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 .
Status of Claims
This action is in reply to the current action filed on March 17th, 2026.
Claims 1-2, 7-10, 12, 15-16, and 19-20 have been amended.
Claims 1-20 are currently pending and have been examined.
This action is made final.
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 judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1 Analysis:
Independent Claims 1, 9, and 16 are within the four statutory categories. Claims 1, 9, and 16 are directed to a device, method, and a device, respectively. Dependent Claims 2-8 and 17-20 are further directed to a device, and Claims 10-15 are directed to a method, and therefore, the dependent claims are also within the four statutory categories.
Step 2A Analysis – Prong One:
The substantially similar independent claims, taking Claim 1 as exemplary, recite the following:
A device, comprising: a processor configured to: receive a first dataflow from a first surgical element,
wherein the first dataflow is associated with a physiological parameter of a patient;
determine that the physiological parameter satisfies a patient safety threshold;
in response to at least the determination that the physiological parameter satisfies the patient safety threshold, determine a second dataflow associated with a second surgical element,
wherein the determination of the second dataflow is based on an indication of a relational link associated with the second dataflow of the second surgical element, control data for the first surgical element, and the physiological parameter of the patient;
transmit, to the second surgical element, a configuration message, wherein the configuration message comprises an indication that the physiological parameter satisfies the patient safety threshold and a request to configure the second surgical element to send the second dataflow;
receive, from the second surgical element, a configuration response comprising the second dataflow;
generate control data for the first surgical element based on the second dataflow, wherein the control data indicates an adjustment to an output characteristic associated with the first surgical element;
and cause the output characteristic associated with the first surgical element to be adjusted based on the control data.
The series of steps in underline above, given the broadest reasonable interpretation, cover the abstract ideas of a mental process and certain methods of organizing human activity because they recite a process that could be practically performed in the human mind (i.e. observations, evaluations, judgements, and/or opinions – in this case, the steps of determining that a dataflow is erroneous and determining a second dataflow are reasonably interpreted as processes that could be performed mentally) or using a pen and paper, but for the recitation of generic computer components (i.e. the processor), and/or managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules and instructions – in this case, receiving a first dataflow (which stems from the collection of physiological parameters of a patient), identifying when adjustments need to be made during surgery, transmitting a configuration message, and causing the output characteristic associated with the first dataflow to be adjusted ), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements” and will be discussed further below.
Dependent Claims 2-8, 10-15, and 17-20 recite other limitations directed toward the abstract idea. For example, Claims 2 and 10 recite the physiological parameter of the patient is a core body temperature, the first dataflow indicates a temperature associated with a heating pad, the second dataflow indicates an insufflated air temperature measurement, the output characteristic is a power level, and the control data indicates an adjustment to the power level associated with the heating pad. Claims 3, 11, and 17 recite the configuration response comprises a surgical element ID, an indication that the second dataflow is available, and a unit of measure. Claims 4 and 12 recite the relational link is determined based on a lookup table which indicates a relationship between the second dataflow, a control data of the first surgical element, and the physiological parameter of the patient. Claims 5 and 13 recite the information that the LUT contains for both dataflows. Claims 6 and 14 recite the use of a training dataset wherein the training dataset comprises a plurality of dataflows and a plurality of control data associated with the physiological parameter of the patient. Claims 7, 15, and 19 recite the second dataflow is determined based on the control data satisfying a threshold or a determination that the first dataflow is unavailable. Claim 8 recites transmitting an interrogation message in response to the parameter satisfying a patient safety threshold, wherein the interrogation message requests dataflow configuration information for the second surgical element and an indication of one or more dataflows associated with the second surgical element that is related to the first dataflow; and receiving an interrogation response, wherein the dataflow configuration information comprises at least one of a communication protocol, a frequency, a destination, or access control credentials. Claim 20 recites in response to determining that the physiological parameter satisfies a patient safety threshold, transmitting a message and receiving a response indicating at least one dataflow associated with the second element. These limitations only serve to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g., see MPEP 2106.04. Additionally, any limitations in dependent Claims 2-8, 10-15, and 17-20 not addressed above are deemed additional elements to the abstract idea and will be further addressed below. Hence, dependent Claims 2-8, 10-15, and 17-20 are nonetheless directed toward fundamentally the same abstract idea of mental processes and certain methods of organizing human activity as independent Claims 1, 9, and 16.
Step 2A Analysis – Prong Two:
Claims 1, 9, and 16 are not integrated into practical application because the additional elements (i.e. the non-underlined portions presented in prong one- in this case, the processor, first surgical element, and second surgical element of Claims 1 and 16 and the first surgical element and second surgical element of Claim 9) are recited at a high level of generality (i.e. as a generic processor performing generic computer functions) such that they amount to no more than mere instruction to apply the exceptions using generic computer components. For example, Applicant’s specification explains that a first surgical element 55610 may be a laparoscopic tool including a temperature sensor, whereas a second surgical element 55620 may be a heating pad configured to heat an insufflated cavity. The laparoscopic tool may transmit a dataflow indicating a measured temperature of an insufflated cavity to the surgical computing system 55630 (Applicant’s specification, ¶ 0095). [T]he control data 55681 may be generated based on a sensor of a second surgical element (e.g., surgical element 55620), and transmitted to a first surgical element (e.g., surgical element 55610) [0184]. A device may include a processor. The device may be configured to receive a first dataflow from a first surgical element [0005]. The hub 20006 includes a display 20048, an imaging module 20049, a generator module 20050 (e.g., an energy generator), a communication module 20056, a processor module 20057, a storage array 20058, and an operating-room mapping module 20059 [0054]. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into practical application because they do not impose any meaningful limits on the abstract idea. Therefore, independent Claims 1, 9, and 16 are directed to an abstract idea without practical application.
Dependent Claims 2-3, 6, 8, 10-11, 14, 17, and 20 recite additional elements. Claims 2 and 10 recite the previously recited processor and a new additional element of a laparoscopic tool and specify the second dataflow indicates an insufflated air temperature measurement from a laparoscopic tool, the output characteristic is a power level associated with the heating pad, and wherein the processor controls the core body temperature of the patient by determining the power level associated with the heating pad based on the insufflated air temperature measurement from the laparoscopic tool. Claims 3, 11, and 17 recite the previously recited second surgical element and specify the configuration response comprises a unit of measure for the second surgical element. Claims 6, 14, and 18 recite a new element of a machine learning model and specifies the ML model is trained based on a training dataset. Claim 8 recites the previously recited processor and second surgical element and specifies the processor transmits an interrogation message to the second surgical element and an indication of one or more dataflows associated with the second surgical element related to the first dataflow. Claim 20 recites the previously recited processor and second surgical element and specifies the processor transmits an interrogation message to the second surgical element. However, these additional elements are used in their expected fashion, so they do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on the abstract idea. These limitations amount to no more than mere instructions to apply an exception, and hence, do not integrate the aforementioned abstract idea into practical application.
