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 the Claims
The office action is in response to the claims filed on November 20, 2024 for the application filed November 20, 2024 which claims priority to provisional applications filed on November 27, 2023 and November 22, 2023. Claims 1-20 are currently pending and have been examined.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Eligibility Step 1:
Under step 1 of the 2019 Revised Patent Subject Matter Eligibility Guidance, claims 1-10 are directed towards a system (i.e. a machine), which is a statutory category. Claims 11-20 are directed towards a method (i.e. a process), which is a statutory category. Since the claims are directed toward statutory categories, it must be determined if the claims are directed towards a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea). In the instant application, the claims are directed towards an abstract idea.
Eligibility Step 2A, Prong One:
Under step 2A, prong one of the 2019 Revised Patent Subject Matter Eligibility Guidance, independent claims 1 and 11 are determined to be directed to an judicial exception because an abstract idea is recited in the claims which fall within the subject matter groupings of abstract ideas. The abstract idea (identified in bold) recited in the representative claim 1 is identified as:
1. A surgical system comprising:
a processor configured to:
obtain a first data stream and a second data stream associated with a same measurement;
determine a first control parameter based at least in part on the first data stream;
determine a second control parameter based at least in part on a second data stream;
compare the first control parameter and the second parameter;
select a data stream between the first data stream and the second data stream based on the comparing; and
generate a control signal based on the selected data stream.
The identified limitations fall within the subject matter grouping of mental processes. The claimed steps of obtaining data streams, determining control parameters, comparing control parameters, selecting a data stream based on the comparing and generating a control based on the selected data stream can be practically performed in the human mind using observations, evaluations, judgments and opinions. If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea.
Accordingly, claims 1 and 11 recite an abstract idea under step 2A, prong one.
Eligibility Step 2A, Prong Two:
Under step 2A, prong two of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether the identified abstract ideas are integrated into a practical application. After evaluation, there is no indication that any additional elements or combination of elements integrate the abstract idea into a practical application, such as through: an additional element that reflects an improvement to the functioning of a computer, or an improvements to any other technology or technical field; an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition; an additional element that implements the judicial exception with, or uses the judicial exception in connection with, a particular machine or manufacture that is integral to the claim; an additional element that effects a transformation or reduction of a particular article to a different state or thing; or an additional element that applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. As shown below, the additional elements, other than the abstract idea per se, when considered both individually and as an ordered combination, amount to no more than a recitation of: generally linking the abstract idea to a particular technological environment or field of use; insignificant extra-solution activity to the judicial exception; and/or adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea as evidenced below.
The additional elements recited in representative claim 1 are identified in italics as:
1. A surgical system comprising:
a processor configured to:
obtain a first data stream and a second data stream associated with a same measurement;
determine a first control parameter based at least in part on the first data stream;
determine a second control parameter based at least in part on a second data stream;
compare the first control parameter and the second parameter;
select a data stream between the first data stream and the second data stream based on the comparing; and
generate a control signal based on the selected data stream.
The additional limitations of “A surgical system comprising: a processor configured to” and generating a control “signal” are determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f). The processor is recited at a high level of generality and merely used to implement the identified abstract idea. Similarly the term “signal” merely confines the abstract idea of generating a control to be done using signals, which is merely using a computer/computer signals as a tool to perform an abstract idea. Therefore, these additional elements amount to no more than a recitation of the words "apply it" (or an equivalent) or no more than mere instructions to implement an abstract idea or other exception on a computer or no more than merely using a computer as a tool to perform an abstract idea.
Accordingly, claims 1 and 11 do not recite additional elements which integrate the abstract idea into a practical application.
Eligibility Step 2B:
Under step 2B of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether provide an inventive concept by determining if the claims include additional elements or a combination of elements that are sufficient to amount to significantly more than the judicial exception. After evaluation, there is no indication that an additional element or combination of elements are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional limitations amount to mere instructions to apply an abstract idea under MPEP §2106.05(f), which does not amount to significantly more than the abstract idea.
Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements amounts to an inventive concept.
Dependent Claims:
The dependent claims merely present additional abstract information in tandem with further details regarding the elements from the independent claims and are, therefore, directed to an abstract idea for similar reasons as given above. None of these limitations are deemed to integrate the claims into a practical application or to amount to significantly more than the abstract idea as detailed below.
Claims 2 and 12 recite additional calculating and selecting steps which are also directed to the abstract idea grouping of mental processes.
Claims 3 and 13 recite additional determining and selecting steps which are also directed to the abstract idea grouping of mental processes.
Claims 4 and 14 recite additional determining, comparing and selecting steps which are also directed to the abstract idea grouping of mental processes.
Claims 5 and 15 recite additional determining and selecting steps which are also directed to the abstract idea grouping of mental processes.
Claims 7 and 17 recite additional identifying, determining and selecting steps which are also directed to the abstract idea grouping of mental processes.
Claims 7 and 17 recite additional detecting and selecting steps which are also directed to the abstract idea grouping of mental processes.
Claims 8 and 18 recite additional detecting, comparing and selecting steps which are also directed to the abstract idea grouping of mental processes.
Claims 9 and 19 the recited additional limitation of “wherein the first data stream and the second data stream are associated with a control loop of the surgical system” is determined to be no more than generally linking the use of a judicial exception to a particular technological environment or field of use under MPEP §2106.05(h).
Claims 10 and 20 recite additional obtaining, comparing, identifying and selecting steps which are also directed to the abstract idea grouping of mental processes.
Therefore, whether taken individually or as an ordered combination, 1-20 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 5-7, 10-11, 13, 15-17 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gross (U.S. Pub. No. 2013/0237775).
Regarding claim 1, Gross discloses a surgical system (Claim 1 discusses a system. The term “surgical” is not given patentable weight.) comprising:
a processor configured to (Paragraphs [0030] and [0041]):
obtain a first data stream and a second data stream associated with a same measurement (Paragraph [0024], the aggregator device 12 can be any device that receives and stores and/or re-transmits the sensor data streams. Paragraph [0027], In some embodiments two or more of the sensors 2, 4, 6, 8 operate independently to acquire different sensor data streams that are indicative of a common physiological parameter.);
determine a first control parameter based at least in part on the first data stream (Paragraph [0038], Table 1 shows that the system derives a physiological parameter from the data streams, such as heart rate.);
determine a second control parameter based at least in part on a second data stream (Paragraph [0038], Table 1 shows deriving a physiological parameter from the data streams, such as heart rate.);
compare the first control parameter and the second parameter (Paragraph [0048], then in an operation 67 a, 67 b executing on sensors Sa, Sb respectively, it is determined whether the other sensor is reporting the same value for the common physiological parameter (heart rate in the instant example).);
select a data stream between the first data stream and the second data stream based on the comparing (Paragraph [0048], On the other hand, if the other sensor also has a passing grade, then in an operation 67 a, 67 b executing on sensors Sa, Sb respectively, it is determined whether the other sensor is reporting the same value for the common physiological parameter (heart rate in the instant example). If yes, then in an operation 68 a, 68 b executing on sensors Sa, Sb respectively, the respective ECG data and SpO2 data are reported. If the operations 67 a, 67 b produce a negative result, that is, the two sensors are generating different heart rate values, then in an operation 69 a multi-parameter algorithm is used to resolve the difference in the signals and report the highest priority source for any heart rate alarms. The multi-parameter algorithm is based on the time invariant priority levels of the two sensors Sa, Sb augmented by the current signal quality grades of the two sensors Sa, Sb. Paragraph [0036], Based on the content of the data structure 44, 44′ including the priorities of the sensors and their current signal quality as indicated by the current grades, a coordination function 46 executing at the aggregator device 12 determines the “best” current sensor for monitoring the common physiological parameter.); and
generate a control signal based on the selected data stream (Paragraph [0034], The illustrative set of functions 30 further includes at least one output function 36, which is different from the reporting function 34. In some embodiments the at least one output function 36 includes an alarm function that outputs an alarm responsive to an alarm condition. The alarm condition includes sensor data acquired by the monitoring function 32 of the sensor indicating an abnormal value for the common physiological parameter but the alarm condition additionally includes a further condition that represents that no other sensor monitoring the common physiological parameter is showing a normal reading for the common physiological parameter. In other embodiments the at least one output function 36 additionally or alternatively includes some other output function that again is performed only conditionally. Paragraph [0054], Thus, as per selection block 62 the highest priority sensor (the “HR” sensor in the example of FIGS. 4-6) is selected as the output sensor, and will alarm.).
