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 is the first office action on the merits in response to Applicant’s election filed on 02/11/2026.
Election/Restrictions
Applicant’s election without traverse of Species I, II, III, and IV in the reply filed on February 11, 2026 is acknowledged. However, this election is considered to be not fully responsive because the restriction requirement required “an election of a species to be examined” (i.e., one species), whereas Applicant elected four species. During a telephone call to Peter Jon Cluck on February 23, 2026, Applicant revised the election to Species VI: Fig. 5 without traverse.
Claims 29-30 are withdrawn as being drawn to a nonelected species.
Regarding claim 29, the limitation “the electronic device comprises a smart pen” is not shown in the elected species of Fig. 5, but rather, is shown in the nonelected Species VII, which includes Figs. 16 and 17-22. Specifically, Fig. 17 shows a smart pen with ref. no. “1602”.
Regarding claim 30, the limitation “the electronic device comprises a smart insulin pen” is not shown in the elected species of Fig. 5, but rather, is shown in the nonelected Species VII, which includes Figs. 16 and 17-22. Specifically, Fig. 17 shows a smart pen with ref. no. “1602”. Note that smart pen 1602 may also be a “smart insulin pen” (see ¶ [0228] of specification).
Since the above limitations are not found in the species of Fig. 5, claims 29-30 are drawn to nonelected species, and are also withdrawn from further consideration pursuant to 37 CFR 1.142(b).
Claims 1-28 are pending and examined.
Claim Objections
Claim 19 is objected to because of the following informalities:
Claim 19, line 2: “the accumulation of recommended doses of medicament” is believed to be in error for --the first accumulation of recommended doses of medicament-- (see claim 14, line 2)
Appropriate correction is required.
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 1-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
STEP 1:
Regarding claim 1, the claim recites a series of structural elements, including a memory and a hardware processor in communication with the memory. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE:
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
a hardware processor in communication with the memory and configured to execute the specific computer-executable instructions to at least:
receive glucose level data associated with the glucose level of the subject;
receive, via user interaction with a dose setup interface, a user-specified medicament-related input related to an amount of insulin to be provided to the subject;
determine, using a control algorithm, a recommended dose of medicament based at least in part on the user-specified medicament-related input and the glucose level data, wherein the control algorithm is configured to control glucose level in the subject based on one or more control parameters of the control algorithm, and wherein at least one control parameter is set based at least in part on the glucose level data; and
output an indication of the recommended dose of medicament
set forth a judicial exception. These steps describe concepts performed in the human mind (including an observation, evaluation, judgment, opinion). Additionally, a control algorithm is a mathematical concept. Thus, the claim is drawn to a mental process and a mathematical concept, which are abstract ideas.
STEP 2A, PRONG TWO:
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation of the judicial exception. Claim 1 recites “output[ting] an indication of the recommended dose of medicament”. The outputting an indication of a recommended dose of medicament does not provide an improvement to the technological field, and the method does not effect a particular treatment or effect a particular change based on the output. In addition, the generically recited computer elements (memory and hardware processor) do not add a meaningful limitation to the abstract idea on a computer because they amount to simply implementing the abstract idea on a computer.
STEP 2B:
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Claim 1 recites the following:
receive glucose level data associated with the glucose level of the subject; (insignificant extra-solution activity: data gathering)
receive, via user interaction with a dose setup interface, a user-specified medicament-related input related to an amount of insulin to be provided to the subject; (insignificant extra-solution activity: data gathering)
determine, using a control algorithm, a recommended dose of medicament based at least in part on the user-specified medicament-related input and the glucose level data, wherein the control algorithm is configured to control glucose level in the subject based on one or more control parameters of the control algorithm, and wherein at least one control parameter is set based at least in part on the glucose level data; and (mental process: evaluation)
output an indication of the recommended dose of medicament (insignificant extra-solution activity: data outputting).
The above steps do not provide significantly more than the judicial exception. The steps of “receive glucose level data…”, “receive, via user interaction with a dose setup interface, a user-specified medicament-related input…”, and “output an indication of the recommended dose of medicament” are merely insignificant extra-solution activities. The step of “determine, using a control algorithm, a recommended dose of medicament based at least in part on the user-specified medicament-related input and the glucose level data…” are mere instructions to implement the judicial exception on a generic computer. Moreover, the additional elements of “a memory configured to store specific computer-executable instructions; and a hardware processor in communication with the memory and configured to execute the specific computer-executable instructions” are well-understood, routine, conventional computer functions as recognized by court decisions listed in MPEP § 2106.05(d).
