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 .
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 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.
Response to Amendment
The Response filed August 4, 2026 has been entered. Claims 1-13 and 19-31 are pending in the application. The previous rejections of claims under 35 U.S.C. 112(b) are withdrawn in light of Applicant’s amendments to the claims. Response to applicant's arguments can be found at the end of this Office action.
Claim Rejections - 35 USC § 102
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.
Claims 1-13 and 19-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sugiyama et al. (U.S. Patent No. 6991634; hereinafter “Sugiyama”).
Regarding claim 1, Sugiyama discloses a tunneler configured to place a portion of a catheter within a subcutaneous tunnel (clip system depicted in Figs. 1-17 is capable of placing a portion of a catheter within a subcutaneous tunnel, such as by gripping a portion of a catheter via arms (111)), comprising:
a shaft (136) extending along a central longitudinal axis (Fig. 2); and
a hub (elements depicted in Fig. 2) disposed at a first end of the shaft, comprising:
a grip (110) coupled to an end portion of the shaft and transitionable between an unlocked position (Fig. 1) and a locked position (Fig. 2), the grip including a cross-beam (113) supporting a first gripping arm (111) and a second gripping arm (111) configured to receive a tip structure of the catheter therebetween (clip (110) is capable of receiving a tip structure of the catheter that has a size that fits within arms (111; Figs. 9-11)), each of the first gripping arm and the second gripping arm in a spaced apart relationship from the tip structure when the grip is in the unlocked position (arms (111) are spaced apart in the open, unlocked position; Fig. 1); and
a sheath (130) extending annularly about a portion of the grip and slidably engaged with the grip to transition the grip between the unlocked position and the locked position (col. 6, ll. 18-47), the grip in the locked position configured to engage the catheter proximal of the tip structure and receive the tip structure into the sheath (clip (110) is capable of engaging a catheter proximal of a tip structure and receiving the tip structure into sheath (130) when the catheter has a size that would fit between arms (111) and an inner diameter of the sheath (Fig .2).
Regarding claim 2, Sugiyama discloses wherein the first gripping arm (111) extends longitudinally from a first end of the cross-beam (113) to a first gripping arm tip (112; Fig. 2), and the second gripping arm (111) extends longitudinally from a second end of the cross-beam, opposite the first end of the cross-beam (Figs. 15 and 17; col. 7, ll. 11-13), to a second gripping arm tip (112), the cross-beam extending perpendicular to the central longitudinal axis (Fig. 2), an inner surface of the first gripping arm and the second gripping arm adjacent the cross-beam remaining in the spaced apart relationship in both the locked position (Fig. 8) and the unlocked position (Fig. 9).
Regarding claim 3¸ Sugiyama discloses wherein each of the first gripping arm and the second gripping arm further includes an outer surface, in the unlocked position the outer surface is angled relative to the central longitudinal axis and the inner surface extends parallel to the central longitudinal axis (Fig. 9), and in the locked the inner surface is angled relative to the central longitudinal axis and the outer surface extends parallel to the central longitudinal axis (Fig. 8).
Regarding claim 4, Sugiyama discloses wherein in the unlocked position the inner surfaces of the first gripping arm and the second gripping arm define an inner diameter (d2) (e.g. diameter defined between respective widened portions of arms (111); annotated Fig. 15 below) that is equal to, or greater than, an outer diameter of the catheter (the diameter defined between widened portions of arms (111) is at least equal to or greater than an object to be held by the grip (110)).
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Regarding claim 5, Sugiyama discloses wherein in the unlocked position (annotated Fig. 15 above) the outer surface of each of the first gripping arm and the second gripping arm extends from an outer diameter (d3) of the cross-beam (outer diameter of end portion (113) matches the inner diameter of tube (120); Fig. 9) to an outer diameter (d4) of a tip of the gripping arm, the outer diameter (d4) at the tip of the gripping arm being larger than the outer diameter (d3) of the cross-beam (annotated Fig. 15 above).
Regarding claim 6, Sugiyama discloses wherein an inner diameter of the sheath is equal to, or greater than the outer diameter (d3) of the cross-beam and is less than the outer diameter (d4) of the tip of the gripping arm (Fig. 9).
