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 § 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.
1. Claims 1-9, 11-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
In accordance with MPEP 2106.04, each of Claims 1, 9, 17 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1 per MPEP 2106.04(a)
Each of Claims 1, 9, 17 recites at least one step or instruction for “calculating a basal dosage of a medicament to be delivered to a user by a medicament delivery device; determining an amount that at least one factor affects a potency of the medicament; and adjusting the calculated basal dosage of the medicament”, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) or a certain method of organizing human activity in MPEP 2106.04(a)(2)(II) or mathematical concept in MPEP 2106.04(a)(2)(I). The claimed limitations involve calculation, determination and adjustment which are mental processes that can be performed in the human mind (see MPEP 2106.04(a)(2)(III)). Accordingly, each of Claims 1, 9, 17 recites an abstract idea.
Specifically claim 1 recites a processor of an electronic device “calculating a basal dosage of a medicament to be delivered to a user by a medicament delivery device (evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III));; determining an amount that at least one factor affects a potency of the medicament (judgment, which is grouped as a mental process in MPEP 2106.04(a)(2)(III));; and adjusting the calculated basal dosage of the medicament to compensate for the determined amount that the at least one factor has affected the potency of the medicament.” (judgment, which is grouped as a mental process in MPEP 2106.04(a)(2)(III));
Specifically claim 9 recites A medicament delivery device (additional element), comprising: a medicament storage (additional element); a pump for pumping medicament out of the storage for delivery to a user (additional element); a storage medium for storing data (additional element) and computer programming instructions (additional element); a processor for executing the computer programming instructions (additional element) calculating a basal dosage of a medicament to be delivered to a user by a medicament delivery device (evaluation); determining an amount that at least one factor affects a potency of the medicament (judgement); and adjusting the calculated basal dosage of the medicament to compensate for the determined amount that the at least one factor has affected the potency of the medicament. (judgment MPEP 2106.04(a)(2)(III)).
Specifically claim 17 recites a processor in an on-body insulin delivery device calculating a basal dosage of a medicament to be delivered to a user by a medicament delivery device (evaluation); determining an amount that at least one factor affects a potency of the medicament (judgement); and adjusting the calculated basal dosage of the medicament to compensate for the determined amount that the at least one factor has affected the potency of the medicament (judgement judgment MPEP 2106.04(a)(2)(III)).
Further, dependent Claims 2-9, 11-16, 18-20 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the claimed functions/steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
Step 2A, Prong 2 per MPEP 2106.04(d)
The above-identified abstract idea in each of independent Claims1, 9, 17 (and their respective dependent Claims 2-8, 11-16, 18-20) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent Claims 1, 9, 17), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) or represent insignificant extra-solution activity according to MPEP 2106.05(g). More specifically, the additional elements of: a processor of an electronic device, a medicament, histogram as recited in independent Claim 1 and its dependent claims; and medicament delivery device, comprising: a medicament storage; a pump for pumping medicament out of the storage for delivery to a user; a storage medium for storing data and computer programming instructions; a processor for executing the computer programming instructions, medicament as recited in independent claim 9 and its dependent claims; and a processor in an on-body insulin delivery device as recited in independent Claim 17 and its dependent claims are generically recited computer elements in independent Claims 1, 9, 17 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claims 1, 9, 17 (and their respective dependent claims) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g. a memory and processor of an electronic device as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1, 9, 17 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claims 1, 9, 17 (and their respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B per MPEP 2106.05
None of Claims 1, 9, 17 include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons.
These claims require the additional elements of: processor of an electronic device (claim 1 and 17), medicament delivery device (claim 1 and 9), comprising: a medicament storage (claim 9); a pump for pumping medicament out of the storage for delivery to a user (claim 9); a storage medium for storing data and computer programming instructions; a processor for executing the computer programming instructions, medicament, in an on-body insulin delivery device (claim 9).
