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 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.
Claim(s) 1-6, 9-11, 14-15, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanner et al. (US 2022/0168049) in view of Fitz (US 6,547,766).
Regarding claim 1, Tanner et al. (henceforth Tanner) discloses (Figures 65A-65G) an anti-buckling device (500) for an interventional device assembly, comprising: a telescoping tube (formed by segments 640) comprising a plurality of concentric telescopically axially extendable and collapsible tube segments (640; ¶ [0508]) each having a proximal end and a distal end, the plurality of tube segments comprising an innermost tube segment (depicted in Figure 65F) and one or more outer tube segments (Figure 65A), the innermost tube segment being configured to couple to a hub (the innermost segment can be seen coupled to a hub in Figure 65F; also, element 490 inside of the telescoping tube is disclosed as a sheath, catheter, or combination thereof) of an interventional device assembly, the telescoping tube being configured to extend distally from the hub (Figure 65E); wherein each of the one or more outer tube segments is coupled to a feature at its proximal end (e.g., stopper elements 641; ¶ [0509]), the proximal end configured to receive an interventional device (Figure 65A) of the interventional device assembly therethrough; and an outer diameter greater than an outer diameter of the outer tube segment to which the feature is coupled (stop elements 641 are formed as expanded flanges on the end of each tubing element; they abut corresponding stops on the larger tubing segments to prevent removal therefrom; ¶ [0509]; Figure 65G). Tanner teaches the stops and abutments as tubing segments and not caps having larger external diameters per se.
Fitz teaches (Figure 3) a catheter assembly (10) which utilizes an annular feature as the stop or abutment element (cap 40; Col. 4, lines 53-64) which has a diameter larger than an outer diameter than the tubing it’s connected to; the cap having a through hole for configured to receive an interventional device therethrough (e.g., bore 46; Figure 3 receives element 52 therethrough and it is of a smaller diameter than body 20; see also stub tube 44 which engages 32 in a frictional engagement). Therefore, Fitz teaches how related caps (40) forming internal lips/stops can be affixed to tubes by sleeving the cap over the end of the tube such that the cap has an outer diameter greater than an outer diameter of the tube segment to which the second cap is coupled thereby providing a secure connection (see Fig. 3).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the stop feature of Tanner to have an outer diameter larger than that of the corresponding tube such that the tube can be received internal to the cap, as disclosed by Fitz, in order to assist with alignment of the cap and tube during assembly to ensure a strong and effective securement therebetween.
Regarding claim 2, Taylor/Fitz further teach wherein the through hole of the cap has a diameter smaller than an inner diameter of the outer tube segment to which the cap is coupled (it can be seen in Figure 3 that the through hole 46 is of smaller diameter than the inner diameter of 20 as it’s only slightly larger than element 52).
Regarding claim 3, Taylor/Fitz further teach wherein an inner diameter portion of a cap of an outer tube segment (e.g., 40 of Fitz) of the one or more outer tube segments can be dimensioned to act as a stop for an outer diameter portion of a cap of an inner tube segment that is concentrically adjacent to the outer tube segment. The cap in Tanner/Fitz provides a reduced diameter inner portion which is fully capable of abutting a stop member by abutting a cap member of an inner tube segment; it is noted that the cap of the inner member is not positively recited and therefore the cap of Tanner/Fitz need only be capable of abutting said feature; because the cap of the outer tube segments of Tanner/Fitz provides for a reduced inner diameter, it would functionally abut any element on an inner member which enlarges the diameter sufficiently to engage with the inner feature of the cap.
Regarding claim 4, Fitz further discloses wherein the cap is ring-shaped (Figures 1-3; it is clearly annular or ring-shaped as claimed).
Regarding claim 5, Fitz further teaches wherein the cap is concentrically attached to the tube segment to which the cap is coupled (Figure 1-3, it extends around the total circumference of the tube member as claimed).
Regarding claim 6, Tanner/Fitz further teach wherein the cap (40 of Fitz) of an outer tube segment can be configured to prevent hyper-extension of an inner tube segment that is concentrically adjacent to the outer tube segment (the cap would replace element 641 of Tanner and which is designed to engage with a corresponding stop feature 642 on concentric inner tubing segments as depicted in Figure 65G of Tanner; in this manner the cap of the Tanner/Fitz would still prevent hyper-extension of an inner tube to maintain the removal prevention features of the telescoping arrangement).
