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 Objections
Claim 11 is objected to because of the following informalities:
in lines 2-3 of claim 11, “a first CGM sensor” should read as “a first continuous glucose monitor (CGM) sensor”. Please spell out the terminology in the first appearance.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-20 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.
Claim 1 recites the limitation "a first CGM sensor" in line 8. It is unclear if it is referring to the limitation ”one or more continuous glucose sensor” or it is referring to limitation. For the purpose of examination, the examiner will interpret the limitation such as “a first CGM sensor of the one or more continuous glucose sensor”.
Claim 1 recites the limitation "a second CGM sensor" in line 10. It is unclear if it is referring to the limitation ”one or more continuous glucose sensor” or it is referring to limitation. For the purpose of examination, the examiner will interpret the limitation such as “a second CGM sensor of the one or more continuous glucose sensor”.
Claim 11 recites the limitation “providing a notification to the user to insert a second CGM sensor a predetermined amount of time prior to expiration of the first CGM sensor…” in lines 5-7. It is unclear wherein the sensor is inserted and a predetermined time is the time of the notification or the time that the second sensor is inserted prior to the expiration occur. For the purpose of examination, the examiner will interpret the limitation such as “upon determining that the first CGM sensor will be expiring, is provided to the user a predetermined amount of time prior to expiration of the first CGM sensor to inset a second CGM sensor in a target tissue of the user”. Also, the applicant is advised to relate how the notification is provided and how the determining step is occur such as “an insulin delivery device comprises a display and a processor and upon determining that the first CGM sensor will be expiring by the processor, the display provides a notification a predetermined amount of time prior to expiration of the first CGM sensor to the user to insert a second CGM sensor in a target tissue of the user”.
Claim 13 recites the limitation “ receiving a communication from the first CGM sensor” in lines 1-2. It is unclear which element is receiving the communication. For the purpose of examination, the examiner will interpret such as “a processor receives
Claim 14 recites the limitation “The ambulatory infusion pump system of claim 11” in line 1. It is unclear if the claim should be depended on claim 1 or claim which does not has any pump. For the purpose of examination, the examiner will interpret such as “the method of claim 11”.
Claim 15 recites the limitation “The ambulatory infusion pump system of claim 11” in line 1. It is unclear if the claim should be depended on claim 1 or claim 11 which does not has any pump. For the purpose of examination, the examiner will interpret such as “the method of claim 11”.
Claim 19 recites the limitation “ automatically transitioning from using data” in lines 1-2. It is unclear which element is automatically transitioning. For the purpose of examination, the examiner will interpret such as “a processor automatically transitioning…”.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 11-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harper et al. (US. 20210077033A1) (“Harper”).
Re claim 11, Harper discloses a method of diabetes therapy (abstract, Fig. 1-26, ¶0005), comprising: delivering insulin to a user based on glucose levels of a user received from a first CGM sensor (¶0251, ¶0277); determining that an ongoing active use state of the first CGM sensor will be expiring (¶0251); and providing a notification to the user to insert a second CGM sensor a predetermined amount of time prior to expiration of the first CGM sensor upon determining that the first CGM sensor will be expiring (¶0251, ¶0301).
Re claim 12, Harper discloses wherein determining that the first CGM sensor will be expiring is based on characteristics of a type of CGM sensor of the first CGM sensor (Harper, ¶0193).
Re claim 13, Harper discloses further comprising receiving a communication from the first CGM sensor that it will be expiring and wherein determining that the first CGM sensor will be expiring is based on the communication (¶0193, ¶0251).
Re claim 14, Harper discloses wherein the predetermined amount of time is a predetermined amount stored in a memory (the device has a memory ¶0076 which can be used the data for software include the time for such notification see ¶0251).
Re claim 15, Harper discloses further comprising determining the predetermined amount of time based on one or more characteristics of a type of CGM sensor of the first CGM sensor (¶0193, code on the sensor).
Re claim 16, Harper discloses wherein the one or more characteristics includes a warmup up period of time required upon insertion of the type of CGM sensor required before data provided by the type of CGM sensor can be used for determining therapy parameters (upon replacing the sensor, the time needs for calibration can be used for determining the time for therapy, ¶0110, ¶0251).
Re claim 17, Harper discloses wherein the predetermined amount of time is sufficient to enable the warmup of period of time to be completed prior to expiration of the first CGM sensor (calibration was done before the life expiration, ¶0110, ¶0251).
Re claim 18, Harper discloses further comprising monitoring a warmup up period of time required upon insertion of the second CGM sensor required before data provided by the type of CGM sensor can be used for determining therapy parameters (upon replacing the sensor, the time needs for calibration can be used for determining the time for therapy, ¶0110, ¶0251).
