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 .
Claims 1 - 24 are pending in this application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1/17/2025 and on 04/04/2025 were filed in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the information disclosure statement is being considered by the examiner.
Applicants have not provided an explanation of relevance of cited document(s) discussed below.
Bleich et al. (U.S PreGrant Publication No. 2006/0258951 A1) teaches a method for locating neural tissue in a patient body may involve: advancing a probe along a natural tissue interface between the neural tissue and another tissue in the body, the probe having a first surface oriented toward the neural tissue and a second surface oriented away from the neural tissue; delivering a first electrical current to a first electrode along the first surface of the probe; delivering a second electrical current to a second electrode along the second surface of the probe; and verifying that the first surface of the advanced probe remains oriented toward the neural tissue and the second surface remains oriented away from the neural tissue by monitoring neural response to the first and second electrical currents.
Hartmann et al. (U.S PreGrant Publication No. 2010/0210939 A1) discloses a surgical navigation system for tracking an instrument relative to a patient. The system can track a portion of the patient, an instrument, and/or both relative to image data, a coordinate system, an atlas, a morphed atlas, or combinations thereof. The system can include a tracking device on the instrument to provide six degree of freedom information regarding the location of the instrument.
Dipl.-Ing., H. Horstmann Gmbh (DE 102017000723 A1) provides a voltage sensor for monitoring electrical lines of high voltage networks, - with a preferably capacitive tap and a housing which is attached to a test point characterized in that, at least one safe low-impedance connection from the voltage sensor is created to ground potential.
Warsaw Orthopedic Inc (CN 102046098 A) discloses a surgical tool that is capable of communicating wireless with either a neural integrity monitoring system or a surgical navigation system. The surgical tool includes electronic circuitry operable to provide a neural stimulation signal to a surgical instrument connected with the tool. If a predetermined response is received by the neural integrity monitoring system, it is capable of automatically stopping rotation of the surgical instrument. Further, if a predetermined safe threshold is breached or about to be breached, the surgical navigation system is operable to automatically stop rotation of the surgical instrument. In addition, the surgical tool is provided with audio and visual feedback of the neurological status of the patient.
Univ Beijing Science & Tech (CN 101579250 A) provides a device having a rotation speed sensor mounted on a contacted position of a transmission shaft and a handle (7) of a remolded operation drill (1), where the transmission shaft is passing through the handle. A host computer (3) is connected with a high-speed embedded system (2) by a communication bus (12) to display and record sensor information to analyze characteristics when the operation drill works abnormally, amend operation dynamic mode of the operation drill and correct a mode identifying programme of the high-speed embedded system.
Application No. 17/555/777 is the closest prior art, however it corresponds to the same inventors and assignee.
Kostrzewski et al. (U.S Patent No. 9241771 B2) describes a surgical instrument guide for use with a robotic surgical system, for example, during spinal surgery. In certain embodiments, the guide is attached to or is part of an end effector of a robotic arm, and provides a rigid structure that allows for precise preparation of patient tissue (e.g., preparation of a pedicle) by drilling, tapping, or other manipulation, as well as precise placement of a screw in a drilled hole or affixation of a prosthetic or implant in a prepared patient situation.
Kostrzewski et al. (U.S Patent No. 9283048 B2) describes systems, apparatus, and methods for precise placement and guidance of tools during a surgical procedure, particularly a spinal surgical procedure. The system features a portable robot arm with end effector for precise positioning of a surgical tool. The system requires only minimal training by surgeons/operators, is intuitive to use, and has a small footprint with significantly reduced obstruction of the operating table. The system works with existing, standard surgical tools, does not require increased surgical time or preparatory time, and safely provides the enhanced precision achievable by robotic-assisted systems.
Simon et al. (U.S PreGrant Publication No. 2008/0242978 A1) teaches identifying point candidates, initial 2D search, 3D refinement, optionally attach fiducial markers and perform segmentation(s).
