DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This office action is responsive to the amendment filed on March 20, 2026. As directed by the amendment: claim 1 has been amended, no claims have been cancelled, and no claims have been added. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see Remarks, filed March 20, 2026, with respect to the rejection of newly amended claim 1 under 35 U.S.C. §103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Montgomery et al. (Montgomery) US 2009/0112154 A1.
Applicant has requested that the double patenting rejections be held in abeyance until such time as all claims are found otherwise allowable. In response, Examiner points to the double patenting rejections below.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1-3, 6, 9-10, 12, 14-15, 17 and 19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Flanders (Pub. No. 2006/0264895) in view of Krogh et al. (Pub. No. 2011/0092907) in view of Galley et al. (Pub. No. 2010/0317950) in view of Montgomery et al. (Montgomery) US 2009/0112154 A1.
Regarding claim 1, Flanders teaches a non-transitory computer readable medium (32, Fig. 1) having stored therein instructions (it is the Examiner’s position that the 32 has instructions as a result of 34 performing measurements and make prediction, see Fig. 2 and [0012]) executable by a computing device (34, Fig. 1) to cause the computing device (32) to perform functions comprising: receive a selection (42, Fig. 2, see [0012]) from a user (16, Fig. 1) of an insulin dosing protocol (10, Fig. 1); prompt the user (12) to provide information (50, Fig. 2, blood glucose and drip rate, see [0012]) specific to a patient (12) based on the selection (see [0010]); generate an insulin dosage recommendation (62, Fig. 2) based on the selection and the information specific to the patient (see [0011]); and provide a graphical user interface (26, Fig. 1) customized to the insulin dosing protocol selected by the user and configured to display the insulin dosage recommendation to the user (16, see [0011]) but does not teach insulin dosing protocol selected from two or more dosing protocols, wherein each of the two or more dosing protocols includes a selectable glucose measurement schedule, a selectable insulin therapy schedule, and a selectable nutritional plan. However, Krogh et al. teaches a protocol (see [0042]) wherein each of the two or more dosing protocols includes an insulin therapy schedule (insulin infusion flow rate, see [0042]), and a nutritional plan (nutritional inputs, see [0042]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device taught by Flanders by adding the interface taught by Krogh et al. and configuring the controller to be in communication with the interface as taught by Krogh et al. to allow the user to control their treatment (see [0042]).
Flanders teaches creating individual patient reports from information stored in a database P0015, but Flanders does not explicitly teach causing the graphical user interface to display patient physiological characteristics and responses to therapy by displaying events related to glucose measurements, patient physiology changes, diet changes, and/or insulin dosing changes in a chronological manner.
However, Galley et al. teaches a graphical user interface for displaying event-aligned information sets related to diabetes having instructions to cause the graphical user interface (GUI, P0037 and shown in Fig. 4) to display patient physiological characteristics and responses to therapy (GUI displays blood glucose over time in response to events, wherein events may include hypoglycemia, exercise, illness, stress, menstrual state, meals, test meals, ketosis, therapeutic changes, hyperglycemia, new exercise or the start of a sport season, P0037) by displaying events related to glucose measurements (blood glucose on the y-axis, P0037), patient physiology changes (hypoglycemia, exercise, illness, stress, menstrual state, hyperglycemia, new exercise or the start of a sport season, P0037), diet changes (meals, test meals, P0037), and/or insulin dosing changes (therapeutic changes, P0037) in a chronological manner (chronological time lapse displayed on the x-axis, P0037 and see Fig. 4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the instructions of Flanders in view of Krogh et al. to include instructions for the GUI to display events in a chronological manner as taught by Galley et al. for the purpose of showing multiple information sets overlaid on a common graph to illustrate blood glucose and events that influence blood glucose.
Flanders teaches generating an insulin dosage recommendation that is delivered via a drip to an IV line P0009, but does not teach adjusting the insulin dosage recommendation if: a long-acting subcutaneous insulin-on-board measurement is greater than a required long-acting subcutaneous insulin or an insulin-on-board measurement remaining from a short-acting subcutaneous insulin dosage has a positive value.