Regarding claim 3, Gross further discloses wherein comparing the first control parameter and the second parameter further comprises:
determining a first risk level associated with the first control parameter;
determining a second risk level associated with the second control parameter; and selecting a control parameter that is associated with a lower risk level, wherein the data stream associated with the selected control parameter is selected (Paragraph [0039], The current signal quality grade for the monitoring function 32 of each sensor is generated by the grading function 38 of that sensor. Various grading algorithms can be employed. For example, if the sensor data is expected to have a certain periodicity, then a fast Fourier transform (FFT) or other spectral analysis can be employed to detect dominant periodicity or periodicities and compare these with an expected range of reasonable periodicities for the sensor data. In the case of a constant value, such as a temperature reading, the grading function 38 may employ simple thresholds if the sensor data are above a maximum threshold or below a minimum threshold, then the grading function 38 indicates a malfunctioning operational status. In some embodiments the grading function 38 outputs a binary “pass” or “fail” grade, while in other embodiments the grading function 38 outputs a multilevel grade or even a continuous grade (e.g., a grade in a continuous range [0,1]). Paragraph [0055], If a grading scheme with finer gradations is employed (e.g., a continuous grade scale of [0,1] where 1 is the highest grade and means the sensor is generating a highly reliable data stream whereas 0 is the lowest grade and indicates the sensor is not communicating at all), then the coordination function 46 can be modified to utilize this additional information. For example, in one approach for utilizing the aforementioned [0,1] grading scale, the decision blocks 52, 58 are suitably modified to make their decisions by comparing a product or other combination of the sensor priority and the current signal quality grade with a decision threshold. Such an approach implements a “sliding scale” in which the highest priority sensor could be selected as the output device even if it has a relatively low current grade, whereas a sensor with a lower priority could only be selected as the output device if its current grade is high while the higher priority sensors have substantially lower grades.).
Regarding claim 5, Gross further discloses wherein comparing the first control parameter and the second parameter further comprises:
determining a current physiologic situation associated with a patient; and selecting, between the first control parameter and the second control parameter, a parameter based on current physiologic situation associated with a patient, wherein the data stream associated with the selected control parameter is selected (Paragraph [0049], If the selected output sensor suddenly acquires an abnormal reading, then it would, in the absence of coordination with other sensors, begin alarming. However, if the abnormal reading is due to a malfunction of the selected output sensor (where “malfunction” includes both internal malfunctions of the sensor itself and “malfunctions” caused by disconnection of an electrode or other loss of operative connection with the subject), then the alarming should be suppressed. Toward this end, the abnormal reading triggers execution of the coordination function 46 (or, in other embodiments, the coordination function executes iteratively on a sufficiently rapid basis to be essentially “real-time”). Execution of the coordination function 46 detects the abnormally functioning sensor (based on the observation that other sensors monitoring the same physiological parameter are not reporting an abnormal reading) and selects a new output sensor that is generating a normal reading for the common physiological parameter. Hence the false alarm is prevented. Paragraph [0050], On the other hand, if the abnormal reading is “real”, that is, due to the common physiological parameter actually taking on an abnormal reading, this will affect all the sensors. Thus, the highest priority sensor is selected as the output sensor (as per selection operation 62, see FIG. 2) and will begin (correctly) alarming. This is not a false alarm—this is a correct alarm alerting medical personnel of an abnormal reading of the common physiological parameter.).
