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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claim(s) 1-7, 10-21 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of copending Application No. 18/525,168 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 1, the ‘168 reference application claims (see claims filed 30 November 2023 which are currently pending):
An anti-buckling device for an interventional device assembly (see Clm. 1), comprising:
a telescoping tube comprising a plurality of concentric telescopically axially extendable and collapsible tube segments each with a proximal end and a distal end (see Clm. 1);
wherein one or more of the plurality of tube segments comprises:
an inner diameter reducing feature (see Clm. 14) configured to reduce an unsupported free length of an interventional device of the interventional device assembly when the interventional device extends through the telescoping tube,
the inner diameter reducing feature attached to the distal end of its associated tube segment (see Clm. 15) and having a first through hole configured to receive the interventional device therethrough (not explicitly recited, but considered to be implicitly required by the functional subject matter receited in Claims 1, 14, and 15 – re: “a telescoping tube comprising a plurality of concentric telescopically axially extendable and collapsible tube segments…”, “each of the one or more outer tube segments… configured to receive an interventional device of the interventional device assembly therethrough…”, “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…” – in other words these claims establish that the inner diameter reducing feature, as part of the telescoping tube segments, receives and supports, an interventional device inserted therethrough which necessitates the presence of at least a first through hole given that the interventional device could not possibly pass through the diameter reducing feature without there being a hole through which it may be received); and
a cap attached to a proximal end of its associated tube segment and having a second through hole configured to receive the interventional device therethrough, the cap having an outer diameter greater than an outer diameter of the tube segment to which the cap is coupled (see Clm. 1).
As such, reference patent Claim 15 anticipates the instant Claim 1.
Regarding Claims 2-7 and 10-21, these features, as recited, are obviated – collectively through nominal structural modifications to Claim 15 of the reference application as established by the prior art. Specifically, Applicant’s attention is directed toward the prior art of U.S. Publication No. 2022/0168049 (“Tanner”), U.S. Publication No. 2022/0313375 (“Zhang”), U.S. Publication No. 2005/0027236 (“Douk”), U.S. Publication No. 2003/0105451 (“Westlund”), and U.S. Patent No. 5,766,184 (“Matsuno”), and U.S. Publication No. 2022/0387069 (“Schneider”) as applied in the Non-Final Office Action mailed on 19 March 2026 and here below.
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.
Claim(s) 1, 2, 4-7, 10, 13-16, 18, 19, 20, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2022/0168049 (“Tanner”) in view of U.S. Publication No. 2022/0313375 (“Zhang”) and U.S. Publication No. 2022/0387069 (“Schneider”).
Regarding Claim 1, Tanner discloses an anti-buckling device (see generally Fig. 65B) for an interventional device assembly (inter alia 490), comprising:
A telescoping tube (500 – see particularly Fig. 65B wherein the proximal end comprises a smaller diameter than the distal end) comprising a plurality of telescopically axially extendable and collapsible tube segments (640) each with a proximal end (i.e. the end toward 84 – i.e. the smaller diameter ends) and a distal end (i.e. the end toward the incision site – i.e. the larger diameter ends – see Fig. 65B; Par. 510)
Tanner discloses the invention substantially as claimed except that one or more of the plurality of tube segments comprises:
an inner diameter reducing feature configured to reduce an unsupported free length of an interventional device (e.g. 490) of the interventional device assembly when the interventional device extends through the telescoping tube, the inner diameter reducing feature attached to the distal end of its associated tube segment and having a first through hole configured to receive the interventional device therethrough.
However, such features are well-known in the art. For example, Zhang discloses a related telescoping tube system (Fig. 18A) comprising a series of concentrically disposed, telescoping tubes increasing in diameter, wherein a second end of the tubes is/are provided with an inner diameter reducing feature (1803) configured to reduce an unsupported free length of an interventional device (see Fig. 18A) of the interventional device assembly when the interventional device extends through the telescoping tube, the inner diameter reducing feature attached to the second end of its associated tube segment and having a through hole (1804) configured to receive the interventional device therethrough (Par. 116). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the distal end(s) of the tubes of the invention of Tanner to include inner diameter reducing features, as disclosed by Zhang, in order to help prevent detachment of the cylinders during extension as well as supporting the received interventional device in the manner described and shown by Zhang to prevent buckling.
