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 .
Status of the Application
Claims 1-20 are currently pending in this case and have been examined and addressed below. This communication is a Final Rejection in response to the Amendments to the Claims and Remarks filed on 12/15/2025.
Claims 1, 10, 19, and 20 are currently amended.
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.
(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.
Claims 10-16 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Montero et al. (US-20210275742-A1)[hereinafter Montero].
As per Claim 10, Montero discloses a method, for preparing a second on-body sensor for use with a user while a first on-body sensor is in use in paragraphs [0022] and [0028-0030] and [0040] and [0045-0046] (a method, for prepare a new analyte sensor device (synonymous to a second on-body sensor), referred to as the second analyte sensor, for use with a user while an old analyte sensor device (synonymous to a first on-body sensor), referred to as the first analyte sensor, is in use), the method comprising: placing the second on-body sensor that is attached to the user in a warming up mode while the first on-body sensor is also attached to the user and is sensing an analyte or other physical characteristic, wherein the warming up mode prepares the second on- body sensor to be activated to sense the analyte or the other physical characteristic while attached to the user in paragraphs [0040] and [0045-0046] (placing the second analyte sensor device that is attached to the user in a warm up mode while the first analyte sensor device is also attached to the user and is still actively providing valid sensor glucose data, wherein the warm up mode prepares the second analyte sensor device to be initialized to sense the glucose data, wherein the analyte is glucose) and wherein the warming up mode is a sufficient duration to ensure that a stabilization period of the second on-body sensor has elapsed so that the second on- body sensor may provide accurate readings in paragraphs [0042] and [0046] and [0058] and [0066] and [0073] and [0077] and [0086] (the warm up mode has a duration of 2 hours (synonymous to a sufficient duration) to ensure the calibration period (synonymous to a stabilization period) of the second analyte sensor has passed so that the second analyte sensor provides sensor accuracy (synonymous to accurate readings)); and while still in the warming up mode, calibrating the second on-body sensor to accurately sense the analyte or the other physical characteristic in paragraphs [0040] and [0046] (while still in the warm up mode, calibrating the second analyte sensor device to accurately sense the glucose).
As per Claim 11, Montero discloses the method of claim 10, Montero also discloses further comprising activating the second on- body sensor to begin sensing the analyte or the other physical characteristic while attached to the user in paragraphs [0022] and [0040] and [0045-0046]] (initializing the second analyte sensor device to begin sensing the glucose while attached to the user).
As per Claim 12, Montero discloses the method of claim 10, Montero also discloses wherein the analyte is blood glucose in paragraph [0040] (the analyte is blood glucose).
As per Claim 13, Montero discloses the method of claim 10, Montero also discloses wherein the sensor is a continuous glucose monitor (CGM), a lactate sensor or a heart rate sensor in paragraph [0023] (the sensor is a continuous glucose sensor device (synonymous to a continuous glucose monitor)).
As per Claim 14, Montero discloses the method of claim 10, Montero also discloses wherein the analyte or the other physical characteristic is one of lactate, a hormone, a drug concentration, heart rate, blood pressure, galvanic skin response, respiration rate, concentration of a substance in blood of the user, or presence of a substance in the blood of the user in paragraph [0040] (the analyte is the presence of glucose (synonymous to a substance) in the blood of the user).
As per Claim 15, Montero discloses the method of claim 10, Montero also discloses further comprising receiving at the second on- body sensor a reading of the analyte or the other physical characteristic from the first on- body sensor to be used in the calibrating in paragraphs [0046-0048] (receiving at the new analyte sensor device sensed glucose data (synonymous to a reading of the analyte), referred to as sensor configuration data from the old analyte sensor device to be used in the calibrating).
As per Claim 16, Montero discloses the method of claim 15, Montero also discloses wherein the calibrating comprises: determining a delta between the received reading of the analyte or of the other physical characteristic from the first on-body sensor and a current reading of the analyte or of the other physical characteristic read by the second on-body sensor in paragraphs [0056-0057] (determining a calibration error (synonymous to a delta) between the received sensor configuration data from the old analyte sensor device and the sensed glucose data from the new analyte sensor device); and using the delta in the calibrating of the second on-body sensor in paragraphs [0056-0057] (using the calibration error in calibrating the new analyte sensor device).
As per Claim 19, Montero discloses the method of claim 15, Montero also discloses wherein the warming up mode is at least one hour in duration in paragraph [0077] (the warm up mode takes up to 2 hours (Examiner notes that the warm up mode lasting up to 2 hours meets the "at least one hour duration " limitation)).
