DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 16 January 2026 has been entered.
The Examiner acknowledges the amendments to claims 1-5, 8, 11-12, 14, and 31-44. Claims 1-14 and 31-44 are pending.
Claim Objections
Claim(s) 8 and 31 is/are objected to because of the following informalities:
Claim 8 should read “the method” [line 2].
Claim 8 should read “[[sef]]self-treating” [line 11].
Claim 31 should read “[[a]] the first self-treat test” [lines 11-12].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 5-7, 9-10, 12-14, 31-32, 37-39, 42, and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halff (US-8803688-B2, cited by Applicant) in view of Volpe (US-20170188979-A1).
Regarding claim 1, Halff teaches
A method comprising:
displaying, via a mobile device, a plurality of self-treat tests configured to test a user's capability of self-treating an extreme diabetic state, wherein the plurality of self-treat tests comprises a first self-treat test comprising a first pass/fail criteria to test the user's capability of self-treating the extreme diabetic state, and wherein the plurality of self-treat tests comprises a second self-treat test comprising a second pass/fail criteria to test the user's capability of self-treating the extreme diabetic state in a different manner than the first pass/fail criteria of the first self-treat test [the user of the glucose monitoring device can specify the order in which the actions are selected and can specify the time given the user to solve a cognitive reasoning skills test before a next action is selected. In some embodiments, the user can select a type of cognitive reasoning skills test, such as, for example, one of an arithmetic problem, a spelling test, a password request, and a fact question (Halff Col 4:15-22); the display of the alarm unit 203 may display a cognitive reasoning skills test (Halff Col 6:63-64); The alarm unit application may also cause the mobile device 303 to display a cognitive reasoning skills test and to receive input of an answer to the cognitive reasoning skills test (Halff Col 7:32-35)];
enabling, in response to a user selection received via the mobile device, the first self-treat test or the second self-treat test of the plurality of self-treat tests, wherein the first self-treat testis enabled to configure the first pass/fail criteria to test the user's capability of self-treating extreme diabetic state, and wherein the second self-treat test is enabled to configure the second pass/fail criteria to test the user's capability of self-treating extreme diabetic state [Halff Col 4:15-22, 6:63-64, 7:32-35; The user's ability to solve the problem is indicative of the user's cognitive ability to attend to the event. The problem to be solved may be an arithmetic problem, a spelling test, a password request, a fact question, or any combination thereof. Other cognitive reasoning skills tests can be provided (Col 5:22-27)];
detecting, via the mobile device, from first information from a glucose monitoring device, that a blood-glucose level of a user is in between a high-end threshold and a low-end threshold [a remote continuous glucose sensor that the user 101 places under the skin to detect glucose in interstitial tissue may wirelessly transmit the sensed glucose level to the glucose monitoring device 104 so that the glucose monitoring device 104 can detect a low or high blood glucose event, for example… the glucose monitoring device 104 may detect an event such as low blood glucose level, high blood glucose level, high glucose rate of change, low power, low memory, or other condition that warrants prompt attention (Halff Col 2:62-37, 42-46), wherein identifying low/high blood glucose level from a normal level through continuous monitoring is also considered to read on identifying a normal blood glucose level (a blood-glucose level between a high-end threshold and a low-end threshold)];
establishing, via the mobile device, a first baseline response associated with the user for the first self-treat test from which subsequent responses to the enabled first self-treat test may be compared, wherein the first baseline response is established based on a first response associated with the first pass/fail criteria for the first self- treat test on the mobile device [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35; The functionality of an alarm unit may include generating and rendering a cognitive reasoning skills test, at 718. Such a test may include an arithmetic test, a spelling test, a pass code request, a fact question, or other test. The functionality may include receiving input from a keypad, touch screen, or other input technology, in response to a prompt to enter a response to the cognitive reasoning skills test (Halff Col 10:37-43), wherein the cognitive reasoning skills tests being pass/fail defines a correct “baseline response” for comparison of later input answers to];
establishing, via the mobile device, a second baseline response associated with the user for the second self-treat test from which subsequent responses to the enabled second self-treat test may be compared, wherein the second baseline response for the second self-treat testis established based on a second response associated with the second pass/fail criteria for the second self-treat test on the mobile device [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42, wherein the cognitive reasoning skills tests being pass/fail defines a correct “baseline response” for comparison of later input answers to];
detecting, via the mobile device, from second information from the glucose monitoring device, a triggering event associated with an extreme diabetic state in response to the blood- glucose level of the user being above the high-end threshold or below the low-end threshold [Halff Col 2:62-37, 42-46];
providing, based on the user selection in response to the detecting of the triggering event associated with the extreme diabetic state, the enabled first self-treat test to test the user's capability of self-treating the extreme diabetic state based on the first pass/fail criteria or the enabled second self-treat test to test the user's capability of self-treating the extreme diabetic state based on the second pass/fail criteria [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42];
receiving a third response to the enabled first self-treat test or to the enabled second self-treat test [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42];
comparing the third response to the first baseline response or the second baseline response associated with the user based on the first pass/fail criteria associated with the first self-treat test or the second pass/fail criteria associated with the second self-treat test that is enabled in response to the user selection [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42];
determining, via the mobile device based on the comparison, whether the third response is within a predefined deviation from the established first baseline response or the established second baseline response associated with the user [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42];
when the third response is outside of the predefined deviation from the established first baseline response or the established second baseline response associated with the user, communicating, via the mobile device, a diabetes-related alert configured to solicit assistance in treatment of the extreme diabetic state [If the user of the glucose monitoring device does not solve a cognitive reasoning skills test within a certain period of time, the alarm center 110 may then initiate a call to an emergency rescuer (Halff Col 4:63-66)]; and
when the third response is within the predefined deviation from the established first baseline response or the established second baseline response associated with the user, determining, via the mobile device, that the user is capable of self-treating the extreme diabetic state and continuing to monitor the blood-glucose level of the user [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42].
However, Halff fails to explicitly disclose wherein establishing the first baseline response associated with the user for the first self-treat test and establishing the second baseline response associated with the user for the second self-treat test are each performed while the blood-glucose level of the user is detected between the high-end threshold and the low-end threshold.
Volpe discloses systems and methods to monitor a user’s blood glucose to identify an abnormality event [Aspects of the present disclosure are directed to monitoring and/or therapeutic medical devices configured to identify a patient physiological event and, in response to the identified event, to provide a notification to the patient wearing the device. The notification can include an instruction or request to perform a patient response activity. Successful completion of the patient response activity can cause the device to suspend or delay a device function, such as administering a treatment to a patient and/or issuing an alert or alarm (Volpe ¶0094); The controller can be configured to detect the patient physiological event based, at least in part, on the sensed physiological information. A patient event can be a temporary physiological problem or abnormality, which can be representative of an underlying patient condition (Volpe ¶0095)], wherein Volpe discloses blood glucose as a relevant patient parameter to measure [In some examples, the medical device can be a patient monitoring device, which can be configured to monitor one or more of a patient's physiological parameters without an accompanying treatment component… In addition to cardiac monitoring, the patient monitor may perform monitoring of other relevant patient parameters, including glucose levels (Volpe ¶0099)], and wherein Volpe discloses notifying the user upon detection of the event and requesting a user response indicative of cognitive function or manual dexterity [the device controller is configured to notify the patient of the detection of the one or more events and to receive a patient response to the notification. The patient response can include performing a response activity identifiable by an input component associated with the medical device. In general, the response activity is selected to demonstrate or to provide information about the status of the patient and, in particular, to confirm that the patient is conscious and substantially aware of his or her surroundings… The response activity can also demonstrate or test a patient ability such as one or more of psychomotor ability, cognitive awareness, and athletic/movement ability. In some examples, the response activity can be a relatively simple action, such as making a simple or reflexive movement in response to a stimulus applied by the device. In other examples, more complex activities, such provided answers to questions requiring reasoning and logical analysis can be required (Volpe ¶0096)]. Volpe further discloses establishing a baseline response associated with the user while the user is in a normal state [In some examples, baseline characteristics for a particular patient can also be determined, for example, during a patient's meeting with the PSR. For example, baseline values related to a patient's cognitive ability and movement ability can be determined… The results of the baseline test and other recorded information can be compared to patient responses given in response to patient notifications when the device is in use. Changes in a patient's cognitive ability could indicate that the patient has experienced a physiological event, such as a stroke. Similarly, changes in speech patterns or movement ability, as evidenced by comparing an initial recording or patient baseline score to a score obtained in response to a patient notification, could be used to confirm that the patient is in distress or, in some cases, to determine a level of physiological distress of the patient (Volpe ¶0150), wherein establishing a baseline cognitive ability or movement ability is considered to read on the user being in a “normal” state that does not require medical intervention].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Halff to employ wherein establishing the first baseline response associated with the user for the first self-treat test and establishing the second baseline response associated with the user for the second self-treat test are each performed while the blood-glucose level of the user is detected between the high-end threshold and the low-end threshold, so as to allow for a comparison to the user’s response in a normal state when assessing the user’s cognitive function or manual dexterity.
