DETAILED ACTION
This is responsive to RCE filed on 02/02/2026 in which claims 1-4, 6-8, 10-14 and 17-20 are presented for examination; Claims 1, 4, 6, 8, 13 have been amended.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/02/2026 has been entered.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites, “disease state” in amended limitations; however based on the specification, and other independent claims, it is clear that limitations should recite “disease state modifier.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 6-8, 10-14 and 17-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding, claims 1, claims recite: “and storing the marked physiological parameter measurements in the electronic medical record with indications that the disease state was active during capture.”
The specification seems to be silent with regard to indication that the disease state was active during capture.
Dependent claims are rejected based on rejected base claim.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 6-8, 10-14 and 17-20 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Recites: “and storing the marked physiological parameter measurements in the electronic medical record with indications that the disease state was active during capture.”
It is not clear, what “indications that the disease state was active during capture”, means in the context of claim. The disclosure is silent with regard to this limitation, and in plane meaning, it is not clear what disease state being active during capture means. The sensors are attached to patient, and data is being recoded and displayed, so one could interpret that disease state was active; but that is true whenever the sensors are attached, so it is not clear in context of claim what is scope of this limitation. Even, if one assumes, it is disease state indicator, the issue remains, as to what disease state indicator being active will mean.
Dependent claims are rejected based on rejected base claim.
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 1-4, 6-8,10-14 and 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding claim 1:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?” Yes, it’s a machine(device).
Step 2a Prong 1 (judicial exception)
Step 2A (1): “Does the claim recite an abstract idea, law of nature, or natural phenomenon? Yes , the claim comes under mental processes.
Claim 1 recites:
“A medical device for assessing a health status of a patient, the medical device comprising: one or more sensor modules for capturing physiological parameter measurements; at least one processing device communicatively coupled to the one or more sensor modules; and a memory device storing instructions which, when executed by the at least one processing device, cause the medical device to: receive a selection of two or more health scores; obtain physiological parameter measurements from one or more sensor modules based on the selection of the two or more health scores; generate the two or more health scores using the physiological parameter measurements received from the one or more sensor modules, the two or more health scores being generated based on a workflow for assessing the patient; determine whether the patient has a disease state; customize the two or more health scores based on the disease state; modify a sensor setting of the one or more sensor modules based on the disease state, wherein modification of the sensor setting causes the one or more sensor modules to adjust a frequency of capturing the physiological parameter measurements; and associate the disease state to an operational session of the medical device, wherein associating the disease state to the operational session includes: electronically associating the disease state with an electronic medical record of the patient; marking physiological parameter measurements captured during the operational session with the disease state; and storing the marked physiological parameter measurements in the electronic medical record with indications that the disease state was active during capture; and wherein associating the disease state to the operational session causes future operational sessions on the medical device to automatically display a prompt that requests confirmation to apply the disease state.
All the limitations above are abstract idea related to the mental process (concepts performed in the human mind (including an observation, evaluation, judgment, opinion)) with the exception of bold and underlined limitations. Claim language pertains to determining health scores based on selected health scores and physiological parameters of the patients. The scores are determined in a single workflow(sequence of tasks) , as for example in a routine medical checkup some orderly tests are run before reaching to a conclusion about a disease. Also, disease can be determined based on the scores from the tests, and any changes can be suggested based on the results. Patient’s physiological parameters can be obtained in a clinical setting as required from a medical record. Relevant symptoms of diseases can be stored and retrieved when needed . All this can be done on paper and pen.
Step 2A(2): Prong Two: evaluate whether the claim recites additional elements that integrate the exception into a practical application of the exception. NO
The claim does recite additional elements; however they don’t integrate the exception into a practical application of the exception.
device (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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
memory device (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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
processing device (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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
obtain physiological parameter measurements from one or more sensor modules (Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g) )
receive a selection of two or more health scores(Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g) )
sensor modules (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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
sensor(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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
electronically associating (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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
electronic medical record (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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
automatically display (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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
Step 2B: evaluate whether the claim recites additional elements that amount to an inventive concept (aka “significantly more”) than the recited judicial exception? NO
As discussed previously with respect to Step 2A Prong Two, the additional element in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
Regarding the claim limitations:
receive a selection of two or more health scores (” the courts have recognized the computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (“i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information”); See, MPEP 2106.05 (d)(II)
obtain physiological parameter measurements from one or more sensor modules (” the courts have recognized the computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (“i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information”); See, MPEP 2106.05 (d)(II)
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Dependent claims 2-4 further narrows the abstract idea and add the additional elements of “display screen”, “disease state modifiers”, “alarm setting,”, “sensor setting”, “physiological parameter setting”, “electronic medical record”, “sensor module”.
Under step 2A, prong two, the additional elements don’t integrate the exception into a practical application of the exception as merely 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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f).
As discussed previously with respect to Step 2A Prong Two, the additional elements in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Regarding claim 6 :
Step 1: Is the claim to a process, machine, manufacture or composition of matter?” Yes, it’s a machine(device).
Step 2a Prong 1 (judicial exception)
Step 2A (1): “Does the claim recite an abstract idea, law of nature, or natural phenomenon? Yes , the claim comes under mental processes.
Claim 6 recites:
“A medical device for assessing a health status of a patient, the medical device comprising: a sensor module for capturing physiological parameter measurements , at least one processing device communicatively coupled to the sensor module; and a memory device storing instructions which, when executed by the at least one processing device, cause the medical device to: receive a disease state modifier; modify at least one of an alarm setting of the sensor module , a workflow setting, a sensor setting of the sensor module, and a physiological parameter setting based on the disease state modifier; and associate the disease state modifier to an operational session. wherein associating the disease state modifier to the operational session includes: electronically associating the disease state modifier with an electronic medical record of the patient; marking physiological parameter measurements captured during the operational session with the disease state modifier; and storing the marked physiological parameter measurements in the electronic medical record with indications that the disease state modifier was active during capture; wherein associating the disease state modifier to the operational session causes future operational sessions on the medical device to automatically display a prompt that requests confirmation to apply the disease state; and Wherein modify the sensor setting of the sensor module based on the disease state modifier causes the sensor module to adjust a frequency of capturing the physiological parameter measurements.”
All the limitations above are abstract idea related to the mental process (concepts performed in the human mind (including an observation, evaluation, judgment, opinion)) with the exception of bold and underlined limitations. Claim language pertains to determining health scores based on selected health scores and physiological parameters of the patients. The scores are determined in a single workflow(sequence of tasks) , as for example in a routine medical checkup some orderly tests are run before reaching to a conclusion about a disease. Also, disease can be determined based on the scores from the tests, and any changes can be suggested based on the results. Patient’s physiological parameters can be obtained in a clinical setting as required from a medical record. Relevant symptoms of diseases can be stored and retrieved when needed . All this can be done on paper and pen.
Step 2A(2): Prong Two: evaluate whether the claim recites additional elements that integrate the exception into a practical application of the exception. NO
The claim does recite additional elements; however they don’t integrate the exception into a practical application of the exception.
device (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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
memory device (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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
processing device (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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
receive a disease state modifier (Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g) )
sensor module(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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
sensor (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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
electronically associating (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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
electronic medical record (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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
automatically display (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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
Step 2B: evaluate whether the claim recites additional elements that amount to an inventive concept (aka “significantly more”) than the recited judicial exception? NO
As discussed previously with respect to Step 2A Prong Two, the additional element in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
Regarding the claim limitations:
receive a selection of two or more health scores (” the courts have recognized the computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (“i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information”); See, MPEP 2106.05 (d)(II)
obtain physiological parameter measurements from one or more sensor modules (” the courts have recognized the computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (“i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information”); See, MPEP 2106.05 (d)(II)
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Dependent claims 7-8, 11-12 further narrows the abstract idea and add the additional elements of “alarm”, “sensor”, “device,”, “display” ,”
Under step 2A, prong two, the additional elements don’t integrate the exception into a practical application of the exception as merely 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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f).
As discussed previously with respect to Step 2A Prong Two, the additional elements in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Regarding claim 13 :
Step 1: Is the claim to a process, machine, manufacture or composition of matter?” Yes, it’s a method(process).
