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 .
Acknowledgment
Claims 1, 8-9, 11, 13-15, 18-19 are amended and filed on 5/22/2026.
Claims 6-7, 16-17 are canceled.
Claim Objections
Claims 13, 19 are objected to because of the following informalities:
In line 1 of claim 13, the limitation“ at a processor” should read as “ the at least one processor” ( as it depends on claim 11),
In line 2 of claim 19, the limitation “a processor” should read as “ the at least one processor” ( as it depends on claim 11). 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 11-15, 18-20 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 11 recites the limitation "the at least one processor…" in in the last 4 lines of claim 11 There is insufficient antecedent basis for this limitation in the claim.
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) 1-5, 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kiani et al. (US 20210236729 A1) (”Kiani”) in view of Harper et al. (US. 20210077033A1) (“Harper”).
Re claim 1, Kiani discloses an ambulatory infusion pump system( Fig. 1-6, ¶004), comprising: a pump mechanism configured to deliver insulin to a user (Fig. 2f, 1130, ¶0222); a communications interface (1140, Fig. 2f) configured to receive data indicative of glucose levels of a user from one or more continuous glucose monitoring(CGM) sensors (1120, ¶0223); and at least one processor (1138, ¶0222) configured to receive the data indicative of glucose levels of the user (¶0222) and to determine therapy parameters for the user based on the glucose levels (¶0222), wherein the at least one processor (1138, ¶0222, several processor of the pump/sensors) is configured to use data provided by the second CGM sensor (¶0026, new first device ¶0215 ) for determining therapy parameters only after the second CGM sensor has been inserted for a warmup period of time and the predetermined amount of time is sufficient to enable the warmup period of time to be completed prior to expiration of the first CGM sensor (the second sensor, ¶0026, Fig. 2c, ¶0215), but it fails to disclose that the at least one processor configured to: determine that an ongoing active use state of a first CGM sensor of the one or more CGM sensors will be expiring; and provide a notification to the user to insert a second CGM sensor of the one or more CGM sensors 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 configured to: determine that an ongoing active use state of a first CGM sensor of the one or more CGM sensors will be expiring; and provide a notification to the user to insert a second CGM sensor of the one or more CGM sensors 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 replacing the sensor before expired to avoid an hassle of glucose measuring (Harper, ¶0251).
Re claim 2, the modified Kiani 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 Kiani 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, Kiani discloses a memory (¶0222, Fig. 2F), 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 Kiani 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 Kiani 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 8, Kiani discloses 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 (the second sensor, ¶0026, Fig. 2c, ¶0215).
Re claim 9, Kiani 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 Kiani 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, Kiani 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 Kiani 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).
Claim(s) 11-15, 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harper in view of Kiani.
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 continuous glucose monitor (CGM) sensor (¶0251, ¶0277); determining that an ongoing active use state of the first CGM sensor will be expiring (¶0251); and upon determining that the first CGM sensor will be expiring, providing a notification to the user via a user interface (¶0301) to insert a second CGM sensor in a target tissue of the user a predetermined amount of time prior to expiration of the first CGM sensor upon determining that the first CGM sensor (¶0251, ¶0301), and further it discloses the at least one processor (104, ¶0156) but it fails to disclose that the at least one processor is configured to use data provided by the second CGM sensor for determining therapy parameters only after the second CGM sensor has been inserted for a warmup period of time and the predetermined amount of time is sufficient to enable the warmup period of time to be completed prior to expiration of the first CGM sensor.
However, Kiani discloses an infusion pump system (Figs. 1-6 abstract, ¶0198) comprising the at least one processor (1138, ¶0222, several processor of the pump/sensors) is configured to use data provided by the second CGM sensor (¶0026, new first device ¶0215 ) for determining therapy parameters only after the second CGM sensor has been inserted for a warmup period of time and the predetermined amount of time is sufficient to enable the warmup period of time to be completed prior to expiration of the first CGM sensor (the second sensor, ¶0026, Fig. 2c, ¶0215).
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 use data provided by the second CGM sensor for determining therapy parameters only after the second CGM sensor has been inserted for a warmup period of time and the predetermined amount of time is sufficient to enable the warmup period of time to be completed prior to expiration of the first CGM sensor as taught by Kiani for the purpose of having accurate reading without interruption (Kiani, ¶0154).
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 at processor, 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 18, the modified Harper discloses further comprising monitoring the warmup up period of time of the second CGM sensor (the second sensor, ¶0026, Fig. 2c, ¶0215).
Re claim 19, the modified Harper discloses further comprising automatically transitioning by a processor 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 of time (as the new sensor is inserted, the processor will detect the sensor and communicate with the new sensor and used the data, ¶0251 of Harper) for calculating therapy parameters upon expiration of the warmup period (the second sensor, ¶0026, Fig. 2c, ¶0215).
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).
Response to Arguments
Applicant’s arguments, see remark, filed 5/22/2026, with respect to the rejection(s) of claim(s) 11 under 102 and claim 1 rejection with regards to new added limitation have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Kiani in view of Harper for claim 1 and Harper in view of Kiani for claim 1.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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