Regarding claim 5, Halff in view of Volpe teaches
The method of claim 1, wherein the enabled first self-treat test or the enabled second self-treat test comprises a manual dexterity test [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42, wherein correctly typing a response is considered to read on the broadest reasonable interpretation of a “manual dexterity” test].
However, while Halff notes that other types of cognitive reasoning skills tests from what is explicitly disclosed in Halff may be provided [Other cognitive reasoning skills tests can be provided (Halff Col 5:26-27)], Halff in view of Volpe as presently modified fails to explicitly disclose wherein the manual dexterity test further comprises detecting a location of a sequence of displayed shapes on the mobile device, and wherein the first pass/fail criteria or the second pass/fail criteria of the manual dexterity test further comprises an ability of the user to select the location of the sequence of shapes within a predetermined response time.
Volpe discloses providing a manual dexterity test, wherein the manual dexterity test further comprises detecting a location of a sequence of displayed shapes on the mobile device, and wherein the first pass/fail criteria or the second pass/fail criteria of the manual dexterity test further comprises an ability of the user to select the location of the sequence of shapes within a predetermined response time [the device can display a patient response screen 720 including an instruction to perform a task representative of, for example, psychomotor ability and/or cognitive ability of the patient (Volpe ¶0172); the task or response activity can include drawing or tracing a figure on the touch screen display. As shown in screen 720, a series of dots 722 are illustrated. The patient is instructed to trace a path by connecting the dots 722 as described by explanatory text 724. The patient can complete the task by touching the screen 720 at a first dot and, while maintaining contact with the touch screen display, tracing a path connecting each of the series of dots 722 (Volpe ¶0173, Figs. 7-8); If the patient response substantially corresponds to an expected response (e.g., the path connects the dots in the correct order), the controller 120 can be configured to suspend or delay treatment (Volpe ¶0174); In some examples, a level of difficulty of a patient response activity can be indicated by a length of time needed to complete the assigned task… A task such as connecting dots or drawing a shape on the touch screen of the controller takes a longer time and, as such, has a higher level of difficulty (Volpe ¶0143), wherein drawing/tracing the dots in the correct order reads on detecting a location of a sequence of displayed shapes].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Halff in view of Volpe to employ wherein the manual dexterity test further comprises detecting a location of a sequence of displayed shapes on the mobile device, and wherein the first pass/fail criteria or the second pass/fail criteria of the manual dexterity test further comprises an ability of the user to select the location of the sequence of shapes within a predetermined response time, as testing the user to detect a location of a sequence of displayed shapes is indicative of user psychomotor ability and/or cognitive ability and as this modification would amount to applying a known technique [manual dexterity test of Volpe] to a known device (method, or product) ready for improvement [method of Halff that assesses a user’s manual dexterity] to yield predictable results [assess a user’s manual dexterity] [MPEP § 2143(I)(D)].
Regarding claim 6, Halff in view of Volpe teaches
The method of claim 1, wherein the extreme diabetic state comprises a hypoglycemic or a hyperglycemic event [Halff Col 2:62-37, 42-46, wherein identifying low/high blood glucose level is considered to read on a hypoglycemic/hyperglycemic event].
Regarding claim 7, Halff in view of Volpe teaches
The method of claim 1, wherein the extreme diabetic state is detected at the high-end threshold or the low-end threshold prior to a threshold for a hypoglycemic event or a hyperglycemic event [Halff Col 2:62-37, 42-46, wherein detecting a high glucose rate of change instead of specifically detecting high or low glucose is considered to read on the claimed limitation].
Regarding claim 9, Halff in view of Volpe teaches
The method of claim 1, wherein the diabetes-related alert is an audible alert communicated via a speaker of the mobile device [The functionality of an alarm unit may include alarm configuration functionality, at 704. The alarm configuration functionality may include functionality to select a vibration alert 714, an audio alert 724, a visual alert 734, and a remote alert notification 744 (Halff Col 9:44-48)].
Regarding claim 10, Halff in view of Volpe teaches
The method of claim 1, wherein the communicating the diabetes-related alert further comprises at least one of the following:
sending a first predefined message for the diabetes-related alert to an external speaker device for audible communication to an occupant of a space [Halff Col 9:44-48, wherein any audio played may be considered to read on any non-particular predefined message];
sending a second predefined message for the diabetes-related alert via telecommunication or text message to an alternate device to the mobile device; or
sending an alert message to control a home automation system to alert the user.
Regarding claim 12, Halff in view of Volpe teaches
The method of claim 1, wherein the enabled first self-treat test comprises a cognitive test to detect a cognitive ability of the user, wherein the first pass/fail criteria of the cognitive test comprises at least one question, and wherein the first baseline response and the second response to the first pass/fail criteria of the cognitive test each comprise an indication of at least one answer to the at least one question [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42].
Regarding claim 13, Halff in view of Volpe teaches
The method of claim 12, wherein providing the cognitive test comprises overlaying the at least one question on a lock screen, a home screen, or another application displayed on the mobile device [Halff 7:32-35, 10:37-42].
Regarding claim 14, Halff in view of Volpe teaches
The method of claim 1, further comprising:
starting a first timer at the mobile device;
failing to receive an indication that the user has treated the extreme diabetic state prior to an expiration of the first timer [if the user does not solve a cognitive reasoning skills test within a prescribed period of time, a second set of actions may be taken (Halff Col 4:2-4)]; and
starting a second timer at the mobile device, wherein the enabled first self-treat test or the enabled second self-treat test is provided in response to the detecting of the triggering event associated with the extreme diabetic state is provided after an expiration of the second timer [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42; when a user answers the cognitive reasoning skills test incorrectly, another cognitive reasoning skills test is presented that is different from the incorrectly answered cognitive reasoning skills test (Halff Col 4:5-8)].