The dependent claims also fail to add significantly more to the abstract independent claim. Claims 2-5 recite steps (receive, determine, output, etc.) that add to the abstract idea, but do not provide an improvement to the technological field or effect a particular treatment or change. Claims 6-28 recite additional elements that are not significantly more (claims 6-13 merely amount to data gathering; claims 14-15, 17, 19, and 21-26 merely add to the control algorithm, which is a mental process to be implemented on a generic computer; and claims 16, 18, 20, and 27-28 merely amount to data outputting).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8, 14, and 23-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brauker (US 2018/0185587 A1: IDS reference).
Regarding claim 1, Brauker teaches (Figs. 1 and 8-9) a glucose level control system (10 – Fig. 1) configured to generate glucose control therapy recommendations for controlling a glucose level of a subject (8 – Fig. 1), the glucose level control system (10) comprising:
a memory (84 and 88 – Fig. 8) configured to store specific computer-executable instructions (¶ [0149], ll. 10-15 and 24-26); and
a hardware processor (82 – Fig. 8) in communication with the memory (84, 88) and configured to execute the specific computer-executable instructions to at least:
receive glucose level data associated with the glucose level of the subject (Fig: 9 – block 132;
receive, via user interaction with a dose setup interface (96 – Fig. 8), a user-specified medicament-related input related to an amount of insulin to be provided to the subject (¶ [0155], ll. 6-8: “input of user information about himself/herself, such as mealtime, exercise, insulin administration, and reference glucose values”. Also block 136 in Fig. 9 – see ¶ [0168], ll. 3-9: “The validation may include a request from the user…such as time of day, meals, sleep, calories, exercise, sickness, or the like”);
determine, using a control algorithm, a recommended dose of medicament based at least in part on the user-specified medicament-related input and the glucose level data (Fig. 9: block 134 – see also ¶ [0167], ll. 4-6: “A variety of algorithms may be used to calculate a recommended therapy as is appreciated by one skilled in the art”), wherein the control algorithm is configured to control glucose level in the subject (via medicament delivery device 16 – Fig. 1) based on one or more control parameters of the control algorithm, and wherein at least one control parameter is set based at least in part on the glucose level data (¶ [0114], ll. 10-15: “algorithms that use parameters provided by the continuous glucose sensor, such as glucose concentration, rate-of-change of the glucose concentration, and acceleration of the glucose concentration to more particularly determine the type, amount, and time of medicament administration”); and
output an indication of the recommended dose of medicament (Fig. 9: block 138).
Regarding claim 2, Brauker teaches the invention as claimed and as discussed above for claim 1, and Brauker further teaches (Figs. 8 and 10) the hardware processor (82 – Fig. 8) is further configured to execute the specific computer-executable instructions to at least:
receive second glucose level data associated with the glucose level of the subject (Fig. 10: block 144);
receive, via second user interaction with the dose setup interface (96 – Fig. 8), a second user-specified medicament-related input that specifies a size of a second amount of insulin to be provided to the subject (as stated in ¶ [0155], ll. 6-8 and ¶ [0168], ll. 3-9); and
determine a second recommended dose of medicament based on the second user-specified medicament-related input and the second glucose level data (Fig. 10: block 148. Note that block 150 repeats the therapy calculation step using new glucose level data. Therefore, these steps may be repeated more than once).
Alternatively, the steps in Brauker’s Fig. 9 may be repeated for another day, thereby teaching the second glucose level data, the second user interaction, and the second recommended dose of medicament.
Regarding claim 3, Brauker teaches the invention as claimed and as discussed above for claim 2, and Brauker further teaches (Figs. 8 and 10) the hardware processor (82 – Fig. 8) is further configured to execute the specific computer-executable instructions to at least:
determine that the second recommended dose of medicament matches the second user-specified medicament-related input within a threshold degree (Fig. 10: block 148 – see also ¶ [0176], ll. 5-6: “In some embodiments, the recommended therapy is validated such as described with reference to FIG. 9 above”); and
output an indication of the second recommended dose of medicament (¶ [0009], ll. 1-3: “the output step includes displaying the sensor therapy recommendations on the user interface”).