Step 2a Prong 1 (judicial exception)
Step 2A (1): “Does the claim recite an abstract idea, law of nature, or natural phenomenon? Yes , the claim comes under mental processes.
Claim 6 recites:
“A method of assessing a health status of a patient, the method comprising: receiving a disease state modifier; modifying at least one of an alarm setting, a workflow setting, a sensor setting, and a physiological parameter setting of the medical device based on the disease state modifier; and associating the disease state modifier to an operational session of a medical device. wherein associating the disease state modifier to the operational session includes: electronically associating the disease state modifier with an electronic medical record of the patient; marking physiological parameter measurements captured during the operational session with the disease state modifier; and storing the marked physiological parameter measurements in the electronic medical record with indications that the disease state modifier was active during capture; wherein associating the disease state modifier to the operational session causes future operational sessions on the medical device to automatically display a prompt that requests confirmation to apply the disease state; and wherein modify the sensor setting based on the disease state modifier causes a sensor module to adjust a frequency of capturing physiological parameter measurements.”
All the limitations above are abstract idea related to the mental process (concepts performed in the human mind (including an observation, evaluation, judgment, opinion)) with the exception of bold and underlined limitations. Claim language pertains to determining health scores based on selected health scores and physiological parameters of the patients. The scores are determined in a single workflow(sequence of tasks) , as for example in a routine medical checkup some orderly tests are run before reaching to a conclusion about a disease. Also, disease can be determined based on the scores from the tests, and any changes can be suggested based on the results. Patient’s physiological parameters can be obtained in a clinical setting as required from a medical record. Relevant symptoms of diseases can be stored and retrieved when needed . All this can be done on paper and pen.
Step 2A(2): Prong Two: evaluate whether the claim recites additional elements that integrate the exception into a practical application of the exception. NO
The claim does recite additional elements; however they don’t integrate the exception into a practical application of the exception.
receiving a disease state modifier (Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g) )
medical device( 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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
sensor module( 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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
sensor( 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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
electronically associating (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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
electronic medical record (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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
automatically display (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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
Step 2B: evaluate whether the claim recites additional elements that amount to an inventive concept (aka “significantly more”) than the recited judicial exception? NO
As discussed previously with respect to Step 2A Prong Two, the additional element in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
Regarding the claim limitations:
receive a disease state modifier (” the courts have recognized the computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (“i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information”); See, MPEP 2106.05 (d)(II)
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Dependent claims 14-20 further narrows the abstract idea and add the additional element of “display screen ”
Under step 2A, prong two, the additional elements don’t integrate the exception into a practical application of the exception as merely 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 uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f).
As discussed previously with respect to Step 2A Prong Two, the additional elements in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 6, 8, 10-13, and 15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over St. Pierre et al. (US 20150342538 A1) in view of Jain et al (US 12230406 B2) and further in view of Gnanasambandam et al.(US 20220384003 A1)
Regarding claim 1, St. Pierre teaches a medical device for assessing a health status of a patient, the medical device comprising:
one or more sensor modules for capturing physiological parameter measurements(para, “[0028]The medical devices 102, 104, 105 can provide various types of functionality, including measuring or monitoring patient physiological parameters. The medical devices 102, 104, 105 can include one or more physiological monitor devices configured to measure and possibly display representations of one or more physiological parameters of a patient. In addition, the medical devices 102, 104, 105 can include one or more desktop, laptop, or wall-mounted devices. In some embodiments, the medical devices 102, 104, 105 are configured to be used by a clinician to monitor the physiological parameters of multiple patients at one time. Such monitor devices are typically not wall mounted.”)
at least one processing device communicatively coupled to the one or more sensor modules (see, para 0005, para 0033);
and a memory device storing instructions which, when executed by the at least one processing device, cause the medical device to (para 0005):
receive a selection of two or more health scores ([0057] Acute care teams have been using early warning scores for several years in an effort to provide more timely assessments and predictions to changes in patient acuity. SAPSII, APACHE, MEWS, PEWS, MEDS, REMS, ASSIST, and SCS are some of the many scoring systems that have been adopted in emergency department (ED), medical/surgical, general care, and ICU environments.”
“[0075] In example embodiments, the medical devices 102, 104, 105 are programmed to calculate early warning scores using one or more of the protocols described above. The devices 102, 104, 105 also are programmed to communicate those scores, both visually to the caregiver, as well as possibly to a central server, such as server device 112 to be stored in an electronic medical records (EMR) system. Further, the devices 102, 104, 105 are programmed to provide configurable alert messages based upon the calculated early warning scores.”);
obtain physiological parameter measurements from one or more sensor modules based on the selection of the two or more health scores (para, “[0059] The NEWS is based on a simple scoring system in which a score is allocated to physiological parameters that are already recorded for patients in general care settings. Six physiological parameters form the basis of the scoring system: [0060] Respiratory rate [0061] Oxygen saturation [0062] Temperature [0063] Systolic blood pressure [0064] Pulse rate [0065] Level of consciousness (AVPU)”);
generate the two or more health scores using the physiological parameter measurements received from the one or more sensor modules, the two or more health scores being generated based on a workflow for assessing the patient (Fig. 5 shows EWS of 1 being calculated using the physiological parameter measurements received from the one or more sensor modules; Fig. 9 shows calculating different score; note, any of the protocols can be used to calculate scores (see, para 0075));
determine whether the patient has a disease state (para, “[0100] At operation 650, instructions and actions are defined for the ranges for the early warning scores. The instructions are textual information for the caregiver. Alternatively, the instructions can include graphical information for the caregiver as well. The instructions can provide guidance for the caregiver about how to interpret the early warning score and what actions should be taken based on the early warning score. For example, the instructions can be based on policies at a health care facility. The actions, on the other hand, define steps for the medical device 102, 104, 105 to perform based on the early warning score. As an example, an early warning score in a range that indicates highly abnormal results can include the instructions “Transfer to Intensive Care Unit Immediately,” and trigger the action “sound alarm at monitoring station.” Other embodiments include different instructions and different actions. “ Also, see Fig. 5, Fig. 9. Note: here scores ranges 1-4 shows different disease state.);
customize the two or more health scores based on the disease state (para, “[0077] This score can be configured by the hospital and/or caregiver to utilize one or more protocols to calculate the early warning score. Each parameter used to calculate the score can be configured, and the raw score shown on the interface 200 can be configured. For example, in this embodiment, the score is the average of the parameter scores used to calculate the score. So, if the parameter scores used to calculate the early warning score are 1, 3, 3, 1, the early warning score 202 would be shown as a “2”. In another example, each parameter score can be weighted differently.”)
and associate the disease state modifier to an operational session of the medical device (“[0075] In example embodiments, the medical devices 102, 104, 105 are programmed to calculate early warning scores using one or more of the protocols described above. The devices 102, 104, 105 also are programmed to communicate those scores, both visually to the caregiver, as well as possibly to a central server, such as server device 112 to be stored in an electronic medical records (EMR) system. Further, the devices 102, 104, 105 are programmed to provide configurable alert messages based upon the calculated early warning scores.” Note: protocols are nothing more than disease state modifiers, as they allow us to configure specific attribute (see. para below)
“[0091] The early warning score protocol configuration module 502 operates to define and modify early warning score protocols. The early warning score protocol configuration module 502 can be used to modify an existing early warning score protocol, such as by replacing or adding one or more physiological parameters to the protocol, changing the mapping from values of physiological parameters to component scores, and changing the calculation method or formula used to combine the component scores. Additionally, the early warning score protocol configuration module 502 can be used to define new early warning score protocols. For example, the early warning score configuration module 502 can be used to enter a name of a protocol, select physiological parameters for the protocol, map values of those physiological parameters to component scores, and enter calculation methods for combining the component scores....” Note: protocol name can be disease, and disease specific parameters can be configured.)
wherein associating the disease state modifier to the operational session includes:
electronically associating the disease state modifier with an electronic medical record of the patient (Fig. 7 teaches disease state modifier (protocol) with specific medical record.
Para, “[0106] FIG. 14 shows another example process 800 performed by some embodiments of the medical devices 102, 104, 105 to calculate and display an early warning score according to an early warning score protocol. The early waning score may be calculated using a predefined early warning score protocol or a customized early warning score protocol.”
