DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Terminal Disclaimer
The terminal disclaimer filed on 11/13/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent No. 9,706,948 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Allowable Subject Matter
The indicated allowability of the claims is withdrawn in view of the newly discovered reference(s) to US 20100063508 A1 to Borja et al. Rejections based on the newly cited reference(s) follow.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 1-16, 21, 22, 24 and 25 is/are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by US 20100063508 A1 to Borja et al. (hereinafter, Borja).
Regarding Claim 1, Borja discloses a surgical navigation system, comprising inter alia:
at least one inertial sensor (paragraph [0107] “…the sensors 1104 comprise at least one single- or multi-axis gyroscope sensor and at least one single- or multi-axis accelerometer sensor.”) that measures its own motion without an external reference (paragraph [0107] “…the sensors provide an inertial navigation or dead reckoning system … without the need for external references.”) and is configured to be removably coupled to an object (paragraph [0009] “…a portable housing configured to connect to a knee bone by way of one or more orthopedic fixtures, a sensor located within the housing…”), wherein the object is at least one of a portion of a patient's anatomy (knee bone, tibia, femur, paragraph [0009]) or a surgical instrument (orthopedic fixtures, paragraph [0009]);
a computer system having a processor in communication with the at least one inertial sensor (paragraph [0103] “The electronic control unit 1102 can be configured to receive the real-time data from the sensor(s) 1104 and to use the sensor data to determine, estimate, and/or calculate an orientation or position of the surgical orientation device 12.”), the computer system being configured to:
receive from the at least one inertial sensor, data indicative of an orientation of the at least one inertial sensor (paragraph [0103] “The electronic control unit 1102 can be configured to receive the real-time data from the sensor(s) 1104 and to use the sensor data to determine, estimate, and/or calculate an orientation or position of the surgical orientation device 12.”) in a common coordinate system that defines orientation coordinates relative to an initial orientation of the at least one inertial sensor (paragraph [0104] “… the sensors 1104 can be configured to provide measurements relative to a reference point(s), line(s), plane(s), and/or gravitational zero. Gravitational zero, as referred to herein, refers generally to an orientation in which an axis of the sensor is perpendicular to the force of gravity, and thereby experiences no angular offset, for example tilt, pitch, roll, or yaw, relative to a gravitational force vector. In other embodiments, the sensor(s) 1104 can be configured to provide measurements for use in dead reckoning or inertial navigation systems.”) (paragraph [0130] “… the reference frame 1200 comprises three orthogonal axes (labeled x, y and z) having a point of origin at the center of a patient's knee joint when the patient's left leg is in flexion.”);
compute, from the received data, an orientation of the object in the common coordinate system (paragraph [0103] “…use the sensor data to determine, estimate, and/or calculate an orientation or position of the surgical orientation device 12.”) ([0129] “Orientation measurements for the surgical orientation device 12 can be determined based on a wide variety of reference frames in conjunction with any of a variety of surgical procedures. For example, when used in conjunction with a total knee replacement arthroscopic procedure, a reference frame can be established as shown in FIG. 12F.”); and
a user interface in communication with the computer system and configured to provide feedback to a user that indicates the computed orientation of the object within the common coordinate system (paragraph [0009] “…device can further comprise a display module configured to display one or more angle measurements corresponding to an offset from a flexion-extension angle or a varus-valgus angle of a mechanical axis of the knee joint…”) (paragraph [0115] “The GUI images can include instructive images, such as illustrated surgical procedure steps, or visual indicators of the orientation information received from the sensor(s) 1104. For example, the display can be configured to display degrees and either a positive or negative sign to indicate direction of rotation from a reference plane and/or a bubble level indicator to aid a user in maintaining a particular orientation. The display can also be configured to display alphanumeric text, symbols, and/or arrows.”).
Regarding Claim 2, Borja discloses the surgical navigation system of claim 1, wherein the computer system is further configured to:
receive from the at least one inertial sensor, data indicative of a position of the at least one inertial sensor (paragraph [0357] “…IMU data for each movement of the femur can be numerically integrated over time to obtain a trajectory of position and velocity points (one point for each IMU input)…”) in the common coordinate system that defines position coordinates relative to an initial position of the at least one inertial sensor (paragraph [0304] “…surgical orientation device 12 can then provide a display of the varus/valgus angle as the varus/valgus angle changes relative to this recorded initial position… relative to initial position … pre-operatively determined value …”) (see discussion of inertial Trajectory frame or T-frame in paragraph [0636] and known fixed position/origin in paragraph [0350] and discussion of known originals in paragraph [0357]-[0363]); and
compute, from the received data, a position of the object in the common coordinate system (see paragraph [0372] where a specific mathematical formula for computing this position “Ith position trajectory position point” and other associated metrics for computing position these positions in common coordinate system) (paragraph [0357] “…numerically integrated over time to obtain a trajectory of position and velocity points…”); and
wherein the feedback provided to the user by the user interface also indicates the computed position of the object within the common coordinate system (see all of paragraph [0426]) (paragraph [0352] “From this IMU data, the surgical orientation device 12 can calculate the location of the center of rotation of the femur, as well as the location of the mechanical axis running through the leg.”).