As per Claim 20, Montero discloses an on-body medical device in paragraphs [0020] and [0022] and [0028-0030] (a continuous glucose sensor attached to the body (synonymous to an on-body medical device)), comprising: a storage for storing processor-executable instructions in paragraphs [0035] (a memory, referred to as a storage medium, for storing computer-executable instructions); a processor for executing the instruction in paragraphs [0034-0035] (a processor device for executing the instruction) to: while a first on-body medical device that has an expiration is positioned on a user and is operational, preparing a second on-body medical device to replace the first on-body delivery device in paragraphs [0022] and [0040] and [0045-0046] (while an old analyte sensor device (synonymous to a first on-body medical device), referred to as the first analyte sensor, that must be replaced regularly, is positioned on a user and is operational, preparing a new analyte sensor device (synonymous to a second on-body medical device), referred to as the second analyte sensor, to replace the old analyte sensor device) by: placing the second on-body medical device in a standby mode where the second device is not fully operational but is powered up and on-body in paragraphs [0005] and [0028] (placing the second analyte sensor device in an initialization mode (synonymous to a standby mode) where the second analyte sensor device is not in measurement mode but is powered up and on body (Examiner notes that the analyze sensor is fully operational in measurement mode, wherein the second analyte sensor generates second sensor signals indicative of the analyte level of the user)), wherein the standby mode is configured to last a sufficient duration to ensure that a stabilization period of the second on-body medical device has elapsed so that the second on-body medical device operates properly in paragraphs [0041-0042] and [0046] and [0058] and [0066] and [0073] and [0077] and [0086] (the initialization mode lasts has a duration of 2 hours (synonymous to a sufficient duration) to ensure the calibration period (synonymous to a stabilization period) of the second analyte sensor has passed so that the second analyte sensor operates properly); establishing wireless communications with at least another device in paragraphs [0022] and [0024] (establishing wireless communications with an intermediary device (synonymous to another device)); and transitioning from the standby mode to an operational mode in which the on- body medical device is fully operational in paragraphs [0005] and [0058] (transitioning from the initialization mode to a measurement mode (synonymous to an operational mode) in which the continuous glucose sensor is generates sensor signals indicative of the analyte level of the user (Examiner notes that the analyze sensor is fully operational in measurement mode, wherein the second analyte sensor generates second sensor signals indicative of the analyte level)).
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.
Claims 1-3 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over EDWARDS (US-20180204636-A1)[hereinafter Edwards], in view of Remde (US-20110218495-A1)[hereinafter Remde].
As per Claim 1, Edwards discloses a method performed by a processor in paragraph [0080] (a computer-implemented method), comprising: preparing a second on-body medicament delivery device to replace a first on- body medicament delivery device that has an expiration with the processor while the first on-body medicament delivery device is positioned on a user and is operational to deliver a medicament to the user, the preparing including with the processor in paragraphs [0094] and [0106-0107] and [0138] and [0286] and [0347] (preparing a second medicament delivery device to replace a first medicament delivery device upon expiration with a processor while the first medicament delivery device is positioned on a user and is operational to deliver a medicament to the user): receiving and storing data and communication information from the first on-body medicament delivery device at the second on-body medicament drug delivery device in paragraphs [0079-0080] and [0108] and [0136] and [0299] (receiving and storing data and communication information from the first medicament delivery device at the second medicament delivery device); and based on the expiration of the first on-body medicament delivery device, activating the second on-body medicament delivery device with the processor to become operational to deliver the medicament to the user in paragraphs [0286] and [0342] and [0347] (based on the expiration date of the first medicament delivery device, activating the second medicament delivery device with the processor to become operational to deliver the medicament to the user).
Edwards does not disclose the following limitations. However, Remde discloses placing the second on-body medicament delivery device in a standby mode in which the second on-body medicament delivery device is not operational to deliver the medicament to the user but is powered up in paragraphs [0018] and [0042] (placing the replacement pump (synonymous to the second on-body medicament delivery device), referred to as a second insulin pump, in a low-energy mode (synonymous to a standby mode) in which the replacement pump is not in use to deliver the insulin to the user but is powered up); priming a pump of the second on-body medicament delivery device so that the pump is ready to deliver the medicament to the user in paragraphs [0039] and [0061] and [0071] (priming the infusion cannula of the replacement pump so that the infusion cannula is ready to deliver the insulin to the patient).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a method for preparing a second on-body medicament delivery device to replace a first on-body medicament delivery device that has an expiration, as disclosed by Edwards, to be combined with placing the second on-body medicament delivery device in a standby mode and priming a pump of the second on-body medicament delivery device so the pump is ready to deliver the medicament, as disclosed by Remde, for the purpose of providing continuous therapy [0006].
