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 .
Applicant’s Response
In Applicant’s Response dated 5/26/26, the Applicant amended Claims 1, 10, 12, canceled Claim 14, added Claim 21 and argued Claims previously rejected in the Office Action dated 4/8/26. Claims 1-13 and 15-21 are pending examination.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Joseph et al., United States Patent Publication 2023/0042032 (hereinafter “Joseph”), in view of Russell et al., United States Patent Publication 2021/0290329 (“hereinafter “Russell”).
Claim 1:
Joseph discloses:
A surgical integrated assistance system comprising:
an integrated surgical device having:
a housing having one or more ports integrated at one side of the housing, wherein the one or more ports are configured for coupling the integrated surgical device with one or more energy instruments (see paragraph [0038]). Joseph teaches a surgical system including a generator, an endoscopic surgical forceps for use in connection with endoscopic surgical procedures, and an endoscope;
a display control unit disposed on the side of the housing, and configured to control operating mechanism of each of the one or more energy instruments (see paragraph [0043] and [0044]). Joseph teaches the display unit to display visual indicators and results and image data of the before, during and after the energy delivery; and
an artificial intelligence and machine learning (AI/ML) enabled module integrated within the housing, to automatically optimize multiple parameters of the one or more energy instruments (see paragraph [0044]). Joseph teaches the AI determines correlations between the input data and the successful and unsuccessful outcomes of energy-based surgical applications, and thereby learns from clinician experience through the training process. In applying a trained artificial intelligence learning system, the controller outputs, from the artificial-intelligence learning system, an indication of whether to maintain a generator's current control parameter values based on tissue image, the current generator control values, and/or patient parameters.
wherein the AI/ML enabled module is configured to train a deep learning model, and the deep learning model is configured to process input data collected from the one or more energy instruments for predicting output conditions of the one or more energy instruments (see claim 2 and paragraphs [0015], [0039]-[0041]). Joseph teaches training a learning model to process input data and use the data to predict the output of the energy instruments.
a human/computer interface configured to enable a user to input or label on the images, control the one or more energy instrument's function, and label the one or more energy instruments and tissue interaction during a surgical procedure (see paragraph [0043]). Joseph teaches enabling a user to input data to tag or label images during surgery.
wherein when the energy device is off, the computer interface enables the user to label the tissue or anatomy during the surgical procedure for training, navigation, or data collection purpose (see paragraph [0018]). Joseph teaches tagging tissue within the images for training.
Joseph fails to expressly disclose an insufflator to reduce smoke and mist.
Russell discloses:
the system is trained to implement an on/off signal to the one or more energy instruments to automatically control an insufflator to reduce smoke and mist (see paragraph [0054]). Russell teaches being automatically implementing an on/off signal of an insufflator to reduce smoke and liquid/mist in the surgical area.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclose by Joseph and Sha to include automatically controlling an insufflator to control the evacuation of smoke and mist for the purpose of eliminating additional workflow operations and improve user workflow and smoke evacuation, allowing for significantly improved surgical site visualization and improved intraoperative performance, as taught by Russell.
Claim 2:
Joseph discloses:
wherein the one or more energy instruments include at least one of bipolar and advanced bipolar shears, monopolar shear, ultrasonic shear, microwave ablation devices, laser ablation devices, laparoscopic devices, robotics control unit, and endoscope (see paragraph [0038]). Joseph discloses an endoscope.
Claim 3:
Joseph discloses:
wherein each of the one or more energy instruments are controlled between high voltage and high frequency energy output of the integrated surgical device (see paragraph [0054]). Joseph teaches controlling the energy instruments by the voltage.
Claim 4:
Joseph discloses:
wherein a display unit is detachably mounted onto the housing and configured to provide a consolidated output related to the one or more energy instruments (see paragraph [0072] and [0073]). Joseph teaches a display configured to provide consolidated output related to the one or more energy instruments based information received by the controller.
EXAMINERS NOTE: It is a design choice to have the display detachable. Josephs display performs the same functions as the Applicant’s display on device. There is no defined reasons in the claims why the display is required to be detachable if the same functions are being performed.
Claim 5:
Joseph discloses:
wherein the integrated surgical device having at least one external image input port, at least one output port, a power port, and at least one external intelligence module port, on the other side of the housing (see paragraphs [0072]-[0075]). Joseph teaches the device having a plurality of ports including an input port, output port, power and a module port for the AI.
Claim 6:
Joseph discloses:
wherein the at least one output port is configured for transmitting an output energy device data, a surgical instrument image data, an instrument information and tissue intelligence (see paragraphs [0062], [0063], [0072] and [0073]). Joseph teaches an output port configured to transmit energy device data, image data, instrument information and tissue intelligence to a controller that determines next steps based on the information.
