DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. According to the Preliminary Amendment, filed 18 April 2024, the status of the claims is as follows:
Claims 2-21 are new; and
Claim 1 is cancelled.
Claim Rejections - 35 USC § 101
3. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
4. Claims 2-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, i.e. abstract idea, without significantly more.
Step 1 of the Patent Subject Matter Eligibility Guidance (see MPEP 2106.03):
Claims 2-11 are directed to a “system”, which describes one of the four statutory categories of patentable subject matter, i.e. a machine.
Claims 12-21 are directed to a “method”, which describes one of the four statutory categories of patentable subject matter, i.e. a process.
Step 2A of the Revised Patent Subject Matter Eligibility Guidance (see MPEP 2106.04):
Claim(s) 2-11, recite the following mental process:
determining, based at least in part on the analyte current signal, a rate of reduction of the analyte concentration is greater than a rate of reduction threshold;
determining a membrane impedance meets a membrane impedance condition; and
executing, in response to determining the rate of reduction of the analyte
concentration is greater than the rate of reduction threshold and determining the membrane impedance meets the membrane impedance condition, a compression low response action.
Based on broadest reasonable interpretation, these limitations are directed to receiving data and performing a mathematical operation, which can be done mentally or using pen and paper.
This judicial exception is not integrated into a practical application because the additional limitations of “an analyte sensor comprising a working electrode and a reference electrode, wherein the analyte sensor is configured to generate an analyte current signal indicative of an analyte concentration in a host” and “receiving the analyte current signal generated by the analyte sensor” in claim 1 add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the mental process. Furthermore, “a processor configured to perform operations” in claim 1 is merely a part of a computer to be used as a tool to perform the mental process.
Claim(s) 12-21, recite the following mental process:
determining, based at least in part on the analyte current signal, the analyte current signal exhibits a rate of reduction greater than a rate of reduction threshold;
determining a membrane impedance meets a membrane impedance condition; and
executing, in response to determining the analyte current signal exhibits a rate of reduction greater than the rate of reduction threshold and determining the membrane impedance meets the membrane impedance condition, a compression low response action.
Based on broadest reasonable interpretation, these limitations are directed to receiving data and performing a mathematical operation, which can be done mentally or using pen and paper.
This judicial exception is not integrated into a practical application because the additional limitations of “receiving an analyte current signal generated by the analyte sensor, the analyte current signal indicative of the analyte concentration in the host;” in claim 12 add insignificant pre-solution activity, i.e. data gathering, to the abstract idea that merely collects data to be used by the mental process.
Step 2B of the Patent Subject Matter Eligibility Guidance (see MPEP 2106.05):
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception, when considered separately and in combination.
Analyzing the additional claim limitations individually, the additional limitations that are not directed to the mental process are “an analyte sensor comprising a working electrode and a reference electrode, wherein the analyte sensor is configured to generate an analyte current signal indicative of an analyte concentration in a host” and “receiving the analyte current signal generated by the analyte sensor” in claim 1, “wherein the analyte sensor further comprises a membrane; and wherein the membrane impedance is associated with the membrane of the analyte sensor” in claim 10, “receiving an analyte current signal generated by the analyte sensor, the analyte current signal indicative of the analyte concentration in the host;” in claim 12, and “wherein the analyte sensor further comprises a membrane; and wherein the membrane impedance is associated with the membrane of the analyte sensor” in claim 21. Such limitations are conventional and routine in the art (see Vanslyke et al., U.S. Patent Application Publication No. 2015/0351672 A1, which is discussed below in the rejection under 35 U.S.C. 103), and add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the abstract idea.
The additional limitation “a processor configured to perform operations” in claim 1 is merely a part of a computer to be used as a tool to perform the mental process.
The additional limitations of dependent claims 3-10 and 13-20 are merely directed to and further narrow the scope of the mental process.
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Their collective functions merely provide computer implementation of the abstract idea using collected data without: improvement to the functioning of a computer or to any other technology or technical field; applying the mental process with, or by use of, a particular machine; effecting a transformation or reduction of a particular article to a different state or thing; applying or using the mental process in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment; or adding a specific limitation other than what is well-understood, routine, conventional activity in the field.
Claim Rejections - 35 USC § 102
5. 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.
Claim Rejections - 35 USC § 103
6. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
7. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
8. Claims 2-5, 8-15, and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Vanslyke et al., U.S. Patent Application Publication No. 2015/0351672 A1 (“Vanslyke”), in view of Patterson, U.S. Patent No. 8,940,542 B2 (“Patterson”).
