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 Objections
Claim 17 is objected to because of the following informalities: inclusion of “a the” in the claim language (line 10). Appropriate correction is required.
Claim Rejections - 35 USC § 102
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) 1-4, 15-19, and 26-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arai (US 2013/0205937).
Regarding claim 1, Arai teaches
A medical scope device, comprising:
a first steerable device extending to a distal end of the medical scope device (second bending section 7, paragraph [0056], see fig. 7); and
a second steerable device extending to the distal end of the medical scope device (first bending section 6, paragraph [0056], see fig. 7);
a first steering actuator (first pulley 41A, paragraph [0050], see Fig.6, 9-10); and
a selector switch that is mechanically coupled to the first steering actuator (switching operation lever 47, paragraph [0057], see Fig. 9-10),
wherein the first steering actuator controls a movement of a distal end of the first steerable device when the selector switch is in a first position (first pulley 41A attached to bending operation wires 35A to 35B to move second bending section 7, paragraph [0056], see. Fig 9-10), and
wherein the first steering actuator controls a movement of a distal end of the second steerable device when the selector switch is in a second position (first pulley 41A attached to bending operation wires 35A to 35B to move first bending section 6, paragraph [0056], see. Fig 9-10). The Examiner notes that the first pulley 41A coupled to bending operation wires 35A to 35B is responsible for the up-down movement for both steering devices when in their respective positions.
Regarding claim 2, Arai teaches:
A medical scope device further comprising a second steering actuator that controls a second movement of the distal end of the first steerable device when the selector switch is in the first position (second pulley 41B attached to bending operation wires 35A to 35B to move second bending section 7, paragraph [0056], see. Fig 9-10). The Examiner notes that the first pulley 41A coupled to bending operation wires 35C to 35D is responsible for the left-right movement for the first steerable device.
Regarding claim 3, Arai teaches:
A medical scope device wherein the first steering actuator is a first control wheel at a handle of the medical scope device, and wherein the second steering actuator is a second control wheel at the handle, the first control wheel and the second control wheel being coaxial (first pulley 41A, second pulley 41B, paragraph [0050], see Fig.6, 9-10). The Examiner notes that in Arai’s disclosure, the first pulley and second pulley is analogous to the first control wheel and second control wheel as claimed.
Regarding claim 4, Arai teaches:
A medical scope device wherein the second steering actuator controls the second movement of the distal end of the second steerable device when the selector switch is in the second position (second pulley 41B attached to bending operation wires 35C to 35D to move first bending section 6, paragraph [0056], see. Fig 9-10). The Examiner notes that the second pulley 41B coupled to bending operation wires 35C to 35D is responsible for the left-right movement for the second steerable device.
Regarding claim 15, Arai teaches:
A medical scope device of claim 1, wherein the second steerable device is extendable distally relative to the first steerable device, and wherein when the first steering actuator selectively controls the second steerable device when the second steerable device is in an extended state (first bending section 6, second bending section 7, paragraph [0056], see fig. 7). The Examiner interprets “extendable” as being able to be moved, not that the bending segments are extended or that the movement is relative. In his disclosure, Arai notes that the second steering section 6 can be controlled and held in place while the first steering section 7 is extended. Therefore, second steering section 6 extends distally to first steering section 7 and is in an extended state when attached distally to first steering section 7 which reads on the limitations of this claim.
Regarding claim 16, Arai teaches:
A medical scope device wherein the selector switch includes a rotatable knob for moving a selector rod in a linear direction to adjust the selector switch (second lever end 49B, paragraph [0057], see Fig. 9-10). The Examiner notes that there is no inherent definition in the shape of a knob and moving the second lever end will result in the selector switch (switching operation lever 47) moving distally in a linear direction which reads on the limitations of this claim.
