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 .
Reopening of Prosecution after Appeal Brief
In view of the Appeal Brief filed on 4/23/2026, PROSECUTION IS HEREBY REOPENED. Procedure set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/CARL H LAYNO/ Supervisory Patent Examiner, Art Unit 3796
Response to Arguments
Applicant’s arguments, see Briefs, filed 4/23/2026, with respect to the rejection(s) of claim(s) 1, 4, 9, 11, 14, 19, and 21 under 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 USC § 103. Applicant argues “receive, from one or more sensors associated with at least one of a surgical instrument or a surgical monitor, one or more signals, the one or more signals representing first information related to the at least one of a surgical instrument or a surgical monitor, wherein the surgical instrument is configured for use on a patient during a medical procedure”, “determine, at a first time and based on the first information, if at least a first indicator is in a first state; automatically trigger, when at least the first indicator is in the first state, at least one first action”, as well as the apparatus repeating this for a second time later than a first time. Shelton discloses “ A surgical device, comprising: an actuator configured to receive an input; and a control circuit configured to: receive a signal from a situationally-aware surgical hub indicative of a surgical state; receive an actuation signal from the actuator in response to the input; and implement a surgical function in response to the actuation signal, wherein the surgical function comprises a first surgical function when the surgical state corresponds to a first surgical state, wherein the surgical function comprises a second surgical function when the surgical state corresponds to a second surgical state, wherein the second surgical state is different than the first surgical state, and wherein the second surgical function is different than the first surgical function[0521]. A non-transitory medium storing computer readable instructions which, when executed, cause a surgical device to: receive a signal from a situationally-aware surgical hub indicative of a surgical state; receive an actuation signal in response to an input applied to an actuator of a surgical device; and implement a surgical function in response to the actuation signal, wherein the surgical function comprises a first surgical function when the surgical state corresponds to a first surgical state, wherein the surgical function comprises a second surgical function when the surgical state corresponds to a second surgical state, wherein the second surgical state is different than the first surgical state, and wherein the second surgical function is different than the first surgical function[0533]. A method, comprising: receiving an input signal from a sensor indicative of a property of airborne particles in a fluid within a patient's abdominal cavity; and in response to the input signal, automatically providing an output signal to a surgical device indicative of an adjustment to a surgical function of the surgical device[0519]. The method of Example 19, further comprising: receiving a second input signal from the sensor indicative of the property of airborne particles in the fluid at a time subsequent to receiving the input signal; and in response to the second input signal, automatically providing a second output signal to a second surgical device indicative of an adjustment to a surgical function of the second surgical device, wherein the second surgical device is different than the first surgical device[0520]. In some exemplifications, the data sources 5126 include, for example, the modular devices 5102 (which can include sensors configured to detect parameters associated with the patient and/or the modular device itself), databases 5122 (e.g., an EMR database containing patient records), and patient monitoring devices 5124 (e.g., a blood pressure (BP) monitor and an electrocardiography (EKG) monitor)[0305]. A surgical hub 5104, which may be similar to the hub 106 in many respects, can be configured to derive the contextual information pertaining to the surgical procedure from the data based upon, for example, the particular combination(s) of received data or the particular order in which the data is received from the data sources 5126[0306]. Shelton does not explicitly word for word express the claimed limitations of the independent claims. However the examples above from Shelton teach that Shelton requires all the necessary components and capability to teach the claimed limitations. Shelton teaches the ability to receive information about the patient during surgery from a sensor, and using that first information to automatically trigger an output signal to create an action. Shelton further teaches obtaining a second signal from the sensor and then automatically providing a second output based on the second signal. The information received is not strictly image data as the applicant argues but can be many forms depending on the monitor and sensors being used.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1,4,9, 11,14,19, and 21 is/are rejected under 35 U.S.C. 103 as being anticipated by Shelton IV et al (US20190104919A1); hereinafter Shelton (cited previously).
Regarding claims 1,11, and 21, Shelton teaches an apparatus, comprising:
a processor (a processor module 132); and
a memory storing instructions thereon that, when processed by the processor, cause the processor to ([0289] machine executable instructions that when executed cause the processors 7008 to execute):
receive, from one or more sensors associated with at least one of a surgical instrument or a surgical monitor ([0220] the imaging device 124 includes at least one image sensor and one or more optical components), one or more signals, the one or more signals representing first information related to the at least one of a surgical instrument or a surgical monitor ([0225] multi-spectrum image, [0304] the instrument sensing an unexpectedly high force), wherein the surgical instrument is configured for use on a patient during a medical procedure, and the surgical monitor is configured to monitor one or more patient vitals during the medical procedure ([0312] physiologic measurement (e.g. blood pressure sensed by a BP monitor) – the system in the reference is capable of performing the claimed function of monitoring patient vitals).
