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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/20/2025 and 04/23/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 Longi, 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 1.321(c) or 1.321(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 § 2146 et seq. 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 1.321(b).
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Claims 2 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 28, 40 and 48 of U.S. Patent No. 11963767 B2 in view of Telson et al (US 20110040163 A1)
Instant application
U.S. Patent No. 11963767 B2
Independent Claims 2 and 13. A method of determining an insertion state of an analyte sensor, the method comprising: applying a voltage to the analyte sensor using sensor electronics; measuring a response to the voltage applied using the sensor electronics; determining an impedance parameter of the analyte sensor based at least on the measured response;
Independent Claims 1, 28, 40 and 48. A method of assessing sensor membrane integrity using sensor electronics, comprising: applying a voltage to an analyte sensor using the sensor electronics; measuring a response to the voltage applied using the sensor electronics; determining an impedance parameter of the analyte sensor based on the response measured by the sensor electronics;
Claim 12. The method of claim 2, wherein the impedance parameter is an impedance of the analyte sensor after hydration.
Claim 11. The method of claim 1, wherein the determined impedance parameter is an impedance of the analyte sensor after hydration.
Regarding claim 2 and 13, U.S. Patent No. 11963767 B2 does not claim determining an insertion state of the analyte sensor based at least on the impedance parameter.
Telson teaches determining an insertion state of the analyte sensor based at least on the impedance parameter (para [0011] This sensor system is arranged to utilize electrochemical impedance spectroscopy to monitor the condition of the sensor membranes of a subcutaneously insertable continuous monitoring sensor while being inserted, and then after insertion.
Para [0012] During the insertion process, the in vivo electrochemical impedance spectroscopy test results can be compared to a previously obtained reference test result to determine whether, for example, the sensor has been inserted properly, has been damaged or otherwise compromised, or is intact).
Here examiner views the insertion state (e.g., check if the sensor is inserted properly or has been damaged) of a sensor is determined or monitored using electrochemical impedance spectroscopy (i.e., impedance parameter).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing of the invention to have incorporated Telson in Estes for the purpose of using an impedance parameter of an analyte sensor so that the insertion state of the analyte sensor (i.e., monitor if the sensor is properly inserted into host) can be accurately determined using the impedance parameter of the sensor.
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.
Claim 4, and 15 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 4 and 15 recite a partially pulled out of an initial insertion position, is unclear as what condition be called a partially pulled out condition of the analyte sensor. Examiner considers the sensor being removed or pulled out from the host also as partially pulled out from an initial insertion position.
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) 2-4, 6, 7, 13-15, 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Estes et al. (US 20130245981 A1) herein after “Estes” in view of Telson et al (US 20110040163 A1) herein after “Telson”.
Regarding claim 2, Estes teaches a method of determining an insertion state of an analyte sensor (para [0182] FIG. 1 is a schematic view of a continuous analyte sensor system 100 attached to a host and communicating with a number of example devices 110-113. Para [0184] inserting the sensor 102 through the host's skin, and/or connecting the sensor 102 to the electronics unit 104.), the method comprising:
applying a voltage to the analyte sensor using sensor electronics ([0168] FIG. 10 is a flowchart illustrating a process for determining an impedance of a sensor, in accordance with the present embodiments.
Para [0218] At step 1002, a stimulus signal in the form of an alternating current (ac) voltage at a given frequency is applied to a working electrode of the sensor being studied.);
Above examiner views the voltage is applied to the sensor (analyte sensor) using sensor electronics (104) in Fig. 1.
measuring a response to the voltage applied using the sensor electronics (Fig. 10 para [0218] The response signal (e.g., in units of current) can then be measured in step 1004);
determining an impedance parameter of the analyte sensor based at least on the measured response (Fig. 10. para [0218] and analyzed in step 1006 to determine an impedance at the given frequency); and
Estes does not clearly teach determining an insertion state of the analyte sensor based at least on the impedance parameter.
