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 .
This communication is in response to the amendment received on 08/14/2025. Claims 1-6, 9-16 and 19-20 remain pending in this application.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6, 9-16 and 19-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-6, 9-10 are drawn to a method which is within the four statutory categories (i.e. process). Claims 11-16, 19-20 are drawn to a system which is within the four statutory categories (i.e. machine).
Step 2A, Prong 1:
The independent claims 1 and 11 have been amended now to recite:
“obtaining glucose measurements of a patient and glucose times associated with a time of measuring each glucose measurement from a glucose sensor associated with the patient, the patient having a diagnosis of diabetes; and
executing a patient management program configured to display on a screen in communication with the data processing hardware a graphical user interface having a trend window of the glucose measurements on a timeline, wherein the patient management program is configured to:
receive, in the trend window, magnifying inputs from a medical professional for a magnification window superimposed on a segment of the timeline to specify a date range for a magnified window;
display, in the graphical user interface, the magnified window including the glucose measurements of the patient from the specified date range, the glucose measurements of the magnified window located within associated ones of scheduled glucose time intervals based on the glucose times;
for each respective date of the specified date range, determine, based on the glucose measurements of the patient from the respective date of the specified date range, a respective estimated hemoglobin A1c value for the patient;
determine, based on the respective estimated hemoglobin A1C values for the patient, an average estimated hemoglobin A1C value for the specified date range for the patient, wherein the average estimated hemoglobin A1C value is determined to be an average of the respective estimated hemoglobin A1C value for the patient determined for each respective date of the specified date range;
display, in the graphical user interface, a first information graphic including quantitative information associated with an average estimated hemoglobin A1c value for the specifies date range;
determine, based on the glucose measurements of the patient from the specified date range, a recommended basal dose of long-acting basal insulin to administer to the patient to treat elevated glucose measurements of the patient due to the diagnosis of diabetes, wherein the recommended basal dose of long-acting basal insulin is determined to maintain glucose measurements of the patient within a target glucose level range for the patient; and
administer the recommended basal dose of long-acting basal insulin to the patient by transmitting first instructions and the recommended basal dose of long-acting basal insulin to a patient device associated with the patient, the first instructions causing the patient device to transmit second instructions and the recommended basal dose of long-acting basal insulin to a smart insulin pen, the second instructions causing the smart insulin pen to automatically dial a number of units of long-acting basal insulin based on the recommended basal dose of long-acting basal insulin and administer the number of units of long-acting basal insulin to the patient to treat elevated glucose measurements of the patient due to the diagnosis of diabetes.”
The limitations of “obtaining glucose measurements of a patient and glucose times associated with a time of measuring each glucose measurement from a glucose sensor associated with the patient…;…for each respective date of the specified date range, determine, based on the glucose measurements of the patient from the specified date range, an estimated hemoglobin A1c value for the patient; determine, based on the respective estimated hemoglobin A1C values for the patient, an average estimated hemoglobin A1C value for the specified date range for the patient;… determine, based on the glucose measurements of the patient from the specified date range, a recommended basal dose of long-acting basal insulin to administer to the patient…” correspond to an abstract idea of certain methods of organizing human activity based on managing personal behavior or relationships or interactions between people, (i.e. user following rules or instructions) with a recitation of generic data processing hardware with graphical user interface and a generic glucose sensor.
These limitations are directed to managing interactions between people regarding obtaining patient measurements and user inputs and obtain a trend window on a timeline (Examiner consider the trend window information indicates the anticipated data for the patient within a timeline). Therefore, these limitations correspond to managing personal behavior or relationships or interactions between people. The mere nominal recitation of a generic data processing hardware, patient device and glucose sensor devices and smart insulin pen does not take the claims out of the methods of organizing human interactions grouping.
Dependent claims also correspond to an abstract idea of certain methods of organizing human activity, such as claims 2/12 recite “receiving insulin dosing parameters for the patient input by a healthcare provider; and transmitting the insulin dosing parameters to a patient device associated with the patient”, claims 6/16 recite “receiving, from a patient device associated with the patient, a message directed toward a healthcare provider of the patient, the message comprising an inquiry related to insulin dosing parameters for the patient;…”, claims 9/19 recite “determining, based on the glucose measurements of the patient from the specified date range, an average glucose measurement value for the specified date range”. These limitations also are directed to managing personal behavior or relationships or interactions between people (such as user following rules and instructions) regarding estimating patient’s average glucose measurement values.