However, Montgomery teaches a user interface for an insulin infusion device that generates an insulin dosage recommendation, and adjusting the insulin dosage recommendation if: an insulin-on-board measurement remaining from a short-acting subcutaneous insulin dosage has a positive value (estimation calculators also account for Insulin-On-Board (IOB), wherein IOB is the insulin delivered to the patient but not yet metabolized into the body, and calculated based on an absorption curve of fast-acting insulin and updated periodically P0034, wherein fast-acting insulin is also known as short-acting insulin, see Bashan et al. US 2011/0319322 P0006).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the insulin dosage recommendation by adjusting for insulin on board for the purpose of providing to the patient a more accurate dosage of insulin according to patient need in light of insulin previously delivered to the patient but not yet metabolized into the body.
Regarding claim 2, Flanders in view of Krogh et al. in view of Galley et al. teaches wherein the insulin dosing protocol comprises an intravenous insulin dosing protocol and the insulin dosage recommendation comprises an intravenous insulin dosage recommendation (see Flanders, 0009] where the insulin is delivered intravenously; hence, the 10 is an intravenous dosing protocol and the insulin recommendation is an intravenous insulin dosage recommendation; see [0011]).
Regarding claim 3, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. teaches wherein the information specific to the patient comprises a current insulin infusion rate (insulin drip rate, see Flanders [0012]) and a glucose measurement (50, Fig. 2) used to determine the current insulin infusion rate (see [0012]).
Regarding claim 6, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. teaches wherein the insulin dosing protocol (10) comprises a starting insulin dosing protocol (48, Fig. 2) and the insulin dosage recommendation comprises an intravenous insulin dosage recommendation (see Flanders [0009]) or a subcutaneous insulin dosage recommendation.
Regarding claim 9, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. teaches wherein the instructions are executable to cause the computing device to further perform functions comprising: receive additional information specific to the patient from a hospital information system communicatively coupled to the computing device (34, see Flanders Fig. 1 and [0010] where the processor communications with communications channel 30 to get access to patient information from other hospitals).
Regarding claim 10, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. teaches wherein the instructions are executable to cause the computing device to further perform functions comprising: disseminate an order embodying the insulin dosage recommendation to various locations within a hospital equipped to execute the order (see Flanders [0010] where the patient information is sent to a nurses’ station or a hospital-wide patient monitor center).
Regarding claim 12, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. teaches wherein the insulin dosage recommendation is executable by an insulin delivery device (pump, see claim 18).
Regarding claim 14, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. teaches wherein the instructions are executable to cause the computing device (34) to further perform functions comprising: generate an instruction indicating when a next glucose measurement should be obtained (see Flanders Fig. 5 indicating that the next blood glucose measurement should be in 60 mins).
Regarding claim 15, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. teaches wherein the instructions are executable to cause the computing device (34) to further perform functions comprising: cause the graphical user interface to display (26) a request for additional information (68-recheck interval, Fig. 2 and see [0013]), a therapy recommendation, or both when an unexpected glucose value is measured after the insulin dosage recommendation is implemented (see [0014]).
Regarding claim 17, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. teaches wherein the instructions are executable to cause the computing device to further perform functions comprising: receive a selection of a hospital and a selection of a unit within the hospital where the patient is located (see Flanders [0009]-[0010] where the processor uses the network to access patient data from other hospitals or in-patient facilities in the intensive care units).
Regarding claim 19, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. teaches wherein the instructions are executable to cause the computing device to further perform functions comprising: generate an alert for visual display or audible transmission to the user when a glucose check is past due (see Flanders 0013]-[0014]).
Claims 4, 7-8, 16 and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Flanders (Pub. No. 2006/0264895) in view of Krogh et al. (Pub. No. 2011/0092907) in view of in view of Galley et al. (Pub. No. 2010/0317950 A1) in view of Montgomery et al. (Pub. No. 2009/0112154) in view of Grounsell et al. (Pub. No. 2007/0078314).
