DETAILED CORRESPONDANCE
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of claims
This final office action on merits is in response to the communication received on 11/26/2025. Claims 10 and 20-33 are cancelled. Amendment to claim 1 is acknowledged and have been carefully considered. Claims 1-9, 11-19, 34, and 35 are pending and considered below.
Subject Matter Free of Art
Claims 1-9 and 11-19, 34, and 35 include subject matter that is free of prior art. The cited prior art of record fails to expressly teach or suggest, either alone or in combination, the features found within independent claim 1. In particular, the cited prior art fails to expressly teach or suggest the specific combination of generating a procedure plan that includes planned kinematic information, generating a performance metric based on sensor information obtained from an actual implementation of a procedure, evaluating the implementation during the procedure by comparing actual kinematic information of a robot-assisted manipulator to the planned kinematic information to generate an implementation score, dynamically revising the procedure plan during the procedure based on the comparison, and automatically adjusting, during the procedure, a configuration of the robot-assisted manipulator based on the revised procedure plan.
For claim 1, the cited prior art of record fails to expressly teach or suggest generating, during an implemented medical procedure, a performance metric derived from sensor information that includes kinematic information of a robot-assisted manipulator, and evaluating that performance metric in real time by comparing the sensed kinematic information to planned kinematic information from a procedure plan to generate an implementation score. Further, the cited prior art fails to teach or suggest dynamically revising the procedure plan during the procedure based on the comparison and automatically adjusting, during the procedure, a configuration of the robot-assisted manipulator based on the revised procedure plan, as recited in claim 1. While individual references may disclose collecting sensor data, modifying surgical plans, or performing kinematic calculations, the cited prior art does not disclose or suggest the claimed integration of real time evaluation, dynamic plan revision, and automatic manipulator configuration adjustment within a single system operating during an actual procedure.
The closest prior art of record includes McGuan et al. (International Publication WO 2020/163358 A1), referred to hereinafter as McGuan, and Guru et al. (International Publication WO 2009/114613 A2), referred to hereinafter as Guru.
McGuan teaches computer assisted surgical systems that collect sensor data during a procedure, generate and modify surgical plans, and provide recommendations or guidance for robot-assisted procedures. McGuan discloses generating procedure plans, receiving intraoperative sensor information, and modifying surgical parameters based on new data. However, McGuan fails to teach or suggest generating a performance metric that includes kinematic information of a robot assisted manipulator during an implemented procedure, evaluating the implementation during the procedure by comparing actual kinematic information to planned kinematic information to generate an implementation score, dynamically revising the procedure plan based on that comparison, and automatically adjusting, during the procedure, a configuration of the robot assisted manipulator based on the revised procedure plan, as recited in claim 1.
Guru teaches inverse kinematics calculations and error determination for robotic systems within a surgical simulation environment. Guru discloses computing differences between goal positions and modeled end effector positions and iteratively refining kinematic solutions in a simulated framework. However, Guru fails to teach or suggest receiving sensor information from an actual implementation of a medical procedure, generating a performance metric based on such sensor information during the procedure, evaluating the implementation of the procedure in real time by comparison to planned kinematic information from a procedure plan, or dynamically revising a procedure plan and automatically adjusting a configuration of a robot assisted manipulator during the procedure, as required by claim 1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9, 11-19, and 34-35 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Under step 1, the analysis is based on MPEP 2106.03, and claims 1-9, 11-19, 34-35 drawn to a system. Thus, each claim, on its face, is directed to one of the statutory categories (i.e., useful process, machine, manufacture, or composition of matter) of 35 U.S.C. §101.
Step 2A Prong One
Claim 1 recites the limitation of generate a procedure plan wherein the procedure plan is based on a first plurality of procedure inputs and includes planned kinematic information, generate a performance metric based on the received sensor information from the implementation of the procedure, wherein the performance metric includes kinematic information about the robot-assisted manipulator during the implementation of the procedure; evaluate, during the procedure, the implementation of the procedure based on the performance metric to generate an implementation score by comparing the kinematic information about the robot-assisted manipulator during the implementation of the procedure to the planned kinematic information from the procedure plan; dynamically revise, during the procedure, the procedure plan based on the comparison; and automatically adjust, during the procedure, a configuration based on the revised procedure plan. These limitations, as drafted, is a process that, under its broadest reasonable interpretation, cover performance of the limitations in the mind or by using a pen and paper. But for the “a processor” and “a memory having computer readable instructions stored thereon, the computer readable instructions, when executed by the processor” language, the claim encompasses a user simply planning a procedure, observing kinematic values, comparing actual vs planned values, scoring the result, and revising the plan in their mind or by using a pen and paper. The mere nominal recitation of “a processor” and “a memory having computer readable instructions stored thereon, the computer readable instructions, when executed by the processor” does not take the claim limitation out of the mental processes grouping. Thus, the claim recites a mental process which is an abstract idea.