Tanner, in view of Zhang, discloses the invention substantially as claimed except that that the device further comprises a “cap” attached to a proximal end of an associated tube segment, the cap having a second through hold configured to receive the interventional device therethrough, the cap having an outer diameter greater than an outer diameter of the tube segment to which the cap is coupled. Rather Tannger and Zhang each provide the reduced, diameter proximal ends with integrally formed flanges (642, Tanner; 1802, Zhang) which project only radially inward and therefore do not constitute a “cap” having “an outer diameter greater than an outer diameter of the tube segment to which the cap is coupled.
However, Schneider discloses a related telescoping, interventional appliance (290) which is formed as a series of concentrically telescopically, axially extendable and collapsible tube segments (294, 300, 302…etc.). Like Tanner and Zhang, the device of Schneider comprises corresponding stops (310, 312) respectively at the distal (this nomenclature being based upon the diameter decrease direction in the invention of Fig. 65B of Tanner) and proximal ends (see Fig. 23). Schneider discloses that these stops may be formed separately from the tube segments (see Fig. 24) such that they can be affixed to the tubing segments during assembly, thereby creating respective distal (312) and proximal (310) caps (see Fig. 23 and 24) which form slide bearings/stops for the telescoping action of the tube segments (Par. 213-216) with the proximal cap (310) having a through hole (see Fig. 23) configured to receive implements inserted therethrough, the cap having an outer diameter which is greater than the outer diameter of the tube segment to which the cap is coupled (see Fig. 23). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the proximal caps/stops of the invention of modified Tanner to comprise separately formed elements which are later affixed to the tubing segments upon assembly thereby providing caps which have an outer diameter greater than that of the respective tube segments, as disclosed by Schneider, in order to allow the components to be formed separate in a preferred manufacturing method and retaining the telescopic tubes in a linked arrangement via corresponding proximal and distal stops while still permitting assembly of the tubing segments. It has been held that constructing a formerly integral structure as a plurality of separate components to be later affixed together is obvious, see In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Regarding Claim 2, Tanner, as modified by Zhang, discloses the through hole (see 1804 – Zhang) of the inner diameter reducing feature is centered relative to the inner diameter of the tube segment to which the inner diameter reducing feature is attached (see Fig. 18A - Zhang).
Regarding Claim 4, Tanner, as modified by Zhang and Schneider, discloses the cap is a first cap (see 310 – Schneider) and the inner diameter reducing feature comprises a second cap (see Zhang).
Regarding Claim 5, Tanner, as modified by Zhang and Scheider, discloses the second cap is concentrically attached to the tube segment to which the cap is coupled (see Fig. 18A – Zhang).
Regarding Claim 6, Tanner, as modified by Zhang, discloses the cap is a disc-shaped cap (see Fig. 18A, Par. 116 – Zhang).
Regarding Claim 7, Tanner, as modified by Zhang and Schneider, discloses that the caps may be cup-shaped (see Schneider – 312), wherein constructing the cap of Tanner/Zhang to comprise a separate cup-shaped components as disclosed by Schneider, in order to allow them to be constructed as separate components are later affixed to the tubing during assembly as an obvious design choice based on manufacturing preferences. It has been held that constructing a formerly integral structure as a plurality of separate components to be later affixed together is obvious, see In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Regarding Claim 10, Tanner, as modified by Zhang and Schneider, discloses wherein the second through hole of the second cap has a diameter smaller than an inner diameter of the tube segment to which the second cap is coupled (see Fig. 23 – Schneider).
Regarding Claim 13, Tanner discloses the plurality of tube segments comprise an outermost tube segment and one or more inner tube segments, wherein each of the one or more inner tube segments comprises a first tube section having a first outer diameter and a second tube section having a second outer diameter (see Fig. 65B).
Regarding Claim 14, Tanner discloses the first outer diameter of the first tube section is greater than the second outer diameter of the second tube section and the first tube section is disposed adjacent the distal end of its corresponding tube segment (see Fig. 65B).
Regarding Claim 15, Tanner discloses the proximal end of an innermost tube segment of the plurality of tube segments is attached to a proximal retainer (see generally Fig. 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 understood to be receivable within a corresponding hub interior of the driver to provide for selective attachment/detachment).
Regarding Claim 16, Tanner discloses the distal end of an outermost tube segment of the plurality of tube segments is attached to a distal retainer (see generally Fig. 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.