Regarding Claim 3, Borja discloses the surgical navigation system of claim 2, wherein the at least one inertial sensor is configured to be removably coupled to a bone of a patient (paragraph [0009] “…a portable housing configured to connect to a knee bone by way of one or more orthopedic fixtures…”), and wherein the computer system is further configured to compute a joint center from the position and the orientation of the object while the bone is moved (paragraph [0350] “… the center of rotation of the head of the femur … can be detected by moving and/or swinging the leg and attached surgical orientation device 12 on a horizontal plane (e.g. a plane along the operating table), starting from a known fixed position and orientation (referred to as the origin, which can be close to the surface of the horizontal plane) and obtaining inertial readings such as angular displacement and acceleration (referred to as IMU data).”) (paragraph [0352] “From this IMU data, the surgical orientation device 12 can calculate the location of the center of rotation of the femur, as well as the location of the mechanical axis running through the leg.”).
Regarding Claim 4, Borja discloses the surgical navigation system of claim 3, wherein the bone is a femur and the joint center is a hip joint center (paragraph [0242] “…the jig 212' can be coupled with a distal femur and the arm 234' is adapted to contact a structure corresponding to a femoral head, a lesser trochanter or a greater trochanter…” wherein the femoral head is known in the art at the hip joint center).
Regarding Claim 5, Borja discloses the surgical navigation system of claim 1, wherein the at least one inertial sensor is configured to be removably coupled to a bone of a patient (paragraph [0009] “…a portable housing configured to connect to a knee bone by way of one or more orthopedic fixtures…”), and wherein the computer system is further configured to compute a joint center from the orientation of the object while the bone is moved (paragraph [0350] “… the center of rotation of the head of the femur … can be detected by moving and/or swinging the leg and attached surgical orientation device 12 on a horizontal plane (e.g. a plane along the operating table), starting from a known fixed position and orientation (referred to as the origin, which can be close to the surface of the horizontal plane) and obtaining inertial readings such as angular displacement and acceleration (referred to as IMU data).”) (paragraph [0352] “From this IMU data, the surgical orientation device 12 can calculate the location of the center of rotation of the femur, as well as the location of the mechanical axis running through the leg.”).
Regarding Claim 6, Borja discloses the surgical navigation system of claim 5, wherein the bone is a femur and the joint center is a hip joint center (paragraph [0242] “…the jig 212' can be coupled with a distal femur and the arm 234' is adapted to contact a structure corresponding to a femoral head, a lesser trochanter or a greater trochanter…” wherein the femoral head is known in the art at the hip joint center).
Regarding Claim 7, Borja discloses the surgical navigation system of claim 5, wherein the computer system is configured to control the user interface to provide instructions to a user for moving the bone of the patient in order to determine the joint center (paragraph [0424] “The screen displays can illustrate the steps to be performed in a surgical procedure and can guide the user through the performance of the steps … on-screen graphic … visual cues or indicators to prompt the user as to what step or steps to take next during one of the procedural methods described above.”) (determination of femoral head center as set forth in paragraph [0362]).
Regarding Claim 8, Borja discloses the surgical navigation system of claim 1, wherein the at least one inertial sensor comprises at least a first inertial sensor configured to be removably coupled to the portion of the patient's anatomy and a second inertial sensor configured to be removably coupled to the surgical instrument (see discussion of sensors and additional sensors that can be located on surgical components and/or various anatomical landmarks in paragraph [0188]).
Regarding Claim 9, Borja discloses the surgical navigation system of claim 1, wherein the at least one inertial sensor is removably coupled to the portion of the patient's anatomy (paragraph [0009] “…a portable housing configured to connect to a knee bone by way of one or more orthopedic fixtures…”) and the computer system is configured to compute a cutting angle relative to the portion of the patient's anatomy based on the computed orientation of the object (paragraph [0009] “… a display module configured to display one or more angle measurements corresponding to an offset from a flexion-extension angle or a varus-valgus angle of a mechanical axis of the knee joint…) ([0450] “The bottom right hand corner of the screen shown in FIG. 59G can provide a real-time degree measurement of the varus/valgus angle of the surgical orientation device 12 and the cutting block. This degree measurement can correspond to the varus/valgus angle of a cutting plane.”) (paragraph [0093] “…an orthopedic fixture or fixtures to orient a cutting plane during an orthopedic procedure or to otherwise identify or track a relative position of one or more surgical devices or anatomical structures, and can encompass any of the embodiments shown in the drawings and as described herein.”).