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the processor, a storage medium for storing data and computer programming instructions and a processor for executing the computer programming instructions, could be any of a number of things including “a microprocessor, a logic circuit, a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), etc. The controller 110 may maintain a date and time as well as other functions (e.g., calculations or the like). The controller 110 may be operable to execute a control application 116 stored in the storage 114 that enables the controller 110 to implement a control system for controlling operation of the medicament delivery device 102. The control application 116 may control medicament delivery to the user 108 as described herein. The storage 114 may hold histories 111 for a user, such as a history of automated basal medicament deliveries, a history of bolus medicament deliveries, meal event history, activity event history, sensor data and the like. In addition, the controller 110 may be operable to receive data or information. The storage 114 may include both primary memory and secondary memory. The storage 114 may include random access memory (RAM), read only memory (ROM), optical storage, magnetic storage, removable storage media, solid state storage or the like.”( ¶0025).
Accordingly, in light of Applicant’s specification, the claimed term processor of an electronic device is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the processor of an electronic device . This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activities’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
Per Applicant’s specification, medicament delivery device (claim 1 and 9), comprising: a medicament storage (claim 9); a pump for pumping medicament out of the storage for delivery to a user (claim 9) as “In accordance with another inventive aspect, a medicament delivery device includes a medicament storage and a pump for pumping medicament out of the storage for delivery to a user.” (¶006)
Accordingly, in light of Applicant’s specification, the claimed term medicament delivery device is reasonably construed as a generic medicament delivery device with generic features to hold and deliver medication. It is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available drug delivery devices, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special features required for the processor of an electronic device . This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activities’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
The recitation of the above-identified additional limitations in Claims 2-8, 11-16, 18-20 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See MPEP 2106.05(f) along with Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. See MPEP 2106.05(a) along with McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, per MPEP 2106.05(a), the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the methods and devices of Claims 1-9, 11-20 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e).
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1-9, 11-20 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Therefore, for at least the above reasons, none of the Claims 1-9, 11-20 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-9, 11-20 are not patent eligible and rejected under 35 U.S.C. 101.
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.
Claim(s) 1-7, 9-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Albertini et al (WO2021059200; hereafter Albertini) in view of Hayter et al (US 20210050085; hereafter Hayter).
Regarding Claim 1, Albertini discloses a method performed by a processor (296) of an electronic device (200), comprising: determining an amount that at least one factor affects a potency of the medicament (¶00157); and adjusting the calculated basal dosage of the medicament to compensate for the determined amount that the at least one factor has affected the potency of the medicament (¶00157, exposure conditions are determined and assessed and then dosage is adjusted).
Albertini is silent on calculating a basal dosage of a medicament to be delivered to a user by a medicament delivery device
Hayter however teaches systems, devices and methods regulating medication dose guidance where a basal dose of the medicament is calculated (¶0014) as a result of both real time physiological detection and anticipation for regularly occurring events such as mealtime. This would be for the purpose of making sure that the basal dosage is as correct as possible for good treatment.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Albertini to include the calculating a basal dosage of a medicament to be delivered to a user by a medicament delivery device as taught by Hayter for the purpose of making sure that the basal dosage is as correct as possible for good treatment.
Regarding Claim 2, the modified Albertini discloses the method of claim 1, wherein the medicament is insulin (¶00071 medication can be insulin).
Regarding Claim 3, the modified Albertini discloses the method of claim 1, wherein the at least one factor comprises temperature, exposure to light or exposure to air (¶00025-00026 “The drug status indicator is configured to indicate an extent of an exposure of the drug to an environmental condition. The reader is configured to detect the drug status indicator. The drug delivery system can vary in one or more ways. For example, the environmental condition can be at least one of temperature, UV exposure, pH, and humidity.”).
Regarding Claim 4, the modified Albertini discloses the method of claim 1.
The current embodiment of Albertini is silent on wherein the at least one factor comprises a duration of time that the medicament has been stored in the medicament delivery device.
