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 .
Status of Claim(s)
Claims 1-20 have been examined.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claim(s) 1 recite(s) a non-transitory readable medium, which is a statutory category (i.e. machine). Claim 12 recites a system, which is a statutory category (i.e. machine). Accordingly, claims 1, 12 are all within at least one of the four statutory categories.
Step 2A - Prong One:
Regarding Prong One of Step 2A (MPEP2106.04-.7), the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes.
The limitation of Independent claims 1, 12 recites at least one abstract idea. Specifically, Claim 1 recites the steps of
A medical device for detecting ingestion of carbohydrates, comprising:
a processor; a memory operable to store programming code, wherein the programming code is executable by the processor; and a communication interface operable to receive and transmit signals or data indicative of a blood glucose level of a user;
wherein the processor, when executing the programming code, is operable to: determine a blood glucose level of the user is below a first threshold;
then determine a user has consumed carbohydrates;
in response to the determination the blood glucose level of the user is below the first threshold and the determination that the user has consumed carbohydrates, reduce delivery of the diabetes drug to the user for a period of time.
The limitations “receive and transmit signals or data indicative of a blood glucose level of a user; determine a blood glucose level of the user is below a first threshold; then determine a user has consumed carbohydrates” constitutes (c) “a mental process” because receiving data can be practically performed in the human mind. Accordingly, the claim is directed toward at least one abstract idea.
Further the limitations “in response to the determination the blood glucose level of the user is below the first threshold and the determination that the user has consumed carbohydrates, reduce delivery of the diabetes drug to the user for a period of time” constitutes (b) certain methods of organizing human activity” because these limitations could be performed by the user, researcher to observe, analyze data sources on a piece of paper. Accordingly, the claim is directed toward at least one abstract idea
Furthermore, the abstract idea for claims 12 is identical as the abstract idea for claim 1, because the only difference between claim 1 and claim 12 is that claims 1 recites a device, whereas claim 14 recites a system.
Furthermore, the following depending claims further define the at least one abstract idea, and thus fail to make the abstract idea any less abstract.
For dependent claims 2-3, the recitation of a second threshold, thus merely define steps that were indicated as being part of the abstract idea, and thus part of mental process..
For claims 5-9 generating a prompt indicting a reduction to a current basal ratem merely were indicated as being part of the abstract idea, and thus part of organizing human activity.
For claims 10-11, recitation of a threshold, a period of tine merely define steps that were indicated as being part of the abstract idea, and thus part of organizing human activity.
Step 2A - Prong Two:
Regarding Prong Two of Step 2A (MPEP2106.04-.07), it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted in MPEP2106.04-07, it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.”
In the present case, the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A medical device for detecting ingestion of carbohydrates, comprising:
a processor; a memory operable to store programming code, wherein the programming code is executable by the processor; and a communication interface operable to receive and transmit signals or data indicative of a blood glucose level of a user;
wherein the processor, when executing the programming code, is operable to: determine a blood glucose level of the user is below a first threshold;
then determine a user has consumed carbohydrates (merely invokes use of computer and computer components as a tool as noted below, see MPEP 2106.05(f)), including functions to:
in response to the determination the blood glucose level of the user is below the first threshold and the determination that the user has consumed carbohydrates, reduce delivery of the diabetes drug to the user for a period of time (merely data gathering steps as noted below, see MPEP 2106.05(g) and Symantec);
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitation of wherein the processor, when executing the programming code, is operable to: determine a blood glucose level of the user is below a first threshold; then determine a user has consumed carbohydrates. The examiner submits that this additional limitation merely adds insignificant extra-solution activity of receiving data to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea of a mental process (see MPEP § 2106.05(g)).
Regarding the additional limitation of in response to the determination the blood glucose level of the user is below the first threshold and the determination that the user has consumed carbohydrates, reduce delivery of the diabetes drug to the user for a period of time , this is merely post-solution activity. The examiner submits that this additional limitation merely adds insignificant extra-solution activity of impractical application to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea of a mental process (see MPEP § 2106.05(g)).
Particularly, the use of a processor, a memory, as described in claims 1 and 12 is not positively claimed in the claims as it defines the service but is claimed at such a high level of generality that it represents mere instructions to implement an abstract idea MPEP 2106.05(f). The Specification describes the processor, a memory as generic component (‘Spec.; Para 0022).
The remaining dependent claim limitations are not addressed above fail to integrate the abstract idea into a practical application
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to implement and revise a treatment plan, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception (see 2019 PEG and MPEP § 2106.05).
