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 .
Claims 1-24 have been examined.
Claim Objections
Claim 24 is objected to because of the following informalities: Claim 24 recites “The system for administration of claim 21, wherein the parameter comprises at least one of an insulin to carbohydrate ratio or a correction factor.”, however, claim 21 is not a system claim. Examiner considers that there is a typographical error and claim should recite “The system for administration of claim 23, wherein the parameter comprises at least one of an insulin to carbohydrate ratio or a correction factor.” Appropriate correction is required.
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 1-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-14 and 23-24 are drawn to a system which is within the four statutory categories (i.e. machine). Claims 15-22 are drawn to a method which is within the four statutory categories (i.e. process).
Step 2A, Prong 1:
The independent claims recite:
“…determine an actual bolus fraction of a total daily insulin that was delivered as a total daily bolus dose; determine a ratio of the actual bolus fraction relative to a target bolus fraction; and based at least partially on the determined ratio of the actual bolus fraction relative to a target bolus fraction, determine at least one new value of a parameter…”-claim 1,
“determining an actual amount of a total daily insulin that was delivered as bolus doses; determining a ratio of the actual amount relative to a target amount; and based at least partially on the determined ratio, determining at least one new value of a parameter to utilize in calculating bolus doses”-claim 15,
“…determine insulin deviations made by the automated medicament delivery device subsequent to administration of bolus dose during postprandial periods throughout a given period of time; and based at least partially on the determined insulin deviations, determine at least one new value of a parameter to utilize in determining bolus doses”-claim 23.
These limitations recite mathematical calculations, therefore the limitation falls within the “mathematical concept” grouping of abstract ideas.
These limitations also correspond to “mental processes”, since the claims steps can be done in human mind (or a user using pen and paper) with a recitation of generic computing devices, such as a processor and an automated medicament delivery device. The current specification describes these components as generic computing components, such as in [0134], the current specification recites “The various illustrative methods, logical blocks, modules, and circuits described in connection with the examples of the system 100, and in particular, the automated medicament delivery device 114 and the handheld electronic computing device 138, disclosed herein may be implemented or performed with a general purpose processor, a special purpose processor, a digital signal processor (DSP), an Integrated Circuit (IC), an Application Specific Integrated Circuit (ASIC), a Field Programmable Gate Array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein…”.
Dependent claims 8, 9 and 12 recite mathematical equations, and MPEP recites “A claim that recites a numerical formula or equation will be considered as falling within the "mathematical concepts" grouping.” in section 2106.04(a)(2). Therefore claims 8, 9 and 12 recite an abstract idea.
Claim 4 recites “…provide a recommendation to change at least one previously utilized value of the parameter to the at least one new value of the parameter; and responsive to a user input, change the at least one previously utilized value of the parameter to the at least one new value of the parameter”, claim 18 recites “…providing a recommendation to change at least one previously utilized value of the parameter to the at least one new value of the parameter; and responsive to a user input, changing the at least one previously utilized value of the parameter to the at least one new value of the parameter”, claim 19 recites “…based at least partially on the determined at least one new value of the parameter, generating a request to deliver a bolus dose to a user” and these limitations recite an abstract idea of “certain methods of organizing human activity”. This is a method of managing interactions between people, such as user following rules and instructions.
Claim 6 recites “…comprising instructions that, when executed by the at least one processor, cause the automated medicament delivery device to deliver the bolus dose responsive to the generated request” and claim 20 recites “…responsive to the generated request, delivering the bolus dose”, which corresponds to “insignificant application” (see MPEP 2106.05 (g)).
Claims 2-14, 16-22 and 24 are ultimately dependent from claims 1, 15, 23 and include all the limitations of claims 1, 15, 23. Therefore, claims 2-14, 16-22 and 24 recite the same abstract idea. Claims 2-14, 16-22 and 24 describe a further limitation regarding the basis for determining bolus fractions and new parameters for the medicament delivery. These are all just further describing the abstract idea recited in 1, 15, 23, without adding significantly more.
After considering all claim elements, both individually and in combination and in ordered combination, it has been determined that the claims do not amount to significantly more than the abstract idea itself.