Regarding claim 4, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. does not specifically teach wherein the insulin dosing protocol comprises a subcutaneous insulin dosing protocol and the insulin dosage recommendation comprises a subcutaneous insulin dosage recommendation. However, Grounsell et al. teaches wherein an insulin dosing protocol (400) comprises a subcutaneous insulin dosing protocol and the insulin dosage recommendation comprises a subcutaneous insulin dosage recommendation (see 20, Fig. 2A, 84, Fig. 4, Fig. 7 and [0029], [0031], [0034, [0036]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device taught by Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. by implementing the computer-directed formulation of predicting and recommending subcutaneous and intravenous insulin dosages taught by Grounsell et al. into the central processing unit taught by Flanders in view of Krogh et al. in view of Galley et al. for ensuring an effective blood glucose management system for patients with various types of diabetes (see [0005]-[0006]). Further, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. teaches switching from intravenous to subcutaneous to provide stabilized treatment (see Flanders [0025]) and that modifications may be made to the device (see [0029]).
Regarding claim 7, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. teaches wherein the information specific to the patient comprises clinical information (blood glucose) but does not specifically teach wherein the information specific to the patient comprises demographic information. However, Grounsell et al. teaches a recommendation and prediction based on demographic information weigh (see [0056] where the patient’s age, weight and height are entered).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device taught by Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. by such that the prediction and recommendation for insulin delivery factors in the patient’s weight, age and height as taught by Grounsell et al. for ensuring an effective blood glucose management system for patients with various types of diabetes (see [0005]-[0006]). Further, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. teaches switching from intravenous to subcutaneous to provide stabilized treatment (see Flanders [0025]) and that modifications may be made to the device (see Flanders [0029]).
Regarding claim 8, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. does not specifically teach wherein the information specific to the patient comprises a diabetes diagnosis, a potassium level, a weight, a targeted blood glucose range, a creatinine level, a date of birth, a sex, or combinations thereof. However, Grounsell et al. teaches wherein the information specific to the patient comprises a diabetes diagnosis, a potassium level, a weigh (see [0056] where the patient’s weight is entered), a targeted blood glucose range, a creatinine level, a date of birth, a sex, or combinations thereof.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device taught by Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. by such that the prediction and recommendation for insulin delivery factors in the patient’s weight, as taught by Grounsell et al. for ensuring an effective blood glucose management system for patients with various types of diabetes (see [0005]-[0006]). Further, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. teaches switching from intravenous to subcutaneous to provide stabilized treatment (see Flanders [0025]) and that modifications may be made to the device (see Flanders [0029]).
Regarding claim 16, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. teaches wherein the instructions are executable to cause the computing device (34) to further perform functions comprising: cause the graphical user interface (26) to display a first interface when the insulin dosing protocol comprises an intravenous insulin doing protocol (see [0009] and [0011]) but does not specifically teach and a second interface, different from the first, when the insulin dosing protocol comprises a subcutaneous insulin dosing protocol. However, Grounsell teaches wherein the instructions are executable to cause the computing device to further perform functions comprising: cause the graphical user interface (406/416) to display a first interface when the insulin dosing protocol comprises an intravenous insulin doing protocol and a second interface, different from the first, when the insulin dosing protocol comprises a subcutaneous insulin dosing protocol (see [0105] and [0110] and see [0051] where predictions and measurements are displayed on 406).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device taught by Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. by implementing the computer-directed formulation of predicting and recommending subcutaneous and intravenous insulin dosages taught by Grounsell et al. into the central processing unit taught by Flanders for ensuring an effective blood glucose management system for patients with various types of diabetes (see [0005]-[0006]). Further, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. teaches switching from intravenous to subcutaneous to provide stabilized treatment (see Flanders [0025]) and that modifications may be made to the device (see Flanders [0029]).
Regarding claim 20, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. does not teach wherein the instructions are executable to cause the computing device to operate without connecting to a server or a hospital information system. However, Grounsell et al. teaches wherein the instructions are executable to cause the computing device (402) to operate without connecting to a server (412, Fig. 1, see [0012]) or a hospital information system.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device taught by Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. by configuring the device to be in communication with a computer server as taught by Grounsell et al. for automatically transmitting patient information to an external station (see [0012]). Further, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. teaches that modifications may be made to the device (see Flanders [0029]).
Claim 5 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Flanders (Pub. No. 2006/0264895) in view of Krogh et al. (Pub. No. 2011/0092907) in view of Galley et al. (Pub. No. 2010/0317950) in view of Montgomery et al. (Pub. No. 2009/0112154) in view of Grounsell et al. (Pub. No. 2007/0078314) in view of Malave et al. (Pub. No. 2002/0193679).
