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 .
Response to Amendment
This office action is responsive to the amendment filed on 5/4/2026. As directed by the amendment: claims 33, 44-46, and 49 have been amended; claims 35, 42-43, and 57 have been cancelled; and no claims have been added. Thus, claims 33, 36-41, 44-49, 51-56, and 58 are presently pending in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 33, 36-41, 44-49, 51-56, and 58 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The specification as originally filed does not provide appropriate support for the claimed limitations of claims 33 and 49. The specification as originally filed states that “In one particular embodiment, the management rule, which is implemented by the processing circuit, comprises an algorithm configured for detecting a state of glycaemic imbalance in the patient when a given percentage of blood glucose values is not within the threshold value range” (Paragraph [0054]). However, the specification as originally filed does not appear to explicitly disclose wherein the total number of said plurality of blood glucose levels is a total number of measurements among measurements that are above the upper blood glucose limit and measurements that are below the lower blood glucose limit. Therefore, it cannot be concluded that the claimed subject matter was described in the application as filed in a manner that would reasonably convey to one of ordinary skill in the art that the applicant had possession of the claimed limitations.
Dependent claims are rejected by virtue of their dependency on the independent claims.
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.
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.
Claims 33, 36-37, 44-49, 51-56, and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Mastrototaro et al. (US 20080269714 A1) in view of Howell et al. (US 20140024907 A1) further in view of Rack-Gomer et al. (US 20150289823 A1).
Regarding claim 33, Mastrototaro discloses a medical device for managing the glycaemic balance of a diabetic patient, said device comprising:
- a memory module configured for storing a plurality of blood glucose levels measured during a glycaemic balance phase over a given period of time (Paragraph [0055]), said plurality of blood glucose levels measured being relative to a content of a blood component representative of a blood glucose level of said patient (Paragraph [0050]), and
- a processing circuit implementing a management rule configured for detecting a glycaemic imbalance state in the patient by comparing said plurality of measured blood glucose levels stored in the memory module with a threshold value (Fig. 12, Paragraphs [0011]-[0012], [0015], [0083], [0089], and [0091]),
said processing circuit being configured for emitting a warning signal when the glycaemic imbalance state is detected (Fig. 12, Paragraphs [0011]-[0012], [0089], and [0091]),
wherein the management rule comprises an algorithm configured for detecting the glycaemic imbalance state in the patient when the distribution of said plurality of blood glucose levels measured over said period of time has a standard deviation above a given threshold deviation (Paragraphs [0109]-[0110] of Mastrototaro discuss how the glycaemic imbalance state can be detected in a patient, even when the standard deviation of measured blood glucose values is above a given threshold deviation indicating that no therapy modification should be made).
Mastrototaro is silent regarding
performing an analysis of the distribution of said plurality of blood glucose levels which comprises: comparing each of said plurality of measured blood glucose levels stored in the memory module with a threshold value range having an upper blood glucose limit corresponding to a high blood glucose state and a lower blood glucose limit corresponding to a low blood glucose state,
wherein the analysis of the distribution of said plurality of blood glucose levels further comprises: detecting the glycaemic imbalance state in the patient when based on a given percentage of measured blood glucose levels that represents a total number of said plurality of blood glucose levels measured over the given period of time which are not in said threshold value range over all of said plurality of blood glucose levels measured over the given period of time
wherein the total number of said plurality of blood glucose levels is a total number of measurements among measurements that are above the upper blood glucose limit and measurements that are below the lower blood glucose limit, and
wherein comparing each of said plurality of measured blood glucose levels stored in the memory module with a threshold value range comprises: determining whether each of said plurality of measured blood glucose levels stored in the memory module is within the threshold value range,
wherein the medical device further comprises at least one activity sensor configured for measuring and supplying information relating to activity of said patient, and
wherein the management rule is configured for processing said activity information so as to detect at least one disrupting event relating to a change in activity of said patient, and detecting the glycaemic imbalance state in the patient as a function of said at least one disrupting event.
