DETAILED ACTION
This action is in response to applicant’s amendment received on November 14th, 2025.
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.
Claims 1, 4, and 8-23 are rejected under 35 U.S.C. 103 as being unpatentable over Zehavi (U.S. Publication 2022/0151714) in view of Dumpe (U.S. Publication 2022/0163409).
Zehavi discloses a device comprising:
(claim 1) a trackable tool (101A/101B) including
(claim 1) a retractor having a retractor tool tip for surgical retraction
(claim 4) wherein the trackable tool is associated with a mechanical tool sensor (for example see paragraphs 8 and 22) to provide the processing unit with tool sensor data associate with the trackable tool
(claim 22) wherein the trackable tool is a first trackable retractor of a plurality of trackable retractors for movement by the robotic manipulator or another robotic manipulator
(claim 1) a robotic manipulator (104A/104B) configured to couple to the trackable tool and move the trackable tool under command
(claim 1) a processing unit (105) configured to
(claim 1) track the poses of the trackable tool including the retractor tool tip (for example see abstract and paragraph 8)
(claim 1) command the robotic manipulator to move the retractor tool tip of the trackable tool coupled to the manipulator from a first position, in engagement with the patient, to a second position while remaining in engagement with the patient to retract soft tissue for bone exposure (for example see paragraphs 25-32 and 47)
(claim 4) wherein the processing unit is configured to determine a patient engagement measure (such as applied force) using the tool sensor data
(claim 9) wherein the second position comprises a retraction point associated with a bone of a patient, for example a position where a bone is exposed
(claim 9) wherein the processing unit is configured to define a soft tissue retraction parameter relative to the tool sensor data (force applied to the soft tissue)
(claim 9) wherein the processing unit is configured to command the robotic manipulator to retract soft tissues at the retraction point in accordance with the soft tissue parameter (for example see paragraph 33)
(claim 10) wherein the soft tissue parameter is defined by a planning value received from a planning system (for example see paragraphs 19-21)
(claim 16) wherein the processing unit is configured to command the robotic manipulator to move the retractor tool tip along a path to the second position
(claim 17) wherein the path is defined according to one or both of a force and/or torque value and direction value relative to the first position (for example see paragraphs 19-21)
(claim 18) wherein the processing unit is configured to command movement of the trackable surgical tool to position the retractor tool tip at an insertion depth at the first position (for example see paragraphs 47 and 53)
(claim 19) wherein the insertion depth is determined using tool sensor data and the retractor tool tip is positioned at the first position until a threshold measure of engagement is achieved responsive to the tool sensor data
(claim 20) wherein the processing unit is configured to use bone proximity as indicated by measured engagement (the sensors on the retractors measure force based on the amount of soft tissue to determine the depth of the retractors which would indicate the proximity of the retractors relative to a bone)
(claim 22) wherein the processing unit is configured to track each of the trackable retractors and command each of the trackable retractors for movement in engagement with the patient between respective first and second positions (for example see Figure 1A and Figure 4)
(claim 23) a localization system (for example see Figure 1)
Zehavi fails to disclose the device wherein the device includes a patient tracking element and the processing unit configured to track the patient via the patient tracking element and the processing unit configured to receive three dimensional date representing a portion of a patient and registering an association between the portion of the patient and the trackable tool.
Regarding the device includes a patient tracking element and the processing unit configured to track the patient via the patient tracking element, Dumpe teaches a device comprising trackable surgical objects, such as surgical tools, and a processing unit configured to track the surgical objects, wherein the device further comprises a patient tracking element associated with a patient such that the processing unit is configured to track a patient via the patient tracking element in order to precisely track both the trackable surgical objects, such as a trackable surgical tool, and the patient in a three dimensional space (for example see paragraphs 35-39). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Zehavi wherein further comprising a patient tracking element such that the processing unit is configured to track a patient via the patient tracking element in order to precisely track both the trackable surgical tool and the patient in three dimensional space.
Regarding the processing unit configured to receive three dimensional date representing a portion of a patient and registering an association between the portion of the patient and the trackable tool, Dumpe teaches a device comprising trackable surgical objects, such as surgical tools, a patient tracking element, and a processing unit configured to track the trackable surgical objects and the patient, wherein the processing unit configured to receive three dimensional data representing a portion of a patient in the second position (claims 11 and 12), register an association between the three dimensional data of the patient and the position of trackable surgical object (claims 11), wherein the processing unit is configured to track the position of the trackable surgical object relative to the patient to determine the arrival of the tool tip at the second position (claim 14), wherein the processor is configured to display via a display device the position of the trackable surgical object relative to the three dimensional data (claim 15), and wherein the processing unit determines insertion depth using three dimensional data to determine a relative position between the trackable surgical object and a bone (claim 21) in order to precisely track the trackable surgical objects relative to the patient in three dimensional space (for example see paragraphs 38-42). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Zehavi wherein the processing unit configured to receive three dimensional date representing a portion of a patient and registering an association between the portion of the patient and the trackable tool in view of Dumpe in order to precisely track the trackable surgical objects relative to the patient in three dimensional space.
Regarding claim 13, the device of Zehavi as modified by Dumpe discloses a device wherein the processing unit is configured to command the robotic manipulator to move the trackable tool to the second position using the second position data (the teachings of Dumpe would configured the processing unit of Zehavi to use the three dimensional data of the patient in the second position in combination with the sensor readings to command the robotic manipulator to move the trackable tool to the second position; Zehavi discloses using both position data and sensor data to move the trackable tool).
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Zehavi (U.S. Publication 2022/0151714) in view of Dumpe (U.S. Publication 2022/0163409) further in view of Pack (U.S. Publication 2016/0030063).
The device of Zehavi as modified by Dumpe discloses the invention as claimed except for the device further comprising an incision tool, such as a soft tissue cutting tool, i.e. a scalpel, wherein the processing unit tracks the position of the incision indicating tool. Pack teaches a system including a robotic arm, i.e. robotic manipulator, having a processing unit and an incision indicating tool, wherein the processing unit tracks the position of the incision indicating tool to determine an incision location in order to create an incision during a surgical procedure (for example see paragraph 23). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Zehavi as modified by Dumpe further comprising an incision indicating tool wherein the processing unit tracks the position of the incision indicating tool to determine an incision location in view of Pack in order to create an incision during a surgical procedure.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Zehavi (U.S. Publication 2022/0151714) in view of Dumpe (U.S. Publication 2022/0163409) further in view of Nawana (U.S. Patent 10,166,019).
The device of Zahavi as modified by Dumpe discloses the invention as claimed except for the processing unit being configured to signal a patient engagement message in response to a patient engagement measure (claims 5-7). Nawana teaches a device comprising a processing unit, wherein the processing unit is configured to signal a patient engagement message in response to a patient engagement measure (for example column 59 line 21 to column 60 line 37) such that tool sensor data is used to determine and signal contact or proximity to a bone or other surgical tool, i.e. a tool in an undesirable area of the anatomy based on preoperative plan (claim 6; for example see column 56 lines 10-52 and column 60 lines 25-37) and wherein the processing unit is configured to initiate a trackable tool repositioning responsive to a detection of contact with or proximity with a bone or other surgical tool (claim 7; for example see column 60 lines 25-37) in order to prevent unintended trauma to the patient during a surgical procedure. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Zahavi as modified by Dumpe wherein the processing unit is configured to signal a patient engagement message in response to a patient engagement measure in view of Nawana in order to prevent unintended trauma to the patient during a surgical procedure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited references the examiner felt were relevant to the application.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775