DETAILED ACTION
The present office action represents a nonfinal action on the merits.
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 .
Priority
This application claims the priority date of a provisional application 63/571, 210 dated March 28, 2024.
Status of Claims
Claims 1-102 are cancelled and claims 103-122 are pending.
Claim Rejections - 35 USC § 101
Claims 103-122 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 103-113 are drawn to a method for managing alarm events associated with each of one or more patients, which is within the four statutory categories (i.e., process). Claims 114-122 are drawn to a processing device for managing alarm events associated with each of one or more patients, which is within the four statutory categories (i.e., machine).
Claim 103 recites a method of titrating an insulin dose, the method comprising:
receiving, by a processor in communication with a glucose monitoring device, glucose data collected by the glucose monitoring device over a first period of time, wherein the glucose monitoring device comprises a first portion positioned below a skin surface of a user, and a second portion positioned above the skin surface of the user;
determining, by the processor, to increase, decrease or maintain the insulin dose based on the glucose data collected over the first period of time;
determining, by the processor, that the insulin dose is fully titrated based on one or more full titration criteria;
performing an action, by the processor, when the processor determines that the insulin dose is fully titrated; and
outputting a recommendation for the insulin dose based on the determination to increase, decrease or maintain the insulin dose when the processor determines that the insulin dose is not fully titrated.
Claims 114-122 recite a system for titrating an insulin dose, the system comprising:
a glucose monitoring device, comprising:
a glucose sensor comprising a first portion configured to be positioned under a skin surface of a user for detecting glucose levels in a bodily fluid, and a second portion configured to be arranged above the skin surface of the user, and sensor electronics coupled to the second portion of the glucose sensor and configured to communicate glucose data; and
one or more processors in communication with the glucose monitoring device, a memory coupled to the one or more processors and storing instructions that, when executed by the one or more processors, cause the one or more processors to:
receive glucose data collected by the glucose monitoring device over a first period of time;
determine to increase, decrease or maintain the insulin dose based on the glucose data collected over the first period of time;
determine whether the insulin dose is fully titrated based on one or more full titration criteria;
perform an action when the insulin dose is fully titrated; and
output the recommendation to increase, decrease or maintain the insulin dose when the insulin dose is not fully titrated.
The bolded limitations, given the broadest reasonable interpretation, cover a certain method of organizing human activity. The underlined limitations are not part of the identified abstract idea (the method of organizing human activity) and are deemed “additional elements,” and will be discussed in further detail below.
Dependent claims 104-113 and 115-122 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
The dependent claims include additional limitations but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 103 and 114.
The additional elements from claim 103 include:
a processor (apply it, MPEP 2106.05(f)).
a glucose monitoring device (apply it, MPEP 2106.05(f)).
The additional elements from claim 114 include:
a system (apply it, MPEP 2106.05(f)).
a glucose monitoring device (apply it, MPEP 2106.05(f)).
a glucose sensor (apply it, MPEP 2106.05(f)).
sensor electronics (apply it, MPEP 2106.05(f)).
one or more processors (apply it, MPEP 2106.05(f)).
a memory coupled to the one or more processors and storing instructions that, when executed by the one or more processors, cause the one or more processors to (apply it, MPEP 2106.05(f)).
The dependent claims contain additional elements including:
a display device (apply it, MPEP 2106.05(f)).
a display (apply it, MPEP 2106.05(f)).