Step 2B Analysis:
The claims do not include additional elements that are sufficient enough to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the abstract idea into a practical application, the additional elements of the processor, first surgical element, and second surgical element of Claims 1 and 16 and the first surgical element and second surgical element of Claim 9 amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). MPEP2106.05(I)(A) indicates that merely stating “apply it” or equivalent to the abstract idea cannot provide an inventive concept (“significantly more”). Accordingly, even in combination, these additional elements do not provide significantly more. As such, the independent Claims 1, 9, and 16 are not patent eligible.
Dependent Claims 4-5, 7, 12-13, 15, and 19 further narrow the abstract idea and do not provide an inventive concept or additional elements. Claims 4 and 12 recite the relational link is determined based on a lookup table which indicates a relationship between the second dataflow, a control data of the first surgical element, and the physiological parameter of the patient. Claims 5 and 13 recite the information that the LUT contains for both dataflows. Claims 7, 15, and 19 recite the second dataflow is determined based on the control data satisfying a threshold or a determination that the first dataflow is unavailable.
Claims 3, 8, 11, 17, and 20 recite previously recited additional elements, which are not eligible for the reasons stated above, and further narrow the abstract idea. Claims 3, 11, and 17 recite the previously recited second surgical element and specify the configuration response comprises a unit of measure for the second surgical element. Claim 8 recites the previously recited processor and second surgical element and specifies the processor transmits an interrogation message to the second surgical element and an indication of one or more dataflows associated with the second surgical element related to the first dataflow. Claim 20 recites the previously recited processor and second surgical element and specifies the processor transmits an interrogation message to the second surgical element in response to the determination that the physiological parameter satisfies a patient safety threshold.
Claims 2, 6, 10, 14, and 18 recite new additional elements. Claims 2 and 10 recite the previously recited processor and a new additional element of a laparoscopic tool and specify the second dataflow indicates an insufflated air temperature measurement from a laparoscopic tool, the output characteristic is a power level associated with the heating pad, and wherein the processor controls the core body temperature of the patient by determining the power level associated with the heating pad based on the insufflated air temperature measurement from the laparoscopic tool. Claims 6, 14, and 18 recite a new element of a machine learning model and specifies the ML model is trained based on a training dataset. Hence, Claims 2-8, 10-15, and 17-20 do not include any additional elements that amount to “significantly more” than the judicial exception.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination does not add anything that is already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 1-20 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
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.
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, 7-9, 15-16, and 19-20 are rejected under 35 USC § 103 as being unpatentable over Trikha et al. (US 20230065864 A1) in view of Roh et al. (US 12029434 B1) and Brauker et al. (US 20090043525 A1).
Regarding Claim 1, Trikha discloses the following:
A device, comprising: a processor configured to: (Trikha discloses the one or more controllers is operatively coupled to a data processing center, the data processing center comprising a cloud, a processor, or another sensor [0007].)
receive a first dataflow from a first…element, (Trikha discloses an apparatus for sensor calibration comprises one or more controllers configured to: (a) operatively couple to a sensor; (b) collect, or direct collection of, sensed data (e.g., data set) during a time window; (c) evaluate, or direct evaluation of, the sensed data to obtain optimal sensed data [0007].)
determine a second dataflow associated with a second…element, (Trikha discloses the second sensor is immediately adjacent to the first sensor such that there is no additional sensor of the first type between the first sensor and the second sensor [0006]. A sensor of one type may have a correlation with at least one other type of sensor. A situation in an enclosure may affect one or more of different sensors. Sensor readings of the one or more different may be correlated and/or affected by the situation. The correlations may be predetermined [0093].)
wherein the determination of the second dataflow is based on an indication of a relational link associated with the second dataflow of the second surgical element, control data for the first surgical element, and the physiological parameter of the patient; (Trikha discloses a sensor of one type may have a correlation with at least one other type of sensor. A situation in an enclosure may affect one or more of different sensors. Sensor readings of the one or more different may be correlated and/or affected by the situation. The correlations may be predetermined [0093]. One or more controllers operatively coupled with the one or more first sensors and the one or more second sensors, the one or more controllers utilizing obtained sensor measurements from the one or more first sensors to calibrate and/or re-calibrate the one or more second sensors [0018]. The term “operatively coupled” or “operatively connected” refers to a first element (e.g., mechanism) that is coupled (e.g., connected) to a second element, to allow the intended operation of the second and/or first element. The coupling may comprise physical or non-physical coupling [0064].)
receive, from the second…element, a configuration response comprising the second dataflow; (Trikha discloses an apparatus for sensor calibration that comprises one or more controllers configured to: (a) operatively couple to a first sensor and to a second sensor; (b) collect, or direct collection of,… (ii) a second sensed data during a second duration,…[0007].)
generate control data for the first surgical element based on the second dataflow, (Trikha discloses performing calibration of sensors comprises:… the one or more first sensors are calibrated, wherein the enclosure is a target location of the one or more first sensors; one or more second sensors in the enclosure, wherein the one or more second sensors are uncalibrated or erroneously calibrated; and one or more controllers operatively coupled with the one or more first sensors and the one or more second sensors, the one or more controllers utilizing obtained sensor measurements from the one or more first sensors to calibrate and/or re-calibrate the one or more second sensors [0018]. The first reading of the first parameter is modified by the second sensor to generate a modified first reading of the first parameter. In some embodiments, the second sensor operates to convert the modified first reading of the first parameter into a correction factor for use by the first sensor [0021].)
wherein the control data indicates an adjustment to an output characteristic associated with the first surgical element; and cause the output characteristic associated with the first surgical element to be adjusted based on the control data. (Trikha discloses the controller may evaluate an erroneous temperature sensor reading and one or more readings of temperature made by one or more other temperature sensors. The controller(s) may determine that the sensor reading is erroneous in response to consideration (e.g., including evaluating and/or comparing with) the sensor reading with one or more readings from other sensors in the same environment …Controller(s) may direct the one sensor providing the erroneous reading to undergo recalibration. For example, the controller(s) may transmit one or more values and/or parameters to the sensor(s) providing the erroneous reading. The sensor(s) providing the erroneous reading may utilize the transmitted value and/or parameter to adjust its subsequent sensor reading(s). For example, the sensor(s) providing the erroneous reading may utilize the transmitted value and/or parameter to adjust its baseline for subsequent sensor reading(s). The baseline can be a value, a set of values, or a function [0089]. The sensor's baseline is interpreted as the output characteristic.)
