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 .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-12, drawn to a product.
Group II, claim(s) 13-20, drawn to a process of use.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of an endoscope system, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Weitzner et al. (US 20170209024 A1, hereinafter Weitzner)
Regarding Claim 1, Weitzner discloses
An endoscope system (endoscopic device 1, FIG. 1), comprising:
a handpiece (handle 10, FIG. 1) having a proximal end region (depicted in FIG. 1),
a distal end region (distal end 11) opposite to the proximal end region (depicted in FIG. 1), and
an interior region (interior space 24, FIG. 1-3);
a catheter (shaft 30, FIG. 1) extending from the distal end region of the handpiece (depicted in FIG. 1),
the catheter including an active bend portion (controllable bends 36A, 36B) distal to the handpiece (depicted in FIG. 1); and
a catheter control system (FIG. 3, par. 29 disclose controller system) including:
a sensor (plurality of sensors 19, FIG. 2) positioned in the interior proximal end region of the handpiece opposite to the catheter (depicted in FIG. 2) and configured to detect movement of the proximal end region of as a user pivots the proximal end region about an axis (FIG. 6 discloses pivot axis P at distal end) defined approximately by the distal end region of the handpiece (par. 29 discloses sensors are motion sensors which generate a directional signal from movement; par. 45 discloses sensors may track the location of handle in a space, such that an equivalent directional signal may be generated by moving the handle in a particular direction relative to a user, without joystick, or in combination therewith);
a motor (actuator 39A, 39B) positioned in the interior region of the handpiece and operably coupled to the sensor (par. 51 discloses each actuator has motor; FIG. 3, par. 33 discloses actuator positioned within exterior perimeter of shaft, i.e. within interior of handle, FIG. 3, par. 40 discloses sensor operably coupled to operative elements, i.e. motor/ actuators),
the motor configured to be activated responsive to the sensor detecting movement of the handpiece (par. 40 discloses correspondence between the directional signal generated by sensors and the actual movement of any operative element, i.e. motor/ actuators); and
one or more wires secured to the active bend portion of the catheter and adjustable responsive to activation of the motor effective to at least partially bend the active bend portion of the catheter (par. 49 discloses Bowden wires may be provided on or within shaft and operated by one or more electrical motors to move any portion of shaft).
During a telephone conversation with Marcus Simon on 02/09/26 a provisional election was made without traverse to prosecute the invention of Group I, claim 1-12. Affirmation of this election must be made by applicant in replying to this Office action. Claim 13-20 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1, 7, 12 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “detect movement of the proximal end region of as a user” which is confusing and unclear because either something is meant to be specified after “of” and the proximal end region is in relation to something or nothing is meant to be specified and the limitation “of” was an error, therefore, the proximal end region is independent.
Claim 1 further recites the term “approximately” which is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Based on the surrounding context of the claimed limitation, how is the axis, being defined by the distal end region, an approximation? What aspect is being approximated? The examiner suggests amending the claim language to specify what aspects of the axis being defined are being approximated and in what way, otherwise, examiner suggests removing the relative term.
Claim 7 recites the term “approximately proportionally” which is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Based on the surrounding context of the claimed limitation, how are the wires being approximately adjusted? What aspect is being approximated? The examiner suggests amending the claim language to specify what aspects of the axis being defined are being approximated and in what way, otherwise, examiner suggests removing the relative term.
Claim 12 recites the limitation “an additional direction” which is confusing and unclear since there are no directions mentioned in the preceding claims 1 or 2 (based on dependency), however, claims 4-6 mention directions, so it becomes confusing as to what the purpose of this limitation is and whether or not the dependency is meant to be different. Moreover, the limitation “in an additional direction effective to activate” is indefinite because it is unclear whether or not the sensor is capable of carrying out the functions that follow the limitation due to the capability of detecting “an additional direction” because of the confusing claim language. Examiner suggests amending the claim language to provide more clarity as to the intended structure and function of the invention as claimed.
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.
Claim(s) 1-8, 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weitzner et al. (US 20170209024 A1, hereinafter Weitzner).