In analogous art, Howell teaches a system for managing glycaemic balance of a diabetic patient (Abstract) comprising detecting the glycaemic imbalance state in the patient based on a given percentage of measured blood glucose levels that represents a total number of said plurality of blood glucose levels measured over the given period of time which are not in said threshold value range over all of said plurality of blood glucose levels measured over the given period of time (Fig. 3, Paragraphs [0028] and [0030]-[0031], 302 or 304), wherein the total number of said plurality of blood glucose levels (N1 or N2) is a total number of measurements among measurements that are above the upper blood glucose limit (N2) and measurements that are below the lower blood glucose limit (N1), and wherein comparing each of said plurality of blood glucose levels measured (302 or 402, Paragraphs [0030]-[0031]) with a threshold value range having an upper blood glucose limit corresponding to a high blood glucose state (402-404, Fig. 3) and a lower blood glucose limit corresponding to a low blood glucose state (302-304, Fig. 3).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the management rule of Mastrototaro to incorporate the teachings of Howell to incorporate performing an analysis to result in pattern determinations that indicate whether a patient is in a state of hyperglycemia or hypoglycemia (Paragraph [0030], Howell). The management rule taught by Mastrototaro in view of Howell teaches detecting the glycaemic imbalance state in the patient based on a given percentage of measured blood glucose levels that represents a total number of said plurality of blood glucose levels measured over the given period of time which are not in said threshold value range over all of said plurality of blood glucose levels measured over the given period of time (Fig. 3, Paragraphs [0028] and [0030]-[0031], 302-306 or 402-406, Howell), and wherein the comparing of each of said plurality of measured blood glucose levels stored in the memory module with a threshold value range comprises: determining whether each of said plurality of measured blood glucose levels stored in the memory module is within the threshold value range (Each blood glucose value is compared with the hypoglycemic threshold (302, Fig. 3) and the hyperglycemic threshold (402, Fig. 3), therefore teaching whether each of the plurality of measured blood glucose levels stored in the memory module is within the threshold value range is determined, Howell).
Mastrototaro in view of Howell are silent regarding
wherein the medical device further comprises at least one activity sensor configured for measuring and supplying information relating to activity of said patient, and
wherein the management rule is configured for processing said activity information so as to detect at least one disrupting event relating to a change in activity of said patient, and detecting the glycaemic imbalance state in the patient as a function of said at least one disrupting event.
In analogous art, Rack-Gomer teaches at least one activity sensor configured for measuring and supplying information relating to the activity of said patient (Paragraphs [0175] and [0177]), and
wherein the management rule is configured for processing said activity information so as to detect at least one disrupting event relating to a change in activity of said patient (Paragraph [0177]), and detecting the glycaemic imbalance state in the patient as a function of said at least one disrupting event (Paragraph [0177]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Mastrototaro in view of Howell to incorporate the teachings of Rack-Gomer to incorporate at least one activity sensor and to have modified the management rule of Mastrototaro to incorporate the teachings of Rack-Gomer to incorporate being configured for: - processing said activity information so as to detect at least one disrupting event relating to a change in activity of said patient, and - detecting the glycaemic imbalance state in the patient as a function of said at least one disrupting event in order to monitor patient activity levels, thus allowing for a better understanding of a patient’s blood glucose value trends (Paragraph [0175]).
Regarding claim 36, Mastrototaro in view of Howell further in view of Rack-Gomer disclose the medical device of claim 33, comprising a processor configured for, upon receipt of the warning signal:
- deactivating said processing circuit (Fig. 12, ending the continued delivery of insulin at a preset basal pattern as in step S520 is the deactivation of the processing circuit, which occurs when step S530 begins, Mastrototaro), and
- activating a titration circuit so as to initiate a titration phase for determining a new daily insulin dose (Fig. 12, circuit used to execute a titration phase as in step S530, Mastrototaro).
Regarding claim 37, Mastrototaro in view of Howell further in view of Rack-Gomer disclose the medical device of Claim 36, in which the titration circuit is configured for implementing a dosage rule configured for calculating said new daily insulin dose as a function of blood glucose levels and of physiological and/or medical parameters specific to said patient (Paragraph [0091], the insulin dose delivered is a function of the blood glucose levels and the patient’s preset basal rate, which is a medical parameter, Mastrototaro).
Regarding claim 44, Mastrototaro in view of Howell further in view of Rack-Gomer disclose the medical device of Claim 33, in which said at least one sensor comprises a movement sensor (Paragraph [0177], Rack-Gomer).
Regarding claim 45, Mastrototaro in view of Howell further in view of Rack-Gomer disclose the medical device of Claim 33, in which said at least one sensor comprises a geolocation probe capable of supplying information relating to a location of said patient (Paragraph [0177], Rack-Gomer).
