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 .
DETAILED ACTION
Claim Rejections - 35 USC § 112b
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.
Claims 28, 29, 31-33, 36, 37, 39-41, 44, 45 are 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.
Claims 28, 29, 31-33, 36, 37, 39-41, 44, 45 recite some form of “a step of driving actuators as necessary” and “to facilitate forward movement”. This is deemed indefinite as it is unclear what the scope of “as necessary” and “to facilitate” is. The claim language does not clearly define what these steps would entail. Additionally, it appears this language occurs only once in the specification at 0028, but does not help to further clarify or narrow the scope of the claim. As such, it will be interpreted as provided in the rejection below.
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)(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) 27-33, 35-41 is/are rejected under 35 U.S.C. 102a2 as being anticipated by Refai 20190231220.
Refai discloses for claim 27, “A non-transitory computer readable medium, configured with executable instructions for implementing a method for automatically and dynamically adjusting bending stiffness and torsional characteristics of an endoscope, operable by a processing circuit (medical scanning and mapping system 10; fig 1A; 0041), the method comprising:
receiving data from inertial measurement units (IMUs) identifying directional changes as an endoscope is pushed through a body cavity of a living body (0125, 0163 describe IMU data used for movement and orientation data);
characterizing anatomic bends according to parameters such as bend length, angle of bend, and distance from prior bend (0048-0050 describes creating models of the surgical environment); and
automatically and dynamically adjusting the bending stiffness and the torsional characteristics of the endoscope to pre-defined specification ranges (0124-0125 describes autonomous or semi-autonomous operation where the instrument needs to change shape, 0135 describes steering the surgical head around tissue and anatomy, e.g. driven along the colon to perform colonoscopy using sensors placed on the device; using the models and measurement data for control and feedback systems to direct movements within a set of parameters dictated by the operator or the procedure and especially 0137 which describes endoscopy procedures requiring that the endoscope traverse a twisting and circuitous path without scraping or damaging tissue at the bends, i.e. navigating sharp bends in the colon, using the model or map of the surrounding tissue along the endoscope’s route; to not only control the head of the endoscope, but also the entire body of the endoscope, ensuring that the shape of the endoscope body conforms to the path through the patient at all times, this is considered to include controlling any and all physical properties of the endoscope in order to accomplish this function, including but not limited to controlling the stiffness and torsional characteristics)”.
Refai discloses for claim 28, “The method of claim 27 wherein, when the IMUs do not register forward movement of the endoscope, further including a step of driving actuators as necessary to adjust the bending stiffness and the torsional characteristics of the endoscope to facilitate forward movement (the disclosed process 0124-0125, 0135, 0137 describes a control and feedback system to perform the claimed steps, i.e. in order to conform the endoscopy body to the path through the patient at all times, the steps are considered to include “facilitating forward movement” by conforming the endoscopy body when the IMU’s do not register forward movement and also when the IMU’s do register forward movement)”.
Refai discloses for claim 29, “The method of claim 27 wherein, when the IMUs register forward movement of the endoscope, further including a step of saving data regarding an anatomical bend, the bending stiffness, and the torsional characteristics in a memory function for future algorithm refinement (the disclosed process 0124-0125, 0135, 0137 describes a control and feedback system to perform these steps, i.e. in order to conform the endoscopy body to the path through the patient at all times, the steps are considered to include “facilitating forward movement” by conforming the endoscopy body when the IMU’s do not register forward movement and also when the IMU’s do register forward movement; the feedback system is considered to take saved data from a prior point in the procedure in order to continuously and dynamically conform the endoscope to the patient anatomy)”.
Refai discloses for claim 30, “The method of claim 27, wherein the IMUs comprise proximal IMUs, intermediate IMUs, and distal IMUs, and the data identifying directional changes of the endoscope are provided from the intermediate IMUs and distal IMUs (0124-0125, 0135, 0137 to not only control the head of the endoscope, but also the entire body of the endoscope)”.