Claims 103-122 are not integrated into a practical application because the additional elements (i.e., the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of “a processor”, “a glucose monitoring device”, “a system”, “a glucose sensor”, “sensor electronics”, “one or more processors”, “a memory coupled to the one or more processors and storing instructions that, when executed by the one or more processors, cause the one or more processors to”, “a display device”, “a display”, which amounts to merely invoking a computer as a tool to perform the abstract idea e.g. see Specification Paragraphs [0126]-[0131], [0138], [0145], [0148] (see MPEP 2106.05(f));
Furthermore, the claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e., the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification discloses that the additional elements are well-understood, routine, and conventional in nature (i.e., Paragraphs [0126]-[0131], [0138], [0145], [0148] of the Specification disclose that the additional elements (i.e., a processor, a glucose monitoring device, a system, a glucose sensor, sensor electronics, one or more processors, a memory coupled to the one or more processors and storing instructions that, when executed by the one or more processors, cause the one or more processors to, a display device, a display) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions that are well understood routine, and conventional activities previously known to the pertinent industry (i.e., healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. MPEP 2106.05(d)(II):
Receiving or transmitting data over a network, e.g. see 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); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buy SAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); – similarly, the current invention receives glucose data collected by the glucose monitoring device.
Dependent claims 104-113 and 115-122 include other limitations, but none of these functions are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims similarly represent no more than those found in the independent claims.
Thus, taken alone, the additional elements do not amount to “significantly more” than the above identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves medication dosing and titration or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 103-122 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 103-110, 112, 114-120, and 122 are rejected under 35 U.S.C. 103 as being unpatentable over Alles (U.S. Pub. No. 2024/0148971 A1) in view of Fuchs (U.S. Pub. No. 2024/0008777 A1) and Patek (U.S. Pub. No. 2024/0058532 A1).
Regarding claim 103, Alles discloses a method of titrating an insulin dose, the method comprising (Paragraph [0046] discusses medicament delivery system performs medicament titration of insulin.):
receiving, by a processor in communication with a glucose monitoring device, glucose data collected by the glucose monitoring device over a first period of time (Examiner notes that the prior art does not specifically reference “first” or “second”, however, the patient is monitored continuously and medicated over various time periods.) (Paragraph [0004] discusses the processor establish medicament delivery rate for delivery of medicament to the diabetes patient and to receive continuous glucose level readings of the patient over time.);
determining, by the processor, to increase, decrease or maintain the insulin dose based on the glucose data collected over the first period of time (Paragraphs [0004], [0008], and [0059] discuss the processor adjusts the medicament delivery rate to a new delivery rate for the diabetes patient based on the received glucose level readings as part of the titration, and the processor causes the delivery of medicament to the diabetes patient at the new delivery rate for the next time window, the basal delivery rate and dose in subsequent time windows may be maintained, increased or decreased.);
determining, by the processor, that the insulin dose is titrated based on one or more titration criteria (Paragraphs [0082]-[0083] and FIGS. 3, 19-20 discuss determine whether the end of the time window is reached, the glucose control is good and the titration process stopped.);
performing an action, by the processor, when the processor determines that the insulin dose is titrated (Paragraphs [0005] discuss the processor may be further configured to receive a request to pause medicament delivery and to pause delivery of medicament in response to receipt of the request.).
Alles does not explicitly disclose:
wherein the glucose monitoring device comprises a first portion positioned below a skin surface of a user, and a second portion positioned above the skin surface of the user;
the insulin dose is fully titrated based on one or more full titration criteria;
the insulin dose is fully titrated; and
outputting a recommendation for the insulin dose based on the determination to increase, decrease or maintain the insulin dose when the processor determines that the insulin dose is not fully titrated.
Fuchs teaches:
wherein the glucose monitoring device comprises a first portion positioned below a skin surface of a user, and a second portion positioned above the skin surface of the user (Paragraphs [0005], [0048], and FIGS. 3A-3D discuss continuous glucose monitoring device implanted in upper dermal of skin and a portion above the skin.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Alles to include, wherein the glucose monitoring device comprises a first portion positioned below a skin surface of a user, and a second portion positioned above the skin surface of the user, as taught by Fuchs, in order to provide a stable sensor signal following implantation, a patient with accurate glucose measurement, and a new and improved analyte monitoring system. (Fuchs Paragraphs [0004] and [0040]).