Claims 3-5, 10, 13-15 and 20 are ultimately dependent from claims 1, 11 and include all the limitations of claims 1, 11. Therefore, claims 3-5, 10, 13-15 and 20 recite the same abstract idea. Claims 3-5, 10, 13-15 and 20 describe a further limitation regarding the basis for estimating patient’s average glucose measurement values. These are all just further describing the abstract idea recited in claims 1, 11, without adding significantly more.
Thus, the claims recite an abstract idea.
Step 2A, Prong 2:
This judicial exception is not integrated into a practical application. In particular, claims recite the additional elements of “a glucose sensor”, “a data processing hardware”, “a graphical user interface”, “a patient device”, “a smart insulin pen”, “executing a patient management program configured to display on a screen in communication with the data processing hardware a graphical user interface having a trend window of the glucose measurements on a timeline”, “the data processing hardware to perform the operations of: receiving, in the trend window, magnifying inputs from a medical professional for a magnification window superimposed on a segment of the timeline to specify a date range for a magnified window, displaying, in the graphical user interface, the magnified window including the glucose measurements of the patient from the specified date range, the glucose measurements of the magnified window located within associated ones of scheduled glucose time intervals based on the glucose times, determining, based on the glucose measurements of the patient from the respective date of the specified date range, a respective estimated hemoglobin A1c value for the patient, determining, based on the respective estimated hemoglobin A1C values for the patient, an average estimated hemoglobin A1C value for the specified date range for the patient, displaying, in the graphical user interface, a first information graphic including quantitative information associated with the average estimated hemoglobin A1C value for the specified date range, determining, based on the glucose measurements of the patient from the specified date range, a recommended basal dose of long-acting basal insulin to administer to the patient to treat elevated glucose measurements of the patient due to the diagnosis of diabetes…”
These additional elements correspond to hardware and software elements, these limitations are not enough to qualify as “practical application” being recited in the claims along with the abstract idea since these elements are merely invoked as a tool to apply instructions of the abstract idea in a particular technological environment, and mere instructions to apply/implement/automate an abstract idea in a particular technological environment and merely limiting the use of an abstract idea to a particular field or technological environment do not provide practical application for an abstract idea (MPEP 2106.05(f) & (h)).
Claims 1 and 11 recite:
“administer the recommended basal dose of long-acting basal insulin to the patient by transmitting first instructions and the recommended basal dose of long-acting basal insulin to a patient device associated with the patient, the first instructions causing the patient device to transmit second instructions and the recommended basal dose of long-acting basal insulin to a smart insulin pen, the second instructions causing the smart insulin pen to automatically dial a number of units of long-acting basal insulin based on the recommended basal dose of long-acting basal insulin and administer the number of units of long-acting basal insulin to the patient to treat elevated glucose measurements of the patient due to the diagnosis of diabetes”.
This limitation corresponds to mere instructions to apply abstract idea the exception using generic computer components, such as a generic data processing hardware to transmit first instructions (data) to a patient device and the patient device to transmit second instructions (data) to a generic smart insulin pen to administer the insulin to the patient.
The data processing hardware and glucose sensor described in the current specification as generic devices. For instance, the data processing hardware is described in the current specification as a generic computing device (“The patient device 110a, 110b, includes data processing hardware 112a, 112b (e.g., a computing device that executes instructions), and non-transitory memory 114a, 114b and a display 116a, 116b (e.g., touch display or non-touch display) in communication with the data processor 112.” in [0054]) and the glucose sensor described in the current specification as a generic glucose meter (“The system 100 may be applied to various devices, including, but not limited to, subcutaneous insulin infusion pumps 123a, insulin pens 123b, glucometers 124, continuous glucose monitoring systems, and glucose sensors.” In [0052]).
