The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-10, drawn to a method of performing robotic surgery, classified in A61B34/30.
II. Claims 11-13, drawn to a surgical tool, classified in one of A61B18/20 (laser or optical tools), A61F 9/00745 (for phacoemulsification tools) or A61F 9/00736 (for vitrectomy tools).
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the specific configuration of the tool in Group II is not required for the process of performing robotic surgery in Group I. Specifically, Group II requires a proximal end of the connector portion to have a tool connection interface to align and connect to a corresponding robotic manipulator. This is a particular manner by which the tool interfaces with the robotic device, which distinct from the methods of Group I. The methods of Group I can be performed by a robotic system and tool pairing even when this particular alignment and connection is not provided at a proximal end of the connector portion. Furthermore, a communication interface could be obviated with, for example, a bar code and bar code reader in order to allow the process of Group I to be performed.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
A search strategy for Group I would result in prior art directed to data transferrable between any surgical tool (i.e., no matter how it is coupled to a surgical robot), which would not relate to Group II. Likewise, a search strategy for the specifics of Group II would not result in prior art that is directed to the data that is transferred between the tool and a surgical robot, nor re-configuration/calibration of the robot.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
By means of telephone on April 2, 2026, a provisional election was made by Russell Henrichs (for applicant) without traverse to prosecute the invention of Group I, claims 1-10. Affirmation of this election must be made by applicant in replying to this Office action. Claims 11-13 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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.
Claims 1-2, 4 and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brik et al. (US Patent Pub. No. 2023/0013550).
Brik discloses a method of performing robotic surgery (see Abstract), comprising:
Receiving data from a surgical tool connected to a working end of a robotic manipulator (see paragraph 15, “methods disclosed herein allow for automatic identification of a particular end effector by a robotic surgical system based on data received from … the end effector” And “the end effector can be prompted by the robotic surgical system to send the data, such as after coupling”); and
Controlling the robotic manipulator based, at least in part, on the data received from the surgical tool (see paragraph 16, “The end effector can store parameter data thereon that is configured to be identified by the system. The system can be configured to adjust its operation based on the parameters.”).
Regarding claim 2, Brik teaches that in step 104 of Figure 1, “the end effector communicates data to the system, and the system identifies the end effector (e.g., using data received from or regarding the end effector). Examples of data include a unique identifier, a version identifier, a class identifier, manufacturing information, shape, a dimension, weight, center of mass, duration of use, lifetime information, service history, or sterilization history” (see paragraph 18), which includes “center of mass”, which is mass-related data. Additionally, Brik teaches “Several different adjustments can be made by the system in view of accessed parameters. For example, the system can compensate for various masses and centers of mass of a given end effector 908 to ensure that the system is balanced and maintains precision” (see paragraph 54; also see paragraph 19, “Examples of adjustments include an adjustment to the robot arm based on an estimated load and/or force exerted by the end effector weight or center of mass”). Therefore, this reads on claim 2.
Regarding claim 4, Brik teaches that “the end effector 908 can store dimensional constrains thereon. … For example, the end effector 908 can store working volume parameters thereon such that the system can determine the length, width, and depth of the overall system when the end effector is attached thereto. Knowledge of the working volume can allow the system to be aware of the extents of the end effector so the system and its components can be prevented from colliding with other known volumes or other objects within the operating room” (see paragraph 56).
Regarding claim 6, Brik teaches that “when the system connects to the end effector 908, the system can be configured to read the information on the end effector and update and/or adjust calibration data to include the parameters of the end effector” (see paragraph 53).
Regarding claim 7, Brik teaches that “the operation adjustment is at least one of an adjustment to the robot arm based on an estimated load and/or force exerted by the end effector weight or center of mass, an adjustment to the robot arm to allow for optimal joint configuration of the robot arm based on tool trajectory, or an adjustment to calibration data. In some embodiments, the adjustment to calibration data reflects a dimension of the end effector” (see paragraph 60).