Patek teaches:
the insulin dose is fully titrated based on one or more full titration criteria (Paragraphs [0079], [0082], and [0154] discuss uses an inputs historical CGM, basal insulin dose information, and past recommendations and generates an adjusted insulin dose along with a report advising whether to continue the titration process, or to stop; dosed injections with timestamps indicating when administered since the beginning of the titration process.);
the insulin dose is fully titrated (Paragraphs [0079], [0082], and [0154] discuss uses an inputs historical CGM, basal insulin dose information, and past recommendations and generates an adjusted insulin dose along with a report advising whether to continue the titration process, or to stop; dosed injections with timestamps indicating when administered since the beginning of the titration process.); and
outputting a recommendation for the insulin dose based on the determination to increase, decrease or maintain the insulin dose when the processor determines that the insulin dose is not fully titrated (Paragraphs [0026], [0079]-[0081], [0100], and [0183] discuss the dose finalizer, when executed by the one or more processors, produces the adjusted basal insulin dose on a periodic basis and generate a recommendation for a dose size to increase or decrease and the termination checker may be configured to run in an ongoing fashion, continuously adapting the patient's insulin dose in response to slowly changing insulin needs, and terminating only when it reaches the conclusion that basal insulin alone is insufficient to meet the patient's needs, negative termination may arise for example, the titration system may have determined that regardless of the dose that is recommended, the EBG (or the BG.sub.ref) remains unacceptably high or the transition from being above an upper EBG limit to being in range also comes with exposure to low EBG values because of natural variability and reasons for terminating negatively may indicate that treatment of the user with basal insulin alone is not sufficient and that the user may require the addition of prandial insulin.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Alles to include, the insulin dose is fully titrated based on one or more full titration criteria, the insulin dose is fully titrated, and outputting a recommendation for the insulin dose based on the determination to increase, decrease or maintain the insulin dose when the processor determines that the insulin dose is not fully titrated, as taught by Patek, in order to provide robust and comprehensive glucose control metrics, which can be coupled with computational techniques to recommend a titration path that is faster and safer. (Patek Paragraph [0004]).
Regarding claims 104 and 115, Alles discloses further comprising repeating titrating the insulin dose over a second period of time when the processor determines that the insulin dose is not fully titrated (Paragraphs [0082]-[0083] and FIGS. 19-20 discuss titration is an iterative process wherein adjustments in the basal delivery rate are made until the process settles on a basal delivery rate that provides good glucose level control for the patient, a check is made to determine whether the end of the time window is reached, the basal delivery rate is adjusted unless the process is done as described above or the system waits and repeats the process.).
Regarding claims 105, Alles discloses wherein repeating titrating the insulin dose comprises receiving glucose data over a second period of time, and determining to increase, decrease, or maintain the insulin dose based on the glucose data received over the second period of time (Paragraphs [0008], [0084], [0088], and FIG. 21 discuss the glucose level values for a time window are obtained, the average glucose level is compared to a target glucose level value (e.g., 120 mg/dL) to determine the difference, and the basal delivery rate of the medicament delivery device is adjusted (increased or decreased) based on the difference. The adjusted basal delivery rate is the one used for the next time window of operation of the medicament delivery device.).
Regarding claims 106 and 116, Alles does not explicitly disclose wherein the action comprises outputting, on a display device in communication with the processor, a notification indicating that the insulin dose is titrated (Paragraph and FIG. 9-12 discuss displaying glucose level and medicament delivery trends and a basal delivery rate over time.).
Alles does not explicitly disclose:
the insulin dose is fully titrated.
Patek teaches:
the insulin dose is fully titrated (Paragraphs [0079], [0082], and [0154] discuss uses an inputs historical CGM, basal insulin dose information, and past recommendations and generates an adjusted insulin dose along with a report advising whether to continue the titration process, or to stop; dosed injections with timestamps indicating when administered since the beginning of the titration process.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Alles to include, the insulin dose is fully titrated, as taught by Patek, in order to provide robust and comprehensive glucose control metrics, which can be coupled with computational techniques to recommend a titration path that is faster and safer. (Patek Paragraph [0004]).