Regarding Claim 1, Weitzner discloses
An endoscope system (endoscopic device 1, FIG. 1), comprising:
a handpiece (handle 10 + proximal end 32, FIG. 1, par. 28 discloses handle attached to proximal end via shaft interface) having a proximal end region (Gripping surface 20 + controller portion 14 + selector portion 16, FIG. 1),
a distal end region (distal end 11 + shaft interface 18 + proximal end 32, FIG. 1) opposite to the proximal end region (depicted in FIG. 1), and
an interior region (interior space 24, FIG. 1-3);
a catheter (shaft 30, FIG. 1) extending from the distal end region of the handpiece (depicted in FIG. 1),
the catheter including an active bend portion (controllable bends 36A, 36B) distal to the handpiece (depicted in FIG. 1); and
a catheter control system (FIG. 3, par. 29 disclose controller system) including:
a sensor (plurality of sensors 19, FIG. 2) positioned in the interior proximal end region of the handpiece opposite to the catheter (depicted in FIG. 2) and configured to detect movement of the proximal end region of as a user pivots the proximal end region about an axis (FIG. 6 discloses pivot axis P at distal end) defined approximately by the distal end region of the handpiece (par. 29 discloses sensors are motion sensors which generate a directional signal from movement; par. 45 discloses sensors may track the location of handle in a space, such that an equivalent directional signal may be generated by moving the handle in a particular direction relative to a user, without joystick, or in combination therewith);
a motor (actuator 39A, 39B + electrical contacts 18C, FIG. 3) positioned in the interior region of the handpiece (par. 47 discloses contacts wired within device) and operably coupled to the sensor (par. 51 discloses each actuator has motor; FIG. 3, par. 33 discloses actuator positioned within exterior perimeter of shaft, i.e. within interior of handle, FIG. 3, par. 40 discloses sensor operably coupled to operative elements, i.e. motor/ actuators),
the motor configured to be activated responsive to the sensor detecting movement of the handpiece (par. 40 discloses correspondence between the directional signal generated by sensors and the actual movement of any operative element, i.e. motor/ actuators); and
one or more wires secured to the active bend portion of the catheter and adjustable responsive to activation of the motor effective to at least partially bend the active bend portion of the catheter (par. 49 discloses Bowden wires may be provided on or within shaft and operated by one or more electrical motors to move any portion of shaft).
Regarding Claim 2, Weitzner discloses
The ureteroscope endoscope system of claim 1, further comprising:
wherein the handpiece includes a working channel port (proximal opening 33A, 33B, FIG. 1) positioned proximate to the distal end region and a cable port (shaft interface 18, depicted in FIG. 1);
wherein the catheter includes a working channel (lumen 37A + controllable channel 38A, FIG. 7A) in fluid communication with the working channel port (par. 34 discloses lumen, and its controllable channel, extend from proximal opening to a distal opening) and
an image sensor (imaging device 70, FIG. 8) positioned at a distal end (distal face 35) of the active bend portion distal to the handpiece (depicted in FIG. 8); and
a cable (electrical contacts 18C + electrical wires, FIG. 3) connected or connectable to the handpiece at the cable port and configured to provide power to at least one of the image sensor and the catheter control system and communicate with one or more electronic devices (par. 32 discloses electrical contacts coupled with power source, a plurality of wires may be routed inside shaft body, from contacts, to power any operative element of shaft).
Regarding Claim 3, Weitzner discloses
The endoscope system of claim 1, further comprising a control (selector 16) positioned on the handpiece (depicted in FIG. 1) and operably coupled to the catheter control system (depicted in FIG. 3) and configured to selectively activate and deactivate the catheter control system such that
(1) when the control activates the catheter control system, the motor adjusts the one or more wires responsive to the sensor detecting movement of the handpiece (par. 9, 31 disclose selector creates switching signal which activates, i.e. or deactivates, any of the operative elements, i.e. motor/ actuator) and
(2) when the control deactivates the catheter control system, the motor does not adjust the one or more wires responsive to the sensor detecting movement of the handpiece (par. 9, 31 disclose selector creates switching signal which activates, i.e. or deactivates, any of the operative elements, i.e. motor/ actuator).
