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 .
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.
Notice to Applicant
Claims 1 – 20 are pending.
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 – 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The claims, understood as a whole, recites subject matter within a statutory category as a process (claims 1 – 20) the abstract idea steps of
receive a user input indicating a selection of a procedure from a plurality of procedures, and a selection of a tactical domain target, wherein the procedure and the tactical domain target are associated with a parameter of a patient;
filter, based on the selection of the procedure, a plurality of surgical elements to obtain a primary surgical element and a secondary surgical element associated with the procedure,
determine a tactical domain data for the procedure, wherein the tactical domain data comprises one or more relationships associated with the primary surgical element, the secondary surgical element, the parameter of the patient, and the tactical domain target;
receive a primary control data from the primary surgical element, wherein the primary control data comprises the output characteristic associated with the primary surgical element;
receive a secondary control data from the secondary surgical element, wherein the secondary control data comprises the output characteristic associated with the secondary surgical element;
generate a recommendation based on the tactical domain data, the primary control data, and the secondary control data, wherein the recommendation comprises an indication of an optimized control loop for the primary surgical element during the procedure, wherein the optimized control loop adjusts the output characteristic associated with the primary surgical element to achieve the tactical domain target;
cause the primary surgical element to adjust the output characteristic associated with the primary surgical element based on the optimized control loop, wherein the primary surgical element adjusts the output characteristic during the procedure to achieve the tactical domain target.
These steps of claims 1 – 20, as drafted, under the broadest reasonable interpretation, includes methods of organizing human activity. The Examiner understands the claimed invention, as a whole, in light of the Specification. It is the instant invention, the Specification describes the claimed invention
DETAILED DESCRIPTION
[0024] Operating rooms are becoming more sophisticated with the introduction of smart devices (e.g., interchangeably referred to herein as "surgical elements"). Smart devices may be used and/or adjusted by a health care personnel (HCP) during a procedure. Smart devices may include one or more advanced capabilities to significantly enhance the precision, safety, and efficiency of a procedure (e.g., a surgical procedure, diagnostic procedure, therapeutic procedure, preventative procedure and/or the like), while reducing the risk of complications to patients. Examples of smart devices may include robotic surgical systems, navigation systems, smart imaging systems, endoscopic and/or laparoscopic systems, energy scalpels, anesthesia machines, patient monitoring systems (pulse oximeters, blood pressure monitors, EKG monitors, EEG monitors, and/or the like), energy devices (e.g., electrosurgical units, laser surgery systems, and/or the like), infusion pumps, and/or the like.
[0028] As a typical example, during an endoscopic procedure an anesthetic device may sedate a patient's body, resulting in a drop in core body temperature. An HCP must analyze, and manually adjust a setpoint associated with multiple smart devices to compensate for the patient's loss of heat. If the patient's body temperature decreases during a critical portion of an endoscopic procedure (e.g. , such as during insertion) the HCP may not have the time to adequately assess and/or determine the one or more relationships between smart devices to make an optimal adjustment to precisely control the patient's body temperature. Additionally, an HCP may not adequately understand how an adjustment to a first smart device may affect the performance of additional smart devices during a portion of the procedure. Consistent, manual adjustments by the HCP may result in an increased workload for the HCP, ultimately leading to fatigue, errors, and/or prolonged procedure times that potentially compromise patient safety and surgical outcomes.
[0029] To resolve issues described herein, systems and methods may include a surgical computing system (referred to herein as a "system"). A system may determine one or more relationships associated with one or more surgical elements for a procedure. The system may receive real-time data generated by smart devices during a procedure (e.g. , operational data), real-time data associated with a patient's physiological parameters, and/or a tactical domain target during a procedure, and in response, recommend an optimal control loop for the one or more smart devices, determine a new tactical domain target, recommend a smart device to be used by an HCP during a portion of a procedure, and/or identify or resolve conflicts to reduce the workload of an HCP. The system may determine one our more outputs (e.g., a tactical domain target, an optimized control loop, a conflict, and/or the like) based on an artificial intelligence/machine learning model (ML model). The ML model may be trained with training data including historical data generated by one or more smart devices during past procedures, historical data associated with a patient's physiological parameters (e.g., biomarkers), and/or historical data associated with the outcomes of one or more past procedures.
It is the Specification that discloses the invention as claimed. The Specification describes the invention as overcoming a problem of HCP (Health Care Providers). This applies technology to the abstract idea to achieve the benefits of applying technology to the abstract idea. The invention is not directed towards a technical improvement or a technological improvement to overcome a technical problem. The invention automates a process performed by the HCP.
It should be emphasized that the claim is written “cause the primary element to…”
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2 – 8, 10 – 15, and 17 – 20), reciting particular aspects of how generating a recommendation may be performed using generic computer components).
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception (such as recitation of a processor configured to amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of receive user input amounts to mere data gathering, recitation of determine tactical domain amounts to selecting a particular data source or type of data to be manipulated, recitation of send recommendation amounts to insignificant application, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2 – 8, 10 – 15, and 17 – 20, additional limitations which amount to invoking computers as a tool to perform the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as claims 1 – 20; receiving, determine, generate, send, e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii))
Additional Elements
Surgical element – paragraph 5 may be a …
Processor – paragraph 85 for example, the processor may include a
Connected device – paragraph 150 smartphone, wearable,…
Computing system – any device suitable
ML model – paragraph 135 such as a decision tree algorithm
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2 – 8, 10 – 15, and 17 – 20, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, data target, e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii)). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Roh et al Patent No.: US 11,931,118 providing updates to a surgical robot in which a surgical robot receives a notification that there is an update available or detects a new hardware component that has been attached to the surgical robot.
Thaker et al Pub. No.: US 2020/0371126 dynamically optimizing an instrument system workflow based on operational monitoring and managing of a workflow for a hardware system
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/NEAL SEREBOFF/
Primary Examiner
Art Unit 3626