As to Claim 2, Vanslyke teaches the following:
An analyte sensor system (see “The present embodiments relate to continuous analyte monitoring, and, in particular, to fault discrimination and responsive processing within a continuous analyte monitoring system.” in para. [0002]), comprising:
an analyte sensor (“implantable glucose sensor”) 10 comprising a working electrode (“platinum working electrode”, not labeled) and a reference electrode (“silver/silver chloride reference electrode”, not labeled) (see “FIG. 1A is an exploded perspective view of one exemplary embodiment comprising an implantable glucose sensor 10 that utilizes amperometric electrochemical sensor technology to measure glucose concentration. … Three electrodes 16 are operably connected to the sensor electronics (FIG. 2) and are covered by a sensing membrane 17 and a biointerface membrane 18, which are attached by a clip 19.” in para. [0134]; and see “In one embodiment, the three electrodes 16, which protrude through the head 14, include a platinum working electrode, a platinum counter electrode, and a silver/silver chloride reference electrode.” in para. [0135]), wherein the analyte sensor 10 is configured to generate an analyte current signal indicative of an analyte concentration in a host (see “The glucose sensor can be any device capable of measuring the concentration of glucose. One exemplary embodiment is described below, which utilizes an implantable glucose sensor. However, it should be understood that the devices and methods described herein can be applied to any device capable of detecting a concentration of glucose and providing an output signal that represents the concentration of glucose.” in para. [0128]); and
a processor (“processor”) 42 configured to perform operations (see “The processor 42, also referred to as the processor module, is the central control unit that performs the processing, such as storing data, analyzing data streams, calibrating analyte sensor data, predicting analyte values, comparing predicted analyte values with corresponding measured analyte values, analyzing a variation of predicted analyte values, downloading data, and controlling the user interface by providing analyte values, prompts, messages, warnings, alarms, and the like.” in para. [0168]) comprising:
receiving the analyte current signal generated by the analyte sensor 10 (see “A quartz crystal 40 is operatively connected to an RF transceiver 41 that together function to receive and synchronize data streams (e.g., raw data streams transmitted from the RF transceiver). Once received, a processor 42 processes the signals, such as described below.” in para. [0167];
determining, based at least in part on the analyte current signal, a rate of reduction of the analyte concentration … (see “When the oxygen level reduces below a threshold value, the enzyme electrode current drops (“oxygen starvation”) while the glucose concentration remains constant. This oxygen starvation may result in reduced accuracy, as lower than actual glucose levels may be reported.” in para. [0318]);
determining a membrane impedance meets a membrane impedance condition (see “The use of impedance data in determining clinical context information is explained more fully in U.S. Patent Publication No. US-2012-0265035-A1, owned by the assignee of the present application and herein incorporated by reference in its entirety. Exemplary uses of impedance data, as well as devices to calculate impedance, are described below.” in para. [0280]; and see “Accordingly, some embodiments can be configured determine sensor reuse based at least in part on one or more measurements of the impedance of the sensor. As discussed in more detail elsewhere herein, the impedance that relates to the membrane resistance of a sensor is typically initially high and then gradually decreases as the sensor is run-in. Thus, in one embodiment, sensor re-use can be detected if an impedance measured soon after sensor implantation is greater than what a sensor should typically have when a sensor is initially implanted, as this can indicate that the sensor had already been used.” in Bohm et al., U.S. Patent Application No. 2012/026035 A1 (“Bohm”), para. [0374]); and
executing, in response to … determining the membrane impedance meets the membrane impedance condition, a compression low response action (see “In some embodiments, the system may be configured to determine, based on recent history, the likelihood of a sensor to recover from the EOL determination. For example, the EOL determination function may determine the EOL status is more than likely if there is a high probability that the sensor will not track glucose in the future or that the sensor is not detecting glucose at all for extended durations. Extended durations may include time periods exceeding 12 hours. In some embodiments, the processor module is configured to suspend display of sensor data during verification or determination of a likelihood of recovery, after which the processor module may be configured to either re-allow display of sensor data if it is determined that the sensor has recovered from the EOL symptoms.” in para. [0335]).
Vanslyke does not teach the following:
determining, based at least in part on the analyte current signal, a rate of reduction of the analyte concentration is greater than a rate of reduction threshold; and
executing, in response to determining the rate of reduction of the analyte concentration is greater than the rate of reduction threshold …, a compression low response action.