Regarding Claim 4, Weitzner discloses
The endoscope system of claim 1, wherein:
the sensor is configured to detect movement of the proximal end region of the handpiece in a first handpiece direction and a second handpiece direction different from the first handpiece direction (par. 29 discloses sensors are motion sensors which generate directional signals when controller is moved in any direction, par. 45 discloses sensors may track the location of handle in a space, such that an equivalent directional signal may be generated by moving the handle in a particular direction relative to a user, without joystick, or in combination therewith, i.e. sensor capable of detecting handle movement in first and second directions different from one another);
the motor is configured to adjust the one or more wires responsive to movement of the proximal end region of the handpiece in the first handpiece direction effective to bend the active bend portion in a first bending direction (par. 33 discloses actuators may move controllable bend in a particular direction in response to an amount of electricity from power source, par. 7 discloses controller, and in turn actuator, controls movement of controllable bends in any direction); and
the motor is configured to adjust the one or more wires responsive to movement of the proximal end region of the handpiece in the second handpiece direction effective to bend the active bend portion in a second bending direction different from the first bending direction (par. 33 discloses actuators may move controllable bend in a particular direction in response to an amount of electricity from power source, par. 7 discloses controller, and in turn actuator, controls movement of controllable bends in any direction).
Regarding Claim 5, Weitzner discloses
The ureteroscope endoscope system of claim 4, wherein:
the one or more wires include at least a first wire portion and a second wire portion each extending at least partially between the motor and the active bend portion (par. 49 discloses set of Bowden wires provided between electrical motor and bend portion of shaft, i.e. first wire is first portion, second wire is second portion);
the motor is configured adjust the first wire portion responsive to movement of the proximal end region of the handpiece in the first handpiece direction effective to bend the active bend portion in the first bending direction (par. 33 discloses actuators may move controllable bend in a particular direction in response to an amount of electricity from power source, par. 51 discloses actuators have motors, par. 49 discloses motor may operate Bowden wires to move any portion of shaft, i.e. in any particular direction); and
the motor is configured to adjust the second wire portion responsive to movement of the proximal end region of the handpiece in the first handpiece direction effective to bend the active bend portion in the second bending direction (par. 33 discloses actuators may move controllable bend in a particular direction in response to an amount of electricity from power source, par. 51 discloses actuators have motors, par. 49 discloses motor may operate Bowden wires to move any portion of shaft, i.e. in any particular direction).
Regarding Claim 6, Weitzner discloses
The endoscope system of claim 4, wherein
the first bending direction is substantially opposite to the first handpiece direction of movement of the proximal end region of the handpiece (par. 40 discloses processor capable of dictating correspondence between directional signal from sensor and actual movement of controllable bend such as being synchronized, i.e. processor capable of doing opposite and making them opposite) and
the second bending direction is substantially opposite to the second handpiece direction of movement of the proximal end region of the handpiece (par. 40 discloses processor capable of dictating correspondence between directional signal from sensor and actual movement of controllable bend such as being synchronized, i.e. processor capable of doing opposite and making them opposite).
Regarding Claim 7, Weitzner discloses
The endoscope system of claim 1, wherein:
the sensor is configured to detect a magnitude of movement of the proximal end region of the handpiece (par. 40 discloses processor dictates correspondence between sensor signal and actual movement, i.e. direction and magnitude, of bend; par. 31 discloses signals from sensors leads to transmission of power/ electrical activation of controllable bend; par. 33 discloses actuators/ motors move bend differently, i.e. with a different magnitude, depending on the amount of electricity from the power source, i.e. which is dependent on sensor signal, therefore sensor detects magnitude of movement and processor dictates amount of electric output accordingly); and
the motor is configured to adjust the one or more wires approximately proportionally to the magnitude of movement of the proximal end region of the handpiece such that the active bend portion bends proportionally to the magnitude of movement of the proximal end region of the handpiece (par. 33 discloses actuators may move controllable bend in a particular direction in response to an amount of electricity from power source, i.e. in an amount proportional to the amount of electricity applied).
Regarding Claim 8, Weitzner discloses
The endoscope system of claim 1, wherein the catheter control system includes a driver (processor 26 + switching element 27, FIG. 3) operably coupled to the sensor and the motor (FIG. 3, par. 31 disclose processor and switching element drive activation of motor after detection of signal).