Under Step 2A Prong Two
The claimed limitations, as per method claim 1, include:
a sensor located in a medical environment and configured to detect sensor information from an implementation of a procedure;
a processor; and
a memory having computer readable instructions stored thereon, the computer readable instructions, when executed by the processor, cause the system to:
generate a procedure plan for performing the procedure with a robot-assisted manipulator, wherein the procedure plan is based on a first plurality of procedure inputs and includes planned kinematic information;
receive the sensor information detected by the sensor in the medical environment;
generate a performance metric based on the received sensor information from the implementation of the procedure, wherein the performance metric includes kinematic information about the robot-assisted manipulator during the implementation of the procedure;
evaluate, during the procedure, the implementation of the procedure based on the performance metric to generate an implementation score by comparing the kinematic information about the robot-assisted manipulator during the implementation of the procedure to the planned kinematic information from the procedure plan;
dynamically revise, during the procedure, the procedure plan based on the comparison; and
automatically adjust, during the procedure, a configuration of the robot-assisted manipulator based on the revised procedure plan.
Examiner Note: underlined elements indicate additional elements of the claimed invention identified as performing the steps of the claimed invention.
The judicial exception expressed in claim 1 is not integrated into a practical application. The claim as a whole merely describes how to generally “apply” the concept of planning, evaluating, scoring, and revising a procedure based on kinematic information in a computer environment. The claimed computer components (i.e., a processor, a memory having computer readable instructions stored thereon, the computer readable instructions, when executed by the processor) are recited at a high level of generality and are merely invoked as tools to perform an existing process of generating and revising plans and comparing actual values to planned values. Simply implementing the abstract idea on a generic computer is not a practical application of the abstract idea. Accordingly, alone and in combination, these additional elements do not integrate the abstract idea into a practical application.
The judicial exception expressed in claim 1 is not integrated into a practical application. The abstract idea is merely carried out in a technical environment or field (i.e., a medical robotics or robot assisted surgery), however fails to contain meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment (see MPEP 2106.05(h)). The additional elements that are carried out in a technical environment includes a sensor located in a medical environment and configured to detect sensor information from an implementation of a procedure, for performing the procedure with a robot-assisted manipulator, and detected by the sensor in the medical environment. Accordingly, alone and in combination, these additional elements do not integrate the abstract idea into a practical application.
The judicial exception expressed in claim 1 is not integrated into a practical application. The claim recites the additional element of receive the sensor information. This limitation is recited at a high level of generality (i.e., as a general means of collecting data for use of subsequent calculations or evaluations), and amounts to merely data gathering, which is a form of insignificant extra-solution activity. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
Therefore, under step 2A, the claims are directed to the abstract idea, and require further analysis under Step 2B.
Under step 2B
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed with respect to Step 2A, the claim as a whole merely describes how to generally “apply” the concept of planning, evaluating, scoring, and revising a procedure based on kinematic information in a computer environment. Thus, even when viewed as a whole, nothing in the claim adds significantly more (i.e., an inventive concept) to the abstract idea.
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed with respect to Step 2A, the abstract idea is merely carried out in a technical environment or field, however fails to contain meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment. Thus, even when viewed as a whole, nothing in the claim adds significantly more (i.e., an inventive concept) to the abstract idea.
Claim 1 does not include an additional element that are sufficient to amount to significantly more than the judicial exception. For the providing limitation that was considered extra-solution activity in Step 2A, this has been re-evaluated in Step 2B and determined to be well-understood, routine, conventional activity in the field. The specification does not provide any indication that the limitation of collecting data for use of subsequent evaluations is anything other than a conventional action that simply comes before the evaluation and revision of the procedure plan (see Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016)). For these reasons, there is no inventive concept. The claim is not patent eligible.
Claims 2-5, 7-9, 11-17, and 34, recite no further additional elements, and only further narrow the abstract idea. The previously identified additional elements, individually and as a combination, do not integrate the narrowed abstract idea into a practical application for reasons similar to those explained above, and do not amount to significantly more than the narrowed abstract idea for reasons similar to those explained above.