Step 2A, Prong 2:
This judicial exception is not integrated into a practical application. In particular, claims recite the additional elements of “at least one processor; and at least one non-transitory computer-readable storage medium storing instructions thereon that, when executed by the at least one processor, cause the automated medicament delivery device to:…” the determining steps-claim 1, “cause the automated medicament delivery device to automatically change at least one previously utilized value of the parameter to the at least one new value of the parameter without user input”-claim 3, “cause the automated medicament delivery device to generate a request to deliver a bolus dose to the user based at least partially on the at least one new value of the parameter”-claim 5, “cause the automated medicament delivery device to adjust the at least one new value of the parameter based at least partially on a selected rate of adaptation prior to providing a recommendation to change at least one previous utilized value of the parameter to the at least one new value of the parameter”-claim 10, “automatically changing at least one previously utilized value of the parameter to the at least one new value of the parameter without user input”-claim 17, which are hardware and software elements, these limitations are not enough to qualify as “practical application” being recited in the claims along with the abstract idea since these elements are merely invoked as a tool to apply instructions of the abstract idea in a particular technological environment, and mere instructions to apply/implement/automate an abstract idea in a particular technological environment and merely limiting the use of an abstract idea to a particular field or technological environment do not provide practical application for an abstract idea (MPEP 2106.05(f) & (h)).
Claims also recite other additional limitations beyond abstract idea, including functions such as “cause the automated medicament delivery device to deliver the bolus dose responsive to the generated request”-claims 6, “responsive to the generated request, delivering the bolus dose”-claim 20, and these limitations are “insignificant application”, since these limitations impose meaningful limits on the claims such that they are not nominally or tangentially related to the invention (see MPEP 2106.05 (g)), which do not provide a practical application for the abstract idea.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform determining and automatically changing a value of the parameter within the automated delivery system steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The claims are not patent eligible.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-7, 10-11, 13-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blomquist (US 8,346,399 B2).
Claim 1 recites a system for administration of medicament to a user-body, the system comprising:
an analyte sensor (Blomquist; col. 5, lines 5-14); and
an automated medicament delivery device comprising:
at least one processor (Blomquist; col. 4, lines 1-8); and
at least one non-transitory computer-readable storage medium storing instructions (Blomquist; col. 35, lines 14-28) thereon that, when executed by the at least one processor, cause the automated medicament delivery device to:
determine an actual bolus fraction of a total daily insulin that was delivered as a total daily bolus dose (Blomquist discloses “…programming a bolus amount into the pump; programming a duration into the pump; programming a percentage into the pump, the percentage defining a portion of the bolus amount to deliver immediately upon executing a deliver command and a remainder of the bolus amount to deliver over the duration upon executing a deliver command; and executing the deliver command.” in col. 1, lines 60-67 and “…the pump configured to present…amount of the last bolus delivered by the insulin pump…” in col. 6, lines 11-20);
determine a ratio of the actual bolus fraction relative to a target bolus fraction (Blomquist discloses “…The recommended bolus amount is the recommended correction bolus 490 or 490′, which the pump 100 calculates using the correction factor as discussed above. This feature allows the user to correct a high blood glucose level and deliver additional insulin to work against carbohydrates that they plan to consume…” in col. 32, lines 19-25); and
based at least partially on the determined ratio of the actual bolus fraction relative to a target bolus fraction, determine at least one new value of a parameter utilized by the automated medicament delivery device to determine bolus doses (Blomquist discloses “…The recommended bolus amount is the recommended correction bolus 490 or 490′, which the pump 100 calculates using the correction factor as discussed above. This feature allows the user to correct a high blood glucose level and deliver additional insulin to work against carbohydrates that they plan to consume…” in col. 32, lines 19-25).
Claim 2 recites the system of claim 1, wherein the parameter comprises at least one of an insulin to carbohydrate ratio or a correction factor (Blomquist discloses “…The pump 100 prompts 444 the user to enter their carbohydrate ratio, which is the number or grams of carbohydrates that each unit of insulin will counteract. The pump 100 also calculates the historical average carbohydrate ratio 445 for a predetermined time-period and displays that historical average with the prompt 444…” in col. 28, lines 16-35 and col. 27, lines 54-66).
Claim 3 recites the system of claim 1, comprising instructions that, when executed by the at least one processor, cause the automated medicament delivery device to automatically change at least one previously utilized value of the parameter to the at least one new value of the parameter without user input (Blomquist discloses “…The pump 100 then calculates a recommended bolus amount 490' using the carbohydrate ratio as described above and displays the recommended bolus amount 490', together with the duration 492 in a user interface that confirms the parameters for delivery of the extended bolus. …” in col. 31, lines 62-66).