Regarding claim 31, Halff teaches
An apparatus comprising:
a display [the display of the alarm unit 203 may display a cognitive reasoning skills test (Halff Col 6:63-64)]; and
a processor [the alarm unit 103 is implemented by processor circuitry executing computer instructions to cause the processor circuitry to perform alarm unit functions (Halff Col 3:2-4)] configured to:
display, via the display, a plurality of self-treat tests configured to test a user's capability of self-treating an extreme diabetic state, wherein the plurality of self-treat tests comprises a first self-treat test comprising a first pass/fail criteria to test the user's capability of self-treating the extreme diabetic state, and wherein the plurality of self-treat tests comprises a second self-treat test comprising a second pass/fail criteria to test the user's capability of self-treating the extreme diabetic state in a different manner than the first pass/fail criteria of the first self-treat test [the user of the glucose monitoring device can specify the order in which the actions are selected and can specify the time given the user to solve a cognitive reasoning skills test before a next action is selected. In some embodiments, the user can select a type of cognitive reasoning skills test, such as, for example, one of an arithmetic problem, a spelling test, a password request, and a fact question (Halff Col 4:15-22); the display of the alarm unit 203 may display a cognitive reasoning skills test (Halff Col 6:63-64); The alarm unit application may also cause the mobile device 303 to display a cognitive reasoning skills test and to receive input of an answer to the cognitive reasoning skills test (Halff Col 7:32-35)];
enable, in response to a user selection, a the first self-treat test or the second self-treat of the plurality of self-treat tests, wherein the first self-treat testis enabled to configure the first pass/fail criteria to test the user's capability of self-treating an extreme diabetic state, and wherein the second self-treat test is enabled to configure the second pass/fail criteria to test the user's capability of self- treating extreme diabetic state [Halff Col 4:15-22, 6:63-64, 7:32-35; The user's ability to solve the problem is indicative of the user's cognitive ability to attend to the event. The problem to be solved may be an arithmetic problem, a spelling test, a password request, a fact question, or any combination thereof. Other cognitive reasoning skills tests can be provided (Col 5:22-27)];
detect, from first information from a glucose monitoring device, that a blood- glucose level of a user is between a high-end threshold and a low-end threshold [a remote continuous glucose sensor that the user 101 places under the skin to detect glucose in interstitial tissue may wirelessly transmit the sensed glucose level to the glucose monitoring device 104 so that the glucose monitoring device 104 can detect a low or high blood glucose event, for example… the glucose monitoring device 104 may detect an event such as low blood glucose level, high blood glucose level, high glucose rate of change, low power, low memory, or other condition that warrants prompt attention (Halff Col 2:62-37, 42-46), wherein identifying low/high blood glucose level from a normal level through continuous monitoring is also considered to read on identifying a normal blood glucose level (a blood-glucose level between a high-end threshold and a low-end threshold)];
establish a first baseline response associated with the user for the first self-treat test from which subsequent responses to the enabled first self-treat test may be compared, wherein the first baseline response is established based on a first response associated with the first pass/fail criteria for the first self-treat test [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35; The functionality of an alarm unit may include generating and rendering a cognitive reasoning skills test, at 718. Such a test may include an arithmetic test, a spelling test, a pass code request, a fact question, or other test. The functionality may include receiving input from a keypad, touch screen, or other input technology, in response to a prompt to enter a response to the cognitive reasoning skills test (Halff Col 10:37-43), wherein the cognitive reasoning skills tests being pass/fail defines a correct “baseline response” for comparison of later input answers to];
establish a second baseline response associated with the user for the second self-treat test from which subsequent responses to the enabled second self-treat test maybe compared, wherein the second baseline response for the second self- treat testis established based on a second response associated with the second pass/fail criteria for the second self-treat test on the mobile device [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42, wherein the cognitive reasoning skills tests being pass/fail defines a correct “baseline response” for comparison of later input answers to];
detect, from second information from the blood glucose monitoring device, a triggering event associated with an extreme diabetic state in response to the blood- glucose level of the user being above the high-end threshold or below the low-end threshold [Halff Col 2:62-37, 42-46];
provide, based on the user selection in response to the detecting of the triggering event associated with the extreme diabetic state, the enabled first self-treat test to test the user's capability of self-treating the extreme diabetic state based on the first pass/fail criteria or the enabled second self-treat test to test the user's capability of self- treating the extreme diabetic state based on the second pass/fail criteria [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42];
receive a third response to the enabled first self-treat test or to the enabled second self-treat test [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42];
compare the third response to the first baseline response or the second baseline response associated with the user based on the first pass/fail criteria associated with the first self-treat test or the second pass/fail criteria associated with the second self-treat test being enabled in response to the user selection [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42];
determine, based on the comparison, whether the third response is within a predefined deviation from the established first baseline response or the established second baseline response associated with the user [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42];
when the third response is outside of the predefined deviation from the established first baseline response or the established second baseline response associated with the user, communicate a diabetes-related alert configured to solicit assistance in treatment of the extreme diabetic state [If the user of the glucose monitoring device does not solve a cognitive reasoning skills test within a certain period of time, the alarm center 110 may then initiate a call to an emergency rescuer (Halff Col 4:63-66)]; and
when the third response is within the predefined deviation from the established first baseline response or the established second baseline response associated with the user, determine that the user is capable of self-treating the extreme diabetic state and continue to monitor the blood-glucose level of the user [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42].
However, Halff fails to explicitly disclose wherein establishing the first baseline response associated with the user for the first self-treat test and establishing the second baseline response associated with the user for the second self-treat test are each performed while the blood-glucose level of the user is detected between the high-end threshold and the low-end threshold.
Volpe discloses systems and methods to monitor a user’s blood glucose to identify an abnormality event [Aspects of the present disclosure are directed to monitoring and/or therapeutic medical devices configured to identify a patient physiological event and, in response to the identified event, to provide a notification to the patient wearing the device. The notification can include an instruction or request to perform a patient response activity. Successful completion of the patient response activity can cause the device to suspend or delay a device function, such as administering a treatment to a patient and/or issuing an alert or alarm (Volpe ¶0094); The controller can be configured to detect the patient physiological event based, at least in part, on the sensed physiological information. A patient event can be a temporary physiological problem or abnormality, which can be representative of an underlying patient condition (Volpe ¶0095)], wherein Volpe discloses blood glucose as a relevant patient parameter to measure [In some examples, the medical device can be a patient monitoring device, which can be configured to monitor one or more of a patient's physiological parameters without an accompanying treatment component… In addition to cardiac monitoring, the patient monitor may perform monitoring of other relevant patient parameters, including glucose levels (Volpe ¶0099)], and wherein Volpe discloses notifying the user upon detection of the event and requesting a user response indicative of cognitive function or manual dexterity [the device controller is configured to notify the patient of the detection of the one or more events and to receive a patient response to the notification. The patient response can include performing a response activity identifiable by an input component associated with the medical device. In general, the response activity is selected to demonstrate or to provide information about the status of the patient and, in particular, to confirm that the patient is conscious and substantially aware of his or her surroundings… The response activity can also demonstrate or test a patient ability such as one or more of psychomotor ability, cognitive awareness, and athletic/movement ability. In some examples, the response activity can be a relatively simple action, such as making a simple or reflexive movement in response to a stimulus applied by the device. In other examples, more complex activities, such provided answers to questions requiring reasoning and logical analysis can be required (Volpe ¶0096)]. Volpe further discloses establishing a baseline response associated with the user while the user is in a normal state [In some examples, baseline characteristics for a particular patient can also be determined, for example, during a patient's meeting with the PSR. For example, baseline values related to a patient's cognitive ability and movement ability can be determined… The results of the baseline test and other recorded information can be compared to patient responses given in response to patient notifications when the device is in use. Changes in a patient's cognitive ability could indicate that the patient has experienced a physiological event, such as a stroke. Similarly, changes in speech patterns or movement ability, as evidenced by comparing an initial recording or patient baseline score to a score obtained in response to a patient notification, could be used to confirm that the patient is in distress or, in some cases, to determine a level of physiological distress of the patient (Volpe ¶0150), wherein establishing a baseline cognitive ability or movement ability is considered to read on the user being in a “normal” state that does not require medical intervention].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Halff to employ wherein establishing the first baseline response associated with the user for the first self-treat test and establishing the second baseline response associated with the user for the second self-treat test are each performed while the blood-glucose level of the user is detected between the high-end threshold and the low-end threshold, so as to allow for a comparison to the user’s response in a normal state when assessing the user’s cognitive function or manual dexterity.
Regarding claim 32, Halff in view of Volpe teaches
The apparatus of claim 31, wherein the first self-treat test comprises a manual dexterity test [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42, wherein correctly typing a response is considered to read on the broadest reasonable interpretation of a “manual dexterity” test] and the second self-treat test comprises a cognitive test [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42], wherein the enabled self-treat test in response to the user selection comprises the manual dexterity test, wherein the first baseline response comprises a measured first manual dexterity of the user, wherein the third response comprises a measured second manual dexterity of the user [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42], the processor being further configured to, in response to the second manual dexterity of the user being outside of the predefined deviation from the established first baseline response associated with the manual dexterity of the user, provide the cognitive test to detect a cognitive ability of the user, wherein the second pass/fail criteria of the cognitive test comprises at least one question [when a user answers the cognitive reasoning skills test incorrectly, another cognitive reasoning skills test is presented that is different from the incorrectly answered cognitive reasoning skills test (Halff Col 4:5-8); Halff 7:32-35, 10:37-42], and wherein the processor is configured to communicate the diabetes-related alert when at least one answer to the at least one question is outside of a predefined deviation from the established second baseline associated with the cognitive ability of the user [Halff Col 4:63-66].
