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 .
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed 11/21/2023 and 08/21/2025 have been considered by the Examiner.
Response to Arguments
Applicant’s arguments in the Remarks dated 04/29/2026 with respect to claims 97-99 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The amended claims include the limitation of a sensor disposed within the hand-held surgical tool and being configured to detect manipulation of the tool, which altered the scope of the claimed invention and required further search and consideration by the Examiner. New grounds of rejection are detailed below.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claims 97 and 105 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hladio et al (US 20190336220 A1).
Regarding claims 97 and 105, Hladio teaches a navigation-assisted system (400) for controlling a hand-held surgical tool (402) to which each of an end effector (404) and a navigation array (414) is coupled, the system comprising:
a sensor (408) disposed within the hand-held surgical tool (see Hladio Fig. 4, [0026]; the shaft 406 of hand-held tool 402 is coupled to sensor 408) configured to detect manipulation of the hand-held surgical tool (see [0025-0026]; sensor 408 may be a multi-dimensional force torque sensor) and generate a movement signal in response to detecting manipulation of the hand-held surgical tool (see [0025-0026]; the sensor may indicate the magnitude and direction of a force applied to the end effector of the tool and may be coupled with a processor which monitors the output of the sensor);
a communication module in communication with the sensor and being configured to transmit the movement signal (see [0025-0026]; sensor 408 is coupled with a computer system so that the computer system may receive the sensor information);
a localizer (412) separate from the sensor configured to generate an identification signal in response to detecting the navigation array (see [0027]; localizer system 412 communicatively coupled to the computing device 410 and having a first tracking element coupled to the surgical tool 402 and a second tracking element 416 which is coupled to a bone of a patient, wherein it can be appreciated that the tracking elements are distinguished from one another); and
a navigation controller (410) being configured to:
receive the identification signal from the localizer (see [0030]; computer device 410 synchronously measures 3d sensor data associated with the first and second tracking elements);
receive the movement signal from the communication module (see [0030]; computer device 410 synchronously measures 3d sensor data associated with the first and second tracking elements and the magnitude and direction of the sensor information from sensor 408); and
generate and store an association between the hand-held surgical tool and one of the navigation array and the end effector based on the movement signal (see [0026]; the tool and bone have respective tracker elements mounted thereto for tracking by the camera, [0030]; as the handheld surgical tool is moved along the initial trajectory, computer device 410 synchronously measures and stores in the storage device 3D sensor data comprising the relative position of the first and second tracking elements 414 and 416 and the magnitude and direction of the sensor information from sensor 408, see also Fig. 7).
Claims 97, 98, 105, and 106 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Malackowski et al (US 20060142656 A1).
Regarding claims 97, 105, and 106, Malackowski teaches a navigation-assisted system (20) for controlling a hand-held surgical tool (22) to which each of an end effector and a navigation array (28) is coupled, the system comprising:
a sensor (28) disposed within the hand-held surgical tool (see tracker 28 in Fig. 1, [0119]; if the tool has moving parts, a sensor or sensors monitors the position of these parts, for example, a potentiometer may be used to monitor the extent to which the arms of forceps are open or closed), configured to detect manipulation of the hand-held surgical tool and generate a movement signal in response to detecting manipulation of the hand-held surgical tool (see [0084]; tracker 28 includes a set of one or more energy transmitting devices that transmit signals used to identify the location of the tracker, [0119]; if the tool has moving parts, a sensor or sensors monitors the position of these parts, for example, a potentiometer may be used to monitor the extent to which the arms of forceps are open or closed);
a communication module (190) in communication with the sensor (see [0083]; microcontroller 190 regulates the overall operation of the electrical components internal to the tracker 28) and being configured to transmit the movement signal (see [0084]; tracker 28 includes a set of one or more energy transmitting devices that transmit signals used to identify the location of the tracker, [0119]; the tracker broadcasts a signal containing the data indicating the open/closed position of the forceps arms),
a localizer (30) separate from the sensor (see localizer 30 separate from hand-held surgical tool in Fig. 1) configured to detect the navigation array (28) and generate an identification signal indicative of an identity of the navigation array in response to detecting the navigation array (see [0051]; tracker 28 transmits a signal containing data regarding the identity of the components of the hand-held surgical device to a receiver 34 positioned in the localizer 30, the receiver 34 then transmits the data comprising the identification signal to the system processor 32); and
a navigation controller (32) being configured to:
receive the identification signal from the localizer (see [0051]; system processor 32 receives signal from localizer receiver 34 containing identifying data of the hand-held surgical instrument);
receive the movement signal from the communication module (see [0050]; data representative of the location and orientation of the tracker 28 are forwarded by the localizer to the system processor 32); and
generate and store an association between the hand-held surgical tool and one of the navigation array and the end effector based on the movement signal (see [0052]; based on the data indicating the position and orientation of the tracker 28 and the data identifying the physical characteristics of the surgical components 22 and 24, processor 32 generates information indicating the position of the surgical components relative to the surgical site, [0112-0115]; system 20 automatically reads the data from the new surgical components as soon as they are attached to the tracker 28 so that the system can continually monitor the location of the surgical elements including the identity/location of the end effector at all times).
Regarding claim 98, Malackowski teaches the navigation-assisted system of claim 97, further comprising a user interface (36) configured to receive an input indicative of a type of the end effector coupled to the hand-held surgical tool (see [0111-0113]; the processor generates information indicating the position of the surgical components relative to the body tissue at the surgical site including a virtual image of the surgical components and presents the information visually using display 36; depending on the end effector and corresponding identification signal, the processor 32 and user interface 36 receive an input from the tracker 28 so that a new virtual image can be generated that reflects the size and shape of the current end effector).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 97-99 are rejected under 35 U.S.C. 103 as being unpatentable over Kang et al (US 20200323540 A1) in view of Hladio et al (US 20190336220 A1).
