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 .
Priority
This application filed 01/20/2023 claims priority from Provisional Application 63302274, filed 01/24/2022. The claims are therefore examined as filed on 01/24/2022, the effective filing date. In future actions, the effective filing date of one or more claims may change, due to amendments to the claims, or further review of the priority application(s).
Claim Status
Claims 1-20 are pending.
Claims 2-3 are objected to.
Claims 1-20 are examined.
Claims 1-20 are rejected.
Information Disclosure Statement
The Information Disclosure Statements are in compliance with the provisions of 37 CFR 1.97. Accordingly, all references have been considered.
Claim Objections
Claims 2 and 3 are objected to because of the following informalities:
The steps of claim 2 should read “identifying…”, “determining…”, multiplying...” and “summing…” to grammatically match the claim preamble.
The steps of claim 3 should similarly read “setting…”, “increasing…” and increasing…” to grammatically match the claim preamble.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8 and 15-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 15 recite a computer apparatus and a non-transitory computer readable storage medium with instructions executed by a processor, respectively. For both of these claims, the final limitation recites that the apparatus and processor “cause the determined dosage of insulin to be delivered to the user in response to an output of the automatic insulin delivery algorithm.” However, there is not sufficient written description for how either the computer apparatus or processor are causing insulin to be administered, as neither of these by themselves are able to administer insulin without additional components.
The specification, however, describes a wearable device and/or insulin pump in communication with the apparatus or processor for administering insulin [0094-99]. It is therefore recommended that this be included in the claims, so that the claims read, for example: “a processor coupled to an insulin delivery system”, that causes “the determined dosage of insulin to be delivered to the user via the insulin delivery system in response to an output of the automatic insulin delivery algorithm.” This would clarify that it is a device other than the general computer components that is performing the delivery, and satisfy the above requirement.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-3, 10, 14, and 16-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2-3, 10, 14, and 16-17 are unclear with respect to the phrase “a relative travel distance of the received input in the graphical user interface” in claims 2, 10, and 16 and similarly the phrase “distance of the user input” in claims 3, 14, and 17. It is unclear what relative travel distance/distance of the user input means in these claims, as more context is required. The specification indicates that there may be a slider bar on the graphical user interface for user input, which provides some possible context for the travel distance (the specification also indicates a range of distance may be measured in pixels in [034], so travel distance in the claims may refer to the distance in pixels along a slider), but this is not clear in the claims, which do not mention a slider or pixels. Therefore these claims are indefinite due to lack of clarity.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim Rejection
Claims 1, 4-5, 7-9, 11-12, 15, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over BARTEE 2021 “TDD Tracking Approaches For Insulin Delivery Systems, Methods, And Devices” (WO 2021236351 A1) in view of SJOLUND 2021 “Insulin Injection Assistance Systems, Methods, And Devices” (US 20210386936 A1).
Claim Interpretation and Scope and Contents of Prior Art
Claims 1, 9, and 15 recite a computer apparatus, method, and computer readable medium, respectively, with the steps of presenting a user input device on a graphical user interface that offers an input device that enables input of a subjective insulin need parameter, and receiving the input of the subjective insulin need parameter via the input device.
With respect to these limitations, BARTEE teaches systems and methods for automatic insulin delivery, comprising computer readable storage media, processors, and graphical user interfaces for receiving input user data [035-39], which can include insulin need data [0059].
BARTEE does not teach that the insulin need is subjective, however SJOLUND similarly teaches methods and systems for the manual dosing of insulin, with a graphical user interface that enables input of user-specific dosage parameters (Abstract, 027, 33, 201-204).
Claims 1, 9, and 15 also recite the limitations of modifying a subjective coefficient value in response to receiving the input of the subjective insulin need parameter; and setting one or more of a number of specific factors useable by an automatic insulin delivery algorithm based on the subjective coefficient value.
With respect to these limitations, BARTEE teaches that the user data can be used to modify values and determine drug delivery control parameters in a control algorithm for insulin delivery [035-39], and determine total daily dose which can be used to set a coefficient for deviation of the control insulin trajectory to account for insulin sensitivity [081-82]. SJOLUND similarly teaches adjusting the insulin therapy based on one or more algorithms, where the user input value can change factors/update parameters to determine dose [027, 33, 63-64, 68, 179].
Claims 1, 9, and 15 also recite the limitations of collecting physiological condition data related to a user; using the one or more of the number of specific factors set based on the subjective coefficient value, determining a dosage of insulin to be delivered to the user based on the collected physiological condition data of the user; and causing the determined dosage of insulin to be delivered to the user in response to an output of the automatic insulin delivery algorithm.
With respect to this limitation, BARTEE teaches that the system can include a sensor for collecting physiological user data, and using this with subjective user input data to determine a dosage of insulin to be delivered in response to the control algorithm [034-39].