Kostrzewski (U.S PreGrant Publication No. 20150305817 A1) provides a surgical instrument holder for use with a robotic surgical system, for example, during spinal surgery. In certain embodiments, the surgical instrument holder is an interface between the robotic arm and a surgical instrument used during surgery. This interface may hold the surgical instrument precisely, rigidly, and in a stable manner while permitting a surgeon to easily and quickly install or withdraw the instrument in case of emergency.
Morad et al. (2016/0235492 A1) describes systems, apparatus, and methods for precise placement and guidance of tools during surgery, particularly spinal surgery, using minimally invasive surgical techniques. Several minimally invasive approaches to spinal surgeries were conceived, percutaneous technique being one of them. This procedures looks to establish a skin opening as small as possible by accessing inner organs via needle-puncture of the skin. The percutaneous technique is used in conjunction with a robotic surgical system to further enhance advantages of manual percutaneous techniques by improving precision, usability and/or shortening surgery time by removal of redundant steps.
Kemp et al. (U.S PreGrant Publication No. 2019/0328461 A1) discloses a navigation system that may be used to at least assist in a procedure. The system may assist in delineating objects and/or determining physical boundaries of image elements. The system may assist in planning and/or a workflow of the procedure.
Bowling (U.S PreGrant Publication No. 2021/0298795 A1) provides a system having a robotic manipulator, and a surgical tool (30) that is coupled to the robotic manipulator and configured to interface with a screw and to rotate the screw about a rotational axis. A haptic device comprises an actuator and a rotational interface coupled to the actuator and the rotational interface is configured to be manually manipulatable by a hand of an operator. A navigation system is configured to track a position of a target site. A measurement indicative of a present interaction is obtained between the screw and the target site. The actuator of the haptic device is controlled to enable the rotational interface to emulate the present interaction between the screw and the target site based on the obtained measurement.
Foley et a. (RE44305 E) provides an apparatus and procedures for percutaneous placement of surgical implants and instruments such as, for example, screws, rods, wires and plates into various body parts using image guided surgery. The invention includes an apparatus for use with a surgical navigation system, an attaching device rigidly connected to a body part, such as the spinous process of a vertebrae, with an identification superstructure rigidly but removably connected to the attaching device. This identification superstructure, for example, is a reference arc and fiducial array which accomplishes the function of identifying the location of the superstructure, and, therefore, the body part to which it is fixed, during imaging by CAT scan or MRI, and later during medical procedures.
Verard et al. (U.S Patent No. 7, 697, 972) is related to an image guided navigation system for navigating a region of a patient includes an imaging device, a tracking device, a controller, and a display. The imaging device generates images of the region of a patient. The tracking device tracks the location of the instrument in a region of the patient. The controller superimposes an icon representative of the instrument onto the images generated from the imaging device based upon the location of the instrument. The display displays the image with the superimposed instrument. The images and a registration process may be synchronized to a physiological event. The controller may also provide and automatically identify an optimized site to navigate the instrument to.
Hartmann et al. (U.S Patent No. 8,644,907) discloses a surgical navigation system for tracking an instrument relative to a patient. Said system can track a portion of the patient, an instrument, and/or both relative to image data, a coordinate system, an atlas, a morphed atlas, or combinations thereof. Said system can include a tracking device on the instrument to provide six degree of freedom information regarding the location of the instrument.
Hartmann et al. (U.S Patent No. 8,238,631) is related to a patient that defines a patient space in which an instrument can be tracked and navigated. An image space is defined by image data that can be registered to the patient space. A tracking device can be connected to a member in a known manner that includes imageable portions that generate image points in the image data. The tracking device can be tracked to register patient space to image space.
Gregerson et al. (U.S Patent No. 7,106,825) teaches an apparatus and method for reconstructing image data for a region are described. A radiation source and multiple one-dimensional linear or two-dimensional planar area detector arrays located on opposed sides of a region angled generally along a circle centered at the radiation source are used to generate scan data for the region from a plurality of diverging radiation beams, i.e., a fan beam or cone beam. Individual pixels on the discreet detector arrays from the scan data for the region are reprojected onto a new single virtual detector array along a continuous equiangular arc or cylinder or equilinear line or plane prior to filtering and backprojecting to reconstruct the image data.