Also, para “[0075] In example embodiments, the medical devices 102, 104, 105 are programmed to calculate early warning scores using one or more of the protocols described above. The devices 102, 104, 105 also are programmed to communicate those scores, both visually to the caregiver, as well as possibly to a central server, such as server device 112 to be stored in an electronic medical records (EMR) system. Further, the devices 102, 104, 105 are programmed to provide configurable alert messages based upon the calculated early warning scores.”);
marking physiological parameter measurements captured during the operational session with the disease state (See, Fig. 7; each parameter in the protocol is marked with title.
Para, “[0080] The interface 300 includes an area 302 in which up to 8 parameters that are used to calculate the early warning score 202 are shown. For each parameter, the title for the parameter can be provided, along with the proper units. For example, a title might be “Systolic BP,” and the units could be “mm Hg.” The required response field 304 is a text field that provides instructions to the caregiver should a given early warning score be displayed. For example, one such instruction could be “Check the patient for congestive heart failure.” Such an instruction can be provided in conjunction with one or more alarms, such as visual and/or audible alarms provided by the medical device 102, 104, 105.” Note: here the marking could also be interpreted to be protocol title.”);
and storing the marked physiological parameter measurements in the electronic medical record with indications that the disease state was active during capture (para, “[0075] In example embodiments, the medical devices 102, 104, 105 are programmed to calculate early warning scores using one or more of the protocols described above. The devices 102, 104, 105 also are programmed to communicate those scores, both visually to the caregiver, as well as possibly to a central server, such as server device 112 to be stored in an electronic medical records (EMR) system. Further, the devices 102, 104, 105 are programmed to provide configurable alert messages based upon the calculated early warning scores.”);
St. Pierre does not explicitly teach:
modify a sensor setting of the one or more sensor modules based on the disease state, wherein modification of the sensor setting causes the one or more sensor modules to adjust a frequency of capturing the physiological parameter measurements.
and wherein associating the disease state to the operational session causes future operational sessions on the medical device to automatically display a prompt that requests confirmation to apply the disease state.
Jain teaches:
and modify a sensor setting of the one or more sensor modules based on the disease state modifier, wherein modification of the sensor setting causes the one or more sensor modules to adjust a frequency of capturing the physiological parameter measurements( col 12, line 4 “The system can progressively adapt the level of monitoring and types of interactions with a user according to the user's predicted exposure level or likelihood of infection. For example, as a user's exposure level increases, the system can automatically increase the frequency and extent of monitoring by user devices, e.g., smartphone, smartwatch or other wearable device, and so on. The system can vary the types of measurements made (e.g., types of sensor data collected) as well as the types of surveys, user prompts, or other user interactions that the system causes to be provided. The system can also vary the monitoring procedures used for a user to reach a desired level of confidence in the predictions.”
Also, col 38 line 12 “The modules 112 may specify various aspects of data collection and analysis. These can include types of sensors to monitor, frequency of monitoring, precision data collected, format of data collected, triggers for conditions that cause sensor data collection or alter sensitive flexion, and so on. The module 112 can include rules that are executed by the user device to selectively perform monitoring actions, for example, to vary the types of data collected in manner of their collection using sensors and user prompts based on conditions or context detected or other factors.”)
It would have been obvious for a person of ordinary skill in the art to apply level of monitoring teachings of Jain into the teachings of St. Pierre at the time the application was filed in order to progressively adapt level of monitoring based on level of condition. ( col 12, line 4 “The system can progressively adapt the level of monitoring and types of interactions with a user according to the user's predicted exposure level or likelihood of infection.)
St. Pierre as modified by Jain does not explicitly teach:
and wherein associating the disease state to the operational session causes future operational sessions on the medical device to automatically display a prompt that requests confirmation to apply the disease state.
Gnanasambandam teaches:
and wherein associating the disease state modifier to the operational session causes future operational sessions on the medical device to automatically display a prompt that requests confirmation to apply the disease state (para “[0608] FIG. 88 shows an example of providing a user interface that shows a health record interface 8800 of a patient. The health record interface 8800 may include categories of patient information for selection by a user, such as a conditions 8802, a lab/vital results 8804, a procedures 8806, a medications 8808, an allergies 8810, an immunization 8812, or any other desired category. The health record interface 8800 may include a drop down box 8914 that includes filter options, such as the number of years of information to display. A timeline 8816 may also be included to display the information in reference to the timeline 8816. As illustrated in FIG. 88, a user has selected the conditions 8802, which includes a list of conditions 8818 of the patient, such as acute bronchitis, chronic sinusitis, or any other desired condition. The data 8920 may display the patient information, for example, along the timeline 8812 next to the related condition 8818. If a patient has had a condition 8818 intermittently, then the data 8820 may be displayed intermittently relative to the timing of the condition 8818. The data 8820 may be displayed as bars, graphs, lines, dots or any other desired graphical feature.” Note: here, patient can select conditions (protocol/disease state modifier), and the display will show data related to the selected conditions. The prompt have to be presented for user to make the selection.)
It would have been obvious for a person of ordinary skill in the art to apply selection prompt teachings of Gnanasambandam into the teachings of St. Pierre as modifed by Jain at the time the application was filed in order to select categories of patient information for health record. (Para 0608, “...The health record interface 8800 may include categories of patient information for selection by a user, such as a conditions 8802...”)
Regarding claim 2, St. Pierre as modified by Jain and Gnanasambandam teaches the medical device of claim 1.
St. Pierre further teaches wherein the instructions further cause the medical device to: provide a plurality of disease state modifiers for selection on a display screen of the medical device, each disease state modifier including a modification of at least one of an alarm setting, a workflow setting, the sensor setting, and a physiological parameter setting based on a disease state of the patient (para, “[0080] The interface 300 includes an area 302 in which up to 8 parameters that are used to calculate the early warning score 202 are shown. For each parameter, the title for the parameter can be provided, along with the proper units. For example, a title might be “Systolic BP,” and the units could be “mm Hg.” The required response field 304 is a text field that provides instructions to the caregiver should a given early warning score be displayed. For example, one such instruction could be “Check the patient for congestive heart failure.” Such an instruction can be provided in conjunction with one or more alarms, such as visual and/or audible alarms provided by the medical device 102, 104, 105.”
Also, para, “[0100] At operation 650, instructions and actions are defined for the ranges for the early warning scores. The instructions are textual information for the caregiver. Alternatively, the instructions can include graphical information for the caregiver as well. The instructions can provide guidance for the caregiver about how to interpret the early warning score and what actions should be taken based on the early warning score. For example, the instructions can be based on policies at a health care facility. The actions, on the other hand, define steps for the medical device 102, 104, 105 to perform based on the early warning score. As an example, an early warning score in a range that indicates highly abnormal results can include the instructions “Transfer to Intensive Care Unit Immediately,” and trigger the action “sound alarm at monitoring station.” Other embodiments include different instructions and different actions.”
Also, para “[0091] The early warning score protocol configuration module 502 operates to define and modify early warning score protocols. The early warning score protocol configuration module 502 can be used to modify an existing early warning score protocol, such as by replacing or adding one or more physiological parameters to the protocol, changing the mapping from values of physiological parameters to component scores, and changing the calculation method or formula used to combine the component scores. Additionally, the early warning score protocol configuration module 502 can be used to define new early warning score protocols. For example, the early warning score configuration module 502 can be used to enter a name of a protocol, select physiological parameters for the protocol, map values of those physiological parameters to component scores, and enter calculation methods for combining the component scores. Changes to existing early warning score protocols and newly defined early warning score protocols can be available locally, such as on one of the medical device 102, 104, 105, or globally, such as across the system 100. Additionally, in some embodiments, changes made using the early warning score protocol configuration module 502 may only be applied to a particular patient. Furthermore, the early warning score protocol configuration module 502 may accessible to all users of the medical devices 102, 104, 105, or alternatively, the early warning score protocol configuration module 502 is only accessible to administrators. Other embodiments are possible as well.”)
Regarding claim 3, St. Pierre as modified by Jain and Gnanasambandam teaches the medical device of claim 2.