Regarding claim 6, Gross further discloses wherein the processor is further configured to:
identify a disagreement between the first data stream and the second data stream; and determine a cause of the identified disagreement, wherein the data stream is selected further based on the cause of the identified disagreement (Paragraph [0049], If the selected output sensor suddenly acquires an abnormal reading, then it would, in the absence of coordination with other sensors, begin alarming. However, if the abnormal reading is due to a malfunction of the selected output sensor (where “malfunction” includes both internal malfunctions of the sensor itself and “malfunctions” caused by disconnection of an electrode or other loss of operative connection with the subject), then the alarming should be suppressed. Toward this end, the abnormal reading triggers execution of the coordination function 46 (or, in other embodiments, the coordination function executes iteratively on a sufficiently rapid basis to be essentially “real-time”). Execution of the coordination function 46 detects the abnormally functioning sensor (based on the observation that other sensors monitoring the same physiological parameter are not reporting an abnormal reading) and selects a new output sensor that is generating a normal reading for the common physiological parameter..
Regarding claim 7, Gross further discloses wherein the processor is further configured to:
detect a disagreement between the first data stream and the second data stream; wherein the comparing of the first control parameter and the second control parameter and the selecting of the data stream is performed based on the detection of the disagreement between the first data stream and the second data stream (Paragraph [0048], in an operation 67 a, 67 b executing on sensors Sa, Sb respectively, it is determined whether the other sensor is reporting the same value for the common physiological parameter (heart rate in the instant example). If yes, then in an operation 68 a, 68 b executing on sensors Sa, Sb respectively, the respective ECG data and SpO2 data are reported. If the operations 67 a, 67 b produce a negative result, that is, the two sensors are generating different heart rate values, then in an operation 69 a multi-parameter algorithm is used to resolve the difference in the signals and report the highest priority source for any heart rate alarms. The multi-parameter algorithm is based on the time invariant priority levels of the two sensors Sa, Sb augmented by the current signal quality grades of the two sensors Sa, Sb. Also see paragraphs [0049]-[0050].).
Regarding claim 10, Gross further discloses wherein the processor is further configured to:
obtain a third data stream associated with the measurement (Paragraph [0027], In some embodiments two or more of the sensors 2, 4, 6, 8 operate independently to acquire different sensor data streams that are indicative of a common physiological parameter. For example, consider the illustrative example in which the sensors 2, 4, 6, 8 include an ECG monitor, a dedicated heart rate monitor, and a plethysmographic sensor (for example, a pulse oximeter mountable on a fingertip or earlobe). Each of these three different sensors acquires a sensor data stream that is indicative of a common physiological parameter, namely heart rate.);
compare the first data stream and the second data stream to the third data stream (Paragraph [0049], the abnormal reading triggers execution of the coordination function 46 (or, in other embodiments, the coordination function executes iteratively on a sufficiently rapid basis to be essentially “real-time”). Execution of the coordination function 46 detects the abnormally functioning sensor (based on the observation that other sensors monitoring the same physiological parameter are not reporting an abnormal reading) and selects a new output sensor that is generating a normal reading for the common physiological parameter.); and
identify, based on the comparing to the third data stream, a data stream consistent with the third data stream, wherein the data stream is selected further based on the identified data stream consistent with the third data stream (Paragraph [0049], the abnormal reading triggers execution of the coordination function 46 (or, in other embodiments, the coordination function executes iteratively on a sufficiently rapid basis to be essentially “real-time”). Execution of the coordination function 46 detects the abnormally functioning sensor (based on the observation that other sensors monitoring the same physiological parameter are not reporting an abnormal reading) and selects a new output sensor that is generating a normal reading for the common physiological parameter. Paragraph [0054], In FIG. 5, the “HR” sensor has a failing current grade whereas the remaining two lower-priority sensors have passing current grades. Thus, as per selection block 60 the ECG sensor which is the highest priority sensor having a passing grade is selected as the output sensor for the heart rate.).