Regarding Claim 10, Borja discloses the navigation system of claim 9, wherein the portion of the patient's anatomy comprises a bone in a lower extremity (knee bone, tibia, femur, paragraph [0009]) and the computer system is configured to compute the cutting angle relative to a mechanical axis of the portion of the patient's anatomy (paragraph [0015] “…moving the moveable portion of the orthopedic fixture to move the portable surgical orientation device in response to a prompt from the portable surgical orientation device to orient a cutting guide at an intended orientation relative to a mechanical axis of the leg…”).
Regarding Claim 11, Borja discloses the surgical navigation system of claim 1, wherein the computer system is configured to compute a cutting plane angle based on the computed orientation of the object, and wherein the feedback provided to the user by the user interface comprises an indication of the cutting plane angle ([0450] “The bottom right hand corner of the screen shown in FIG. 59G can provide a real-time degree measurement of the varus/valgus angle of the surgical orientation device 12 and the cutting block. This degree measurement can correspond to the varus/valgus angle of a cutting plane.”) (paragraph [0093] “…an orthopedic fixture or fixtures to orient a cutting plane during an orthopedic procedure or to otherwise identify or track a relative position of one or more surgical devices or anatomical structures, and can encompass any of the embodiments shown in the drawings and as described herein.”).
Regarding Claim 12, Borja discloses the surgical navigation system of claim 11, wherein the cutting plane angle is a coronal cutting plane angle ([0215] “Once the location of the coronal and sagittal planes containing the mechanical axis has been acquired and registered by the surgical orientation device 12, the surgical orientation device 12 can calculate and store the location and orientation of the mechanical axis of the leg. Based on this stored information, the surgical orientation device 12 can be used to adjust the cutting block 84 in order to obtain a desired orientation for resection of the proximal tibia. For example, the universal jig 16, 16' can be adjusted to move the surgical orientation device 12.”).
Regarding Claim 13, Borja discloses the surgical navigation system of claim 12, wherein the coronal cutting plane angle comprises at least one of a varus angle or a valgus angle (paragraph [0009] “…module configured to display one or more angle measurements corresponding to an offset from a flexion-extension angle or a varus-valgus angle of a mechanical axis of the knee joint…”).
Regarding Claim 14, Borja discloses the surgical navigation system of claim 11, wherein the cutting plane angle is a sagittal cutting plane angle (paragraph [0133] “…the reference varus/valgus angle corresponds with the orientation of the sagittal plane of the tibia.”).
Regarding Claim 15, Borja discloses the surgical navigation system of claim 1, wherein the user interface comprises
a display in communication with the computer system (paragraph [0423] “…the surgical orientation device 12 can comprise … a display”), and wherein the computer system computes an object display element from the computed orientation of the object (paragraph [0426] “…control module configured to receive the orientation data from the sensor module and convert it to objective signals for presentation on the display module, the control module also configured to display a set of GUI images or other on-screen graphics on the display module, the GUI images or on-screen graphics representing the orientation data…”) (paragraph [0450] “The left-hand portion of the screen can show the varus/valgus angle of the surgical orientation device 12 and the cutting block graphically.”) and the display comprises a graphical user interface that receives the object display element from the computer system and displays the object display element to provide a graphical depiction of the orientation of the object in the common coordinate system (paragraph [0440] “…the display 24 can be configured to display a pictorial representation of a bubble that, for so long as the surgical orientation device 12 remains parallel to the coronal plane of the tibia within an allowable range, stays within the confines of two vertical lines, one line on either side of the bubble.”) (paragraph [0450] “FIG. 59G can also provide an animated depiction of the second pin being inserted through the block and into the proximal tibia, to suggest its insertion. The left-hand portion of the screen can show the varus/valgus angle of the surgical orientation device 12 and the cutting block graphically.”).