Regarding claim 37, Halff in view of Volpe teaches
The apparatus of claim 31, wherein the enabled first self-treat test comprises a cognitive test to detect a cognitive ability of the user, wherein the first pass/fail criteria of the cognitive test comprises at least one question, and wherein the first baseline response and the third response each comprise an indication of at least one answer to the at least one question [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42].
Regarding claim 38, Halff teaches
A non-transitory computer-readable medium having computer-executable instructions stored thereon that are configured to, when executed by a processor [the alarm unit 103 is implemented by processor circuitry executing computer instructions to cause the processor circuitry to perform alarm unit functions (Halff Col 3:2-4)], cause the processor to:
display, via a display, a plurality of self-treat tests configured to test a user's capability of self-treating an extreme diabetic state, wherein the plurality of self-treat tests comprises a first self-treat test comprising a first pass/fail criteria to test the user's capability of self-treating the extreme diabetic state, and wherein the plurality of self-treat tests comprises a second self-treat test comprising a second pass/fail criteria to test the user's capability of self-treating the extreme diabetic state in a different manner than the first pass/fail criteria of the first self-treat test [the user of the glucose monitoring device can specify the order in which the actions are selected and can specify the time given the user to solve a cognitive reasoning skills test before a next action is selected. In some embodiments, the user can select a type of cognitive reasoning skills test, such as, for example, one of an arithmetic problem, a spelling test, a password request, and a fact question (Halff Col 4:15-22); the display of the alarm unit 203 may display a cognitive reasoning skills test (Halff Col 6:63-64); The alarm unit application may also cause the mobile device 303 to display a cognitive reasoning skills test and to receive input of an answer to the cognitive reasoning skills test (Halff Col 7:32-35)];
enable, in response to a user selection, the first self-treat test or the second self-treat of the plurality of self-treat tests, wherein the first self-treat testis enabled to configure the first pass/fail criteria configured to test the user's capability of self-treating an extreme diabetic state, and wherein the second self-treat testis enabled to configure the second pass/fail criteria to test the user's capability of self-treating extreme diabetic state [Halff Col 4:15-22, 6:63-64, 7:32-35; The user's ability to solve the problem is indicative of the user's cognitive ability to attend to the event. The problem to be solved may be an arithmetic problem, a spelling test, a password request, a fact question, or any combination thereof. Other cognitive reasoning skills tests can be provided (Col 5:22-27)];
detect, from first information from a glucose monitoring device, that a blood-glucose level of a user is between a high-end threshold and a low-end threshold [a remote continuous glucose sensor that the user 101 places under the skin to detect glucose in interstitial tissue may wirelessly transmit the sensed glucose level to the glucose monitoring device 104 so that the glucose monitoring device 104 can detect a low or high blood glucose event, for example… the glucose monitoring device 104 may detect an event such as low blood glucose level, high blood glucose level, high glucose rate of change, low power, low memory, or other condition that warrants prompt attention (Halff Col 2:62-37, 42-46), wherein identifying low/high blood glucose level from a normal level through continuous monitoring is also considered to read on identifying a normal blood glucose level (a blood-glucose level between a high-end threshold and a low-end threshold)];
establish a first baseline response associated with the user for the first self-treat test from which subsequent responses to the enabled first self-treat test may be compared, wherein the first baseline response is established based on the a first response associated with the first pass/fail criteria for the first self-treat test [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35; The functionality of an alarm unit may include generating and rendering a cognitive reasoning skills test, at 718. Such a test may include an arithmetic test, a spelling test, a pass code request, a fact question, or other test. The functionality may include receiving input from a keypad, touch screen, or other input technology, in response to a prompt to enter a response to the cognitive reasoning skills test (Halff Col 10:37-43), wherein the cognitive reasoning skills tests being pass/fail defines a correct “baseline response” for comparison of later input answers to];
establish a second baseline response associated with the user for the second self-treat test from which subsequent responses to the enabled second self-treat test may be compared, wherein the second baseline response for the second self-treat testis established based on a second response associated with the second pass/fail criteria for the second self-treat test [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42, wherein the cognitive reasoning skills tests being pass/fail defines a correct “baseline response” for comparison of later input answers to];
detect, from second information from the blood glucose monitoring device, a triggering event associated with an extreme diabetic state in response to the blood-glucose level of the user being above the high-end threshold or below the low-end threshold [Halff Col 2:62-37, 42-46];
provide, based on the user selection in response to the detecting of the triggering event associated with the extreme diabetic state, the enabled first self-treat test to test the user's capability of self-treating the extreme diabetic state based on the first pass/fail criteria or the enabled second self-treat test to test the user's capability of self-treating the extreme diabetic state based on the second pass/fail criteria [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42];
receive a third response to the enabled first self-treat test or to the enabled second self-treat test [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42];
compare the third response to the first baseline response or the second baseline response associated with the user based on the first pass/fail criteria associated with the first self-treat test or the second pass/fail criteria associated with the second self-treat test that is enabled in response to the user selection [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42];
determine, based on the comparison, whether the third response is within a predefined deviation from the established first baseline response or the established second baseline response associated with the user [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42];
when the third response is outside of the predefined deviation from the established first baseline response or the established second baseline response associated with the user, communicate a diabetes-related alert configured to solicit assistance in treatment of the extreme diabetic state [If the user of the glucose monitoring device does not solve a cognitive reasoning skills test within a certain period of time, the alarm center 110 may then initiate a call to an emergency rescuer (Halff Col 4:63-66)]; and
when the third response is within the predefined deviation from the established first baseline response or the established second baseline response associated with the user, determine that the user is capable of self-treating the extreme diabetic state and continue to monitor the blood-glucose level of the user [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42].
However, Halff fails to explicitly disclose wherein establishing the first baseline response associated with the user for the first self-treat test and establishing the second baseline response associated with the user for the second self-treat test are each performed while the blood-glucose level of the user is detected between the high-end threshold and the low-end threshold.
Volpe discloses systems and methods to monitor a user’s blood glucose to identify an abnormality event [Aspects of the present disclosure are directed to monitoring and/or therapeutic medical devices configured to identify a patient physiological event and, in response to the identified event, to provide a notification to the patient wearing the device. The notification can include an instruction or request to perform a patient response activity. Successful completion of the patient response activity can cause the device to suspend or delay a device function, such as administering a treatment to a patient and/or issuing an alert or alarm (Volpe ¶0094); The controller can be configured to detect the patient physiological event based, at least in part, on the sensed physiological information. A patient event can be a temporary physiological problem or abnormality, which can be representative of an underlying patient condition (Volpe ¶0095)], wherein Volpe discloses blood glucose as a relevant patient parameter to measure [In some examples, the medical device can be a patient monitoring device, which can be configured to monitor one or more of a patient's physiological parameters without an accompanying treatment component… In addition to cardiac monitoring, the patient monitor may perform monitoring of other relevant patient parameters, including glucose levels (Volpe ¶0099)], and wherein Volpe discloses notifying the user upon detection of the event and requesting a user response indicative of cognitive function or manual dexterity [the device controller is configured to notify the patient of the detection of the one or more events and to receive a patient response to the notification. The patient response can include performing a response activity identifiable by an input component associated with the medical device. In general, the response activity is selected to demonstrate or to provide information about the status of the patient and, in particular, to confirm that the patient is conscious and substantially aware of his or her surroundings… The response activity can also demonstrate or test a patient ability such as one or more of psychomotor ability, cognitive awareness, and athletic/movement ability. In some examples, the response activity can be a relatively simple action, such as making a simple or reflexive movement in response to a stimulus applied by the device. In other examples, more complex activities, such provided answers to questions requiring reasoning and logical analysis can be required (Volpe ¶0096)]. Volpe further discloses establishing a baseline response associated with the user while the user is in a normal state [In some examples, baseline characteristics for a particular patient can also be determined, for example, during a patient's meeting with the PSR. For example, baseline values related to a patient's cognitive ability and movement ability can be determined… The results of the baseline test and other recorded information can be compared to patient responses given in response to patient notifications when the device is in use. Changes in a patient's cognitive ability could indicate that the patient has experienced a physiological event, such as a stroke. Similarly, changes in speech patterns or movement ability, as evidenced by comparing an initial recording or patient baseline score to a score obtained in response to a patient notification, could be used to confirm that the patient is in distress or, in some cases, to determine a level of physiological distress of the patient (Volpe ¶0150), wherein establishing a baseline cognitive ability or movement ability is considered to read on the user being in a “normal” state that does not require medical intervention].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the non-transitory computer-readable medium of Halff to employ wherein establishing the first baseline response associated with the user for the first self-treat test and establishing the second baseline response associated with the user for the second self-treat test are each performed while the blood-glucose level of the user is detected between the high-end threshold and the low-end threshold, so as to allow for a comparison to the user’s response in a normal state when assessing the user’s cognitive function or manual dexterity.