For these reasons, representative independent claim 1 and analogous independent claims 12 do not recite additional elements that integrate the judicial exceptions into a practical application.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set below:
Dependent claims 2-10, 13-20 recite further computer processor to perform the functions of to use, to determine, to generate and thus amount to no more than performing the method with a computer component, merely represent insignificant extra solution activity (see MPEP § 2106.05(g))
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Step 2B:
Regarding Step 2B, independent claims 1, 12 do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
For claims 1, 2 and dependent claims 2-11, 13-20 limit the use of determination a first/second threshold level, detemination of carbohydrate measurement as well-understood, routine, conventional activity (Berkheimer v. HP, Inc., 881 F.3d 1360, 1368, 125 USPQ2d 1649, 1654 (Fed. Cir. 2018).), and MPEP 2106.05(d)(I)(2)
For the reasons stated, the claims fail the Subject Matter Eligibility Test and are consequently rejected under 35 USC 101. Therefore, claims 1-20 are rejected under 35 USC 101 as being patent ineligibility.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Budiman et al. (US20100317952A1 hereinafter Budiman) in view of Estes (US20140107607A1)
With respect to claim 1, Budiman teaches a medical device for detecting ingestion of carbohydrates, comprising:
a processor; a memory operable to store programming code, wherein the programming code is executable by the processor; and a communication interface operable to receive and transmit signals or data indicative of a blood glucose level of a user (‘952; Para 0010, 0016);
wherein the processor, when executing the programming code, is operable to: determine a blood glucose level of the user is below a first threshold (‘952; Para 0013 ; Budiman describes a system for monitoring the glucose level of a user, comprising: a continuous glucose monitor; a processor configured to receive signals from the continuous glucose monitor and also adapted to analyze those signals in accordance with software commands, the software commands including commands to program at least a portion of the processor to operate as a state machine, the state machine having a first state when the signals from the continuous glucose monitor indicate a not hypoglycemic state and a second state when the signals indicate that a glucose value is below a selected threshold value);
then determine a user has consumed carbohydrates (‘952; Para 0017: the second subsystem includes requesting a confirmation measurement of glucose level when the first subsystem presents an alarm or when a value of a previous glucose level measurement is below a selected threshold value. In still another alternative aspect, the second subsystem includes recommending administration of rescue carbohydrates if the confirmation measurement glucose value is below a selected threshold.);
Estes teaches
in response to the determination the blood glucose level of the user is below the first threshold and the determination that the user has consumed carbohydrates, reduce delivery of the diabetes drug to the user for a period of time (‘607; Para 0006: by disclosure, Estes describes e infusion pump system can be configured to provide an indication to a user that a blood glucose level in the future (e.g., a predicted blood glucose level) may reach an upper or lower threshold level, and thus the infusion pump system can suggest to the user to “consume carbohydrates” or “reduce insulin dose” (e.g., if the predicted blood glucose level is below a lower threshold limit) or suggest to the user to “increase insulin dosage” or “avoid consuming carbohydrates” (e.g., if the predicted glucose level is above an upper threshold limit). Such a result can be used to reduce the likelihood of the user's blood glucose level reaching an alarm limit, thereby more consistently maintaining the user's blood glucose level within a desired range over an extended period of time).
It would have been obvious to one of ordinary skill in the art before the effective filing date of claimed invention to t modify the system of Budiman with the technique of providing infusion pump system as taught by Estes and the motivation is to reduce the delivery of diabetes drug for the user with consumed carbohydrates.
Claim 12 is rejected as the same reason with Claim 1.
With respect to claim 2, the combined art teaches the medical device of claim 1, wherein the period of time is until the user's BG value increases above a second threshold (‘952; Para 0083).
With respect to claim 3, the combined art teaches the medical device of claim 2, wherein the second threshold is different than the first threshold (‘952; Paras 0017-0018).
With respect to claim 4, the combined art teaches the medical device of claim 1, wherein the processor is further operable to: determine an amount of carbohydrates consumed based on an input to the processor, wherein the input is received via a user interface, an application associated with the user, or a global-positioning system (‘952; Para 00038: user input of some amount of information from which the system 10 determines, at least in part, insulin bolus administration information. Such insulin bolus administration information may be or include, for example, insulin bolus quantity or quantities, bolus type, insulin bolus delivery time, times or intervals (e.g., single delivery, multiple discrete deliveries, continuous delivery, etc.), and the like. Examples of user supplied information may be, for example but not limited to, user glucose level concentration, interstitial glucose level information, information relating to a meal or snack that has been ingested, is being ingested).
With respect to claim 5, the combined art teaches the medical device of claim 1, wherein the processor is further operable to: generate a prompt indicating a reduction to a current basal rate (607; Para 0025: to supply scheduled basal dosages of insulin (or other medication) along with user-selected bolus dosages. The basal rate can be selected to maintain a user's blood glucose level in a target range during normal activity when the user is not eating or otherwise consuming food items).
With respect to claim 6, the combined art teaches the medical device of claim 1, wherein the processor is further operable to: generate a prompt indicating that delivery of a meal bolus is inappropriate (‘607; Para 0076).