Snyder et al. (U.S PreGrant Publication No. 2020/0237445 A1 ) discloses a system for assisting in guiding and performing a procedure on a subject. The subject may be any appropriate subject such as inanimate object and/or an animate object. The guide and system may include various manipulable or movable members and may be registered to selected coordinate systems.
Haider et al. (U.S PreGrant Publication No. 2008/0009697 A) provides a number of improvements are provided relating to computer aided surgery. The improvement relates to both the methods used during computer aided surgery and the devices used during such procedures. Some of the improvement relate to controlling the selection of which data to display during a procedure and/or how the data is displayed to aid the surgeon. Other improvements relate to the structure of the tools used during a procedure and how the tools can be controlled automatically to improve the efficiency of the procedure. Still other improvements relate to methods of providing feedback during a procedure to improve either the efficiency or quality, or both, for a procedure.
Kostrzewskiet al. (U.S PreGrant Publication No. 2018/0289432 A1) is another of the closest prior arts, wherein describe systems and methods for use in preparing holes in bones. In certain embodiments, the trajectory followed in preparing a hole in a bone is optimized by adjusting characteristics of rotation of a drill bit (e.g., an anti-skiving drill bit). In certain embodiments, a change in material is determined once a hard outer layer of a bone has been drilled. Subsequently, characteristics of rotation of a drill bit are altered to allow natural features of a patient's anatomy to guide the drill bit. In this way, certain hard walls of certain bones can act to redirect a drill bit. The change in material may be determined, and/or characteristics of rotation altered, by a surgeon or a robotic surgical system (e.g., automatically). In certain embodiments, a robotic surgical system notifies a surgeon of a change in material to prompt the surgeon to alter the characteristics of rotation.
Bush et al. (U.S PreGrant Publication No. 2019/0269469 A1) is related to tool assemblies, system, and methods for manipulating tissue and methods for performing a surgical procedure on a vertebral body adjacent soft tissue. A manipulator moves an end effector, and a screw is coupled to the end effector. A sleeve is disposed coaxially around the screw, and the screw and the sleeve are releasably engaged to one another. A navigation system is configured to track the vertebral body, and one or more controllers control the end effector to advance the screw relative to the sleeve along an insertion trajectory defined with respect to a surgical plan. The screw disengages the sleeve during advancement, and the screw is secured to the vertebral body. A distal working portion of the screw may be freely slidable through a distal end of the sleeve when disengaged. The screw may be a tap marker removably couplable with a tracking device of the navigation system.
Jacobsen et al. (U.S PreGrant Publication No.2022/0192683 A1) is another closest prior art, but qualified to be used in the current rejection, wherein provides a system has a sensor sensing an operation of a motor of a powered drill 20 and transmitting a sensor signal based on the operation. A processor module receives the sensor signal and executes instructions to operate the drill and alter an operation parameter of the drill. The sensor signal includes a set of signals. The drill operation includes a full rotation when one of the signals is received and an oscillation when the other signal is received. A tracking device 40 is associated with the drill. A navigation system determines a pose of drill based on tracking of the tracking device by a user 24.
Smart Medical Devices (WO 2017/139674) is related to a system including an instrument having a working tool configured to penetrate a tissue; a sensor configured to generate in real-time one or more torque signals related to torque of the working tool; a controller in operative communication with the sensor and configured to receive the one or more torque signals. The controller processes the torque signals into one or more processed signals representative of torque, energy, power or a combination thereof. The system also includes a display providing to the user in real-time the one or more processed signals. Related devices, systems, methods, and articles are provided.