Regarding claim 9, Tanner/Fitz further teach wherein a cap (40 of Fitz) of an outer tube segment of the plurality of outer tube segments can be configured to prevent hyper-collapse of an inner tube segment that is concentrically adjacent to the outer tube segment (the cap limits the travel of an inner shaft relative to an outer shaft to some dimension which is still within the outer shaft since the cap closes the outer shaft to achieve the function of preventing movement of the inner shaft past a certain point. This will necessarily prevent hyper-collapse since the inner shaft can only move proximally to the cap engagement point.
Regarding claim 10, Tanner further discloses the proximal end of an innermost tube segment of the plurality of tube segments is attached to a proximal retainer (see generally Figure 65E as it pertains to defining the proximal end connector between the proximal-most tube and the driver 84), the proximal retainer being configured to secure within an interior of a hub of the interventional device assembly between a proximal end of the hub and a distal end of the hub (see the proximal lug, which is unlabeled but clearly coupled to the smallest shaft 640 in Figure 65E; this connector is understood to be receivable within a corresponding hub interior of the driver to provide for selective attachment/detachment thereto; see also 65F which depicts the innermost tubing segment attached to the connector as claimed).
Regarding claim 11, Tanner further discloses the distal end of an outermost tube segment of the plurality of tube segments is attached to a distal retainer (see Figure 65D which illustrates the connecting geometry that will be understood to be provided on the distal end of the configuration shown schematically in Fig. 65B), the distal retainer being configured to releasably attach to the distal end of the hub or a proximal end of a second hub (it can be seen in Figure 65A that both ends of the shaft attach to separate hubs at either the proximal or distal end and the connection must be some form of retaining configuration as claimed).
Regarding claim 14, Tanner/Fitz further teach wherein each of the plurality of tube segments comprises an inner diameter reducing feature configured to reduce an unsupported free length of the interventional device when the interventional device extends through the telescoping tube (the opening 46 in the cap 40 of Fitz provides an access bore to slidably receive an interventional device 52; this is considered to teach the limitation of reducing the unsupported free length of the device since it will be abutting sequential caps on each shaft section).
Regarding claim 15, Tanner/Fitz further teach wherein the inner diameter reducing feature is attached to the distal end of each of the plurality of tube segments (as each successive segment is moved distally, the cap on the proximal end of the previous segment will abut at stop feature at the distal end of the slightly larger segment to provide for the retention means. This is considered to meet the claim limitation as the two shafts are in abutment, the diameter reducing portion of the cap is adjacent the distal end or can be considered attached thereto. The claim does not require the distal end of each shaft to comprise the inner diameter reducing feature, only that the feature is “attached to” the distal end and not necessarily formed thereon.
Regarding claim 18, Tanner further discloses wherein each of the plurality of tube segments has a wall thickness that is substantially the same (e.g., Figure 65G, all of the segments have the same wall thickness as claimed).
Regarding claim 19, Tanner further disclose wherein the telescoping tube is contained by the hub when fully axially collapsed (see e.g., Figure 65F wherein the recess in the distal end of the hub is configured to, or at the very least capable of, receiving the stack of telescoping shafts therein).
Claim(s) 7-8 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanner in view of Fitz, and further in view of Berthiaume (US 5,591,194).
Regarding claim 7, Tanner/Fitz teach the claimed invention substantially as set forth above for claim 1, and further teach that the cap is configured to act as a stop for an inner tube segment that is concentrically adjacent to the outer tube segment to which the stop is coupled (as above, the cap secures to the outer tubing element and comprises internal features which would abut any stop features on the outer surface of a concentric inner member) but fail to explicitly disclose the use of a shim on one or more of the outer tube segments.
Berthiaume teaches a telescoping catheter system (e.g., Figure 8) comprising shims (e.g., 158, 156, 153; Col. 5, lines 39-43 disclose the stop members as being formed from pieces of tubing which are analogous to shims); also, Berthiaume does not place a stop element at one end of tubing 190 since there is no additional tube to prevent removal of tube 190 from which would require the stop member (Figure 8).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Tanner/Fitz to comprise the stop shims of Berthiaume as engagement means on the inner members for engaging with the cap elements on the outer members since Berthiaume teaches that such elements are known to be used as stop features in telescoping catheter systems to prevent removal of an inner shaft from an outer shaft.