St. Pierre further teaches wherein the instructions further cause the medical device to: update the disease state modifiers to include a customization of one or more of the alarm setting, the workflow setting, the sensor setting, and the physiological parameter setting (para “[0091] The early warning score protocol configuration module 502 operates to define and modify early warning score protocols. The early warning score protocol configuration module 502 can be used to modify an existing early warning score protocol, such as by replacing or adding one or more physiological parameters to the protocol, changing the mapping from values of physiological parameters to component scores, and changing the calculation method or formula used to combine the component scores. Additionally, the early warning score protocol configuration module 502 can be used to define new early warning score protocols. For example, the early warning score configuration module 502 can be used to enter a name of a protocol, select physiological parameters for the protocol, map values of those physiological parameters to component scores, and enter calculation methods for combining the component scores. Changes to existing early warning score protocols and newly defined early warning score protocols can be available locally, such as on one of the medical device 102, 104, 105, or globally, such as across the system 100. Additionally, in some embodiments, changes made using the early warning score protocol configuration module 502 may only be applied to a particular patient. Furthermore, the early warning score protocol configuration module 502 may accessible to all users of the medical devices 102, 104, 105, or alternatively, the early warning score protocol configuration module 502 is only accessible to administrators. Other embodiments are possible as well.”)
Regarding claim 4, St. Pierre as modified by Jain and Gnanasambandam teaches the medical device of claim 2.
St. Pierre further teaches wherein the disease state modifiers are selectable for association with the electronic medical record of the patient ((para “[0091] The early warning score protocol configuration module 502 operates to define and modify early warning score protocols. The early warning score protocol configuration module 502 can be used to modify an existing early warning score protocol, such as by replacing or adding one or more physiological parameters to the protocol, changing the mapping from values of physiological parameters to component scores, and changing the calculation method or formula used to combine the component scores. Additionally, the early warning score protocol configuration module 502 can be used to define new early warning score protocols. For example, the early warning score configuration module 502 can be used to enter a name of a protocol, select physiological parameters for the protocol, map values of those physiological parameters to component scores, and enter calculation methods for combining the component scores. Changes to existing early warning score protocols and newly defined early warning score protocols can be available locally, such as on one of the medical device 102, 104, 105, or globally, such as across the system 100. Additionally, in some embodiments, changes made using the early warning score protocol configuration module 502 may only be applied to a particular patient. Furthermore, the early warning score protocol configuration module 502 may accessible to all users of the medical devices 102, 104, 105, or alternatively, the early warning score protocol configuration module 502 is only accessible to administrators. Other embodiments are possible as well.”
Also, para “[0092] The early warning score protocol selection module 504 operates to select a particular early warning score protocol to apply to a particular patient or group of patients. For example, the early warning score protocol selection module 504 can be used to select an early warning score protocol based on the patient's age, such as a pediatric protocol for pediatric patients, a standard protocol for adult patients, and a geriatric protocol for geriatric patients. The early warning score protocol selection module 504 automatically selects or suggests an appropriate protocol for a patient based on demographic information about the patient. Alternatively, the early warning score protocol selection module 504 generates a user interface for a caregiver to select the appropriate protocol.”
Also, para “[0075] In example embodiments, the medical devices 102, 104, 105 are programmed to calculate early warning scores using one or more of the protocols described above. The devices 102, 104, 105 also are programmed to communicate those scores, both visually to the caregiver, as well as possibly to a central server, such as server device 112 to be stored in an electronic medical records (EMR) system. Further, the devices 102, 104, 105 are programmed to provide configurable alert messages based upon the calculated early warning scores.” Fig. 6 teaches setting for Mary.)
Regarding claim 6, St. Pierre teaches a medical device for assessing a health status of a patient, the medical device comprising (see, Fig. 2):
a sensor module for capturing physiological parameter measurements (para, “[0028]The medical devices 102, 104, 105 can provide various types of functionality, including measuring or monitoring patient physiological parameters. The medical devices 102, 104, 105 can include one or more physiological monitor devices configured to measure and possibly display representations of one or more physiological parameters of a patient. In addition, the medical devices 102, 104, 105 can include one or more desktop, laptop, or wall-mounted devices. In some embodiments, the medical devices 102, 104, 105 are configured to be used by a clinician to monitor the physiological parameters of multiple patients at one time. Such monitor devices are typically not wall mounted.”)
at least one processing device communicatively coupled to the sensor module(see, para 0005, para 0033);
and a memory device storing instructions which, when executed by the at least one processing device, cause the medical device to (see, para 0005):
receive a disease state modifier ((para, “[0080] The interface 300 includes an area 302 in which up to 8 parameters that are used to calculate the early warning score 202 are shown. For each parameter, the title for the parameter can be provided, along with the proper units. For example, a title might be “Systolic BP,” and the units could be “mm Hg.” The required response field 304 is a text field that provides instructions to the caregiver should a given early warning score be displayed. For example, one such instruction could be “Check the patient for congestive heart failure.” Such an instruction can be provided in conjunction with one or more alarms, such as visual and/or audible alarms provided by the medical device 102, 104, 105.”
Also, para, “[0100] At operation 650, instructions and actions are defined for the ranges for the early warning scores. The instructions are textual information for the caregiver. Alternatively, the instructions can include graphical information for the caregiver as well. The instructions can provide guidance for the caregiver about how to interpret the early warning score and what actions should be taken based on the early warning score. For example, the instructions can be based on policies at a health care facility. The actions, on the other hand, define steps for the medical device 102, 104, 105 to perform based on the early warning score. As an example, an early warning score in a range that indicates highly abnormal results can include the instructions “Transfer to Intensive Care Unit Immediately,” and trigger the action “sound alarm at monitoring station.” Other embodiments include different instructions and different actions.”
Also, para “[0091] The early warning score protocol configuration module 502 operates to define and modify early warning score protocols. The early warning score protocol configuration module 502 can be used to modify an existing early warning score protocol, such as by replacing or adding one or more physiological parameters to the protocol, changing the mapping from values of physiological parameters to component scores, and changing the calculation method or formula used to combine the component scores. Additionally, the early warning score protocol configuration module 502 can be used to define new early warning score protocols. For example, the early warning score configuration module 502 can be used to enter a name of a protocol, select physiological parameters for the protocol, map values of those physiological parameters to component scores, and enter calculation methods for combining the component scores. Changes to existing early warning score protocols and newly defined early warning score protocols can be available locally, such as on one of the medical device 102, 104, 105, or globally, such as across the system 100. Additionally, in some embodiments, changes made using the early warning score protocol configuration module 502 may only be applied to a particular patient. Furthermore, the early warning score protocol configuration module 502 may accessible to all users of the medical devices 102, 104, 105, or alternatively, the early warning score protocol configuration module 502 is only accessible to administrators. Other embodiments are possible as well.”);
modify at least one of an alarm setting of the sensor module, a workflow setting, a sensor setting of the sensor module, and a physiological parameter setting based on the disease state modifier ((para “[0091] The early warning score protocol configuration module 502 operates to define and modify early warning score protocols. The early warning score protocol configuration module 502 can be used to modify an existing early warning score protocol, such as by replacing or adding one or more physiological parameters to the protocol, changing the mapping from values of physiological parameters to component scores, ………….Changes to existing early warning score protocols and newly defined early warning score protocols can be available locally, such as on one of the medical device 102, 104, 105, or globally, such as across the system 100. Additionally, in some embodiments, changes made using the early warning score protocol configuration module 502 may only be applied to a particular patient. Furthermore, the early warning score protocol configuration module 502 may accessible to all users of the medical devices 102, 104, 105, or alternatively, the early warning score protocol configuration module 502 is only accessible to administrators. Other embodiments are possible as well.”
Also, para “[0054] …..The medical device 104 is shown on a mobile cart, and the medical device 104 is programmed in a manner similar to that described above to monitor physiological parameters of a patient. In some examples, the medical device 104 can be a more compact device that includes a touch screen (e.g., 7 inches) and the ability to execute multiple workflows. In embodiments, the medical device 105 is configured to be mounted on a wall and may also be programmed in a manner similar to that described above to monitor physiological parameters of a patient…...”