Regarding claim 39, Halff in view of Volpe teaches
The non-transitory computer-readable medium of claim 38, wherein the first self-treat test comprises a manual dexterity test [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42, wherein correctly typing a response is considered to read on the broadest reasonable interpretation of a “manual dexterity” test] and the second self-treat test comprises a cognitive test [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42], wherein the enabled self-treat test in response to the user selection comprises the manual dexterity test, wherein the first baseline response comprises a measured first manual dexterity of the user, wherein the third response comprises a measured second manual dexterity of the user [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42], the processor being further configured to, in response to the second manual dexterity of the user being outside of the predefined deviation from the established first baseline response associated with the manual dexterity of the user, provide the cognitive test to detect a cognitive ability of the user, wherein the second pass/fail criteria of the cognitive test comprises at least one question [when a user answers the cognitive reasoning skills test incorrectly, another cognitive reasoning skills test is presented that is different from the incorrectly answered cognitive reasoning skills test (Halff Col 4:5-8); Halff 7:32-35, 10:37-42], and wherein the processor is configured to communicate the diabetes-related alert when at least one answer to the at least one question is outside of a predefined deviation from the established second baseline associated with the cognitive ability of the user [Halff Col 4:63-66].
Regarding claim 42, Halff in view of Volpe teaches
The non-transitory computer-readable medium of claim 38, wherein the enabled first self-treat tests comprise a cognitive test to detect a cognitive ability of the user, wherein the first pass/fail criteria of the cognitive test comprises at least one question, and wherein the first baseline response and the third response each comprise an indication of at least one answer to the at least one question [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42].
Regarding claim 44, Halff in view of Volpe teaches
The non-transitory computer-readable medium of claim 42, wherein the instructions being configured to cause the processor to provide the cognitive test comprises the instructions being configured cause the processor to overlay the at least one question on a lock screen, a home screen, or another application displayed on a mobile device [Halff 7:32-35, 10:37-42].
Claim(s) 2-3, 34, and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halff in view of Volpe, as applied to claim 1, 31, and 38 above, in further view of Costa (US-20140330159-A1, previously presented).
Regarding claim 2, Halff in view of Volpe teaches
The method of claim 1, wherein the first self-treat test comprises a manual dexterity test [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42, wherein correctly typing a response is considered to read on the broadest reasonable interpretation of a “manual dexterity” test].
However, while Halff notes that other types of cognitive reasoning skills tests from what is explicitly disclosed in Halff may be provided [Other cognitive reasoning skills tests can be provided (Halff Col 5:26-27)], Halff in view of Volpe as presently modified fails to explicitly disclose wherein the manual dexterity test is configured to test an ability of the user to trace a displayed shape on the mobile device, and wherein the first pass/fail criteria of the manual dexterity test comprises an ability of the user to trace the displayed shape on the mobile device within a predefined distance.
Volpe discloses a manual dexterity test that is configured to test an ability of the user to trace a displayed shape on the mobile device [the device can display a patient response screen 720 including an instruction to perform a task representative of, for example, psychomotor ability and/or cognitive ability of the patient (Volpe ¶0172); the task or response activity can include drawing or tracing a figure on the touch screen display. As shown in screen 720, a series of dots 722 are illustrated. The patient is instructed to trace a path by connecting the dots 722 as described by explanatory text 724. The patient can complete the task by touching the screen 720 at a first dot and, while maintaining contact with the touch screen display, tracing a path connecting each of the series of dots 722 (Volpe ¶0173, Figs. 7-8); If the patient response substantially corresponds to an expected response (e.g., the path connects the dots in the correct order), the controller 120 can be configured to suspend or delay treatment (Volpe ¶0174), wherein the dots as depicted in Volpe Figs. 7-8 may be considered to define a shape to be traced].
Costa discloses systems for assessing a user’s cognitive status and motor skills, wherein Costa discloses a manual dexterity test configured to test an ability of the user to trace a displayed shape on a mobile device [one or more software application programs can be executed by the processor 112 to cause the circle and the object to appear on the screen. Other indicia (not shown), such as instructions and a count-down timer can be provided to assist the subject in performing the task. The subject can be instructed to perform the task of following the object around the circle and the task monitoring device 120 can sense the position of the subject's finger (or a pointing device, such as a stylus) and transfer this information to the computer system 110. The computer system 110, under software application control can record the position information along with time synchronization information (Costa ¶0042), wherein the test of Costa being employed to assess cognitive status and motor skills is considered to define a “manual dexterity” test (see Costa ¶0069, which while discloses application of the tests of Costa in the field of sobriety testing, is still understood to define tests indicative of a subject’s motor skills, which is considered to be equivalent to manual dexterity], wherein a pass/fail criteria of the manual dexterity test comprises an ability of the user to trace the displayed shape on the mobile device within a predefined distance [This micro-error signal can also be calculated by determining the difference between the stylus position and the target region. In some embodiments of the invention, the micro-error signal can include position (angular or Cartesian coordinates) (Costa ¶0055)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Halff in view of Volpe to employ a manual dexterity test configured to test an ability of the user to trace a displayed shape on the mobile device, and wherein a pass/fail criteria of the manual dexterity test comprises an ability of the user to trace the displayed shape on the mobile device within a predefined distance, as testing an ability of the user to trace a displayed shape is considered to be indicative of possible impairment of the user’s motor skills [Costa ¶¶0042,0069] and as this modification would amount to applying a known technique [“manual dexterity” test of Costa] to a known device (method, or product) ready for improvement [method of Halff in view of Volpe that assesses a user’s manual dexterity] to yield predictable results [assess a user’s manual dexterity] [MPEP § 2143(I)(D)].
Regarding claim 3, Halff in view of Volpe and Costa teaches
The method of claim 2, wherein the second self-treat test comprises a cognitive test [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42], wherein the first baseline response indicates a baseline manual dexterity associated with the user, wherein the third response comprises a measured second manual dexterity of the user [see § 103 modification of claim 2 above; Costa ¶¶0042, 0055, 0069], the method further comprising, in response to the second manual dexterity of the user being outside of the predefined deviation from the established first baseline response associated with the manual dexterity of the user, providing the cognitive test via the mobile device to detect a cognitive ability of the user by overlaying a question on a lock screen, a home screen, or another application displayed on the mobile device wherein the second pass/fail criteria of the cognitive test comprise at least one question [when a user answers the cognitive reasoning skills test incorrectly, another cognitive reasoning skills test is presented that is different from the incorrectly answered cognitive reasoning skills test (Halff Col 4:5-8); Halff 7:32-35, 10:37-42], and wherein the diabetes-related alert is communicated when an answer to the at least one question is outside of a predefined deviation from the established second baseline associated with the cognitive ability of the user [Halff Col 4:63-66].
Regarding claim 34, Halff in view of Volpe teaches
The apparatus of claim 31, wherein the enabled first self-treat test comprises a manual dexterity test [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42, wherein correctly typing a response is considered to read on the broadest reasonable interpretation of a “manual dexterity” test].
However, while Halff notes that other types of cognitive reasoning skills tests from what is explicitly disclosed in Halff may be provided [Other cognitive reasoning skills tests can be provided (Halff Col 5:26-27)], Halff in view of Volpe as presently modified fails to explicitly disclose wherein the manual dexterity test is configured to test an ability of the user to trace a displayed shape on the display, and wherein the first pass/fail criteria of the manual dexterity test comprises an ability of the user to trace the displayed shape on the display within a predefined distance.