As per Claim 2, Edwards and Remde disclose the method of claim 1, Edwards also discloses wherein the medicament is one of insulin, glucagon or a glucagon-like peptide (GLP)-1 receptor agonist in paragraphs [0388-0389] (the medicament is insulin).
As per Claim 3, Edwards and Remde disclose the method of claim 1, Edwards also discloses wherein the medicament includes at least one of a chemotherapeutic agent, a pain relief agent, a blood thinner agent, a hormonal agent, a pharmaceutical agent or a therapeutic agent in paragraphs [0388-0389] (the medicament includes insulin (Examiner notes that insulin is a pharmaceutical agent and a therapeutic agent)).
As per Claim 5, Edwards and Remde disclose the method of claim 1, Edwards also discloses further comprising notifying the user that the second on-body medicament delivery device is ready for activating after the preparing is complete in paragraphs [0341-0343] (notifying the user that the second medicament delivery device is ready for activating after the preparing is complete).
As per Claim 6, Edwards and Remde disclose the method of claim 1, Edwards also discloses wherein the second on-body medicament delivery device has a controller and the controller performs the placing of the second on- body medicament delivery device in a standby mode in paragraphs [0107] and [0131-0133] (the second medicament delivery device has an electronic circuit system (synonymous to a controller), wherein the electronic circuit system includes a processor, and the electronic circuit system places the second medicament delivery device in a standby configuration).
As per Claim 7, Edwards and Remde disclose the method of claim 1, Edwards also discloses wherein the activating is responsive to a received communication in paragraphs [0342] (activating is responsive to a received communication).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over EDWARDS (US-20180204636-A1)[hereinafter Edwards], in view of Remde (US-20110218495-A1)[hereinafter Remde], in view Taub et al. (US-20140200426-A1)[hereinafter Taub].
As per Claim 4, Edwards and Remde disclose the method of claim 1, Edwards also discloses wherein the received and stored data includes delivery history of the medicament for the user in paragraphs [0114] (the received and stored data includes delivery history of the medicament for the user).
Edwards discloses receiving and storing delivery history of the medicament for the user, but does not disclose receiving and storing blood glucose history of the user. However, Taub discloses wherein the received and stored data includes blood glucose history for the user in paragraphs [0138] (the received and stored analyte information includes historical analyte information for the user).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a method for preparing a second on-body medicament delivery device to replace a first on-body medicament delivery device that has an expiration, as disclosed by Edwards, to be combined with receiving and storing blood glucose history of the user, as disclosed by Taub, for the purpose of determining a level of analyte from a sample [0002].
Claims 8 and 9 is rejected under 35 U.S.C. 103 as being unpatentable over EDWARDS (US-20180204636-A1)[hereinafter Edwards], in view of Remde (US-20110218495-A1)[hereinafter Remde], in view Sjolund et al. (US-20190175841-A1)[hereinafter Sjolund].
As per Claim 8, Edwards and Remde disclose the method of claim 1.
Edwards and Remde do not disclose the following limitations. However, Sjolund discloses wherein the preparing further comprises initiating communication set up between a sensor and the second on-body medicament delivery device at a predetermined period of time before the expiration of the first medicament on-body delivery device in paragraphs [0025] and [0111-0112] and [0127] and [0208-0210] and [0333-0334] (initiating communication set up between a glucose sensor and a replacement pen cap for a manual insulin delivery device (synonymous to the second on-body medicament delivery device) at a predetermined time before expiration of the pen cap for a manual insulin delivery device (synonymous to the first medicament on-body delivery device)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a method for preparing a second on-body medicament delivery device to replace a first on-body medicament delivery device that has an expiration, as disclosed by Edwards and Remde, to be combined with initiating communication set up between a sensor and the second medicament on-body delivery device before the first medicament on-body delivery device expires, as disclosed by Sjolund, for the purpose of assisting users to make appropriate therapy decisions while minimizing the burdens [0006].
As per Claim 9, Edwards, Remde, and Sjolund disclose the method of claim 8.
Edwards and Remde do not disclose the following limitations. However, Sjolund discloses wherein the sensor is a glucose monitor for monitoring blood glucose levels of the user in paragraphs [0035] and [0041] (the sensor is a glucose monitor for monitoring blood glucose levels of the user).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a method for preparing a second on-body medicament delivery device to replace a first on-body medicament delivery device that has an expiration, as disclosed by Edwards and Remde, to be combined with the sensor being a glucose monitor for monitoring blood glucose levels, as disclosed by Sjolund, for the purpose of assisting users to make appropriate therapy decisions while minimizing the burdens [0006].