Regarding claim 97, Kang teaches a navigation-assisted system for controlling a hand-held surgical tool (42) to which each of an end effector (40) and a navigation array (18) is coupled, the system comprising:
a sensor (S) configured to detect manipulation of the hand-held surgical tool (42) and generate a movement signal in response to detecting manipulation of the hand-held surgical tool (see Fig. 1, [0049-0050]; optical sensors S are positioned with a field of view of tracking devices 18, [0050-0055]; sensors S receive signals from the trackers 18 to detect position/orientation of trackers, which may be on instrument 42);
a communication module (50) in communication with the sensor (S) and being configured to transmit the movement signal (see [0050]; localizer controller 50 in communication with optical sensors S to receive signals from the optical sensors S and communicate with the navigation controller 48);
a localizer (16) configured to generate an identification signal in response to detecting the navigation array (see [0050-0051]; localizer 16 includes localizer control 50 in communication with optical sensors S to transmit position and orientation signals for the purpose of tracking the objects, [0054]; the position and the working end of the tool 40 are capable of being tracked by virtue of the trackers 18); and
a navigation controller (48) being configured to:
receive the identification signal from the localizer (see [0050-0051]; navigation controller 48 receives signals from localizer 16 via localizer controller 50, Fig. 19, [0120]; step 302 the position and/or orientation of the cutting tool 40 is tracked relative to a virtual object);
receive the movement signal from the communication module (see [0049-0051]; navigation controller 48 receives signals from localizer 16 via localizer controller 50, where the localizer 16 comprises optical sensors S which track the tracking device 18); and
generate and store an association between the hand-held surgical tool and one of the navigation array and the end effector based on the movement signal (see [0056]; navigation controller 48 generates image signals that indicate the relative potion of the working end of the cutting tool 40 and the tissue to be removed, these image signals are applied to the displays 20).
Kang is silent regarding wherein the sensor configured to detect manipulation of the hand-held surgical tool and generate a movement signal in response to detecting manipulation of the hand-held surgical tool is disposed within the hand-held surgical tool.
However, Hladio teaches a navigation-assisted system (400) for controlling a hand-held surgical tool (402) to which each of an end effector (404) and a navigation array (414) is coupled, the system comprising:
a sensor (408) disposed within the hand-held surgical tool (see Hladio Fig. 4, [0026]; the shaft 406 of hand-held tool 402 is coupled to sensor 408) and being configured to detect manipulation of the hand-held surgical tool (see Hladio [0025-0026]; sensor 408 may be a multi-dimensional force torque sensor) and generate a movement signal in response to detecting manipulation of the hand-held surgical tool (see Hladio [0025-0026]; the sensor may indicate the magnitude and direction of a force applied to the end effector of the tool and may be coupled with a processor which monitors the output of the sensor);
a communication module in communication with the sensor and being configured to transmit the movement signal (see Hladio [0025-0026]; sensor 408 is coupled with a computer system so that the computer system may receive the sensor information).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Kang’s system which uses an optical sensor to track instrument location via a tracker array with Hladio’s system which utilizes a sensor housed within the hand-held surgical tool in addition to a tracker array to track/associate instrument location. One of ordinary skill in the art would have been motivated to make this modification in order to synchronously measure 3D sensor data from both the tracker array associated with the tool and the magnitude and direction of the sensor information, wherein the sensor may be able to offer more precise data regarding the force experienced by the end effector, which may be impacted by the end effector’s location, e.g. whether the end effector is in contact with bone (Hladio [0030]).
Regarding claim 98, Kang in view of Hladio teaches the navigation-assisted system of claim 97, further comprising a user interface (UI, Fig. 2) configured to receive an input indicative of a type of the end effector coupled to the hand-held surgical tool (see [0092]; data regarding a length and/or width of the cutting tool 40 may be input into the memory of the control system, [0110-0111]; the identification of the cutting guide 38 may already be stored in the memory in the navigation controller as a result of being selected by the user on the user interface, it can be appreciated that the controller has a lookup table which associates each cutting tool with an acceptable cutting guide so inputting the identity of the cutting guide is also indicative of the identity of the cutting tool).
Regarding claim 99, Kang in view of Hladio teaches the navigation-assisted system of claim 97, further comprising a camera (93) configured to detect a characteristic of the end effector indicative of a type of the end effector coupled to the hand-held surgical tool (see [108]; identification device 87 may comprise a camera 93 employing machine vision technology to detect a shape, size, and/or configuration of the cutting tool 40 by obtaining images and matching the images to a library of stores images to identify the tool 40).
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Wu (US 20140088410 A1) which teaches a surgical navigation system including optical and non-optical sensors.
Haider et al (US 20140107471 A1) which teaches an on-board tool tracking system and methods of computer assisted surgery.
Breisacher et al (US 20190387149 A1) which teaches systems and methods for tracking objects within an operating room.
Lindeman et al (US 20230068121 A1) which teaches robotic hand-held surgical instrument systems with a visual indicator.
Morgan (US 20210007809 A1) which teaches navigation systems for communicating tracker status conditions.
Moctezuma de la Barrera et al (US 20220175464 A1) which teaches a system for tracker-based surgical navigation.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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/A.J.S./Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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