Telson teaches determining an insertion state of the analyte sensor based at least on the impedance parameter (para [0011] This sensor system is arranged to utilize electrochemical impedance spectroscopy to monitor the condition of the sensor membranes of a subcutaneously insertable continuous monitoring sensor while being inserted, and then after insertion.
Para [0012] During the insertion process, the in vivo electrochemical impedance spectroscopy test results can be compared to a previously obtained reference test result to determine whether, for example, the sensor has been inserted properly, has been damaged or otherwise compromised, or is intact).
Here examiner views the insertion state (e.g., check if the sensor is inserted properly or has been damaged) of a sensor is determined or monitored using electrochemical impedance spectroscopy (i.e., impedance parameter).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing of the invention to have incorporated Telson in Estes for the purpose of using an impedance parameter of an analyte sensor so that the insertion state of the analyte sensor (i.e., monitor if the sensor is properly inserted into host) can be accurately determined using the impedance parameter of the sensor.
Regarding claim 3, the combination of Estes and Telson teach the method of claim 2, Telson teaches wherein determining the insertion state includes detecting a dislodgment of the analyte sensor from an insertion position in a host (Para [0012] During the insertion process, the in vivo electrochemical impedance spectroscopy test results can be compared to a previously obtained reference test result to determine whether, for example, the sensor has been inserted properly, has been damaged or otherwise compromised, or is intact).
para [0063] Such tests monitor the sensor coating changes and either adjust the sensor performance according to the EIS results (calibration), or in the case of pitoning detection warn the users that the sensor may need reinsertion or replacement.).
Herein examiner views checking if the sensor is properly inserted and warning of reinsertion or replacement condition of the sensor as being detecting a dislodgement of the analyte sensor from an insertion position in a host.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing of the invention to have incorporated Telson in Estes for the purpose of using an impedance parameter of an analyte sensor so that the insertion state of the analyte sensor can be accurately determined using the impedance parameter of the sensor and recommend reinsertion or replacement of the sensor.
Regarding claim 4, the combination of Estes and Telson teach the method of claim 3, Estes teaches further comprising detecting that the analyte sensor has been at least partially pulled out of an initial insertion position (Fig. 8 and 9, para [0215] In some embodiments, the system may compare a signal from the sensor with a signal from a most recently used sensor, particularly if a short period of time elapses in between sensor removal and implantation. For example, and with reference to FIG. 8, the curve C.sub.1 represents the sensor signal from a mature sensor, i.e. one that has been implanted for a sufficient length of time that its signal does not exhibit substantial drift. The sensor is removed at time t).
Examiner views in Fig. 8 the detection of the analyte sensor that has been removed or pulled out (i.e., also include partially pulled out) from the initial insertion position.
Regarding claim 6, the combination of Estes and Telson teach, the method of claim 2, Telson teaches further comprising providing an alert based at least on the insertion state (para [0052] a. NO CAPACITANCE--If no value is returned, or if the value fluctuates between zero and a value reading, the sensor is likely not hydrated indicating that the sensor is not inserted in the liquid environment, such as interstitial fluid, cerebral fluid, blood, or the like. This may also indicate that at least the external counter electrode is not in contact with the skin.
[0055] When there is no value returned, a warning may be given to the user to reinsert the sensor.
Examiner views the alert provides the insertion state of a sensor (i.e., sensor is not in contact with fluid, blood or body parts) and requires a reinsertion of the sensor for its intended use.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing of the invention to have incorporated Telson in Estes for the purpose of providing an alert regarding the insertion state of a sensor, so that the user or health care personnel can be take appropriate action based on the insertion state of the sensor.
Regarding claim 7, the combination of Estes and Telson teach the method of claim 6, Telson teaches wherein the alert indicates that the analyte sensor has been dislodged (Para [0012] During the insertion process, the in vivo electrochemical impedance spectroscopy test results can be compared to a previously obtained reference test result to determine whether, for example, the sensor has been inserted properly, has been damaged or otherwise compromised, or is intact.
para [0063] Such tests monitor the sensor coating changes and either adjust the sensor performance according to the EIS results (calibration), or in the case of pitoning detection warn the users that the sensor may need reinsertion or replacement).
