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 .
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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) 1-11, 13-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Spivey (US 20110295242 A1).
Regarding claim 1, Spivey teaches A medical device, comprising:
a handle (fig. 1a, element 14, [0175], handle 14);
a sheath (fig. 1a, element 12, [0175], elongate shaft 12) extending along a longitudinal axis, wherein the sheath includes a proximal end (fig. 1a, element 12a, [0175], a proximal end 12a) and a distal end (fig. 1a, element 12b, [0179], the distal end 12b), and wherein the proximal end of the sheath extends from the handle;
an articulation joint (fig. 2, element 12, [0176], the elongate shaft 12 is hollow and is formed from multiple connecting segments to allow the elongate shaft 12 to flex) extending from a proximal end to a distal face, wherein the articulation joint includes a distalmost end of the medical device, wherein the articulation joint includes a plurality of links;
an imaging device (fig. 1a, [0188], the device 10 of FIG. 1A can include an optical image gathering unit disposed on a distal end of the elongate shaft 12 and configured to acquire images during endoscopic procedures) at the distal face of the articulation joint a piezoelectric member (fig. 2, element 34a-d, [0177, 0206], The distal end of the cables 34a-d can be mated to the end effector 16 to control movement of the end effector 16. the cable actuators disclosed herein used to effect articulation of a working end of a device can be formed from an electroactive polymer material. Electroactive polymers (EAPs), also referred to as artificial muscles, are materials that exhibit piezoelectric, pyroelectric, or electrostrictive properties in response to electrical or mechanical fields) attached to and extending between adjacent links on a side of the articulation joint,
wherein the piezoelectric member includes an expanded state and a contracted state, wherein, in the expanded state, the piezoelectric member is parallel to the longitudinal axis, and wherein, in the contracted state, the piezoelectric member is bent or deflected relative to the longitudinal axis (fig. 2, element 34a-d, [0177], The distal end of the cables 34a-d can be mated to the end effector 16 to control movement of the end effector 16).
Regarding claim 2, Spivey teaches The medical device of claim 1,
wherein the piezoelectric member extends from a proximal end of the piezoelectric member at the proximal end of the articulation joint to a distal end of the piezoelectric member at the distal face of the articulation joint (fig. 2/4a, element 34a-d, 4a shows proximal end of control elements 34a-d at the handle, and 2 shows them at the distal end).
Regarding claim 3, Spivey teaches The medical device of claim 1,
wherein the piezoelectric member extends distally from a proximal end of the piezoelectric member that is distal to a proximalmost link of the plurality of links ([0177] The distal end of the cables 34a-d can be mated to the end effector 16 to control movement of the end effector 16.).
Regarding claim 4, Spivey teaches The medical device of claim 3,
wherein the piezoelectric member extends proximally from a distal end of the piezoelectric member that is proximal to a distalmost link of the plurality of links (The medical device of claim 3, wherein the piezoelectric member extends proximally from a distal end of the piezoelectric member that is proximal to a distalmost link of the plurality of links.).
Regarding claim 5, Spivey teaches The medical device of claim 1,
wherein the piezoelectric member is attached to exterior surfaces of the plurality of links (Fig. 2, element 34a-d, cables on exterior of links).
Regarding claim 6, Spivey teaches The medical device of claim 1,
wherein the piezoelectric member is attached to interior surfaces of the plurality of links (fig. 3b, element 28a-d, [0181] four bores 28a, 28b, 28c, 28d for receiving the four cables 34a, 34b, 34c, 34d).
Regarding claim 7, Spivey teaches The medical device of claim 1,
wherein the piezoelectric member is a first piezoelectric member and the side of the articulation joint is a first side of the articulation joint,
wherein the medical device further comprises a second piezoelectric member attached to and extending between adjacent links on a second side of the articulation joint, wherein the second piezoelectric member includes an expanded state and a contracted state, wherein, in the expanded state, the second piezoelectric member is parallel to the longitudinal axis, and, wherein, in the contracted state, the second piezoelectric member is bent or deflected relative to the longitudinal axis ([0177], The distal end of the cables 34a-d can be mated to the end effector 16 to control movement of the end effector 16).
Regarding claim 8, Spivey teaches The medical device of claim 7,
wherein, in the expanded state, the first piezoelectric member and the second piezoelectric member bend in the same direction relative to the longitudinal axis ([0181], In use, the connection of the cables 34a-d at the distal end of the flexible neck 26 will allow the cables 34a-d to apply a tension to the flexible neck 26 when an axial force is applied to the cables 34a-d by the handle 14. This tension will cause the neck 26 to flex in a direction dictated by the amount of tension applied to each cable 34a-d,).
