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 .
Response to Amendment
The amendments filed on 01/26/2026 have been entered. Claims 71 and 80-95 remain pending in the application. The amendments overcome the previous rejection under 35 USC 112(a) by cancelling rejected claims 76-80.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Examiner notes that in the newly filed claims dated 01/26/2026, a “new” claim 80 is presented which is different from claim 80 of the claim set dated 07/14/2025. Applicant states in the response filed 01/26/2026 that claim 80 is cancelled and new claims 80-95 are added. Therefore, the numbering of the claims is incorrect because the newly added claims should start at 81, following previously cancelled claim 80. Appropriate correction is required.
Election/Restrictions
Regarding the newly filed claims, examiner notes that pursuant to the election of Species B, encompassing FIGS 37-39 wherein the tube is axially compressible, claim 86 should be withdrawn from examination at this time because it is drawn to non-elected Species A, encompassing FIGs 34-36.
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) 71, 80-85, 87-89, and 94-95 are rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (US 2019/0262016) in view of Harlev et al. (US 2017/0312420), further in view of Salmon et al. (US 5,314,408).
Regarding claim 71, Zheng et al. discloses a method of handling an elongate endovascular element (184, [0041]) for treating a lesion in a blood vessel ([0049-0050]), the method comprising: supporting a portion of the element within an elongate tube (270 and 182, FIG 1-2B) extending distally from an activation unit (110, FIG 1, [0040]), the activation unit including an ultrasonic transducer (130, [0040-0041]) that is coupled to the element; activating the element ultrasonically via the ultrasonic transducer ([0041] “A proximal end of the core wire 184 is vibrationally coupled to the ultrasound transducer 130” and activated by the foot switch 140).
Zheng et al. is silent regarding varying a longitudinal spacing between the activation unit and a distal structure spaced distally from the activation unit.
However, Harlev et al. teaches in the same field of endeavor a method of handling an elongate endovascular element (122, FIG 2 and FIG 13A-13E, [0173]) for treating a lesion ([0176, 0248], using electrode 124), the elongate endovascular element being supported in an elongate tube (164, FIGs 13A-13E, [0250-0252]), coupled to an activation unit (120), and further comprising a distal structure (162, [0249-0254]) which aids in the inserting of the endovascular element into the patient, wherein the method comprises varying a longitudinal spacing between the activation unit and the distal structure spaced distally from the activation unit (See steps FIG 13A-13E where the distance between 120 and 162 is varied as the instrument is inserted into 162 and this into the insertion site of the patient).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of Sheng to comprise using a distal structure in the form of an introducer sheath at the insertion site of the patient and providing a step of advancing the activation unit towards the distal structure to insert the endovascular element into the structure, as taught by Harlev, for the purpose of providing small insertion site for guiding the endovascular element to the treatment site, thus reducing the likelihood of infection and/or reducing the amount of time required for healing ([0254]).
Zheng et al. is silent regarding varying a length of the tube by applying a longitudinal force to a telescopic, concertina or braid structure of the tube.
However, Salmon et al. teaches a device (FIG 11A or 11B) used in translating an ultrasonic element (72/75) within the lumen of a tube (122, 120), wherein a step of handling the element includes varying the length of the tube by applying longitudinal force to a telescopic, concertina or braid structure of the tube (118 is an axially expandable member in the form of telescopic elements or bellows which function to change the effective length of the tube, col 9 line 23-col 10 line 15)).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the tube of Zheng to comprise a segment implemented as a collapsible and extendable telescoping tubes and thereby modify method of Zheng et al. to comprise a step of varying the length of the tube by applying longitudinal force to a telescopic structure of the tube, as taught by Salmon et al., for the purpose of using a structure commonly known in the art for controlling extension and retraction on the length of a tube structure and thereby achieving the predictable result of controllably and reversible housing or extending the element relative to the tube.
Regarding claim 80, Zheng et al./Harlev/ Salmon disclose invention substantially as claimed, as set forth above for claim 71. The method as modified further discloses the distal structure is a catheter or an entry point (As modified by Harlev, the distal structure, introducer sheath 162, is a catheter).
Regarding claim 81, Zheng et al./Harlev/ Salmon disclose invention substantially as claimed, as set forth above for claim 71. The method as modified further discloses the distal structure is a catheter (the distal structure, introducer sheath 162, is a catheter) and further comprising fitting the tube into a proximal end of the catheter and then moving the catheter telescopically along the tube (FIGs 13B-13C shows inserting tube 164 into 162. The two elements are slid longitudinally relative to one another and therefore are moved telescopically, [0251]).
