DETAILED ACTION
This action is in response to the claim set filed on 06/27/2025.
Claims 1-13 are currently pending and have been examined.
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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not
patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg,
140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d
2010 (Fed. Cir. 1993); In re Langi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van
Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
(CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR l.32I(c) or l.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717. 02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP
§ § 706.02(1)(1) - 706.02(1)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR l.32l(b).
The USPTO Internet website contains terminal disclaimer forms which may be used.
Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or
PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal
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Claim 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of App. 16/955,191 (Pat. 11901060). Although the claims at issue are not identical, they are not patentably distinct from each other because both are directed toward addressing a similar scope. The table/chart below exhibits the similarity* between the independent claims while claim 1 of the current application ‘264 are broader variation of the claims of the reference Applications ‘191.
* Similarities highlighted in BOLD
App No. 19252264 (current app.) – Claim 1
App. No. 16955191 (Pat. 11901060) (ref app) –Claim 1
a medication delivery device configured to deliver a medication dose to the patient;
A system to control glucose in a patient, the system comprising:
a medication delivery device configured to deliver a medication dose to the patient
a medication delivery device configured to deliver insulin to the patient
a user device comprising a controller, the controller comprising a processor communicatively coupled to the medication delivery device, wherein the controller is configured to:
a controller in communication with the medication delivery device and including control logic operative to:
execute a control algorithm to determine a first medication dose, the control algorithm including a first set of tunable parameters
execute a model predictive controller algorithm to determine a first medication dose of a first type of insulin having a first pharmacokinetic profile, the model predictive controller algorithm includes a plurality of model parameters having a first set of values that are predetermined and associated with the first type of insulin
determine a change in at least one of a glycemic pattern and a type of medication;
determine a change from the first type of insulin to a second type of insulin having a second pharmacokinetic profile,
in response to the determined change in the at least one of the glycemic pattern and the type of medication
in response to determining a change in a glycemic pattern or detecting a user notification,
identify a second set of tunable parameters
execute the control algorithm using the second set of tunable parameters to determine a second medication dose,
execute the model predictive controller algorithm including the plurality of model parameters having a second set of values that are predetermined and associated with the second type of insulin
in response to the determined change to the second type of insulin, to determine a second medication dose of the second type of insulin, wherein the first pharmacokinetic profile is different than the second pharmacokinetic profile
wherein the medication delivery device is controlled by the controller to deliver the medication dose to the patient according to the determined first medication dose and the determined second medication dose
wherein the medication delivery device is controlled by the controller to deliver insulin to the patient, according to the determined first medication dose and the determined second medication dose
As per the above chart, it shows the similarities between the current application ‘264 and reference Applications ‘191 mentioned above, in bold, with independent claims of the reference as such the current application exhibits a broader and more generic than the reference(s) as such the current application is the genus and the patent is the species. Thus, this is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claim 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1-13 are drawn to system/device, which are within the four statutory categories (i.e. a machine and a process). Claims 1-13 are further directed to an abstract idea on the grounds set out in detail below.
Under Step 2A, Prong 1, the steps of the claim for the invention represents an abstract idea of a series of steps that recite a process controlling medication dosage delivery. This abstract idea could have been performed by a human actor to implement the abstract idea for steps citing a process directed to collecting a user health data such as glycemic, using the data to determine changes, and determine new dose of medication which is/are an abstract idea that could have been performed by a human mind but for the fact that the claims recite a general-purpose computer processor to implement the abstract idea for which both the instant claims and the abstract idea are defined as Mental Process.
Independent Claim 1 recites the steps of: “a medication delivery device configured to deliver a medication dose to the patient;
a user device comprising a controller, the controller comprising a processor communicatively coupled to the medication delivery device, wherein the controller is configured to:
execute a control algorithm to determine a first medication dose, the control algorithm including a first set of tunable parameters;
determine a change in at least one of a glycemic pattern and a type of medication;
in response to the determined change in the at least one of the glycemic pattern and the type of medication, identify a second set of tunable parameters;
execute the control algorithm using the second set of tunable parameters to determine a second medication dose,
wherein the medication delivery device is controlled by the controller to deliver the medication dose to the patient according to the determined first medication dose and the determined second medication dose.”