Regarding claim 17, Arai teaches:
A medical scope device, comprising:
a first steerable device extending to a distal end of the medical scope device (second bending section 6, paragraph [0056], see fig. 7);
a second steerable device extending to a distal end of the medical scope device (first bending section 7, paragraph [0056], see fig. 7);
a first control wheel (first pulley 41A, paragraph [0050], see Fig.6, 9-10);
a second control wheel (second pulley 41B, paragraph [0050], see Fig.6, 9-10); and
a selector switch having a rod that is coaxial with the first control wheel and the second control wheel (switching operation lever 47, paragraph [0057], see Fig. 9-10), wherein the first control wheel controls a movement of the first steerable device when the selector switch is in a first position (first pulley 41A; switching operation lever 47, paragraph [0050]; paragraph [0057], see Fig.6, 9-10), and
wherein the first control wheel controls a movement of a distal end of the second steerable device when the selector switch is in a second position (second pulley 41A; switching operation lever 47, paragraph [0050]; paragraph [0057], see Fig.6, 9-10).
Regarding claim 18, Arai teaches:
A medical scope device wherein the second steerable device is moveable distally relative to the first steerable device, and wherein the second steerable device is controllable via the first control wheel when the second steerable device is in an extended state (first bending section 7, second bending section 6, paragraph [0056], see fig. 7). The Examiner interprets “extendable” as being able to be moved, not that the bending segments are extended or that the movement is relative. In his disclosure, Arai notes that the second steering section 6 can be controlled and held in place while the first steering section 7 is extended. Therefore, second steering section 6 extends distally to first steering section 7 and is in an extended state when attached distally to first steering section 7 which reads on the limitations of this claim.
Regarding claim 19, Arai discloses a medical scope device further comprising a first wire drum mechanically coupled to the first steerable device and a second wire drum mechanically coupled to the second steerable device, wherein at least one of the first wire drum and the second wire drum moves linearly when the rod of the selector switch moves linearly (wires 43A and 43B, paragraph [0050], see. Fig 9-10).
Regarding claim 26, Arai teaches:
A method, comprising:
assembling a medical scope device (assembled device, see Fig. 1),
the medical scope device comprising:
a first steerable device extending to a distal end of the medical scope device (second bending section 7, paragraph [0056], see fig. 7);
a second steerable device extending to a distal end of the medical scope device (first bending section 6, paragraph [0056], see fig. 7), the second steerable device being extendable distally relative to the first steerable device (first bending section 6, second bending section 7, paragraph [0056], see fig. 7);
a first steering actuator (first pulley 41A, paragraph [0050], see Fig.6, 9-10); and
a selector switch that is mechanically coupled to the first steering actuator (switching operation lever 47, paragraph [0057], see Fig. 9-10),
wherein the first steering actuator controls a movement of a distal end of the first steerable device when the selector switch is in a first position (first pulley 41A attached to bending operation wires 35A to 35B to move second bending section 7, paragraph [0056], see. Fig 9-10), and
wherein the first steering actuator controls a movement of a distal end of the second steerable device when the selector switch is in a second position (first pulley 41A attached to bending operation wires 35A to 35B to move first bending section 6, paragraph [0056], see. Fig 9-10). The Examiner notes that the first pulley 41A coupled to bending operation wires 35A to 35B is responsible for the up-down movement for both steering devices when in their respective positions.
Regarding claim 27, Arai teaches:
A method wherein the medical scope device further comprises a second steering actuator that controls a second movement of the distal end of the first steerable device when the selector switch is in the first position (first pulley 41A attached to bending operation wires 35C to 35D to move second bending section 7, paragraph [0056], see. Fig 9-10). The Examiner notes that the first pulley 41A coupled to bending operation wires 35C to 35D is responsible for the left-right movement for the first steerable device.
Claim Rejections - 35 USC § 103
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) 5 is/are rejected under 35 U.S.C. 103 as unpatentable by Arai (US 2013/0205937) in view of Schultz (US 2023/0172440).
Regarding claim 5, Arai discloses the claimed invention substantially as claimed above. Arai does not teach a medical scope device further comprising a first brake for selectively preventing rotation of the first steering actuator and a second brake for selectively preventing rotation of the second steering actuator. Schultz teaches a first braking portion adapted to (non-rotatably) connect the endoscope handle/a housing of the endoscope handle (directly or indirectly) to the first control wheel for braking said first control wheel and may further comprise a second braking portion adapted to (non-rotatably) connect the endoscope handle/a housing of the endoscope handle (directly or indirectly) to the first control wheel for braking said first control wheel (selective switch 13; first braking 20a; second braking portion 20b, paragraph [0075]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the present invention to include Schultz’s braking mechanism. Such a modification would allow users to hold the distal tip in a desired orientation without holding the steering inputs manually as recited in paragraph [0007] in Schultz’s disclosure.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as unpatentable by Arai (US 2013/0205937) in view of Quinn et al. (US 2017/0035993).