Regarding claim 4, Brauker teaches the invention as claimed and as discussed above for claim 2, and Brauker further teaches (Figs. 8 and 10) the hardware processor (82 – Fig. 8) is further configured to execute the specific computer-executable instructions to at least:
determine that the second recommended dose of medicament matches the second user-specified medicament-related input within a threshold degree (Fig. 10: block 148 – see also ¶ [0176], ll. 5-6: “In some embodiments, the recommended therapy is validated such as described with reference to FIG. 9 above”); and
output an indication that the second user-specified medicament-related input satisfies an approval condition (¶ [0007] teaches “the therapy validation is configured to trigger a fail-safe module, if the validation fails, wherein the user must confirm a therapy decision prior to outputting therapy recommendations”. Therefore, if the validation passes, the user will be notified).
Regarding claim 5, Brauker teaches the invention as claimed and as discussed above for claim 2, and Brauker further teaches (Figs. 8 and 10) the hardware processor (82 – Fig. 8) is further configured to execute the specific computer-executable instructions to at least:
determine that the second recommended dose of medicament does not match the second user-specified medicament-related input within a threshold degree (Fig. 10: block 148 – see also ¶ [0176], ll. 5-6: “In some embodiments, the recommended therapy is validated such as described with reference to FIG. 9 above”); and
output an indication of a modification to the second user-specified medicament-related input based at least in part on a difference between the second recommended dose of medicament and the second user-specified medicament-related input (Fig. 10: block 150 re-calculates the medicament therapy after the validation step in block 148. ¶ [0009] teaches outputting medicament therapy).
Regarding claim 6, Brauker teaches the invention as claimed and as discussed above for claim 1, and Brauker further teaches at least one control parameter is set based at least in part on the user-specified medicament-related input (¶ [0170], ll. 5-9: “exercise, food or medicament intake, rest, or the like may input into the receiver for incorporation into a parameter of the programming (algorithms) that processing the therapy recommendations”).
Regarding claim 7, Brauker teaches the invention as claimed and as discussed above for claim 1, and Brauker further teaches (Figs. 1 and 9) the glucose level data (Fig. 9: block 132) is received from a glucose sensor (12 – Fig. 1) operatively coupled to the subject (8 – Fig. 1).
Regarding claim 8, Brauker teaches the invention as claimed and as discussed above for claim 1, and Brauker further teaches (Fig. 9) the glucose level data (block 132) comprises one or more isolated glucose measurements (¶ [0074], ll. 9-11: “a plurality of time spaced data points from a substantially continuous analyte sensor, which comprises individual measurements taken at time intervals”).
Regarding claim 14, Brauker teaches the invention as claimed and as discussed above for claim 1, and Brauker further teaches the control algorithm is further configured to account for a first accumulation of recommended doses of medicament for the subject over time (¶ [0176], ll. 2-3: “calculates the recommended medicament based on the…medicament delivery data”).
Regarding claim 23, Brauker teaches the invention as claimed and as discussed above for claim 1, and Brauker further teaches the control algorithm is further configured to adapt at least one of the one or more control parameters in response to determined glycemic control associated with medicament provided during a prior therapy period (¶ [0184], ll. 3-4: “programming to track a patient during hypoglycemic or near-hypoglycemic conditions”).
Regarding claim 24, Brauker teaches the invention as claimed and as discussed above for claim 23, and Brauker further teaches the determined glycemic control is determined based at least in part on the glucose level data, prior glucose level data associated with the prior therapy period, or both the glucose level data and the prior glucose level data (¶ [0184], ll. 2-4: “the continuous glucose sensor (and its receiver) comprises programming to track a patient during hypoglycemic or near-hypoglycemic conditions”. Note that the glucose sensor provide the glucose level data, as shown by Fig. 9, block 132).
Regarding claim 25, Brauker teaches the invention as claimed and as discussed above for claim 24, and Brauker further teaches (Figs. 1 and 9) one or more of the glucose level data (Fig. 9: block 132) or the prior glucose level data is received from a glucose sensor (12 – Fig. 1) operatively coupled to the subject (8 – Fig. 1).
Regarding claim 26, Brauker teaches the invention as claimed and as discussed above for claim 24, and Brauker further teaches (Fig. 9) one or more of the glucose level data (Fig. 9: block 132) or the prior glucose level data is determined from one or more isolated glucose measurements (¶ [0074], ll. 9-11: “a plurality of time spaced data points from a substantially continuous analyte sensor, which comprises individual measurements taken at time intervals”).