Regarding claim 7, Sugiyama discloses wherein in the locked position the inner surface of each of the first gripping arm and the second gripping arm extends from the inner diameter (d2) adjacent the cross-beam (e.g. diameter defined between respective widened portions of arms (111); Figs. 3 and 15)), to an inner diameter (d5) adjacent the first gripping arm tip and the second gripping arm tip (e.g. diameter defined between respective claw portions (112) of arms (111); Fig. 3), respectively, that is less than the outer diameter of the catheter (the diameter defined between gripping arm tips is less than that of an object to be held by the grip (110); Fig. 13).
Regarding claim 8, Sugiyama discloses wherein one or both of the first gripping arm and the second gripping arm includes a beveled surface (surface of claw portion (112); Figs. 2-3) adjacent a tip thereof and angled radially inwards towards the central longitudinal axis (Fig. 3).
Regarding claim 9, Sugiyama discloses wherein one of the first gripping arm and the second gripping arm is biased towards the unlocked position (col. 6, ll. 23-47).
Regarding claim 10, Sugiyama discloses grip is formed of a resilient material including one or more of a plastic, a polymer, a metal, an alloy, and a composite (col. 5, ll. 11-12).
Regarding claim 11, Sugiyama discloses the device further including a handle (140; Fig. 1) disposed at a second end of the shaft, the handle including an actuator (132) configured to slide the sheath longitudinally between a first position and a second position and transition the hub between the locked position and the unlocked position (col. 4, ln. 60 – col. 5, ln. 5).
Regarding claim 12, Sugiyama discloses wherein the grip further includes a first shaft arm (120) extending longitudinally from the first end of the cross-beam, and a second shaft arm (135) extending longitudinally from the second end of the cross-beam, the first shaft arm and the second shaft arm engaging the end portion of the shaft in one of a press-fit, snap-fit, or interference fit engagement (Fig. 2).
Regarding claim 13, Sugiyama discloses wherein the grip further includes a third gripping arm (111) disposed opposite a fourth gripping arm (111) across the central longitudinal axis (Fig. 15), each of the third gripping arm and the fourth gripping arm extending longitudinally and transitionable between an unlocked position and a locked position (col. 7, ll. 11-13; see also col. 6, ll. 18-47).
Regarding claim 19, Sugiyama discloses a method of making a tunneler for placing a portion of a catheter within a subcutaneous tunnel (clip system depicted in Figs. 1-17 is capable of placing a portion of a catheter within a subcutaneous tunnel, such as by gripping a portion of a catheter via arms (111)), comprising:
forming a shaft (136) extending along a central longitudinal axis (Fig. 2); and
coupling a hub (elements depicted in Fig. 2) at a first end of the shaft, comprising:
coupling a grip (110) to an end portion of the shaft, the grip transitionable between an unlocked position (Fig. 1) and a locked position (Fig. 2) and including a cross-beam (113) supporting a first gripping arm (111) extending to a tip thereof and a second gripping arm (111) extending to a tip thereof (Figs. 2-3), the second gripping arm laterally spaced from the first gripping arm so as to receive a tip structure of the catheter in between in the unlocked position (clip (110) is capable of receiving a tip structure of the catheter that has a size that fits within arms (111; Figs. 9-11); and
slidably engaging a sheath (130) with the grip, the sheath transitionable between a first position and a second position to transition the grip between the unlocked position and the locked position (col. 6, ll. 18-47), the sheath in the second position enclosing the tip of the first gripping arm and the tip of the second gripping arm (Fig. 3).
Regarding claim 20, Sugiyama discloses wherein the first gripping arm (111) extends longitudinally from a first end of the cross-beam (113) and the second gripping arm (111) extends longitudinally from a second end of the cross-beam, opposite the first end of the cross-beam (Figs. 15 and 17; col. 7, ll. 11-13), the cross-beam extending perpendicular to the central longitudinal axis (Fig. 3), and an inner surface adjacent the tip of each of the first gripping arm and the second gripping arm configured to engage the catheter proximal of the tip structure (clip (110) is capable of engaging a catheter proximal of a tip structure and receiving the tip structure into sheath (130) when the catheter has a size that would fit between arms (111) and an inner diameter of the sheath (Fig .2)), and an inner surface of each of the first gripping arm and the second gripping arm adjacent the cross-beam remains in a spaced apart relationship from the tip structure, when the grip is in the locked position (Fig. 8).