wherein the surgical instrument is configured for use on a patient during a medical procedure ([0225] Multi-spectrum monitoring can be a useful tool in relocating a surgical field after a surgical task is completed to perform one or more of the previously described tests on the treated tissue - medical procedure=surgical task), and the surgical monitor is configured to monitor one or more patient vitals during the medical procedure ([0305] patient monitoring devices 5124 (e.g., a blood pressure (BP) monitor and an electrocardiography (EKG) monitor);
determine, at a first time and based on the first information, if at least a first indicator is in a first state ([0013] determining, by the computer system, an attribute of the surgical device from the images);
automatically trigger, when at least the first indicator is in the first state, at least one first action ([0338] a resulting action of the surgical function (e.g. changing an energy modality), adjusting a type of measurement for affecting the surgical function (e.g. from an on-off activation to an operator-controlled variable activation));
receive, from the one or more sensors associated with the at least one of a surgical instrument or a surgical monitor, or from another sensor associated with at least one of another surgical instrument or another surgical monitor, at a second time later than the first time, second information ([0342] situational awareness of the surgical hub, [0336] Operation of a robotic surgical system, including the various robotic surgical systems disclosed herein, for example, can be controlled by the hub 106, 206 based on its situational awareness and/or feedback from the components thereof and/or based on information from the cloud 104);
determine, at a second time and based on the second information, if at least a second indicator is in a second state ([0342] second surgical state (determined by the situational awareness of the surgical hub)); and
automatically trigger, based on the second information and when the at least one first action is triggered ([0354] actuating a first control/actuator can cause a second control/actuator to have an adjusted function), at least one second action ([0343] second surgical function).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the situational awareness for surgical network method of Shelton to teach the claimed material. Doing so would allow for the control circuit receiving multiple rounds of signals from sensors or actuators throughout the surgical procedure and making adjustments based on information received to teach the claimed material to similar components completing a task for the same goal.
Regarding claims 4 and 14, Shelton discloses the apparatus of claim 1 and the method of claim 11. Shelton further discloses that the processor can receive, at a third time later than the second time, third information; and automatically trigger, based on the third information and when the at least one second action is triggered, at least one third action ([0353] third surgical step).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the situational awareness for surgical network method of Shelton to teach the claimed material. Doing so would allow for the control circuit receiving multiple rounds of signals from sensors or actuators throughout the surgical procedure and making adjustments based on information received to teach the claimed material to similar components completing a task for the same goal.
Regarding claims 9 and 19, Shelton discloses the apparatus of claim 1 and the method of claim 11. Shelton further discloses the at least one first action comprises adjusting one or more surgical lights ( adjust modular devices based on the context (e.g., activate monitors, adjust the field of view (FOV) of the medical imaging device, or change the energy level of an ultrasonic surgical instrument or RF electrosurgical instrument), and take any other such action described above).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the situational awareness for surgical network method of Shelton to teach the claimed material. Doing so would allow for the control circuit receiving multiple rounds of signals from sensors or actuators throughout the surgical procedure and making adjustments based on information received to teach the claimed material to similar components completing a task for the same goal.
Claim(s) 2,3,5,6,12,13,15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton and further in view of Shelton IV et al (US20220249097A1); hereinafter Shelton 2 (cited previously).
Regarding claims 2 and 12, Shelton discloses the apparatus of claim 1 and the method of claim 11. Shelton fails to disclose that the first indicator is enabled when in the first state. Shelton 2 discloses the first indicator is enabled when in the first state ([0318] binary classification includes states). It would have been obvious to a person having ordinary skill in the art the time of the filing date of this invention to modify Shelton with the teachings of Shelton 2 because there is some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention (MPEP 2143). Shelton teaches potential benefits of binary classification into states namely “identification of notable features or configuration (e.g., trends), management of redundant data sets, and storage of the data in paired data sets which can be grouped by surgery but not necessarily keyed to actual surgical dates and surgeons” (Shelton [0318]).
Regarding claims 3 and 13, Shelton teaches apparatus of claim 1 and the method of claim 11. Shelton fails to teach that the first action comprises an automated function of the surgical monitor and the second action comprises an automated function of the surgical instrument. Shelton 2 teaches the at least one first action comprises a first automatable function of the surgical monitor ([0338] display automatically adjusts throughout the surgical procedure) and the at least one second action comprises a second automatable function of the surgical instrument ([0338] automatically controlling the paired modular devices). It would have been obvious to a person having ordinary skill in the art the time of the filing date of this invention to modify Shelton with the teachings of Shelton 2 because there is some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention (MPEP 2143). Shelton 2 teaches that “fluid, power, and/or data lines from different sources are often entangled during the surgical procedure. Valuable time can be lost addressing this issue during a surgical procedure. Detangling the lines may necessitate disconnecting the lines from their respective modules, which may require resetting the modules. The hub modular enclosure 136 offers a unified environment for managing the power, data, and fluid lines, which reduces the frequency of entanglement between such lines” ([0258]).