Another embodiment of Albertini however teaches the at least one factor comprises a duration of time that the medicament has been stored in the medicament delivery device (¶00152 “For example, the sensor 1002 can be configured to track temperature and/or ultraviolet exposure throughout a time period, e.g., from the time the drug is disposed within the drug holder 1000 to the time of administration, or any portion therebetween. Further, the sensor 1002 can be configured to log or store the tracking data. In certain embodiments, the sensor 1002 can also be configured to track the expiration date of the drug.”). It can track the time that the drug is stored, the drug is stored during exposure periods or the time until the drug is expected to expire and this is for the purpose of understanding whether there was degradation of the drug potency and thus if changes need to be made to dosage (¶00158).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Albertini to include the at least one factor comprises a duration of time that the medicament has been stored in the medicament delivery device as taught by another embodiment of Albertini for the purpose of understanding whether there was degradation of the drug potency and thus if changes need to be made to dosage.
Regarding Claim 5, the modified Albertini discloses the method of claim 1.
The current embodiment of the modified Albertini is silent on wherein the at least one factor decreases the potency of the medicament and the calculated dosage is adjusted to a larger dosage to compensate.
Another embodiment of Albertini however teaches that the at least one factor decreases the potency of the medicament and the calculated dosage is adjusted to a larger dosage to compensate (¶00157 “As such, the sensor and the processor can be part of a closed-loop feedback system. The stored data within the memory can include predetermined threshold(s) for one or more exposure conditions of the drug. During data sensing, the processor can receive feedback input from the sensor. The processor can aggregate the received feedback input(s), perform any necessary calculations, compare it to the predetermined threshold for the corresponding exposure condition, and provide data output. If at any time during an exposure condition, the processor determines that the received feedback exceeds a predetermined control threshold, the processor can modify the data output to adjust the dosage of the drug and/or a rate of delivery of the drug.”). This is for the purpose of anticipating medicament degradation and adjusting treatment to a proper levels.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Albertini to include the at least one factor decreases the potency of the medicament and the calculated dosage is adjusted to a larger dosage to compensate as taught by another embodiment of Albertini for the purpose of anticipating medicament degradation and adjusting treatment to a proper.
Regarding Claim 6, the modified Albertini discloses the method of claims 1,
This embodiment of Albertini is silent on wherein the at least one factor comprises temperature, an average temperature or a histogram of temperatures and a duration of time that the medicament has been stored in the medicament delivery device at a particular temperature or at a particular average temperature.
Another embodiment of Albertini however discloses that one of the exposure conditions that can be sensed and accounted for is temperature of the environment as sensed by a temperature sensor in the device as well as the time (¶00134). This is for the purpose of tracking the duration, frequency and intensity of the exposure condition (¶00134) in order to understand whether there was degradation of the drug potency and thus if changes need to be made to dosage (¶00158).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Albertini to include the wherein the at least one factor comprises temperature, an average temperature or a histogram of temperatures and a duration of time that the medicament has been stored in the medicament delivery device at a particular temperature or at a particular average temperature as taught by another embodiment of Albertini for the purpose of tracking the duration, frequency and intensity of the exposure condition in order to understand whether there was degradation of the drug potency and thus if changes need to be made to dosage.
Regarding Claim 7, the modified Albertini discloses the method of claim 1,
The modified Albertini is silent on wherein the adjusting comprises adjusting the calculated basal dosage based on how much a current temperature is above a target temperature.
In another embodiment however, Albertini teaches that the basal dosage of the drug can be adjusted as a result of the anticipated potency change which is a function of the intensity (degrees above target temperature) and duration (time at degrees above target temperature) and can be anticipated and adjusted accordingly (¶00158). This is for the purpose of tracking the duration, frequency and intensity of the exposure condition in order to understand whether there was degradation of the drug potency and thus if changes need to be made to dosage (¶00158).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Albertini to include the adjusting comprises adjusting the calculated basal dosage based on how much a current temperature is above a target temperature as taught by another embodiment of Albertini for the purpose of tracking the duration, frequency and intensity of the exposure condition in order to understand whether there was degradation of the drug potency and thus if changes need to be made to dosage.
