ray opaque marker 48 is nearer a base end (interpreted as a proximal end) of the balloon catheter 10 than is a joint portion between the inner shaft 44 and the outer shaft 42 (see annotated Fig. 2A [1] of Jorgensen below), the joint portion being within the balloon 46 (see annotated Fig. 2A [1] of Jorgensen below), and
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).
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Annotated Fig. 2A [1] of Jorgensen
However, Jorgensen fails to disclose that the X-ray opaque marker is covered by and spaced apart from the outer shaft and disposed between the joint portion of a distal end of the reduced diameter area of the outer shaft and the inner shaft, and the proximal end of the portion corresponding to the balloon joint, and in the balloon, and an outer diameter on an outermost periphery of a structure formed by the inner shaft, the X-ray opaque marker, and the outer shaft decreases continuously from the base end toward the distal end of the balloon.
Miki in the same field of endeavor of balloon catheters teaches that it is known in the art to position an X-ray opaque marker 7b such that is covered by and spaced apart from an outer shaft 3 and disposed at a joint portion j2d between an inner shaft 9 and a proximal end of a portion corresponding to a balloon joint j2p (see Fig. 2, page 4, eight paragraph: “Therefore, both ends of the proximal marker 7b are disposed across the proximal joint position j2p of the joint j2 between the balloon 5 and the outer shaft 3 in the longitudinal direction of the inner shaft”).
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 such that its covered by and spaced apart from the outer shaft and disposed at a joint portion between the inner shaft and the balloon joint 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 Miki would result in a product wherein the X-ray opaque marker (taught to be positioned between the inner shaft and the balloon joint, see Fig. 2 of Miki) is disposed between the joint portion of a distal end of the reduced diameter area of the outer shaft 43 and the inner shaft 44 of Jorgensen, and the proximal end of the portion corresponding to the balloon joint 47; and would result in a product wherein in the balloon 46 (see Fig. 2A of Jorgensen), an outer diameter on an outermost periphery of a structure formed by the inner shaft 44 of Jorgensen (Fig. 2A of Jorgensen), the X-ray opaque marker (positioned on the inner shaft 44 and covered by the balloon joint/reduced diameter area of the outer shaft 42) as taught by Miki (see Fig. 2 of Miki), and the outer shaft 42 of Jorgensen (Fig. 2A) decreases continuously from the base end of the balloon 46 toward the distal end of the balloon 46 (see Fig. 2A of Jorgensen).
Regarding claim 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 above, 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 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
However, Jorgensen fails to disclose that the X-ray opaque marker is covered by and spaced apart from the outer shaft and disposed between the joint portion of a distal end of the reduced diameter area of the outer shaft and the inner shaft, and the proximal end of the portion corresponding to the balloon joint, and in the balloon, and an outer diameter on an outermost periphery of a structure formed by the inner shaft, the X-ray opaque marker, and the outer shaft decreases continuously from the base end toward the distal end of the balloon.
Miki in the same field of endeavor of balloon catheters teaches that it is known in the art to position an X-ray opaque marker 7b such that is covered by and spaced apart from an outer shaft 3 and disposed at a joint portion j2d between an inner shaft 9 and a proximal end of a portion corresponding to a balloon joint j2p (see Fig. 2, page 4, eight paragraph: “Therefore, both ends of the proximal marker 7b are disposed across the proximal joint position j2p of the joint j2 between the balloon 5 and the outer shaft 3 in the longitudinal direction of the inner shaft”).
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 such that its covered by and spaced apart from the outer shaft and disposed at a joint portion between the inner shaft and the balloon joint 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 Miki would result in a product wherein the X-ray opaque marker (taught to be positioned between the inner shaft and the balloon joint, see Fig. 2 of Miki) is disposed between the joint portion of a distal end of the reduced diameter area of the outer shaft 43 and the inner shaft 44 of Jorgensen, and the proximal end of the portion corresponding to the balloon joint 47; and would result in a product wherein in the balloon 46 (see Fig. 2A of Jorgensen), an outer diameter on an outermost periphery of a structure formed by the inner shaft 44 of Jorgensen (Fig. 2A of Jorgensen), the X-ray opaque marker (positioned on the inner shaft 44 and covered by the balloon joint/reduced diameter area of the outer shaft 42) as taught by Miki (see Fig. 2 of Miki), and the outer shaft 42 of Jorgensen (Fig. 2A) decreases continuously from the base end of the balloon 46 toward the distal end of the balloon 46 (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 Miki et al. (WO 2019180928) [see attached English translation attached] 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
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.
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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