Regarding claims 11, 13, 15-17 and 20: all limitations as recited have been analyzed and rejected with respect to claims 1, 3, 5-7 and 10. Claims 11, 13, 15-17 and 20 pertain to a method, corresponding to the system of claims 1, 3, 5-7 and 10. Claims 11, 13, 15-17 and 20 do not teach or define any new limitations beyond claims 1, 3, 5-7 and 10; therefore claims 11, 13, 15-17 and 20 are rejected under the same rationale.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Gross (U.S. Pub. No. 2013/0237775) in view of Lee et al. (U.S. Pub. No. 2023/0160923).
Regarding claim 2, Gross does not appear to explicitly disclose, but Lee teaches that it was old and well known in the art of sensor data acquisition at the time of the filing wherein comparing the first control parameter and the second parameter further comprises: calculating a first difference between the first control parameter and a current control parameter; calculating a second difference between the second control parameter and the current control parameter; and selecting a control parameter that is associated with less difference, wherein the data stream associated with the selected control parameter is selected (Lee, paragraph [0046], Electronic device 1 110 may calculate measurement accuracy of each of the electronic devices (e.g., electronic device 2 130 and electronic device 3 150) based on at least one of the sample sensor data or the reference data, in each predetermined period. The measurement accuracy may include accuracy in measurement of a sensor included in an electronic device. For example, electronic device 1 110 may receive sample sensor data from electronic device 2 130. In this example, electronic device 1 110 may calculate measurement accuracy based on a similarity between the sample sensor data from electronic device 2 130 and the reference data. The higher the similarity, the higher the measurement accuracy may be. Electronic device 1 110 may calculate the measurement accuracy based on the similarity between the sample sensor data from electronic device 2 130 and the reference data, in each predetermined period. Paragraph [0047], Electronic device 1 110 may determine priority information of each of the electronic devices (e.g., electronic device 2 130 and electronic device 3 150) based on the measurement accuracy and state information of each of the electronic devices, in each predetermined period. Paragraph [0062], The electronic device 1001 may generate the reference data based on an average value of the normalized pieces of sample sensor data. For example, the sensor data may be heart rate data. Paragraph [0094], operation 950 of determining a measurement-activated electronic device and a measurement-deactivated electronic device from among the electronic devices based on the priority information; operation 960 of receiving sensor data from the measurement-activated electronic device for a time unit of a predetermined period. Also see figs. 4-6.) to prevent unnecessary duplicate measurement data from being generated and a user from being confused by duplicate alarms (Lee, paragraph [0006]).
Therefore, it would have been obvious to one of ordinary skill in the art of sensor data acquisition at the time of the filing to modify the system of Gross such that comparing the first control parameter and the second parameter further comprises: calculating a first difference between the first control parameter and a current control parameter; calculating a second difference between the second control parameter and the current control parameter; and selecting a control parameter that is associated with less difference, wherein the data stream associated with the selected control parameter is selected, as taught by Lee, in order to prevent unnecessary duplicate measurement data from being generated and a user from being confused by duplicate alarms.
Claim 12 is rejected based on the same rationale as claim 2.
Claims 4, 9, 14 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gross (U.S. Pub. No. 2013/0237775) in view of Shelton et al. (U.S. Pub. No. 2022/0233119).