Regarding Claim 9, Albertini discloses a medicament delivery device (Fig 2 200), comprising: a medicament storage (reservoir 210); a pump for pumping medicament out of the storage for delivery to a user (pump 216); a storage medium (memory 297) for storing data and computer programming instructions; a processor (296) for executing the computer programming instructions (P00986: parameters for performance stored in memory 297), determining an amount that at least one factor affects a potency of the medicament (¶0148 data is gathered in the form of an environmental sensor which can be a temperature of the medication or the environment); and adjusting the calculated basal dosage of medicament to compensate for the determined amount that the at least one factor has affected the potency of the medicament (¶00157, exposure conditions are determined and assessed and then dosage is adjusted).
Albertini is silent the computer programming instructions causing the processor to perform the following: calculating a basal dosage of a medicament to be delivered to a user by the medicament delivery device.
Hayter however teaches systems, devices and methods regulating medication dose guidance where a basal dose of the medicament is calculated (¶0014) as a result of both real time physiological detection and anticipation for regularly occurring events such as mealtime. This would be for the purpose of making sure that the basal dosage is as correct as possible for good treatment.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Albertini to include the calculating a basal dosage of a medicament to be delivered to a user by a medicament delivery device as taught by Hayter for the purpose of making sure that the basal dosage is as correct as possible for good treatment.
Regarding Claim 10, the modified Albertini discloses the medicament delivery device of claim 9, wherein the computer programming instructions additionally cause the processor to control the pump to deliver the adjusted basal dosage of medicament to the user (¶0073 actuation of the pump is controlled by the processor which is in communication with the pump for specific parameters).
Regarding Claim 11, the modified Albertini discloses the medicament delivery device of claim 9, wherein the medicament is insulin (¶0071 medication can be insulin).
Regarding Claim 12, the modified Albertini discloses the medicament delivery device of claim 9, wherein the at least one factor comprises temperature ((¶0025-0026 “The drug status indicator is configured to indicate an extent of an exposure of the drug to an environmental condition. The reader is configured to detect the drug status indicator. The drug delivery system can vary in one or more ways. For example, the environmental condition can be at least one of temperature, UV exposure, pH, and humidity.”).
Regarding Claim 13, the modified Albertini teaches the medicament delivery of claim 9, wherein the at least one factor comprises a duration of time that the medicament has been stored in the medicament delivery device.
Another embodiment of Albertini however discloses that one of the exposure conditions that can be sensed and accounted for is temperature of the environment as sensed by a temperature sensor in the device as well as the time (¶00134). Even further, the embodiment also teaches that the expiration date can be taken into account and that the expiration of the drug can be accounted for being faster as a result of the exposures to the at least one factor (¶00161) This is for the purpose of tracking the duration, frequency and intensity of the exposure condition (¶00134) in order to understand whether there was degradation of the drug potency and thus if changes need to be made to dosage (¶00158).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Albertini to include the wherein the at least one factor comprises temperature, an average temperature or a histogram of temperatures and a duration of time that the medicament has been stored in the medicament delivery device at a particular temperature or at a particular average temperature as taught by another embodiment of Albertini for the purpose of tracking the duration, frequency and intensity of the exposure condition in order to understand whether there was degradation of the drug potency and thus if changes need to be made to dosage.
Regarding Claim 14, medicament delivery device of claim 9, wherein the at least one factor comprises temperature and a duration of time that the medicament has been stored in the medicament delivery device ((¶0025-0026 “The drug status indicator is configured to indicate an extent of an exposure of the drug to an environmental condition. The reader is configured to detect the drug status indicator. The drug delivery system can vary in one or more ways. For example, the environmental condition can be at least one of temperature, UV exposure, pH, and humidity.”).
Regarding Claim 15, the modified Albertini discloses the medicament delivery device of claim 9.
The modified Albertini is silent on wherein the adjusting comprises adjusting the calculated basal dosage based on how much an average temperature is above a target temperature.