Claim 7:
Joseph discloses:
wherein the display unit is configured to display integrated display instrument information, tissue intelligence information, and at least one optical image or an ultrasound image (see paragraphs [0044] and [0060]-[0062]). Joseph teaches display information related to the display instrument information, the AI information and the image information.
Claim 8:
Joseph discloses:
wherein the AI/ML enabled module is configured for data acquisition, computation, automation, multi-modality devices connection and data storage (see paragraphs [0039], [0040] and [0044]). Joseph teaches the AI configured to acquire data, process and automate data, determine if parameters need adjusting and adjust parameters associated with connected devices.
Claim 9:
Joseph discloses:
wherein the AI/ML enabled module is communicatively coupled to for training models of the AI/ML enabled module (see paragraphs [0010], [0039] and [0041]-[0043]). Joseph teaches the AI communicates for training models to collect real time information from energy instruments.
Joseph fail to expressly disclose communicating with a cloud network.
Russell discloses:
wherein the enabled module is communicatively coupled to a cloud network and to collect real-time information related to the one more energy instruments (see paragraphs [0058] and [0060]). Russell teaches communicated with cloud web services for the device and collecting real-time video information.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclose by Joseph to include communicating with a cloud network for the purpose of accurately receiving real-time data, as taught by Russell.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Joseph et al., United States Patent Publication 2023/0042032 (hereinafter “Joseph”), in view of Sha et al., United States Patent Publication 20240293939 (hereinafter “Sha”), in further view of Russell et al., United States Patent Publication 2021/0290329 (“hereinafter “Russell”).
Claim 10:
Joseph fails to expressly disclose generating a 3D model based on CT or MRI.
Sha discloses:
generate a three-dimensional (3D) reconstruction of a multi-organ model using a pre-operation magnetic resonance imaging (MRI) or computed tomography (CT) scan images as reference points (see paragraph [0178]). Sha teaches generate a 3D model of the subjects body based on the MRI or CT;
collect real time inference with live video feed from the one or more energy instruments to highlight location of diagnosis see paragraph [0178]). Sha teaches collecting real-time 3D data;
calculate operation curve of each of the one or more energy instruments to display onto the display unit, wherein the operation curve provides information related to progress of the diagnosis (see paragraph [0178]). Sha teaches comparing the reference points based on the model and positions of the subject; and
display an operation status reminder of the one or more energy instruments for surgeon’s reference (see paragraph [0178] and [0187]). Sha teaches displaying the output of the energy instruments based on the monitoring.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Joseph to include generating a model from CT or MRI and monitoring position for the purpose of producing the most accurate surgical procedure, as taught by Sha.
Claims 12-13, 15-16, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Joseph, in view of Sanker and Frangieh et al., United States Patent Publication 20180316557 (hereinafter “Frangieh”).
Claim 12:
Joseph discloses:
A system on chip (SOC) based board design integrated within an integrated surgical device, wherein the SOC based board design comprising:
one or more primary connectivity ports fabricated over the SOC based board design, wherein the one or more primary connectivity ports establish connection with one or more energy instruments (see paragraph [0045]). Joseph teaches connections with the energy instruments based on the particular type of instrument.
one or more secondary connectivity ports fabricated over the SOC based board design and connect with a display unit (see paragraph [0045]). Joseph teaches connections with the energy instruments based on the particular type of instrument and can connect to a display output.
wherein the one or more secondary connectivity ports include a high-speed connectivity unit configured to connect the SOC based board design with multiple devices used in a minimally invasive procedure, the multiple devices including one or more of a laparoscope, a stapling device, and an energy device, to receive image data (see paragraph [0045]). Joesph teaches either endoscopic forceps, open forceps, or any other suitable surgical instrument and/or system may be utilized in accordance with the disclosure. Obviously, different electrical and mechanical connections and considerations apply to each particular type of instrument and system; however, the aspects and features of the disclosure remain generally consistent regardless of the configuration of the instrument or system used therewith.
Joseph fails to expressly disclose a video processing unit.
Sanker discloses:
a video processing unit (VPU) communicatively coupled to the processing unit, and configured to retrieve the input data and convert into a high-resolution output signal (see paragraph [0068] and [0069]). Sanker a video processing unit that take input and produces a high-resolution output signal; and
connect with a display unit to display the high-resolution output signal retrieved from the processing unit and/or VPU (see paragraph [0068] and [0069]). Sanker a video processing unit that take input and produces a high-resolution output signal to the display unit.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclose by Joseph to include connecting to a VPU to high resolution output signal for the purpose of producing a high resolution video for display as output to the system, as taught by Sanker.