With respect to claim 7, the combined art teaches the medical device of claim 1, wherein the processor is further operable to: generate a prompt indicating a bolus will not be delivered (‘607; Para 0076: the process 500 may rely upon an IOB value that accounts for all bolus dosages (e.g., including both meal boluses and correction bolus) that have been delivered but have not yet acted in the user's body. ).
With respect to claim 8, the combined art teaches the medical device of claim 1, wherein the processor is further operable to: generate a prompt indicating a requested bolus amount will be decreased (‘607; Para 0027).
With respect to claim 9, the combined art teaches the medical device of claim 1, wherein the processor is further operable to: generate on a user interface a prompt providing a recommendation to avoid a meal bolus (‘607; Para 0006: avoid consumed carbohydrates).
With respect to claim 10, the combined art teaches the medical device of claim 1, wherein the period of time is ninety minutes (‘607; Para0101).
With respect to claim 11, the combined art teaches the medical device of claim 1, wherein the first threshold is selected from a value within the range of 80-120 mg/dL or 70-140 mg/dL, or a value of 110 mg/dL (‘607; Paras 0093-0097).
With respect to claim 13, the combined art teaches the system of claim 12, wherein the processor, when determining the user has consumed carbohydrates, is operable to: use an elapsed time from a previous meal or identify a current time as a typical time of meal ingestion for the user (952; Para 0019).
With respect to claim 14, the combined art teaches the system of claim 13, wherein the processor, when determining the user has consumed carbohydrates, is further operable to: determine either the elapsed time from the previous meal or identification of the current time as the typical time for meal ingestion based on a time of day and a glucose trajectory of the user's glucose measurement values (‘607; Para 0075: blood glucose data equations can be curve-fit and extrapolated using linear regression techniques to estimate the blood glucose trajectory. In another example, the straight-line slope of the recent blood glucose data points can be determined and the slope of the fitted-line can be extrapolated to provide a prediction.).
With respect to claim 15, the combined art teaches the system of claim 12, wherein the processor, when in response to the determination the blood glucose level of the user is below the first threshold and the determination that the user has consumed carbohydrates, the processor is operable to: use a glucose trajectory of glucose measurement values of the user to determine the consumed carbohydrates are rescue carbohydrates (‘607; Para 0075, 0158: if the user's calculated PBG level is below the lower threshold level, the controller device 200 can communicate a predicted low blood glucose alarm/alert to the user (e.g., an audible alarm or alert, display of text on the display 222 describing an alarm or alert, a vibratory alarm or alert, another communicative output, or a combination thereof). Optionally, the controller device 200 can also prompt the user to take action to correct the predicted low blood glucose level. In one example, the controller device 200 (via user interface 220) can suggest that the user consume some food to increase their blood glucose level, and can prompt the user to accept, modify, or decline the suggestion).
With respect to claim 16, the combined art teaches the system of claim 12, wherein the processor, when in response to the determination the blood glucose level of the user is below the first threshold and the determination that the user has consumed carbohydrates, the processor is operable to: determine that the consumed carbohydrates are slow-absorbing carbohydrates or fast-absorbing carbohydrates based on a glucose trajectory of glucose measurement values of the user; and use the determination that the consumed carbohydrates are fast-absorbing carbohydrates to determine the consumed carbohydrates are rescue carbohydrates (‘942; Para 0014: the second state includes presenting an alarm to the user and requesting a confirmation measurement of glucose level when the glucose value is below a second selected threshold value that is lower than the first threshold value. In still a further aspect, the second state includes recommending administration of rescue carbohydrates if the confirmation measurement glucose value is below a selected threshold.).
With respect to claim 17, the combined art teaches the system of claim 12, wherein the processor is further operable to: generate a prompt indicating an estimated reduction to a current basal rate of the diabetes drug (607; Para 0025: to supply scheduled basal dosages of insulin (or other medication) along with user-selected bolus dosages. The basal rate can be selected to maintain a user's blood glucose level in a target range during normal activity when the user is not eating or otherwise consuming food items).
With respect to claim 18, the combined art teaches the system of claim 12, wherein the processor is further operable to: determine whether a bolus was recently administered (952; Para 0011).
With respect to claim 19, the combined art teaches the system of claim 12, further comprises: a glucose sensor communicatively coupled to the processor, wherein the blood glucose sensor is operable to: measure a blood glucose value at a predetermined time interval; and provide glucose measurement values to the processor (‘942; Para 0040).
With respect to claim 20, the combined art teaches the system of claim 19, wherein the processor is included in a medical device and the glucose sensor is positioned within the medical device (‘942; Para 0041).
Conclusion
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/HIEP V NGUYEN/Primary Examiner, Art Unit 3686
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