Regarding claims 5,6,15 and 16, Shelton discloses the apparatus of claim 1 and the method of claim 11. Shelton fails to teach comparing datasets and triggering an action based on the comparison. Shelton 2 teaches that the apparatus/device will compare a first set of data with a second set of data ([0340] The surgical hub 5104 can compare the relative positions of the devices to a recommended or anticipated layout for the particular surgical procedure) ; and automatically trigger, when the comparing produces a first result, at least one third action ([0340] the surgical hub 5104 can be configured to provide an alert indicating that the current layout for the surgical procedure deviates from the recommended layout). It is implied that the system will omit from triggering, when the comparing produces a second result, the at least one third action” because if a difference between the recommended and actual layouts triggers an alert then the second result of the two layouts would result in the trigger to alert being omitted. It would have been obvious to a person having ordinary skill in the art the time of the filing date of this invention to modify Shelton with the teachings of Shelton 2 because some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention (MPEP 2143). Shelton 2 teaches that “another benefit (of comparing the datasets) includes checking for errors during the setup of the surgical procedure or during the course of the surgical procedure” ([0340]).
Claim(s) 7,8,17, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton in view of Wang et al (US 7259652 B2); hereinafter Wang.
Regarding claims 7 and 17, the combination of Shelton and Shelton 2 discloses the apparatus of claim 6 and the method of claim 16. The combination fails to disclose that the third action comprises adjusting a surgical light. Wang discloses the at least one third action comprises at least one of adjusting one or more surgical lights (Fig. 1 part 26 operating room lighting column 5 lines 4-17). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Shelton and Shelton 2 with Wang because there is some teaching, suggestion, or motivation to do so. Wang teaches that “it would be highly advantageous for the doctor to be able to control such changes directly to keep movement in the operating room to a minimum to increase sterility” (col 5 lines 6 – 10).
Regarding claims 8 and 18, Shelton discloses the apparatus of claim 1 and the method of claim 11. Shelton fails to disclose an electrocautery device. Wang discloses the surgical instrument comprises an electrocautery device (Fig. 1 part 18 electrocautery device column 4 line 49-50) and the one or more sensors are wireless sensors (col. 2 line 26-28). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Shelton with Wang because there is some teaching, suggestion, or motivation to do so. Wang teaches that any electrically controlled device can be attached to the master controller (column 4 liens 58-61) so using an electrocautery device would be an obvious choice from a limited number of choices. Shelton and Wang fail to disclose a surgical monitor that comprises at least one of a heart rate monitor, a blood pressure monitor, a body temperature monitor, a pulse rate monitor, a respiration monitor, and a heart rhythm monitor. Shelton 2 teaches a surgical monitor that comprises a heart rate monitor (heart rate monitoring device), a blood pressure monitor (blood pressure monitoring device), and/or a respiration monitor (ventilator data) ([0622] FIG. 42 the patient data 206532). It would have been obvious to a person having ordinary skill in the art the time of the filing date of this invention to modify Wang and Shelton with the teachings of Shelton 2 because combining prior art elements according to known methods to yield predictable results (MPEP 2143). The only difference between the references is the actual combination of the surgical instruments and the surgical monitor. One of ordinary skill in the art could have combined the surgical instrument and the surgical monitor as claimed by known methods because it is obvious to want to visualize and measure what is happening as a result of the treatment administered by the instrument, and that in combination, each element merely performs the same function as it does separately. One of ordinary skill in the art would have also recognized that the results of the combination were predictable in that combining a monitor and instrument has the obvious result that you can give a treatment and visualize the result in real time.
Claim(s) 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton and further in view of Liang et al (US20170254527A1); hereinafter Liang (cited previously).
Shelton teaches the apparatus of claim 1 and the method of claim 11. Shelton fails to teach that there is an indicator signaling when an action has been completed. Liang teaches that the system will render, to a display, an indicator that the at least one first action has been triggered ([0023] operation interface 3 is provided with indicators 32,22 for indicating the status of activation or deactivation). It would have been obvious to a person having ordinary skill in the art the time of the filing date of this invention to modify Shelton with the teachings of Liang because it is obvious to apply a known technique to a known device/method ready for improvement to yield predictable results (MPEP 2143). The base device from Shelton is a computer-implemented method for contextually controlling a surgical device. The known technique found in Liang is adding an indicator light to alert to the user some state of the device they are using. One of ordinary skill in the art would have recognized that applying the known technique would have yielded predictable results. Adding an indicator light means that the user can see the status of the system which is a good idea in any automated medical system and resulted in an improved system namely that the user knows when the action has been triggered.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
Prosecution Insights