Regarding claim 82, Zheng et al./Harlev/ Salmon disclose invention substantially as claimed, as set forth above for claim 81. The method as modified further discloses the element remains covered as the activation unit and a hub of the catheter move closer together or further apart (The step of FIG 13B shows the distal end of the element 122/124 is covered by 164 and then movement of 120 towards 162 occurs).
Regarding claim 83, Zheng et al./Harlev/ Salmon disclose invention substantially as claimed, as set forth above for claim 71. The method as modified further discloses the tube connects the activation unit to the distal structure (Through mechanical connection for example as shown in FIG 13E).
Regarding claim 84, Zheng et al./Harlev/ Salmon disclose invention substantially as claimed, as set forth above for claim 83. The method as modified further discloses the tube fixes the activation unit to the distal structure (Through mechanical connection for example as shown in FIG 13E).
Regarding claim 85, Zheng et al./Harlev/ Salmon disclose invention substantially as claimed, as set forth above for claim 71. The method as modified further discloses keeping the portion of the element outside of a body by using the tube to limit distal advancement of the activation unit toward the body (FIG 13E shows that the length of tube 164 sets forth a separation distance between 120and 162. Therefore a portion of element 122 is kept outside of the body at all times).
Regarding claim 87, Zheng et al./Harlev/ Salmon disclose invention substantially as claimed, as set forth above for claim 71. Zheng et al. further discloses the tube provides strain relief to the element (By surrounding the element, the tube provides strain relief by absorbing some of the forces applied to the device and limiting the bending of the element therewithin).
Regarding claim 88, Zheng et al./Harlev/ Salmon disclose invention substantially as claimed, as set forth above for claim 71. The method as modified further discloses varying the length of the tube in response to varying the longitudinal spacing between the activation unit and the distal structure (Varying the length of the tube occurs as a step of the method wherein the device is being inserted into the body for treatment, which coincides with varying the longitudinal spacing between the activation unit and the distal structure).
Regarding claim 89, Zheng et al./Harlev/ Salmon disclose invention substantially as claimed, as set forth above for claim 71. The device as modified further discloses varying the length of the tube adjusts damping of the activated element (Extending or retracting the distal end of the tube from covering the distal end of the element affects the damping of the ultrasonic energy applied to the element).
Regarding claim 94, Zheng et al./Harlev/ Salmon disclose invention substantially as claimed, as set forth above for claim 71. Zheng et al. further discloses capturing and holding the element within the tube (In the assembled device, the element is captured and held within the tube).
Regarding claim 95, Zheng et al./Harlev/ Salmon disclose invention substantially as claimed, as set forth above for claim 71. Zheng et al. further discloses immersing the element in a liquid medium within the tube (irrigation port 172 is used to introduce a fluid into the tube for cooling the element, [0042]).
Claim(s) 90-93 are rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (US 2019/0262016) in view of Harlev et al. (US 2017/0312420), further in view of Salmon et al. (US 5,314,408), further in view of Shturman et al. (US 6,077,282).
Regarding claim 90, 92, and 93, Zheng et al./Harlev/ Salmon disclose invention substantially as claimed, as set forth above for claim 71.
The method as modified by Salmon is silent regarding any process or mechanisms used to expand or contract the telescopic structure of the tube, and therefore is silent regarding applying the longitudinal force by pressing a distal end of the tube to shorten the tube, applying the longitudinal force by pulling a distal end of the tube to extend the tube, and gripping the distal end of the tube to extend the tube.
However, Shturman teaches a tube (70) comprising movable telescopic tube elements (76, 72) which can be expanded or retracted by manually applying a force at the distal end of the tube (FIG 17-18, col 13 lines 35-45).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the methods of carrying the length of the tube to comprise pressing a distal end of the tube to shorten the tube an gripping the distal end of the tube to pull a distal end of the tube to extend the tube, for the purpose of utilizing a technique commonly known in the art for adjusting telescopic length adjusting tubes and thereby achieving the predictable result of controlling the varying of the tube.
Regarding claim 91, Zheng et al./Harlev/ Salmon/ Shturman disclose invention substantially as claimed, as set forth above for claim 90. The method as modified further comprises pressing the distal end of the tube against the distal structure (Inserting the tube into the distal structure as taught by Harlev is interpreted as pressing the distal end of the tube against the distal structure).
Response to Arguments
Applicant’s arguments, see pages 2-6, filed 01/26/2026, with respect to the rejection(s) of claim(s) 71 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Harlev and Salmon.
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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771