Regarding Claim 18, Tanner discloses each of the plurality of tube segments has a wall thickness that is substantially the same (see generally Fig. 65G).
Regarding Claim 19, Tanner discloses an innermost tube segment of the plurality of tube segments is bonded to the interventional device of the interventional device assembly (see Fig. 65B).
Regarding Claim 20, Tanner discloses that the interventional device comprises a guidewire or catheter (Par. 475 – Par, 25).
Regarding Claim 21, Tanner, as modified in view of Zhang and Schneider, discloses the one or more of the plurality of tube segments comprises a first tube segment, wherein the cap comprises a first cap, wherein the first cap comprises an inner diameter portion extending radially inward relative to an inner diameter of the first tube segment (see Fig. 65B – Tanner in consideration as to modification of the distal ends in view of Zhang, Fig. 18A and modification of the proximal ends in view of Schneider, Fig. 23), wherein the plurality of tube segments comprises a second tube segment having a second cap attached to its proximal end, the second cap having a third through hole configured to receive the interventional device therethrough, the second cap having an outer diameter greater than an outer diameter of the second tube segment and having an outer diameter portion extending radially beyond the outer diameter of the second tube segment, wherein the outer diameter portion of the second tube segment is configured to interact with the inner diameter portion of the first tube segment to restrict proximal movement of the first tube segment relative to the second tube segment (see Fig. 65B – Tanner in consideration as to modification of the distal ends in view of Zhang, Fig. 18A and modification of the proximal ends in view of Schneider, Fig. 23),.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2022/0168049 (“Tanner”) in view of U.S. Publication No. 2022/0313375 (“Zhang”) and U.S. Publication No. 2022/0387069 (“Schneider”) as applied above, and further in view of U.S. Publication No. 2005/0027236 (“Douk”).
Regarding Claim 3, Tanner, as modified by Zhang, discloses the invention substantially as claimed except that through hole of the inner diameter reducing feature is off-centered relative to the inner diameter of the tube segment to which the inner diameter reducing feature is attached. However, Douk discloses a related telescoping tube system (100, 400) which can include an inner diameter reducing feature with a through hole which can either be centered (Fig. 1) or off-centered (Fig. 4). While Douk fails to disclose any particular benefit to off-centering the through opening it would be understood that the location of the through hole constitutes an obvious design choice given that Applicant has failed to present any specific or particular benefit to such a configuration to suggest that the two configurations are anything more than an arbitrary design choice to obtain a predictable and expected outcome pursuant to a known change in shape and a known location of a through hole for receipt of an interventional device within a telescoping tubular guide, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) and In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2022/0168049 (“Tanner”) in view of U.S. Publication No. 2022/0313375 (“Zhang”) and U.S. Publication No. 2022/0387069 (“Schneider”) as applied above, and further in view of U.S. Publication No. 2003/0105451 (“Westlund”).
Regarding Claims 11 and 12, Tanner discloses the plurality of tube segments comprises an outermost tube segment and one or more inner tube segments (see Fig. 65G). Tanner discloses the invention substantially as claimed except that that each of the inner tube segments comprise a shim attached around a portion of its outer diameter. However, Westlund discloses a related telescoping tube system (Fig. 1) wherein an inner tube segment (101) is telescopically received within an outer tube segment (102). In order to index the two tubes Westlund discloses a shim (202) attached around a portion of the outer diameter with the shim being adjacent of the end of the tube which is received within the outer tube (Par. 43, 44). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide a shim at the distal end of the outer surface of the inner tube segments of Tanner, as disclosed by Westlund, in order to index the inner tube within the outer tube and prevent relative rotation between the two tubes, thereby rotationally locking the tubes together to reduce misalignment and buckling.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2022/0168049 (“Tanner”) in view of U.S. Publication No. 2022/0313375 (“Zhang”) and U.S. Publication No. 2022/0387069 (“Schneider”) as applied above, and further in view of U.S. Patent No. 5,766,184 (“Matsuno”).
Regarding Claim 17, 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 0.0110 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. For example, 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, Ln. 32-41). Matsuno provides an exemplary arrange 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 0.0110”, a range obviated by Matusuno, in order to optimize the clearance to provide a stable interface without large sliding friction as a product of routine and customary optimization of a result effective variable, see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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 WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 09/15/2026
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