Joseph and Sanker fails to expressly disclose segregating surgical data into packets.
Frangieh discloses:
a processing unit configured to segregate and process an input data retrieved from the one or more energy instruments into small packets independently to eliminate lag, delay, or interferences between the input data of the one or more energy instruments in real-time processing (see paragraphs [0044], [0056], [0057]). Frangieh teaches a system designed to receive data, processing the data by using segregation, creating packets and sending the packets on a transmission schedule that happens along the path at different times;
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclose by Joseph and Sanker to include segregating data into packets for transmission for the purpose of efficiently sending sensitive data and improve traffic flow of information, as taught by Frangieh.
Claim 13:
Joseph and Frangieh fail to expressly disclose a video processing unit.
Sanker discloses:
wherein the processing unit is configured to provide stability while processing the input data by eliminating possible interference and delays caused due to the connected one or more energy instruments. (see paragraph [0005]). Sanker teaches sensors are integrated within the energy tool such that they do not interfere with energy application of the bipolar grasping tools, provide continuous accurate data in the presence of fluids in/around the jaws and/or high heat application, can withstand the sterilization cycle, and so the data can be, in some aspects, transmittable wirelessly.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclose by Joseph and Frangieh to include providing stabile transmission for the purpose of producing the most accurate data, as taught by Sanker.
Claim 15:
Joseph discloses:
wherein the processing unit is configured to provide customization to the operator to enhance usability and form factor during conducting an operation (see paragraph [0050] and [0066]). Joseph teaches providing customized parameters and operations to enhance usability.
Claim 16:
Joseph discloses:
wherein the input data includes audio, image, video and/or signal data (see paragraph [0072]). Joseph teaches input data is signal data received from the object and can also receive image data.
Claim 18:
Joseph discloses:
wherein the one or more primary connectivity ports are fabricated to establish high speed connectivity with the one or more energy instruments (see paragraph [0045]). Joseph teaches connections with the energy instruments.
Claim 19:
Joseph discloses:
wherein the one or more secondary connectivity ports are fabricated to establish high speed connectivity with the display unit (see paragraph [0045]). Joseph teaches connections with the energy instruments based on the particular type of instrument.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Joseph, Sanker and Frangieh, in view of Sugie et al., United States Patent Publication 20190053857 (hereinafter “Sugie”).
Claim 17:
Joseph, Sanker and Frangieh fail to expressly disclose handling high resolution 4K videos/images.
Sugie:
wherein the VPU is configured to input and output 4K 60 Hz videos (see paragraph [0059]). Sugie teaches receiving input and outputting high resolution 4k videos/images.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclose by Joseph, Sanker and Frangieh to include inputting and outputting high resolution 4k media for the purpose of producing high quality video for the surgical procedure, as taught by Sugie.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Joseph, and Russell, in view of Kim et al., WO2015005623A1 (hereinafter “Kim”).
Claim 20:
Joseph, Sha and Russell fail to expressly disclose handling high resolution 4K videos/images.
Kim discloses:
wherein the AI/ML model enabled module is trained to enhance the at least one optical image or ultrasound image to reduce the impact from smoke or mist (see page 5, 2-5th paragraph). Kim teaches selecting an algorithm according to the type of noise obtained through automatic control or manual control to remove the noise. The controller may remove at least one noise from water vapor mist on the lens surface, water droplets formed on the lens surface, smoke generated during laser surgery, particles flying during laser surgery, low contrast and strong reflection, and consequent blurring. The enhanced image is then transmitted.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclose by Joseph, Sha and Russell to include inputting and outputting high resolution 4k media for the purpose of producing high quality video for the surgical procedure, as taught by Sugie.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Joseph, and Russell, in view of Daraeizadeh et al., 2022/0199888 (hereinafter “Daraeizadeh”).
Claim 21:
Joseph and Russell fail to expressly disclose the model generating multiple inputs having multiple outputs using a qubit calculation.
Daraeizadeh discloses:
wherein the AI/ML enabled module is configured to generate multiple inputs having multiple possibilities of accurate outputs using a qubit calculation. (see paragraphs [0013], [0079] and [0084]). Daraeizadeh teaches noisy measurements from sensors (i.e. multiple inputs) close to the data qubits are provided as input to the machine-learning engine, which learns how these sensor values are related to the control parameters. The machine-learning engine can then use the learned correlation to predict new control parameters (e.g., new/adjusted DC pulses) (i.e. outputs) to compensate for real-time changes in the system.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Joseph, Sha and Russell to include to generate multiple inputs having multiple possibilities of accurate outputs using a qubit calculation for the purpose of producing accurate results of real-time calibration of qubits, as taught by Daraeizadeh.