Regarding claim 4, Gross does not appear to explicitly disclose, but Shelton teaches that it was old and well known in the art of medical systems at the time of the filing wherein comparing the first control parameter and the second parameter further comprises:
determining a first surgical action of the surgical system associated with the first control parameter (Shelton, paragraph [0821], The engine selector 23034 may activate and/or deactivate one or more settings recommendation engines 23024 in accordance with received procedure data 23033. For example, the procedure data 23033 may include a procedure ID 23036 that reflects a particular procedure being performed. The engine selector 23034 may include a lookup table to select one or more settings recommendation engines 23024 that are associated with the procedure ID 23036. The procedure data 23033 may include a procedure element ID 23036 that reflects a particular portion of the procedure being performed at a particular time 23040. Paragraph [0823], An active settings recommendations engine 23024 may process incoming first sensor data 23029 and second sensor data 23031 in view of active settings recommendations engine's factors 23026. The factors 23026 may be applied to procedure data 23033. For example, the factors 23026 may be used to filter and/or pre-process on specific procedure IDs, on specific procedure element IDs, on time within a procedure, on time within a procedure element, on updated procedure IDs, on updated procedure elements, and on any other data included in the procedure data stream.);
determining a second surgical action of the surgical system associated with the second control parameter (Shelton, paragraph [0821], The engine selector 23034 may activate and/or deactivate one or more settings recommendation engines 23024 in accordance with received procedure data 23033. For example, the procedure data 23033 may include a procedure ID 23036 that reflects a particular procedure being performed. The engine selector 23034 may include a lookup table to select one or more settings recommendation engines 23024 that are associated with the procedure ID 23036. The procedure data 23033 may include a procedure element ID 23036 that reflects a particular portion of the procedure being performed at a particular time 23040. Paragraph [0823], An active settings recommendations engine 23024 may process incoming first sensor data 23029 and second sensor data 23031 in view of active settings recommendations engine's factors 23026. The factors 23026 may be applied to procedure data 23033. For example, the factors 23026 may be used to filter and/or pre-process on specific procedure IDs, on specific procedure element IDs, on time within a procedure, on time within a procedure element, on updated procedure IDs, on updated procedure elements, and on any other data included in the procedure data stream.);
comparing the first surgical action and the second surgical action to a predetermined list of preferred surgical actions (Shelton, paragraph [0832], the user interface 23072 may be used to manage at least a portion of the operation of the computing device 23006. The user interface may be used to create, delete, and/or modify the device settings recommendation engines. Paragraph [0838], As a result, when the procedure is being performed, the settings recommendation manager 23024 may scan the incoming sensor and procedure data for matches to the sensor systems and procedure data entered via this interface 23072. The settings recommendation manager 23024 may process that sensor and procedure data according to the entered factors and evaluate it according to the entered scoring rubric 23030. The evaluation of the scoring rubric 23030 may indicate one or more applicable configuration packages 23032, as entered. Paragraph [0499], the analytics system 20338 may determine optimal and/or preferred operating parameters for the various types of modular devices, generate adjustments to the control programs for the surgical devices 20337, and transmit (or “push”) the updates or control programs to the one or more surgical devices 20337.); and
selecting a control parameter that is associated with a preferred surgical action, wherein the data stream associated with the selected control parameter is selected (Shelton, paragraph [0827], Based on the evaluation of the scoring rubric 23030, one or more configuration packages 23032 may be selected for output. The processor may output information in accordance with the selected configuration package 23032 and the other available data, such as information from the scoring rubric 23030. For example, the processor may output a signal 23060 indicative of a determined surgical device setting. The signal may include a timestamp 23062, a surgical device ID 23064, recommended setting information 23066, a degree-of-confidence 23068, and/or any other information relevant to the operation of presenting a recommended surgical device setting. Paragraph [0831], based on one or more sensor values and procedure data, the processor 23018 outputs a signal 23060 that provides a recommended settings change to the health care professional. Paragraph [0823], An active settings recommendations engine 23024 may process incoming first sensor data 23029 and second sensor data 23031 in view of active settings recommendations engine's factors 23026. Paragraph [0799], The system 23000 may make this notification and/or configuration-change recommendation based on data from a single source or based on data from multiple sources.) to improve patient outcomes (Shelton, paragraph [0798]).
Therefore, it would have been obvious to one of ordinary skill in the art of medical systems at the time of the filing to modify the system of Gross to include the limitations above, as taught by Shelton, in order to improve patient outcomes.