The limitations, as drafted, given the broadest reasonable interpretation, cover performance of the limitations by a human mind with aid of pen and paper along with Mathematical concepts, thus, an abstract idea, but for the recitation of generic computer components. The claimed concept encompasses to performance of the limitations of a mental process for determining initial dosage of medication for a patient, determine a change in glycemic pattern and type of medication to determine a new dose to be delivered to the patient which are steps reciting mental process that could have been performed by a human mind along with mathematical concepts (e.g., executing algorithm) but for the fact that the claim(s) recites a general-purpose controller/processor and hardware to implement the abstract idea for performing the steps of observing, evaluating, judgment and opinion which is/are citing a process for which can be performed using a human mind with the aid of pencil and paper, see MPEP § 2106.04(a)(2)(III). Accordingly, the claim limitations (in BOLD) recite an abstract idea. Any limitations not identified above as part of the Mental Process are deemed "additional elements," and will be discussed in further detail below.
Under Step 2A, Prong 2, this judicial exception is not integrated into a practical application because the remaining elements amount to no more than a component programmed to perform the abstract ideas and linking the abstract idea to a particular technological environment. In particular, the claims recite the additional elements such as “medication delivery device, user device, controller/processor” that is/are disclosed at a high - level of generality and is described in the specification in an arbitrary form without disclosing any description how that implements the identified abstract idea. This recitation of additional element(s), is merely implemented as a tool such that it amounts no more than adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea, see MPEP 2106.05(f), (e.g. “execute...”), generally linking the use of the judicial exception to a particular technological environment or field of use, see MPEP 2106.05(h) (e.g. medication delivery device “controlled to deliver,…”, “to deliver medication…”), and mere data gathering process that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.05(g). As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 "merely include[ing] instructions to implement an abstract idea on a computer" is an example of when an abstract idea has not been integrated into a practical application. Accordingly, looking at the claim as a whole, individually and in combination, 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 claim is directed to an abstract idea.
Under step 2B, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they do not present improvements to another technology or technical field and the additional elements amount to no more than a generic computer components, recited at a high level of generality, that amounts to no more than adding the words "apply it" (or an equivalent) to apply the exception using generic computer component, see MPEP 2106.05(f), and generally linking the use of the judicial exception to a particular technological environment or field of use, see MPEP 2106.05(h). Their collective functions merely provide conventional computer implementation and mere instructions to apply an exception using a generic computer component to the abstract idea cannot provide an inventive concept, see Alice, 573 U.S. at 223 ("mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention"). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea
Dependent Claims 2-13 include all of the limitations of claim(s) 1, and therefore likewise incorporate the above-described abstract idea. While the depending claims add additional limitations, such as
As for claim 2-5, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind using pen and paper, but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
As for claims 6-13, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. The claims recite additional elements “glucose measurement device, medication delivery device, medication reservoir, glucose monitor, controller, user interface, user device, mobile phone, touch screen” that implement the identified abstract idea. These hardware components are recited at a high level of generality such that it amounts no more than mere instructions to apply the exception using generic computer components and hardware. The claims recite the steps “transmit a user interface for display…”, which are a nominal or tangential addition to the abstract idea and does not affect the generation of the data object and as such amounts to insignificant extra-solution activity. Moreover, these additional elements effectively amount to no more than the words "apply it" with a computer because it appears to intend to do so, which would still amount to mere instructions to apply the exception using generic computer components and linking the use of the judicial exception to a particular technological environment or field of use. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 6-7, 11-13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Morales (US 2016/0038673 A1)
Regarding Claim 1, Morales teaches a system to control glucose in a patient, the system comprising:
a medication delivery device configured to deliver a medication dose to the patient Morales discloses drug delivery device 102 is an insulin infusion device (Morales: [Fig. 1], [0096]),
