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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/25/2024 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 11/6/2024. As directed by the amendment: claims 33 and 49 have been amended; no claims have been cancelled; and no claims have been added. Thus, claims 33, 35-49, and 51-58 are presently pending in this application.
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, 35-37, 47-49, 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).
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]).
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, 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.
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], 302/304), which comprises comparing each of said plurality of blood glucose levels measured (302, 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 and 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).
Regarding claim 35, Mastrototaro in view of Howell disclose the medical device of Claim 33, in which 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).
Regarding claim 36, Mastrototaro in view of Howell 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 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 47, Mastrototaro in view of Howell 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 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]).
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, 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.
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], 302/304), which comprises comparing at once the whole of said plurality of blood glucose levels measured (302, 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 and 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).
Regarding claim 51, Mastrototaro in view of Howell 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 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 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 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 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 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 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 Karan et al. (US 20120245447 A1).
Regarding claim 38, Mastrototaro in view of Howell 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 is 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 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 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 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).
Claims 42-46 and 57 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 42, Mastrototaro in view of Howell disclose the medical device of claim 33, but are silent regarding comprising at least one activity sensor configured for measuring and supplying information relating to activity of said patient.
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]).
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 in order to monitor patient activity levels, thus allowing for a better understanding of a patient’s blood glucose value trends (Paragraph [0175], Rack-Gomer)
Regarding claim 43, Mastrototaro in view of Howell further in view of Rack-Gomer disclose the medical device of Claim 42, but Mastrototaro in view of Howell are silent regarding a 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.
Rack-Gomer teaches in which said 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 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 provide a better understanding of a patient’s blood glucose value trends (Paragraph [0175], Rack-Gomer).
Regarding claim 44, Mastrototaro in view of Howell further in view of Rack-Gomer disclose the medical device of Claim 42, 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 42, 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 42, 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 57, Mastrototaro in view of Howell disclose the method of Claim 49, but 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:
- measurement of the physical activity of a patient (Paragraph [0175]),
- detection of at least one disrupting event relating to a change in activity of said patient, in which, during an analysis step (Paragraph [0177]),
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).
Response to Arguments
Applicant's arguments filed 11/6/2024 have been fully considered but they are not persuasive.
In response to applicant's arguments, on pages 14-19, that Howell does not teach “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” because “Howell fails to suggest using N1+N2 or V1+V2”, the Examiner respectfully disagrees. The claim does not require calculating N1+N2 (i.e., the total number of times the fasting BG measurements are outside the hypoglycemic threshold and the hyperglycemic threshold) or calculating V1+V2 (i.e., the total percentage of time that the fasting BG measurements are outside the hypoglycemic threshold and the hyperglycemic threshold). The claim only requires detecting a 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, a total being a total that is above the threshold value range or a total that is below the threshold value rage. In Mostrototaro, when a measured blood glucose value is not consistent with a target blood glucose value, which indicates a glycaemic imbalance state, the therapy delivery parameter is adjusted. An alarm is also triggered when the measured blood glucose value is not consistent with a target blood glucose value. In Howell, when a percentage of blood glucose levels measured is below a hypoglycemic threshold or above a hyperglycemic threshold, a hypoglycemic or hyperglycemic state (i.e., a glycaemic imbalance state) is detected, see 302-310 and 402-410 in Fig. 3. In other words, Howell detects a glycaemic imbalance state of hypoglycemia or hyperglycemia when a given percentage of blood glucose levels measured (V1 or V2) is not in a threshold value range (the range between the hypoglycemic threshold and the hyperglycemic threshold, which may be 70-180mg/dL in the example provided at [0030]-[0031] of Howell).
Conclusion
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/HONG-VAN N TRINH/Examiner, Art Unit 3783
/James D Ponton/Primary Examiner, Art Unit 3783