Regarding claim 8, Brik teaches that the data related to the surgical tool comprises identification data (see paragraph 18, “In some embodiments, the end effector sends a unique identifier, and the system uses the unique identifier to query a database and obtain data regarding the end effector”). Brik teaches that “the controller is further configured to determine a parameter regarding the end effector. In some embodiments, the parameter is retrieved from a database. In some embodiments, the parameter is detected by the controller. In some embodiments, the parameter is at least one of a version, a class, manufacturing information, shape, a dimension, weight, center of mass, duration of use, lifetime information, service history, or sterilization history” (see paragraph 60). It is noted that “dimension” as underlined above reads on “dimensional data” as claimed, and “center of mass” (and weight) reads on “mass-related data” as claimed. Additionally, paragraph 50 of Brik teaches the querying of a database to determine “specific model information and specifications stored for various types (e.g., models) of end effectors. The end effector 908 can send data identifying its type or model. The controller 1012 can retrieve information indicating certain dimensions associated with the type or model. For example, such that the robot arm 1020 can detect and attach to the end effector 908 in a proper configuration). Alternatively, the dimensions can be used to calibrate a position of a center line of a tool (not depicted). A distance (D) between a trajectory A3 of the tool from an axial axis A4 of the distal end of the robot arm 1020 can be retrieved by the controller 1012. An angle (C) of the end effector trajectory A3 relative to a longitudinal axis L3 of the distal end of the robot arm 1020 can be retrieved by the controller 1012”, which reads on “calibration data” as claimed and controlling operation of the surgical tool based on this data.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Brik in view of Asadian et al. (US Patent Pub. No. 2021/0045827).
Regarding claim 3, Brik teaches in paragraph 18 that one of the many data that be obtained by the robotic system include weight. While weight is not the same as mass, it is known that mass is simply the weight divided by gravity, and it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to obtain mass or weight within the system of Brik, as these are easily converted from one to another and can contribute to the same effective utilization by such a system. Brik explicitly teaches the obtaining of the center of mass (see, at least, paragraph 18). Additionally, Brik teaches that “data can include general characteristics of the end effector, such as dimensions, shape” (see paragraph 15), and paragraph 56 explicitly teaches that “the end effector 908 can store dimensional constrains thereon. … For example, the end effector 908 can store working volume parameters thereon such that the system can determine the length, width, and depth of the overall system when the end effector is attached thereto.”.
However, Brik does not teach that the data would include a moment of inertia.
Asadian teaches a robotic system with a surgical tool connected thereto (see Figure 2). Particularly, Asadian teaches that “preset torque threshold may be selected based on the moment of inertia for the surgical tool 240 and/or the drive system. For example, when the surgical tool 240 is coupled to the tool driver 230, the processor 312 may determine (e.g., through electrical contact, RFID tag, bar code, or other techniques) an identifier for the surgical tool 240 or end effector 246. In addition, data for the identifiers for the tool disks being used, the type of transmission for the tool disks, and/or one or more tool calibration values may be received at the processor 312. The processing 312 or memory 314 may include a lookup table that associates the possible identifiers for the surgical tool and/or drive system with inertial values or with preset torque thresholds” (see paragraph 107).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application include additional data points such as a moment of inertia for the surgical tool, as taught by Asadian, within the system and methods of Brik in order to more optimally control the engagement between the robot arm and the driving mechanisms of the tool (see paragraph 105-106 of Asadian), thereby improving performance of the overall robotic system.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Brik alone.
Brik teaches that “the end effector 908 can store dimensional constrains thereon. … For example, the end effector 908 can store working volume parameters thereon such that the system can determine the length, width, and depth of the overall system when the end effector is attached thereto. Knowledge of the working volume can allow the system to be aware of the extents of the end effector so the system and its components can be prevented from colliding with other known volumes or other objects within the operating room” (see paragraph 56). Although this does not explicitly state a first/second/third maximum offset from a centerline, it does state “the system can determine the length, width, and depth of the overall system”. In other words, the system (i.e., the robotic arm) will obviously know its own dimensions, and then determining “the length … of the overall system” would therefore require the system to know the length of the surgical tool that extends beyond the attachment point of the robotic arm. Similarly, determining “the width … of the overall system” would therefore require the system to know the width of the surgical tool that extends beyond the attachment point of the robotic arm, and determining “the depth … of the overall system” would therefore require the system to know the depth of the surgical tool that extends beyond the attachment point of the robotic arm. Each of these refers to a maximum offset in a distinct direction from the point of connection to the surgical robot, which would be a “centerline of the surgical tool” (also see paragraph 50, which states that “the dimensions can be used to calibrate a position of a center line of a tool”).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Brik in view of Culp et al. (US Patent No. 6,017,354).