Regarding Claim 16, Borja discloses the surgical navigation system of claim 15, wherein the feedback indicates a planned resection plane (paragraph [0438] “… information on the screen regarding the status of the acquisition of the coronal plane can be designed to attract the attention of the user by, for example, flashing a first color such as green to indicate that the surgical orientation device 12 is aligned and a second color, such as grey, to indicate that the surgical orientation device 12 is out of alignment.”) (paragraph [0440] “…the display 24 can be configured to display a pictorial representation of a bubble that, for so long as the surgical orientation device 12 remains parallel to the coronal plane of the tibia within an allowable range, stays within the confines of two vertical lines…”), and wherein the graphical user interface displays a planned surgical cut display element and the object display element together (paragraph [0450] “The pictorial representation of the proximal tibia and cutting block at the right of the screen can informs the user to insert a second pin through the block and into the proximal tibia.” Where the proximal tibia is the planned surgical cut display element and the cutting block is the object display element which are displayed together in FIG. 59G) (paragraph [0443] “) (paragraph [0443] “… the screen shot in FIG. 59D can comprise a visual cue or indicator which can comprise an image of the tibia and the surgical instrument displayed adjacent to a particular aspect of the tibia (e.g., the anterior surface), with the surgical orientation device 12 or other measuring device coupled with an anterior surface or side of the surgical instrument.”) to provide a graphical depiction of the orientation of the planned resection plane relative to the orientation of the object in the common coordinate system (paragraph [0450] “… screen shown in FIG. 59G can provide a real-time degree measurement of the varus/valgus angle of the surgical orientation device 12 and the cutting block. … degree measurement can correspond to the varus/valgus angle of a cutting plane … pictorial representation of the proximal tibia and cutting block … informs the user to … suggest … insertion.”) (see paragraph [0446] for discussion of feedback to maintain parallel to coronal plan using bubble pictorial method).
Regarding Claim 21, Borja discloses the surgical navigation system of claim 1, wherein the object comprises one of a tibial cut guide or a femoral cut guide (paragraph [0195] sets forth tibial preparation with a cutting block and paragraph [0380] sets forth femoral preparation with a cutting block).
Regarding Claim 22, Borja discloses the surgical navigation system of claim 1, wherein the at least one inertial sensor is calibrated to the common coordinate system via the user interface while the at least one inertial sensor is held still on a flat surface (paragraph [0360] “…the surgical orientation device 12 can be placed at the origin with no motion for a pre-determined time period to signal positioning at the origin, e.g., at least one second in between swing trajectories.”) (paragraph [0350] “…starting from a known fixed position and orientation (referred to as the origin, which can be close to the surface of the horizontal plane)” where the flat surface is the horizontal surface.).
Regarding Claim 24, Borja discloses the surgical navigation system of claim 1, wherein the at least one inertial sensor is configured to compensate for temperature fluctuations in the at least one inertial sensor (paragraph [0109] “… the one or more sensors 1104 comprise a temperature sensor to monitor system temperature of the electrical system 1100. Operation of some of the electrical components can be affected by changes in temperature. The temperature sensor can be configured to transmit signals to the electronic control unit 1102 to take appropriate action. In addition, monitoring the system temperature can be used to prevent overheating.”)
Regarding Claim 25, Borja discloses the surgical navigation system of claim 1, wherein the at least one inertial sensor comprises a three-axis gyroscope (paragraph [0107] “…the sensors 1104 comprise at least one single- or multi-axis gyroscope sensor and at least one single- or multi-axis accelerometer sensor.”).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 23 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Borja in view of Evaluation of Methods That Locate the Center of the Ankle for Computer-assisted Total Knee Arthroplasty to Siston.
Borja discloses the surgical navigation system of claim 2 except for expressly disclosing wherein the at least one inertial sensor is configured to be removably coupled to a foot of a patient, and wherein the computer system is further configured to compute an ankle joint center from the position and the orientation of the foot while the foot is moved. However, it is noted that Borja does teach at paragraph [0091] a universal jig that can be attached to bones and portions of joints on the anatomy and further teaches at paragraph [0423] that a sensor module and coupling member can be used in combination with the jig. Furthermore, Borja teaches at paragraphs [0090] the importance of knowing the center of the ankle. Siston teaches locating the ankle center for knee navigation and teaches that both anatomic and kinematic methods are used to locate the center of the ankle, “Kinematic methods require the surgeon to displace the foot and ankle through prescribed motion”, and that “an algorithm estimates the center of the ankle from these data.” One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the universal jig, coupling member and sensor, which are capable of being attached to the foot/ankle of Borja with the known foot/ankle displacement and associated sensors and algorithms to estimate ankle center of Siston as Siston teaches in the abstract that such a method would have been accurate, precise and objective for establishing center of ankle. A skilled artisan would have recognized that establishing ankle center would have improved knee replacement procedures.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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, 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.
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.
/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791