In another embodiment however, Albertini teaches that the basal dosage of the drug can be adjusted as a result of the anticipated potency change which is a function of the intensity (degrees above target temperature) and duration (time at degrees above target temperature) and can be anticipated and adjusted accordingly (¶00158). This is for the purpose of tracking the duration, frequency and intensity of the exposure condition in order to understand whether there was degradation of the drug potency and thus if changes need to be made to dosage (¶00158).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Albertini to include the adjusting comprises adjusting the calculated basal dosage based on how much a current temperature is above a target temperature as taught by another embodiment of Albertini for the purpose of tracking the duration, frequency and intensity of the exposure condition in order to understand whether there was degradation of the drug potency and thus if changes need to be made to dosage.
Claim(s) 8, 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Albertini in view of Hayter as applied to claims 1 and 9 above in further view of Sjolund et al (US20190184111; hereafter Sjolund).
Regarding Claim 8, the modified Albertini discloses the method of claim 1.
The modified Albertini is silent on wherein the adjusting comprises adjusting the calculated basal dosage based on how much an actual blood glucose level compares with a projected blood glucose level.
Sjolund however teaches a temperature sensor which can be used in unison with blood glucose sensors where an alarm or alert can be issued when the actual glucose level is different than the expected glucose level which can be as a result of environmental factors (¶0096), this can then be used to adjust insulin delivery parameters over time (¶0032). This would be for the purpose of having a closed loop system (¶0092) that accounts for the changes in medication potency (¶0032)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Albertini to include the adjusting comprises adjusting the calculated basal dosage based on how much a current temperature is above a target temperature as taught by another embodiment of Albertini for the purpose of tracking the duration, frequency and intensity of the exposure condition in order to understand whether there was degradation of the drug potency and thus if changes need to be made to dosage.
Regarding Claim 16, the modified Albertini discloses the medicament delivery device of claim 9.
The modified Albertini is silent on wherein the adjusting comprises adjusting the calculated basal dosage based on how much an actual blood glucose level compares with a projected blood glucose level.
Sjolund however teaches a temperature sensor which can be used in unison with blood glucose sensors where an alarm or alert can be issued when the actual glucose level is different than the expected glucose level which can be as a result of environmental factors (¶0096), this can then be used to adjust insulin delivery parameters over time (¶0032). This would be for the purpose of having a closed loop system (¶0092) that accounts for the changes in medication potency (¶0032)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Albertini to include the adjusting comprises adjusting the calculated basal dosage based on how much a current temperature is above a target temperature as taught by another embodiment of Albertini for the purpose of tracking the duration, frequency and intensity of the exposure condition in order to understand whether there was degradation of the drug potency and thus if changes need to be made to dosage.
Regarding Claim 17, Albertini discloses a method performed by a processor (296) in an on-body insulin delivery device (200).
Albertini is silent on calculating a basal dosage for a user based on at least a current blood glucose level.
Hayter however teaches systems, devices and methods regulating medication dose guidance where a basal dose of the medicament is calculated (¶0014) as a result of both real time physiological detection (¶0112 such as blood glucose level) and anticipation for regularly occurring events such as mealtime. This would be for the purpose of making sure that the basal dosage is as correct as possible for good treatment.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Albertini to include the calculating a basal dosage of a medicament to be delivered to a user by a medicament delivery device as taught by Hayter for the purpose of making sure that the basal dosage is as correct as possible for good treatment.
The modified Albertini is silent on calculating how much a potency of the insulin has decreased over a time period.
Sjolund however teaches a temperature sensor which can be used in unison with blood glucose sensors where an alarm or alert can be issued when the actual glucose level is different than the expected glucose level which can be as a result of environmental factors (¶0096), this can then be used to adjust insulin delivery parameters over time (¶0032). This would be for the purpose of having a closed loop system (¶0092) that accounts for the changes in medication potency (¶0032)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Albertini to include the adjusting comprises adjusting the calculated basal dosage based on how much a current temperature is above a target temperature as taught by another embodiment of Albertini for the purpose of tracking the duration, frequency and intensity of the exposure condition in order to understand whether there was degradation of the drug potency and thus if changes need to be made to dosage.