Trikha does not disclose the devices being used for the application or surgery which is met by Roh:
wherein the first dataflow is associated with a physiological parameter of a patient; (Roh teaches sensors are used in association with minimally invasive surgery devices. The sensor may be used in minimally invasive surgeries for tactile sensing of tool—tissue interaction forces. During minimally invasive surgeries field of view and workspace of tools are compromised due to the indirect access to the anatomy and lack of surgeon's hand-eye coordination (col. 11, lines 17-23).)
transmit… a configuration message, wherein the configuration message comprises… and a request to configure the second surgical element to send the second dataflow; (Roh teaches the method may include: …sending, responsive to a determination that the current time matches the procedure time, a request to the wearable patient device for a procedure data set, the procedure data set including one or more patient metrics collected by the one or more biological sensors during the procedure time (col. 2, lines 13-21).)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for receiving dataflows from devices, determining the data has an error, and adjusting the output of the device based on a second device as disclosed by Trikha to incorporate the devices being for surgical purposes and the transmission of a configuration message to the device to request a dataflow to be sent as taught by Roh. This modification would create a system and method capable of assisting a surgeon in performing surgical tasks and maintaining the environment of the operating room (see Roh, col. 1, lines 9-31).
Trikha and Roh do not teach determining if a physiological parameter exceeds a patient safety threshold which is met by Brauker:
determine that the physiological parameter satisfies a patient safety threshold; in response to at least the determination that the physiological parameter satisfies the patient safety threshold,… (Brauker teaches "clinically acceptable," as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, an analyte concentration, rate of change, and/or acceleration associated with that measured analyte that is considered to be safe for a patient. In one exemplary embodiment, clinical acceptability is determined by a measured glucose concentration within a threshold (for example, 80-200 mg/dL) and/or its rate of change [0196]. [E]stimation can be applied only during approaching clinical risk to warn a patient or doctor in an effort to avoid the clinical risk, for example when the measured glucose concentration is outside of a clinically acceptable threshold (for example, 100 to 200 mg/dL)… [0253]. If the result of the evaluation is satisfactory (for example, 10% average deviation, correlation coefficient above 0.79, all estimated analyte values within A or B region of the Clarke Error Grid, all estimated analyte values within physiological boundaries, or the like), the processing continues to the next step, using the selected estimative algorithm [0300]. The Examiner interprets the clinically acceptable threshold as a patient safety threshold. )
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for receiving dataflows from devices, determining the data has an error, and adjusting the output of the device based on a second device as disclosed by Trikha to incorporate the determination that a physiological parameter satisfies a safety threshold as taught by Brauker. This modification would create a system and method which improves data processing in continuous sensors to better handle inconsistencies and instabilities that can occur in physiological measurements (see Brauker, ¶ 0006).
Regarding Claim 9, this Claim recites limitations that are substantially similar to those recited in Claim 1 above; thus, the same rejection applies. Trikha further discloses:
a method comprising: (Trikha discloses a method for sensor calibration comprises: (a) using a sensor to collect sensed data (e.g., data set) during a time window; (b) evaluating the sensed data (e.g., data set)…[0005].)
Regarding Claim 7, Trikha, Roh, and Brauker teach the limitations as seen in the rejection of Claim 1 above. Trikha discloses the following:
the second dataflow is determined further in response to a determination that control data satisfies a threshold or a determination that the first dataflow is unavailable. (Trikha discloses detection by a first type of sensor that is not accompanied by detection by a second type of sensor may result in a sensor posting an error message [0094]. The Examiner interprets this as the dataflow being unavailable. One or more controllers operatively coupled with the one or more first sensors and the one or more second sensors, the one or more controllers utilizing obtained sensor measurements from the one or more first sensors to calibrate and/or re-calibrate the one or more second sensors [0018]. the controller(s) may transmit one or more values and/or parameters to the sensor(s) providing the erroneous reading. The sensor(s) providing the erroneous reading may utilize the transmitted value and/or parameter to adjust its subsequent sensor reading(s). For example, the sensor(s) providing the erroneous reading may utilize the transmitted value and/or parameter to adjust its baseline for subsequent sensor reading(s) [0089])
Regarding Claims 15 and 19, these claims recite limitations that are substantially similar to those recited in Claim 7 above; thus, the same rejection applies.
Regarding Claim 8, Trikha, Roh, and Brauker teach the limitations as seen in the rejection of Claim 1 above. Trikha discloses the following:
wherein the … dataflow configuration information for the …element (Trikha discloses a sensor…provides an output signal indicating an erroneous measurement. The sensor may be operatively coupled to at least one controller. The controller(s) may obtain erroneous sensor reading from the sensor [0089]. The Examiner interprets the erroneous sensor reading as configuration information.)
…and an indication of one or more dataflows associated with the second…element that are related to the first dataflow; (Trikha discloses one or more controllers configured to: (a) operatively couple to a first sensor and to a second sensor; (b) collect, or direct collection of,… (ii) a second sensed data during a second duration [0007]. A sensor of one type may have a correlation with at least one other type of sensor…Sensor readings of the one or more different may be correlated and/or affected by the situation [0093]. One or more controllers operatively coupled with the one or more first sensors and the one or more second sensors, the one or more controllers utilizing obtained sensor measurements from the one or more first sensors to calibrate and/or re-calibrate the one or more second sensors [0018].)
…indicating at least one dataflow associated with the second…element and dataflow configuration information, (Trikha discloses an apparatus for sensor calibration that comprises one or more controllers configured to: (a) operatively couple to a first sensor and to a second sensor; (b) collect, or direct collection of,… (ii) a second sensed data during a second duration,…[0007].)
…and dataflow configuration information, wherein the dataflow configuration information comprises at least one of a communication protocol, a frequency, a destination, or access control credentials. (Trikha discloses certain sensors may modify (e.g., increase or decrease) a frequency at which sensor readings are sampled. Timing and/or frequency of the sensor operation may depend on the sensor type, location in the (e.g., target) environment, and/or time of day…A sensor may be assigned a timing and/or frequency of operation [0090]. The data indicating the frequency of sensor operation is interpreted as dataflow configuration information.)