Regarding claim 9, Spivey teaches The medical device of claim 7,
wherein, in the expanded state of the first piezoelectric member, the articulation joint is deflected along a first plane, wherein, in an expanded state of the second piezoelectric member, the articulation joint is deflected along a second plane, different from the first plane ([0181], In use, the connection of the cables 34a-d at the distal end of the flexible neck 26 will allow the cables 34a-d to apply a tension to the flexible neck 26 when an axial force is applied to the cables 34a-d by the handle 14. This tension will cause the neck 26 to flex in a direction dictated by the amount of tension applied to each cable 34a-d,).
Regarding claim 10, Spivey teaches The medical device of claim 1,
wherein adjacent links of the plurality of links are connected by one or more connectors, wherein the connectors are formed from a nickel titanium alloy ([0210], In other aspects, the cable actuators can be formed from a shape-memory material, such as Nitinol).
Regarding claim 11, Spivey teaches The medical device of claim 1, further comprising:
an actuator positioned on the handle, the actuator is operably connected to the piezoelectric member to transition the piezoelectric member between the expanded state and the contracted state ([0183], In use, the handle 14 can articulate or pivotally move relative to the shaft 12 to cause the end effector 16 to mimic the movement of the handle 14. This can be achieved by coupling the proximal end of the cables 34a-d to the handle 14.).
Regarding claim 13, Spivey teaches The medical device of claim 1, further comprising: an end effector attached to the distal face of the articulation joint ([0177], The distal end of the cables 34a-d can be mated to the end effector 16 to control movement of the end effector 16).
Regarding claim 14, Spivey teaches The medical device of claim 1,
further comprising: a working channel extending from the proximal end of the sheath to a distal opening at the distal face (fig. 7, element 100, [0189], the medical device is in the form of an accessory channel 100 for use with an endoscope. An accessory channel 100 is an external device that can mate to and slide along an endoscope to allow other tools, such as grasper, cutters, etc., to be introduced therethrough and positioned in proximity to the viewing end of the endoscope).
Regarding claim 15, Spivey teaches A medical system including the medical device of claim 14, further comprising:
a medical instrument ([0189], other tools, such as grasper, cutters, etc., to be introduced therethrough and positioned in proximity to the viewing end of the endoscope),
wherein the handle includes a port in communication with the working channel (fig. 7, element 107, [0199], the joystick on the handle 106 can include a lumen 107 formed therethrough and axially aligned with the lumen 102c in the elongate shaft 102 for allowing a tool to be introduced through the device 100.),
wherein the medical instrument is slidably received within the working channel and extended to the distal opening ([0199], the joystick on the handle 106 can include a lumen 107 formed therethrough and axially aligned with the lumen 102c in the elongate shaft 102 for allowing a tool to be introduced through the device 100.),
wherein transitioning the piezoelectric member from the expanded state to the contracted state deflects the articulation joint and the medical instrument relative to the longitudinal axis ([0196], The articulating movement of the handle 106 can allow the motion of the handle 106 to be mimicked by the flexible neck 108,).
Regarding claim 16, Spivey teaches A medical device, comprising:
a handle (fig. 1a, element 14, [0175], handle 14);
a sheath (fig. 1a, element 12, [0175], elongate shaft 12) extending from the handle and having a longitudinal axis;
an articulation joint (fig. 2, element 12, [0176], the elongate shaft 12 is hollow and is formed from multiple connecting segments to allow the elongate shaft 12 to flex) connected to a distal end of the sheath, the articulation joint having a plurality of connected links;
an imaging device (fig. 1a, [0188], the device 10 of FIG. 1A can include an optical image gathering unit disposed on a distal end of the elongate shaft 12 and configured to acquire images during endoscopic procedures) at a distal face of the articulation joint;
a first set of piezoelectric members attached to and extending between adjacent links on a first side of the articulation joint; and
a second set of piezoelectric members attached to and extending between the adjacent links on a second side of the articulation joint (fig. 2, element 34a-d, [0177, 0206], The distal end of the cables 34a-d can be mated to the end effector 16 to control movement of the end effector 16. the cable actuators disclosed herein used to effect articulation of a working end of a device can be formed from an electroactive polymer material. Electroactive polymers (EAPs), also referred to as artificial muscles, are materials that exhibit piezoelectric, pyroelectric, or electrostrictive properties in response to electrical or mechanical fields).