Refai discloses for claim 31, “The method of claim 30 wherein, when the intermediate IMUs and distal IMUs do not register forward movement of an insertion tube of the endoscope, further including a step of driving actuators as necessary to adjust the bending stiffness and the torsional characteristics of the insertion tube of the endoscope (the disclosed process 0124-0125, 0135, 0137 describes a control and feedback system to perform the claimed steps, i.e. in order to conform the endoscopy body to the path through the patient at all times, the steps are considered to include “facilitating forward movement” by conforming the endoscopy body when the IMU’s do not register forward movement and also when the IMU’s do register forward movement)”.
Refai discloses for claim 32, “The method of claim 30 wherein, when the intermediate IMUs and the distal IMUs register forward movement of an insertion tube of the endoscope, further including a step of saving data regarding an anatomical bend, the bending stiffness, and the torsional characteristics in a memory function for future algorithm refinement (the disclosed process 0124-0125, 0135, 0137 describes a control and feedback system to perform these steps, i.e. in order to conform the endoscopy body to the path through the patient at all times, the steps are considered to include “facilitating forward movement” by conforming the endoscopy body when the IMU’s do not register forward movement and also when the IMU’s do register forward movement; the feedback system is considered to take saved data from a prior point in the procedure in order to continuously and dynamically conform the endoscope to the patient anatomy)”.
Refai discloses for claim 33, “The method of claim 30 wherein, when the intermediate IMUs and distal IMUs do not register forward movement of an insertion tube of the endoscope, despite movement being registered by the proximal IMUs, further including a step of driving actuators as necessary to adjust the bending stiffness and the torsional characteristics of the insertion tube of the endoscope (the disclosed process 0124-0125, 0135, 0137 describes a control and feedback system to perform the claimed steps, i.e. in order to conform the endoscopy body to the path through the patient at all times, the steps are considered to include “facilitating forward movement” by conforming the endoscopy body when the IMU’s do not register forward movement and also when the IMU’s do register forward movement)”.
Refai discloses for claim 35, “An endoscope system comprising:
an endoscope (0107 describes the driving of an endoscope);
a computer configured for steering and/or adjusting bending stiffness and torsional characteristics of the endoscope (medical scanning and mapping system 10; fig 1A; 0041);
inertial measurement units (IMUs) configured for generating data identifying directional changes as the endoscope is pushed through a body cavity of a living body (0125, 0163 describe IMU data used for movement and orientation data);
wherein the computer is configured to characterize anatomic bends according to parameters such as bend length, angle of bend, and distance from prior bend, and to automatically and dynamically adjust the bending stiffness and the torsional characteristics of the endoscope to pre-defined specification ranges based on the data generated from the IMUs (0124-0125 describes autonomous or semi-autonomous operation where the instrument needs to change shape, 0135 describes steering the surgical head around tissue and anatomy, e.g. driven along the colon to perform colonoscopy using sensors placed on the device; using the models and measurement data for control and feedback systems to direct movements within a set of parameters dictated by the operator or the procedure and especially 0137 which describes endoscopy procedures requiring that the endoscope traverse a twisting and circuitous path without scraping or damaging tissue at the bends, i.e. navigating sharp bends in the colon, using the model or map of the surrounding tissue along the endoscope’s route; to not only control the head of the endoscope, but also the entire body of the endoscope, ensuring that the shape of the endoscope body conforms to the path through the patient at all times, this is considered to include controlling any and all physical properties of the endoscope in order to accomplish this function, including but not limited to controlling the stiffness and torsional characteristics)”.
Refai discloses for claim 36, “The endoscope system of claim 35 wherein, when the IMUs do not register forward movement of the endoscope, the computer drives actuators as necessary to adjust the bending stiffness and the torsional characteristics of the endoscope to facilitate forward movement (the disclosed process 0124-0125, 0135, 0137 describes a control and feedback system to perform the claimed steps, i.e. in order to conform the endoscopy body to the path through the patient at all times, the steps are considered to include “facilitating forward movement” by conforming the endoscopy body when the IMU’s do not register forward movement and also when the IMU’s do register forward movement)”.
Refai discloses for claim 37, “The endoscope system of claim 35 wherein, when the IMUs register forward movement of the endoscope, the computer saves data regarding an anatomical bend, the bending stiffness, and the torsional characteristics in a memory function for future algorithm refinement (the disclosed process 0124-0125, 0135, 0137 describes a control and feedback system to perform these steps, i.e. in order to conform the endoscopy body to the path through the patient at all times, the steps are considered to include “facilitating forward movement” by conforming the endoscopy body when the IMU’s do not register forward movement and also when the IMU’s do register forward movement; the feedback system is considered to take saved data from a prior point in the procedure in order to continuously and dynamically conform the endoscope to the patient anatomy)”.