Re claim 19, Harper discloses further comprising automatically transitioning from using data from the first CGM sensor to using data from the second CGM sensor for calculating therapy parameters upon expiration of the warmup period (as the new sensor is inserted, the processor will detect the sensor and communicate with the new sensor and used the data, ¶0251) for calculating therapy parameters upon expiration of the warmup period (¶0085, ¶0106, so that the calibration period of the second sensor will be in the processor ¶0110).
Re claim 20, Harper discloses further comprising providing a notification to the user to remove the first CGM sensor from the user's body following transitioning to the second CGM sensor (as the new sensor is inserted, the processor will detect the sensor and communicate with the new sensor and used the data, ¶0251).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zade et al. (US. 20210128831A1) (“Zade”) in view of Harper et al. (US. 20210077033A1) (“Harper”).
Re claim 1, Zade discloses an ambulatory infusion pump system (Figs. 1-4, abstract, ¶0028), comprising: a pump mechanism configured to deliver insulin to a user (102 Fig. 1-2, ¶0028); a communications interface (125, 122) configured to receive data indicative of glucose levels of a user from one or more continuous glucose monitoring sensors (¶0045 like 108 sensor ¶0034); and at least one processor (¶0029), but it fails to disclose that the at least one processor is configured to receive the data indicative of glucose levels of the user and to determine therapy parameters for the user based on the glucose levels, the at least one processor configured to: determine that an ongoing active use state of a first CGM sensor will be expiring; and provide a notification to the user to insert a second CGM sensor a predetermined amount of time prior to expiration of the first CGM sensor upon determining that the first CGM sensor will be expiring.
However, Harper discloses an infusion pump system (Figs. 1-6 abstract, ¶0227) comprising a pump (¶0277), a communications interface (102, ¶0049) configured to receive data indicative of glucose levels of a user from one or more continuous glucose monitoring sensors (101, ¶0251); and at least one processor (104, 105, ¶0105), is configured to receive the data indicative of glucose levels of the user and to determine therapy parameters for the user based on the glucose levels (age of the sensor, ¶0251), the at least one processor configured to: determine that an ongoing active use state of a first CGM sensor will be expiring (¶0251); and provide a notification to the user to insert a second CGM sensor a predetermined amount of time prior to expiration of the first CGM sensor upon determining that the first CGM sensor will be expiring (¶0251, ¶0301).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify at least one processor of Zade so that the at least one processor is configured to receive the data indicative of glucose levels of the user and to determine therapy parameters for the user based on the glucose levels, the at least one processor configured to: determine that an ongoing active use state of a first CGM sensor will be expiring; and provide a notification to the user to insert a second CGM sensor a predetermined amount of time prior to expiration of the first CGM sensor upon determining that the first CGM sensor will be expiring as taught by Harper for the purpose of replace the sensor before expired to avoid an hassle of glucose measuring (Harper, ¶0251).
Re claim 2, the modified Zade discloses wherein the at least one processor is configured to determine that the first CGM sensor will be expiring based on characteristics of a type of CGM sensor of the first CGM sensor (Harper, ¶0193).
Re claim 3, the modified Zade discloses wherein the at least one processor is configured to determine that the first CGM sensor will be expiring based on a communication received from the first CGM sensor (Harper, ¶0193).
Re claim 4, Zade discloses a memory (2015, Fig. 3), but it fails to disclose wherein the predetermined amount of time is a predetermined amount stored in a memory.
However, Harper discloses an infusion pump system (Figs. 1-6 abstract, ¶0227) comprising a pump (¶0277), a communications interface (102, ¶0049) configured to receive data indicative of glucose levels of a user from one or more continuous glucose monitoring sensors (101, ¶0251) and wherein the predetermined amount of time is a predetermined amount stored in a memory (¶0076, ¶0251).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify at least one processor of Zade so that the predetermined amount of time is a predetermined amount stored in a memory as taught by Harper for the purpose of replace the sensor before expired to avoid an hassle of glucose measuring (Harper, ¶0251).
Re claim 5, the modified Zade discloses wherein the predetermined amount of time is based on one or more characteristics of a type of CGM sensor of the first CGM sensor (Harper, ¶0193, ¶0252).
Re claim 6, Zade fails to disclose wherein the one or more characteristics includes a warmup up period of time required upon insertion of the type of CGM sensor required before data provided by the type of CGM sensor can be used for determining therapy parameters.