Regarding claim 17, Spivey teaches The medical device of claim 16,
wherein piezoelectric members from each of the first set of piezoelectric members and the second set of piezoelectric members are independently controlled such that (1) the articulation joint bends at different angles between adjacent sets of links, and (2) the articulation joint bends in different directions relative to the longitudinal axis between adjacent sets of links (fig. 2, element 34a-d, [0177], The distal end of the cables 34a-d can be mated to the end effector 16 to control movement of the end effector 16).
Regarding claim 18, Spivey teaches The medical device of claim 16,
wherein the handle further comprises a first actuation device and a second actuation device (fig. 7, element 124a-d [0198], the handle 106 includes four legs 124a, 124b, 124c, 124d formed thereon. The legs 124a-d are spaced around a circumference of the joystick 122, such that they are substantially aligned with the cables, and each leg 124a-d is configured to mate to a terminal end of one of the cables 110a-d),
wherein actuation of the first actuation device supplies a voltage to piezoelectric members of the first set of piezoelectric members, and wherein actuation of the second actuation device supplies a voltage to piezoelectric members of the second set of piezoelectric members ([0209], Electroactive polymers (EAPs), also referred to as artificial muscles, are materials that exhibit piezoelectric, pyroelectric, or electrostrictive properties in response to electrical or mechanical fields, supply of an electric signal is disclosed by positing the substitution of piezoelectric material for control cables).
Regarding claim 19, Spivey teaches A medical device, comprising:
a handle (fig. 1a, element 14, [0175], handle 14);
a sheath (fig. 1a, element 12, [0175], elongate shaft 12) extending from the handle and having a longitudinal axis;
an articulation joint (fig. 2, element 12, [0176], the elongate shaft 12 is hollow and is formed from multiple connecting segments to allow the elongate shaft 12 to flex) connected to a distal end of the sheath, wherein the articulation joint includes a plurality of connected links;
an imaging device (fig. 1a, [0188], the device 10 of FIG. 1A can include an optical image gathering unit disposed on a distal end of the elongate shaft 12 and configured to acquire images during endoscopic procedures) at a distal face of the articulation joint;
a working channel (fig. 7, element 100, [0189], the medical device is in the form of an accessory channel 100 for use with an endoscope. An accessory channel 100 is an external device that can mate to and slide along an endoscope to allow other tools, such as grasper, cutters, etc., to be introduced therethrough and positioned in proximity to the viewing end of the endoscope) configured to slidably receive a medical instrument therethrough, wherein the working channel extends from the handle to a distal opening at the distal face of the articulation joint;
a first piezoelectric member attached to and extending between adjacent links on a first side of the articulation joint; and
a second piezoelectric member attached to and extending between the adjacent links on a second side of the articulation joint (fig. 2, element 34a-d, [0177, 0206], The distal end of the cables 34a-d can be mated to the end effector 16 to control movement of the end effector 16. the cable actuators disclosed herein used to effect articulation of a working end of a device can be formed from an electroactive polymer material. Electroactive polymers (EAPs), also referred to as artificial muscles, are materials that exhibit piezoelectric, pyroelectric, or electrostrictive properties in response to electrical or mechanical fields).
Regarding claim 20, Spivey teaches The medical device of claim 19,
wherein the first piezoelectric member and the second piezoelectric member are independently controlled (fig. 2, element 34a-d, [0177], The distal end of the cables 34a-d can be mated to the end effector 16 to control movement of the end effector 16).
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) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spivey as applied to claim 11 above, and further in view of Raj (US 20200221936 A1).
Regarding claim 12, Spivey teaches The medical device of claim 11,
Spivey does not explicitly teach wherein the actuator is a push button.
However, Raj teaches wherein the actuator is a push button.
([0254] In various embodiments, the angle of the bend in the probing portion may be controllable by the operator. For example, the operator may use a button, slider, or other actuator to vary the bend from zero degrees to as much as 45 degrees. (Various embodiments contemplate other ranges of angles as well). The bend may be controlled via an adjustable hinge, a piezoelectric material that can expand or contract one side of the probing arm (thereby causing it to bend))
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 control system of Spivey to include a push button as taught in Raj in order to control the device through a protective sheath (Raj [0205]).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY TUAN LUU/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