Herein examiner views checking if the sensor is properly inserted and providing warning or alert for reinsertion condition of an analyte sensor as indicating a dislodgement or removal of the analyte sensor from an insertion position in a host.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing of the invention to have incorporated Telson in Estes for the purpose of providing an alert that indicates the insertion state (i.e., dislodged) of an analyte sensor so that a recommended action (i.e., reinsertion or replacement) of the sensor is can be performed.
Claims 13-15, 17, 18 are rejected as claims 2-4, 6, 7 respectively having same claims limitations.
Claim(s) 5 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Estes and Telson in view of Reinert et al (US 20130079861 A1) herein after “Reinert”
Regarding claim 5, the combination of Estes and Telson teach the method of claim 3, the combination does not clearly teach wherein dislodgment is detected based upon an increase in impedance.
Reinert teaches wherein dislodgment is detected based upon an increase in impedance (para [0111] The clinician may initially insert LPD 16 into patient 14.
[0077] Sensing module 60 may also measure electrode impedance of electrodes 34 and 36. If the impedance of electrode 34, for example, increases above a predetermined threshold or rolling average threshold, stability module 62 may determine that LPD 16 is at least partially dislodged from tissue.)
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing of the invention to have incorporated Reinert in Estes for the purpose of detecting a higher impedance parameter of an analyte sensor so that the insertion state (i.e., dislodgment) of the analyte sensor can be accurately determined.
Claim 16 is rejected as claim 5 having same claim limitations
Claim(s) 8, 9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Estes and Telson in view of Rosinko et al (US20140378898A1)
Regarding claim 8, the combination of Estes and Telson teach the method of claim 2, further comprising: causing an adjustment in operation of a therapy delivery device based at least on the insertion state (para [0034] FIG. 6A, the CGM sensor 226 is integrated around the cannula 222 such that the sensor and cannula share a single site.
para [0036] FIGS. 7A and 7B depict a portion of another embodiment of an infusion set 300 that can be utilized to determine if the cannula 322 has become dislodged from the skin…. When the adhesive layer 328 of the infusion set 300 is properly attached to the skin 302, the sensor 330 will be in constant contact with the skin. Thus, the temperature, pressure, capacitance, ECG, etc. readings will remain nominal, e.g., relatively constant.
Para [0037] If the CGM readings of any of the systems described above indicate that the cannula of an infusion set may have come dislodged from the patient, a user interface 60 of the corresponding infusion pump 12 system can provide a warning 62 indicating that the cannula may have dislodged and prompting the user to check the cannula for dislodgement. The user can then have the option of selecting a confirm object 66 to confirm the cannula is properly inserted or cancelling the warning with a cancel object 64. In some embodiments, the pump can automatically stop delivering fluid until the user has indicated that the cannula is properly attached.).
Herein examiner views automatically stop the delivery fluid from the infusion set (i.e., therapy delivery device) until the cannula is properly attached to the host as an adjusting in operation of a therapy delivery device based at least on the insertion state of the CGM sensor.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing of the invention to have incorporated Rosinko in Estes for the purpose of causing adjusting the operation (i.e., turning on or off) of a therapy delivery device based at least on the insertion state so that the patient can be properly administered with a required amount of medicine.
Regarding claim 9, the combination of Estes, Telson and Rosinko teach the method of claim 8, Rosinko teaches, wherein the adjustment in the operation of the therapy delivery device causes a change in therapy provided by the therapy device (Para [0037] If the CGM readings of any of the systems described above indicate that the cannula of an infusion set may have come dislodged from the patient, …In some embodiments, the pump can automatically stop delivering fluid until the user has indicated that the cannula is properly attached ).
Examiner views the stoppage of infusion set or pump as adjustment in the operation of the therapy delivery device, stoppage of infusion causes change in the infusion therapy provided by the infusion set.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing of the invention to have incorporated Rosinko in Estes for the purpose of causing adjusting the operation (i.e., turning on or off) of a therapy delivery device to change the therapy provided by the delivery device based at least on the insertion state so that the patient can be properly administered with a required amount of medicine.
