CTNF 18/525,107 CTNF 84188 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 § 112 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claim(s) 8 and dependents is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding Claim 8, Applicant recites “wherein each of the one or more outer tube segments is coupled to a second cap at its proximal end, the second cap having a second through hole configured to receive the interventional device therethrough” [emphasis added]. Here the grammar of this claim creates confusion as it is unclear if the “a second cap” is a common “second cap” shared between each of the one or more outer tube segments or if the “a second cap” is a respective “second cap”, whereby each outer tube segment has its own individual “second” cap. The term “second cap” is used in the specification, but only in Summary section (Par. 56) and not with respect to any of the explicitly disclosed embodiments. It is presumed that the “a second cap” was intended to reference the plurality of caps 815 and that the “a second cap” is a “respective second cap” provided on respective proximal ends of the one or more outer tube segments. Appropriate correction is required. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim (s) 1, 2, 4-6, 13-16, and 18-20 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”) . Regarding Claim 1, Tanner discloses an anti-buckling device for an interventional device assembly, comprising: a telescoping tube (500 – see specifically Fig. 6B wherein the proximal end comprises a smaller diameter than the distal end) comprising a plurality of concentric telescopically axially extendable and collapsible tube segments (640) each with a proximal end (i.e. the end toward 84) and a distal end (i.e. the end toward the incision site). Tanner discloses the invention substantially as claimed except that 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 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. 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, discloses the inner diameter reducing feature comprises a cap (see Fig. 18A, Par. 116 – Zhang). Regarding Claim 5, Tanner, as modified by Zhang, discloses the 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 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) . 07-21-aia AIA 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”) 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) . 07-21-aia AIA Claim (s) 7 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”) as applied above, and further in view of U.S. Patent No. 6,547,766 (“Fitz”) . Regarding Claim 7, Tanner, as modified by Zhang, discloses the invention substantially as claimed except that that cap is a cup-shaped cap. However, Fitz discloses a related telescoping tube system which also includes a cap (40) enclosing an end of the tube and providing a through hole for receipt of an interventional device (52) wherein the cap is engaged with the end of the tube via a cup shaped arrangement (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 cap of modified Tanner to be cup shaped, as disclosed by Fitz, in order to assist in aligning the cap with the tube during fitting thereby improving the integrity of the bond between the two components . 07-21-aia AIA Claim (s) 8, 10 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”) as applied above, and further in view of U.S. Patent No. 5,120,317 (“Luther”) . Regarding Claim 8, Tanner, as modified by Zhang, discloses the cap is a first cap (see Zhang – Fig. 18A), wherein the plurality of tube segments comprises an innermost tube segment (see Tanner – Fig. 65B, i.e. the proximal-most, smallest diameter segment) and one or more outer tube segments (e.g. the subsequently distally located, increasing diameter segments). Tanner discloses the invention substantially as claimed except that each of the one or more outer tube segments is coupled to a respective proximal cap and its proximal end, the proximal cap having a second through hole configured to receive the interventional device. Zhang discloses an “inner lip” (1802) coupled to the second end of the outer tube segment(s) having a through hole configured to receive an interventional device therethrough, but fails to disclose that this lip should be provided as a separate and distinct component so as to constitute a “cap”, rather Zhang provides this inner lip integrally. However, Luther discloses a related telescoping tube system (Fig. 5) comprising an integrally formed inner lip (102) which like that of Zhang serves as a stop for the inner tube (18), wherein the inner lip can be formed integrally (Fig. 5) or can be formed as a separate cap component (see 40, 48 – Fig. 7). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the inner lip of the invention of modified Tanner to comprise a separate cap component used to define the travel stop for the inner, telescoping tubular members, as disclosed by Luther, since it has been held that forming in multiple separate pieces a construction which was previously formed integrally is obvious and requires only routine and customary skill in the art when only predictable and expected results are to be obtained, see In Nerwin v. Erlichman, 168 USPQ 177, 179 – whereby any benefits (such as improving the ease of manufacture or assembly) flow naturally from such an obvious modification with the prior art exemplifying the two configurations to be suitable alternatives to one another to achieving the same effect. Regarding Claim 10, Tanner, as modified, presents such that 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 Zhang, element 1802 – Fig. 18A; Luther, element 40, 48 – Fig. 7) . 07-21-aia AIA Claim (s) 9 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. Patent No. 5,120,317 (“Luther”) as applied above, and further in view of U.S. Patent No. 6,547,766 (“Fitz”) . Regarding Claim 9, Tanner, as modified by Zhang and Luther, discloses the invention substantially as claimed except that second cap has an outer diameter greater than an outer diameter of the tube to which the second cap is coupled. Rather Luther and Zhang both illustrate the second cap to have an outer diameter equal to that of the tube (see 40, 48 Fig. 7, Luther; see 1802, Fig. 18A, Zhang). However, Douk discloses 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 cap of modified 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 ensure a strong and effective securement therebetween . 07-21-aia AIA Claim (s) 11-12 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”) 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 . 07-21-aia AIA 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”) 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). Conclusion 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). 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, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 03/11/2026 Application/Control Number: 18/525,107 Page 2 Art Unit: 3783 Application/Control Number: 18/525,107 Page 3 Art Unit: 3783 Application/Control Number: 18/525,107 Page 4 Art Unit: 3783 Application/Control Number: 18/525,107 Page 5 Art Unit: 3783 Application/Control Number: 18/525,107 Page 6 Art Unit: 3783 Application/Control Number: 18/525,107 Page 7 Art Unit: 3783 Application/Control Number: 18/525,107 Page 8 Art Unit: 3783 Application/Control Number: 18/525,107 Page 9 Art Unit: 3783 Application/Control Number: 18/525,107 Page 10 Art Unit: 3783 Application/Control Number: 18/525,107 Page 11 Art Unit: 3783 Application/Control Number: 18/525,107 Page 12 Art Unit: 3783 Application/Control Number: 18/525,107 Page 13 Art Unit: 3783