a user device comprising a controller, the controller comprising a processor communicatively coupled to the medication delivery device Morales discloses a controller device 104 such as a mobile phone communicating with the drug delivery device (Morales: [Fig. 1], [0096-0097]), wherein the controller is configured to:
execute a control algorithm to determine a first medication dose, the control algorithm including a first set of tunable parameters Morales discloses closed-loop control algorithms in the form of a model predictive controller (MPC) that automatically regulates the rate of insulin delivery based on the glucose level of the patient and control signal to deliver desired quantity of insulin into the patient while tuning parameters to tune the controller (Morales: [Fig. 2, 8], [0055], [0057], [0101-0103], [0137]):;
determine a change in at least one of a glycemic pattern and a type of medication Morales discloses receiving desired glucose concentration or range of glucose concentration and where mismatch and/or change my be identified, taking difference between measures concentration and MPC predication and provided to an estimator to determine parameters to include insulin type used for adjusting the parameters (Morales: [Fig. 2, 3, 8], [0055], [0059], [0102-0103], [0119-0120]);
in response to the determined change in the at least one of the glycemic pattern and the type of medication, identify a second set of tunable parameters Morales discloses updating and refining the parameters of the control algorithm to determining different/second parameters sets such that (Morales: [0056], [0060], [0119]);
execute the control algorithm using the second set of tunable parameters to determine a second medication dose, Morales discloses the controller updating the parameters based on sensor reading and determine amount of insulin to be delivered based on new insulin dose (Morales: [Fig. 2], [0058-0059], [0119], [0137]),
wherein the medication delivery device is controlled by the controller to deliver the medication dose to the patient according to the determined first medication dose and the determined second medication dose Morales disclose the drug delivery device 102 is configured to transmit and receive data to and from remote controller 104 by, for example, radio frequency communication ... is an insulin infusion device and remote controller 104 is a hand-held portable controller (Morales: [[0097-0098], [0138]).
Regarding Claim 2, Morales teaches the system of claim 1, wherein the control algorithm is one of a model predictive controller algorithm, a proportional-integral-derivative (PID) control algorithm, or a fuzzy logic control algorithm Morales discloses the closed-loop controller can be PID controller (Morales: [0006], [0152]).
Regarding Claim 3, Morales teaches the system of claim 1, wherein the control algorithm is a proportional-integral-derivative (PID) control algorithm, and wherein the tunable parameters comprise at least one of: a rate of change of glucose, a difference between a measured glucose level and a target glucose level, or insulin-on-board Morales discloses adjustable parameters of the controller to include determining parameters of glucose infusion rate (GIF) (Morales: [0056], [0060]).
Regarding Claim 6, Morales teaches the system claim 1, further comprising a glucose measurement device communicatively coupled to the controller and configured to measure glucose data associated with the patient Morales discloses measuring glucose level in the subject from the glucose sensor The controller is configured to include an MPC controller that has been programmed to receive continuous glucose readings from a CGM sensor (Morales: [Fig. 2] [0094], [0103]).
Regarding Claim 7, Morales teaches the system claim 6, wherein the glucose measurement device is configured as a continuous glucose monitor Morales discloses measuring glucose level in the subject from the glucose sensor The controller is configured to include an MPC controller that has been programmed to receive continuous glucose readings from a CGM sensor (Morales: [Fig. 2] [0094], [0099], [0103]).
Regarding Claim 11, Morales teaches the system of claim 1, further comprising a user interface communicatively coupled to the controller and configured to receive input from the patient (Morales: [Fig. 1, 3], [0055], [0139]).
Regarding Claim 12, Morales teaches the system of claim 1, wherein the user device is configured as a mobile phone or a tablet with a touch screen for providing input from the patient (Morales: [Fig. 1, 3], [0097]).
Regarding Claim 13, Morales teaches the system of claim 12, wherein the processor is configured to transmit a user interface for display on the touch screen (Morales: [Fig. 1, 3], [0097]).
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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) 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Morales (US 2016/0038673 A1) in view of Monirabbasi et al. (US 2016/0162662 Al- “Monirabbasi”)
Regarding Claim 4, Morales teaches the system of claim 3, wherein the tunable parameters comprise the insulin-on-board as the proportional in PID, the difference between a measured glucose level and a target glucose level as the integral in the PID, and the rate of change of glucose as the derivative in the PID
However, Morales does not expressly discloses using insulin-on-board as parameters of algorithm.