Claims 6, 18, 19, and 35 recite the additional elements of to display the procedure plan on a display device (claim 6), in an environment of the robot-assisted manipulator (claim 6), the computer readable instructions further cause the system to provide a feedback communication (claim 18), store the implementation score (claim 19), the computer readable instructions further cause the system to display, during the procedure, the implementation score (claim 35). However, these additional elements amount to implementing an abstract idea on a generic computing device, or mere linking to a particular environment or mere data gathering (i.e., an insignificant extra-solution activity)). As such, these additional elements, when considered individually or in combination with the prior devices, does not integrate the abstract idea into a practical application or amount to significantly more than the abstract idea.
Thus, as the dependent claims remain directed to a judicial exception, and as the additional elements of the claims do not amount to significantly more, the dependent claims are not patent eligible.
Therefore, the claims here fail to contain any additional element(s) or combination of additional elements that can be considered as significantly more and the claim is rejected under 35 U.S.C. 101 for lacking eligible subject matter.
Claim Rejections - 35 USC § 103
Regarding the rejection of claims 1-9, 11-19, 34, and 35 the Examiner has considered Applicant’s arguments in light of the present amendments and withdraws the prior art rejection.
Response to Arguments
Applicant’s arguments and amendments, see Remarks/Amendments submitted on 11/26/2025 with respect to the rejection of the claims have been carefully considered and is addressed below.
Claim Rejections - 35 USC § 101
Applicant’s arguments have been fully considered but are not persuasive. Claim 1 recites limitations directed to planning, evaluating, comparing, scoring, and revising a procedure based on information, which fall within the mental processes grouping under MPEP 2106.04. The amendment to recite “automatically adjusting, during the procedure, a configuration of the robot-assisted manipulator” does not remove the claim from this grouping. Under the broadest reasonable interpretation, this limitation remains an abstract decision making and advisor process that may be performed mentally.
Applicant’s states that the Office Action improperly characterized the “automatically adjust, during the procedure, a configuration of the robot-assisted manipulator” limitation is not persuasive. Under the broadest reasonable interpretation, the amended claim reciting an “adjustment” encompasses abstract decision making actions (updating a procedure plan or providing revised instructions), which may be performed mentally. Because the claim does not require actuator level control, joint specific commands, or enforced robotic motion, the limitation remains within the mental processes grouping and applies the output of an abstract evaluation to a robot-assisted manipulator, which does not integrate the judicial exception into a practical application (see MPEP 2106.04(a)(2) and 2106.05(h)).
Applicant’s arguments regarding an alleged improvement to technology and reliance on Diamond v. Diehr are also unpersuasive. Although the specification describes adaptive planning and potential benefits, an improvement must be recited in the claim, not described in the specification. Claim 1 does not recite a specific technical improvement to robotic control or operation, nor does it require a particular automated control mechanism. The claim does not recite a specific technological process that directly controls a physical transformation, but broadly applies abstract decision making within a robotic environment.
Because the claim is not integrated into a practical application, analysis under Step 2B is required. The additional elements recited in claim 1, whether considered individually or in combination, do not amount to significantly more than the judicial exception, as they are either well-understood, routine, and conventional or expressed as high level functional results. Claims 2-9, 11-19, and 34-35, which depend from claim 1, do not add additional elements sufficient to overcome the judicial exception for similar reasons. Accordingly, the rejection under 35 U.S.C. § 101 is maintained.
Claim Rejections - 35 USC § 103
Regarding the rejection of claims 1-9, 11-19, 34, and 35 the Examiner has considered Applicant’s arguments in light of the present amendments and withdraws the prior art rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure.
Lacal et al. (U.S. Patent Publication US/2019 0151031) teaches a computer implemented method that analyzes data from prior robotic medical procedures to identify patterns and automatically generate and display guidance for performing a future robotic procedure on a patient.
MITRA et al. (U.S. Patent Publication 2021/0322148 A1) teaches a surgical planning method for planning and placing a ligament graft by capturing knee joint kinematics with tracking markers and probes, generating a 3D knee model, and computing a graft tunnel surgical plan based on the collected motion and anatomical data.
FARLEY et al. (U.S. Publication 2021/0307833 A1) teaches a method for determining patient-specific implant parameters by generating and updating surgical plans based on preoperative and intraoperative input factors such as using initial transfer functions, ultimately guiding implant selection for the patient.
Farley (U.S. patent 12,127,791) teaches a computer-implemented method for updating a surgical plan for joint implant placement by selecting performance equations from a library, calculating and graphically displaying output responses across parameter ranges, receiving user selected parameter values, and updating the surgical plan, accordingly.
Couture (U.S. patent 11,967,422) teaches a system that uses robotic surgical device and a processor to generate and provide real-time, intraoperative recommendations to a surgeon based on past surgical information.
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.
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/K.R.L./Examiner, Art Unit 3685
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685