Volpe discloses a manual dexterity test that is configured to test an ability of the user to trace a displayed shape on the mobile device [Volpe ¶¶0172-0174, Figs. 7-8, wherein the dots as depicted in Volpe Figs. 7-8 may be considered to define a shape to be traced].
Costa discloses systems for assessing a user’s cognitive status and motor skills, wherein Costa discloses a manual dexterity test configured to test an ability of the user to trace a displayed shape on a mobile device [Costa ¶0042, wherein the test of Costa being employed to assess cognitive status and motor skills is considered to define a “manual dexterity” test (see Costa ¶0069, which while discloses application of the tests of Costa in the field of sobriety testing, is still understood to define tests indicative of a subject’s motor skills, which is considered to be equivalent to manual dexterity], wherein a pass/fail criteria of the manual dexterity test comprises an ability of the user to trace the displayed shape on the mobile device within a predefined distance [Costa ¶0055].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Halff in view of Volpe to employ wherein the manual dexterity test is configured to test an ability of the user to trace a displayed shape on the display, and wherein the first pass/fail criteria of the manual dexterity test comprises an ability of the user to trace the displayed shape on the display within a predefined distance, as testing an ability of the user to trace a displayed shape is considered to be indicative of possible impairment of the user’s motor skills [Costa ¶¶0042,0069] and as this modification would amount to applying a known technique [“manual dexterity” test of Costa] to a known device (method, or product) ready for improvement [method of Halff in view of Volpe that assesses a user’s manual dexterity] to yield predictable results [assess a user’s manual dexterity] [MPEP § 2143(I)(D)].
Regarding claim 41, Halff in view of Volpe teaches
The non-transitory computer-readable medium of claim 38, wherein the enabled first self-treat test comprises a manual dexterity test [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42, wherein correctly typing a response is considered to read on the broadest reasonable interpretation of a “manual dexterity” test].
However, while Halff notes that other types of cognitive reasoning skills tests from what is explicitly disclosed in Halff may be provided [Other cognitive reasoning skills tests can be provided (Halff Col 5:26-27)], Halff in view of Volpe as presently modified fails to explicitly disclose wherein the manual dexterity test is configured to test an ability of the user to trace a displayed shape on the display, and wherein the first pass/fail criteria of the manual dexterity test comprises an ability of the user to trace the displayed shape on the display within a predefined distance.
Volpe discloses a manual dexterity test that is configured to test an ability of the user to trace a displayed shape on the mobile device [Volpe ¶¶0172-0174, Figs. 7-8, wherein the dots as depicted in Volpe Figs. 7-8 may be considered to define a shape to be traced].
Costa discloses systems for assessing a user’s cognitive status and motor skills, wherein Costa discloses a manual dexterity test configured to test an ability of the user to trace a displayed shape on a mobile device [Costa ¶0042, wherein the test of Costa being employed to assess cognitive status and motor skills is considered to define a “manual dexterity” test (see Costa ¶0069, which while discloses application of the tests of Costa in the field of sobriety testing, is still understood to define tests indicative of a subject’s motor skills, which is considered to be equivalent to manual dexterity], wherein a pass/fail criteria of the manual dexterity test comprises an ability of the user to trace the displayed shape on the mobile device within a predefined distance [Costa ¶0055].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the non-transitory computer-readable medium of Halff in view of Volpe to employ wherein the manual dexterity test is configured to test an ability of the user to trace a displayed shape on the display, and wherein the first pass/fail criteria of the manual dexterity test comprises an ability of the user to trace the displayed shape on the display within a predefined distance, as testing an ability of the user to trace a displayed shape is considered to be indicative of possible impairment of the user’s motor skills [Costa ¶¶0042,0069] and as this modification would amount to applying a known technique [“manual dexterity” test of Costa] to a known device (method, or product) ready for improvement [method of Halff in view of Volpe that assesses a user’s manual dexterity] to yield predictable results [assess a user’s manual dexterity] [MPEP § 2143(I)(D)].
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halff in view of Volpe and Costa, as applied to claim 3 above, in further view of Davis (US-9974903-B1, previously presented).
Regarding claim 4, Halff in view of Volpe and Costa teaches
The method of claim 3.
However, Halff in view of Volpe and Costa fails to explicitly disclose wherein the baseline manual dexterity of the user and the second manual dexterity of the user are measured using at least one sensor, wherein the at least one sensor includes an accelerometer or a gyroscope, wherein the first pass/fail criteria of the manual dexterity test comprises a relative change in acceleration or a relative change in orientation of the mobile device measured over a period of time, and wherein the baseline manual dexterity of the user and the second manual dexterity of the user each comprises a measurement of the acceleration of the mobile device based on accelerometer data or an indication of the orientation of the mobile device based on gyroscope data.
Davis discloses systems and methods for monitoring blood glucose and providing a manual dexterity test to the user upon determining an extreme diabetic event, wherein Davis discloses a baseline manual dexterity of the user and a measured manual dexterity of the user are measured using at least one sensor, wherein the at least one sensor includes an accelerometer or a gyroscope [The estimating or predicting a cognitive awareness of the user may be based at least partially on real-time data, and where the real-time data may include one or more of the following:… data associated with an accelerometer in the monitoring device, data associated with behavioral or contextual information (Davis Col 5:29-35); data from a user interface may be employed to measure what a “significant” amount of user interaction is, relative to a “normal” or “typical” amount. For example, a normal or typical amount may be determined by user input data over time, e.g., via an average number of apps opened or taps per minute or per hour. That number may be employed as the basis for a threshold… Haphazard and frantic interaction of such apps may indicate user cognitive unawareness and a desire for interaction. The measurement of haphazard and frantic interaction may in some implementations take into account accelerometer data, e.g., where the device is being handled in a frantic way. The smart alert would be generated in this instance (Davis Col 24:15-21, 33-39); Context information can include a frequency of touching or grabbing the monitoring device, even if not interacted with, based on a sensed motion of the device, e.g., from an in-device accelerometer and/or application (Davis Col 28:43-47)], wherein a pass/fail criteria of the manual dexterity test comprises a relative change in acceleration or a relative change in orientation of the mobile device measured over a period of time [Davis Col 5:29-35; Col 24:15-21, 33-39; Col 28:43-47], and wherein the baseline manual dexterity of the user and the measured manual dexterity of the user each comprises a measurement of the acceleration of a mobile device based on accelerometer data or an indication of the orientation of the mobile device based on gyroscope data [Davis Col 5:29-35; Col 24:15-21, 33-39; Col 28:43-47].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Halff in view of Volpe and Costa to employ wherein the baseline manual dexterity of the user and the second manual dexterity of the user are measured using at least one sensor, wherein the at least one sensor includes an accelerometer or a gyroscope, wherein the first pass/fail criteria of the manual dexterity test comprises a relative change in acceleration or a relative change in orientation of the mobile device measured over a period of time, and wherein the baseline manual dexterity of the user and the second manual dexterity of the user each comprises a measurement of the acceleration of the mobile device based on accelerometer data or an indication of the orientation of the mobile device based on gyroscope data, as a measured relative change in acceleration as compared to a baselines relative change in acceleration is considered to be indicative of user manual dexterity/cognitive awareness.
Claim(s) 8, 33, 35, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halff in view of Volpe, as applied to claims 1, 31, and 38 above, in further view of Davis.
Regarding claim 8, Halff in view of Volpe teaches
The method of claim 1, wherein the first self-treat testis enabled based on the user selection, the metho further comprising:
enabling, in response to another user selection received via the mobile device, the second self-treat test instead of the first self-treat test to configure the second pass/fail criteria to be provided via the mobile device to test the user's capability of self-treating extreme diabetic state [Halff Col 4:15-22];
detecting, via the mobile device, from third information from the glucose monitoring device, another triggering event associated with the extreme diabetic state in response to the blood-glucose level of the user being above the high-end threshold or below the low-end threshold [Halff Col 2:62-37, 42-46, wherein continuous monitoring reads on detecting another triggering event];
providing, in response to the another triggering event, the enabled second self- treat test to test the user's capability of sef-treating the extreme diabetic state based on the second pass/fail criteria, wherein the enabled second self-treat test is provided for a period of time [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42]; and
communicating the diabetes-related alert after a failure to receive a user input responding to the enabled second self-treat test within the period of time [Halff Col 4:63-66].