Claim 4 recites the system of claim 1, comprising instructions that, when executed by the at least one processor, cause the automated medicament delivery device to:
provide a recommendation to change at least one previously utilized value of the parameter to the at least one new value of the parameter (Blomquist discloses “…The pump 100 then calculates a recommended bolus amount 490' using the carbohydrate ratio as described above and displays the recommended bolus amount 490', together with the duration 492 in a user interface that confirms the parameters for delivery of the extended bolus. …” in col. 31, lines 62-66); and
responsive to a user input, change the at least one previously utilized value of the parameter to the at least one new value of the parameter (Blomquist discloses “…The user activates the Deliver function 384 to begin delivery of the extended bolus using the parameters displayed in the user interface.” in col. 32, lines 1-4).
Claim 5 recites the system for administration of claim 4, comprising instructions that, when executed by the at least one processor, cause the automated medicament delivery device to generate a request to deliver a bolus dose to the user based at least partially on the at least one new value of the parameter (Blomquist; col. 31, line 54 to col. 32, line 4).
Claim 6 recites the system of claim 5, comprising instructions that, when executed by the at least one processor, cause the automated medicament delivery device to deliver the bolus dose responsive to the generated request (Blomquist; col. 31, line 54 to col. 32, line 4).
Claim 7 recites the system of claim 1, wherein the target bolus fraction is about 0.5 (Blomquist; col. 25, lines 35-54).
Claim 10 recites the system of claim 1, comprising instructions that, when executed by the at least one processor, cause the automated medicament delivery device to adjust the at least one new value of the parameter based at least partially on a selected rate of adaptation prior to providing a recommendation to change at least one previous utilized value of the parameter to the at least one new value of the parameter (Blomquist; col. 25, lines 1-5).
Claim 11 recites the system of claim 10, wherein adjusting the at least one new value of the parameter based at least partially on a selected rate of adaptation comprises weighting the previously utilized parameter higher than the determined at least one new value of the parameter (Blomquist; col. 23, line 52 to col. 24, line 2).
Claim 13 recites the system of claim 1, comprising instructions that, when executed by the at least one processor, cause the at least one processor to:
compare a count of manual bolus doses over a most-recent 24-hour period to a count of manual bolus doses over a further 24-hour period, the further 24-hour period preceding the most-recent 24-hour period; and determine at least one new value of the parameter utilized to calculate bolus doses at least partially responsive to the comparison (Blomquist; col. 19, lines 53-62, col. 23, line 52 to col. 24, line 2).
Claim 14 recites the system of claim 13, comprising instructions that, when executed by the at least one processor, cause the at least one processor to:
determine the at least one new value of the parameter utilized to calculate bolus doses at least partially responsive to a difference between the count of manual bolus doses over a most-recent 24-hour period and the count of manual bolus doses over the further 24-hour period exceeding a predetermined threshold (Blomquist; col. 19, lines 53-62, col. 23, line 52 to col. 24, line 2).
Claim 15 recites a method for recommending new values of parameters for determining bolus doses, the method comprising:
determining an actual amount of a total daily insulin that was delivered as bolus doses (Blomquist discloses “…programming a bolus amount into the pump; programming a duration into the pump; programming a percentage into the pump, the percentage defining a portion of the bolus amount to deliver immediately upon executing a deliver command and a remainder of the bolus amount to deliver over the duration upon executing a deliver command; and executing the deliver command.” in col. 1, lines 60-67 and “…the pump configured to present…amount of the last bolus delivered by the insulin pump…” in col. 6, lines 11-20);
determining a ratio of the actual amount relative to a target amount (Blomquist discloses “…The recommended bolus amount is the recommended correction bolus 490 or 490′, which the pump 100 calculates using the correction factor as discussed above. This feature allows the user to correct a high blood glucose level and deliver additional insulin to work against carbohydrates that they plan to consume…” in col. 32, lines 19-25); and
based at least partially on the determined ratio, determining at least one new value of a parameter to utilize in calculating bolus doses (Blomquist discloses “…The recommended bolus amount is the recommended correction bolus 490 or 490′, which the pump 100 calculates using the correction factor as discussed above. This feature allows the user to correct a high blood glucose level and deliver additional insulin to work against carbohydrates that they plan to consume…” in col. 32, lines 19-25).