However, Patterson teaches the following:
determining, based at least in part on the analyte current signal, a rate of reduction of the analyte concentration is greater than a rate of reduction threshold (see “As used herein, a membrane which selectively quenches ROS typically has an ROS quenching activity sufficient to quench a solution having an H.sub.2O.sub.2 concentration of at least 10 ppm, and substantially does not deplete analyte (e.g. it has an analyte depletion rate of 1 mmol/hour or less, preferably 0.05 mmol/hour or less and/or it depletes analyte by no more than 80%, preferably no more than 95% when analyte is passed through the membrane).” in col. 9, ll. 11-19; and see “A membrane which substantially does not cause depletion of analyte typically provides a rate of depletion of no more than 0.1 mmol analyte per hour, preferably no more than 0.08 mmol/hour, more preferably no more than 0.05 mmol/hour.” in col. 9, ll. 39-43); and
executing, in response to determining the rate of reduction of the analyte concentration is greater than the rate of reduction threshold, a compression low response action (see “In some embodiments the extent or rate of analyte depletion is controlled by selecting an appropriate ROS-quenching agent, as described above.” in col. 9, ll. 44-46, where exceeding the rate of depletion would lead to adjusting the depletion for the sensor function).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify the system of Vanslyke to incorporate the specific rate of analyte depletion analysis of Patterson in order to allow for the optimal sensor function for controlling analyte depletion rate (see Patterson, col. 9, ll. 20-52).
As to Claim 3, Vanslyke in view of Patterson teaches the following:
wherein the operations further comprise determining, in response to determining the rate of reduction of the analyte concentration is greater than the rate of reduction threshold (see “As used herein, a membrane which selectively quenches ROS typically has an ROS quenching activity sufficient to quench a solution having an H.sub.2O.sub.2 concentration of at least 10 ppm, and substantially does not deplete analyte (e.g. it has an analyte depletion rate of 1 mmol/hour or less, preferably 0.05 mmol/hour or less and/or it depletes analyte by no more than 80%, preferably no more than 95% when analyte is passed through the membrane).” in col. 9, ll. 11-19; and see “A membrane which substantially does not cause depletion of analyte typically provides a rate of depletion of no more than 0.1 mmol analyte per hour, preferably no more than 0.08 mmol/hour, more preferably no more than 0.05 mmol/hour.” in Patterson, col. 9, ll. 39-43), whether the membrane impedance meets the membrane impedance condition (see “The use of impedance data in determining clinical context information is explained more fully in U.S. Patent Publication No. US-2012-0265035-A1, owned by the assignee of the present application and herein incorporated by reference in its entirety. Exemplary uses of impedance data, as well as devices to calculate impedance, are described below.” in Vanslyke, para. [0280]; and see “Accordingly, some embodiments can be configured determine sensor reuse based at least in part on one or more measurements of the impedance of the sensor. As discussed in more detail elsewhere herein, the impedance that relates to the membrane resistance of a sensor is typically initially high and then gradually decreases as the sensor is run-in. Thus, in one embodiment, sensor re-use can be detected if an impedance measured soon after sensor implantation is greater than what a sensor should typically have when a sensor is initially implanted, as this can indicate that the sensor had already been used.” in Bohm, para. [0374]).
As to Claim 4, Vanslyke in view of Patterson teaches the following:
wherein the rate of reduction threshold is a highest rate of reduction in the analyte concentration expected in the host (see “As used herein, a membrane which selectively quenches ROS typically has an ROS quenching activity sufficient to quench a solution having an H.sub.2O.sub.2 concentration of at least 10 ppm, and substantially does not deplete analyte (e.g. it has an analyte depletion rate of 1 mmol/hour or less, preferably 0.05 mmol/hour or less and/or it depletes analyte by no more than 80%, preferably no more than 95% when analyte is passed through the membrane).” in Patterson, col. 9, ll. 11-19).
As to Claim 5, Vanslyke teaches the following:
wherein the compression low response action comprises suspending reporting of the analyte concentration at a user interface (see “In some embodiments, the processor module is configured to suspend display of sensor data during verification or determination of a likelihood of recovery, after which the processor module may be configured to either re-allow display of sensor data if it is determined that the sensor has recovered from the EOL symptoms.” in para. [0335]).
As to Claim 8, Vanslyke teaches the following:
wherein determining the membrane impedance meets the membrane impedance condition comprises determining the membrane impedance is less than a threshold impedance (see “The use of impedance data in determining clinical context information is explained more fully in U.S. Patent Publication No. US-2012-0265035-A1, owned by the assignee of the present application and herein incorporated by reference in its entirety. Exemplary uses of impedance data, as well as devices to calculate impedance, are described below.” in Vanslyke, para. [0280]; and see “Accordingly, some embodiments can be configured determine sensor reuse based at least in part on one or more measurements of the impedance of the sensor. As discussed in more detail elsewhere herein, the impedance that relates to the membrane resistance of a sensor is typically initially high and then gradually decreases as the sensor is run-in. Thus, in one embodiment, sensor re-use can be detected if an impedance measured soon after sensor implantation is greater than what a sensor should typically have when a sensor is initially implanted, as this can indicate that the sensor had already been used.” in Bohm, para. [0374]).