Regarding claims 107 and 117, Alles discloses wherein the action comprises repeating titration of the insulin dose over a second period of time following the first period of time by receiving glucose data over the second period of time, and determining to increase, decrease, or maintain the insulin dose based on the glucose data received during the second period of time, wherein the second period of time is longer than the first period of time (Paragraphs [0082]-[0083] and FIGS. 19-20 discuss titration is an iterative process wherein adjustments in the basal delivery rate are made until the process settles on a basal delivery rate that provides good glucose level control for the patient, a check is made to determine whether the end of the time window is reached, the basal delivery rate is adjusted unless the process is done as described above or the system waits and repeats the process.).
Regarding claims 108 and 118, Alles does not explicitly disclose wherein the action comprises outputting a recommendation to initiate a new medication on a display of a display device in communication with the processor.
Fuchs teaches:
outputting, on a display of a display device in communication with the processor (Paragraphs [0039] discuss continuous glucose monitoring device includes a processor and a mobile computing device for display to a user.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Alles to include, outputting, on a display of a display device in communication with the processor, as taught by Fuchs, in order to provide a stable sensor signal following implantation, a patient with accurate glucose measurement, and a new and improved analyte monitoring system. (Fuchs Paragraphs [0004] and [0040]).
Patek teaches:
wherein the action comprises outputting a recommendation to initiate a new medication on a display of a display device in communication with the processor (Paragraphs [0034], [0079], and [0092] discuss generate and output a new recommendation on a regular basis (e.g., each day) until it determines an adequate, consistent dose size, for example, the termination report indicates that titration of the basal insulin dose should terminate if a target value for a daily reference blood glucose parameter cannot be reached without introducing prandial insulin.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Alles to include, wherein repeating titrating the insulin dose comprises receiving glucose data over a second period of time, and determining to increase, decrease, or maintain the insulin dose based on the glucose data received over the second period of time, as taught by Patek, in order to provide robust and comprehensive glucose control metrics, which can be coupled with computational techniques to recommend a titration path that is faster and safer. (Patek Paragraph [0004]).
Regarding claim 109, Alles does not explicitly disclose wherein the action comprises preventing, by the processor, further titration of the insulin dose.
Patek teaches:
wherein the action comprises preventing, by the processor, further titration of the insulin dose (Paragraphs [0079] and [0081] discuss generates an adjusted insulin dose along with a report advising whether to continue the titration process, or to stop, the system and method also incorporate checks that ensure safe and meaningful dose recommendation, for instance, one check may ensure that the dose does not increase following recent non-severe hypoglycemia, issue an alert when clinical guidelines indicate that a maximum per-kilogram dose has been reached, and force dose reductions in the presence of CGM-detected and patient-reported severe hypoglycemia.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Alles to include, wherein the action comprises preventing, by the processor, further titration of the insulin dose, as taught by Patek, in order to provide robust and comprehensive glucose control metrics, which can be coupled with computational techniques to recommend a titration path that is faster and safer. (Patek Paragraph [0004]).
Regarding claims 110 and 120, Alles does not explicitly disclose wherein the one or more full titration criteria comprises a determination that the insulin dose has not changed over a predetermined period of time.
Patek teaches:
wherein the one or more full titration criteria comprises a determination that the insulin dose has not changed over a predetermined period of time (Paragraphs [0082] and [0191] discuss the Dose Adapter, which, titrates an ideal daily basal insulin dose that is optimal under the assumption that the daily dose is taken at the same time (or times) every day, if the patient takes a daily Adjusted Dose 8 hours late, the Dose Adapter is able to modify the daily Adjusted Dose to take into account that it has been 32 hours since the last dose was taken. Conversely, if it has only been 17 hours since the last daily Adjusted Dose was taken, the Dose Adapter will reduce the Adjusted Dose to take into account that it has been less than 24 hours since the last dose was taken; dosed injections with timestamps indicating when administered since the beginning of the titration process.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Alles to include, wherein the one or more full titration criteria comprises a determination that the insulin dose has not changed over a predetermined period of time, as taught by Patek, in order to provide robust and comprehensive glucose control metrics, which can be coupled with computational techniques to recommend a titration path that is faster and safer. (Patek Paragraph [0004]).