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Montero et al. (US-20210275742-A1)[hereinafter Montero], in view of Remde (US-20110218495-A1)[hereinafter Remde].
As per Claim 17, Montero discloses the method of claim 15, Montero also discloses and wherein the calibrating is based in part upon a time it takes for a tracer solution or disturbance introduced into the user to be sensed by the respective first and second on-body sensors in paragraphs [0022] and [0040-0043] and [0048] (the calibrating is based upon a time it takes for a disturbance introduced into the user to be sensed by the respective first analyte sensor (synonymous to a first on-body sensor) and second analyte sensor (synonymous to a second on-body sensor)).
Montero does not disclose the following limitations. However, Remde discloses wherein the first on-body sensor and the second on-body sensor are positioned a known distance apart on the user in paragraphs [0018] and [0045-0047] (the first insulin pump (synonymous to the first on-body sensor), referred to as the source pump, and the second insulin pump (synonymous to the second on-body sensor), referred to as the replacement pump are positioned are positioned a known distance a part on the user).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a method for preparing a second on-body sensor for use with a user while a first on-body sensor is in use, as disclosed by Montero, to be combined with the first on-body sensor and the second on-body sensor are positioned a known distance a part on the user, as disclosed by Remde, for the purpose of providing continuous therapy [0006].
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Montero et al. (US-20210275742-A1)[hereinafter Montero], in view of Bhavaraju (US-20190339223-A1)[hereinafter Bhavaraju].
As per Claim 18, Montero discloses the method of claim 15.
Montero does not disclose the following limitations. However, Bhavaraju discloses wherein the calibrating is based the user ingesting a calibration liquid and monitoring a change in blood glucose concentration with the second on-body sensor in paragraphs [0017] and [0039] and [0165] and [0203] and [0207] and [0211] (the calibrating is based on the calibration solution (synonymous to a calibration liquid) and monitoring a change in blood glucose concentration with the continuous analyte sensor (synonymous to the second on-body sensor)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a method for preparing a second on-body sensor for use with a user while a first on-body sensor is in use, as disclosed by Montero, to be combined with calibrating is based on the user ingesting a calibration liquid and monitoring a change in blood glucose concentration with the second on-body sensor, as disclosed by Bhavaraju, for the purpose of assisting users make educated insulin therapy decisions [0004].
Response to Arguments
Applicant’s arguments, see Pages 6-8, “Claim Rejections - 35 U.S.C. § 102”, filed 12/15/2025 with respect to claims 10-16 and 20 have been fully considered. With regards to Claims 10-16 and 20, Applicant argues that Montero does not disclose the amended limitations of the claims. Examiner disagrees and points Applicant to the updated rejection and citations in the 102 rejections above. In response to the argument that the reference does not disclose a stabilization period and having a warming up mode configured to last until the stabilization period elapses, Examiner respectfully disagrees. Montero discloses in paragraphs [0042], [0058], [0066], and [0077] that the warmup mode has a duration of 2 hours to ensure that the calibration period has passed so that the accuracy of the sensor readings improved.
Applicant’s arguments, see Pages 8-11, “Claim Rejections - 35 U.S.C. § 103”, filed 12/15/2025 with respect to claims 1-9 and 17-19 have been fully considered. With regards to Claims 1-3 and 5-7, Applicant argues that Edwards and Remde fail to teach or suggest a second on-body medicament device receiving and storing data and communication from a first on-body medicament delivery device as part of preparing to the second medicament device replacing the first medicament delivery device. Examiner respectfully disagrees. Examiner notes that Edwards discloses in paragraphs [0078-0079] and [0299] the second medicament device is able to receive and store a wireless signal characterized by a communication interval indicating communication information from the first medicament device. With regards to claims 4, 8, 9 and 17-19, Applicant argues since the claims depend on their respective independent claims the references applied fail to teach the amended limitations of the claims. Examiner respectfully disagrees and points Applicant to updated rejection and citations in the 103 rejections above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lee, Seung Ho et al. “Implantable batteryless device for on-demand and pulsatile insulin administration” (2017) teaches on implantable insulin delivery devices with noninvasive actuation.
McGarraugh G, “FreeStyle Navigator Continuous Glucose Monitoring System with TRUstart Algorithm, a 1-Hour Warm-up Time” (2011) teaches on a glucose monitoring system that has an decreased warm up period to avoid inaccurate glucose readings.
THIS ACTION IS MADE FINAL. 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 KRYSTEN N WRIGHT whose telephone number is (571)272-5116. The examiner can normally be reached Monday thru Friday 8 - 5 pm, ET.
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/K.N.W./Examiner, Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682