Regarding claim 6, Arai discloses the claimed invention substantially as claimed above. Arai does not teach a medical scope device wherein the first steering actuator is rotationally fixed to a first spline shaft, and wherein the second steering actuator is rotationally fixed to a second spline shaft. Quinn teaches a coaxial first drum is configured to engage the steering spline shaft to produce tension on the first wire (steering shaft 36; splines 80; first wire drum 50, paragraph [0066], see Fig. 7). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the present invention to include Quinn’s spline shaft. Such a modification would allow for adjustment of the tension in the wire before the shaft and drum (pulley) are engaged via the splines as disclosed by Quinn.
Claim(s) 28-31 is/are rejected under 35 U.S.C. 103 as unpatentable by Arai (US 2013/0205937) in view of Scutti et al. (US 2023/0157521).
Regarding claim 28, Arai discloses a medical scope device comprising a steering system; a first steerable device extending to a distal end of the medical scope device, wherein the steering system controls steering of the first steerable device when in a first state (second bending section 7, paragraph [0056], see fig. 7); a second steerable device, wherein the steering system controls steering of the second steerable device when in a second state (first bending section 6, paragraph [0056], see fig. 7); a selector rod configured to switch the steering system from the first state to the second state wheel (switching operation lever 47, paragraph [0057], see Fig. 9-10).
Although Arai suggests that air/water supply valves (fluid control system) are conventional for endoscopes (see paragraph [0005]) and portrays what appears to be air/water valves on the handle of the endoscope shown in Figure 1, Arai fails to explicitly mention that the endoscope includes a fluid control system, the fluid control system being mechanically coupled to the selector rod such that: in a first state, the fluid control system provides fluid communication between a first port and a second port; and in a second state, the fluid control system prevents fluid communication between the first port and the second port.
Scutti teaches that a conventional fluid control system for use with in an endoscope includes a valve in the handle (paragraph [0003]) such that in a first state, the fluid control system provides fluid communication between a first port and a second port (in the state shown in Fig.1C, first port 20 is fluidly connected to port 18); and in a second state, the fluid control system prevents fluid communication between the first port and the second port (in the state shown in Fig.1B, fluid communication is prevented between port 20 and port 18). Since Arai suggests that a fluid control system could be used in the disclosed endoscope, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provide a known fluid control system, as taught by Scutti, to provide the endoscope with the functionality of delivering fluids to the site of procedure (Scutti: paragraph [0003]). Since the fluid control system would be mechanically coupled to the endoscope, it will be mechanically coupled to the selector rod through mechanical association.
Regarding claim 29, Arai in view of Scutti discloses a medical scope device wherein the second port includes an interface for at least one of an insufflation flowpath, an irrigation flowpath, and a suction flowpath leading to a distal end of the first steerable device (Scutti: tubing containing second port 18 with flowpaths reaching the distal end of an endoscope, paragraph [0005], see Fig. 1A-1C).
Regarding claim 30, Arai in view of Scutti discloses a medical scope device, wherein further comprising a third port is in fluid communication with the first port when the fluid control system is in a second state (Scutti: second state in which fluid flows through a water channel between the third port 22 and first port 20, paragraph [0035], see Fig. 1B).
Regarding claim 31, Arai in view of Scutti discloses a medical scope device wherein the third port forms fluid communication to at least one of an insufflation flowpath, an irrigation flowpath, and a suction flowpath leading to a distal end of the second steerable device a third port (Scutti: tubing containing third port 22 with flowpaths reaching the distal end of an endoscope, paragraph [0005], see Fig. 1A-1C).
Allowable Subject Matter
Claims 7-14, 20-25 and 32-33 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Inglis et al. (US 20210137350) teaches an endoscopic device with multiple steerable components. Tah et al. (US 9357903 B2) teaches a steering mechanism for endoscopes with two degrees of freedom. Wilson Jr. et al. (US 5540668) discloses an anti-cross contamination valve for fluid delivery.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571) 272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.N./Examiner, Art Unit 3795
/JOHN P LEUBECKER/Primary Examiner, Art Unit 3795