Claim 19 is rejected as claim 8 having same claim limitations.
Claim(s) 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Estes, Telson and Rosinko in view of Wilinska et al (US20100280441A1) herein after “Wilinska”
Regarding claim 10, the combination of Estes, Telson and Rosinko the method of claim 8, the combination does not clearly teach wherein the adjustment in the operation of the therapy delivery device causes the therapy delivery device to operate based on sensor data previously collected by the analyte sensor.
Wilinska teaches wherein the adjustment in the operation of the therapy delivery device causes the therapy delivery device to operate based on sensor data previously collected by the analyte sensor. (FIG. 1A a basic block diagram of a closed-loop system 20 for continuous glucose monitoring and for continuous subcutaneous insulin infusion using a model predictive controller 26. The patient receives exogenous inputs, such as meals. The patient's glucose is measured 24, evaluated by the model predictive controller (MPC) and is used by the MPC to control a delivery device, such as a pump 28, to deliver medication to the patient to control blood glucose.)
Herein examiner views a closed-loop system that uses a previously collected analyte sensor data (i.e., measured glucose) to control or adjust the operation of a delivery device pump 28 (i.e., therapy delivery device).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing of the invention to have incorporated Wilinska into Estes for the purpose of controlling or adjusting the operation of a delivery device pump (i.e., therapy delivery device) by using a historical or previously collected sensor data so that the proper therapy or medication can be provided to a patient.
Claim 20 is rejected as claim 10 having same claim limitations
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Estes and Telson in view of Bohm et al (US20120078071 A1).
Regarding claim 11, the combination of Estes and Telson teach, the method of claim 2, the combination does not clearly teach wherein the impedance parameter indicates an insertion depth of the analyte sensor.
Bohm teaches wherein the impedance parameter indicates an insertion depth of the analyte sensor (para [300] A sensor depth detector can reside at a point on the sensor just below where the sensor should interface a host's skin when the sensor is properly implanted into the host. The sensor detector can then detect if the sensor detector is not positioned the host. As one example, the detector can be implemented using impedance measurements to determine whether or not the detector is implanted in the host's body. For example, the resistance (e.g., impedance) of a detector may change depending upon whether the detector is located in a host's tissue.)
Above examiner views an impedance measurement is used by the sensor depth detector to indicates the specific or correct insertion depth of an analyte sensor that is located inside the host.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing of the invention to have incorporated Bohm into Estes for the purpose of determining the height of an analyte sensor inside the host using an impedance parameter so that a proper sensor height installment can be obtained for proper medication supply to the patient.
Claim(s) 12 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Estes and Telson in view of Gottlieb et al (US 20100030045 A1) herein after “Gottlieb”
Regarding claim 12, the combination of Estes and Telson teach the method of claim 2, the combination does not clearly teach wherein the impedance parameter is an impedance of the analyte sensor after hydration.
Gottlieb teaches wherein the impedance parameter is an impedance of the analyte sensor after hydration. (para [0025] Yet another embodiment of the invention is an analyte sensor apparatus that includes a processor that detects whether a sensor is sufficiently hydrated for analyte detection comprising calculating an impedance value.)
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing of the invention to have incorporated Gottlieb into Estes for the purpose of determining an impedance of an analyte sensor after hydration of the sensor so that the accurate impedance of the analyte sensor can be obtained.
Claim 21 is rejected as claim 12 having same claim limitations
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Brister et al. (US 20070027385 A1) discusses monitoring analyte sensor in a host.
Taylor et al. (US 20160030683 A1) discusses smart adapter for infusion devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARAD TIMILSINA whose telephone number is (571)272-7104. The examiner can normally be reached Monday-Friday 9:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Catherine Rastovski can be reached at 571-270-0349. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHARAD TIMILSINA/Examiner, Art Unit 2863
/Catherine T. Rastovski/Supervisory Primary Examiner, Art Unit 2863