Regarding claim 9, Gross does not appear to explicitly disclose, but Shelton teaches that it was old and well known in the art of medical systems at the time of the filing wherein the first data stream and the second data stream are associated with a control loop of the surgical system (Shelton, paragraph [0794], A computing device may include an input, a processor, and an output. The device may be configured to receive two points of surgical sensor data from different sensors. The sensors may include wearable patient sensors and/or surgical theater environmental sensor system. The processor may determine a surgical device setting (e.g., a closure load for a powered surgical stapler, or for example, a power level of a surgical energy device). And the output may send a signal indicative of the determined setting. A surgical device may receive the signal and perform a surgical action based on the determined setting. Using a combination of patient-specific and/or surgical-environment-specific sensor inputs to determine a more optimal device setting may lead to better device perform and ultimately better patient outcomes.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical systems at the time of the filing to modify the system of Gross to be a surgical system such that the first data stream and the second data stream are associated with a control loop of the surgical system, as taught by Shelton, in order to provide better patient outcomes.
Claims 14 and 19 are rejected based on the same rationale as claims 4 and 9.
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gross (U.S. Pub. No. 2013/0237775) in view of Barbagli et al. (U.S. Pub. No. 2020/0078096).
Regarding claim 8, Gross further discloses wherein the processor is further configured to:
detect a measurement difference between the first data stream and the second data stream (Paragraph [0048], in an operation 67 a, 67 b executing on sensors Sa, Sb respectively, it is determined whether the other sensor is reporting the same value for the common physiological parameter (heart rate in the instant example).); and
Paragraph [0048], If the operations 67 a, 67 b produce a negative result, that is, the two sensors are generating different heart rate values, then in an operation 69 a multi-parameter algorithm is used to resolve the difference in the signals and report the highest priority source for any heart rate alarms. The multi-parameter algorithm is based on the time invariant priority levels of the two sensors Sa, Sb augmented by the current signal quality grades of the two sensors Sa, Sb. Paragraph [0049], the abnormal reading triggers execution of the coordination function 46 (or, in other embodiments, the coordination function executes iteratively on a sufficiently rapid basis to be essentially “real-time”). Execution of the coordination function 46 detects the abnormally functioning sensor (based on the observation that other sensors monitoring the same physiological parameter are not reporting an abnormal reading) and selects a new output sensor that is generating a normal reading for the common physiological parameter.).
Gross does not appear to explicitly disclose to compare the measurement difference to a threshold value such that comparing of the first control parameter and the second control parameter and the selecting of the data stream is performed based on the measurement difference being above the threshold value.
Barbagli teaches that it was old and well known in art of medical systems at the time of the filing to detect a measurement difference between the first data stream and the second data stream and compare the measurement difference to a threshold value (Barbagli, paragraph [0038], When redundant sensors provide different readings (e.g., readings that differ by more than a threshold amount), the control system 112 may detect that this difference is a fault in the medical system 100. Paragraph [0063], Many different heuristics may be used to classify detected faults. Such heuristics may include the system or subsystem implicated by the fault, such as a motion system, a physiological sensing system, a communication system) to prevent system failures that may compromise patient safety and facilitate mitigation of such failures or faults by taking the appropriate actions with as little delay as possible (Barbagli, paragraph [0073]).
Therefore, it would have been obvious to one of ordinary skill in the art of medical systems at time of the filing to modify the system of Gross to compare the measurement difference to a threshold value, as taught by Barbagli, in order to prevent system failures that may compromise patient safety and facilitate mitigation of such failures or faults by taking the appropriate actions with as little delay as possible and such that the comparing of the first control parameter and the second control parameter and the selecting of the data stream is performed based on the measurement difference being above the threshold value.
Claim 18 is rejected based on the same rationale as claim 8.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Devin C. Hein whose telephone number is (303)297-4305. The examiner can normally be reached 9:00 AM - 5:00 PM M-F MDT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason B. Dunham can be reached at (571) 272-8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEVIN C HEIN/Examiner, Art Unit 3686
Prosecution Insights