Regarding claim 46, Mastrototaro in view of Howell further in view of Rack-Gomer disclose the medical device of Claim 33, in which said at least one sensor is coupled to an internal clock (The glucose sensor of Mastrototaro takes readings at the end of basal time intervals, see Paragraph [0090], so an internal clock is required to mark the basal time intervals. Therefore, the sensor incorporated in the device taught by Mastrototaro in view of Rack-Gomer is at least physically coupled to an internal clock).
Regarding claim 47, Mastrototaro in view of Howell further in view of Rack-Gomer disclose the medical device of claim 33, comprising a glycaemic probe (“glucose sensor” in 10, Mastrototaro) configured for measuring the content of the blood component representative of the blood glucose level of said patient (Fig. 1, Paragraphs [0050]-[0051], Mastrototaro).
Regarding claim 48, Mastrototaro in view of Howell further in view of Rack-Gomer disclose the medical device of Claim 47, in which said glycaemic probe is configured for carrying out said measurement at regular time intervals (Paragraph [0090], glucose sensor takes readings at the end of basal time intervals, Mastrototaro).
Regarding claim 49, Mastrototaro discloses a method for managing the glycaemic balance of a diabetic patient, said method carried out by computer means comprising:
- storing in memory a plurality of blood glucose levels measured during a glycaemic balance phase over a given period of time (Paragraph [0055]), said plurality of blood glucose levels measured being relative to a content of a blood component representative of a blood glucose level of said patient (Paragraph [0050]);
- implementing a management rule configured for detecting a glycaemic imbalance state in the patient by performing an analysis of said plurality of blood glucose levels measured with a threshold value (Fig. 12, Paragraphs [0083] and [0091]);
- in an event of detection of the glycaemic imbalance state in the patient, emitting a warning signal (Fig. 12, Paragraph [0091]),
wherein the management rule comprises an algorithm configured for detecting the glycaemic imbalance state in the patient when the distribution of said plurality of blood glucose levels measured over said period of time has a standard deviation above a given threshold deviation (Paragraphs [0109]-[0110] of Mastrototaro discuss how the glycaemic imbalance state can be detected in a patient, even when the standard deviation of measured blood glucose values is above a given threshold deviation indicating that no therapy modification should be made).
Mastrototaro is silent regarding
performing an analysis of the distribution of said plurality of blood glucose levels which comprises: comparing each of said plurality of measured blood glucose levels stored in memory with a threshold value range having an upper blood glucose limit corresponding to a high blood glucose state and a lower blood glucose level corresponding to a low blood glucose state;
wherein the analysis of the distribution of said plurality of blood glucose levels further comprises: detecting the glycaemic imbalance state in the patient based on a given percentage of measured blood glucose levels that represents a total number of said plurality of blood glucose levels measured over the given period of time which are not in said threshold value range over all of said plurality of blood glucose levels measured over the given period of time
wherein the total number of said plurality of blood glucose levels is a total number of measurements among measurements that are above the upper blood glucose limit and measurements that are below the lower blood glucose limit, and
wherein the comparing of each of said plurality of measured blood glucose levels stored in the memory module with a threshold value range comprises: determining whether each of said plurality of measured blood glucose levels stored in the memory module is within the threshold value range,
wherein detecting a glycaemic imbalance state in the patient comprises
- measuring a physical activity of said patient,
- detecting at least one disrupting event relating to a change in the physical activity of said patient, and
wherein the management rule takes into consideration said at least one disrupting event for detecting the glycaemic imbalance state in the patient.