Regarding claim 27, Brauker teaches the invention as claimed and as discussed above for claim 1, and Brauker further teaches (Fig. 8) the hardware processor (82) is further configured to output the indication of the recommended dose of medicament on a display (106) of the glucose level control system (¶ [0155], ll. 15-16: “The LCD 106 can be provided, for example, to provide the user with visual data output”).
Regarding claim 28, Brauker teaches the invention as claimed and as discussed above for claim 1, and Brauker further teaches (Figs. 1 and 8) the hardware processor (82 – Fig. 8) is further configured to output the indication of the recommended dose of medicament (¶ [0009] teaches outputting medicament therapy) by at least causing the indication of the recommended dose of medicament to be transmitted to an electronic device (receiver 14 – Fig. 1) in communication with the glucose level control system (10 – Fig. 1).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 9 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Brauker (US 2018/0185587 A1: IDS reference), in view of Hayter (US 2022/0249779 A1).
Regarding claim 9, Brauker teaches the invention as claimed and as discussed above for claim 1, except for the user-specified medicament-related input comprises a fast-acting insulin dose size.
Hayter teaches (Figs. 1B and 4A) a similar glucose level control system (100) comprising a user interface (121) for providing a user-specified medicament-related input; and further teaches:
wherein the user-specified medicament-related input comprises a fast-acting insulin dose size (¶ [0152], ll. 7-9: “he DGS may prompt the user to enter the amount of rapid-acting insulin that they typically take for each meal”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Brauker such that the user-specified medicament-related input comprises a fast-acting insulin dose size, in order to learn the patient’s dosing strategy during a learning period and use this to provide titrations and corrections of the dose guidance to the patent, as taught by Hayter (¶ [0007], ll. 8-18).
Regarding claim 21, Brauker teaches the invention as claimed and as discussed above for claim 14, except for the first accumulation of recommended doses of medicament comprises an accumulation of basal insulin doses.
Hayter teaches (Figs. 1B and 4A) a similar glucose level control system (100) comprising a user interface (121) for providing a user-specified medicament-related input; and further teaches:
a recommended dose of medicament comprises a basal insulin dose (¶ [0225], ll. 1-5: “Dosing information can include, for example, dose regimen, meal-dose type, dose parameters, and dose range. Dose regimens may include, for example, basal dose plus BF, basal plus LU, basal plus DI, basal plus BF/LU, basal plus BF/DI, basal plus LU/DI, and basal plus”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Brauker such that the first accumulation of recommended doses of medicament comprises an accumulation of basal insulin doses, in order to provide a dose of long acting insulin, as taught by Hayter (¶ [0540], ll. 4-5).
Regarding claim 22, Brauker, in view of Hayter as discussed so far, teaches the invention as claimed and as discussed above for claim 21, except for the first accumulation of recommended doses of medicament further comprises at least one correction dose of medicament.
Hayter further teaches a recommended dose of medicament comprises at least one correction dose of medicament (¶ [0007], ll. 7-11: “The dose guidance system can include a dose guidance application (e.g., software) that can determine and output dose guidance (e.g., recommendations regarding dose amounts, corrections, and titrations) to a patient”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Brauker, in view of Hayter as discussed so far, such that the first accumulation of recommended doses of medicament further comprises at least one correction dose of medicament, in order to account for a missed insulin dose and provide a means for the patient to dose late safely, which will help reduce their overall glucose levels, as taught by Hayter (¶ [0009], ll. 28-32).
Claims 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Brauker (US 2018/0185587 A1: IDS reference), in view of Sjolund (US 2019/0175841 A1).
Regarding claim 10, Brauker teaches the invention as claimed and as discussed above for claim 1, except for the user-specified medicament-related input comprises a long-acting insulin dose size.
Sjolund teaches (Fig. 1) a similar glucose level control system (10) comprising a user interface (140) for providing a user-specified medicament-related input; and further teaches:
wherein the user-specified medicament-related input comprises a long-acting insulin dose size (¶ [0034], ll. 19-20: “based on the user's entered amount of long-acting insulin”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Brauker such that the user-specified medicament-related input comprises a long-acting insulin dose size, in order to use this information to provide recommended insulin doses, as taught by Sjolund (¶ [0032], ll. 4-16).
Regarding claim 12, Brauker teaches the invention as claimed and as discussed above for claim 1, except for the user-specified medicament-related input comprises a quantitative indication of carbohydrates, and wherein the recommended dose of medicament is based at least in part on the quantitative indication of the carbohydrates.