However, while Halff discloses modifying the period of time for providing the enabled second self-treat test [Also, an amount of time given to respond to a first action may be specified to be different from an amount of time given to respond to a second action (Halff Col 4:22-24)], Halff in view of Volpe fails to explicitly disclose wherein the period of time is based on a severity level associated with the blood-glucose level of the user determined from the third information.
Davis discloses wherein an alert provided to a user regarding a diabetic event may be based on the severity of the diabetic event [instead of basing an alert based on cognitive awareness of the diabetic state warranting attention, this aspect modifies the system definition of the diabetic state warranting attention. In implementations, the amount of alert level increase can be configurable, e.g., from 0 to 200 mg/dL in 25 mg/dL increments, with the default level being 100 mg/dL (Davis Col 22:31-37); Thus, in one implementation, it has been found useful to display on the user interface a current value of glucose, a threshold alert level, e.g., the most relevant threshold alert or alarm level given the current value of glucose, e.g., ‘55’, a symbol, and a color, e.g., yellow or red in the case of a diabetic state warranting attention for which the user is cognitively unaware, the particular color depending on the urgency of the state (Davis Col 39:56-63)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Halff in view of Volpe to employ wherein the period of time is based on a severity level associated with the blood-glucose level of the user determined from the third information, so as to prioritize the urgency of the diabetic event.
Regarding claim 33, Halff in view of Volpe teaches
The apparatus of claim 31, wherein the enabled first self-treat test comprises a manual dexterity test [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42, wherein correctly typing a response is considered to read on the broadest reasonable interpretation of a “manual dexterity” test].
However, Halff in view of Volpe fails to explicitly disclose further comprising at least one sensor, wherein the first baseline response comprises a measured first manual dexterity of the user, wherein the third response comprises a measured second manual dexterity of the user, wherein the at least one sensor comprises an accelerometer or gyroscope, wherein the first pass/fail criteria of the manual dexterity test comprises a relative change in acceleration or a relative change in orientation of the apparatus measured over a period of time, and wherein the first manual dexterity of the user and the second manual dexterity of the user each comprises a measurement of the acceleration of the apparatus based on accelerometer data or an indication of the orientation of the apparatus based on gyroscope data.
Davis discloses systems and methods for monitoring blood glucose and providing a manual dexterity test to the user upon determining an extreme diabetic event, wherein Davis discloses a baseline manual dexterity of the user and a measured manual dexterity of the user are measured using at least one sensor, wherein the at least one sensor includes an accelerometer or a gyroscope [Davis Col 5:29-35, 24:15-21, 33-39, 28:43-47], wherein a pass/fail criteria of the manual dexterity test comprises a relative change in acceleration or a relative change in orientation of the mobile device measured over a period of time [Davis Col 5:29-35; Col 24:15-21, 33-39; Col 28:43-47], and wherein the baseline manual dexterity of the user and the measured manual dexterity of the user each comprises a measurement of the acceleration of a mobile device based on accelerometer data or an indication of the orientation of the mobile device based on gyroscope data [Davis Col 5:29-35; Col 24:15-21, 33-39; Col 28:43-47].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Halff in view of Volpe and Costa to employ further comprising at least one sensor, wherein the first baseline response comprises a measured first manual dexterity of the user, wherein the third response comprises a measured second manual dexterity of the user, wherein the at least one sensor comprises an accelerometer or gyroscope, wherein the first pass/fail criteria of the manual dexterity test comprises a relative change in acceleration or a relative change in orientation of the apparatus measured over a period of time, and wherein the first manual dexterity of the user and the second manual dexterity of the user each comprises a measurement of the acceleration of the apparatus based on accelerometer data or an indication of the orientation of the apparatus based on gyroscope data, as a measured relative change in acceleration as compared to a baselines relative change in acceleration is considered to be indicative of user manual dexterity/cognitive awareness.
Regarding claim 35, Halff in view of Volpe teaches
The apparatus of claim 31, wherein the processor is further configured to communicate the diabetes-related alert after a failure to receive a user input responding to the enabled first self-treat test or the enabled second self-treat test within the period of time [Halff Col 4:63-66].
However, while Halff discloses modifying the period of time for providing the enabled second self-treat test [Also, an amount of time given to respond to a first action may be specified to be different from an amount of time given to respond to a second action (Halff Col 4:22-24)], Halff in view of Volpe fails to explicitly disclose wherein the period of time is based on a severity level associated with the blood-glucose level of the user determined from the third information.
Davis discloses wherein an alert provided to a user regarding a diabetic event may be based on the severity of the diabetic event [Davis Col 22:31-37, 39:56-63].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Halff in view of Volpe to employ wherein the period of time is based on a severity level associated with the blood-glucose level of the user determined from the third information, so as to prioritize the urgency of the diabetic event.
Regarding claim 40, Halff in view of Volpe teaches
The non-transitory computer-readable medium of claim 38, wherein the selected enabled first self-treat test comprises a manual dexterity test, wherein the first baseline response comprises a measured first manual dexterity of the user, wherein the third response comprises a measured second manual dexterity of the user [Halff Col 4:15-22, 5:22-27, 6:63-64, 7:32-35, 10:37-42, wherein correctly typing a response is considered to read on the broadest reasonable interpretation of a “manual dexterity” test].
However, Halff in view of Volpe and Costa fails to explicitly disclose wherein the instructions are configured to cause the processor to measure the first manual dexterity of the user and the second manual dexterity of the user using at least one sensor, wherein the at least one sensor comprises an accelerometer or gyroscope, wherein the first pass/fail criteria of the manual dexterity test comprises a relative change in acceleration or a relative change in orientation of the display measured over a period of time, and wherein the first manual dexterity of the user and the second manual dexterity of the user each comprises a measurement of the acceleration of the display based on accelerometer data or an indication of the orientation of the display based on gyroscope data.
Davis discloses systems and methods for monitoring blood glucose and providing a manual dexterity test to the user upon determining an extreme diabetic event, wherein Davis discloses a baseline manual dexterity of the user and a measured manual dexterity of the user are measured using at least one sensor, wherein the at least one sensor includes an accelerometer or a gyroscope [Davis Col 5:29-35, 24:15-21, 33-39, 28:43-47], wherein a pass/fail criteria of the manual dexterity test comprises a relative change in acceleration or a relative change in orientation of the mobile device measured over a period of time [Davis Col 5:29-35; Col 24:15-21, 33-39; Col 28:43-47], and wherein the baseline manual dexterity of the user and the measured manual dexterity of the user each comprises a measurement of the acceleration of a mobile device based on accelerometer data or an indication of the orientation of the mobile device based on gyroscope data [Davis Col 5:29-35; Col 24:15-21, 33-39; Col 28:43-47].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the non-transitory computer-readable medium of Halff in view of Volpe and Costa to employ wherein the instructions are configured to cause the processor to measure the first manual dexterity of the user and the second manual dexterity of the user using at least one sensor, wherein the at least one sensor comprises an accelerometer or gyroscope, wherein the first pass/fail criteria of the manual dexterity test comprises a relative change in acceleration or a relative change in orientation of the display measured over a period of time, and wherein the first manual dexterity of the user and the second manual dexterity of the user each comprises a measurement of the acceleration of the display based on accelerometer data or an indication of the orientation of the display based on gyroscope data, as a measured relative change in acceleration as compared to a baselines relative change in acceleration is considered to be indicative of user manual dexterity/cognitive awareness.
Claim(s) 11, 36, and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halff in view of Volpe, as applied to claims 1, 31, and 38 above, in further view of Wilson (US-20190361437-A1, effective filing date of 22 May 2018).