Regarding claim 112, Alles does not explicitly disclose wherein the one or more full titration criteria comprises a determination that a change in a time in range based on the glucose data collected over the first period of time is less than a predetermined change from a time in range determined based on glucose data collected over a period of time preceding the first period of time.
Patek teaches:
wherein the one or more full titration criteria comprises a determination that a change in a time in range based on the glucose data collected over the first period of time is less than a predetermined change from a time in range determined based on glucose data collected over a period of time preceding the first period of time (Paragraphs [0082] and [0191] discuss the Dose Adapter, which, titrates an ideal daily basal insulin dose that is optimal under the assumption that the daily dose is taken at the same time (or times) every day, if the patient takes a daily Adjusted Dose 8 hours late, the Dose Adapter is able to modify the daily Adjusted Dose to take into account that it has been 32 hours since the last dose was taken. Conversely, if it has only been 17 hours since the last daily Adjusted Dose was taken, the Dose Adapter will reduce the Adjusted Dose to take into account that it has been less than 24 hours since the last dose was taken; dosed injections with timestamps indicating when administered since the beginning of the titration process.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Alles to include, wherein the one or more full titration criteria comprises a determination that a change in a time in range based on the glucose data collected over the first period of time is less than a predetermined change from a time in range determined based on glucose data collected over a period of time preceding the first period of time, as taught by Patek, in order to provide robust and comprehensive glucose control metrics, which can be coupled with computational techniques to recommend a titration path that is faster and safer. (Patek Paragraph [0004]).
Regarding claim 114, Alles discloses system for titrating an insulin dose, the system comprising:
a glucose monitoring device, comprising (Paragraph [0046] discusses medicament delivery system performs medicament titration of insulin.):
a glucose sensor comprising a first portion configured to be positioned on a user for detecting glucose levels in a bodily fluid, and sensor electronics coupled to the second portion of the glucose sensor and configured to communicate glucose data (Paragraphs [0046] and [0055] discuss the processor establish medicament delivery system performs medicament titration based on glucose level readings for the patient, provided wirelessly from a glucose sensor coupled to the user, such as a continuous glucose monitor, sensing levels of analytes.); and
one or more processors in communication with the glucose monitoring device, a memory coupled to the one or more processors and storing instructions that, when executed by the one or more processors, cause the one or more processors to (Paragraphs [0004] and [0049]-[0050] discuss a processor and medicament delivery device and storage for the device, device includes a non-transitory computer-readable storage medium storing computer programming instructions and a processor configured for executing the computer programming instructions.):
receive glucose data collected by the glucose monitoring device over a first period of time (Paragraph [0004] discusses the processor establish medicament delivery rate for delivery of medicament to the diabetes patient and to receive continuous glucose level readings of the patient over time.);
determine to increase, decrease or maintain the insulin dose based on the glucose data collected over the first period of time (Paragraphs [0004], [0008], [0059] discuss the processor adjusts the medicament delivery rate to a new delivery rate for the diabetes patient based on the received glucose level readings as part of the titration, and the processor causes the delivery of medicament to the diabetes patient at the new delivery rate for the next time window, the basal delivery rate and dose in subsequent time windows may be maintained, increased or decreased.);
determine whether the insulin dose is titrated based on one or more full titration criteria (Paragraphs [0082]-[0083] and FIGS. 3, 19-20 discuss determine whether the end of the time window is reached, the glucose control is good and the titration process stopped.);
perform an action when the insulin dose is fully titrated (Paragraphs [0005] discuss the processor may be further configured to receive a request to pause medicament delivery and to pause delivery of medicament in response to receipt of the request.).