Orthodrill Medical (WO 2016/199152) provides an adaptor for modifying the operation of a surgical bone- tool, comprising: a housing having a distal end and a proximal end coupled between a chuck and an operating bit of said tool, such that force generated by a motor of the tool is delivered to the operating bit through the adaptor; a clutch, contained in the housing, having an engaged and a disengaged configurations, respectively interconnecting and disconnecting the chuck to the operating bit; the clutch automatically disengages in response to an electric current, causing a cutoff of the force delivery; wherein the housing comprises a proximal fastener, sized and shaped to connect with the operating bit and a distal fastener, sized and shaped to connect with the chuck.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1 - 24 are rejected under 35 U.S.C. 101 as claiming the same invention as that of at least claims 1 - 24 of prior U.S. Patent No. 12,245,772 B2. This is a statutory double patenting rejection.
It is clear that all the elements of the instant claim 1 is to be found in parent claim (as the instant claim 1 fully encompass the parent claim 1).
No difference between the instant application claim 1 and the patent claim 1 is found. However, the invention of parent claim 1 is in effect a “species” of the “generic” invention of the instant application claim 1.
It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since parent application claim 1 is anticipated by claim 1 of the instant application, it is not patentably distinct from claim 1 the instant claims.
Below is a side-by-side comparison (bolded where significant different, and underlined where limitation is mentioned in subsequent dependent claims):
Instant Application 19/027,852
12,245,772
Claim 1
A system to control operation of a drill, comprising:
a processor module configured to receive a sensor signal and execute instructions to operate the drill and alter an operation parameter of the drill based at least on the sensor signal;
wherein the sensor signal includes at least a first signal and a second signal;
wherein the operation of the drill includes at least a full rotation when the first signal is received and an oscillation when the second signal is received.
Claim 1
A system to control operation of a drill, comprising:
a sensor configured to sense at least one operation of a motor of the drill and transmit a sensor signal based thereon;
a processor module configured to receive the sensor signal and execute instructions to operate the drill and alter an operation parameter of the drill based at least on the sensor signal;
wherein the sensor signal includes at least a first signal and a second signal;
wherein the operation of the drill includes at least a full rotation of the drill about a drill axis of rotation when the first signal is received and an oscillation of the drill about the drill axis of rotation where the drill will rotate a selected amount in a first direction about the drill axis of rotation and then rotate a selected amount in a second opposite direction about the drill axis of rotation when the second signal is received.
Claim 2
The system of Claim 1, further comprising a voltage sensor configured to sense a back voltage to a motor of the drill; wherein the first signal is a first back voltage and the second signal is a second back voltage.
Claim 2
The system of Claim 1, further comprising a voltage sensor configured to sense a back voltage to a motor of the drill; wherein the first signal is a first back voltage and the second signal is a second back voltage.
Claim 3
The system of Claim 1, further comprising: a tracking device configured to be associated with the drill; a navigation system configured to determine a pose of the drill based on tracking the tracking device; and wherein the processor module is configured to execute further instructions to alter the operation parameter based on the determined pose of the drill; wherein the operation parameter of the drill is selected based on both (i) the first signal or the second signal and (ii) the determined pose.
Claim 3
The system of Claim 1, further comprising: a tracking device configured to be associated with the drill; a navigation system configured to determine a pose of the drill based on tracking the tracking device; and wherein the processor module is configured to execute further instructions to alter the operation parameter based on the determined pose of the drill; wherein the operation parameter of the drill is selected based on both (i) the first sensor signal or the second sensor signal and (ii) the determined pose.
Claim 4
The system of Claim 3, further comprising:
a boundary determination system configured to determine a boundary in an image;
wherein the operation parameters are altered based on the determined position of the drill relative to the boundary.
Claim 4
The system of claim 3, further comprising:
a boundary determination system configured to determine a boundary in an image;
wherein the operation parameters are altered based on the determined position of the drill relative to the boundary.
Claim 5
The system of Claim 4, wherein the boundary determination system comprises:
a display device configured to display an image; and
an input system configured to allow an input of a user regarding a boundary of at least a portion of displayed in the image.
Claim 5
The system of claim 4, wherein the boundary determination system comprises:
a display device configured to display an image; and
an input system configured to allow an input of a user regarding a boundary of at least a portion of displayed in the image.