Trikha does not disclose the devices being used for the application or surgery and the transmission of a request message which is met by Roh:
… transmit an interrogation message to the…surgical element, (Roh teaches the method may include: …sending, responsive to a determination that the current time matches the procedure time, a request to the wearable patient device for a procedure data set, the procedure data set including one or more patient metrics collected by the one or more biological sensors during the procedure time (col. 2, lines 13-21).)
and receive an interrogation response … (Roh teaches the method also includes receiving a sensor data set for the subject, the sensor data set may include one or more patient metrics that indicate one or more biological conditions of the subject and that are based on signals produced by one or more biological sensors included in a wearable device on the subject,…(col. 3, lines 22-28). The method where the wearable patient device activates and collects data from one or more sensors based on the requested one or more patient metrics that correspond to a procedure type. The method may include: repeatedly sending requests to the wearable patient device for an updated procedure data set (col. 3, lines 55-63).)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for receiving dataflows from devices, determining the data has an error, and adjusting the output of the device based on a second device as disclosed by Trikha to incorporate the devices being for surgical purposes and the transmission of a configuration message to the device to request a dataflow to be sent as taught by Roh. This modification would create a system and method capable of assisting a surgeon in performing surgical tasks and maintaining the environment of the operating room (see Roh, col. 1, lines 9-31).
Trikha and Roh do not teach determining if a physiological parameter exceeds a patient safety threshold which is met by Brauker:
determine that the physiological parameter satisfies a patient safety threshold; in response to at least the determination that the physiological parameter satisfies the patient safety threshold,… (Brauker teaches "clinically acceptable," … is a broad term and is used in its ordinary sense, including,…an analyte concentration, rate of change, and/or acceleration associated with that measured analyte that is considered to be safe for a patient. In one exemplary embodiment, clinical acceptability is determined by a measured glucose concentration within a threshold (for example, 80-200 mg/dL) and/or its rate of change [0196]. [E]stimation can be applied only during approaching clinical risk to warn a patient or doctor in an effort to avoid the clinical risk, for example when the measured glucose concentration is outside of a clinically acceptable threshold (for example, 100 to 200 mg/dL)… [0253]. If the result of the evaluation is satisfactory, …the processing continues to the next step, using the selected estimative algorithm [0300]. The Examiner interprets the clinically acceptable threshold as a patient safety threshold.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for receiving dataflows from devices, determining the data has an error, and adjusting the output of the device based on a second device as disclosed by Trikha to incorporate the determination that a physiological parameter satisfies a safety threshold as taught by Brauker. This modification would create a system and method which improves data processing in continuous sensors to better handle inconsistencies and instabilities that can occur in physiological measurements (see Brauker, ¶ 0006).
Regarding Claim 16, Trikha discloses:
A…device comprising: a processor configured to: determine a second dataflow based on a relational link associated with the first…element… (Trikha discloses a sensor of one type may have a correlation with at least one other type of sensor. A situation in an enclosure may affect one or more of different sensors. Sensor readings of the one or more different may be correlated and/or affected by the situation. The correlations may be predetermined [0093]. One or more controllers operatively coupled with the one or more first sensors and the one or more second sensors, the one or more controllers utilizing obtained sensor measurements from the one or more first sensors to calibrate…the one or more second sensors [0018]. The term “operatively coupled” or “operatively connected” refers to a first element…that is coupled…to a second element, to allow the intended operation of the second and/or first element. The coupling may comprise physical or non-physical coupling [0064].)
receive, from the second surgical element, a configuration response comprising the second dataflow; (Trikha discloses an apparatus for sensor calibration that comprises one or more controllers configured to: (a) operatively couple to a first sensor and to a second sensor; (b) collect, or direct collection of,… (ii) a second sensed data during a second duration,…[0007].)
and cause an output characteristic associated with the first surgical element to be adjusted based on control data associated with the second dataflow, wherein the control data indicates an adjustment to the output characteristic associated with the first surgical element. (Trikha discloses the controller may evaluate an erroneous temperature sensor reading and one or more readings of temperature made by one or more other temperature sensors. The controller(s) may determine that the sensor reading is erroneous in response to consideration (e.g., including evaluating and/or comparing with) the sensor reading with one or more readings from other sensors in the same environment …Controller(s) may direct the one sensor providing the erroneous reading to undergo recalibration. For example, the controller(s) may transmit one or more values and/or parameters to the sensor(s) providing the erroneous reading. The sensor(s) providing the erroneous reading may utilize the transmitted value and/or parameter to adjust its subsequent sensor reading(s). For example, the sensor(s) providing the erroneous reading may utilize the transmitted value and/or parameter to adjust its baseline for subsequent sensor reading(s). The baseline can be a value, a set of values, or a function [0089]. The sensor's baseline is interpreted as the output characteristic.)
Trikha does not disclose the devices being used for the application or surgery which is met by Roh:
the first surgical element and a physiological parameter of a patient; (Roh teaches sensors are used in association with minimally invasive surgery devices. The sensor may be used in minimally invasive surgeries for tactile sensing of tool—tissue interaction forces. During minimally invasive surgeries field of view and workspace of tools are compromised due to the indirect access to the anatomy and lack of surgeon's hand-eye coordination (col. 11, lines 17-23).)
transmit… a configuration message, wherein the configuration message comprises… and a request to configure the second surgical element to send the second dataflow; (Roh teaches the method may include: …sending, responsive to a determination that the current time matches the procedure time, a request to the wearable patient device for a procedure data set, the procedure data set including one or more patient metrics collected by the one or more biological sensors during the procedure time (col. 2, lines 13-21).)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for receiving dataflows from devices, determining the data has an error, and adjusting the output of the device based on a second device as disclosed by Trikha to incorporate the devices being for surgical purposes and the transmission of a configuration message to the device to request a dataflow to be sent as taught by Roh. This modification would create a system and method capable of assisting a surgeon in performing surgical tasks and maintaining the environment of the operating room (see Roh, col. 1, lines 9-31).