Alles does not explicitly disclose:
a glucose sensor comprising a first portion configured to be positioned under a skin surface of a user for detecting glucose levels in a bodily fluid, and a second portion configured to be arranged above the skin surface of the user;
the insulin dose is fully titrated based on one or more full titration criteria;
the insulin dose is fully titrated; and
output the recommendation to increase, decrease or maintain the insulin dose when the insulin dose is not fully titrated.
Fuchs teaches:
a glucose sensor comprising a first portion configured to be positioned under a skin surface of a user for detecting glucose levels in a bodily fluid, and a second portion configured to be arranged above the skin surface of the user (Paragraphs [0005], [0048], and FIGS. 3A-3D discuss continuous glucose monitoring device implanted in upper dermal of skin and a portion above the skin.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Alles to include, a glucose sensor comprising a first portion configured to be positioned under a skin surface of a user for detecting glucose levels in a bodily fluid, and a second portion configured to be arranged above the skin surface of the user, as taught by Fuchs, in order to provide a stable sensor signal following implantation, a patient with accurate glucose measurement, and a new and improved analyte monitoring system. (Fuchs Paragraphs [0004] and [0040]).
Patek teaches:
the insulin dose is fully titrated based on one or more full titration criteria (Paragraphs [0079], [0082], and [0154] discuss uses an inputs historical CGM, basal insulin dose information, and past recommendations and generates an adjusted insulin dose along with a report advising whether to continue the titration process, or to stop; dosed injections with timestamps indicating when administered since the beginning of the titration process.);
the insulin dose is fully titrated (Paragraphs [0079], [0082], and [0154] discuss uses an inputs historical CGM, basal insulin dose information, reports of hypoglycemia, and past recommendations and generates an adjusted insulin dose along with a report advising whether to continue the titration process, or to stop; dosed injections with timestamps indicating when administered since the beginning of the titration process.); and
output the recommendation to increase, decrease or maintain the insulin dose when the insulin dose is not fully titrated (Paragraphs [0026], [0079]-[0081], [0100], and [0183] discuss the dose finalizer, when executed by the one or more processors, produces the adjusted basal insulin dose on a periodic basis and generate a recommendation for a dose size to increase or decrease and the termination checker may be configured to run in an ongoing fashion, continuously adapting the patient's insulin dose in response to slowly changing insulin needs, and terminating only when it reaches the conclusion that basal insulin alone is insufficient to meet the patient's needs, negative termination may arise for example, the titration system may have determined that regardless of the dose that is recommended, the EBG (or the BG.sub.ref) remains unacceptably high or the transition from being above an upper EBG limit to being in range also comes with exposure to low EBG values because of natural variability and reasons for terminating negatively may indicate that treatment of the user with basal insulin alone is not sufficient and that the user may require the addition of prandial insulin.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Alles to include, the insulin dose is fully titrated based on one or more full titration criteria, the insulin dose is fully titrated, and output the recommendation to increase, decrease or maintain the insulin dose when the insulin dose is not fully titrated, as taught by Patek, in order to provide robust and comprehensive glucose control metrics, which can be coupled with computational techniques to recommend a titration path that is faster and safer. (Patek Paragraph [0004]).
Claim 119, recites the same limitations as claim 109 with the exception of the processor.
Regarding claim 122, Alles discloses wherein the determination to increase, decrease or maintain the insulin dose is further based on a glucose level goal that is selectable by the user (Paragraphs [0003] and [0063]-[0065] discuss a dropdown list of possible basal delivery rates that may be selected by the patient or populated/selected by the application itself based on the user's prior input (e.g., the user's weight). In the example shown, the highlighted rate of 10 units of insulin per day is selected, select a titration frequency (i.e., how often to update the basal delivery rate as part of the titration process), a patient may, in some instances, reduce a daily insulin amount to reduce the risk of a hypoglycemic event. Conversely, the patient may need to increase daily insulin delivery levels due to the patient's diet, in order to avoid a hyperglycemic event, for example, since the user is preferably set to start with a low total daily insulin (TDI) level (e.g., 10 units per day in this example), it is often the case that the user's insulin level needs to be titrated upwards (e.g., in increments of 5 units in this example) which can occur in automated fashion (e.g., incrementing and decrementing) until the user's blood glucose levels reach a desired level or range for a period of time, such as a period of one day.).
