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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/29/2025 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) p. 7, para. 2 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.
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2,9 and 22-38 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Alvarez (US 20160151122 A1).
Regarding claim 1, Alvarez teaches A medical instrument comprising:
an elongate flexible body (fig. 1, element 108, [0059], instrument assembly 108) including a proximal section (fig. 2a/b, element 202, [0057], control unit 202) and a steerable distal section (fig. 3a, element 300, [0058], steerable elongate instrument 300);
a control tendon (fig. 3a, element 314, [0062], pull wire 314) extending within the elongate flexible body; and
an axially variable stiffening mechanism (fig. 3a, element 306, [0063], flex tubes 306) adjustable between a first state in which applying an actuation force to the control tendon produces a first bend radius at a location in the steerable distal section and a second state in which applying the actuation force to the control tendon produces a second bend radius at the location in the steerable distal section, the second bend radius being different than the first bend radius ([0063], when the flex tubes are stiffened by tensioning pull wires that may be attached to the flex tubes (306). In such application, the flex tubes (306) may support not only axial forces or loads, but also lateral forces or loads. As such, the flex tubes may increase the lateral as well as bending stiffness of at least a portion or section of the elongate instrument (300). In addition, the flex tubes (306) may also affect the bending radius of at least a portion or section of the elongate instrument (300) as the elongate instrument is steered, articulated, or manipulated).
Regarding claim 2, Alvarez teaches The instrument of claim 1,
wherein the control tendon extends within the axially variable stiffening mechanism (fig. 3a, element 314, [0063], wires are within flex tubes 306).
Regarding claim 9, Alvarez teaches The instrument of claim 1,
further comprising a control element configured to engage the axially variable stiffening mechanism to selectively adjust the axially variable stiffening mechanism between the first state and the second state ([0063], the flex tubes are stiffened by tensioning pull wires that may be attached to the flex tubes (306)).
Regarding claim 22, Alvarez teaches The instrument of claim 1,
wherein the axially variable stiffening mechanism comprises a first conduit (fig. 3a, element 306, [0061], flex tube may be made from a coil of wire, a stack of rings, or a tube with spirally cut features, tubes being conduits) extending through a second conduit (fig. 3a, element 304, [0059], operation tube 304).
Regarding claim 23, Alvarez teaches The instrument of claim 22,
further comprising a first grip element secured to a proximal portion of the first conduit and a second grip element secured to a proximal portion of the second conduit (fig. 3a, element 302, flexible tube 306 extends proximally to operational tubes 304, both of which are secured via grip to the outer tube 302).
Regarding claim 24, Alvarez teaches The instrument of claim 22,
wherein the control tendon extends through the first conduit (fig. 3a, element 314, [0063], wires are within flex tubes 306) and terminates within the steerable distal section (fig. 3a, element 316, [0062], distal end of pull wires may be fixed to control ring 316).
Regarding claim 25, Alvarez teaches The instrument of claim 24,
further comprising a proximal transition section (fig. 3a, element 302, flexible tube 306 extends proximally to operational tubes 304, both of which are secured via grip to the outer tube 302, attachment points could be considered transition sections) between the proximal section and the steerable distal section.
Regarding claim 26, Alvarez teaches The instrument of claim 25,
wherein the second conduit terminates at the proximal transition section ([0064], fig. 3a, element 302, flexible tube 306 extends proximally to operational tubes 304, both of which are secured via grip to the outer tube 302).
Regarding claim 27, Alvarez teaches The instrument of claim 25,
further comprising a distal transition section between a proximal steerable portion and a distal steerable portion of the distal steerable section ([0064],fig. 3a, element 302, flexible tube 306 extends proximally to operational tubes 304, both of which are secured via grip to the outer tube 302, attachment points could be considered transition sections).
Regarding claim 28, Alvarez teaches The instrument of claim 27,
wherein the first conduit terminates at the distal transition section ([0064],fig. 3a, element 302, flexible tube 306 extends proximally to operational tubes 304, both of which are secured via grip to the outer tube 302).