Trikha and Roh do not teach determining if a physiological parameter exceeds a patient safety threshold which is met by Brauker:
determine that the physiological parameter satisfies a patient safety threshold; in response to at least the determination that the physiological parameter satisfies the patient safety threshold,… (Brauker teaches "clinically acceptable," as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, an analyte concentration, rate of change, and/or acceleration associated with that measured analyte that is considered to be safe for a patient. In one exemplary embodiment, clinical acceptability is determined by a measured glucose concentration within a threshold (for example, 80-200 mg/dL) and/or its rate of change [0196]. [E]stimation can be applied only during approaching clinical risk to warn a patient or doctor in an effort to avoid the clinical risk, for example when the measured glucose concentration is outside of a clinically acceptable threshold (for example, 100 to 200 mg/dL)… [0253]. If the result of the evaluation is satisfactory (for example, 10% average deviation, correlation coefficient above 0.79, all estimated analyte values within A or B region of the Clarke Error Grid, all estimated analyte values within physiological boundaries, or the like), the processing continues to the next step, using the selected estimative algorithm [0300]. The Examiner interprets the clinically acceptable threshold as a patient safety threshold.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for receiving dataflows from devices, determining the data has an error, and adjusting the output of the device based on a second device as disclosed by Trikha to incorporate the determination that a physiological parameter satisfies a safety threshold as taught by Brauker. This modification would create a system and method which improves data processing in continuous sensors to better handle inconsistencies and instabilities that can occur in physiological measurements (see Brauker, ¶ 0006).
Regarding Claim 20, Trikha, Roh, and Brauker teach the limitations as seen in the rejection of Claim 16 above. Trikha discloses the following:
wherein the processor is further configured to: in response to the determination that the first dataflow is erroneous,… (Trikha discloses once a correlation between two or more sensor types is established, a deviation from the correlation (e.g., from the correlation value) may indicate an irregular situation and/or malfunction of a sensor of the correlating sensors. The malfunction may include a slippage of a calibration. The malfunction may indicate a requirement for re-calibration of the sensor. A malfunction may comprise complete failure of the sensor [0094].)
… of one or more dataflows associated with the second…element that is related to the first dataflow; (Trikha discloses data from sensors may be correlated. Once a correlation between two or more sensor types is established, a deviation from the correlation…may indicate an irregular situation and/or malfunction of a sensor of the correlating sensors [0094]. A sensor reading may be any type of reading, such as detection of movement of individuals within an enclosure, temperature, humidity, or any other property detected by the sensor. At 1660, correlation data may be accessed from other sensors disposed in the enclosure. Correlation data may relate to output readings from a sensor of the same type or a sensor of a different type operating within the enclosure [0154].)
and receive an interrogation response indicating at least one dataflow associated with the second…element. (Trikha discloses an apparatus for sensor calibration that comprises one or more controllers configured to: (a) operatively couple to a first sensor and to a second sensor; (b) collect, or direct collection of,… (ii) a second sensed data during a second duration,…[0007].)
Trikha does not disclose the devices being used for the application or surgery and the transmission of a request message which is met by Roh:
…transmit an interrogation message to the … surgical element, wherein the interrogation message requests an indication… (Roh teaches the method may include: …sending, responsive to a determination that the current time matches the procedure time, a request to the wearable patient device for a procedure data set, the procedure data set including one or more patient metrics collected by the one or more biological sensors during the procedure time (col. 2, lines 13-21).)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for receiving dataflows from devices, determining the data has an error, and adjusting the output of the device based on a second device as disclosed by Trikha to incorporate the devices being for surgical purposes and the transmission of a configuration message to the device to request a dataflow to be sent as taught by Roh. This modification would create a system and method capable of assisting a surgeon in performing surgical tasks and maintaining the environment of the operating room (see Roh, col. 1, lines 9-31).
Claims 2 and 10 are rejected under 35 USC § 103 as being unpatentable over Trikha, Roh, and Brauker in view of Roth et al. (US 20170042727 A1) and Robson et al. (Robson et al. "Increased visceral tissue perfusion with heated, humidified carbon dioxide insufflation during open abdominal surgery in a rodent model.” PloS one vol. 13, Apr. 2018).
Regarding Claim 2, Trikha, Roh, and Brauker teach the limitations as seen in the rejection of Claim 1 above. Trikha further discloses:
the first dataflow… the second dataflow… (Trikha discloses an apparatus for sensor calibration that comprises one or more controllers configured to: (a) operatively couple to a first sensor and to a second sensor; (b) collect, or direct collection of, (i) a first sensed data during a first duration and (ii) a second sensed data during a second duration,…[0007].)
Trikha, Roh, and Brauker do not teach the data being for measuring pad temperatures and internal body temperature and using a adjusting the internal body temperature of a patient which is met by Roth:
wherein the physiological parameter of the patient is a core body temperature of the patient, (Roth teaches an apparatus and a method for controlling a body temperature wherein the controlling accuracy of the body temperature is increased [0012]. The targeted temperature adjustment of the patient's body core temperature …[0364].)
the…dataflow indicates a temperature associated with a heating pad, (Roth teaches it is known to control a temperature of a patient by heating or cooling the surface of a patient, for instance with disposable pads containing ice, water or gel. Other devices use temperature controlled pads, such as known pad systems [0002].)
the output characteristic is a power level associated with the heating [apparatus], (Roth teaches the second temperature adjusting device may improve patient's comfort via, e.g., surface pads on the skin that are tempered above the normal body temperature. The targeted temperature adjustment of the patient’s body core temperature via the infusion needle 200 may be a fast systemic cooling of the patient via rapid inflow of cold saline, this being beneficial from the medical view, however rather uncomfortable for the patient [0364]. While Roth teaches adjusting temperature of infusion fluids to change the internal body temperature of the patient, the modification to the warming being completed by heating pads would have been a simple substitution of one known object for another.)
the control data indicates an adjustment to the power level associated with the heating pad, and wherein the processor is further configured to: control the core body temperature of the patient by determining the power level associated with the heating [apparatus] (Roth teaches apparatus for controlling a body temperature… comprising a controller (100), the controller being adapted to control the body temperature (T.sub.b) by controlling at least two different body temperature adaption devices (200, 300), [0016] wherein one body temperature adaption device is an infusion device (200); and [0017] wherein at least one further body temperature adaption device (300) is different from the one body temperature adaption device and, preferably, not an infusion device [0014].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for receiving dataflows from devices, determining the data has an error, and adjusting the output of the device based on a second device as disclosed by Trikha to incorporate the dataflow providing internal body temperature and heating pad temperature and determining what power level of a heating apparatus to change internal body temperature as taught by Roth. This modification would create a system and method capable of adjusting a patient’s body temperature as efficiently as possible in the event of changing physiological conditions (see Roth, ¶ 0011-0014).