In analogous art, Howell teaches a system for managing glycaemic balance of a diabetic patient (Abstract) detecting the glycaemic imbalance state in the patient based on a given percentage of measured blood glucose levels that represents a total number of said plurality of blood glucose levels measured over the given period of time which are not in said threshold value range over all of said plurality of blood glucose levels measured over the given period of time (Fig. 3, Paragraphs [0028] and [0030]-[0031], 302 or 304), wherein the total number of said plurality of blood glucose levels (N1 or N2) is a total number of measurements among measurements that are above the upper blood glucose limit (N2) and measurements that are below the lower blood glucose limit (N1), and wherein comparing at once the whole of said plurality of blood glucose levels measured (302 or 402, Paragraphs [0030]-[0031]) with a threshold value range having an upper blood glucose limit corresponding to a high blood glucose state (402-404, Fig. 3) and a lower blood glucose limit corresponding to a low blood glucose state (302-304, Fig. 3).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the management rule of Mastrototaro to incorporate the teachings of Howell to incorporate performing an analysis to result in pattern determinations that indicate whether a patient is in a state of hyperglycemia or hypoglycemia (Paragraph [0030], Howell). The management rule taught by Mastrototaro in view of Howell teaches detecting the glycaemic imbalance state in the patient based on a given percentage of measured blood glucose levels that represents a total number of said plurality of blood glucose levels measured over the given period of time which are not in said threshold value range over all of said plurality of blood glucose levels measured over the given period of time (Fig. 3, Paragraphs [0028] and [0030]-[0031], 302-306 or 402-406, Howell), and wherein the comparing of each of said plurality of measured blood glucose levels stored in the memory module with a threshold value range comprises: determining whether each of said plurality of measured blood glucose levels stored in the memory module is within the threshold value range (Each blood glucose value is compared with the hypoglycemic threshold (302, Fig. 3) and the hyperglycemic threshold (402, Fig. 3) - therefore whether each of the plurality of measured blood glucose levels stored in the memory module is within the threshold value range is determined, Howell).
Mastrototaro in view of Howell are silent regarding
wherein detecting a glycaemic imbalance state in the patient comprises
- measuring a physical activity of said patient,
- detecting at least one disrupting event relating to a change in the physical activity of said patient, and
wherein the management rule takes into consideration said at least one disrupting event for detecting the glycaemic imbalance state in the patient.
In analogous art, Rack-Gomer teaches a detection step comprising:
- measuring a physical activity of a patient (Paragraph [0175]),
- detecting at least one disrupting event relating to a change in activity of said patient, in which, during an analysis step, a management rule takes into consideration said at least one disrupting event for detecting a glycaemic imbalance state in the patient (Paragraph [0177]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method of Mastrototaro in view of Howell to incorporate the teachings of Rack-Gomer to incorporate measurement of physical activity of a patient and an analysis step in which a management rule takes into consideration the resulting activity information so as to detect at least one disrupting event relating to a change in activity of said patient and to detect a glycaemic imbalance state in the patient as a function of said at least one disrupting event in order to provide a better understanding of a patient’s blood glucose value trends (Paragraph [0175], Rack-Gomer).
Regarding claim 51, Mastrototaro in view of Howell further in view of Rack-Gomer disclose the method of Claim 49, wherein the analysis of the distribution of said plurality of blood glucose levels further comprises: detecting a glycaemic imbalance state in the patient based on more than 50% of said plurality of blood glucose levels not being in said threshold value range (Paragraph [0091], Mastrototaro teaches a glycaemic imbalance will be detected if 100% [which is >%50] of the blood glucose values taken are not in the threshold value range).
Regarding claim 52, Mastrototaro in view of Howell further in view of Rack-Gomer disclose the method of Claim 49, wherein the analysis of the distribution of said plurality of blood glucose levels further comprises: detecting a glycaemic imbalance state in the patient based on more than 66% of said plurality of blood glucose levels not being in said threshold value range (Paragraph [0091], Mastrototaro teaches a device wherein a glycaemic imbalance will be detected if 100% [which is >%66] of the blood glucose values taken are not in the threshold value range).
Regarding claim 53, Mastrototaro in view of Howell further in view of Rack-Gomer disclose the method of Claim 49, further comprising: following the receipt of the warning signal, initializing a titration phase, said titration phase comprising a titration during which a dosage rule is implemented for determining a new daily insulin dose (Fig. 12, Paragraph [0091], Mastrototaro).
Regarding claim 54, Mastrototaro in view of Howell further in view of Rack-Gomer disclose the method of Claim 53, further comprising: during the titration, implementing the dosage rule by calculating said new daily insulin dose as a function of blood glucose values and of physiological and/or medical parameters specific to said patient (Paragraph [0091], the insulin dose delivered is a function of the blood glucose levels and the patient’s preset basal rate, which is a medical parameter, Mastrototaro).