Brik is described above with regard to claim 8. However, Brik does not teach that the data includes a serial number, a description and a name.
Culp teaches “an integrated surgical tool system for energizing different powered surgical handpieces. Internal to each handpiece is a non-volatile memory (72) which stores data regarding the operating parameters of the handpiece” (see Abstract). Culp teaches that “FIG. 13 is a block diagram of the data fields contained within the NOVRAM 72 within a handpiece. … Handpiece identification fields 343-345 contain such information as the name of the handpiece, for example, sagittal saw, the part number for the handpiece, the handpiece serial number” (see column 15, lines 40-58). Additionally, “Handpiece definition field 350 contains information that Describes the characteristics of the handpiece. This information can include a description of: whether the handpiece is a micro duty or heavy duty handpiece; if the forward/reverse direction controls are convention or in reverse orientation, whether the motor is run with or without feedback; whether the light and water accessories can be used with the handpiece; and the number of significant digits that should be presented on the image formed on display screen 37” (see column 16, lines 1-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to include additional data points, such as various different identification fields, as taught by Culp, within the system and methods of Brik because the more information a handpiece can provide to the system of Brik, the more efficiently the overall system can function and the quicker and more safely the procedure can be accomplished (see column 55, lines 55-64 of Culp).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Brik in view of Asadian, and further in view of Hendrick et al. (US Patent Pub. No. 2022/0296225).
Brik comprises replaceable tools, the tool is shown as being held in a particular holding component (e.g., “An instrument mount 410 extends from the housing 409. The instrument mount 410 can hold the guide cannula 412 that receives any of a variety of instruments 414, e.g., a drill, tap, saw, or combination instrument” – see paragraph 38). While Brik states that the tool could be any of a variety of instruments, it is not taught as being one of those listed in claim 10.
Asadian teaches a surgical tool (see numeral 240 in Figure 2) that includes a tool portion (see numeral 246 in Figure 2) and a connector portion (see the box to the left to which numeral 240 points). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize the instrument of Asadian with the corresponding connecting portion and coupling mechanism in the system of Brik as such a modification amounts to substitution of known equivalents for coupling a surgical tool to the end of a robotic arm to yield predictable results (KSR v. Teleflex).
However, neither Brik nor Asadian teach that the tool is one of those listed in claim 10.
Hendricks teaches a system for minimally invasive surgery, which includes a surgical robot 10 (see Figure 1). Figure 31 illustrates an exchangeable instrument cartridge 410 that has an RFID tag 186 thereon that includes “information on the tool type of the instrument cartridge 410, information on if the instrument cartridge 410 has previously been used” (see paragraph 132) and more. Additionally, Hendricks teaches that “The system 10 can deliver an array of tools 46 including gripping tools, tools that surround tissue and grasp it such as a basket or a snare, or energy-delivery tools such as lasers or electrosurgical probes, among others” (see paragraph 124, emphasis added).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize a laser-based surgical tool, as taught by Hendricks, with the system and methods of Brik and Asadian because Brik teaches that “The instrument mount 410 can hold the guide cannula 412 that receives any of a variety of instruments” (see paragraph 38 of Brik) and Asadian teaches that “Due to the varied nature of surgical procedures, different surgical tools or instruments may be selectively attached to the same arm of a surgical robotic system before and during a surgical procedure” (see paragraph 4 of Asadian), and while neither teach a laser-based surgical tool, having this type of tool capable of use with their system would increase the utility of that system in being able to perform a plethora of additional types of surgeries.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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