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
Amendments to claims 1, 23, 24, 31, 33, 36 of 4/21/2026 acknowledged and entered.
Cancellation of claims 22, 30, 35 of 4/21/2026 acknowledged and entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 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 § 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.
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, 9, 23-26, 31-34, 36-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alvarez (US 201000280449 A1) in view of Nguyen (US 20070270679 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).
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).
the first conduit comprise coil pipes ([0061], flex tubes may be formed from a coil of wire, [0059]).
Alvarez does not explicitly teach wherein the second conduit comprise coil pipes.
However, Nguyen teaches wherein the second conduit comprise coil pipes (fig. 2, element 21/22, [0046], coil 22 is disposed within braided wire 21, thus concentric coil stiffening members are disclosed in Nguyen).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second conduit of Alvarez to be a coil as taught in Nguyen in order to adjust bending radius of the catheter (Nguyen [0036]).
Regarding claim 2, Alvarez in view of Nguyen teaches The instrument of claim 1,
Further, Alvarez teaches 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 in view of Nguyen teaches The instrument of claim 1,
Further, Alvarez teaches 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 23, Alvarez in view of Nguyen teaches The instrument of claim 1,
Further, Alvarez teaches 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 in view of Nguyen teaches The instrument of claim 1,
Further, Alvarez teaches 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 in view of Nguyen teaches The instrument of claim 24,
Further, Alvarez teaches 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 in view of Nguyen teaches The instrument of claim 25,
Further, Alvarez teaches 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 in view of Nguyen teaches The instrument of claim 25,
Further, Alvarez teaches 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 in view of Nguyen teaches The instrument of claim 27,
Further, Alvarez teaches 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 in view of Nguyen teaches The instrument of claim 27,
Further, Alvarez teaches 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 31, Alvarez in view of Nguyen teaches The instrument of claim 1,
Further, Alvarez teaches 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 in view of Nguyen teaches The instrument of claim 31,
Further, Alvarez teaches 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) 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)
the first conduit comprise coil pipes ([0061], flex tubes may be formed from a coil of wire, [0059]).
Alvarez does not explicitly teach wherein the second conduit comprise coil pipes.
However, Nguyen teaches wherein the second conduit comprise coil pipes (fig. 2, element 21/22, [0046], coil 22 is disposed within braided wire 21, thus concentric coil stiffening members are disclosed in Nguyen).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second conduit of Alvarez to be a coil as taught in Nguyen in order to adjust bending radius of the catheter (Nguyen [0036]).
Regarding claim 34, Alvarez in view of Nguyen teaches The instrument of claim 33,
Further, Alvarez teaches wherein the control tendon extends within the axially variable stiffening mechanism (fig. 3a, element 314, [0063], wires are within flex tubes 306).
Regarding claim 36, Alvarez in view of Nguyen teaches The instrument of claim 33,
Further, Alvarez teaches 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 in view of Nguyen teaches The instrument of claim 36,
Further, Alvarez teaches 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 in view of Nguyen teaches The instrument of claim 37,
Further, Alvarez teaches 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
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/TIMOTHY TUAN LUU/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
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