Pertinent Art
S. M. Hussain, A. Brunetti, G. Lucarelli, R. Memeo, V. Bevilacqua and D. Buongiorno, "Deep Learning Based Image Processing for Robot Assisted Surgery: A Systematic Literature Survey," in IEEE Access, vol. 10, pp. 122627-122657
although the art is related to the invention, it did not teaches the new limitations.
Response to Arguments
Applicants’ arguments filed 5/26/26 have been fully considered but they are not persuasive.
103 Rejections
Applicant argues Joseph alone or in Combination with Sha and/or Russell, Fails to Teach or Suggest that the AI/ML enabled module is configured to train a deep learning model, wherein the deep learning model is configured to process input data collected from the one or more energy instruments for predicting output conditions of the one or more energy instruments.
The Examiner disagrees.
Joseph teaches training a learning model to process input data and use the data to predict the output of the energy instruments (see claim 2 and paragraphs [0015], [0039]-[0041]). Joseph recites training of the artificial intelligence learning system may use training data that includes images, and current generator control parameter values as inputs to the artificial intelligence learning system. In various embodiments, the training data can include patient parameters, which will be discussed in more detail in connection with FIG. 4 (see paragraphs [0039]-[0041]). Joseph also teaches the output of the artificial-intelligence learning system relates to a predicted outcome of applying the energy based on the control parameter values to the tissue (see paragraph [0015]). Thus, Joseph teaches this limitation.
Applicant argues Joseph alone or in Combination with Sha and/or Russell, Fails to Teach or Suggest a human/computer interface to enable a user to input or label on the images, control the one or more energy instrument's function, and label the one or more energy instruments and tissue interaction during a surgical procedure for training, navigation, or data collection purpose.
The Examiner disagrees.
Joseph teaches enabling a user to input data to tag or label images during surgery (see paragraph [0043]). Joseph recites the “tagging” may be accomplished through audio capture and voice recognition. For example, the instrument or the generator may include a microphone to capture the clinician's speech indicating the outcome of the energy application. Examples of such tagging is shown in Table 1 provided below. In various embodiments, the system can display in text on the generator the words that were recorded from the clinician and that were recognized by speech recognition. In various embodiments, the generator may include indicator lights, which reflect the outcome of the energy application, as indicated by the clinician speech. Thus, Joseph teaches this limitation.
The applicant argues that Sha does not disclose a human/computer interface configured to enable a user to input or label on surgical images in real time during a live surgical procedure. Sha does not describe any user-driven annotation mechanism of any kind, does not address labeling of tissue or anatomy during a surgical procedure, and does not teach or suggest any interface capability that is specifically enabled when an energy device is in a deactivated state.
The Examiner disagrees.
The Examiner no longer uses the Sha reference for Claim 1.
Applicant argues Russell does not address intraoperative image annotation of any kind, does not describe any user-driven labeling mechanism, and does not teach or suggest any annotation capability that operates when an energy device is in a deactivated state.
The Examiner disagrees.
Russell is not used to teach the argued limitation of “labelling tissue”.
Applicant argues Joseph alone or in Combination with Sanker and/or Frangieh, Fails to Teach or Suggest the one or more secondary connectivity ports include a high-speed connectivity unit configured to connect the SOC based board design with multiple devices used in a minimally invasive procedure, the multiple devices including one or more of a laparoscope, a stapling device, and an energy device, to receive image data.
The Examiner disagrees.
Joesph teaches either endoscopic forceps, open forceps, or any other suitable surgical instrument and/or system may be utilized in accordance with the disclosure. Obviously, different electrical and mechanical connections and considerations apply to each particular type of instrument and system; however, the aspects and features of the disclosure remain generally consistent regardless of the configuration of the instrument or system used therewith (see paragraph [0045]). Joseph teaches many different devices that can be used and connected to the board. Thus, Joseph teaches the argued limitation.
. Applicant argues The Qubit Calculation feature of the AI/ML enabled module of claim 1, as further evidenced by newly added Dependent Claim 21, further confirms the Non-Obviousness of Claim 1 over Joseph alone or in Combination with Sha, Russell, Sanker, Sugie, Frangieh, and/or Kim.
The Examiner agrees.
The Examiner introduced new art, Daraeizadeh, to teach of the limitation of Claim 21. See the above rejection of Claim 21.
Conclusion
Applicants’ 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 TIONNA M BURKE whose telephone number is (571)270-7259. The examiner can normally be reached M-F 8a-4p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Stephen Hong can be reached at (571)272-4124. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIONNA M BURKE/Examiner, Art Unit 2178 8/21/26
/STEPHEN S HONG/Supervisory Patent Examiner, Art Unit 2178
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