Also, para “[0080] The interface 300 includes an area 302 in which up to 8 parameters that are used to calculate the early warning score 202 are shown. For each parameter, the title for the parameter can be provided, along with the proper units. For example, a title might be “Systolic BP,” and the units could be “mm Hg.” The required response field 304 is a text field that provides instructions to the caregiver should a given early warning score be displayed. For example, one such instruction could be “Check the patient for congestive heart failure.” Such an instruction can be provided in conjunction with one or more alarms, such as visual and/or audible alarms provided by the medical device 102, 104, 105.”)
and associate the disease state modifier to an operational session (See, Fig. 5, Fig. 9)
wherein associating the disease state modifier to the operational session includes:
electronically associating the disease state modifier with an electronic medical record of the patient(Fig. 7 teaches disease state modifier (protocol) with specific medical record.
Para, “[0106] FIG. 14 shows another example process 800 performed by some embodiments of the medical devices 102, 104, 105 to calculate and display an early warning score according to an early warning score protocol. The early waning score may be calculated using a predefined early warning score protocol or a customized early warning score protocol.”
Also, para “[0075] In example embodiments, the medical devices 102, 104, 105 are programmed to calculate early warning scores using one or more of the protocols described above. The devices 102, 104, 105 also are programmed to communicate those scores, both visually to the caregiver, as well as possibly to a central server, such as server device 112 to be stored in an electronic medical records (EMR) system. Further, the devices 102, 104, 105 are programmed to provide configurable alert messages based upon the calculated early warning scores.”);
marking physiological parameter measurements captured during the operational session with the disease state (See, Fig. 7; each parameter in the protocol is marked with title.
Para , “[0080] The interface 300 includes an area 302 in which up to 8 parameters that are used to calculate the early warning score 202 are shown. For each parameter, the title for the parameter can be provided, along with the proper units. For example, a title might be “Systolic BP,” and the units could be “mm Hg.” The required response field 304 is a text field that provides instructions to the caregiver should a given early warning score be displayed. For example, one such instruction could be “Check the patient for congestive heart failure.” Such an instruction can be provided in conjunction with one or more alarms, such as visual and/or audible alarms provided by the medical device 102, 104, 105.” Note: here the marking could also be interpreted to be protocol title.”);
and storing the marked physiological parameter measurements in the electronic medical record with indications that the disease state modifier was active during capture(para, “[0075] In example embodiments, the medical devices 102, 104, 105 are programmed to calculate early warning scores using one or more of the protocols described above. The devices 102, 104, 105 also are programmed to communicate those scores, both visually to the caregiver, as well as possibly to a central server, such as server device 112 to be stored in an electronic medical records (EMR) system. Further, the devices 102, 104, 105 are programmed to provide configurable alert messages based upon the calculated early warning scores.”);
St. Pierre does not explicitly teach:
and wherein modify the sensor setting of the sensor module based on the disease state modifier causes the sensor module to adjust a frequency of capturing the physiological parameter measurements.
wherein associating the disease state modifier to the operational session causes future operational sessions on the medical device to automatically display a prompt that requests confirmation to apply the disease state;
Jain teaches:
wherein modify the sensor setting of the sensor module based on the disease state modifier causes the sensor module to adjust a frequency of capturing the physiological parameter measurements( col 12, line 4 “The system can progressively adapt the level of monitoring and types of interactions with a user according to the user's predicted exposure level or likelihood of infection. For example, as a user's exposure level increases, the system can automatically increase the frequency and extent of monitoring by user devices, e.g., smartphone, smartwatch or other wearable device, and so on. The system can vary the types of measurements made (e.g., types of sensor data collected) as well as the types of surveys, user prompts, or other user interactions that the system causes to be provided. The system can also vary the monitoring procedures used for a user to reach a desired level of confidence in the predictions.
Also, col 38 line 12 “The modules 112 may specify various aspects of data collection and analysis. These can include types of sensors to monitor, frequency of monitoring, precision data collected, format of data collected, triggers for conditions that cause sensor data collection or alter sensitive flexion, and so on. The module 112 can include rules that are executed by the user device to selectively perform monitoring actions, for example, to vary the types of data collected in manner of their collection using sensors and user prompts based on conditions or context detected or other factors.)
It would have been obvious for a person of ordinary skill in the art to apply level of monitoring teachings of Jain into the teachings of St. Pierre at the time the application was filed in order to progressively adapt level of monitoring based on level of condition. ( col 12, line 4 “The system can progressively adapt the level of monitoring and types of interactions with a user according to the user's predicted exposure level or likelihood of infection.)
St. Pierre as modified by Jain does not explicitly teach:
wherein associating the disease state modifier to the operational session causes future operational sessions on the medical device to automatically display a prompt that requests confirmation to apply the disease state;
Gnanasambandam teaches:
wherein associating the disease state modifier to the operational session causes future operational sessions on the medical device to automatically display a prompt that requests confirmation to apply the disease state(para “[0608] FIG. 88 shows an example of providing a user interface that shows a health record interface 8800 of a patient. The health record interface 8800 may include categories of patient information for selection by a user, such as a conditions 8802, a lab/vital results 8804, a procedures 8806, a medications 8808, an allergies 8810, an immunization 8812, or any other desired category. The health record interface 8800 may include a drop down box 8914 that includes filter options, such as the number of years of information to display. A timeline 8816 may also be included to display the information in reference to the timeline 8816. As illustrated in FIG. 88, a user has selected the conditions 8802, which includes a list of conditions 8818 of the patient, such as acute bronchitis, chronic sinusitis, or any other desired condition. The data 8920 may display the patient information, for example, along the timeline 8812 next to the related condition 8818. If a patient has had a condition 8818 intermittently, then the data 8820 may be displayed intermittently relative to the timing of the condition 8818. The data 8820 may be displayed as bars, graphs, lines, dots or any other desired graphical feature.” Note: here, patient can select conditions (protocol/disease state modifier), and the display will show data related to the selected conditions. The prompt have to be presented for user to make the selection.)
It would have been obvious for a person of ordinary skill in the art to apply selection prompt teachings of Gnanasambandam into the teachings of St. Pierre as modifed by Jain at the time the application was filed in order to select categories of patient information for health record. (Para 0608, “...The health record interface 8800 may include categories of patient information for selection by a user, such as a conditions 8802...”)
Regarding claim 8, St. Pierre as modified by Jain and Gnanasambandam teaches the medical device of claim 6.
St. Pierre further teaches wherein modify the workflow setting alters types of physiological parameters measurements captured by one or more sensor modules of the medical device during a spot checking mode or an interval monitoring mode (para, “[0043] In various embodiments, the medical device 102 operates within various workflows. For example, in some embodiments, the medical device 102 can operate within a monitoring workflow or a non-monitoring workflow. Example types of non-monitoring workflows include, but are not limited to, a spot check workflow, an office workflow, and a triage workflow. A non-limiting example of a monitoring workflow is an intervals workflow.”
Also, “[0048] In one example, when the medical device 102 is operating within a spot check workflow, the medical device 102 obtains blood pressure measurements from a series of previously-identified patients. In this other example, the medical device 102 displays a spot check workflow home screen containing a blood pressure measurement of a given patient in the series of previously-identified patients. In this way, a user of the medical device 102 can perform spot checks on the blood pressures of patients who have already been admitted to a hospital.”)
Regarding claim 10, St. Pierre as modified by Jain and Gnanasambandam teaches the medical device of claim 6.
St. Pierre further teaches wherein modify the physiological parameter setting alters a weighting for one or more physiological parameters for calculating a health score (para, “[0077] This score can be configured by the hospital and/or caregiver to utilize one or more protocols to calculate the early warning score. Each parameter used to calculate the score can be configured, and the raw score shown on the interface 200 can be configured. For example, in this embodiment, the score is the average of the parameter scores used to calculate the score. So, if the parameter scores used to calculate the early warning score are 1, 3, 3, 1, the early warning score 202 would be shown as a “2”. In another example, each parameter score can be weighted differently.”
Also, para “[0088] In addition, for the selected protocol, the caregiver can select different parameters and how those parameters are weighted to calculate the early warning score. For example, in the area 404, the user can select a value for the level of consciousness (AVPU) parameter for the patient, and in area 406 the white blood cell count for the patient. By defining the values, the caregiver can modify the protocol to provide the desire warning.”)
Regarding claim 11, St. Pierre as modified by Jain and Gnanasambandam teaches the medical device of claim 6.