Regarding claim 21, Sugiyama discloses wherein each of the first gripping arm and the second gripping arm further includes an outer surface, in the unlocked position the outer surface is angled relative to the central longitudinal axis and the inner surface extends parallel to the central longitudinal axis (Fig. 9), and in the locked position the inner surface is angled relative to the central longitudinal axis and the outer surface extends parallel to the central longitudinal axis (Fig. 8).
Regarding claim 22, Sugiyama discloses wherein in the unlocked position the inner surfaces of the first gripping arm and the second gripping arm define an inner diameter (d2) (e.g. diameter defined between respective widened portions of arms (111); annotated Fig. 15 below)that is equal to, or greater than, an outer diameter of the portion of the catheter (the diameter defined between widened portions of arms (111) is at least equal to or greater than an object to be held by the grip (110)).
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Regarding claim 23, Sugiyama discloses wherein in the unlocked position (annotated Fig. 15 above) the outer surface of each of the first gripping arm and the second gripping arm extends from an outer diameter (d3) of the cross-beam (outer diameter of end portion (113) matches the inner diameter of tube (120); Fig. 9) to an outer diameter (d4) at the tip of the gripping arms, the outer diameter (d4) at the tip of the gripping arms being larger than the outer diameter (d3) of the cross-beam (annotated Fig. 15 above).
Regarding claim 24, Sugiyama discloses wherein an inner diameter of the sheath is equal to, or greater than, the outer diameter (d3) of the cross-beam and is less than the outer diameter (d4) of the tip of the gripping arms (Fig. 9).
Regarding claim 25, Sugiyama discloses wherein in the locked position the inner surface of each of the first gripping arm and the second gripping arm extends from the inner diameter (d2) adjacent the cross-beam (e.g. diameter defined between respective widened portions of arms (111); Figs. 3 and 15)), to an inner diameter (d5) adjacent the tip of the gripping arms (e.g. diameter defined between respective claw portions (112) of arms (111); Fig. 3) that is less than the outer diameter of the portion of the catheter (the diameter defined between gripping arm tips is less than that of an object to be held by the grip (110); Fig. 13).
Regarding claim 26, Sugiyama discloses wherein one or both of the first gripping arm and the second gripping arm includes a beveled surface (surface of claw portion (112); Figs. 2-3) adjacent the tip thereof and angled radially inwards towards the central longitudinal axis (Fig. 3).
Regarding claim 27, Sugiyama discloses wherein one of the first gripping arm and the second gripping arm is biased towards the unlocked position (col. 6, ll. 23-47).
Regarding claim 28, Sugiyama discloses wherein the grip is formed of a resilient material including one or more of a plastic, a polymer, a metal, an alloy, or a composite (col. 5, ll. 11-12).
Regarding claim 29, Sugiyama discloses the method further including a handle (140; Fig. 1) disposed at a second end of the shaft and including an actuator (132) configured to slide the sheath longitudinally between the first position and the second position and transition the grip between the locked position and the unlocked position (col. 4, ln. 60 – col. 5, ln. 5).
Regarding claim 30, Sugiyama discloses wherein the grip further includes a first shaft arm (120) extending longitudinally from the first end of the cross-beam, and a second shaft arm (135) extending proximally from the second end of the cross-beam, the first shaft arm and the second shaft arm engaging the end portion of the shaft in one of a press-fit, snap-fit, or interference fit engagement (Fig. 2).
Regarding claim 31, Sugiyama discloses wherein the grip further includes a third gripping arm (111) disposed opposite a fourth gripping arm (111) across the central longitudinal axis (Fig. 15), each of the third gripping arm and the fourth gripping arm extending longitudinally and transitionable between an unlocked position and a locked position (col. 7, ll. 11-13; see also col. 6, ll. 18-47).
Response to Arguments
Applicant’s arguments with respect to claims 1-13 and 19-31 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.
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 Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/JONATHAN A HOLLM/Examiner, Art Unit 3771