As to Claim 9, Vanslyke teaches the following:
wherein determining the membrane impedance meets the membrane impedance condition comprises determining a rate of reduction of the membrane impedance is greater than an impedance rate threshold (see “The use of impedance data in determining clinical context information is explained more fully in U.S. Patent Publication No. US-2012-0265035-A1, owned by the assignee of the present application and herein incorporated by reference in its entirety. Exemplary uses of impedance data, as well as devices to calculate impedance, are described below.” in Vanslyke, para. [0280]; and see “Accordingly, some embodiments can be configured determine sensor reuse based at least in part on one or more measurements of the impedance of the sensor. As discussed in more detail elsewhere herein, the impedance that relates to the membrane resistance of a sensor is typically initially high and then gradually decreases as the sensor is run-in. Thus, in one embodiment, sensor re-use can be detected if an impedance measured soon after sensor implantation is greater than what a sensor should typically have when a sensor is initially implanted, as this can indicate that the sensor had already been used.” in Bohm, para. [0374]).
As to Claim 10, Vanslyke in view of Patterson teaches the following:
wherein determining the membrane impedance meets the membrane impedance condition comprises determining the membrane impedance is less than a threshold impedance (see “The use of impedance data in determining clinical context information is explained more fully in U.S. Patent Publication No. US-2012-0265035-A1, owned by the assignee of the present application and herein incorporated by reference in its entirety. Exemplary uses of impedance data, as well as devices to calculate impedance, are described below.” in Vanslyke, para. [0280]; and see “Accordingly, some embodiments can be configured determine sensor reuse based at least in part on one or more measurements of the impedance of the sensor. As discussed in more detail elsewhere herein, the impedance that relates to the membrane resistance of a sensor is typically initially high and then gradually decreases as the sensor is run-in. Thus, in one embodiment, sensor re-use can be detected if an impedance measured soon after sensor implantation is greater than what a sensor should typically have when a sensor is initially implanted, as this can indicate that the sensor had already been used.” in Bohm, para. [0374]) and determining a rate of reduction of the membrane impedance is greater than an impedance rate threshold (see “As used herein, a membrane which selectively quenches ROS typically has an ROS quenching activity sufficient to quench a solution having an H.sub.2O.sub.2 concentration of at least 10 ppm, and substantially does not deplete analyte (e.g. it has an analyte depletion rate of 1 mmol/hour or less, preferably 0.05 mmol/hour or less and/or it depletes analyte by no more than 80%, preferably no more than 95% when analyte is passed through the membrane).” in col. 9, ll. 11-19; and see “A membrane which substantially does not cause depletion of analyte typically provides a rate of depletion of no more than 0.1 mmol analyte per hour, preferably no more than 0.08 mmol/hour, more preferably no more than 0.05 mmol/hour.” in Patterson, col. 9, ll. 39-43).
As to Claim 11, Vanslyke teaches the following:
wherein the analyte sensor further comprises a membrane; and wherein the membrane impedance is associated with the membrane of the analyte sensor (see “Examples of this type of fault or error include those in which the membrane of the sensor has been deleteriously affected. In general, however, such faults are characteristic of sensors nearing an “end-of-life” period. For example, biofouling can cause such a fault. In this case, exemplary signal criteria may include the amount of time since sensor implantation, as well as certain characteristic noise patterns. Other criteria include increased noise at higher glucose levels compared to that at lower glucose levels. In yet other signal criteria which may be employed to detect faults due to such local effects of the sensor, an impedance measurement between the working electrode and an external electrode may be employed to measure increase in electrochemical impedance between the physiological environment and the working electrode.” in para. [0286]).
As to Claims 12-15 and 18-21, because the subject matter of claims 12-15 and 18-21 directed to a method is not distinct from the subject matter of claims 2-5 and 8-11 directed to the analyte sensor system, Vanslyke in view of Patterson teaches claims 12-15 and 18-21 for the same reasons as that provided for the rejection of claims 2-5 and 8-11 above.
Allowable Subject Matter
9. Claims 6, 7, 16 and 17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office Action.
10. The following is a statement of reasons for the indication of allowable subject matter:
As to Claims 6, 7, 16, and 17, neither Vanslyke, Patterson, nor the prior art of record teaches the analyte sensor system of base claim 2, and the method of base claim 12, including the following, in combination with all other limitations of the base claim:
wherein the compression low response action comprises applying a correction factor to the analyte concentration.
Conclusion
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 01/22/2026