Claims 111 and 121 are rejected under 35 U.S.C. 103 as being unpatentable over Alles in view of Fuchs and Patek and in further view of Mayou (U.S. Pub. No. 20130035575 A1).
Regarding claim 111, Alles discloses further comprising determining a glucose reading for each of a plurality of time of day periods based on the glucose data received during the first period of time, and determining the insulin dose is titrated (Paragraph and FIG. 3 discuss glucose readings and basal delivery rates over time.).
Alles does not disclose:
further comprising determining a glucose pattern for each of a plurality of time of day periods based on the glucose data received during the first period of time, and determining the insulin dose is fully titrated when the determined glucose pattern for a time of day period of the plurality of time of day periods has not changed over a predetermined period of time.
Patek teaches:
determining the insulin dose is fully titrated over a predetermined period of time (Paragraphs [0079], [0082], [0154], and [0191] discuss the Dose Adapter, which, titrates an ideal daily basal insulin dose that is optimal under the assumption that the daily dose is taken at the same time (or times) every day, if the patient takes a daily Adjusted Dose 8 hours late, the Dose Adapter is able to modify the daily Adjusted Dose to take into account that it has been 32 hours since the last dose was taken. Conversely, if it has only been 17 hours since the last daily Adjusted Dose was taken, the Dose Adapter will reduce the Adjusted Dose to take into account that it has been less than 24 hours since the last dose was taken; uses an inputs historical CGM, basal insulin dose information, and past recommendations and generates an adjusted insulin dose along with a report advising whether to continue the titration process, or to stop, dosed injections with timestamps indicating when administered since the beginning of the titration process.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Alles to include, determining the insulin dose is fully titrated over a predetermined period of time, as taught by Patek, in order to provide robust and comprehensive glucose control metrics, which can be coupled with computational techniques to recommend a titration path that is faster and safer. (Patek Paragraph [0004]).
Mayou teaches:
further comprising determining a glucose pattern for each of a plurality of time of day periods based on the glucose data received during the first period of time, and determining glucose pattern for a time of day period of the plurality of time of day periods has not changed over a predetermined period of time (Paragraph [0041] and FIGS. 5A-5C discuss glucose levels over a time period and patterns.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Alles to include, wherein the one or more full titration criteria comprises a determination that the insulin dose has not changed over a predetermined period of time, as taught by Mayou, in order to provide patient with information that helps them stay in the target range and improves the average glucose over a period of time. (Mayou Paragraph [0006]).
Regarding claim 121, Alles does not explicitly disclose wherein the one or more processors are further caused to determine a glucose pattern for each of a plurality of time of day periods, and wherein the one or more full titration criteria comprises a determination that the glucose pattern for a time of day period of the plurality of time of day periods has not changed over a predetermined period of time.
Patek teaches:
wherein the one or more full titration criteria comprises a determination that the glucose pattern for a time of day period of the plurality of time of day periods has not changed over a predetermined period of time (Paragraphs [0006], [0079], [0082], [0154], and [0191] discuss a basal titration adjustment device with a processor, the Dose Adapter, which, titrates an ideal daily basal insulin dose that is optimal under the assumption that the daily dose is taken at the same time (or times) every day, if the patient takes a daily Adjusted Dose 8 hours late, the Dose Adapter is able to modify the daily Adjusted Dose to take into account that it has been 32 hours since the last dose was taken. Conversely, if it has only been 17 hours since the last daily Adjusted Dose was taken, the Dose Adapter will reduce the Adjusted Dose to take into account that it has been less than 24 hours since the last dose was taken; uses an inputs historical CGM, basal insulin dose information, and past recommendations and generates an adjusted insulin dose along with a report advising whether to continue the titration process, or to stop, dosed injections with timestamps indicating when administered since the beginning of the titration process.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Alles to include, wherein the one or more full titration criteria comprises a determination that the glucose pattern for a time of day period of the plurality of time of day periods has not changed over a predetermined period of time, as taught by Patek, in order to provide robust and comprehensive glucose control metrics, which can be coupled with computational techniques to recommend a titration path that is faster and safer. (Patek Paragraph [0004]).
Mayou teaches:
wherein the one or more processors are further caused to determine a glucose pattern for each of a plurality of time of day periods (Paragraphs [0041], [0069], and FIGS. 5A-5C discuss a processor and continuous analyte sensor generate glucose levels over a time period and patterns.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Alles to include, wherein the one or more processors are further caused to determine a glucose pattern for each of a plurality of time of day periods, as taught by Mayou, in order to provide patient with information that helps them stay in the target range and improves the average glucose over a period of time. (Mayou Paragraph [0006]).
Claim 113 is rejected under 35 U.S.C. 103 as being unpatentable over Alles in view of Fuchs and Patek and in further view of Ward (U.S. Pub. No. 2006/0281985 A1).
Regarding claim 113, Alles discloses wherein the one or more titration criteria comprises a determination that a glucose measurement based on the glucose data collected during the first period of time is within a predetermined amount of a glucose median goal (Paragraphs [0069]-[0070] discuss user’s time in range based on prior blood glucose values over the previous titration frequency period and an estimate of the user's insulin-to-carbohydrate ratio, and the new, suggested basal delivery rate.).
Alles does not disclose:
wherein the one or more full titration criteria comprises a determination that a glucose median based on the glucose data collected during the first period of time is within a predetermined amount of a glucose median goal.
Patek teaches:
wherein the one or more full titration criteria comprises (Paragraphs [0082], [0092] and [0100] discuss the outputs of the CGM, Insulin, and Reported Hypo Modules, along with the Recommendation History, dosed injections, are read into a Termination Checker, producing a Termination Report articulating whether the titration process should terminate or continue and also making other follow-on recommendations, e.g. when appropriate, suggesting that prandial (rapid-acting) insulin should be added to the patient's therapy regime; the termination checker may be configured to run in an ongoing fashion, continuously adapting the patient's insulin dose in response to slowly changing insulin needs, and terminating only when it reaches the conclusion that basal insulin alone is insufficient to meet the patient's needs; dosed Insulin History refers to dosed basal (long-acting) insulin injections with timestamps indicating when administered (e.g., injected) since the beginning of the titration process.)).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Alles to include, wherein the one or more full titration criteria comprises, as taught by Patek, in order to provide robust and comprehensive glucose control metrics, which can be coupled with computational techniques to recommend a titration path that is faster and safer. (Patek Paragraph [0004]).
Ward teaches:
comprises a determination that a glucose median based on the glucose data collected during the first period of time is within a predetermined amount of a glucose median goal (Paragraphs [0018] and FIGS. 5-7 discuss (1) using more than one sensor signal value and/or more than one capillary blood glucose value, and/or by (2) delaying the acquisition of a sensor output value that is compared with a capillary blood glucose value during a calibration, the median of a series of measured values, or a median of the medians or of the means, may be utilized to provide more consistent and accurate measurement data and/or to compensate for error or artifact.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Alles to include, comprises a determination that a glucose median based on the glucose data collected during the first period of time is within a predetermined amount of a glucose median goal, as taught by Ward, in order to provide more consistent and accurate glucose measurement data. (Ward Paragraph [0018]).
Conclusion
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/DAWN T. HAYNES/
Art Unit 3686
/RACHELLE L REICHERT/ Primary Examiner, Art Unit 3686
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