Trikha, Roh, Brauker, and Roth do not teach the use of a laparoscopic tool which is met by Robson:
the…dataflow indicates an insufflated air temperature measurement from a laparoscopic tool,… based on the insufflated air temperature measurement from the laparoscopic tool. (Robson teaches heating and humidifying CO2 can significantly ameliorate the damages induced by CD CO2 as well as prevent hypothermia frequently seen in laparoscopic procedures. Similarly, the use of HH CO2 during open surgery has been shown to significantly increase surgical wound and core body temperature (p. 10, ¶ 0003). Still photographs of the thermal images identified that abdominal cavity visceral temperatures were maintained (no heat loss) in the HH CO2 group (Fig 2E and 2H). In comparison, viscera temperatures appeared cooler in the CD CO2 group (Fig 2G), and an even cooler visceral temperature was observed in the ambient air group after 60 minutes (Fig 2F) (p. 7, ¶ 0004).)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for receiving dataflows from devices, determining the data has an error, and adjusting the output of the device based on a second device as disclosed by Trikha to incorporate the use of a laparoscopic tool as taught by Robson. This modification would create a system and method capable of providing optimal core body temperature during invasive abdominal surgeries (see Robson, p. 1, ¶ 0001).
Regarding Claim 10, this claim recites limitations that are substantially similar to those recited in Claim 2 above; thus, the same rejection applies.
Claims 3-4, 11-12, and 17 are rejected under 35 USC § 103 as being unpatentable over Trikha, Roh, and Brauker in view of Dang et al. (US 20200000952 A1).
Regarding Claim 3, Trikha, Roh, and Brauker teach the limitations as seen in the rejection of Claim 1 above. Trikha discloses the following:
the configuration response…and a unit of measure for the second…element. (Trikha discloses controllers configured to: (a) operatively couple to a first sensor and to a second sensor; (b) collect, or direct collection of, (i) a first sensed data during a first duration and (ii) a second sensed data during a second duration,…[0007]. Sensors may be configured to process, measure, analyze, detect and/or react to one or more of: data, temperature, humidity, sound, force, pressure, electromagnetic waves, position, distance, movement, flow, acceleration, speed, vibration, dust, light, glare, color, gas(es), and/or other aspects (e.g., characteristics) of an environment (e.g., of an enclosure) [0008]. The example of a temperature sensor is interpreted as being associated with a unit of measure (i.e., degrees Celsius or Kelvin).)
Trikha, Roh, and Brauker do not teach the following limitations met by Dang:
the… response further comprises a surgical element ID, (Dang teaches identifying the medical device directly or using a device lookup table that is locally stored, or stored on server (106), stored in sterility guide database (110), or stored on another device or server; capturing image data of a barcode, QR code, or other visual identifier that encodes or otherwise represents data, and using that data to identify the medical device using the device lookup table [0040].)
an indication that the [data] is available, (Dang teaches FIG. 11 shows an interface (540) that displays a set of sterilization devices available to a user (e.g., a device the user is presently interacting with, devices available in the same room, devices available in other areas of a hospital) [0066]. The Examiner interprets displaying device availability as an indication of data that is available.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for receiving dataflows from devices, determining the data has an error, and adjusting the output of the device based on a second device as disclosed by Trikha to incorporate the indication of data that is available and surgical element IDs as taught by Dang. This modification would create a system and method capable of monitoring and maintaining medical devices (see Dang, ¶ 0001-2).
Regarding Claims 11 and 17, these claims recite limitations that are substantially similar to those recited in Claim 3 above; thus, the same rejection applies.
Regarding Claim 4, Trikha, Roh, and Brauker teach the limitations as seen in the rejection of Claim 1 above. Trikha further discloses:
… the relational link…relationship between the second dataflow, the control data for the first surgical element, and the physiological parameter of the patient. (Trikha discloses a sensor of one type may have a correlation with at least one other type of sensor. A situation in an enclosure may affect one or more of different sensors. Sensor readings of the one or more different may be correlated and/or affected by the situation. The correlations may be predetermined [0093]. One or more controllers operatively coupled with the one or more first sensors and the one or more second sensors, the one or more controllers utilizing obtained sensor measurements from the one or more first sensors to calibrate and/or re-calibrate the one or more second sensors [0018]. The term “operatively coupled” refers to a first element (e.g., mechanism) that is coupled (e.g., connected) to a second element, to allow the intended operation of the second and/or first element. The coupling may comprise physical or non-physical coupling [0064].)
Trikha, Roh, and Brauker do not teach the use of a lookup table which is met by Dang:
the relational link is determined based on a lookup table (LUT), wherein the LUT indicates a relationship between the second dataflow,… (Dang teaches identifying the medical device directly or using a device lookup table that is locally stored, or stored on server (106), stored in sterility guide database (110), or stored on another device or server; capturing image data of a barcode, QR code, or other visual identifier that encodes or otherwise represents data, and using that data to identify the medical device using the device lookup table [0040]. Sterility guide database (110) comprises a set of records that associate a plurality of medical devices with a plurality of sterilization devices (e.g., sterilizing cabinet (100), etc.),…[0037].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for receiving dataflows from devices, determining the data has an error, and adjusting the output of the device based on a second device as disclosed by Trikha to incorporate the use of a lookup table as taught by Dang. This modification would create a system and method capable of monitoring and maintaining medical devices (see Dang, ¶ 0001-2).
Regarding Claim 12, this claim recites limitations that are substantially similar to those recited in Claim 4 above; thus, the same rejection applies.
Claims 5 and 13 are rejected under 35 USC § 103 as being unpatentable over Trikha, Roh, Brauker, and Dang in view of Miller et al. (US 20160301690 A1).
Regarding Claim 5, Trikha, Roh, Brauker, and Dang teach the limitations as seen in the rejection of Claim 4 above. Trikha further discloses:
…for the first dataflow and the second dataflow,… (Trikha discloses an apparatus for sensor calibration that comprises one or more controllers configured to: (a) operatively couple to a first sensor and to a second sensor; (b) collect, or direct collection of, (i) a first sensed data during a first duration and (ii) a second sensed data during a second duration,…[0007].)
…scheduling and frequency information,… (Trikha discloses certain sensors may modify (e.g., increase or decrease) a frequency at which sensor readings are sampled. Timing and/or frequency of the sensor operation may depend on the sensor type, location in the (e.g., target) environment, and/or time of day… A sensor may be assigned a timing and/or frequency of operation [0090].)
…a destination,… (Trikha discloses a sensor transmits (e.g., beacons) data to a receiver, e.g., a sensor or suite of sensors. The suite of sensors can also be referred to as an “ensemble of sensors.” The sensors in the suite of sensors can be analogous to those deployed in a space of an enclosure [0118]. The Examiner interprets the information the data destination being a receiver as the destination.)