Regarding claim 55, Mastrototaro in view of Howell further in view of Rack-Gomer disclose the method of Claim 54, further comprising: communicating information relating to a dose actually injected into the body of said patient by an insulin injector (Paragraph [0020], the controller is configured for comparing a calculated dose of insulin with the dose of insulin actually injected into the body, therefore to determine the dose delivered, the controller must communicate [directly or indirectly] with an insulin injector, Mastrototaro).
Regarding claim 56, Mastrototaro in view of Howell further in view of Rack-Gomer disclose the method of Claim 54, further comprising: comparing said new daily insulin dose calculated during the titration with the dose injected into the body of the patient (Paragraph [0020], the controller performs a comparison between the dose delivered and the dose of insulin expected to be delivered, i.e. the calculated dose, Mastrototaro).
Regarding claim 58, Mastrototaro in view of Howell further in view of Rack-Gomer disclose a non-transitory computer- readable recording medium on which is recorded a computer program comprising instructions which, when executed by a computer, perform the method according to Claim 49 (Paragraph [0085], Mastrototaro).
Claims 38-41 are rejected under 35 U.S.C. 103 as being unpatentable over Mastrototaro et al. (US 20080269714 A1) in view of Howell et al. (US 20140024907 A1) further in view of Rack-Gomer et al. (US 20150289823 A1) further in view of Karan et al. (US 20120245447 A1).
Regarding claim 38, Mastrototaro in view of Howell further in view of Rack-Gomer disclose the medical device of Claim 37, in which said dosage rule is configured for:
- decreasing said new daily insulin dose when, during a period of at least one day, the mean of the plurality of blood glucose levels measured is strictly below said lower blood glucose limit (Paragraphs [0081] and [0090]-[0091], Mastrototaro), and
- increasing said new daily insulin dose when, during a period of at least one day, the mean of the blood glucose levels measured is strictly above said upper blood glucose limit (Paragraphs [0081] and [0090]-[0091], Mastrototaro).
Mastrototaro in view of Howell further in view of Rack-Gomer are silent regarding
decreasing or increasing said new daily insulin dose by at least one unit.
In analogous art, Karan teaches an insulin dose that may be adjusted by at least one unit (Paragraph [0395]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the increment by which the daily insulin dose increases or decreases of increment by which the daily insulin dose increases or decreases to incorporate the teachings of Karan to incorporate being by at least one unit because it is a well-known adjustment increment in the art of insulin delivery.
Regarding claim 39, Mastrototaro in view of Howell further in view of Rack-Gomer further in view of Karan disclose the medical device of Claim 38, comprising a control circuit configured for comparing said new daily insulin dose with the dose injected into the body of said patient (Paragraph [0020], the controller is configured for comparing a calculated dose of insulin with the dose of insulin actually injected into the body, Mastrototaro).
Regarding claim 40, Mastrototaro in view of Howell further in view of Rack-Gomer further in view of Karan disclose the medical device of Claim 38, in which said titration circuit is configured for communicating with an insulin injector in order to recover information relating to the dose actually injected into the body of said patient by said insulin injector (Paragraph [0020], the controller is configured for comparing a calculated dose of insulin with the dose of insulin actually injected into the body, therefore in order to determine the dose delivered, the controller must communicate [directly or indirectly] with an insulin injector, Mastrototaro).
Regarding claim 41, Mastrototaro in view of Howell further in view of Rack-Gomer further in view of Karan disclose the medical device of Claim 40, in which said titration circuit is configured for communicating with said insulin injector in order to transmit to said insulin injector the information relating to said calculated dose so as to inject said dose into the body of said patient (Paragraph [0073], Mastrototaro).
Response to Arguments
Applicant's arguments filed 5/4/2026 have been fully considered but they are not persuasive.
In response to applicant’s arguments, on pages 14-16, that Howell does not teach “wherein the total number of said plurality of blood glucose levels is a total number of measurements among measurements that are above the upper blood glucose limit and measurements that are below the lower blood glucose limit”, the examiner respectfully disagrees. Howell teaches determining a total number of said plurality of blood glucose levels that are above the blood glucose limit (N2) and a total number of said plurality of blood glucose levels that are below the blood glucose limit (N1), see Fig. 3: 302 and 402. Moreover, box 302 discloses that N1 is the number of fasting BG below the hypoglycemic threshold (i.e., N1 is “measurements that are below the lower blood glucose limit”) and box 402 discloses that N2 is the number of fasting BG above the hyperglycemic threshold (i.e., N2 is “measurements that are above the upper blood glucose limit”), thus N1 and N2 are “measurements that are above the upper blood glucose limit and measurements that are below the lower blood glucose limit” and N1 or N2 are “the total number of said plurality of blood glucose levels is a total number of measurements among measurements that are above the upper blood glucose limit and measurements that are below the lower blood glucose limit”.