Regarding claim 5, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. in view of Grounsell et al. does not teach wherein the information specific to the patient comprises a total basal insulin units administered per day and a total bolus insulin units administered per day. However, Malave et al. teaches wherein information specific to the patient comprises a total basal insulin units administered per day and a total bolus insulin units administered per day (see [0114] and Fig. 24).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device taught by Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. in view of Grounsell et al. by configuring the device to include the totally basal insulin units and the total bolus insulin units administered per day to the patient as taught by Malave et al. for closely monitoring the patient’s condition and treatment regimen (see [0003]). Further, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. in view of Grounsell et al. teaches that modifications may be made to the device (see [0029]).
Claim 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Flanders (Pub. No. 2006/0264895) in view of Krogh et al. (Pub. No. 2011/0092907) in view of Galley et al. (Pub. No. 2010/0317950 A1) in view of Montgomery et al. (Pub. No. 2009/0112154) in view of Simpson et al. (Pub. No. 2008/0197024).
Regarding claim 11, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. does not teach wherein the instructions are executable to cause the computing device to further perform functions comprising: receive a current glucose level from a continuous glucose monitor connected to the patient. However, Simpson et al. teaches receiving a current glucose level from a continuous glucose monitor (14, Fig. 1C2) connected to the patient (see [0735]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device taught by Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. by adding the continuous glucose monitoring system and sensor electronics to the intravenous line as taught by Simpson et al. for continuously monitoring the patient’s blood glucose concentration in the patient’s circulatory system (see [0164]). Further, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. teaches that other methods of determining the patient’s blood glucose levels can be used (see [0010]) such as a continuous glucose measurement device (see Flanders [0028]) and modifications may be made to the device (see Flanders [0029]).
Claim 13 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Flanders (Pub. No. 2006/0264895) in view of Krogh et al. (Pub. No. 2011/0092907) in view of Galley et al. (Pub. No. 2010/0317950) in view of Montgomery et al. (Pub. No. 2009/0112154) in view of Wei et al. (Pub. No. 2011/0021898).
Regarding claim 13, Flanders in view of in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. does not teach wherein the instructions are executable to cause the computing device to further perform functions comprising: generate a carbohydrate dosage recommendation based at least in part on the information specific to the patient. However, in the same field of endeavor Wei et al. teaches generate a carbohydrate dosage recommendation based (see [0037] where the device recommends taking 36g of carbohydrates) at least in part on the information (blood glucose) specific to the patient (see [0034]-[0037] and Table 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device taught by Flanders in view of in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. such that the processor is configured to generate a carbohydrate dosage as taught by Wei et al. for managing the patient’s blood glucose levels when the patient has an excess of insulin (see [0034] and [0037]). Further, Flanders in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. teaches that modifications may be made to the device (see Flanders [0029]).
Claim 18 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Flanders (Pub. No. 2006/0264895) in view of Krogh et al. (Pub. No. 2011/0092907) in view of Galley et al. (Pub. No. 2010/0317950) in view of Montgomery et al. (Pub. No. 2009/0112154) in view of Besterman et al. (Pub. No. 2008/0249386).