…and a unit of measure for the first dataflow and the second dataflow. (Trikha discloses controllers configured to: (a) operatively couple to a first sensor and to a second sensor; (b) collect, or direct collection of, (i) a first sensed data during a first duration and (ii) a second sensed data during a second duration,…[0007]. Sensors may be configured to process, measure, analyze, detect and/or react to one or more of: data, temperature, humidity, sound, force, pressure, electromagnetic waves, position, distance, movement, flow, acceleration, speed, vibration, dust, light, glare, color, gas(es), and/or other aspects (e.g., characteristics) of an environment (e.g., of an enclosure) [0008]. The example of a temperature sensor is interpreted as being associated with a unit of measure (i.e., degrees Celsius or Kelvin).)
Trikha does not disclose the following limitations met by Roh:
…a communication protocol,… (Roh teaches the communication interface 766 can provide for communications under various modes or protocols, such as GSM voice calls (Global System for Mobile communications), SMS (Short Message Service), EMS (Enhanced Messaging Service), or MMS messaging (Multimedia Messaging Service),…(col. 43, lines 4-10).)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for receiving dataflows from devices, determining the data has an error, and adjusting the output of the device based on a second device as disclosed by Trikha to incorporate the use of communication protocol information as taught by Roh. This modification would create a system and method capable of assisting a surgeon in performing surgical tasks and maintaining the environment of the operating room (see Roh, col. 1, lines 9-31).
Trikha, Roh, and Brauker do not teach the following limitations met by Dang:
the LUT comprises, a surgical element ID,… (Dang teaches identifying the medical device directly or using a device lookup table that is locally stored, or stored on server (106), stored in sterility guide database (110), or stored on another device or server; capturing image data of a barcode, QR code, or other visual identifier that encodes or otherwise represents data, and using that data to identify the medical device using the device lookup table [0040].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for receiving dataflows from devices, determining the data has an error, and adjusting the output of the device based on a second device as disclosed by Trikha to incorporate the use of a lookup table as taught by Dang. This modification would create a system and method capable of monitoring and maintaining medical devices (see Dang, ¶ 0001-2).
Trikha, Roh, Brauker, and Dand do not teach the data points being in the lookup table which is met by Miller:
…security and access control credentials,… (Miller teaches the data may include …medical information, patient information, authentication data, and other personal and security-related information and the like [0028].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for receiving dataflows from devices, determining the data has an error, and adjusting the output of the device based on a second device as disclosed by Trikha to incorporate the use of security and access information as taught by Miller. This modification would create a system and method capable of ensuring authenticated access (see Miller, ¶ 0002).
Regarding Claim 13, this claim recites limitations that are substantially similar to those recited in Claim 5 above; thus, the same rejection applies.
Claims 6, 14, and 18 are rejected under 35 USC § 103 as being unpatentable over Trikha, Roh, and Brauker in view of Patil et al. (US 20230351204 A1).
Regarding Claim 6, Trikha, Roh, and Brauker teach the limitations as seen in the rejection of Claim 1 above. Trikha further discloses:
the relational link is determined based on……and a plurality of control data associated with....(Trikha discloses a sensor of one type may have a correlation with at least one other type of sensor. A situation in an enclosure may affect one or more of different sensors. Sensor readings of the one or more different may be correlated and/or affected by the situation. The correlations may be predetermined [0093]. One or more controllers operatively coupled with the one or more first sensors and the one or more second sensors, the… controllers utilizing obtained sensor measurements from the…first sensors to calibrate and/or re-calibrate the one or more second sensors [0018]. The term “operatively coupled” refers to a first element …that is coupled… to a second element, to allow the intended operation of the second and/or first element. The coupling may comprise physical or non-physical coupling [0064].)
Trikha does not disclose the use of physiological data which is met by Roh:
… the physiological parameter of the patient…(Roh teaches sensors are used in association with minimally invasive surgery devices. The sensor may be used in minimally invasive surgeries for tactile sensing of tool—tissue interaction forces. During minimally invasive surgeries field of view and workspace of tools are compromised due to the indirect access to the anatomy and lack of surgeon's hand-eye coordination (col. 11, lines 17-23).)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for receiving dataflows from devices, determining the data has an error, and adjusting the output of the device based on a second device as disclosed by Trikha to incorporate the devices being for surgical purposes and the transmission of a configuration message to the device to request a dataflow to be sent as taught by Roh. This modification would create a system and method capable of assisting a surgeon in performing surgical tasks and maintaining the environment of the operating room (see Roh, col. 1, lines 9-31).
Trikha, Roh, and Brauker do not teach the use of machine learning and a training dataset which is met by Patil:
…a machine learning (ML) model, wherein the ML model is trained based on a training data set,…wherein the training data set comprises a plurality of dataflows (Patil teaches there is provided a computer implemented method in a central server of selecting a training dataset with which to train a model using a distributed machine learning process, wherein the training dataset is to comprise medical data that satisfies one or more clinical requirements [0006]. Medical data may comprise any type of data that can be used, produced and/or obtained in a medical setting, including but not limited to: clinical diagnostic data, such as patient vital signs, or physiological parameters,…[0039].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for receiving dataflows from devices, determining the data has an error, and adjusting the output of the device based on a second device as disclosed by Trikha to incorporate the use of a machine learning model and training dataset as taught by Patil. This modification would create a system and method capable of processing large volumes of patient data (see Patil, ¶ 0002-0003).
Regarding Claims 14 and 18, these claims recite limitations that are substantially similar to those recited in Claim 6 above; thus, the same rejection applies.
Relevant Art Not Currently Being Applied
The following is considered pertinent to the Applicant’s disclosure but is not currently being applied:
Fix et al. (DE 102014204631 A1) teaches a device which detects erroneous measured data from a first sensor by comparing it to a second sensor unit and making proper adjustments based on the comparison.
Response to Arguments
Regarding rejections under 35 USC 101 to Claims 1-20, Applicant’s arguments have been considered but are not persuasive. The rejection has been updated in light of the amendments above.
Applicant argues the detailed technical features beyond any abstract idea that are recited in the claims elevate them to patent-eligible subject matter. For example, Claim 1 is directed to a technical solution to a problem that may arise in safety-critical surgical control systems because "smart devices and/or their associated sensors may transmit erroneous data," and, "[i]nstead of replacing a smart device, pausing and/or cancelling a procedure, or continuing a procedure with a reduced number of smart devices, a surgical computing system may use sensor data from a second smart device to generate control data for the first smart device" so that "[t]he control data may cause the first smart device to adjust an output characteristic to allow a procedure to continue without interruption." (see Applicant’s Remarks, p. 8).