The smart insulin pen/injection pen is a generic device known and used in the field, as evidenced by Dobbles et al. (hereinafter Dobbles) (US 2008/0306434 A1). In particular, Dobbles discloses:
“An integrated system for the monitoring and treating diabetes is provided, including an integrated receiver/hand-held medicament injection pen, including electronics, for use with a continuous glucose sensor. In some embodiments, the receiver is configured to receive continuous glucose sensor data, to calculate a medicament therapy (e.g., via the integrated system electronics) and to automatically set a bolus dose of the integrated hand-held medicament injection pen, whereby the user can manually inject the bolus dose of medicament into the host. In some embodiments, the integrated receiver and hand-held medicament injection pen are integrally formed, while in other embodiments they are detach ably connected and communicated via mutually engaging electrical contacts and/or via wireless communication.” in abstract.
Also, administering the patient the recommended basal dose of insulin (medication) and the recited limitation of “the smart insulin pen to automatically dial a number of units of long-acting basal insulin based on the recommended basal dose of long-acting basal insulin and administer the number of units of long-acting basal insulin to the patient to treat elevated glucose measurements of the patient due to the diagnosis of diabetes” corresponds to an insignificant application (see MPEP 2106.05(g)).
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a data processing hardware (a computer) to perform the receiving data/displaying data/transmitting data/determining steps amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Claims recite “administer the recommended basal dose of long-acting basal insulin to the patient by transmitting first instructions and the recommended basal dose of long-acting basal insulin to a patient device associated with the patient, the first instructions causing the patient device to transmit second instructions and the recommended basal dose of long-acting basal insulin to a smart insulin pen, the second instructions causing the smart insulin pen to automatically dial a number of units of long-acting basal insulin based on the recommended basal dose of long-acting basal insulin and administer the number of units of long-acting basal insulin to the patient to treat elevated glucose measurements of the patient due to the diagnosis of diabetes”.
This limitation corresponds to mere instructions to apply abstract idea the exception using generic computer components, such as a generic data processing hardware to transmit data to a patient device and the patient device to transmit the data (recommended basal dose of insulin) to a smart insulin pen to administer the insulin to the patient. Also, administering the patient the recommended basal dose of insulin (medication) and the recited limitation of “the smart insulin pen to automatically dial a number of units of long-acting basal insulin based on the recommended basal dose of long-acting basal insulin and administer the number of units of long-acting basal insulin to the patient to treat elevated glucose measurements of the patient due to the diagnosis of diabetes” corresponds to an insignificant application (see MPEP 2106.05(g)).
The smart insulin pen/injection pen is a generic device known and used in the field, as evidenced by Dobbles et al. (hereinafter Dobbles) (US 2008/0306434 A1). In particular, Dobbles discloses:
“An integrated system for the monitoring and treating diabetes is provided, including an integrated receiver/hand-held medicament injection pen, including electronics, for use with a continuous glucose sensor. In some embodiments, the receiver is configured to receive continuous glucose sensor data, to calculate a medicament therapy (e.g., via the integrated system electronics) and to automatically set a bolus dose of the integrated hand-held medicament injection pen, whereby the user can manually inject the bolus dose of medicament into the host. In some embodiments, the integrated receiver and hand-held medicament injection pen are integrally formed, while in other embodiments they are detach ably connected and communicated via mutually engaging electrical contacts and/or via wireless communication.” in abstract.
Therefore, using a smart insulin device to receive dosing data and automatically administer the insulin to the patient is a well-understood, routine and conventional activity in the field.
Claims 1 and 11 have been amended to recite “receive, in the trend window, magnifying inputs from a medical professional for a magnification window superimposed on a segment of the timeline to specify a date range for a magnified window; and “display, in the graphical user interface, the magnified window including the glucose measurements of the patient from the specified date range, the glucose measurements of the magnified window located within associated ones of scheduled glucose time intervals based on the glucose times”, and these limitations correspond to mere instructions to apply the exception using a generic computer components.
In particular, the newly added feature of “magnifying inputs”, “a magnification window superimposed on a segment of the timeline to specify a date range for a magnified window”, “display, in the graphical user interface, the magnified window including the glucose measurements of the patient from the specified date range” is a well-understood, routine and conventional activity in the field, as evidenced by the newly added prior art reference, Stott et al. (hereinafter Stott) (EP2823753A1). Stott teaches “…providing a trend window arranged to display blood glucose levels of a user on a timeline; providing a magnifying window superimposed on a segment of the timeline, the relative position of the magnifying window with respect to the timeline being movable; providing a magnified window arranged to display, over an area which is larger than the magnifying window, the information contained in the segment of the timeline; and providing at least one contextual information window arranged to display, over an area of the same size as the magnified window, information which is contextual to the blood glucose levels.” in [0017], “Overlaid upon trend window 201 is magnifying window 210. Magnifying window 210 is operable to slide along trend window 201 in both directions (i.e. forwards and backwards in time along the timeline). The content of the magnifying window 210 is represented in magnified window 202. The horizontal axis of the magnified window 202 represents the portion of the timeline of trend window 201 captured by the magnifying window 210.” in [0030], and “…variations in the number and/or locations of the blood glucose readings in the magnifying window 210 (resulting from changes in the relative position of the magnifying window 210 with respect to the timeline) will also be displayed on the magnified window 202.” in [0036].
Thus, the claims are not patent eligible.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6, 9-16 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ray et al. (hereinafter Ray) (US 2008/0235053 A1), Thukral et al. (hereinafter Thukral) (WO 2010/149392 A1), Stott et al. (hereinafter Stott) (EP2823753A1), Carlsgaard et al. (hereinafter Carlsgaard) (US 9,990,581 B2), and further in view of Dobbles et al. (hereinafter Dobbles) (US 2008/0306434 A1).
Claim 1 has been amended now to recite a computer-implemented method executing on data processing hardware that causes the data processing hardware to perform operations comprising:
obtaining glucose measurements of a patient and glucose times associated with a time of measuring each glucose measurement from a glucose sensor associated with the patient, the patient having a diagnosis of diabetes (Ray discloses “…a diabetes management system or process is provided herein that may be used to analyze and recognize patterns for a large number of glucose concentration measurements and other physiological or external parameters related to the glycemia of a patient. In particular, a method of monitoring glycemia in a patient may include storing a patient's data on a suitable device, such as, for example, a glucose meter. The patient's data may include blood glucose concentration measurements. The diabetes management system or process may be installed on, but is not limited to, a personal computer, an insulin pen, an insulin pump, or a glucose meter. The diabetes management system or process may identify a plurality of pattern types from the data including a testing/dosing pattern, a hypoglycemic pattern, a hyperglycemic pattern, a blood glucose variability pattern, and a comparative pattern…” in [0003], “…To show trends or patterns, the blood glucose variability can be obtained for each combined median of glucose and time over the plurality of temporal periods…” in [0105]); and
executing a patient management program configured to display on a screen in communication with the data processing hardware a graphical user interface having a trend window of the glucose measurements on a timeline (Ray discloses “…a communication medium to assist in diabetes management. The communication medium, as shown in FIG. 18, includes a first display area D1 that has second, third, fourth, and fifth display areas D2, D3, D4, and D5, respectively, in the first display area… the first display area D1 includes a display selected from any one of a video display monitor, a light projector, a sheet of paper, a hologram, an audio representation of the patient's variability trends (e.g., an automated voice response to the patient stating "high-variability between the hours of 3 A.M. and 9 A.M.), or combinations thereof…” in [0152]).
Ray fails to expressly teach the following features. However, these features are well known in the art, as evidenced by Thukral. In particular, Thukral discloses:
“wherein the patient management program is configured to:
for each respective date of the specified date range, determine, based on the glucose measurements of the patient from the respective date of the specified date range, a respective estimated hemoglobin A1c value for the patient (Thukral discloses “…a method for providing both an estimated true mean blood glucose value and estimated glycated hemoglobin (HbAlC) value from spot blood glucose (bG) measurements is disclosed…” in [0006]);
determine, based on the respective estimated hemoglobin A1C values for the patient, an average estimated hemoglobin A1C value for the specified date range for the patient, wherein the average estimated hemoglobin A1C value is determined to be an average of the respective estimated hemoglobin A1C value for the patient determined for each respective date of the specified date range (Thukral discloses “…a method for providing both an estimated true mean blood glucose value and estimated glycated hemoglobin (HbA1C) value from spot blood glucose (bG) measurements is disclosed…” in [0006]), “…an optimal sampling schema for determination of true mean bG and HbAlC…” in [0081]-[0088], “…The bG data may include, but not limited thereto, the glucose values of the patient 142, the insulin dose values, the insulin types, and the parameter values used by processor 102 to calculate future glucose values, supplemental insulin doses, and carbohydrate supplements…” in [0105] and “In the following example, one daily lifestyle pattern (habit) examined consisted of an overnight period and a day period consisting of multiple meals and snacks for a patient. The daily lifestyle pattern repeats itself over a period of months whereby the timing of meals varied randomly around expected meal times. The size and composition of the meal was similarly modeled by assigning the parameters of the gamma function values generated from statistical distribution. In general, it was assumed that by considering more or less a 3 month time frame, the persistent average behavior would be observed in HbAlC value even though from meal to meal there could be potentially large variability…” in [0047]);
display, in the graphical user interface, a first information graphic including quantitative information associated with an average estimated hemoglobin A1c value for the specifies date range based on the respective estimated hemoglobin A1c value for the patient (Thukral discloses “…The system further includes a computer having a display, memory and a second processor programmed: to receive the collected bG measurements and associated context from the meter; to weight each of the collected bG measurements based on the associated context; to determine the estimated true mean bG value and the estimated HbA1C value from the weighted measurements of the collected bG measurements; and to provide the estimated true mean bG and the estimated HbA1C values to the display...” in [0008]).”
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include the aforementioned limitation as disclosed by Thukral with the motivation of user able to better manage diabetes (Thukral; [0031]).
Ray fails to expressly teach: “receive, in the trend window, magnifying inputs from a medical professional for a magnification window superimposed on a segment of the timeline to specify a date range for a magnified window; and “display, in the graphical user interface, the magnified window including the glucose measurements of the patient from the specified date range, the glucose measurements of the magnified window located within associated ones of scheduled glucose time intervals based on the glucose times“. However, this feature is well known in the art, as evidenced by Stott.
In particular, Stott discloses “…providing a trend window arranged to display blood glucose levels of a user on a timeline; providing a magnifying window superimposed on a segment of the timeline, the relative position of the magnifying window with respect to the timeline being movable; providing a magnified window arranged to display, over an area which is larger than the magnifying window, the information contained in the segment of the timeline; and providing at least one contextual information window arranged to display, over an area of the same size as the magnified window, information which is contextual to the blood glucose levels.” in [0017], “Overlaid upon trend window 201 is magnifying window 210. Magnifying window 210 is operable to slide along trend window 201 in both directions (i.e. forwards and backwards in time along the timeline). The content of the magnifying window 210 is represented in magnified window 202. The horizontal axis of the magnified window 202 represents the portion of the timeline of trend window 201 captured by the magnifying window 210.” in [0030], and “…variations in the number and/or locations of the blood glucose readings in the magnifying window 210 (resulting from changes in the relative position of the magnifying window 210 with respect to the timeline) will also be displayed on the magnified window 202.” in [0036].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include the aforementioned limitation as disclosed by Stott with the motivation of user able to identify a trend without switching between scales (Stott; [0006]).
Ray fails to expressly teach “determine, based on the glucose measurements of the patient from the specified date range, a recommended basal dose of long-acting basal insulin to administer to the patient to treat elevated glucose measurements of the patient due to the diagnosis of diabetes, wherein the recommended basal dose of long-acting basal insulin is determined to maintain glucose measurements of the patient within a target glucose level range for the patient”. However, this feature is well known in the art, as evidenced by Carlsgaard.
In particular, Carlsgaard discloses “the therapy advice tool may impose a predefined window of time (e.g., two weeks). In other embodiments, the therapy advice tool may provide a limit which may be overridden by the user. Presenting data to the user, such as the weekly mean and standard deviation of blood glucose readings, may help to identify which time periods of control are most representative of the current state of therapy” in col. 6, lines 1-17, and “When the blood glucose values are deemed stable according to structured testing, the therapy advice tool can recommend maintaining the current basal insulin dosage as indicated at 45. Additionally or alternatively, the therapy advice tool can proceed with an evaluation of the bolus insulin therapy as indicated at 46. On the other hand, when the blood glucose values are deemed unstable, the therapy advice tool can recommend different corrective actions to the patient or the patient's healthcare provider. For example, the therapy advice tool may recommend an adjustment to the basal insulin dosage as indicated at 49. In one embodiment, the therapy advice tool can recommend increasing the insulin dosage when the blood glucose values are above the target range and decreasing the insulin dosage when the blood glucose values are below the target range.” in col. 8, lines 11-28.
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include the aforementioned limitation as disclosed by Carlsgaard with the motivation of maintaining stable blood glucose levels (Carlsgaard; col. 8, lines 11-28).
Ray fails to expressly teach “administer the recommended basal dose of long-acting basal insulin to the patient by transmitting first instructions and the recommended basal dose of long-acting basal insulin to a patient device associated with the patient, the first instructions causing the patient device to transmit second instructions and the recommended basal dose of long-acting basal insulin to a smart insulin pen, the second instructions causing the smart insulin pen to automatically dial a number of units of long-acting basal insulin based on the recommended basal dose of long-acting basal insulin and administer the number of units of long-acting basal insulin to the patient to treat elevated glucose measurements of the patient due to the diagnosis of diabetes”. However, this feature is well known in the art, as evidenced by Dobbles.
In particular, Dobbles discloses “In some embodiments, the hand-held medicament injection pen 16 includes a motor configured for electronic control of at least a portion of the hand-held medicament injection pen. In some embodiments, a motor is configured to automatically set an amount of medicament to be delivered to the host, such as but not limited to a medicament bolus amount, for example, using a step motor. In some embodiments, a motor is configured to control a rate of medicament injection into the host. In some embodiments, the integrated electronics (e.g., the receiver), described in more detail elsewhere herein, are configured to remotely control at least one motor, such as those described above. In some embodiments, the integrated electronics are configured to provide a recommended therapy amount (e.g., medicament bolus amount), which can be communicated to the hand-held medicament injection pen (or which can be integral with the pen); in some Such embodiments, the integrated electronics and/or handheld medicament injection pen electronics are configured to automatically set the bolus amount using the motor (e.g., a stepmotor),…” in [207].
It would have been obvious to one of ordinary skill in the art to include in the diabetes management system of Rays the ability to use an injection pen that is automatically set as taught by Dobbles since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Claim 2 recites the computer-implemented method of claim 1, wherein the operations further comprise: receiving insulin dosing parameters for the patient input by a healthcare provider; and transmitting the insulin dosing parameters to the patient device associated with the patient (Ray; [0126]).
Claim 3 recites the computer-implemented method of claim 2, wherein the insulin dosing parameters for the patient comprise a carbohydrate-to-insulin ratio for the patient (Ray; [0045], [0120]).
Claim 4 recites the computer-implemented method of claim 2, wherein the insulin dosing parameters for the patient comprise a correction factor for the patient (Ray; [0003]).
Claim 5 recites the computer-implemented method of claim 2, wherein the insulin dosing parameters for the patient comprise a target glucose range for the patient (Ray; [0127]).
Claim 6 recites the computer-implemented method of claim 1, wherein the operations further comprise: receiving, from a patient device associated with the patient, a message directed toward a healthcare provider of the patient, the message comprising an inquiry related to insulin dosing parameters for the patient; and displaying the message on the screen (Ray; abstract, [0003]).
Claim 9 recites the computer-implemented method of claim 1, wherein the operations further comprise determining, based on the glucose measurements of the patient from the specified date range, an average glucose measurement value for the specified date range (Ray; [0005], [0102]).
Claim 10 recites the computer-implemented method of claim 9, wherein the operations further comprise displaying, in the graphical user interface, a second information graphic including quantitative information associated with the average glucose measurement value for the specified date range (Ray; [0124]).