Regarding Claim 12, Weitzner discloses
The endoscope system of claim 2, further comprising a light (light source 72) at the distal end of the active bend portion (depicted in FIG. 8),
wherein the sensor is configured to detect movement of the proximal end region of the handpiece in an additional direction effective to activate or deactivate the light (par. 39 discloses movement of controller in lower direction will activate or deactivate light, i.e. sensor detects movement direction of controller and sends signal to activate or deactivate light),
activate or deactivate the image sensor (par. 39 discloses movement of controller, i.e. in turn detection of sensor, will result in activation or deactivation of camera),
change an image collection mode of the image sensor from a still image mode to a video stream mode,
activate a frame grab to record a still image during the video stream mode,
adjust zoom of the image sensor,
deploy a tool in the working channel, and/or
adjust at least one of a brightness, a zoom, a focus, or a contrast of the one or more images from the image sensor displayed on a display.
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) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weitzner et al. (US 20170209024 A1, hereinafter Weitzner) as applied to claim 8 above, and further in view of Chu et al. (US 20210085153 A1, hereinafter Chu).
Regarding Claim 9, Weitzner discloses all of the elements of the current invention disclosed in claim 8, Weitzner further discloses wherein the driver includes a stepper driver (par. 40 discloses processor is capable of dictating any correspondence between the sensor signal and the actual movement of the controllable bend, i.e. capable of being a stepper driver)
However, Weitzner does not disclose the motor includes a stepper motor.
Chu teaches an analogous endoscope system (endoscopic device 100, FIG. 1) having a handpiece (handle 102) that has a motorized deployment device (400, i.e. catheter control system, FIG. 4A), as well as, pressure/ flow sensor devices (200/300, i.e. sensor, FIG. 2-3) attached. The motorized deployment device is compatible with an elongated end effector device (i.e. catheter) and can actuate it via its motor (412, FIG. 4A). The motor may be a stepper motor [0058-0059].
It would have been obvious to one of ordinary skill in the art at the effective filing date of
the invention to provide the catheter control system of Weitzner with the motor of Chu in order to provide an improved motor device which can allow for more precise positioning and holding of the shaft tip and/or precise control of the end effector feature of the elongated device [Chu - 0042].
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weitzner et al. (US 20170209024 A1, hereinafter Weitzner) as applied to claim 1 above, and further in view of Hatakeyama et al. (US 20160213224 A1, hereinafter Hatakeyama).
Regarding Claim 10, Weitzner discloses all of the elements of the current invention disclosed in claim 1, however, Weitzner does not disclose
further comprising a wire wheel secured to the interior region of the handpiece and the motor,
wherein one or more wires are secured to the wire wheel and the motor is configured to rotate the wire wheel in one or more directions effective to adjust the one or more wires responsive to movement detected by the sensor.
Hatakeyama teaches an analogous endoscope system (manipulator 1, FIG. 1) having an operating part (2, i.e. catheter control system + handpiece, FIG. 11A-11D). The handpiece (2) has a motor (61) which rotates an operating-side pulley (41, i.e. wire wheel), which is connected to wires (43a, 43b, FIG. 11A), for the removal of slack from the wires and for bending operation, i.e. to adjust the wires [0044, 0057].
It would have been obvious to one of ordinary skill in the art at the effective filing date of
the invention to provide the catheter control system of Weitzner with the pulley of Chu in order to provide an intuitive design of operation force communication between the handle and the distal end of an endoscopic device [Chu - 0044], as well as, a device which allows for removal of dynamic slack in control wires [Chu - 0057].
Regarding Claim 11, Weitzner as previously modified by Chu, discloses all of the elements of the current invention disclosed in claim 10, Weitzner further discloses further comprising a steering controller (controller 14, FIG. 1) secured to the handpiece and positioned at least partially outside the interior region of the handpiece (depicted in FIG. 1-2), bend the active bend portion of the catheter (par. 31 discloses controller may be used to control the controllable bend).
Chu further teaches the steering controller (handle 21) operably secured to the wire wheel (depicted in FIG. 11A) and selectively movable effective to move the wire wheel (depicted in FIG. 11A-11D) and adjust the one or more wires secured to the wire wheel (depicted in FIG. 11A-11D).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABDUL HADI ABBASI whose telephone number is (571)272-4076. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ABDUL HADI ABBASI/
Examiner, Art Unit 3795
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795