St. Pierre further teaches wherein the instructions further cause the medical device to: display the disease state modifier proximate to one or more physiological variable measurements displayed on the medical device (See, Fig. 9; here when disease state modifier is “4”, the workflow modifier for disease state of “4” is displayed proximate to one or more physiological variable measurements.”)
Regarding claim 12, St. Pierre as modified by Jain and Gnanasambandam teaches the medical device of claim 6.
St. Pierre further teaches wherein the instructions further cause the medical device to: update a customization of at least one of the alarm setting, the workflow setting, the sensor setting, and the physiological parameter setting for the disease state modifier (para “[0091] The early warning score protocol configuration module 502 operates to define and modify early warning score protocols. The early warning score protocol configuration module 502 can be used to modify an existing early warning score protocol, such as by replacing or adding one or more physiological parameters to the protocol, changing the mapping from values of physiological parameters to component scores, and changing the calculation method or formula used to combine the component scores. Additionally, the early warning score protocol configuration module 502 can be used to define new early warning score protocols. For example, the early warning score configuration module 502 can be used to enter a name of a protocol, select physiological parameters for the protocol, map values of those physiological parameters to component scores, and enter calculation methods for combining the component scores. Changes to existing early warning score protocols and newly defined early warning score protocols can be available locally, such as on one of the medical device 102, 104, 105, or globally, such as across the system 100. Additionally, in some embodiments, changes made using the early warning score protocol configuration module 502 may only be applied to a particular patient. Furthermore, the early warning score protocol configuration module 502 may accessible to all users of the medical devices 102, 104, 105, or alternatively, the early warning score protocol configuration module 502 is only accessible to administrators. Other embodiments are possible as well.”)
Regarding claim 13, St. Pierre teaches a method of assessing a health status of a patient, the method comprising:
receiving a disease state modifier ((para, “[0080] The interface 300 includes an area 302 in which up to 8 parameters that are used to calculate the early warning score 202 are shown. For each parameter, the title for the parameter can be provided, along with the proper units. For example, a title might be “Systolic BP,” and the units could be “mm Hg.” The required response field 304 is a text field that provides instructions to the caregiver should a given early warning score be displayed. For example, one such instruction could be “Check the patient for congestive heart failure.” Such an instruction can be provided in conjunction with one or more alarms, such as visual and/or audible alarms provided by the medical device 102, 104, 105.”
Also, para, “[0100] At operation 650, instructions and actions are defined for the ranges for the early warning scores. The instructions are textual information for the caregiver. Alternatively, the instructions can include graphical information for the caregiver as well. The instructions can provide guidance for the caregiver about how to interpret the early warning score and what actions should be taken based on the early warning score. For example, the instructions can be based on policies at a health care facility. The actions, on the other hand, define steps for the medical device 102, 104, 105 to perform based on the early warning score. As an example, an early warning score in a range that indicates highly abnormal results can include the instructions “Transfer to Intensive Care Unit Immediately,” and trigger the action “sound alarm at monitoring station.” Other embodiments include different instructions and different actions.”
Also, para “[0091] The early warning score protocol configuration module 502 operates to define and modify early warning score protocols. The early warning score protocol configuration module 502 can be used to modify an existing early warning score protocol, such as by replacing or adding one or more physiological parameters to the protocol, changing the mapping from values of physiological parameters to component scores, and changing the calculation method or formula used to combine the component scores. Additionally, the early warning score protocol configuration module 502 can be used to define new early warning score protocols. For example, the early warning score configuration module 502 can be used to enter a name of a protocol, select physiological parameters for the protocol, map values of those physiological parameters to component scores, and enter calculation methods for combining the component scores. Changes to existing early warning score protocols and newly defined early warning score protocols can be available locally, such as on one of the medical device 102, 104, 105, or globally, such as across the system 100. Additionally, in some embodiments, changes made using the early warning score protocol configuration module 502 may only be applied to a particular patient. Furthermore, the early warning score protocol configuration module 502 may accessible to all users of the medical devices 102, 104, 105, or alternatively, the early warning score protocol configuration module 502 is only accessible to administrators. Other embodiments are possible as well.”);
modifying at least one of an alarm setting, a workflow setting, a sensor setting, and a physiological parameter setting of a medical device based on the disease state modifier ((para “[0091] The early warning score protocol configuration module 502 operates to define and modify early warning score protocols. The early warning score protocol configuration module 502 can be used to modify an existing early warning score protocol, such as by replacing or adding one or more physiological parameters to the protocol, changing the mapping from values of physiological parameters to component scores, and changing the calculation method or formula used to combine the component scores. Additionally, the early warning score protocol configuration module 502 can be used to define new early warning score protocols. For example, the early warning score configuration module 502 can be used to enter a name of a protocol, select physiological parameters for the protocol, map values of those physiological parameters to component scores, and enter calculation methods for combining the component scores. Changes to existing early warning score protocols and newly defined early warning score protocols can be available locally, such as on one of the medical device 102, 104, 105, or globally, such as across the system 100. Additionally, in some embodiments, changes made using the early warning score protocol configuration module 502 may only be applied to a particular patient. Furthermore, the early warning score protocol configuration module 502 may accessible to all users of the medical devices 102, 104, 105, or alternatively, the early warning score protocol configuration module 502 is only accessible to administrators. Other embodiments are possible as well.”);
and associating the disease state modifier to an operational session of a medical device (See, Fig. 5, Fig. 9)
wherein associating the disease state modifier to the operational session includes:
electronically associating the disease state modifier with an electronic medical record of the patient(Fig. 7 teaches disease state modifier (protocol) with specific medical record.
Para, “[0106] FIG. 14 shows another example process 800 performed by some embodiments of the medical devices 102, 104, 105 to calculate and display an early warning score according to an early warning score protocol. The early waning score may be calculated using a predefined early warning score protocol or a customized early warning score protocol.”
Also, para “[0075] In example embodiments, the medical devices 102, 104, 105 are programmed to calculate early warning scores using one or more of the protocols described above. The devices 102, 104, 105 also are programmed to communicate those scores, both visually to the caregiver, as well as possibly to a central server, such as server device 112 to be stored in an electronic medical records (EMR) system. Further, the devices 102, 104, 105 are programmed to provide configurable alert messages based upon the calculated early warning scores.”);
marking physiological parameter measurements captured during the operational session with the disease state modifier(Fig. 7 teaches disease state modifier (protocol) with specific medical record.
Para, “[0106] FIG. 14 shows another example process 800 performed by some embodiments of the medical devices 102, 104, 105 to calculate and display an early warning score according to an early warning score protocol. The early waning score may be calculated using a predefined early warning score protocol or a customized early warning score protocol.”
Also, para “[0075] In example embodiments, the medical devices 102, 104, 105 are programmed to calculate early warning scores using one or more of the protocols described above. The devices 102, 104, 105 also are programmed to communicate those scores, both visually to the caregiver, as well as possibly to a central server, such as server device 112 to be stored in an electronic medical records (EMR) system. Further, the devices 102, 104, 105 are programmed to provide configurable alert messages based upon the calculated early warning scores.”);
and storing the marked physiological parameter measurements in the electronic medical record with indications that the disease state modifier was active during capture(para, “[0075] In example embodiments, the medical devices 102, 104, 105 are programmed to calculate early warning scores using one or more of the protocols described above. The devices 102, 104, 105 also are programmed to communicate those scores, both visually to the caregiver, as well as possibly to a central server, such as server device 112 to be stored in an electronic medical records (EMR) system. Further, the devices 102, 104, 105 are programmed to provide configurable alert messages based upon the calculated early warning scores.”);
St. Pierre does not explicitly teach:
and wherein modify the sensor setting based on the disease state modifier causes a sensor module to adjust a frequency of capturing physiological parameters measurements.
wherein associating the disease state modifier to the operational session causes future operational sessions on the medical device to automatically display a prompt that requests confirmation to apply the disease state;
Jain teaches:
wherein modify the sensor setting based on the disease state modifier causes a sensor module to adjust a frequency of capturing physiological parameters measurements( col 12, line 4 “The system can progressively adapt the level of monitoring and types of interactions with a user according to the user's predicted exposure level or likelihood of infection. For example, as a user's exposure level increases, the system can automatically increase the frequency and extent of monitoring by user devices, e.g., smartphone, smartwatch or other wearable device, and so on. The system can vary the types of measurements made (e.g., types of sensor data collected) as well as the types of surveys, user prompts, or other user interactions that the system causes to be provided. The system can also vary the monitoring procedures used for a user to reach a desired level of confidence in the predictions.”