The modified Albertini is silent on increasing the calculated basal dosage of the insulin to offset the calculated decrease in potency of the insulin.
Sjolund however teaches a temperature sensor which can be used in unison with blood glucose sensors where an alarm or alert can be issued when the actual glucose level is different than the expected glucose level which can be as a result of environmental factors (¶0096), this can then be used to adjust insulin delivery parameters over time (¶0032). This would be for the purpose of having a closed loop system (¶0092) that accounts for the changes in medication potency (¶0032)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Albertini to include the adjusting comprises adjusting the calculated basal dosage based on how much a current temperature is above a target temperature as taught by another embodiment of Albertini for the purpose of tracking the duration, frequency and intensity of the exposure condition in order to understand whether there was degradation of the drug potency and thus if changes need to be made to dosage.
Regarding Claim 18, the modified Albertini discloses the method of claim 17.
The modified Albertini is silent on wherein calculating how much the potency of the insulin has decreased over the time period comprises determining a temperature for the insulin and adjusting for the determined temperature if the determined temperature exceeds a threshold.
In another embodiment however, Albertini teaches that the basal dosage of insulin can be adjusted as a result of the anticipated potency change of the insulin which is a function of the intensity (degrees above target temperature) and duration (time at degrees above target temperature) and can be anticipated and adjusted accordingly (¶00158). This is for the purpose of tracking the duration, frequency and intensity of the exposure condition in order to understand whether there was degradation of the drug potency and thus if changes need to be made to dosage (¶00158).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Albertini to include the adjusting comprises adjusting the calculated basal dosage based on how much a current temperature is above a target temperature as taught by another embodiment of Albertini for the purpose of tracking the duration, frequency and intensity of the exposure condition in order to understand whether there was degradation of the drug potency and thus if changes need to be made to dosage.
Regarding Claim 19, the modified Albertini discloses the method of claim 18, further comprising determining a delta of how much the determined temperature exceeds the threshold and a magnitude of the adjustment for the determined temperature is based on a magnitude of the delta.
In another embodiment however, Albertini teaches that the basal dosage of the drug can be adjusted as a result of the anticipated potency change which is a function of the intensity (degrees above target temperature) and duration (time at degrees above target temperature) and can be anticipated and adjusted accordingly (¶00158). Because of the change in dosage being a direct response to the change in the temperature intensity magnitude after threshold passing, this sensed magnitude of temperature above the threshold can be called the delta and the adjustment by the processor in reaction to this magnitude would be the adjustment based on the magnitude of the delta. This is for the purpose of tracking the duration, frequency and intensity of the exposure condition in order to understand whether there was degradation of the drug potency and thus if changes need to be made to dosage (¶00158).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Albertini to include the adjusting comprises adjusting the calculated basal dosage based on how much a current temperature is above a target temperature as taught by another embodiment of Albertini for the purpose of tracking the duration, frequency and intensity of the exposure condition in order to understand whether there was degradation of the drug potency and thus if changes need to be made to dosage.
Regarding Claim 20, the modified Albertini discloses the method of claim 17, wherein calculating how much the potency of the insulin has decreased over the time period comprises determining a delta between a projected blood glucose level for the user and an actual blood glucose level for the user and determining how much the potency of the insulin has decreased based on a magnitude of the determined delta.
Sjolund however teaches a temperature sensor which can be used in unison with blood glucose sensors where an alarm or alert can be issued when the actual glucose level is different than the expected glucose level which can be as a result of environmental factors (¶0096), this difference of magnitude can then be used to adjust insulin delivery parameters over time (¶0032). This would be for the purpose of having a closed loop system (¶0092) that accounts for the changes in medication potency (¶0032)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Albertini to include the adjusting comprises adjusting the calculated basal dosage based on how much a current temperature is above a target temperature as taught by another embodiment of Albertini for the purpose of tracking the duration, frequency and intensity of the exposure condition in order to understand whether there was degradation of the drug potency and thus if changes need to be made to dosage.
Conclusion
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/A.C.M./Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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