Regarding claim 11, Halff in view of Volpe teaches
The method of claim 1, further comprising:
displaying a suggestion of a remedial action on the mobile device in response to the third response being within the predefined deviation from the established first baseline response or the established second baseline response associated with the user [a user can input a solution to the cognitive skills reasoning test using the keypad 614 or a touch tone screen. In response, the alarm unit 603 may cause display of a suggested remedial action at the display 612 (Halff Col 9:3-7)].
However, Halff is non-specific regarding the remedial action to be taken, such that Halff in view of Volpe fails to explicitly disclose wherein the displaying of the suggestion is a request to communicate the diabetes-related alert, and wherein the diabetes-related alert is communicated in response to receipt of a user indication to communicate the diabetes-related alert.
Volpe discloses functionality of a user interface to prompt the user to contact medical attention even if the user is capable of self-treating a medical event [If a suitable patient response to the second notification 519 is received, as indicated by box 522b, the controller 120 can be configured to suspend or cancel treatment… In some examples, the treatment suspended screen 534 can include an instruction to contact a patient service representative (PSR) for assistance (Volpe ¶0121); After treatment is completed, the patient interface can be configured to provide a treatment completed screen 726… The screen 726 can also include instructions that the patient or a bystander should follow for caring for the patient after the treatment is administered. For example, appropriate care can include seeking medical attention immediately. The patient or a bystander can also be instructed to call the patient's PSR to check the status of the device to confirm that the device is operating normally following the treatment event. The screen 726 can also ask the patient to acknowledge that he or she understands, such as touching an “Agree” button 728 (Volpe ¶0177)].
Wilson discloses systems and methods for monitoring a user for a medical condition, wherein Wilson discloses prompting the user with a request to communicate a medical condition-related alert, wherein the medical condition-related alert is communicated in response to receipt of a user indication to communicate the medical condition-related alert [receiving direct input from a passenger indicating a medical emergency (e.g., a passenger saying “help me”) (Wilson ¶0046); In some embodiments, operation 304 comprises interacting with the user and requesting the user confirm the detected medical condition. For example, the autonomous vehicle can verbally or textually ask the passenger if the passenger is experiencing the detected medical condition. In another example, the autonomous vehicle can provide an indication that the autonomous vehicle will contact an emergency service in a certain amount of time (e.g., five seconds) unless receiving an input from the passenger (e.g., the passenger touching a button on a touchscreen, the passenger stating that s/he does not need medical assistance, etc.) (Wilson ¶0055)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Halff in view of Volpe to employ wherein the displaying of the suggestion is a request to communicate the diabetes-related alert, and wherein the diabetes-related alert is communicated in response to receipt of a user indication to communicate the diabetes-related alert, so as to allow for user control of requesting medical assistance.
Regarding claim 36, Halff in view of Volpe teaches
The apparatus of claim 31, wherein the processor is further configured to display a suggestion of a remedial action on the display in response to the third response being within the predefined deviation from the established first baseline response or the established second baseline response associated with the user [Halff Col 9:3-7].
However, Halff is non-specific regarding the remedial action to be taken, such that Halff in view of Volpe fails to explicitly disclose wherein the displaying of the suggestion is a request to communicate the diabetes-related alert, and wherein the processor is further configured to communicate the diabetes-related alert in response to receipt of a user indication to communicate the diabetes-related alert.
Volpe discloses functionality of a user interface to prompt the user to contact medical attention even if the user is capable of self-treating a medical event [Volpe ¶¶0121, 0177].
Wilson discloses systems and methods for monitoring a user for a medical condition, wherein Wilson discloses prompting the user with a request to communicate a medical condition-related alert, wherein the medical condition-related alert is communicated in response to receipt of a user indication to communicate the medical condition-related alert [Wilson ¶¶0046, 0055].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Halff in view of Volpe to employ wherein the displaying of the suggestion is a request to communicate the diabetes-related alert, and wherein the processor is further configured to communicate the diabetes-related alert in response to receipt of a user indication to communicate the diabetes-related alert, so as to allow for user control of requesting medical assistance.
Regarding claim 43, Halff in view of Volpe teaches
The non-transitory computer-readable medium of claim 38, wherein the instructions are further configured to cause the processor to:
display a suggestion of a remedial action on a display in response to the third response being within the predefined deviation from the established first baseline response or the established second baseline response associated with the user [Halff Col 9:3-7].
However, Halff is non-specific regarding the remedial action to be taken, such that Halff in view of Volpe fails to explicitly disclose wherein the displaying of the suggestion is a request to communicate the diabetes-related alert, and to communicate the diabetes-related alert in response to receipt of a user indication to communicate the diabetes-related alert.
Volpe discloses functionality of a user interface to prompt the user to contact medical attention even if the user is capable of self-treating a medical event [Volpe ¶¶0121, 0177].
Wilson discloses systems and methods for monitoring a user for a medical condition, wherein Wilson discloses prompting the user with a request to communicate a medical condition-related alert, wherein the medical condition-related alert is communicated in response to receipt of a user indication to communicate the medical condition-related alert [Wilson ¶¶0046, 0055].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the non-transitory computer-readable medium of Halff in view of Volpe to employ wherein the displaying of the suggestion is a request to communicate the diabetes-related alert, and communicate the diabetes-related alert in response to receipt of a user indication to communicate the diabetes-related alert, so as to allow for user control of requesting medical assistance.
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 17, filed 16 January 2026, with respect to the previously presented claim objections have been fully considered and are persuasive. The objections to claims 1, 31, and 44 have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 17-20, with respect to the rejection(s) of claim(s) 1, 31, and 38 under § 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection(s) has/have been withdrawn. However, upon further consideration, a new ground(s) of rejection with respect to each of claims 1, 31, and 38 is made under § 103 as being obvious over Halff (US-8803688-B2, cited by Applicant) in view of Volpe (US-20170188979-A1).
The Applicant asserts that the amended limitations wherein the plurality of self-treat tests comprises a first self-treat test comprising a first pass/fail criteria to test the user’s capability of self-treating the extreme diabetic state and a second self-treat test comprising a second pass/fail criteria to test the user’s capability of self-treating the extreme diabetic state in a different manner than the first pass/fail criteria of the first self-treat test, as well as enabling, in response to a user selection received via the mobile device, the first self-treat test or the second self-treat test of the plurality of self-treat tests to configure the first pass/fail criteria or the second pass/fail criteria to test the user’s capability of self-treating extreme diabetic state fails to be taught by Davis, as the Applicant notes that the selections in Davis are for configuring how the alerts are provided, and not for different self-treat tests with different pass/fail criteria for testing the user’s capability of self-treating an extreme diabetic state; and wherein the Applicant further notes that Davis fails to teach establishing a baseline response for each self-treat test and comparing the baseline response of the enabled self-treat test to a subsequent response to the enabled self-treat test for determining whether to provide a diabetes-related alert. However, the Examiner notes that the Applicant’s arguments with respect to claim(s) 1, 31, and 38 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Halff in view of Volpe is presently applied to teach the argued subject matter [the user of the glucose monitoring device can specify the order in which the actions are selected and can specify the time given the user to solve a cognitive reasoning skills test before a next action is selected. In some embodiments, the user can select a type of cognitive reasoning skills test, such as, for example, one of an arithmetic problem, a spelling test, a password request, and a fact question (Halff Col 4:15-22); the display of the alarm unit 203 may display a cognitive reasoning skills test (Halff Col 6:63-64); The alarm unit application may also cause the mobile device 303 to display a cognitive reasoning skills test and to receive input of an answer to the cognitive reasoning skills test (Halff Col 7:32-35); In some examples, baseline characteristics for a particular patient can also be determined, for example, during a patient's meeting with the PSR. For example, baseline values related to a patient's cognitive ability and movement ability can be determined… The results of the baseline test and other recorded information can be compared to patient responses given in response to patient notifications when the device is in use. Changes in a patient's cognitive ability could indicate that the patient has experienced a physiological event, such as a stroke. Similarly, changes in speech patterns or movement ability, as evidenced by comparing an initial recording or patient baseline score to a score obtained in response to a patient notification, could be used to confirm that the patient is in distress or, in some cases, to determine a level of physiological distress of the patient (Volpe ¶0150), wherein establishing a baseline cognitive ability or movement ability is considered to read on the user being in a “normal” state that does not require medical intervention].
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791