Claims 4, 11 and 18 recite the limitation wherein the specific factor includes open loop basal, input basal, glucose target, duration of insulin action, and maximum automated insulin delivery limit. With respect to this limitation, BARTEE teaches that factors determined by insulin need can include open loop basal, input basal, glucose target, duration of the insulin action, and maximum insulin limit [039, 51, 59-60, 73-74].
Claims 5, 12, and 19 recite the limitation of updating the at least one subjective coefficient after a period of time. With respect to this limitation, BARTEE teaches updating the user data over time [0059-60].
Claim 7 recites the limitation wherein the user interface is a touchscreen display controllable by the processor and operable to present the graphical user interface, and the touchscreen display is operable to: in response to the received input, generate a signal indicative of the subjective insulin need parameter. With respect to this limitation, BARTEE teaches that the user interface can be a touchscreen display controlled by the processor with which the user can interact and provide information to the system [0035, 38].
Claim 8 recites the limitation wherein the computing apparatus further comprises: a communication device coupled to the processor, wherein the communication device is operable to transmit and receive communication signals from a wearable drug delivery device and an analyte sensor. With respect to this limitation, BARTEE teaches that the system comprises a communication device coupled to the processor that can transmit and receive communication signals from a wearable drug delivery device and analyte sensor for continuous glucose monitoring [0034-39].
Resolving Ordinary Skill in the Art and Obviousness Rationale
A teaching, suggestion, or motivation in the prior art would have led one of ordinary skill in the art to modify or combine the prior art to arrive at the claimed invention. Specifically, a person of ordinary skill in insulin delivery systems would have been motivated to combine the teachings of BARTEE with the teachings of SJOLUND, in order to achieve the claimed invention, because user-specific dosage parameters input by the user for insulin management can be used in determining an appropriate dosage of insulin for the user, and ease the burden of treatment [027-28]. A person of ordinary skill would reasonably expect success from combining these teachings, as both BARTEE and SJOLUND teach methods of determining appropriate personalized insulin dose for a user, and the subjective input of SJOLUND can be applied in the calculations of BARTEE for automatic insulin administration. Therefore, the claims at issue would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention as there is both a reason to modify or combine the prior art, and a reasonable expectation of success (see MPEP 2143.02 (I)).
Claim Rejection
Claims 6, 13 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over BARTEE and SJOLUND as applied to claims 1, 4-5, 7-9, 11-12, 15, and 18-19 above, and further in view of BARASCH 2020 “Automation and interoperability of a nurse-managed insulin infusion protocol as a model to improve safety and efficiency in the delivery of high-alert medications.”
Claim Interpretation and Scope and Contents of Prior Art
BARTEE in view of SJOLUND teaches the limitations of above claims 1, 4-5, 7-9, 11-12, 15, and 18-19 above.
Claims 6, 13 and 20 recite the limitations of determining a form of an equation and/or an algorithm to use to calculate the subjective coefficient based on the subjective insulin need parameter; selecting the form of the equation or the algorithm from a look up table; and calculating the subjective coefficient using the form of the equation or the algorithm selected from the look up table.
With respect to these limitations, BARTEE teaches determining an algorithm to calculate the system’s parameters [038-39] but does not teach selecting the form of the equation or the algorithm from a look up table or calculating the subjective coefficient using the form of the equation or the algorithm selected from the look up table.
However, BARASCH teaches using lookup tables to calculate parameters and determine an appropriate action for insulin management (pg 8, Fig 2).
Resolving Ordinary Skill in the Art and Obviousness Rationale
A teaching, suggestion, or motivation in the prior art would have led one of ordinary skill in the art to modify or combine the prior art to arrive at the claimed invention. Specifically, a person of ordinary skill in insulin-related calculations would have been motivated to combine the teachings of BARTEE in view of SJOLUND with the teachings of BARASCH, in order to achieve the claimed invention, because lookup tables allow for quick calculation of parameters in insulin/glucose concentrations, can be used as part of an intelligent support tool for diabetes management (Fig 2, pg 8). A person of ordinary skill would reasonably expect success from combining these teachings, as BARTEE in view of SJOLUND and BARASCH teach insulin-related calculations based on user data, and because it would be obvious to one of ordinary skill that lookup tables could also be used in determining a subjective coefficient or other parameter. Therefore, the claims at issue would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention as there is both a reason to modify or combine the prior art, and a reasonable expectation of success (see MPEP 2143.02 (I)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY C LEVERETT whose telephone number is (571)272-5494. The examiner can normally be reached 8:00am - 5:00pm M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karlheinz R. Skowronek can be reached at (571) 272-9047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY C LEVERETT/Examiner, Art Unit 1687
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