Also, col 38 line 12 “The modules 112 may specify various aspects of data collection and analysis. These can include types of sensors to monitor, frequency of monitoring, precision data collected, format of data collected, triggers for conditions that cause sensor data collection or alter sensitive flexion, and so on. The module 112 can include rules that are executed by the user device to selectively perform monitoring actions, for example, to vary the types of data collected in manner of their collection using sensors and user prompts based on conditions or context detected or other factors.”)
It would have been obvious for a person of ordinary skill in the art to apply level of monitoring teachings of Jain into the teachings of St. Pierre at the time the application was filed in order to progressively adapt level of monitoring based on level of condition. ( col 12, line 4 “The system can progressively adapt the level of monitoring and types of interactions with a user according to the user's predicted exposure level or likelihood of infection.)
St. Pierre as modified by Jain does not explicitly teach:
wherein associating the disease state modifier to the operational session causes future operational sessions on the medical device to automatically display a prompt that requests confirmation to apply the disease state;
Gnanasambandam teaches:
wherein associating the disease state modifier to the operational session causes future operational sessions on the medical device to automatically display a prompt that requests confirmation to apply the disease state((para “[0608] FIG. 88 shows an example of providing a user interface that shows a health record interface 8800 of a patient. The health record interface 8800 may include categories of patient information for selection by a user, such as a conditions 8802, a lab/vital results 8804, a procedures 8806, a medications 8808, an allergies 8810, an immunization 8812, or any other desired category. The health record interface 8800 may include a drop down box 8914 that includes filter options, such as the number of years of information to display. A timeline 8816 may also be included to display the information in reference to the timeline 8816. As illustrated in FIG. 88, a user has selected the conditions 8802, which includes a list of conditions 8818 of the patient, such as acute bronchitis, chronic sinusitis, or any other desired condition. The data 8920 may display the patient information, for example, along the timeline 8812 next to the related condition 8818. If a patient has had a condition 8818 intermittently, then the data 8820 may be displayed intermittently relative to the timing of the condition 8818. The data 8820 may be displayed as bars, graphs, lines, dots or any other desired graphical feature.” Note: here, patient can select conditions (protocol/disease state modifier), and the display will show data related to the selected conditions. The prompt have to be presented for user to make the selection.)
It would have been obvious for a person of ordinary skill in the art to apply selection prompt teachings of Gnanasambandam into the teachings of St. Pierre as modified by Jain at the time the application was filed in order to select categories of patient information for health record. (Para 0608, “...The health record interface 8800 may include categories of patient information for selection by a user, such as a conditions 8802...”)
Regarding claim 15, St. Pierre as modified by Jain and Gnanasambandam teaches the method of claim 13.
St. Pierre further teaches wherein modify the workflow setting includes: altering types of physiological parameters measurements captured during a spot checking mode or an interval monitoring mode (para, “[0043] In various embodiments, the medical device 102 operates within various workflows. For example, in some embodiments, the medical device 102 can operate within a monitoring workflow or a non-monitoring workflow. Example types of non-monitoring workflows include, but are not limited to, a spot check workflow, an office workflow, and a triage workflow. A non-limiting example of a monitoring workflow is an intervals workflow.”
Also, “[0048] In one example, when the medical device 102 is operating within a spot check workflow, the medical device 102 obtains blood pressure measurements from a series of previously-identified patients. In this other example, the medical device 102 displays a spot check workflow home screen containing a blood pressure measurement of a given patient in the series of previously-identified patients. In this way, a user of the medical device 102 can perform spot checks on the blood pressures of patients who have already been admitted to a hospital.”)
Regarding claim 17, St. Pierre as modified by Jain and Gnanasambandam teaches the method of claim 13.
St. Pierre further teaches wherein modify the physiological parameter setting includes: altering a weighting of a physiological parameter for calculating a health score (para, “[0077] This score can be configured by the hospital and/or caregiver to utilize one or more protocols to calculate the early warning score. Each parameter used to calculate the score can be configured, and the raw score shown on the interface 200 can be configured. For example, in this embodiment, the score is the average of the parameter scores used to calculate the score. So, if the parameter scores used to calculate the early warning score are 1, 3, 3, 1, the early warning score 202 would be shown as a “2”. In another example, each parameter score can be weighted differently.”
Also, para “[0088] In addition, for the selected protocol, the caregiver can select different parameters and how those parameters are weighted to calculate the early warning score. For example, in the area 404, the user can select a value for the level of consciousness (AVPU) parameter for the patient, and in area 406 the white blood cell count for the patient. By defining the values, the caregiver can modify the protocol to provide the desire warning.”)
Regarding claim 18, St. Pierre as modified by Jain and Gnanasambandam teaches the method of claim 13.
St. Pierre further teaches further comprising: displaying the disease state modifier proximate to one or more physiological variable measurements on a display screen of a medical device (See, Fig. 9; here when disease state modifier is “4”, the workflow modifier for disease state of “4” is displayed proximate to one or more physiological variable measurements.”)
Regarding claim 19, St. Pierre as modified by Jain and Gnanasambandam teaches the method of claim 13.
St. Pierre further teaches further comprising: updating a customization of at least one of the alarm setting, the workflow setting, the sensor setting, and the physiological parameter setting for the disease state modifier (para “[0091] The early warning score protocol configuration module 502 operates to define and modify early warning score protocols. The early warning score protocol configuration module 502 can be used to modify an existing early warning score protocol, such as by replacing or adding one or more physiological parameters to the protocol, changing the mapping from values of physiological parameters to component scores, and changing the calculation method or formula used to combine the component scores. Additionally, the early warning score protocol configuration module 502 can be used to define new early warning score protocols. For example, the early warning score configuration module 502 can be used to enter a name of a protocol, select physiological parameters for the protocol, map values of those physiological parameters to component scores, and enter calculation methods for combining the component scores. Changes to existing early warning score protocols and newly defined early warning score protocols can be available locally, such as on one of the medical device 102, 104, 105, or globally, such as across the system 100. Additionally, in some embodiments, changes made using the early warning score protocol configuration module 502 may only be applied to a particular patient. Furthermore, the early warning score protocol configuration module 502 may accessible to all users of the medical devices 102, 104, 105, or alternatively, the early warning score protocol configuration module 502 is only accessible to administrators. Other embodiments are possible as well.”)
Regarding claim 20, St. Pierre as modified by Jain and Gnanasambandam teaches the method of claim 13.
St. Pierre further teaches further comprising: marking past physiological parameter measurements to identify a disease state modifier present at time of capturing the past physiological parameter measurements (para, “[0030] The medical devices 102, 104, 105 can send various types of data and can receive various types of data through the network 108. For example, in some embodiments, the medical devices 102, 104, 105 can send measurements of physiological parameters. In another example, the medical devices 102, 104, 105 can retrieve past measurements of physiological parameters of patients.” Also Fig. 5 shows past physiological parameter measurements to identify a disease state modifier of “1”, and Fig. 9 shows past physiological parameter measurements to identify a disease state modifier of “4”)
Claims 7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over St. Pierre as modified by Jain and Gnanasambandam and further in view of Boyer et al. (US 20160093205 A1)
Regarding claim 7, St. Pierre as modified by Jain and Gnanasambandam teaches the medical device of claim 6.
St. Pierre as modified by Jain and Gnanasambandam does not explicitly teaches wherein modify the alarm setting alters at least one of an alarm limit threshold and an alarm delay triggered by a physiological parameter measurement captured by a sensor module of the medical device.
Boyer teaches wherein modify the alarm setting alters at least one of an alarm limit threshold and an alarm delay triggered by a physiological parameter measurement captured by the sensor module of the medical device (para “[0054] Additionally, the method 300 may include modifying at least one of the alarm conditions based on the analysis (block 308). In particular, the at least one alarm condition may be modified to reduce nuisance alarms and to improve the relevancy of the generated alarms. Modifying the alarm conditions may include changing an alarm threshold, such as moving it up or down, to reduce the number of alarm events. For example, an alarm condition may include a lower threshold of 90% for oxygen saturation, and modifying this alarm condition may include reducing the threshold to 89% or 85% or other appropriate value.”)