However, Harper discloses an infusion pump system (Figs. 1-6 abstract, ¶0227) comprising a pump (¶0277), a communications interface (102, ¶0049) configured to receive data indicative of glucose levels of a user from one or more continuous glucose monitoring sensors (101, ¶0251) and the one or more characteristics includes a warmup up period of time required upon insertion of the type of CGM sensor required before data provided by the type of CGM sensor can be used for determining therapy parameters (the time needs for calibration can be used for determining the time for therapy, ¶0110, ¶0251).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify at least one processor of Zade so that the predetermined amount of time is a predetermined amount stored in a memory as taught by Harper for the purpose of replace the sensor before expired to avoid an hassle of glucose measuring (Harper, ¶0251).
Re claim 7, Zade fails to disclose wherein the predetermined amount of time is sufficient to enable the warmup of period of time to be completed prior to expiration of the first CGM sensor.
However, Harper discloses an infusion pump system (Figs. 1-6 abstract, ¶0227) comprising a pump (¶0277), a communications interface (102, ¶0049) configured to receive data indicative of glucose levels of a user from one or more continuous glucose monitoring sensors (101, ¶0251) and wherein the predetermined amount of time is sufficient to enable the warmup of period of time to be completed prior to expiration of the first CGM sensor (calibration was done before the life expiration, ¶0110, ¶0251).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify at least one processor of Zade so that the predetermined amount of time is sufficient to enable the warmup of period of time to be completed prior to expiration of the first CGM sensor as taught by Harper for the purpose of replace the sensor before expired to avoid an hassle of glucose measuring (Harper, ¶0251).
Re claim 8, Zade fails to disclose wherein the at least one processor is further configured to monitor a warmup up period of time required upon insertion of the second CGM sensor required before data provided by the type of CGM sensor can be used for determining therapy parameters.
However, Harper discloses an infusion pump system (Figs. 1-6 abstract, ¶0227) comprising a pump (¶0277), a communications interface (102, ¶0049) configured to receive data indicative of glucose levels of a user from one or more continuous glucose monitoring sensors (101, ¶0251) and the at least one processor (104, 105) is further configured to monitor a warmup up period of time required upon insertion of the second CGM sensor required before data provided by the type of CGM sensor can be used for determining therapy parameters (upon replacing the sensor, the time needs for calibration can be used for determining the time for therapy, ¶0110, ¶0251).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify at least one processor of Zade so that at least one processor is further configured to monitor a warmup up period of time required upon insertion of the second CGM sensor required before data provided by the type of CGM sensor can be used for determining therapy parameters as taught by Harper for the purpose of replace the sensor before expired to avoid an hassle of glucose measuring (Harper, ¶0251).
Re claim 9, Zade fails to disclose wherein the at least one processor is configured to automatically transition from using data from the first CGM sensor to using data from the second CGM sensor for calculating therapy parameters upon expiration of the warmup period.
However, Harper discloses an infusion pump system (Figs. 1-6 abstract, ¶0227) comprising a pump (¶0277), a communications interface (102, ¶0049) configured to receive data indicative of glucose levels of a user from one or more continuous glucose monitoring sensors (101, ¶0251) and the at least one processor (104, 105, ¶0144) is configured to automatically transition from using data from the first CGM sensor to using data from the second CGM sensor (as the new sensor is inserted, the processor will detect the sensor and communicate with the new sensor and used the data, ¶0251) for calculating therapy parameters upon expiration of the warmup period (¶0085, ¶0106, so that the calibration period of the second sensor will be in the processor ¶0110).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify at least one processor of Zade so that at least one processor is configured to automatically transition from using data from the first CGM sensor to using data from the second CGM sensor for calculating therapy parameters upon expiration of the warmup period as taught by Harper for the purpose of replace the sensor before expired to avoid an hassle of glucose measuring (Harper, ¶0251).
Re claim 10, Zade fails to disclose wherein the at least one processor is configured to provide a notification to the user to remove the first CGM sensor from the user's body following transitioning to the second CGM sensor.
However, Harper discloses an infusion pump system (Figs. 1-6 abstract, ¶0227) comprising a pump (¶0277), a communications interface (102, ¶0049) configured to receive data indicative of glucose levels of a user from one or more continuous glucose monitoring sensors (101, ¶0251) and the at least one processor (104, 105, ¶0144) is configured to provide a notification to the user to remove the first CGM sensor from the user's body following transitioning to the second CGM sensor (as the new sensor is inserted, the processor will detect the sensor and communicate with the new sensor and used the data, ¶0251).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify at least one processor of Zade so that the at least one processor is configured to provide a notification to the user to remove the first CGM sensor from the user's body following transitioning to the second CGM sensor as taught by Harper for the purpose of replace the sensor before expired to avoid an hassle of glucose measuring (Harper, ¶0251).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783