Regarding claim 29, Alvarez teaches The instrument of claim 27,
wherein the second conduit terminates at the distal transition section, and the first conduit terminates distal to the distal transition section within the steerable distal section ([0064], fig. 3a, element 302, flexible tube 306 extends proximally to operational tubes 304, both of which are secured via grip to the outer tube 302).
Regarding claim 30, Alvarez teaches The instrument of claim 22,
wherein the first conduit and the second conduit comprise coil pipes ([0061], flex tubes may be formed from a coil of wire, [0059], operational tubes 304 may be braided and composed of metal or polymer).
Regarding claim 31, Alvarez teaches The instrument of claim 22,
further comprising a first control element configured to selectively adjust the axial stiffness of the first conduit, and a second control element configured to selectively adjust the axial stiffness of the second conduit ([0063], the flex tubes are stiffened by tensioning pull wires that may be attached to the flex tubes (306), [0068], flex tubes may be slid up and down the operational tubes, resulting in a change of stiffness of the operational tube at the location the flex tube is moved to).
Regarding claim 32, Alvarez teaches The instrument of claim 31,
further comprising a controller (fig. 2a, element 202, [0057], control unit 202), wherein each of the first control element and the second control element comprises at least one screw that is selectively adjustable by the controller (fig. 13d, element 1310, [0085], interface slide carriage may be a screw drive).
Regarding claim 33, Alvarez teaches A medical instrument comprising:
an elongate flexible body (fig. 1, element 108, [0059], instrument assembly 108) including
a proximal section (fig. 2a/b, element 202, [0057], control unit 202),
a steerable distal section (fig. 3a, element 300, [0058], steerable elongate instrument 300), and
a steerable proximal section disposed between the proximal section and the steerable distal section (fig. 3a, element 300, [0058], steerable elongate instrument 300);
a control tendon (fig. 3a, element 314, [0062], pull wire 314) extending within the elongate flexible body; and
an axially variable stiffening mechanism (fig. 3a, element 306, [0063], flex tubes 306) being adjustable between a first state in which applying an actuation force to the control tendon produces a first bend radius at a location in the steerable proximal section and a second state in which applying the actuation force to the control tendon produces a second bend radius at the location in the steerable proximal section, the second bend radius being different than the first bend radius ([0063], when the flex tubes are stiffened by tensioning pull wires that may be attached to the flex tubes (306). In such application, the flex tubes (306) may support not only axial forces or loads, but also lateral forces or loads. As such, the flex tubes may increase the lateral as well as bending stiffness of at least a portion or section of the elongate instrument (300). In addition, the flex tubes (306) may also affect the bending radius of at least a portion or section of the elongate instrument (300) as the elongate instrument is steered, articulated, or manipulated).
Regarding claim 34, Alvarez teaches The instrument of claim 33,
wherein the control tendon extends within the axially variable stiffening mechanism (fig. 3a, element 314, [0063], wires are within flex tubes 306).
Regarding claim 35, Alvarez teaches The instrument of claim 34,
wherein the axially variable stiffening mechanism comprises a first conduit (fig. 3a, element 306, [0061], flex tube may be made from a coil of wire, a stack of rings, or a tube with spirally cut features, tubes being conduits) extending through a second conduit (fig. 3a, element 304, [0059], operation tube 304).
Regarding claim 36, Alvarez teaches The instrument of claim 35,
wherein the control tendon extends through the first conduit (fig. 3a, element 314, [0063], wires are within flex tubes 306) and terminates within the steerable distal section (fig. 3a, element 316, [0062], distal end of pull wires may be fixed to control ring 316).
Regarding claim 37, Alvarez teaches The instrument of claim 36,
wherein the second conduit terminates at a proximal end of the steerable proximal section ([0064], fig. 3a, element 302, flexible tube 306 extends proximally to operational tubes 304, both of which are secured via grip to the outer tube 302).
Regarding claim 38, Alvarez teaches The instrument of claim 37,
wherein the first conduit terminates at a proximal end of the steerable distal section ([0064], fig. 3a, element 302, flexible tube 306 extends proximally to operational tubes 304, both of which are secured via grip to the outer tube 302).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY TUAN LUU whose telephone number is (703)756-4592. The examiner can normally be reached Monday-Tuesday, Thursday-Friday.
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/TIMOTHY TUAN LUU/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795