Monirabbasi discloses the parameters calculated by the PID control algorithm include the amount of insulin on board (IOB), and a glucose target (Monirabbasi: [0374], [0376]).
Morales discloses a closed-loop controller algorithm to include proportional-integral-derivative (PID) for a dynamic insulin delivery adjusting parameters. Monirabbasi discloses insulin infusion device operating in a closed-loop mode and adjustment therapy comprising proportional-integral-derivative (PID) and insulin on board (IOB) adjustment module. Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have Morales incorporate insulin on board (IOB) parameters in the proportional-integral-derivative (PID), as taught by Monirabbasi which may help avoid over or under delivery of insulin by the controller (Monirabbasi: [0398]).
Regarding Claim 5, Morales teaches the system of claim 1, wherein one of the tunable parameters comprises insulin-on-board, and wherein the second set of tunable parameters includes an insulin-on-board that differs from the insulin-on-board included in the first set of tunable parameters
However, Morales does not expressly disclose adjustment of the insulin-on-board parameters.
Monirabbasi discloses the PID control calculates the current insulin dose as infusion rate and adjustment or compensation of insulin on board (IOB) module in an ongoing manner over time intervales and adjust the delivery to compensate the final infusion rate (: [0397-0398]).
Morales discloses a closed-loop controller algorithm to include proportional-integral-derivative (PID) for a dynamic insulin delivery adjusting parameters. Monirabbasi discloses insulin infusion device operating in a closed-loop mode and adjustment therapy comprising proportional-integral-derivative (PID) and insulin on board (IOB) adjustment module. Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have Morales incorporate the insulin on board (IOB) parameters and adjustment, as taught by Monirabbasi which may help avoid over or under delivery of insulin by the controller (Monirabbasi: [0398]).
Claim(s) 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Morales (US 2016/0038673 A1) in view of Amirouche et al. (US 20180103897 Al- “Amirouche”)
Regarding Claim 8, Morales teaches the system of claim 1, wherein the medication delivery device comprises a first medication reservoir and a second medication reservoir, wherein at least the first medication reservoir contains a first type of insulin
Morales discloses delivery device but does not expressly disclose medication reservoirs.
Amirouche discloses a first reservoir having a first medicament and a second reservoir having a second medicament where the first medicament may contain a first type of insulin (e.g., fast-acting or slow-acting insulin) (Amirouche [0013]).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have Morales delivery device incorporate the delivery device with different medication reservoirs, as taught by Amirouche which may help alternately or simultaneously the delivery of mediations (Amirouche: [0009]).
Regarding Claim 9, the combination of Morales and Amirouche teaches the system of claim 8, wherein the second medication reservoir contains one or more of a second type of insulin, glucagon, a GLP-1, pramlintide, amylin, or an amylin analogue Amirouche discloses a second reservoir having a second medicament where the second medicament may contain a second type of insulin (e.g., fast-acting or slow-acting insulin) where in the case of fast-acting insulin (Amirouche: [007-0008] [0013]).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 8, and incorporated herein.
Regarding Claim 10, the combination of Morales and Amirouche teaches the system of claim 8, wherein the second medication reservoir contains a second type of insulin, wherein the first type of insulin and the second type of insulin have different pharmacokinetic profiles Amirouche discloses first reservoir may be different from the medicament in the second reservoir (Amirouche [0017]).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 8, and incorporated herein.
Prior Art Cited but not Applied
The following document(s) were found relevant to the disclosure but not applied:
US 2014/0163517- “Finan” discloses a controller is programmed receives signals from glucose sensor and a pump and configured to issue signals to the pump to deliver an amount of insulin determined by a feedback controller that utilizes a model predictive control of the subject and deliver insulin using a tuning factor based on either one of an omission index module or a calibration index module.
US 2017/0049383- “McMahon” discloses obtaining input data for a user of a diabetes management device and identifies a tracked glycemic response event.
US 2013/0338629- “Agrawal” discloses a device receives sensor data for a user of an insulin infusion device indicates blood glucose levels of the user for a specified period of time, and over a plurality of days and to detect an event occurrence indicative of a correctable basal rate setting of the insulin infusion device.
The references are relevant since it discloses using collected diabetic patient data to determine devices deliver parameters.
Conclusion
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/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687
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