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
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) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Makower (USPN 2016/0270863)
Regarding claim 1, Makower discloses a medical instrument, comprising: a body comprising a lumen (figures 4, 16-17, [0081]-[0090], [0126]-[0129]); a shaft assembly extending distally from the body (figures 4, 16-17, [0081]-[0090], [0126]-[0129]); a guidewire extending through the lumen and having a position sensor configured to provide a first signal indicating a position of the guidewire in three-dimensional space (figures 4, 16-17, [0081]-[0090], [0126]-[0129]); a working element slidably coupled to the body and translatable in a distal direction along the guidewire (figures 4, 16-17, [0081]-[0090], [0126]-[0129]); and a movement tracker comprising a first component coupled to the working element and a second component coupled to at least one of the body or the guidewire, the tracker being configured to generate a second signal when the first component moves relative to the second component (figures 4, 16-17, [0081]-[0090], [0126]-[0129]).
Regarding claim 2, the second component is coupled to the body, and the second signal indicates a movement of the working element relative to the body (figures 4, 16-17, [0081]-[0090], [0126]-[0129]).
Regarding claim 3, the second component is coupled to the guidewire, and the second signal indicates a movement of the working element relative to the guidewire (figures 4, 16-17, [0081]-[0090], [0126]-[0129]).
Regarding claim 4, the second component is coupled to the body and the guidewire, and the second signal indicates a movement of the working element relative to the body and the guidewire (figures 4, 16-17, [0081]-[0090], [0126]-[0129]).
Regarding claim 5, the working element comprises an actuator that is movable relative to the body to drive longitudinal movement of the working element relative to the body, the first component is coupled to the actuator, and the second component is coupled to the body (figures 4, 16-17, [0081]-[0090], [0126]-[0129]).
Regarding claim 6, the shaft assembly comprises a guide rail, the working element is translatable relative to the guide rail, and the second component is coupled to the guide rail (figures 4, 16-17, [0081]-[0090], [0126]-[0129]).
Regarding claim 7, the guide rail comprises a malleable distal portion (figures 4, 16-17, [0081]-[0090], [0126]-[0129]).
Regarding claim 8, the second component is coupled to a distal portion of the guidewire, and the first component is coupled to a distal portion of the working element (figures 4, 16-17, [0081]-[0090], [0126]-[0129]).
Regarding claim 9, the first component overlaps the second component with a degree of overlap that varies based on a position of the working element relative to at least one of the body or the guidewire (figures 4, 16-17, [0081]-[0090], [0126]-[0129]).
Regarding claim 10, the second signal is directly related to the degree of overlap (figures 4, 16-17, [0081]-[0090], [0126]-[0129]).
Regarding claim 11, the first component comprises a first capacitor plate, the second component comprises a second capacitor plate, and the second signal is a capacitance (figures 4, 16-17, [0081]-[0090], [0126]-[0129]).
Regarding claim 12, the tracker is configured to provide varying capacitance based on a position of the working element relative to the body to thereby track the position of the working element relative to the body (figures 4, 16-17, [0081]-[0090], [0126]-[0129]).
Regarding claim 13, the working element comprises a dilation catheter assembly, and the dilation catheter assembly comprises a balloon that is operable to dilate an anatomical passageway within a head of a patient (figures 4, 16-17, [0081]-[0090], [0126]-[0129]).
Regarding claim 14, a processor configured to: receive the first signal from the position sensor of the guidewire ([0134]); receive the second signal from the tracker; determine a real-time position of the guidewire in three-dimensional space based on the first signal ([0134]); and determine a real-time position of the working element in three-dimensional space based on a combination of the first signal and the second signal ([0134]).
Regarding claim 15, an actuator that is movable through a first range of motion and a second range of motion, wherein the actuator is configured to: drive translation of the working element relative to the body and the guidewire as the actuator is moved through the first range of motion; and drive simultaneous translation of the working element and the guidewire relative to the body as the actuator is moved through the second range of motion (figures 4, 16-17, [0081]-[0090], [0126]-[0129]).
Regarding claim 16, a first actuator that is movable relative to the body to drive longitudinal movement of the working element relative to the body (figures 4, 16-17, [0081]-[0090], [0126]-[0129]); and a second actuator that is movable relative to the body to drive longitudinal movement of the guidewire relative to the body, the second actuator being operable independently relative to the first actuator (figures 4, 16-17, [0081]-[0090], [0126]-[0129]).
Regarding claim 17, a body comprising a lumen (figures 4, 16-17, [0081]-[0090], [0126]-[0129]); a guidewire extending through the lumen and having a position sensor (figures 4, 16-17, [0081]-[0090], [0126]-[0129]); a working element that movably coupled to the body and translatable along the guidewire (figures 4, 16-17, [0081]-[0090], [0126]-[0129]); and a movement tracker comprising a first component configured to move with the working element and a second component configured to move with at least one of the body or the guidewire, wherein the first component overlaps the second component with a degree of overlap that varies based on the movement of the working element relative to at least one of the body or the guidewire, wherein the tracker is configured to provide a signal, the signal being directly related to the degree of overlap (figures 4, 16-17, [0081]-[0090], [0126]-[0129]).
Regarding claim 18, a method for using a medical instrument with real-time position sensing, the method comprising: inserting a shaft assembly of the medical instrument into a patient, wherein the shaft assembly extends distally from a body of the medical instrument (figures 4, 16-17, [0081]-[0090], [0126]-[0129]); advancing a guidewire through the body and the shaft assembly, wherein the guidewire has a position sensor configured to provide a signal indicating a real-time position of the guidewire in three-dimensional space (figures 4, 16-17, [0081]-[0090], [0126]-[0129]); translating a working element distally along the guidewire; and in response to translating the working element, causing a movement tracker to provide a signal indicating movement of the working element relative to at least one of the body or the guidewire (figures 4, 16-17, [0081]-[0090], [0126]-[0129]).
Regarding claim 19, translating the working element comprises moving a first component of the movement tracker relative to a second component of the movement tracker, the first component being coupled to the working element, and the second component being coupled to at least one of the body or the guidewire (figures 4, 16-17, [0081]-[0090], [0126]-[0129]).
Regarding claim 20, the first component comprises a first capacitor plate, the second component comprises a second capacitor plate, and moving the first component relative to the second component comprises changing a capacitance between the first capacitor and the second capacitor (figures 4, 16-17, [0081]-[0090], [0126]-[0129]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARJAN FARDANESH whose telephone number is (571)270-5508. The examiner can normally be reached Monday-Friday 9:00-17:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARJAN FARDANESH/Primary Examiner, Art Unit 3791
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