Refai discloses for claim 38, “The endoscope system of claim 35, wherein the IMUs comprise proximal IMUs, intermediate IMUs, and distal IMUs (0124-0125, 0135, 0137 to not only control the head of the endoscope, but also the entire body of the endoscope)”.
Refai discloses for claim 39, “The endoscope system of claim 38 wherein, when the intermediate IMUs and distal IMUs do not register forward movement of an insertion tube of the endoscope, further including a step of driving actuators as necessary to adjust the bending stiffness and the torsional characteristics of the insertion tube of the endoscope (the disclosed process 0124-0125, 0135, 0137 describes a control and feedback system to perform the claimed steps, i.e. in order to conform the endoscopy body to the path through the patient at all times, the steps are considered to include “facilitating forward movement” by conforming the endoscopy body when the IMU’s do not register forward movement and also when the IMU’s do register forward movement)”.
Refai discloses for claim 40, “The endoscope system of claim 38 wherein, when the intermediate IMUs and the distal IMUs register forward movement of an insertion tube of the endoscope, further including a step of saving data regarding an anatomical bend, the bending stiffness, and the torsional characteristics in a memory function for future algorithm refinement (the disclosed process 0124-0125, 0135, 0137 describes a control and feedback system to perform these steps, i.e. in order to conform the endoscopy body to the path through the patient at all times, the steps are considered to include “facilitating forward movement” by conforming the endoscopy body when the IMU’s do not register forward movement and also when the IMU’s do register forward movement; the feedback system is considered to take saved data from a prior point in the procedure in order to continuously and dynamically conform the endoscope to the patient anatomy)”.
Refai discloses for claim 41, “The endoscope system of claim 38 wherein, when the intermediate IMUs and distal IMUs do not register forward movement of an insertion tube of the endoscope, despite movement being registered by the proximal IMUs, further including a step of driving actuators as necessary to adjust the bending stiffness and the torsional characteristics of the insertion tube of the endoscope (the disclosed process 0124-0125, 0135, 0137 describes a control and feedback system to perform the claimed steps, i.e. in order to conform the endoscopy body to the path through the patient at all times, the steps are considered to include “facilitating forward movement” by conforming the endoscopy body when the IMU’s do not register forward movement and also when the IMU’s do register forward movement)”.
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) 34, 42-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Refai as applied to claim 27 above, and further in view of Hunter 20150011830.
Refai does not disclose for claim 34, “The method of claim 27 further including a plurality of actuators operatively associated with a corresponding cable extending proximally from an insertion tube of the endoscope, wherein the step of automatically and dynamically adjusting the bending stiffness and the torsional characteristics of the endoscope to pre-defined specification ranges is achieved by driving the plurality of actuators in response to the data received from the IMUs”, the lacking disclosure being the simply the specific mechanism to control the stiffness/torsion/shape of the body of the endoscope, i.e. via cables and an actuator. Hunter teaches in the same field of endeavor, using cables and motors/actuators to control the shape of the body of an endoscope (0062). Since Refai fails to disclose the nature of the mechanism to control the body of the 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 used any suitable control mechanism known in the art, including the one taught by Hunter to achieve the predictable result of controlling the stiffness/torsion/shape of the body of the endoscope.
Refai does not disclose for claim 42, “The endoscope system of claim 35, further including a plurality of actuators operatively associated with a corresponding cable extending proximally from an insertion tube of the endoscope, wherein the step of automatically and dynamically adjusting the bending stiffness and the torsional characteristics of the endoscope to pre-defined specification ranges is achieved by driving the plurality of actuators in response to the data received from the IMUs”. Hunter teaches in the same field of endeavor, using cables and motors/actuators to control the shape of the body of an endoscope (0062). Since Refai fails to disclose the nature of the mechanism to control the body of the 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 used any suitable control mechanism known in the art, including the one taught by Hunter to achieve the predictable result of controlling the stiffness/torsion/shape of the body of the endoscope.
Modified Refai discloses for claim 43 (as provided in claim 34), “An endoscope system comprising:
an endoscope (0107 describes the driving of an endoscope) having an insertion tube (fig 12), and a plurality of actuators operatively associated with a corresponding cable extending proximally from the insertion tube (Hunter: 0062);
a computer configured for steering and/or adjusting bending stiffness and torsional characteristics of the insertion tube;
inertial measurement units (IMUs) configured for generating data identifying directional changes as the insertion tube is pushed through a body cavity of a living body (0125, 0163 describe IMU data used for movement and orientation data);
wherein the computer is configured to characterize anatomic bends according to parameters such as bend length, angle of bend, and distance from prior bend, and to automatically and dynamically adjust the bending stiffness and the torsional characteristics of the insertion tube to pre-defined specification ranges based on the data generated from the IMUs (0124-0125 describes autonomous or semi-autonomous operation where the instrument needs to change shape, 0135 describes steering the surgical head around tissue and anatomy, e.g. driven along the colon to perform colonoscopy using sensors placed on the device; using the models and measurement data for control and feedback systems to direct movements within a set of parameters dictated by the operator or the procedure and especially 0137 which describes endoscopy procedures requiring that the endoscope traverse a twisting and circuitous path without scraping or damaging tissue at the bends, i.e. navigating sharp bends in the colon, using the model or map of the surrounding tissue along the endoscope’s route; to not only control the head of the endoscope, but also the entire body of the endoscope, ensuring that the shape of the endoscope body conforms to the path through the patient at all times, this is considered to include controlling any and all physical properties of the endoscope in order to accomplish this function, including but not limited to controlling the stiffness and torsional characteristics)”.
Refai discloses for claim 44, “The endoscope system of claim 42 wherein, when the IMUs do not register forward movement of the insertion tube, the computer drives the plurality of actuators as necessary to adjust the bending stiffness and the torsional characteristics of the insertion tube to facilitate forward movement (the disclosed process 0124-0125, 0135, 0137 describes a control and feedback system to perform the claimed steps, i.e. in order to conform the endoscopy body to the path through the patient at all times, the steps are considered to include “facilitating forward movement” by conforming the endoscopy body when the IMU’s do not register forward movement and also when the IMU’s do register forward movement)”.
Refai discloses for claim 45, “The endoscope system of claim 42 wherein, when the IMUs register forward movement of the insertion tube, the computer saves data regarding an anatomical bend, the bending stiffness, and the torsional characteristics in a memory function for future algorithm refinement (the disclosed process 0124-0125, 0135, 0137 describes a control and feedback system to perform these steps, i.e. in order to conform the endoscopy body to the path through the patient at all times, the steps are considered to include “facilitating forward movement” by conforming the endoscopy body when the IMU’s do not register forward movement and also when the IMU’s do register forward movement; the feedback system is considered to take saved data from a prior point in the procedure in order to continuously and dynamically conform the endoscope to the patient anatomy)”.
Refai discloses for claim 46, “The endoscope system of claim 42, wherein the step of automatically and dynamically adjusting the bending stiffness and the torsional characteristics of the insertion tube to pre-defined specification ranges is achieved by driving the plurality of actuators in response to the data received from the IMUs (0124-0125 describes autonomous or semi-autonomous operation where the instrument needs to change shape, 0135 describes steering the surgical head around tissue and anatomy, e.g. driven along the colon to perform colonoscopy using sensors placed on the device; using the models and measurement data for control and feedback systems to direct movements within a set of parameters dictated by the operator or the procedure and especially 0137 which describes endoscopy procedures requiring that the endoscope traverse a twisting and circuitous path without scraping or damaging tissue at the bends, i.e. navigating sharp bends in the colon, using the model or map of the surrounding tissue along the endoscope’s route; to not only control the head of the endoscope, but also the entire body of the endoscope, ensuring that the shape of the endoscope body conforms to the path through the patient at all times, this is considered to include controlling any and all physical properties of the endoscope in order to accomplish this function, including but not limited to controlling the stiffness and torsional characteristics)”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAE K WOO whose telephone number is (571)272-0837. The examiner can normally be reached M-F 8:30-2:30p, 6p-9p.
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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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/Jae Woo/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
7/31/26
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