Regarding (a), Examiner respectfully disagrees. It is unclear to Examiner how the specific additional elements, alone or in combination, provide a solution to the stated problem in context of the abstract idea of detecting a deviation in expected operation of the medical device. An indication that the claimed invention provides an improvement can include a discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art (MPEP § 2106.05(a)). Additionally, an important consideration in determining whether a claim improves technology is the extent to which the claim covers a particular solution to a problem or a particular way to achieve a desired outcome, as opposed to merely claiming the idea of a solution or outcome. McRO, 837 F.3d at 1314-15, 120 USPQ2d at 1102-03 (MPEP § 2106.05(a)(II)).
Here, the specification does not provide any evidence as to how the two devices determine a value has exceeded a safety threshold and further how the devices adjust the output characteristic. MPEP 2106.05(f) states when determining whether a claim simply recites a judicial exception with the words "apply it" (or an equivalent), such as mere instructions to implement an abstract idea on a computer, examiners may consider the following: (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words “apply it”. See Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1356, 119 USPQ2d 1739, 1743-44 (Fed. Cir. 2016); Intellectual Ventures I v. Symantec, 838 F.3d 1307, 1327, 120 USPQ2d 1353, 1366 (Fed. Cir. 2016); Internet Patents Corp. v. Active Network, Inc., 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1417 (Fed. Cir. 2015).
Applicant argues the claims do not recite abstract mental steps or information organization. Instead, they recite a control mechanism in which a processor receives a first dataflow from a first surgical element, wherein the first dataflow is associated with a physiological parameter of a patient; determines that the physiological parameter satisfies a patient safety threshold; in response to at least the determination that the physiological parameter satisfies the patient safety threshold, determines a second dataflow associated with a second surgical element, wherein the determination of the second dataflow is based on an indication of a relational link associated with the second dataflow of the second surgical element, control data for the first surgical element, and the physiological parameter of the patient; transmits, to the second surgical element, a configuration message, wherein the configuration message comprises an indication that the physiological parameter satisfies the patient safety threshold and a request to configure the second surgical element to send the second dataflow; receives, from the second surgical element, a configuration response comprising the second dataflow; generates control data for the first surgical element based on the second dataflow, wherein the control data indicates an adjustment to an output characteristic associated with the first surgical element; and adjusts the output characteristic associated with the first surgical element to be adjusted based on the control data.
These operations cannot be performed mentally and are not implemented using generic computer functions. They recite, for example, coordinated inter-device communication, dynamic device reconfiguration, relational dataflow selection, and control of surgical hardware. The claimed invention therefore improves the functioning of surgical systems by providing fault-tolerant physiological control under adverse conditions. This integration of specific technical steps into a real-world surgical control environment constitutes a practical application under Step 2A, Prong Two (p. 8-9).
Regarding (b), Examiner respectfully disagrees. The claims recite the abstract ideas of certain method of organizing human activity and mental processes because they recite steps that could reasonably be accomplished by a person mentally (see MPEP 2106.04(a)(2)(III) which recites claims can recite a mental process even if they are claimed as being performed on a computer. The Supreme Court recognized this in Benson, determining that a mathematical algorithm for converting binary coded decimal to pure binary within a computer’s shift register was an abstract idea. The Court concluded that the algorithm could be performed purely mentally even though the claimed procedures "can be carried out in existing computers long in use, no new machinery being necessary." 409 U.S at 67, 175 USPQ at 675.) Examiner notes that the steps of determining that a physiological parameter satisfies a threshold, transmitting a message, and receiving a response are all steps that can be done with a person using a pen and paper or a generic computer
Furthermore, Examiner notes that the human interaction subgroup “managing personal behavior or relationships or interactions between people” would include a system for augmenting dataflows to adjust characteristics of a surgical element. It is important to note that the text within the parentheses stating social activities, teaching, and following rules or instructions are provided as examples and not an exclusive listing and that the October 2019 Update: Subject Matter Eligibility on p. 5 states certain activity between a person and a computer may fall within the “certain methods of organizing human activity” grouping. Because it is not specified in the claims, it is assumed that the surgical elements are being controlled by a person.
Applicant argues these improvements amount to more than extra-solution activity. Applicant respectfully submits that the claim elements, and the ordered arrangement of those elements as a whole, are non-conventional and non-generic. As described above, Claim 1 recites a processor configured to determine that a physiological parameter satisfies a patient safety threshold, based on an indication of a relational link associated with the second dataflow of the second surgical element, control data for the first surgical element, and the physiological parameter of the patient, generates control data that indicates an adjustment to an output characteristic associated with the first surgical element, and causes the output characteristic associated with the first surgical element to be adjusted based on the control data. The integration of these elements yields a concrete practical benefit by allowing surgical systems to continue regulating patient physiology without pausing the procedure, replacing equipment, or reverting to degraded operation, thereby improving system robustness, safety, and real-time surgical control rather than merely implementing an abstract idea (p. 9-10).
Regarding (c), Examiner respectfully disagrees. An improvement to the abstract ideas of data transmission and calibration does not amount to an improvement to technology or a technical field (see MPEP § 2106.05(a)(III) stating “it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology.”). There is no indication in the instant disclosure that the involvement of a computer assists in improving the technology for the outlined problem statement. Here, the improvement is to the adjustment of an output characteristic based on receiving data. The instant application and claim language fail to detail how a computer aids the method, the extent to which the computer aids the method, or the significance of a computer to the performance of the method. Merely adding generic computer components to perform the method is not sufficient.
Furthermore, there is no indication in the claims or in the specification of how the method of controlling dataflows of the device provide an improvement upon the existing solutions in the technological area.
Regarding rejections under 35 USC 103 to Claims 1-20, Applicant’s arguments have been considered and are persuasive in light of the amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new rejection of the independent claims has been made, rejecting the claims over Trikha in view of Roh and Brauker.
Applicant argues it would not have been obvious to a person having ordinary skill in the art to combine Roh with Trikha, as Roh is directed to establishing and updating baseline physiological metrics for patient monitoring, whereas Trikha is directed to sensor calibration frameworks for infrastructure monitoring (p. 11).
Examiner respectfully disagrees. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system for detecting errors and calibrating sensors as disclosed by Trikha to incorporate the sensors being for the application of surgery as taught by Roh. create a system and method capable of assisting a surgeon in performing surgical tasks and maintaining the environment of the operating room (see Roh, col. 1, lines 9-31).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA R GEDRA whose telephone number is (571)270-0944. The examiner can normally be reached Monday - Friday 8:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter H Choi can be reached at (469)295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA R. GEDRA/Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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