In response to applicant’s arguments, on pages 17-18, that Mastrototaro does not teach “wherein the management rule comprises an algorithm configured for detecting the glycaemic imbalance state in the patient when the distribution of said plurality of blood glucose levels measured over said period of time has a standard deviation above a given threshold deviation”, the examiner respectfully disagrees. Applicant further appears to be arguing that the detection of the glycemic imbalance state results in a therapy modification, which is not claimed. The claims only require an algorithm configured for detecting the glycemic imbalance state when the distribution of the plurality of blood glucose levels measured over a period of time has a standard deviation above a given threshold deviation. The cited paragraphs of Mastrototaro teach determining a glycemic condition based on the variablility of a plurality of measured blood glucose values. Paragraphs [0109]-[0110] of Mastrototaro explain that the control algorithm determines the variability of the glucose history using a standard deviation of a cluster of the most recent glucose data and compares the standard deviation against the difference between the average blood glucose value and the target blood glucose value. Therefore, Mastrototaro uses the standard deviation of a plurality of blood glucose measurements over a period of time as a criterion in determining whether the patient’s glucose history exhibits a significant variation that would warrant a response when the standard deviation is greater than a given threshold deviation (i.e., the difference between the average blood glucose and target blood glucose).
In response to applicant’s arguments, on pages 19-21, that Rack-Gomer does not teach “detecting at least one disrupting event relating to a change in the physical activity of said patient, and wherein the management rule takes into consideration said at least one disrupting event for detecting the glycaemic imbalance state in the patient”, the examiner respectfully disagrees. Rack-Gomer discloses obtaining activity information from activity-sensing devices, i.e. accelerometer, GPS, Wi-Fi data indicating location. These devices can determine whether the mobile device user is stationary, walking, running, see Paragraph [0177]. Rack-Gomer expressly teaches processing the activity information in determining the patient’s glycemic condition or risk. Paragraph [0175] discloses activity information including the amount, type, and duration of activity and expressly states that such activity information can feed into determination of the glycemic urgency index. Paragraph [0178] further explains that exercise can be detected and that predictive analytics may be used to predict when the exercise may begin to affect the glucose value and associated risk state, including the GUI. Accordingly, Rack-Gomer teaches detecting a change or occurrence in the patient’s activity and uses the detected activity in connection with determining a glycemic risk state. Applicant’s assertion that Rack-Gomer does not disclose a “discrete disrupting event” is not persuasive because the applicant has taken a narrower interpretation for the claim language. The claims only require an event relating to a change in physical activity of the patient. Rack-Gomer’s disclosure of detecting exercise or other activity states from the activity-sensor information and using such detected activity to determine or modify the GUI provides that relationship. Applicant further treats the claimed glycemic-imbalance determination as though it must be based exclusively on the detected activity event. The claims only recite detecting the glycemic imbalance state as a function of the disrupting event. This language does not require that the activity event constitute the sole input to the determination. Rack-Gomer teaches that the activity information feeds into the GUI determination and that detected physical activity can affect the glucose-related risk determination. For example, Rack-Gomer explains that activity information may be used to determine whether a change in glucose is attributable to physical activity and, based on that determination, to modify or maintain the GUI, therefore the glycemic risk determination is at least a function of the detected activity. Applicant’s assertion that Rack-Gomer’s architecture is “inverse” -i.e. that glucose data drives the GUI while activity merely “shades” the index is also not persuasive. Again, the claims do not recite that the disrupting event must independently generate the glycemic imbalance determination, nor does it exclude other inputs from the management rule. Rather, it only requires that the glycemic imbalance state be detected as a function of the activity-related event. Rack-Gomer teaches that activity information affects the GUI, which represents a glycemic urgency/risk state, therefore teaches the claimed functional relationship.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG-VAN N TRINH whose telephone number is (571)272-8039. The examiner can normally be reached Thursday-Thursday 12-8 ET.
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, Chelsea Stinson can be reached at (571) 270-1744. 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.
/HONG-VAN N TRINH/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights