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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites “a processor” in lines 3 and line 6. It is unclear is the recitation in line 6 refers to the same processor that is introduced in line 3 or if this is an additional/second processor in the system. Furthermore, it is unclear if the recitation of “the processor” in line 7 of claim 9 refers to the processor introduced in line 3 or line 6 (the same issue is prevalent with the dependent claims as recited below). For purposes of examination is it interpreted that there is only one processor in the system.
Claims 10-16 are rejected due to their dependence on claim 9.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Agrawal et al. (US 20130338630 hereinafter “Agarwal”) in view of Mastrototaro et al. (US 20080269723 “Mastrototaro”).
Regarding Claim 1, Agarwal teaches a non-transitory computer readable medium embodied with programming code executable by a processor (See [0183] teaching 100 includes a processor), and the processor when executing the programming code is operable to perform functions to:
obtain a series of glucose concentration values as measured at regular time intervals by a glucose monitor (See [0013] teaching a continuous glucose monitor sensor this is considered 'regular time intervals' since is 'continuous' ; see [0087] teaching "the database layer 28, may calculate average blood glucose or sensor glucose readings for specified timeframes." );
detect a rapid rate of increase in the glucose concentration values (See [0256]);
determine the rapid rate of increase in glucose concentration values is indicative of ingestion of carbohydrates to address or prevent a hypoglycemic event (See [0256]).
Agarwal does not specify in response to the determination that the detected rapid rate of increase of the glucose concentration values being indicative of ingestion of carbohydrates, limit delivery of medication to a user to an amount of medication lower than would otherwise be delivered.
Mastrototaro teaches [0056] a sensor system that analyzed blood for glucose concentration at fixed intervals (preferably 5-20 minutes). Mastrototaro also teaches that [0065] the controller could calculate the amount of insulin to infuse (delivery of medication) based on the insulin sensitivity, carbohydrate ratio, glucose level, ingested carbohydrates and with the focus of prevent hypoglycemia. Mastrototaro teaches one of these methods to prevent hypoglycemia could be lower basal rate, and [0067] teaches using a control algorithm which determines optimal insulin dose to administer (This is considered to meet the limitation of "limit delivery of medication to a user to an amount of medication lower than would otherwise be delivered").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Agarwal such that in response to the determination that the detected rapid rate of increase of the glucose concentration values being indicative of ingestion of carbohydrates, limit delivery of medication to a user to an amount of medication lower than would otherwise be delivered as taught by Mastrototaro. One of ordinary skill in the art would have been motivated to do so in order to prevent hypoglycemic excursions in the patient (Mastrototaro [0065]).
Regarding Claim 2, the combination of Agarwal and Mastrototaro teaches the non-transitory computer readable medium of claim 1, wherein the processor upon executing the programming code, when limiting delivery of medication to the user, is operable to: set the maximum amount of medication to be delivered to a predetermined value for a set amount of time (see Mastrototaro [0088-0090] teaching how max boundaries are modified with the adjusted basal rate and time intervals)
Regarding Claim 3, the combination of Agarwal and Mastrototaro teaches the non-transitory computer readable medium of claim 1, wherein the processor upon executing the programming code, when limiting delivery of medication to the user, is operable to: apply a delivery constraint to reduce the delivery of medication (see Mastrototaro [0088-0090] teaching how max boundaries are modified with the adjusted basal rate and time intervals).
Regarding Claim 4, the combination of Agarwal and Mastrototaro teaches the non-transitory computer readable medium of claim 1, wherein the processor upon executing the programming code, when limiting delivery of medication to the user, is operable to: reduce the amount of medication based on a maximum volume of a user's basal insulin delivery volume divided by either a time increment, at which the adjusted basal dosage is administered or a percentage of an hourly basal rate (see Mastrototaro [0088-0090] teaching how max boundaries are modified with the adjusted basal rate and time intervals).
Regarding Claim 5, the combination of Agarwal and Mastrototaro teaches the non-transitory computer readable medium of claim 1, wherein the processor upon executing the programming code, when determining the rapid rate of increase in glucose concentration values is indicative of the ingestion of carbohydrates to address or prevent the hypoglycemic event, is operable to: determine the rapid rate of increase in glucose concentration values is beyond a certain threshold rate of increase (see Mastrototaro [0088-0090] teaching how max boundaries are modified with the adjusted basal rate and time intervals; the boundaries are considered thresholds; similarity in Agarwal [0256] the determination of the rapid increase is done based on a 'threshold').
Regarding Claim 6, the combination of Agarwal and Mastrototaro teaches the non-transitory computer readable medium of claim 1, wherein the processor upon executing the programming code, when determining the rapid rate of increase in glucose concentration values is indicative of the ingestion of carbohydrates to address or prevent the hypoglycemic event, is operable to: determine the rapid rate of increase over a series of glucose concentration values that a first glucose concentration value in the series of glucose concentration values is below a hypoglycemic threshold (see Agarwal Fig 2a-2k, at least one of the data points of the series of glucose concentrations values is below hypoglycemic threshold; also see Agarwal [0256] it is determining a rapid increase, therefore at least one value would be below hypoglycemic threshold before the increase).
Regarding Claim 7, the combination of Agarwal and Mastrototaro teaches the non-transitory computer readable medium of claim 1, wherein the processor upon executing the programming code, when determining the rapid rate of increase in glucose concentration values is indicative of the ingestion of carbohydrates to address or prevent the hypoglycemic event, is operable to: determine the rapid rate of increase over a series of glucose concentration values that any glucose concentration value in the series of glucose concentration values is below a predetermined threshold greater than the hypoglycemic threshold (See Agarwal Figs 2a-2k and [0256] teaching how a series of glucose concentration values are analyzed and determined if there are below are greater than a threshold; furthermore, see Mastrototaro [0088-0090] teaching how modified boundaries are used to compare the values as well; meaning adjusted thresholds could be used to compare the blood glucose concentration values as well).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Agarwal in view of Mastrototaro as applied to claim 1 above, and further in view of Rack Gomer et al. (US 20150289823 hereinafter “Rack Gomer”).
Regarding Claim 8, the combination of Agarwal and Mastrototaro teaches all elements of claim 1 as described above. The combination does not specify the non-transitory computer readable medium wherein the processor upon executing the programming code, when determining the rapid rate of increase in glucose concentration values is indicative of the ingestion of carbohydrates to address or prevent the hypoglycemic event, is operable to: determine the rapid change of a second derivative of the glucose concentration is higher than a predetermined threshold.
Rack Gomer teaches [0148-150] teaches a processor using a first derivative and a second derivative of glucose concentration values to calculate of the glucose concentration is higher than a threshold to determine if the patient is predicted to go into a hypoglycemic state.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Agarwal such that it is operable to: determine the rapid change of a second derivative of the glucose concentration is higher than a predetermined threshold as taught by Rack Gomer. One of ordinary skill in the art would have been motivated to do so in order to help determine speed in which glucose levels are changing or stabling (Rack Gomer [0148-150]) which would help treat a patient prior to the patient reaching an hypoglycemic state.
Claim(s) 9-15, 17-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mastrototaro (US 20080269723) in view of Agrawal (US 20130338630).
Regarding Claim 9, Mastrototaro teaches (Figs 1-3a) a system, comprising: a medical device (all elements of Fig 3a), wherein the medical device includes a pump (34), a reservoir (50; see Fig 7) configured to contain insulin (See [0006] teaching infusion of insulin), a processor (12) and a transceiver (30) and is operable to deliver insulin in response to outputs from the processor; a sensor (10) operable to measure blood glucose and output a blood glucose value (See [0044]); a management device including a processor (see 112 rejection above; interpreted to be same as 12 recited above), a memory configured to store programming code and a transceiver (See [0049] last sentence teaching there is some memory in the device), wherein the processor when executing the programming code is operable to: obtain a series of glucose concentration values as measured at regular time intervals by the sensor ([0056] a sensor system that analyzed blood for glucose concentration at fixed intervals (preferably 5-20 minutes)); and limit delivery of medication to a user to an amount of medication lower than would otherwise be delivered (see [0065] teaching that the controller could calculate the amount of insulin to infuse (delivery of medication) based on the insulin sensitivity, carbohydrate ratio, glucose level, ingested carbohydrates and with the focus of prevent hypoglycemia. Mastrototaro teaches one of these methods to prevent hypoglycemia could be lower basal rate, and [0067] teaches using a control algorithm which determines optimal insulin dose to administer (This is considered to meet the limitation of "limit delivery of medication to a user to an amount of medication lower than would otherwise be delivered").
Mastrototaro does not specify wherein the processor when executing the programming code is operable to: obtain a series of glucose concentration values as measured at regular time intervals by the sensor; detect a rapid rate of increase in the glucose concentration values; determine the rapid rate of increase in glucose concentration values is indicative of ingestion of carbohydrates to address or prevent a hypoglycemic event; and in response to the determination that the detected rapid rate of increase of the glucose concentration values being indicative of ingestion of carbohydrates.
Agarwal teaches a processor (See [0183] teaching 100 includes a processor), is operable to perform functions to:
obtain a series of glucose concentration values as measured at regular time intervals by a glucose monitor (See [0013] teaching a continuous glucose monitor sensor this is considered 'regular time intervals' since is 'continuous' ; see [0087] teaching "the database layer 28, may calculate average blood glucose or sensor glucose readings for specified timeframes." );
detect a rapid rate of increase in the glucose concentration values (See [0256]);
determine the rapid rate of increase in glucose concentration values is indicative of ingestion of carbohydrates to address or prevent a hypoglycemic event (See [0256]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Mastrototaro such that it is operable to obtain a series of glucose concentration values as measured at regular time intervals by the sensor; detect a rapid rate of increase in the glucose concentration values; determine the rapid rate of increase in glucose concentration values is indicative of ingestion of carbohydrates to address or prevent a hypoglycemic event; and in response to the determination that the detected rapid rate of increase of the glucose concentration values being indicative of ingestion of carbohydrates as taught by Agarwal. One of ordinary skill in the art would have been motivated to do so in order to check for a high increase in blood glucose level occurring a short time after a food bolus event (Agarwal [0256]) and prevent a hypoglycemic event.
Regarding Claim 10, the combination of Mastrototaro and Agarwal teaches the system of claim 9, wherein the processor is further operable to: set the maximum amount of medication to be delivered to a predetermined value for a set amount of time (see Mastrototaro [0088-0090] teaching how max boundaries are modified with the adjusted basal rate and time intervals).
Regarding Claim 11, the combination of Mastrototaro and Agarwal teaches the system of claim 9, wherein the processor, when limiting delivery of medication to the user, is operable to: apply a delivery constraint to reduce the delivery of medication (see Mastrototaro [0088-0090] teaching how max boundaries are modified with the adjusted basal rate and time intervals; this is considered to be a ‘constraint’).
Regarding Claim 12, the combination of Mastrototaro and Agarwal teaches the system of claim 9, wherein the processor, when limiting delivery of medication to the user, is operable to: reduce the amount of medication based on a maximum volume of a user's basal insulin delivery volume divided by either a time increment, at which the adjusted basal dosage is administered or a percentage of an hourly basal rate (see Mastrototaro [0087] teaching a percentage; and [0088-0090] teaching how max boundaries are modified with the adjusted basal rate and various time intervals).
Regarding Claim 13, the combination of Mastrototaro and Agarwal teaches the system of claim 9, wherein the processor upon executing the programming code, when determining the rapid rate of increase in glucose concentration values is indicative of the ingestion of carbohydrates to address or prevent the hypoglycemic event, is operable to: determine the rapid rate of increase in glucose concentration values is beyond a certain threshold rate of increase (see Mastrototaro [0088-0090] teaching how max boundaries are modified with the adjusted basal rate and time intervals; the boundaries are considered thresholds; similarly in Agarwal [0256] the determination of the rapid increase is done based on a 'threshold’).
Regarding Claim 14, the combination of Mastrototaro and Agarwal teaches the system of claim 9, wherein the processor upon executing the programming code, when determining the rapid rate of increase in glucose concentration values is indicative of the ingestion of carbohydrates to address or prevent the hypoglycemic event, is operable to: determine the rapid rate of increase over a series of glucose concentration values that a first glucose concentration value in the series of glucose concentration values is below a hypoglycemic threshold (see Agarwal Fig 2a-2k, at least one of the data points of the series of glucose concentrations values is below hypoglycemic threshold; also see Agarwal [0256] it is determining a rapid increase, therefore at least one value would be below hypoglycemic threshold before the increase).
Regarding Claim 15, the combination of Mastrototaro and Agarwal teaches the system of claim 9, wherein the processor upon executing the programming code, when determining the rapid rate of increase in glucose concentration values is indicative of the ingestion of carbohydrates to address or prevent the hypoglycemic event, is operable to: determine the rapid rate of increase over a series of glucose concentration values that any glucose concentration value in the series of glucose concentration values is below a predetermined threshold greater than the hypoglycemic threshold (See Agarwal Figs 2a-2k and [0256] teaching how a series of glucose concentration values are analyzed and determined if there are below are greater than a threshold; Furthermore, see Mastrototaro [0088-0090] teaching how modified boundaries are used to compare the values as well; meaning adjusted thresholds could be used to compare the blood glucose concentration values as well).
Regarding Claim 17, Mastrototaro teaches (Figs 1-3a) A device, comprising: a processor (12); a transceiver (30) coupled to the processor (12); and a memory (See [0049] last sentence teaching there is some memory in the device) coupled to the processor (12) configured to store programming code, wherein the processor when executing the programming code is operable to: obtain a series of glucose concentration values as measured at regular time intervals by the sensor ([0056] a sensor system that analyzed blood for glucose concentration at fixed intervals (preferably 5-20 minutes)); limit delivery of medication to a user to an amount of medication lower than would otherwise be delivered (see [0065] teaching that the controller could calculate the amount of insulin to infuse (delivery of medication) based on the insulin sensitivity, carbohydrate ratio, glucose level, ingested carbohydrates and with the focus of prevent hypoglycemia. Mastrototaro teaches one of these methods to prevent hypoglycemia could be lower basal rate, and [0067] teaches using a control algorithm which determines optimal insulin dose to administer (This is considered to meet the limitation of "limit delivery of medication to a user to an amount of medication lower than would otherwise be delivered").
Mastrototaro does not specify wherein the processor when executing the programming code is operable to: obtain a series of glucose concentration values as measured at regular time intervals by the sensor; detect a rapid rate of increase in the glucose concentration values; determine the rapid rate of increase in glucose concentration values is indicative of ingestion of carbohydrates to address or prevent a hypoglycemic event; and in response to the determination that the detected rapid rate of increase of the glucose concentration values being indicative of ingestion of carbohydrates.
Agarwal teaches a processor (See [0183] teaching 100 includes a processor), is operable to perform functions to:
obtain a series of glucose concentration values as measured at regular time intervals by a glucose monitor (See [0013] teaching a continuous glucose monitor sensor this is considered 'regular time intervals' since is 'continuous' ; see [0087] teaching "the database layer 28, may calculate average blood glucose or sensor glucose readings for specified timeframes." );
detect a rapid rate of increase in the glucose concentration values (See [0256]);
determine the rapid rate of increase in glucose concentration values is indicative of ingestion of carbohydrates to address or prevent a hypoglycemic event (See [0256]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Mastrototaro such that it is operable to obtain a series of glucose concentration values as measured at regular time intervals by the sensor; detect a rapid rate of increase in the glucose concentration values; determine the rapid rate of increase in glucose concentration values is indicative of ingestion of carbohydrates to address or prevent a hypoglycemic event; and in response to the determination that the detected rapid rate of increase of the glucose concentration values being indicative of ingestion of carbohydrates as taught by Agarwal. One of ordinary skill in the art would have been motivated to do so in order to check for a high increase in blood glucose level occurring a short time after a food bolus event (Agarwal [0256]) and prevent a hypoglycemic event.
Regarding Claim 18, the combination of Mastrototaro and Agarwal teaches the device of claim 17, wherein the processor is further operable to: set the maximum amount of medication to be delivered to a predetermined value for a set amount of time (see Mastrototaro [0088-0090] teaching how max boundaries are modified with the adjusted basal rate and time intervals).
Regarding Claim 19, the combination of Mastrototaro and Agarwal teaches the device of claim 17, wherein the processor, when limiting delivery of medication to the user, is operable to: apply a delivery constraint to reduce the delivery of medication (see Mastrototaro [0088-0090] teaching how max boundaries are modified with the adjusted basal rate and time intervals; this is considered to be a ‘constraint’).
Regarding Claim 20, the combination of Mastrototaro and Agarwal teaches the device of claim 17, wherein the processor, when limiting delivery of medication to the user, is operable to: reduce the amount of medication based on a maximum volume of a user's basal insulin delivery volume divided by either a time increment, at which the adjusted basal dosage is administered or a percentage of an hourly basal rate (see Mastrototaro [0087] teaching a percentage; and [0088-0090] teaching how max boundaries are modified with the adjusted basal rate and various time intervals).
Regarding Claim 21, the combination of Mastrototaro and Agarwal teaches the device of claim 17, wherein the processor, when determining the rapid rate of increase in glucose concentration values is indicative of the ingestion of carbohydrates to address or prevent the hypoglycemic event, is operable to: determine the rapid rate of increase in glucose concentration values is beyond a certain threshold rate of increase (see Mastrototaro [0088-0090] teaching how max boundaries are modified with the adjusted basal rate and time intervals; the boundaries are considered thresholds; similarly in Agarwal [0256] the determination of the rapid increase is done based on a 'threshold’).
Regarding Claim 22, the combination of Mastrototaro and Agarwal teaches the device of claim 17, wherein the processor, when determining the rapid rate of increase in glucose concentration values is indicative of the ingestion of carbohydrates to address or prevent the hypoglycemic event, is operable to: determine the rapid rate of increase over a series of glucose concentration values that a first glucose concentration value in the series of glucose concentration values is below a hypoglycemic threshold (see Agarwal Fig 2a-2k, at least one of the data points of the series of glucose concentrations values is below hypoglycemic threshold; also see Agarwal [0256] it is determining a rapid increase, therefore at least one value would be below hypoglycemic threshold before the increase).
Regarding Claim 23, the combination of Mastrototaro and Agarwal teaches the device of claim 17, wherein the processor, when determining the rapid rate of increase in glucose concentration values is indicative of the ingestion of carbohydrates to address or prevent the hypoglycemic event, is operable to: determine the rapid rate of increase over a series of glucose concentration values that any glucose concentration value in the series of glucose concentration values is below a predetermined threshold greater than the hypoglycemic threshold (See Agarwal Figs 2a-2k and [0256] teaching how a series of glucose concentration values are analyzed and determined if there are below are greater than a threshold; Furthermore, see Mastrototaro [0088-0090] teaching how modified boundaries are used to compare the values as well; meaning adjusted thresholds could be used to compare the blood glucose concentration values as well).
Claim(s) 16 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mastrototaro in view of Agarwal as applied to claims 9 and 17 above, and further in view of Rack Gomer (US 20150289823).
Regarding Claim 16, the combination of Mastrototaro and Agarwal teaches all elements of claim 9 as described above. The combination does not specify the system wherein the processor, when determining the rapid rate of increase in glucose concentration values is indicative of the ingestion of carbohydrates to address or prevent the hypoglycemic event, is operable to: determine the rapid change of a second derivative of the glucose concentration is higher than a predetermined threshold.
Rack Gomer teaches [0148-150] teaches a processor using a first derivative and a second derivative of glucose concentration values to calculate of the glucose concentration is higher than a threshold to determine if the patient is predicted to go into a hypoglycemic state.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Mastrototaro such that it is operable to: determine the rapid change of a second derivative of the glucose concentration is higher than a predetermined threshold as taught by Rack Gomer. One of ordinary skill in the art would have been motivated to do so in order to help determine speed in which glucose levels are changing or stabling (Rack Gomer [0148-150]) which would help treat a patient prior to the patient reaching an hypoglycemic state.
Regarding Claim 24, the combination of Mastrototaro and Agarwal teaches all element of claim 17 as described above. The combination does not specify the device of claim 17, wherein the processor, when determining the rapid rate of increase in glucose concentration values is indicative of the ingestion of carbohydrates to address or prevent the hypoglycemic event, is operable to: determine the rapid change of a second derivative of the glucose concentration is higher than a predetermined threshold.
Rack Gomer teaches [0148-150] teaches a processor using a first derivative and a second derivative of glucose concentration values to calculate of the glucose concentration is higher than a threshold to determine if the patient is predicted to go into a hypoglycemic state.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Mastrototaro such that it is operable to: determine the rapid change of a second derivative of the glucose concentration is higher than a predetermined threshold as taught by Rack Gomer. One of ordinary skill in the art would have been motivated to do so in order to help determine speed in which glucose levels are changing or stabling (Rack Gomer [0148-150]) which would help treat a patient prior to the patient reaching an hypoglycemic state.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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, Michael Tsai can be reached at (571) 270-5246. 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.
/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
Prosecution Insights