Regarding claim 18, Flanders in view of in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. does not teach wherein the instructions are executable to cause the computing device to further perform functions comprising: determine that a most recent glucose measurement was received longer than a maximum length of time before a current time, wherein the insulin dosing protocol comprises a restarting insulin dosing protocol. However, Besterman et al. teaches wherein the instructions are executable to cause the computing device to further perform functions comprising: determine that a most recent glucose measurement was received longer than a maximum length of time before a current time, wherein the insulin dosing protocol comprises a restarting insulin dosing protocol (see [0052], [0101], [0105] and [0108]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device taught by Flanders in view of in view of Krogh et al. in view of Galley et al. in view of Montgomery et al. by configuring the processor to determine that a most recent glucose measurement was received longer than a maximum length of time before a current time, wherein the insulin dosing protocol comprises a restarting insulin dosing protocol as taught by Besterman et al. for providing flexibility to avoid burdening the medical staff and also possibly eliminating medically unnecessary glucose checks (see [0052]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4, 6-8 and 13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 10 of U.S. Patent No. 10,046,113 (hereinafter 113’) in view of Krogh et al. (Pub. No. 2011/0092907) in view of Galley et al. (Pub. No. 2010/0317950). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, 113’ teaches a non-transitory computer readable medium having stored therein instructions executable by a computing device to cause the computing device to perform functions comprising: receive a selection from a user of an insulin dosing protocol; prompt the user to provide information specific to a patient based on the selection; generate an insulin dosage recommendation based on the selection and the information specific to the patient; and provide a graphical user interface customized to the insulin dosing protocol and configured to display the insulin dosage recommendation to the user (see claim 1 of 113’) and adjusting the insulin dosage recommendation if: a long-acting subcutaneous insulin-on-board measurement is greater than a required long-acting subcutaneous insulin (see claim 1 of 113’, c 30 ln 49-64)or an insulin-on-board measurement remaining from a short-acting subcutaneous insulin dosage has a positive value, but does not teach insulin dosing protocol selected from two or more dosing protocols, wherein each of the two or more dosing protocols includes a selectable glucose measurement schedule, a selectable insulin therapy schedule, and a selectable nutritional plan. However, Krogh et al. teaches a protocol (see [0042]) wherein each of the two or more dosing protocols includes an insulin therapy schedule (insulin infusion flow rate, see [0042]), and a nutritional plan (nutritional inputs, see [0042]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device taught by 113’ by adding the interface taught by Krogh et al. and configuring the controller to be in communication with the interface as taught by Krogh et al. to allow the user to control their treatment (see [0042]).
113’ does not explicitly teach causing the graphical user interface to display patient physiological characteristics and responses to therapy by displaying events related to glucose measurements, patient physiology changes, diet changes, and/or insulin dosing changes in a chronological manner.
However, Galley et al. teaches a graphical user interface for displaying event-aligned information sets related to diabetes having instructions to cause the graphical user interface (GUI, P0037 and shown in Fig. 4) to display patient physiological characteristics and responses to therapy (GUI displays blood glucose over time in response to events, wherein events may include hypoglycemia, exercise, illness, stress, menstrual state, meals, test meals, ketosis, therapeutic changes, hyperglycemia, new exercise or the start of a sport season, P0037) by displaying events related to glucose measurements (blood glucose on the y-axis, P0037), patient physiology changes (hypoglycemia, exercise, illness, stress, menstrual state, hyperglycemia, new exercise or the start of a sport season, P0037), diet changes (meals, test meals, P0037), and/or insulin dosing changes (therapeutic changes, P0037) in a chronological manner (chronological time lapse displayed on the x-axis, P0037 and see Fig. 4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the instructions of 113’ in view of Krogh et al. to include instructions for the GUI to display events in a chronological manner as taught by Galley et al. for the purpose of showing multiple information sets overlaid on a common graph to determine cause and effect between blood glucose over time and events that influence blood glucose.
Regarding claim 2, 113’ teaches wherein the insulin dosing protocol comprises an intravenous insulin dosing protocol and the insulin dosage recommendation comprises an intravenous insulin dosage recommendation (see claim 1 of 113’).
Regarding claim 4, 113’ teaches wherein the insulin dosing protocol comprises a subcutaneous insulin dosing protocol and the insulin dosage recommendation comprises a subcutaneous insulin dosage recommendation (see claim 1 of 113’).
Regarding claim 6, 113’ teaches wherein the insulin dosing protocol comprises a starting insulin dosing protocol and the insulin dosage recommendation comprises an intravenous insulin dosage recommendation or a subcutaneous insulin dosage recommendation (see claim 1 of 113’).
Regarding claim 7, 113’ teaches wherein the information specific to the patient comprises demographic information and clinical information (see claim 3 of 113’).
Regarding claim 8, 113’ teaches wherein the information specific to the patient comprises a diabetes diagnosis, a potassium level, a weight, a targeted blood glucose range, a creatinine level, a date of birth, a sex, or combinations thereof (see claim 3 of 113’).
Regarding claim 13, 113’ teaches wherein the instructions are executable to cause the computing device to further perform functions comprising: generate a carbohydrate dosage recommendation based at least in part on the information specific to the patient (see claim 10 of 113’).