Sjolund teaches (Fig. 1) a similar glucose level control system (10) comprising a user interface (140) for providing a user-specified medicament-related input; and further teaches:
wherein the user-specified medicament-related input comprises a quantitative indication of carbohydrates (¶ [0032], l. 11: “user estimated carbohydrates”), and wherein a recommended dose of medicament is based at least in part on the quantitative indication of the carbohydrates (¶ [0032], ll. 4-11: “recommended insulin dosages may be based upon…meal data (mealtimes, user estimated carbohydrates, user estimated meal categorizations, user estimated glycemic impact of meal user meal history, user meal trends, etc.)”)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Brauker such that the user-specified medicament-related input comprises a quantitative indication of carbohydrates, and wherein the recommended dose of medicament is based at least in part on the quantitative indication of the carbohydrates, in order to use this information to provide the “correct” insulin dose, as taught by Sjolund (¶ [0005], ll. 1-5).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Brauker (US 2018/0185587 A1: IDS reference), in view of Mandro (US 2011/0040247 A1: IDS reference).
Regarding claim 11, Brauker teaches the invention as claimed and as discussed above for claim 1, except for the user-specified medicament-related input comprises a user-specified volume of insulin.
Mandro teaches (Fig. 1A) a similar glucose level control system (100) comprising a user interface (106 and 108) for providing a user-specified medicament-related input; and further teaches:
wherein the user-specified medicament-related input comprises a user-specified volume of insulin (¶ [0011], ll. 4-5: “he user input related to volume of insulin delivery”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Brauker such that the user-specified medicament-related input comprises a user-specified volume of insulin, in order to use this information to calculate the insulin on board (action of the insulin currently in the user), which is critical for performing bolus calculations, as taught by Mandro (¶ [0011], ll. 4-6 and ¶ [0138], ll. 4-10).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Brauker (US 2018/0185587 A1: IDS reference), in view of Reinke (US 2011/0124996 A1).
Regarding claim 13, Brauker teaches the invention as claimed and as discussed above for claim 1, and Brauker further teaches the user-specified medicament-related input comprises a user-specified quantitative characterization of an amount of food-intake, and wherein the recommended dose of medicament is based at least in part on the user-specified quantitative characterization of the amount of food-intake (¶ [0170], ll. 5-9: “exercise, food or medicament intake, rest, or the like may input into the receiver for incorporation into a parameter of the programming (algorithms) that processing the therapy recommendations”).
However, Brauker does not teach the user-specified medicament-related input comprises a user-specified quantitative characterization of a macronutrient content of the food-intake, and wherein the recommended dose of medicament is based at least in part on the user-specified quantitative characterization of the macronutrient content of the food-intake.
Reinke teaches (Fig. 3) a similar glucose level control system (100) comprising a user interface (18) for providing a user-specified medicament-related input; and further teaches:
the user-specified medicament-related input comprises a user-specified quantitative characterization of a macronutrient content of the food-intake (¶ [0042], ll. 6-7: “The user may manually enter a food item and a serving size”; ¶ [0042], ll. 15-17: “The food item categories 111 may comprise the food item name, serving size, and nutritional attributes 113 such as total fat, saturated fat, total carbohydrates, etc.”), and wherein a recommended dose of medicament is based at least in part on the user-specified quantitative characterization of the macronutrient content of the food-intake (¶ [0006], ll. 12-17: “to determine a therapy advice message based at least in part on the received blood glucose measurement values, the received insulin dosage data, and the health data entries stored in the memory”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Brauker such that the user-specified medicament-related input comprises a user-specified quantitative characterization of a macronutrient content of the food-intake, and wherein the recommended dose of medicament is based at least in part on the user-specified quantitative characterization of the macronutrient content of the food-intake, in order to use this information to provide accurate and effective insulin therapy, as taught by Reinke (¶ [0004], ll. 10-12).
Claims 15-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Brauker (US 2018/0185587 A1: IDS reference), in view of Rometo (US 2025/0174328 A1).
Regarding claim 15, Brauker teaches the invention as claimed and as discussed above for claim 14, except for the control algorithm accounts for the first accumulation of recommended doses of medicament by reducing the recommended dose of medicament based at least in part on the first accumulation of recommended doses of medicament.