Regarding claim 8, Berthiaume further teaches that the shims are attached adjacent the distal end of the corresponding tubing segment (Figure 8, Berthiaume teaches shims such as 154 on tubing 170, which is on the distal end as claimed; see Figure 8 wherein stop element 154 is disposed on an outer surface of the distal end of 170; Col. 8, lines 50-57). It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the shims of Berthiaume on any portion of an inner shaft of the device of Tanner/Fitz to provide a stop abutment surface to prevent removal of telescoping shafts during use as taught by Berthiaume.
Regarding claims 12 and 13, Tanner/Fitz/Berthiaume further teach wherein the innermost tubing segment and all but an outermost tubing segment of the one or more outer tube segments comprises a first tube section having a first outer diameter and a second tube section having a second outer diameter and wherein the first tube section diameter is greater than the second section diameter, and the first section is disposed adjacent the distal end of its corresponding segment (the first tube section may be considered as any of the stop elements on the distal ends of the inner tubes (e.g., 152, 154 of Berthiaume) and the second segment diameter may be considered any section of the tube proximal of that section which does not comprise the stop feature; in this manner, the stop feature provides the increased diameter at the distal end relative to the rest of the shaft section (distal of the proximal stop features). The claim allows for any arbitrary section of the shaft to be the second tube section.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanner in view of Fitz, and further in view of Matsuno (US 5,766,184).
Regarding Claim 16, Tanner discloses the invention substantially as claimed except that the clearance between adjacent concentric tubes of the plurality tube segments is between about 0.001 inches and about 0.010 inches. However, it is well understood that in sliding/telescoping tubes such as those described by Tanner clearance between respective tubes is required to balance sliding friction while maintaining an optimal, stable connection.
Matsuno discloses that in sliding tubes excessively large clearance will cause deformation and buckling, while an excessively small clearance will unduly increase the sliding resistance between the tubes and therefore the value should be optimized (Col. 4, lines 32-41). Matsuno provides an exemplary range of 0.1mm to 0.5mm (i.e., 0.004" to 0.02") a range which substantially overlaps the instantly claimed range. It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the invention of Tanner with a clearance between about 0.001" to 0.010” to ensure smooth operation while reducing the tendency for the shafts to buckle during use as clearly taught by Matsuno.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanner in view of Fitz, and further in view of Borries et al. (US 2016/0066973).
Regarding claim 17, Tanner/Fitz disclose the claimed invention substantially as set forth above for claim 1, but do not explicitly disclose that an outer tube segment is shorter than an inner tube segment that is concentrically adjacent thereto.
Borries et al. (henceforth Borries) teaches a telescoping device (Figure 1, 100) which comprises different shaft segments (120, 130), and wherein the shafts are of different lengths (¶ [0059]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the telescoping assembly of Tanner/Fitz to comprise at least one outer section which is shorter in length than an inner section, since Borries teaches that such a configuration is known in the art of telescoping shaft sections. Borries teaches that an inner shaft (120) is longer than an outer shaft (130) and such a modification to, for example, the largest diameter shaft of the assembly, of Tanner/Fitz would have been obvious since such Borries discloses differential length sections. This modification would retain the function of the device of Tanner/Fitz and teaches that it is not necessary to form all shaft of the same length in a telescoping shaft system.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanner in view of Fitz, and further in view of Swainston et al. (US 2004/0220612).
Regarding claim 20, Tanner/Fitz teach the claimed invention substantially as set forth above for claim 1, and Tanner further discloses wherein the innermost tube segment is attached to the interventional device. However, Tanner/Fitz fail to teach that the inner segment is bonded to the interventional device.
Swainston et al. (henceforth Swainston) teaches (Figure 4) a catheter device (100) comprising telescoping shaft sections (inner shaft 136 and outer shaft 134), and wherein the inner shaft is bonded to an interventional device (¶ [0066] discloses that the inner member is bonded to deploying member 120).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Tanner/Fitz to provide for the step of bonding the inner member to the interventional device, as taught by Swainston, for the purpose of securing the elements together in a known manner. Tanner already teaches the connection of the inner shaft to an interventional device (e.g., proximal hub depicted in Figures 65D-65F, which is seen in Figure 65F to be at least frictionally engaged at the hub to the inner member). Therefore, it would have been obvious to use a different securement technique such as bonding, since such a connection means is known in the art from Swainston.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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