It would have been obvious for a person of ordinary skill in the art to apply alarm modification teachings of Boyer into the teachings of St. Pierre as modified by Jain and Gnanasambandam at the time the application was filed in order to reduce nuisance alarms. (para, 0042] As described above, the system 200 may be configured to store relevance indicators 220 and relevance event data 222. Additionally, the system 200 may be configured to analyze the relevance indicators 220 and the relevance event data 222 to identify nuisance alarms and modify alarm conditions to reduce nuisance alarms….”)
Regarding claim 14, St. Pierre as modified by Jain and Gnanasambandam teaches the method of claim 13.
St. Pierre as modified by Jain and Gnanasambandam does not explicitly teaches wherein modify the alarm setting includes: altering at least one of an alarm limit threshold and an alarm delay triggered by a physiological parameter measurement.
Boyer teaches wherein modify the alarm setting includes: altering at least one of an alarm limit threshold and an alarm delay triggered by a physiological parameter measurement (para “[0054] Additionally, the method 300 may include modifying at least one of the alarm conditions based on the analysis (block 308). In particular, the at least one alarm condition may be modified to reduce nuisance alarms and to improve the relevancy of the generated alarms. Modifying the alarm conditions may include changing an alarm threshold, such as moving it up or down, to reduce the number of alarm events. For example, an alarm condition may include a lower threshold of 90% for oxygen saturation, and modifying this alarm condition may include reducing the threshold to 89% or 85% or other appropriate value.”)
It would have been obvious for a person of ordinary skill in the art to apply alarm modification teachings of Boyer into the teachings of St. Pierre as modified by Jain and Gnanasambandam at the time the application was filed in order to reduce nuisance alarms. (para, 0042] As described above, the system 200 may be configured to store relevance indicators 220 and relevance event data 222. Additionally, the system 200 may be configured to analyze the relevance indicators 220 and the relevance event data 222 to identify nuisance alarms and modify alarm conditions to reduce nuisance alarms….”)
Response to Arguments
Applicant's arguments filed on 02/02/2026 have been fully considered but they are not persuasive.
Remarks - 35 USC § 101
In remarks, Pg. 9, applicant contends:
“The Office Action states that the claimed invention "optimizes medical sensor operation for diverse patient populations" and questions whether this represents "improvement to medical monitoring technology." This characterization ignores the technological mechanisms by which the claimed subject matter achieves this optimization. The claims do not broadly recite "optimizing sensor operation" in the abstract. Rather, the claims recite concrete technological steps including modifying sensor settings to adjust capture frequency, electronically associating disease states with EMR records, marking measurements with disease state metadata during capture, storing marked measurements with contextual indicators in the EMR, and automatically generating prompts in future sessions based on stored EMR associations. These are specific technological operations performed by the medical device recited in the claims.”
The applicant states modifying sensor setting as optimizing sensor operation, but the limitation is devoid of any detail that how sensor setting has been modified/changed. Merely changing sensor setting to adjust frequency is not optimization in technology.
Similarly electronically associating disease states with EMR is simply associating relevant disease states with EMR, and capturing and storing disease state can be done in a clinical setting and comes under abstract idea. Storing diseases state/symptoms in EMR and generating automatic prompt is simply generating relevant data automatically, the computer can be used as a tool to perform this task. This is merely display of information. The examiner agrees that displaying the related information will be convenient, and save time; however, that is not an improvement in the display technology, rather falls under organizing the data.
In remarks, Pg. 10, applicant contends:
“Furthermore, the automatic prompting feature in future operational sessions represents a technical improvement to medical device workflow management. As described in the specification, the medical device determines whether the EMR is flagged or associated with disease state modifiers, and if so, automatically presents those modifiers for confirmation in subsequent sessions. This cross-session state management functionality requires technical integration between the medical device's operational session logic, its network communication protocols for querying the EMR system, and its user interface generation logic for displaying contextually appropriate prompts. This is not merely using a computer as a tool to perform an abstract idea, but rather implementing a specific technical solution for maintaining operational continuity across discrete sessions in a networked medical device environment.”
The relevant claim language seems to be “wherein associating the disease state to the operational session causes future operational sessions on the medical device to automatically display a prompt that requests confirmation to apply the disease state.” The claim language is not supported by the specification. The specification somewhat discusses, the similar concept with regard to “disease state modifiers.”
“[0134] FIG. 16 illustrates an example of a graphical user interface 1600 displayed on the display screen 218 of the medical device 106 in accordance with an example of the operation 1502 in the method 1500. In this illustrative example, the graphical user interface 1600 includes a prompt 1602 that requests the user of the medical device 106 to confirm whether they would like to apply one or more disease state modifiers. The prompt 1602 includes a “Yes” icon 1604 that when selected causes the medical device to display a graphical user interface that allows the user to select one or more disease state modifiers. The prompt 1602 further includes a “No” icon 1606 that when selected causes the prompt 1602 to close and return to a home screen display.”
If, it is assumed that claim meant to states modifiers, then, it is not clear what applicant means in remarks by “this cross-session state management functionality requires technical integration between the medical device's operational session logic.” The above paragraph merely discusses if user would like to apply disease modifier; and applying the disease modifier will allow certain features related to modifier to be displayed, which is organization of data.
In remarks, Pg. 11, applicant contends:
“The Office Action characterizes the claimed subject matter as merely "changing the setting of the device" and states that "changing the frequency based on state is abstract idea itself." However, the claims do not merely recite changing a setting in the abstract. The claims recite a specific ordered combination of technical operations: determining disease state, modifying sensor settings including frequency adjustment, associating the disease state to the operational session through a multi-step process involving EMR integration and marking, and automatically triggering prompts in future sessions based on persistent EMR associations. This ordered combination creates a technical architecture for disease state-aware medical device operation that maintains data integrity and operational continuity across operational sessions. The automatic prompting goes beyond conventional data storage and retrieval. It implements a specific technical solution for context-aware medical device configuration management that persists across the temporal and spatial boundaries of discrete operational sessions.”
The argued limitation has been addressed above and as mentioned about context-aware device configuration, it is merely adjusting device setting according to current or historical/stored data and retrieving relevant data. As mentioned, the invention as claimed is more about data organization, what to display, or store etc...; the claims don’t discuss how the display technology, or sensor technology etc... is being improved. The examiner agrees, that sensors are being applied to capture the data, and display is being used to display the selected data; however the claims don’t recite any technical detail that shows improvement into the sensor technology or display technology. Yes, the sensors are being configured, and display is being configured, however that is merely applying the available technology as tool.
Remarks - 35 USC § 103
In remarks, Pg. 14, applicant contends:
“The Office Action relies on Jain for disclosing sensor frequency adjustment based on condition or state. However, Jain does not cure the deficiencies of St. Pierre with respect to the subject matter of amended claim 1. Jain's disclosure relates to a different technical field and context. Jain is directed to clinical trials, contact tracing, and monitoring programs for geographically distributed devices collecting data over communication networks for disease surveillance and research study management. Jain's system involves remote monitoring of multiple individuals across populations to manage clinical trial diversity and engagement, not point-of-care medical devices for real-time patient health assessment. Jain does not disclose associating the disease state to an operational session of the medical device. The portions of Jain cited by the Examiner (column 150, lines 6-27) discuss adjusting monitoring levels and data collection frequency for clinical trial participants based on predicted exposure levels or infection likelihood. Jain's disclosure concerns data packages sent to remote devices to adjust monitoring protocols for research participants over extended periods. This is fundamentally different from the integration of disease state context into individual operational sessions of a point-of-care medical device and the automatic prompting in future sessions based on prior disease state associations.”
The amended claim language have been addressed in the prior art section. Also, please see 35 U.S.C 112 rejections related to claim limitations. Furthermore, for portion of amended claims, new reference has been introduced to address the selection prompt feature.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HUMA WASEEM whose telephone number is (571)272-1316. The examiner can normally be reached Monday-Friday(9:00am - 5:00 pm) EST.
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 on (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.
/HUMA WASEEM/Examiner, Art Unit 3686
/JASON B DUNHAM/Supervisory Patent Examiner, Art Unit 3686
Prosecution Insights