Claim 6
The system of Claim 1, further comprising: an imaging system configured to image the subject; and a boundary determination system configured to determine a boundary within the image.
Claim 6
The system of claim 3, further comprising: an imaging system configured to image the subject; and a boundary determination system configured to determine a boundary within the image.
Claim 7
The system of Claim 6, wherein the boundary determination system includes a user input to select at least a seed portion.
Claim 7
The system of claim 6, wherein the boundary determination system includes a user input to select at least a seed portion.
Claim 8
The system of Claim 1, wherein the oscillation parameter is selected at a distance relative to a boundary.
Claim 9
The system of claim 1, wherein the oscillation parameter is selected at a distance relative to a boundary in the image.
Claim 9
The system of Claim 1, further comprising: a sensor operable to sense an electrical signal transmitted through a nerve;
wherein the processor module is further configured to receive a sensor signal from the sensor.
Claim 10
The system of claim 1, further comprising: an auxiliary sensor operable to sense an electrical signal transmitted through a nerve;
wherein the processor module is further configured to receive an auxiliary sensor signal from the auxiliary sensor.
Claim 10
The system of Claim 6, wherein the boundary determination system includes an image segmentation system configured to segment images of the subject.
Claim 8
The system of claim 3, wherein the boundary determination system includes an image segmentation system configured to segment images of the subject.
Claim 11
A system to control operation of a drill, comprising:
a sensor configured to sense an electrical signal transmitted through a nerve in a subject and transmit a sensor signal based thereon; and
a processor module configured to receive the sensor signal and execute instructions to operate the drill and alter an operation parameter of the drill based on the sensor signal;
wherein the sensor signal includes at least a first signal and a second signal.
Claim 11
A system to control operation of a drill, comprising:
a sensor configured to sense an electrical signal transmitted through a nerve in a subject and transmit a sensor signal based thereon;
processor module configured to receive the sensor signal and execute instructions to operate the drill and alter an operation parameter of the drill based on the sensor signal;
wherein the sensor signal includes at least a first signal and a second signal;
wherein the operation of the drill includes at least a full rotation the drill about a drill axis of rotation when the first signal is received and an oscillation of the drill about the drill axis of rotation where the drill will rotate a selected amount in a first direction about the drill axis of rotation and then rotate a selected amount in a second opposite direction about the drill axis of rotation when the second signal is received.
Claim 12
The system of Claim 11, wherein the first signal includes no nerve signal and the second signal includes a nerve signal.
Claim 12
The system of claim 11, wherein the first signal includes no nerve signal and the second signal includes a nerve signal.
Claim 13
The system of Claim 12, further comprising:
a tracking device configured to be associated with the drill; a navigation system configured to determine a pose of the drill based on tracking the tracking device; and wherein the processor module is configured to execute further instructions to alter the operation parameter based on the determined pose of the drill; wherein the operation parameter of the drill is selected based on both (i) the first sensor signal or the second sensor signal and (ii) the determined pose.
Claim 13
The system of claim 12, further comprising:
a tracking device configured to be associated with the drill; a navigation system configured to determine a pose of the drill based on tracking the tracking device; and wherein the processor module is configured to execute further instructions to alter the operation parameter based on the determined pose of the drill; wherein the operation parameter of the drill is selected based on both (i) the first sensor signal or the second sensor signal and (ii) the determined pose.
Claim 14
The system of Claim 13, further comprising: a boundary determination system configured to determine a boundary in an image; wherein the operation parameters are altered based on the determined pose of the drill relative to the boundary.
Claim 14
The system of claim 13, further comprising: a boundary determination system configured to determine a boundary in an image; wherein the operation parameters are altered based on the determined pose of the drill relative to the boundary.
Claim 15
The system of Claim 14, wherein the boundary determination system comprises:
a display device configured to display an image; and
an input system configured to allow an input of a user regarding a boundary of at least a portion of displayed in the image.