Rometo teaches (Fig. 1) a similar glucose level control system (5) comprising a control algorithm for determining a recommended dose of medicament (¶ [0028], ll. 24-25: “the algorithm determines the suggested dose for the patient using several parameters”); and further teaches:
the control algorithm accounts for the first accumulation of recommended doses of medicament by reducing the recommended dose of medicament based at least in part on the first accumulation of recommended doses of medicament (¶ [0051], ll. 2-3: “the new dose is calculated as a percent decrease from yesterday's dose”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Brauker such that the control algorithm accounts for the first accumulation of recommended doses of medicament by reducing the recommended dose of medicament based at least in part on the first accumulation of recommended doses of medicament, in order to allow the system to adjust insulin doses for the patient as needed without the need for the patient to make any determinations and/or do any calculations on their own, as taught by Rometo (¶ [0029], ll. 7-12).
Regarding claim 16, Brauker, in view of Rometo, teaches the invention as claimed and as discussed above for claim 15, and the combination further teaches outputting the indication of the recommended dose of medicament comprises outputting the reduced recommended dose of medicament (¶ [0009] of Brauker teaches outputting medicament therapy, which would also output a reduced recommended dose of medicament).
Regarding claim 18, Brauker, in view of Rometo, teaches the invention as claimed and as discussed above for claim 17, and the combination further teaches said outputting the indication of the recommended dose of medicament comprises outputting an indication of the second accumulation of recommended doses of medicament (¶ [0009] of Brauker teaches outputting medicament therapy, which would also output the second accumulation of recommended doses of medicament).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Brauker (US 2018/0185587 A1: IDS reference), in view of Rometo (US 2025/0174328 A1), and in further view of Andrews (US 2022/0285003 A1).
Regarding claim 17, Brauker, in view of Rometo, teaches the invention as claimed and as discussed above for claim 15, except for the reduced recommended dose of medicament is added to the first accumulation of recommended doses of medicament to obtain a second accumulation of recommended doses of medicament.
Andrews teaches a computerized method for determining a dose injected into a user (Abstract), and further teaches:
a first sub-injection event and a second sub-injection event, wherein “the device can determine the total injected dose by adding the doses of the last injection events in each sub-injection event group” (¶ [0082], ll. 17-20).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Brauker, in view of Rometo, such that the reduced recommended dose of medicament is added to the first accumulation of recommended doses of medicament to obtain a second accumulation of recommended doses of medicament, in order to determine a total accumulation of recommended doses of medicament, as taught by Andrews (¶ [0082], ll. 17-20). Note that the “second accumulation of recommended doses of medicament” represents the total accumulation of recommended doses of medicament.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Brauker (US 2018/0185587 A1: IDS reference), in view of Andrews (US 2022/0285003 A1).
Regarding claim 19, Brauker teaches the invention as claimed and as discussed above for claim 14, except for the control algorithm accounts for the accumulation of recommended doses of medicament by adding the recommended dose of medicament to the first accumulation of recommended doses of medicament to obtain a second accumulation of recommended doses of medicament.
Andrews teaches a computerized method for determining a dose injected into a user (Abstract), and further teaches:
a first sub-injection event and a second sub-injection event, wherein “the device can determine the total injected dose by adding the doses of the last injection events in each sub-injection event group” (¶ [0082], ll. 17-20).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Brauker such that the control algorithm accounts for the accumulation of recommended doses of medicament by adding the recommended dose of medicament to the first accumulation of recommended doses of medicament to obtain a second accumulation of recommended doses of medicament, in order to determine a total accumulation of recommended doses of medicament, as taught by Andrews (¶ [0082], ll. 17-20). Note that the “second accumulation of recommended doses of medicament” represents the total accumulation of recommended doses of medicament.
Regarding claim 20, Brauker, in view of Andrews, teaches the invention as claimed and as discussed above for claim 19, and the combination further teaches said outputting the indication of the recommended dose of medicament comprises outputting an indication of the second accumulation of recommended doses of medicament (¶ [0009] of Brauker teaches outputting medicament therapy, which would also output the second accumulation of recommended doses of medicament).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure: see attached form PTO-892 “Notice of References Cited”.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY NG whose telephone number is (571)272-2318. The examiner can normally be reached M-F 9:30 AM - 6:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Devon Kramer can be reached at 571-272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HENRY NG/Examiner, Art Unit 3741 /DEVON C KRAMER/Supervisory Patent Examiner, Art Unit 3741