Claim 16 recites the method of claim 15, wherein the parameter comprises at least one of an insulin to carbohydrate ratio or a correction factor (Blomquist discloses “…The pump 100 prompts 444 the user to enter their carbohydrate ratio, which is the number or grams of carbohydrates that each unit of insulin will counteract. The pump 100 also calculates the historical average carbohydrate ratio 445 for a predetermined time-period and displays that historical average with the prompt 444…” in col. 28, lines 16-35 and col. 27, lines 54-66).
Claim 17 recites the method of claim 15, comprising automatically changing at least one previously utilized value of the parameter to the at least one new value of the parameter without user input (Blomquist discloses “…The pump 100 then calculates a recommended bolus amount 490' using the carbohydrate ratio as described above and displays the recommended bolus amount 490', together with the duration 492 in a user interface that confirms the parameters for delivery of the extended bolus. …” in col. 31, lines 62-66).
Claim 18 recites the method of claim 15, comprising:
providing a recommendation to change at least one previously utilized value of the parameter to the at least one new value of the parameter (Blomquist discloses “…The pump 100 then calculates a recommended bolus amount 490' using the carbohydrate ratio as described above and displays the recommended bolus amount 490', together with the duration 492 in a user interface that confirms the parameters for delivery of the extended bolus. …” in col. 31, lines 62-66); and
responsive to a user input, changing the at least one previously utilized value of the parameter to the at least one new value of the parameter (Blomquist discloses “…The user activates the Deliver function 384 to begin delivery of the extended bolus using the parameters displayed in the user interface.” in col. 32, lines 1-4).
Claim 19 recites the method of claim 18, further comprising, based at least partially on the determined at least one new value of the parameter, generating a request to deliver a bolus dose to a user (Blomquist; col. 31, line 54 to col. 32, line 4).
Claim 20 recites the method of claim 19, further comprising, responsive to the generated request, delivering the bolus dose (Blomquist; col. 31, line 54 to col. 32, line 4).
Claim 21 recites the method of claim 15, comprising:
comparing a count of manual bolus doses over a most-recent 24-hour period to a count of manual bolus doses over a further 24-hour period, the further 24-hour period preceding the most-recent 24-hour period; and determining at least one new value of the parameter utilized to calculate bolus doses at least partially responsive to the comparing (Blomquist; col. 19, lines 53-62, col. 23, line 52 to col. 24, line 2).
Claim 22 recites the method of claim 21, wherein the comparing comprises:
determine whether a difference between the count of manual bolus doses over a most-recent 24-hour period and the count of manual bolus doses over the further 24-hour period exceeding a predetermined threshold (Blomquist; col. 19, lines 53-62, col. 23, line 52 to col. 24, line 2).
As per claims 23-24, they are system claims which repeat the same limitations of claims 1-2, the corresponding method claims, as a collection of elements as opposed to a series of process steps. Since the teachings of Blomquist disclose the underlying process steps that constitute the methods of claims 1-2, it is respectfully submitted that they provide the underlying structural elements that perform the steps as well. As such, the limitations of claims 23-24 are rejected for the same reasons given above for claims 1-2.
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.
Claims 8-9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Blomquist (US 8,346,399 B2).
Claim 8 recites the system of claim 1, wherein the parameter comprises an insulin to carbohydrate ratio, and wherein the at least one new value of the parameter is determined via the equation:
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656
454
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Claim 9 recites the system of claim 1, wherein the parameter comprises a correction factor, and wherein the at least one new value of the parameter is determined via the equation:
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654
450
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Claim 12 recites the system of claim 11, comprising wherein adjusting the at least one new value of the parameter via the equation:
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360
430
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As per claims 8, 9 and 12, Blomquist teaches correction bolus equations through columns 23 and 24, but does not disclose the equations recited in the claims. However, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to have used the method of Blomquist with any particular absolute consumption rate, since it has been held that merely discovering an optimum value of a result effective variable involves only routine skill in the art. In reBoesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DILEK B COBANOGLU whose telephone number is (571)272-8295. The examiner can normally be reached 8:30-5:00 ET.
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/DILEK B COBANOGLU/ Primary Examiner, Art Unit 3687
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