As per claims 11-16, 19-20, they are system claims which repeat the same limitations of claims 1-6, 9-10, the corresponding method claims, as a collection of elements as opposed to a series of process steps. Since the teachings of Ray disclose the underlying process steps that constitute the methods of claims 1-6, 9-10, it is respectfully submitted that they provide the underlying structural elements that perform the steps as well. As such, the limitations of claims 11-16, 19-20 are rejected for the same reasons given above for claims 1-6, 9-10.
Response to Arguments
Applicant's arguments filed 08/14/2025 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed in the order in which they appear.
Arguments about 35 USC 101 rejection:
Step 2A, Prong 1: Applicant argues that claims do not cause a person to perform an action, nor do they involve interactions or relationships between people. In response, Examiner submits that using a generic computing device (a processing hardware) to perform “for each respective date of the specified date range, determine, based on the glucose measurements of the patient from the respective date of the specified date range, a respective estimated hemoglobin A1c value for the patient; determine, based on the respective estimated hemoglobin A1C values for the patient, an average estimated hemoglobin A1C value for the specified date range for the patient;…determine, based on the glucose measurements of the patient from the specified date range, a recommended basal dose of long-acting basal insulin to administer to the patient to treat elevated glucose measurements of the patient due to the diagnosis of diabetes” correspond to an abstract idea of certain methods of organizing human activity based on managing personal behavior or relationships or interactions between people, (i.e. user following rules or instructions) (see MPEP 2106.04(a)(2 II C) “Managing Personal Behavior or Relationships or Interactions Between People”.
Step 2A, Prong 2: Applicant argues that claims 1 and 11 represent a practical application, since claims 1 and 11 apply any underlying alleged abstract idea to “effect a particular treatment or prophylaxis for a disease or medical condition”. Applicant argues that claims 1 and 11 clearly effect a particular treatment (i.e., treating elevated glucose measurement of the patient due to a diagnosis of diabetes) by administering a particular dosage (i.e., the determined recommended basal dose) of a particular medication (i.e., long-acting basal insulin that is specific for treating diabetes) to a particular patient (i.e., the patient having the diagnosis of diabetes for whom glucose measurements were obtained and used to determine the recommended basal dose).
In response, Examiner submits that 2106.04(d)(2) recites “The treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). For example, consider a claim that recites mentally analyzing information to identify if a patient has a genotype associated with poor metabolism of beta blocker medications. This falls within the mental process grouping of abstract ideas enumerated in MPEP § 2106.04(a). The claim also recites "administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype." This administration step is particular, and it integrates the mental analysis step into a practical application. Conversely, consider a claim that recites the same abstract idea and "administering a suitable medication to a patient." This administration step is not particular, and is instead merely instructions to "apply" the exception in a generic way. Thus, the administration step does not integrate the mental analysis step into a practical application.”. The current claims recite “determining a recommended basal dose of insulin to administer to the patient based on the glucose measurements of the patient from the specified date range and administering the insulin…by transmitting…to patient device…patient device causing to transmit the recommended basal dose insulin to a smart insulin pen that…automatically dial a number…to administer to the patient…the insulin”, this corresponds to determining a suitable medication for the patient and then administering the suitable medication to the patient using well-understood, routine and conventional methods in the industry (using a smart insulin pen in connection with the patient device). The administration of the medication step of the claims is not particular, and is instead merely instructions to "apply" the exception in a generic way-recommended insulin basal dose based on glucose measurements of the patient from the specified date range.
Therefore, the arguments are not persuasive and claims are ineligible under 35 USC 101 as being directed to non-statutory subject matter.
Arguments about 35 USC 103 rejection:
Applicant argues that Thukral does not teach “average computed for a plurality of HbA1C values”. In response, Examiner submits that Thukral discloses “In the following example, one daily lifestyle pattern (habit) examined consisted of an overnight period and a day period consisting of multiple meals and snacks for a patient. The daily lifestyle pattern repeats itself over a period of months whereby the timing of meals varied randomly around expected meal times. The size and composition of the meal was similarly modeled by assigning the parameters of the gamma function values generated from statistical distribution. In general, it was assumed that by considering more or less a 3 month time frame, the persistent average behavior would be observed in HbAlC value even though from meal to meal there could be potentially large variability…” in [0047]).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/DILEK B COBANOGLU/Primary Examiner, Art Unit 3687