Claim 15
The system of claim 14, wherein the boundary determination system comprises:
a display device configured to display an image; and
an input system configured to allow an input of a user regarding a boundary of at least a portion of displayed in the image.
Claim 16
The system of Claim 11, further comprising:
an imaging system configured to image the subject; and
a boundary determination system configured to determine a boundary within the image.
Claim 16
The system of claim 15, further comprising:
an imaging system configured to image the subject; and
a boundary determination system configured to determine a boundary within the image.
Claim 17
The system of Claim 16, wherein the boundary determination system includes a user input to select at least a seed portion.
Claim 17
The system of claim 16, wherein the boundary determination system includes a user input to select at least a seed portion.
Claim 18
The system of Claim 17, wherein the operation parameter is selected at a distance relative to the boundary in the image;
wherein the operation of the drill includes at least a full rotation when the first signal is received and an oscillation when the second signal is received.
Claim 18
The system of claim 17, wherein the oscillation parameter is selected at a distance relative to the boundary in the image.
Claim 19
A method to control operation of a drill, comprising: determining a sensor signal from a sensor configured to sense a condition relative to the drill;
determining a pose of the drill with a navigation system configured to determine a pose of the drill; and
controlling an operation of the drill according to a selected operation parameter,
wherein controlling the operation includes executing instructions with a processor module to alter the operation parameter of the drill based on both (i) the determined pose of the drill and (ii) the sensor signal.
Claim 19
A method to control operation of a drill, comprising: determining a sensor signal from a sensor configured to sense a condition relative to the drill;
determining a pose of the drill with a navigation system configured to determine a pose of the drill; and
controlling an operation of the drill according to a selected operation parameter,
wherein controlling the operation includes executing instructions with a processor module to alter the operation parameter of the drill based on both (i) the determined pose of the drill and (ii) the sensor signal;
wherein controlling the operation of the drill includes at least a full rotation of the drill about a drill axis of rotation and an oscillation of the drill about the drill axis of rotation where the drill will rotate a selected amount in a first direction about the drill axis of rotation and then rotate a selected amount in a second opposite direction about the drill axis of rotation.
Claim 20
The method of Claim 19, wherein determine the sensor signal includes at least one of:
an electrical signal transmitted through a nerve in a subject and transmit a sensor signal based thereon, or at least one operation of a motor of the drill.
Claim 20
The method of claim 19, wherein determine the sensor signal includes at least one of:
an electrical signal transmitted through a nerve in a subject and transmit a sensor signal based thereon, or at least one operation of a motor of the drill.
Claim 21
The method of Claim 20, further comprising:
determining a boundary in an image;
wherein controlling the operation of the instrument is based on both (i) the determined pose of the instrument relative to the boundary and (ii) the sensor signal.
Claim 21
The method of claim 20, further comprising: determining a boundary in an image;
wherein controlling the operation of the instrument is based on both (i) the determined pose of the instrument relative to the boundary and (ii) the sensor signal.
Claim 22
The method of Claim 21, further comprising:
displaying the image; and
inputting a user selection regarding the boundary of at least a portion of displayed in the image.
Claim 22
The method of claim 21, further comprising: displaying the image; and
inputting a user selection regarding the boundary of at least a portion of displayed in the image.
Claim 23
The method of Claim 22, wherein determining the boundary within the image includes receiving a user input to select at least a seed portion.
Claim 23
The method of claim 22, wherein determining the boundary within the image includes receiving a user input to select at least a seed portion.
Claim 24
The method of Claim 21, wherein controlling the operation of the drill includes at least a full rotation of the drill and an oscillation of the drill;
wherein the oscillation of the drill is selected at a distance relative to the determined boundary in the image.
Claim 24
The method of claim 21, wherein the oscillation of the drill is selected at a distance relative to the determined boundary in the image.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUAN M GUILLERMETY whose telephone number is (571)270-3481. The examiner can normally be reached 9:00AM - 5:00PM.
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/JUAN M GUILLERMETY/Primary Examiner, Art Unit 2682
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