Claims 1-2, 6-8 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5 and 7 of U.S. Patent No. 10,842,935 (hereinafter 935’) in view of Krogh et al. (Pub. No. 2011/0092907) in view of Galley et al. (Pub. No. 2010/0317950). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, 935’ teaches a non-transitory computer readable medium having stored therein instructions executable by a computing device to cause the computing device to perform functions comprising: receive a selection from a user of an insulin dosing protocol; prompt the user to provide information specific to a patient based on the selection; generate an insulin dosage recommendation based on the selection and the information specific to the patient; and provide a graphical user interface customized to the insulin dosing protocol and configured to display the insulin dosage recommendation to the user (see claim 1 of 935’), adjusting the insulin dosage recommendation if: there is insulin-on-board remaining from an intravenous insulin dosage (see claim 1 of ‘935), or if a long-acting subcutaneous insulin-on-board measurement is greater than a required long-acting subcutaneous insulin or an insulin-on-board measurement remaining from a short-acting subcutaneous insulin dosage has a positive value, but does not teach insulin dosing protocol selected from two or more dosing protocols, wherein each of the two or more dosing protocols includes a selectable glucose measurement schedule, a selectable insulin therapy schedule, and a selectable nutritional plan. However, Krogh et al. teaches a protocol (see [0042]) wherein each of the two or more dosing protocols includes a selectable insulin therapy schedule (insulin infusion flow rate, see [0042]), and a nutritional plan (nutritional inputs, see [0042]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device taught by 935’ by adding the interface taught by Krogh et al. and configuring the controller to be in communication with the interface as taught by Krogh et al. to allow the user to control their treatment (see [0042]).
935’ does not explicitly teach causing the graphical user interface to display patient physiological characteristics and responses to therapy by displaying events related to glucose measurements, patient physiology changes, diet changes, and/or insulin dosing changes in a chronological manner.
However, Galley et al. teaches a graphical user interface for displaying event-aligned information sets related to diabetes having instructions to cause the graphical user interface (GUI, P0037 and shown in Fig. 4) to display patient physiological characteristics and responses to therapy (GUI displays blood glucose over time in response to events, wherein events may include hypoglycemia, exercise, illness, stress, menstrual state, meals, test meals, ketosis, therapeutic changes, hyperglycemia, new exercise or the start of a sport season, P0037) by displaying events related to glucose measurements (blood glucose on the y-axis, P0037), patient physiology changes (hypoglycemia, exercise, illness, stress, menstrual state, hyperglycemia, new exercise or the start of a sport season, P0037), diet changes (meals, test meals, P0037), and/or insulin dosing changes (therapeutic changes, P0037) in a chronological manner (chronological time lapse displayed on the x-axis, P0037 and see Fig. 4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the instructions of 935’ in view of Krogh to include instructions for the GUI to display events in a chronological manner as taught by Galley et al. for the purpose of showing multiple information sets overlaid on a common graph to determine cause and effect between blood glucose over time and events that influence blood glucose.
Regarding claim 2, 935’ teaches wherein the insulin dosing protocol comprises an intravenous insulin dosing protocol and the insulin dosage recommendation comprises an intravenous insulin dosage recommendation (see claim 1 of 935’).
Regarding claim 6, 935’ teaches wherein the insulin dosing protocol comprises a starting insulin dosing protocol and the insulin dosage recommendation comprises an intravenous insulin dosage recommendation or a subcutaneous insulin dosage recommendation (see claim 1 of 935’).
Regarding claim 7, 935’ teaches wherein the information specific to the patient comprises demographic information and clinical information (see claim 5 of 935’).
Regarding claim 8, 935’ teaches wherein the information specific to the patient comprises a diabetes diagnosis, a potassium level, a weight, a targeted blood glucose range, a creatinine level, a date of birth, a sex, or combinations thereof (see claim 5 of 935’).
Regarding claim 10, 935’ teaches wherein the instructions are executable to cause the computing device to further perform functions comprising: disseminate an order embodying the insulin dosage recommendation to various locations within a hospital equipped to execute the order (see claim 7 of 935’).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
